Denso SQAM Rev4

Suppliers Quality Assurance
Classification
Manual
First edition 1st Apr 2005
Revised 4th revision, Oct. 1. 2018
Suppliers
Quality Assurance Manual
Parts (Product) Edition

（for parts/products suppliers）
About this publication
About this publication
Due to the recent emergence of global standards for quality management systems represented by ISO9001, there
are more than just a handful of companies today that require compliance with a quality management system as a
precondition for doing business.
This manual has been revised according to the requirements of IATF 16949.
(IATF16949 is the central standard of the automotive Quality Management System with automotive specific
requirements added to ISO9001.)
We would like to ask for your understanding on the purpose of the revision, and request you to establish a quality
management system in your company.
October 2018.
DENSO （CHINA）INVESTMENT CO., LTD.
Purchasing Dept.
Suppliers Quality Assurance Manual (Parts (Product) Edition)

Ⅰ
Construction of manuals
Construction of manuals
This manual contains a Common Edition and Individual Editions. The Common Edition describes Denso’s basic philosophies on
quality and the requirements to achieve them. Individual Editions describe actual steps to handling the unique requirements of
parts (products), raw materials.
＜Basic requirements；＜Individual requirements；

Common Edition＞ Individual Editions＞
Parts （Product） Edition

Common Edition
Raw Materials Edition
tems and their definitions

■ Part (product); Parts, products
■ Delivered parts; Parts (products) delivered to Denso
■ Raw materials; Raw materials, Sub material.
■ Delivered raw materials; Raw materials delivered to Denso.
■ Equipment & machinery; Equipment, devices, instrumentation, dies & molds, jigs,
blades, tools, equipment parts, and accessory equipment
■ Delivered equipment
& machinery; Equipment & machinery delivered to Denso
■ Delivered product; Delivered raw materials, delivered equipment & machinery
and delivered-parts Denso.
■ Self procured parts; All articles procured independently that a supplier uses for
production purposes.
■ Supplied parts; All articles supplied by Denso to be used for a supplier’s
own production purposes.
Expressions and their definitions

■ Document; “to put things and activities into written form.” It may be recognized
as a document and some time not, it depends on the case.
■ Determine; “to define and differentiate from others.”
■ Ensure; “to set up a system for doing something, carry it out, repeatedly check
and validate the results.”
Priority
Any materials mentioned in Common Edition, which is also contained in Individual Edition
as “detailed explanation”, contents of the Individual Editions, takes priority.

Ⅱ
Contents
Contents
Introduction ･･･ 1
Chapter 3 Items to be implemented by Denso and items to be complied with

by suppliers ･･･ 2
3.1 Indication of control category by importance ･･･ 2
3.2 Implementation of receiving inspection ･･･ 2
3.3 Disposal of defective part found in the process of Denso ･･･ 2
3.4 Audit of quality assurance conditions ･･･ 2
3.4.1 QC audit ･･･ 2
3.4.2 QA audit of special process ･･･ 3
3.4.3 Process audit of new product prior to mass production ･･･ 3
3.4.4 Periodical process audit ･･･ 3
3.4.5 Process audit when the process was changed ･･･ 3
3.4.6 Process audit when a defect occurred ･･･ 3
3.4.7 Subcontractor Process Audit prior to mass production ･･･ 3
3.4.8 Quality Management System audit ･･･ 3
3.4.9 Temporary process audit ･･･ 3
3.5 Issuance and follow-up of Defective Corrective Action Request ･･･ 3
3.6 Supplier performance monitoring ･･･ 4
3.7 Quality management system architecture / audit of compliance ･･･ 4
3.7.1 Range of suppliers required to obtain ISO9001 certification ･･･ 4
3.7.2 Compliance with IATF16949 ･･･ 4
Chapter 4 Individual Requirements ･･･ 5

4.1 Notification procedure of QA related responsible personnel ･･･ 5
4.1.1 Purpose ･･･ 5
4.1.2 Scope ･･･ 5
4.1.3 Explanation ･･･ 5
4.1.4 Supplier responsibilities ･･･ 5
4.1.4.1 Main job of QA related responsible personnel ･･･ 5
4.1.4.2 Notification ･･･ 6
4.2 Functional Safety operation procedure ･･･ 7
4.2.1 Purpose ･･･ 7
4.2.2 Scope ･･･ 7
4.3 Notification of QA Requirement procedure ･･･ 8
4.3.1 Purpose ･･･ 8
4.3.2 Scope ･･･ 8
4.4 The early-stage production control procedure ･･･ 9
4.4.1 Purpose ･･･ 9
4.4.2 Scope ･･･ 9

Ⅲ
Contents
4.4.4.1 The maintenance of the early-stage production control system ･･･ 9

4.4.4.2 The early-stage production control designation by Denso ･･･11
4.4.4.3 The early-stage production control in case Denso does not designate
･･･12
4.5 Quality Assurance Schedule preparation procedure ･･･13
4.5.1 Purpose ･･･13
4.5.2 Scope ･･･13
4.5.3 Explanation ･･･13
4.5.4 Supplier responsibilities ･･･13
4.5.4.1 Quality assurance schedule ･･･13
4.5.4.2 Supplier Approval ･･･14
4.5.4.3 Submission to Denso ･･･14
4.6 Evaluation and Elimination of Process Risk procedure ･･･15
4.6.1 Purpose ･･･15
4.6.2 Scope ･･･15
4.6.5 Process FMEA ･･･16
4.6.5.1 Merit of process FMEA ･･･16
4.6.5.2 Implementation procedure of process FMEA ･･･16
4.6.5.3 How to implement process FMEA ･･･16
4.6.5.4 Evaluation of process FMEA ･･･17
4.6.5.5 Preparation method of process FMEA ･･･18
4.6.5.6 Points to be noted when preparing the process FMEA ･･･19
4.6.6 QA network ･･･24
4.6.6.1 Purpose of QA network ･･･24
4.6.6.2 QA network forms and their characteristics ･･･24
4.6.6.3 Application of QA network forms ･･･24
4.6.6.4 Evaluation of QA network sheet ･･･25
4.6.6.5 Kaizen for unachieved items ･･･27
4.6.6.6 Preparation of QA network sheet/ QA network kaizen planning sheet
･･･28
4.6.6.7 Remarks for preparing QA network sheet ･･･28
4.7 Control Plan procedure ･･･31
4.7.1 Purpose ･･･31
4.7.2 Scope ･･･31
4.7.5 Quality assurance process chart ･･･32
4.7.5.1 Introduction ･･･32
4.7.5.2 Quality assurance process char ･･･32
4.7.5.3 Quality assurance process charts subject to submission ･･･32
4.7.5.4 Submission timing and method ･･･32
4.7.5.5 Check of quality assurance process chart ･･･32
4.7.5.6 Change procedure of quality assurance process chart ･･･32
4.7.5.7 Explanation of quality assurance process chart ･･･33
4.7.6 Supplier shipping inspection standard ･･･35
4.7.6.1 Introduction ･･･35
4.7.6.2 Definition of supplier shipping inspection standard ･･･35

Ⅳ
Contents
4.7.6.3 Request for preparation of supplier shipping inspection standard ･･･35

4.7.6.4 Submission timing and method ･･･35
4.7.6.5 Approval of shipping inspection standard ･･･35
4.7.6.6 Revision procedure of shipping inspection standard ･･･36
4.7.6.7 Others ･･･36
4.8 Work standard procedure ･･･37
4.8.1 Purpose ･･･37
4.8.2 Scope ･･･37
4.8.4 Requests to supplier ･･･37
4.8.4.1 Items to be noted into job instruction and check instruction ･･･37
4.8.4.2 Points on creation ･･･38
4.8.5 Points to consider before and after creating work standard ･･･39
4.9 Control procedure of critical control designated parts ･･･41
4.9.1 Purpose ･･･41
4.9.2 Scope ･･･41
4.9.3.1 Definition ･･･41
4.9.3.2 Indication mark ･･･42
4.9.3.3 Definition of ◇, ◎, and ○ designated ･･･42
4.9.3.4 100% guarantee and designation ･･･43
4.9.4.1 Process study of critical control designated parts ･･･44
4.9.4.2 Signboard indication of critical control designated items ･･･44
4.9.4.3 Indication of critical control designated parts
on the standards and forms ･･･45
4.9.4.4 Inspection of critical control designated parts ･･･45
4.9.4.5 Record of quality history ･･･45
4.9.4.6 First delivery of critical control designated parts ･･･45
4.9.4.7 Troubleshooting ･･･46
4.9.4.8 Re-outsourcing of critical control designated parts ･･･46
4.10 Installation portion control procedure ･･･47
4.101 Purpose ･･･47
4.10.2 Scope ･･･47
4.10.3.1 Definition ･･･47
4.10.3.2 Procedure of Installation portion control ･･･47
4.10.3.3 Designation code of Installation portion ･･･47
4.10.4.1 Control method of Installation portion ･･･47
4.10.4.2 Indication of Installation portion on the standards and forms ･･･48
4.11 The special process control procedure ･･･49
4.11.1 Purpose ･･･49
4.11.2 Scope ･･･49
4.11.4.1 Manufacturing process control ･･･49
4.11.4.2 Target parts/products of special control and items to be
implemented ･･･49

Ⅴ
Contents
4.11.4.3 Cautions for plating process:

Removal of hydrogen embrittlement of the plated parts ･･･51
4.11.4.4 Others ･･･51
4.12 Secondary supplier usage procedure based on pollution prevention agreement
･･･52
4.12.1 Purpose ･･･52
4.12.2 Scope ･･･52
4.12.3.1 Process audit ･･･52
4.12.3.2 Notification to suppliers ･･･53
4.12.3.3 Expiration date of special approval ･･･53
4.13 Packaging specification preparation procedure ･･･54
4.13.1 Purpose ･･･54
4.13.2 Scope ･･･54
4.14 Initial product inspection procedure ･･･55
4.14.1 Purpose ･･･55
4.14.2 Scope ･･･55
4.15 Production part approval process (PPAP) procedure ･･･58
4.15.1 Purpose ･･･58
4.15.2 Scope ･･･58
4.16 Part shipment notification procedure ･･･60
4.16.1 Purpose ･･･60
4.16.2 Scope ･･･60
4.17 Special deviation acceptance ･･･61
4.17.1 Purpose ･･･61
4.17.2 Scope ･･･61
4.18 Reporting procedure of contained substances (components) associated with
the substances of environmental concern (SoC) regulation ･･･63
4.18.1 Purpose ･･･63
4.18.2 Scope ･･･63
4.19 Material control procedures ･･･65
4.19.1 Purpose ･･･65
4.19.2 Scope ･･･65
4.19.3.1 Self-procurement materials ･･･65
4.19.3.2 Supplied materials ･･･65

Ⅵ
Contents

4.19.4.1 Material quality control ･･･66
4.20 Parts supply procedure ･･･68
4.20.1 Purpose ･･･68
4.20.2 Scope ･･･68
4.21 Lot control procedure ･･･70
4.21.1 Purpose ･･･70
4.21.2 Scope ･･･70
4.22 Quality troubleshooting procedure ･･･72
4.22.1 Purpose ･･･72
4.22.2 Scope ･･･72
4.22.4.1 Reporting and handling route when a problem was detected ･･･74
4.22.4.2 Troubleshooting implementation items ･･･75
4.22.4.3 Training and instruction for problem report ･･･78
4.22.4.4 Procedure of the case of defect flow out to customer
of Denso or found at Denso ･･･78
4.22.4.5 Application procedure of deviation permit ･･･78
4.23 Rework procedure ･･･79
4.23.1 Purpose ･･･79
4.23.2 Scope ･･･79
4.24 Boundary sample / Master sample preparation procedure ･･･81
4.24.1 Purpose ･･･81
4.24.2 Scope ･･･81
4.25 Process change notification procedure ･･･83
4.25.1 Purpose ･･･83
4.25.2 Scope ･･･83
4.25.4.1 Creation of process change notification ･･･84
4.25.4.2 Submission of process change notification ･･･85
4.25.4.3 Cautions for process change notification ･･･85
4.25.4.4 Cautions for process change ･･･85
4.25.4.5 Voluntarily control of process changes ･･･85
4.26 Design Change Request procedure ･･･86
4.26.1 Purpose ･･･86
4.26.2 Scope ･･･86

Ⅶ
Contents
4.27 Audit inspection receiving system procedure ･･･87

4.27.1 Purpose ･･･87
4.27.2 Scope ･･･87
4.28 Quality records control procedure ･･･89
4.28.1 Purpose ･･･89
4.28.2 Scope ･･･89
Chapter 5 Request for compliance with the rules ･･･92

5.1 Action when this manual is not adhered to ･･･92
5.2 Examples of the problems due to incompliance with the rule ･･･92
Chapter 6 Quality assurance related documents ･･･98

6.1 Classifications for the category column ･･･98
6.2 Symbols in the category column ･･･98
6.3 Document list of quality assurance ･･･98
Attachment
A； Definition of Terms ･･A-1
B； History of Revision ･･B-1

Ⅷ
Introduction
Introduction
This manual was prepared for suppliers of DENSO（CHINA）INVESTMENT CO,.LTD and Denso group
manufacturing companies (hereafter refer to as Denso) to clarify our requirements and to familiarize themselves with the
SQAM to deliver parts/products which comply with quality requirements based on “General Purchase Agreement”.
Please check understand contents of this manual and conform with it.
Complete quality assurance involves creating in-house manuals, educating personnel, and devising ways to create
common understanding and respect for QA activities. Please combine both in-house QA manuals and education to
ensure all staff engaging in quality activities, whether directly or indirectly, fully understand Denso’s quality requirements
and how they are actually performed.
When we get special requirements from our customers, we inform and request each supplier as required.
This manual and its contents should not be opened to anyone out of the supplier chain
Please contact the responsible procurement department at Denso in the case of trading companies, for all supplier
chain need to be registed.
Questions regarding this manual should be referred one of the following Denso’s departments in charge: Procurement
Dept. and Inspection Dept. or Quality Assurance Dept..
DENSO （CHINA）INVESTMENT CO., LTD.

Purchasing Dept.
Suppliers Quality Assurance Manual (Parts (Product) Edition) 1

№ P_SQAM3
Chapter3
Chapter 3 Items to be implemented by Denso and items to be

complied with by suppliers
3.1 Indication of control category by importance

Denso classifies and manages the products as follows according to functional importance.
Suppliers are expected to fully understand and perform appropriate control.
Category Type Control code
Safety Designation S S S
Emission Designation E E E
Critical control designated Regulation Designation R R R

parts
Fahren* (Driving) Function F F F
Designation
Critical Designation C C C
Installation portion of the customer mating In

Installation portion
parts
General parts Except for critical control designated parts None
* Fahren: This is a German word for “run”.
For the definitions of critical control designated parts, installation portion and their
indication methods to suppliers, see Section 4.9 “Control procedure of critical control
designated parts” and see 4.10 “Installation portion control procedure” in Chapter 4.
3.2 Implementation of receiving inspection

Although all parts that are delivered from suppliers to Denso are assumed to be good
ones, Denso performs receiving inspection to confirm the quality level of the delivered
parts.
As a rule, the inspection method is sampling inspection. If a part that does not meet the
standard is found in the sampled parts, all applicable lots are returned. The supplier is
requested to identify the root cause and take preventive measures for the process as well
as take measures for those applicable lots.
3.3 Disposal of defective part found in the process of Denso

If a defective part (product) is found in Denso’s process, Denso notifies the supplier with
document (See document No. 31 or 32). The supplier is asked to identify the cause of
defective part and take preventive measures.
3.4 Audit of quality assurance conditions

To confirm the quality assurance system, quality control conditions of individual part and
manufacturing process of suppliers, Denso visits suppliers (including the subcontractors)
to conduct audit as needed.
If kaizen is necessary in management, Denso requests suppliers to work on kaizen by
giving advice and making proposals.
Denso carries out the following audits.
3.4.1 QC audit
Confirm and give instructions for the “progress situation of strengthening quality assurance
constitution activities focused on product quality”, especially for the activity conditions of
the constitutional weak points.

№ P_SQAM3
Chapter3
3.4.2 QA audit of special process

Improve the control level of serious quality problems, and prevent occurrence of safety and
pollution problems by cross-functional team audit.
3.4.3 Process audit of new product prior to mass production

Perform a process audit of the quality control conditions in the product manufacturing
process for early process stabilization.
3.4.4 Periodical process audit

Perform a process audit on the quality control conditions such as critical control designated
parts, audit inspection receiving parts.
3.4.5 Process audit when the process was changed

Check the process change contents according to the process change notice to prevent the
serious troubles caused due to insufficient control.
3.4.6 Process audit when a defect occurred

When a defect occurred, perform a process audit as needed to confirm the cause and the
countermeasure status.
3.4.7 Subcontractor Process Audit prior to mass production

As a rule, we conduct process audit to judge if application of subcontracting of restricted
parts/products is OK or NOT.
3.4.8 Quality Management System audit

Denso conducts Quality Management System audit to check if the supplier to be
approved as a recommended supplier or not and conducts the periodical audit to check
compliance of this manual.
3.4.9 Temporary process audit

Other than 3.4.1 to 3.4.8, Denso conducts process audit as needed.
3.5 Issuance and follow-up of Defective Corrective Action Request

When Denso judges that the problem information found at receiving inspection, in-
process of Denso or outside Denso( automobile manufacturer or market ) shall be
provided to the supplier and its countermeasure shall be reported by the supplier,
Inspection Dept. or Quality Dept. issues “Quality problems report” (See document No. 26)
or “Electronic parts problems survey and action request” (See document No. 27). The
supplier is requested to identify the root cause of the defect, take preventive
countermeasures, and report its result to Denso by the specified date.

№ P_SQAM3
Chapter3
3.6 Supplier performance monitoring

Denso periodically evaluates suppliers based on the delivery records and the audit
results of quality assurance conditions in order to select the appropriate supplier and
manage the procurement and inspection operations appropriately. When Denso judges
from the evaluation results that the supplier need to improve its performance,
Purchasing Dept., Inspection Dept. or Quality Dept. requests the supplier to take
countermeasures. Then, identify the root cause and take preventive countermeasures.
When the performance record of quality or delivery is considered not to be the supplier’s
fault, supplier should take the prescribed procedures for Inspection Dept.( or Quality Dept.)
in charge for acceptance ratio, Prod. Control Dept. in charge for delivery performance ratio.
3.7 Quality management system architecture / audit of compliance

3.7.1 Range of suppliers required to obtain ISO9001 certification
In principle, a primary supplier holding Denso’s supplier code number shall obtain the
certification of ISO9001.
The certification shall be issued by the certification body bearing the accreditation mark
of the recognized IAF MLA member.
(Apply it from the update examination on the next time.)
If the primary supplier happens to be a trading company and is impossible to obtain
the certification as a manufacturer, secondary suppliers become the required supplier.
In this case, it is the primary supplier’s responsibility to request secondary suppliers to
obtain the certification.
3.7.2 Compliance with IATF16949

With the ultimate objective of becoming certified to IATF16949
(hereafter, referred to as IATF).
All the requirements described in Denso’s “Suppliers Quality Assurance Manual”
Common Edition and Individual Editions need to be implemented in order to achieve
“compliance with IATF” which is the requirements of IATF.
Denso may conduct on site audit (second party inspection) in order to verify the
“compliance with IATF”.

№ P_SQAM4
Chaper4
Chapter 4 Individual Requirements
4.1 Notification procedure of QA related responsible personnel

4.1.1 Purpose
The purpose of this procedure is to clarify tasks of QA related responsible personnel and
to observe to notify to Denso.
4.1.2 Scope
Applies to suppliers who deliver parts/products to Denso (Only 1st tier).
4.1.3 Explanation
Suppliers shall establish the consistent quality assurance system over all production
processes of the parts (products) delivered to Denso, satisfy all quality requirements of
Denso, and ensure high reliability.
For that purpose, suppliers need to appoint a qualified person who controls the overall
quality assurance (director or higher position) as the QA responsible personnel as well as
contact person, and also another responsible personnel for administering SQAM of
Denso.
4.1.4 Supplier responsibilities

4.1.4.1 Main job of QA related responsible personnel
(1) QA responsible personnel
The QA responsible personnel have responsibility for ensuring the quality
assurance tasks as the executive and for organizing the quality assurance tasks
to Denso. Therefore, he/she should control at least the following tasks.
① Establishment and maintenance of quality assurance system
② Standardization
③ The early-stage production control
④ Establishment of inspection system
⑤ Control of manufacturing processes
⑥ Accuracy control of measuring instruments
⑦ Control of critical control designated parts
⑧ Reliability control
⑨ Control of raw materials and parts
⑩ Control of design change parts and process change parts
⑪ Assurance of shipping quality
⑫ Guidance for quality control of subcontractors
⑬ Activation of QC circle activity
(2) Contact personnel in emergency situation
The contact personnel shall cope with the tasks described above when QA
responsible personnel is absent on behalf of QA responsible personnel.
(3) Responsible personnel for administering SQAM of Denso.
Responsible personnel for administering SQAM of Denso shall perform following
tasks.
① Throughout the company including 2nd tiers and after to let be well-known and
to be observed by all related members.
②To update control of latest SQAM of Denso.

№ P_SQAM4
Chaper4
4.1.4.2 Notification
Suppliers(NOTE1) are expected to fill the following items in “Notification of QA related
responsible personnel” (See document No.3) and submit it to responsible
Purchasing Dept.before starting business with Denso. (Only 1st tier needs to
submit.)
① Company name and company code.
② Business address, position title, name, business Tel No., Tel No. of after office
hours, E-mail address of QA responsible personnel.
③ Business address, position title, name, business Tel No., Tel No. of after office
hours, E-mail address of Contact personnel in emergency situation.
④ Business address, position title, name, business Tel No., E-mail address of
Responsible personnel for administering SQAM of Denso.
Please attach organization chart (any format acceptable) which shows the
position of QA responsible related personnel to “Notification of QA related
responsible personnel”.
When the QA related responsible personnel is changed (any changes within
the form notified), immediately notify Purchasing Dept. in charge with
“Notification of QA related responsible personnel”.
NOTE1: The suppliers refer to the 1st tier which has the account for trading
business with Denso..

№ P_SQAM4
Chaper4
4.2 Functional Safety operation procedure

4.2.1 Purpose
This procedure is to be comply with ISO26262 “Road vehicles-Functional Safety” as one
of means of providing with safe system/products which have no serious risks caused by
malfunction of electric/electronic system in the market.
4.2.2 Scope
Apply to the supplier (including secondary and relevant supplier of Denso) who designs,
manufactures, and delivers the electric, electronic and programmable electronic system
parts to Denso, and development consigned suppliers of those, which are defined in
Functional Safety standard of ISO26262.
*Examples being but not limited to: Electronic circuits / Electronic components (ASIC:
application specific integrated circuit / microcomputer / active component / passive
component), Software / Development tool and Development process / System of those,
etc.
The selection of applicable Functional Safety activities and work products will be agreed
between Denso and Supplier.
4.2.3 Explanation
“Functional Safety” requirements of Denso’s or Denso’s customer will be
specified on the Denso drawing or Denso specification etc..
In addition, normally correspondence of Functional Safety to be exchanged between
Design Engineering Dept. in charge of Denso and Design Engineering Dept. of the
supplier when starts development or design (when the supplier is selected) of the product.

Denso requests suppliers and development consigned suppliers the following as
needed.
1. Suppliers of electrical, electronic, programmable electronic (E/E/PE)
system/parts shall comply with the ISO 26262 standard as per the agreed
application scope.
2. Suppliers must submit the required evidence of compliance with the ISO 26262 standard
by Denso’s due date.
3. The Functional Safety records retention periods may be different from those defined in
"4.28 Quality records control procedure". Therefore please confirm about retention
period to Denso.
4. Denso may perform audits and assessments to verify the compliance with ISO 26262
at the supplier's premises.
5. When the supplier is requested details such as preparation or submission of each design
documents by “Development Interface Agreement (DIA)”, the supplier shall respond
according to the agreed DIA.
6. The supplier shall submit relevant specification such as electronic part’s
temperature characteristics, electric characteristics, and quantity of
transistor to Denso when Denso requests.
7. The supplier shall establish system (structure, process, etc.) to enable
development in compliance with ISO26262 when it is required, by due date
specified by Denso.
*Development Interface Agreement (DIA) : DIA is the term which shows “Duties
and responsibility of the customer and the supplier” which is defined in
ISO26262.

№ P_SQAM4
Chaper4
4.3 Notification of QA Requirement procedure

4.3.1 Purpose
This procedure is to clarify how to utilize “Notification of QA Requirement” (NQAR)
(See document No. 29) which is issued by Denso to inform the supplier of technical
and managerial important items or caution points when Denso controls
critical process and critical characteristics.
4.3.2 Scope
Applies to the case of new product, design change, and process change, etc. of
manufacturing parts and other cases when Inspection Dept. or QA Dept. in charge decides
to issue NAQR.
4.3.3 Explanation
The NQAR informs the supplier of parts quality assurance requirements and specific
requirements from Denso’s customer.

1. Denso will issue an NQAR to the supplier to inform critically controlled items
within the supplier's manufacturing process..
2. Denso will indicate due dates for each requirement in NQAR for the supplier.
The supplier should use the Submission Date to help track actual submission dates for
each requirement.
3. If the supplier has any comments or concerns about the requirements, the supplier
must contact Denso Purchasing Department as soon as possible.
4. When the supplier receives the NQAR, each requirement should be reviewed
thoroughly to determine if the requirements are feasible, and then reply with the answer
by using "QA confirmation results report".(See document No. 4).
5. The supplier shall reply with "QA confirmation results report" within 1 month
after receipt of the NQAR, unless otherwise stipulated by Denso.
6. Please reply for NQAR with the document listed in Attached table 2 “DENSO Quality
assurance related document list”.
In case no relevant document in the list, please use the document agreed with Denso
to use individually.

№ P_SQAM4
Chaper4
4.4 The early-stage production control procedure

4.4.1 Purpose
This procedure is to clarify how to implement the early-stage production control for new
products, design changed product, and process changed products from production
preparing stage through to mass production stage, and also indicates what to do at each
step from designation of early-stage production control till Release from the early-stage
production control designation.
4.4.2 Scope
Apply to new products, design changed products, and process changed products.
4.4.3 Explanation
The early-stage production control is a activity to implement the intensive quality
assurance activity and to stabilize the process early under the close cooperation among
Quality Assurance Dept., Mfg. Dept., Inspection Dept., and other related Depts.

4.4.4.1 The maintenance of the early-stage production control system
To maintain the early-stage production control system, suppliers are asked to clarify at
least the following items.
1. The person responsible for designation and cancellation of
the early-stage production control
2. Standard for designating the part as the early-stage production control
3. Selection standard for control items
4. Control Dept.
5. Data arrangement
6. Advancement of countermeasures for problem items
General implementation items about the early-stage production control parts are
described below. Suppliers are requested to voluntarily perform them regardless of
whether the early-stage production control is designated by Denso.
(1）Clarification of process control method of the early-stage production control parts
① Machining and processing sequence
② Clearly specify the particularly important operation condition during machining
and processing. Specify how to satisfy that condition or how to check and judge
whether it is well performed.
③ Determine the check method (sampling method, measurement item, measuring
method, and acceptance criteria) and the person in charge of the current
products.
④ Determine in which process and what kind of control data shall be
recorded.
⑤ Determine which machinery and equipment, die, jig and tool, and measuring
instrument are important and how to maintain and inspect them.
⑥ Clearly specify the person in charge of checking whether the lot classification of
the current products is clarified, or the stratification conditions (separation from
similar parts, classification of lot, distinction between good and
defective parts, prevention of mixing of unprocessed parts,
un-treatment parts, and uninspected parts) of the current products.

№ P_SQAM4
Chaper4
(2) Securing of process capability

Denso takes Cpk > 1.00 for the general items and Cpk > 1.33 for the critical
control designated items basically
If individually requested, suppliers shall follow the instructions.
① Survey the process capabilities for the critical characteristics.
② For the characteristics whose process capability is insufficient,
1. Improve the machining accuracy by improving the production equipment and
operation condition.
2. Revise the drawing and inspection standard through consultation with the
personnel concerned of Denso. Secure the process capability by taking
action such as request a design change with data attached.
3. If the process capability cannot be improved even by the above actions,
implement 100% inspection to assure the quality.
(3) Implementation of careful inspection
① Make sure to inspect initial products of the lot of the early stage production
control as well as the initial lot that is produced by mass production processes
and equipment.
②Prepare the inspection standard used during the early-stage production control
period based on the inspection standard, process capability investigation result
and initial product inspection result. Implement careful inspection according to
this.
Suppliers shall prepare this early-stage production control inspection standard.
③Strengthen especially the following items compared to the current general
products.
1. Selection of inspection items
Are the items to be inspected surely selected?
2. Sampling rate and sampling quantity
Can the defective parts manufactured in an unstable process be absolutely
rejected?
3. Acceptance criteria
Is the acceptance criteria given so that the inspector can certainly judge?
Or is the necessary inspection tool prepared?
4. Inspection record
Is the way to record the inspection clarified to utilize for stabilization the
process?
5. Selection of inspector
Is the inspector assigned, who has received the instructions and training
necessary to take charge of important test or inspection?
(4) Final approval of shipping by the QA responsible personnel (refer to 4.1)
Regarding the early-stage production control parts, the QA responsible
personnel (or delegated personnel who are nominated by QA responsible
personnel) shall receive reports of the process control contents and the
inspection results, check them, and make a final shipping approval.

№ P_SQAM4
Chaper4
(5) About the early-stage production control designation

There are two cases which are “Designation by Denso” and “Designation
by suppliers”. Please refer below for details of each case.
Regardless of designation of early-stage production control, new product need to
be produced with same dies, same process for mass production from the stage of
trial mass production. In case it is not able to do so, please consult Inspection/
QA section of Denso.
4.4.4.2 The early-stage production control designation by Denso

Inspection Dept. or QA Dept. of Denso prepares “The early-stage production control
request sheet” (See document No. 28) and notifies suppliers via Purchasing Dept.
that the part is designated as early-stage production control part.
All related members of the supplier should understand the purpose of early-stage
production control activity, and then implement following important items.
(1) Implementation of the process FMEA
Please refer item 4.6.5 “Process FMEA“.
(2) Implementation of the QA network
Please refer item 4.6.6 “QA network”.
(3) Thorough process control
Prepare the operation standards and ensure the process control.
① Investigate the process capability for the critical characteristic (NOTE1), and
improve the process or take measures such as revision of drawing through
consultation with the personnel concerned of Denso for the problems.
② Maintain and store the information and result data regarding items (1) and (2)
above so that Denso members can refer to when visiting the suppliers.
NOTE1: When Denso designates the important process and critical characteristic,
Denso issues “Notification of QA
Requirement” (See document No. 29).
(4) Implementation of Initial product inspection
① When inspecting the initial product, follow the section 4.14 ” Initial product
inspection procedure” and the instruction of Denso’s
department in charge of Inspection (or QA).
② Regarding componential analysis on substances of environmental concerns,
follow the section 4.18 “Reporting procedure of contained substances
(components) associated with the substances of environmental concern
(SoC) regulation” and the instruction of Denso’s department in charge of
Inspection(or QA).
(5) Implementation of inspection during the early-stage production control period
Prepare the inspection standard applied during the early-stage production control
period based on the drawing of Denso and the process capability investigation
results and initial product inspection result of suppliers, and perform inspection.
Do not ease the inspection level during the early-stage production control period.
(6) Final approval of shipping by the QA responsible personnel (Please refer 4.1).
Regarding the early-stage production control parts, the QA responsible
personnel (or delegated personnel who are nominated by QA responsible
personnel) shall receive reports of the process control contents and the
inspection results, check them, and make a final shipping approval.

№ P_SQAM4
Chaper4
(7) Indication for the actual part when delivered

When delivering the early-stage production control parts (products) for the first
time, suppliers shall deliver them with “Stratification control tag” (See document
No.15) attached.
When the tag needs to be attached to every lot, responsible Dept. of Denso gives
instructions separately.
(8) Release from the early-stage production control designation
When it is determined that the supplier have a sufficient process capability and
there is no problem with the part assembled to the final product, Inspection Dept.
or QA Dept. of Denso notifies the supplier of release of designation via
Purchasing Dept., using “The early-stage production control release notice”
(See document No. 28)
4.4.4.3 The early-stage production control in case Denso does not designate.
(1) Designation by suppliers
Suppliers are expected to designate all products subject to initial product
inspection, and to establish the voluntary control system.
(2) The early-stage production control by the supplier
Suppliers shall establish the rule of the early-stage production control, and
construct company-wide systems to implement the procedure.
General examples of how to establish the early-stage production control system
are explained in Section 4.4.4.1 of Chapter 4. Please maintain the system,
considering the actual conditions.

№ P_SQAM4
Chaper4
4.5 Quality Assurance Schedule preparation procedure

4.5.1 Purpose
This procedure aims to be ready for production preparation as planned according to the
planned schedule by making the Quality Assurance Schedule (QAS).
4.5.2 Scope
Applies to the case of new product, design change, and process change, etc. of
manufacturing parts.
4.5.3 Explanation
The supplier shall make up the schedule plan of quality control activities and
production from production preparation stage through to initial stage of
mass-production.

4.5.4.1 Quality assurance schedule
The supplier shall include following items in QAS. if not applicable note
“N/A” in Remarks column etc. of the QAS.
(1) Master schedule
The master schedule is a general summary of schedules that should include
the following information:
① Supplier’s Parts Submission Warrant (PSW), production trial, and mass
production timing. The template of the PSW document will be defined by
Denso.
② Supplier’s ship dates of parts to Denso for production trial and
mass production.
③ Build out and ramp up schedules for mass production at sub-supplier (The
sub-supplier is the supplier’s supplier).
④ Supplier’s quality system development.
⑤ Supplier’s hiring and training timing
(2) Production Process Development
This should be a general schedule showing design, build, debug, trial and ISIR
Schedules.
The schedule shall include following items.
① Tooling.
② Equipment.
③ Jigs.
④ Assembly Checking Fixture.
(3) Quality System Development
Quality System Development shall include all activities concerning quality control
of production parts.
Please include following items.

№ P_SQAM4
Chaper4
① Control plan
② Procured checking fixture, gauge, and test equipment request/ approval.
③ Process FMEA, QA network
④ Material certification or material test report
⑤ Process capability study (initial stage).
⑥ Gage repeatability and reproducibility studies
⑦ Parts Submission Warrant.
⑧ Packaging information and traceability
⑨ Boundary sample/ master sample
⑩ Operator work instructions & check sheets.
⑪ Training
⑫ IMDS or JAMA sheet
⑬ Material testing
⑭ Dimensional and/or electrical characteristics.
⑮ Appearance /Color evaluation
⑯ Part/Assembly performance
(4) Product assembling and shipping schedule at sub-supplier
Applies to the case to utilize sub-supplier.
Please include following information.
① Selection timing of sub-supplier
② Evaluation of manufactured parts and materials
③ Parts Submission Warrant and Build out and ramp up schedules for mass
production at sub-supplier.
④ Quality Assurance Schedule of sub-supplier.
4.5.4.2 Supplier Approval

Persons with approval authority of all related departments within the supplier
should approve the QAS
QA responsible personnel of the supplier shall monitor the schedules and ensure
all milestones are achieved.
4.5.4.3 Submission to Denso:

Denso requests the submission of Quality Assurance Schedule to supplier by
NQAR when required. (See document No. 29).
The supplier must submit the QAS to Purchasing Dept. in charge of Denso by
the date indicated on the NQAR document.

№ P_SQAM4
Chaper4
4.6 Evaluation and Elimination of Process Risk procedure

4.6.1 Purpose
This procedure aims to grasp process weak spots
by abstracting potential defects, and improve reliability of processes through
preventive activities for quality problems.
4.6.2 Scope
To apply following cases.
1. development/production of new parts
2. introduction of the new manufacturing methods
3. relocation of plants/equipment
4. design changes
5. process changes
6. if nonconforming part has occurred
4.6.3 Explanation
Supplier shall minimize risks by taking proper countermeasures for items of which
rank identified based on possibility of occurrence and flow-out for each quality
assurance item.

1. The supplier shall evaluate risks of potential failure mode and failure mode
occurred in the past.
2. The supplier is responsible to coordinate the FMEA(Note-1)/QA Network
sheet(Note-2) from sub-supplier and sub-contracted process considering the full
supply chain.
3. The supplier is responsible to take appropriate action to improve any weak areas
identified based on evaluation results.
4. The supplier is responsible to maintain and revise the process FMEA (Note-1), QA
Network(Note-2) when required.
and make available for review on-site.
5. Suppliers are to follow the records retention periods defined by Denso in this manual.
Note-1: FMEA in this sentence means Process FMEA. However, FMEA includes Design
FMEA also when the supplier designs part/product.
Please refer 4.6.5 “Process FMEA”
Note-2 :Please refer 4.6.6 “QA network".

№ P_SQAM4
Chaper4
4.6.5 Process FMEA

4.6.5.1 Merit of process FMEA
The process FMEA is the method to find out potential failure modes in a process
(abbreviation: process failure mode), to analyze/evaluate their factors and influences
in a logical manner, and to study the means for eliminating or decreasing the
occurrence probability of the process failure mode.
In the process FMEA, the study is logically carried out to some extent with information
of process design, without the actual process. Therefore, a measure is planned and
incorporated in the process specification by utilizing the process idea to prevent the
process failure mode.
* The process failure mode is the state where the original function of the process
cannot be retained, in other words, the state where the process condition deviates
from the “range in which good products can be manufactured (= good product
condition)” due to time degradation of the process elements and other reasons.
4.6.5.2 Implementation procedure of process FMEA

Study is carried out according to the table below and the study result is recorded on
the process FMEA sheet (Document No. 22). In order to conduct the study efficiently,
it is realistic to review the draft in the review meeting.
The procedure above is applied when newly implementing a process FMEA for the
new process, when reviewing based on process FMEA result of a similar process,
and implementing an additional FMEA at the production preparation stage because
the settlement level of the process has increased more than the previous review.
№ Items Remarks
1 Collection and arrangement of relevant information Refer to the section 4.6.5.6 (1) for details.
2 Check of production assurance items ―
3 Listing of process failure modes ―
Analysis of occurrence factor of process failure Precautions for analysis: Refer to the
4
mode (Mechanism) section 4.6.5.6 (3).
Precautions for analysis: Refer to the
5 Decision of necessity of countermeasures
section 4.6.5.6 (4).
Study of countermeasures for preventing
Precautions for analysis: Refer to the
6 occurrence/outflow (Review meeting with relevant
section 4.6.5.6 (5).
personnel participated)
7 Realization and check of countermeasures ―
4.6.5.3 How to implement process FMEA
Carry out the process FMEA according to the stage from production preparation
through mass production as shown below:
When requested by the div. in charge of inspection (or the div. in charge of quality) of
our company via the “Notification of QA Requirement” (Document No.29), etc.,
submit the process FMEA sheet by the submission deadline to have it checked by the
div. in charge of inspection (or the div. in charge of quality).

№ P_SQAM4
Chaper4
(1) Before installing the equipment

When examining feasibility of manufacturing of prototype of a new product or a
new production technology by using antecedently introduced equipment or
existing machine, the supplier need to find out the process failure modes of the
process using the antecedently introduced equipment, etc. to establish the
countermeasure plan to be reflected on new equipment or process.
(2) Before starting trial mass production
At this stage, the process design has been established and study of the
application method of important control points has been completed. The supplier
to find out the process failure modes and make countermeasure plan against
them.
(3) Before starting mass production
The supplier has to find out the process failure mode for all the functions of the
process based on the actual machine and actual operation and clarify the
countermeasure against it.
(4) During mass production
When the following cases occur even after the start of mass production, carry out
review, always secure stability of the process, and document the details of the
review.
① When changing the process
② When the process failure mode against which a countermeasure has been
taken occurs
③ When an unexpected process failure mode occurs
4.6.5.4 Evaluation of process FMEA

(1) Target of production assurance items
The production assurance items in process FMEA shall target those represented
by product/part “deki-bae”* that should be assured in a manufacturing process.
*deki-bae: an outcome of processing (such as product/part dimension,
appearance, and strength)
(2) Evaluation criteria
① The evaluation criteria consists of severity(S) of effect, likelihood of
occurrence(O), and likelihood of detection(D). An evaluation is made on the risk
priority number(RPN) which is the multiplying ratings of one to ten for each
(smaller number shows less risks).
Refer to the table below for details of the evaluation criteria for each category:
Severity Occurrence Detection RPN

Extent of damage when a Possibility of failure mode Failure mode can be Three items at the left are
failure mode occurs found or not multiplied for evaluation
1：Physically
1：No influence on the impssible to 1：Can be found
product occur certainly Minimum value：
1 point
× × ＝ Maximum value：
10：Occurrence 1000 points
10：Big influence on continues 10：Cannot be
the product found
・Not enough
・Important control item process ・No inspection
・Where it is installed capability ・Defect cannot
on the actual be fonud

№ P_SQAM4
Chaper4
However, when the dept. in charge of inspection (or the div. in charge of quality)
of Denso individually indicates the evaluation criteria via the “Notification of QA
Requirement”, etc., please follow the instruction.
② Please refer to "Process FMEA" (Document No. 22) for each rating rank of
severity, occurrence and detection and for RPN.
③ The severity of effect evaluated based on “influence on the process”
as a basic rule. When specified by Denso, evaluate it based on “influence on
the product”.
However, when evaluation is made based on “influence on the product”, Denso
provides the information.
4.6.5.5 Preparation method of process FMEA

Process FMEA is means in order to consider to improve the process stability,
which is made by related departments such as design, production engineering,
production, inspection, quality assurance as "one team“.
(1) Process FMEA sheet
Use the form as shown below (Document No. 22) to prepare the process FMEA
sheet.
The form we specified shall be used as a general rule. However, when
equivalent entry items are included, it is allowed to use your company’s form. In
this case, obtain approval from the division in charge of Denso.
(2) Creation of process FMEA
The creation procedure of process FMEA is prepared according to the "Process
FMEA (creation procedure)" (Document No. 22).

№ P_SQAM4
Chaper4
4.6.5.6 Points to be noted when preparing the process FMEA

(1) Collection and arrangement of relevant information
① List the production assurance items at the target process (processing,
inspection, transportation etc.) from drawings, and other requirements from
Denso (requirements via Notification of QA Requirement, etc.) without
omission.
② The process failure mode includes all process functions such as main
processing, measurement (including
not only measuring dimensions and performance inspection but also
measurement for controlling the main processing function, etc.), sub processing
(insertion with position moving, carrying out, carrying out, transferring, reversing
with position change etc. and confirming work position, reading product number
and serial number, writing information on work palette, etc.) .
③Please make all members can image, such as where to process, how to
process, what to chuck on the workpiece, what will happen to the work motion,
what the structure/motion of the equipment, and so on.
④ List new points and change points for the target process without omission
studying the process FMEA of the similar existing process and add or change
the contents.
⑤ Based on the failure factor in the past trouble or the prototype and the
countermeasure against it, study the process failure mode, factor, and
countermeasure of the target process. Clarify the difference between the target
process and past trouble or the prototype.
(2) Requirement (good product condition) and process failure mode
In order to detect the process failure mode without omission, study the good
product conditions to be secured for each process function from four viewpoints
(Note 2) and study the process failure mode based on them.
Note 2: Four perspectives are as shown below:
① State of workpiece, ② Processing parameter, ③ Processing environment,
④ Work
Table 1 shows the example of process failure mode.

№ P_SQAM4
Chaper4
Table 1 – Example of process failure mode
Viewpoint
Type of good product condition Example of process failure mode
(Four perspectives)
Dislocation
Position/Posture Not horizontal, Not perpendicular
Front and back reversed
State of workpiece
Foreign material attached
State of surface
Static electricity
Correct part No. Incorrect part
 speed Insufficient/excessive feeding speed
 length Insufficient/excessive insertion amount
Processing parameter  time Insufficient/excessive heating time
 accuracy Insufficient measurement accuracy
Limit of auxiliary material use Old flux (already expired)
Temperature/humidity Too low temperature, Too high humidity
Degree of cleanliness Insufficient cleanliness
Processing environment
Atmosphere Excessive mist amount, Insufficient oxygen
Illuminance Too dark, Too bright

Correct work order Process skipped, Work forgotten
Holding of tool or workpiece Insufficient holding force
Work Incorrect use of tools
Correct work Check item omitted
Contact with obstacles
(3) Analysis of occurrence factor of process failure mode
Study the occurrence factor of each process failure mode without omission.
To do this, follow two steps below:
① Study the failure phenomena leading to the process failure mode for each
element that constitutes the process function referring to the Table 2.
② As for the factor of failure phenomenon, repeat WHYWHY to analyze
process change with time and factor of operation mistake.
As for equipment and jigs, stress might change their dimension and
characteristic with time and cause failure. Study it referring to the Table 3,
Stress keyword.

№ P_SQAM4
Chaper4
Table 2 – Example of element failure when the process function is “assembly”
Type of good product Example of process

Viewpoint Element defect examples
condition failure mode
Defect of element relating to positioning

- Wrong jig type
Dislocation - Foreign material attached on the reference
face of workpiece
Position/Posture - Equipment positioning chuck deformed, etc.
Defect of element relating to posture (front/back)

Posture – Front/back - Posture (front/back) of the supplied part
reversed, etc.
State of Cause of foreign material attachment

workpiece - Dirty hand
Foreign material - Dirty working gloves
State of surface
attached - Brought from the previous process
(countermeasure to be taken at the previous
process), etc.
Factor causing incorrect part assembly
-A worker mistakes a similar part for the
correct one.
Correct part No. Incorrect part
- Lot quantity of the product is different from the
number of supplied part.
(Gap due to lockout, etc.), … etc.
Defect of element relating to insertion amount
Processing Insufficient insertion
Insertion amount - Insufficient push-in amount of cylinder
parameter amount
- Insufficient insertion by a worker, etc.
Defect of element relating to cleanliness
- Opening of equipment door which should be
Processing
Degree of cleanliness Insufficient cleanliness kept shut.
environment
- Damaged air filter
- Malfunction of particle counter, etc.
Defect of element relating to process skip
Process skipped, Work
Correct work order - Stopper kept down
forgotten
- A worker forgets to assemble a part, etc.
Defect of element relating to holding of workpiece

- Reduced friction coefficient of the chuck
Holding of tool or Insufficient holding
fingers
Work workpiece force of workpiece
- Reduced spring force of the hand
- Insufficient holding force of a worker, etc.
State of element relating to assembling route

- Different posture due to PTP control of the
Assembling route off
Correct work robot
the position
- Interference of cables or jigs
- Different ways of holding among workers, etc.
Table 3 – Stress keyword
High temperature (radiant heat, conductive heat, or heat generated by sliding),Low

Due to environment temperature, Cold heat, Humidity, Rain water, Sweat, Solar radiation, Ultraviolet, Invasion of
wind or insects, Mixture of sand or dust, etc.
Pulling, Compression, Bending, Pressure, Repeated stress, Residual stress, Gravity, Magnetic
Dynamic stress
force, Water pressure, Wind pressure, Centrifugal force, Impact, Sliding, Vibration, etc.
Oxidation, Reduction, Ionization, Dissolution, Corrosion (adhesion of or exposure to cutting oil,

Chemical stress
rust preventive oil, paint, adhesive, cleaning fluid, electrolytic solution, exhaust gas), etc.
Normal potential difference, Voltage fluctuation (surge voltage, noise, and reverse voltage),
Electrical stress Overvoltage, Overcurrent, Electromagnetic wave, Radiant heat, Static electricity, Battery
effect, etc.

№ P_SQAM4
Chaper4
(4) Decision the priority of countermeasures

In principle, decide the priority with the rank of RPN.
However, as severity, occurrence, detection often ranks differently depending on
the evaluator, there would be a risk of misjudgment if you decide whether to take
countermeasures only by numerical magnitude of severity.
Therefore, please decide priority of countermeasures by consideration of multiple
related persons.
The points to be considered for severity, occurrence, detection are as follows.
①Consideration items regarding the severity
1. Importance of the manufacturing-quality assurance items affected
by the process failure mode
・Critical control designation, Strictness of specification, Effect on following
process
2. Extent of change in the manufacturing-quality assurance item when a process
failure mode occurs.
3. Number of manufacturing-quality assurance items affected by the occurrence
of a process failure mode
②Consideration items regarding the occurrence
1. Probability of the occurrence of cause of process failure mode
③Consideration items regarding the detection
1. Reasonableness of means of detecting the occurrence of cause
2. Reasonableness of means of detecting the occurrence of process failure mode
・Detection accuracy, Adequacy of detection timing regarding the manner of
occurrence of the least detectable cause.

№ P_SQAM4
Chaper4
(5) Study of occurrence precaution measure and occurrence detection measure of

process failure mode
① For process failure mode, there are two types of occurrence prevention
measure: occurrence precaution measure and occurrence detection measure.
Classify the measures, put priority on the occurrence precaution measure and
study it.
② The occurrence precaution measure is to reduce the occurrence possibility by
removing the occurrence factors or reducing the occurrence frequency.
Review the process specification or study the control method of process as
shown in the examples below:
1. Welding process is adopted so that screws can not loosen.
2. A foolproof device is installed in order to prevent setting mistake.
3. The material is changed into the wear-resistant one to prolong life of the
cutting tool, jig and tool.
4. The cutting tool and jig and tool are periodically replaced before they are
worn away.
5. Cleaning around the nozzle is periodically performed to prevent adhesion of
foreign materials.
③ The occurrence detection measure is to detect the occurrence cause or the
process failure mode in order to take corrective measures promptly.
Review the process specification or study the control method of process as
shown in the examples below:
1. The dimension of jig and tool is periodically checked and replaced if there is a
sign of abnormality such as deformation, abrasion, etc.
2. It is made a rule to check whether there is the process failure mode or not
after modification or maintenance of the equipment.

№ P_SQAM4
Chaper4
4.6.6 QA network/
4.6.6.1 Purpose of QA network
The QA network is a group of activities to find out, from perspectives of occurrence
and flow-out preventions, how to spot defects in a process by “thorough QA checks”
at a manufacturing site in order to prevent defects from flowing out of the company.
These activities are carried out to improve process reliability through processes
where related sections (such as design, production engineering, production,
inspection, and QA), “as a team,” discuss and apply optimal solutions until
management of work instructions and daily checkups.
As tools to describe the progress of the activities, QA network forms are utilized.
4.6.6.2 QA network forms and their characteristics

The QA network forms are composed of TWO parts, a “QA network sheet” (See
document No.5-A) and a “QA network kaizen planning sheet.” ( “Kaizen” means “to
improve.”) (See document No.5-B)
(1) QA network sheet
This is a matrix table that shows in which processes of each line defects related
to all production assurance items are prevented from occurring and flowing out. It
also evaluates their assurance levels in ranks based on occurrence and flow-out
prevention criteria and shows how the evaluation result is reflected to
manufacturing control forms.
The characteristics of the sheet are listed below:
① It enables all people involved to share assurance levels because the matrix
chart describes a whole line.
② It makes it easy to come up with flow-out prevention measures covering several
processes and to consider changing a flow-out prevention process because the
whole line can be easily looked over.
③ It helps to find out strengths and weaknesses of a process since occurrence
and flow-out prevention levels are evaluated in ranks in a comprehensive way.
④Reflection to manufacturing control forms of the production site becomes clear.
(2) QA network kaizen planning sheet
This form reflects discussion results that the related sections come up with
regarding necessity for improving all unachieved items(NOTE) taken from the QA
network sheet. It also helps to record and manage corrective action plans as well
as schedules for attaining the unachieved targets after the corrective actions are
implemented. The characteristics of the sheet are listed below:
① It is easy to share unachieved items and discussion results as well as process
weaknesses.
② It is easy to understand details of the Kaizen and the plan.
NOTE: Unachieved items: production assurance items whose designated target
ranks have not been achieved (See Section 4.6.6.5)
4.6.6.3 Application of QA network forms

The QA network sheet shall be applied consistently from production
preparation to mass production as shown below. Therefore, it shall be updated
regularly according to the latest process quality assurance status.
However, when supplier get request from Inspection/QA section of Denso to submit
QA network sheets & QA network improvement plan by “Notification of QA
Requirement”(Document No.29) etc., please reply in time and get approval.

№ P_SQAM4
Chaper4
(1) Prior to installation of production equipment

After evaluating assurance level with a QA network sheet and entering possible
unachieved items on a QA network kaizen planning sheet, the related sections
shall discuss necessity for equipment installation or pokayoke (means
“error-proof” functions) and reflect the conclusion to equipment installation
specifications.
(2) Before shipping products of trial mass production
After filling out the QA network sheet including the field for “related control
items,” the related sections shall verify the assurance level by checking on a
process (on site). The QA network sheet shall be reviewed based on the
verification, and all people involved shall clarify problems to be included into a
QA network kaizen planning sheet.
(3) Before first shipment of products of mass production
Including changes after the trial mass production and new defects during in the
trial mass production, the related sections shall make a final check on the
process reliability and complete all necessary measures.
(4) During mass production
Any changes in the process reliability shall be confirmed every time a design
and/or a process change have been made. Especially, it is important to review
the occurrence and flow-out prevention measures and to verify the process
reliability each time defect is detected, such as a field claim, a customer return
(0-km claim), an inspection defect, or in-process. Unachieved items shall be
(1-regularly reviewed because it may be possible to make improvements by some
device becoming more popular lead to lower cost to pay or drastic technique
enable to adopt.
4.6.6.4 Evaluation of QA network sheet

(1) Objects for production assurance items
The production assurance items in the QA network shall target those
represented by product/part “deki-bae” that should be assured in a
manufacturing process.
 deki-bae: an outcome of processing (such as product/part dimension, appearance,
and strength etc.)
(2) Target rank
Please apply Table 1 for setting target rank.
In addition supplier can set higher target rank if supplier judge as “critical item”
such as installation dimensions, past quality issues and individual request from
Denso (ex: field claim defect mode to be ranked as A, customer return defect
mode to be ranked as B). In such a case, please fill in appropriate description in
“added item column”.
<examples of added item>
Field claim defect mode: A rank
Customer return defect mode: B rank
Product performance: A rank
Installation dimensions at customer: B rank

№ P_SQAM4
Chaper4
Table 1
Classification Target rank Additional items by Division
S E R F Ａ NOTE(2)
S E R F Ａ NOTE(2)
S E R F Ｂ NOTE(2)
C C C
Ａ or Ｂ NOTE(2)
NOTE(1)
General Ｃ
NOTE(1) In principle, target rank of “Critical designated C” shall be “B”.
However, when Denso requests supplier to set target rank “A”,
please follow instruction.
NOTE(2) Space for ranked up content
(3) Occurrence prevention levels & flow-out prevention levels
Occurrence prevention means a system to avoid producing defects.
Flow-out prevention means a system to avoid letting defects out.
Table 2 Difference between occurrence and flow-out preventions
A system to avoid producing defects
Occurrence - Control manufacturing conditions
prevention (100% continuous monitoring, operation standardization, for example)
- Pokayoke by jigs, etc.
A system to avoid letting defects out after processing and assembling
Flow-out - Inspect “deki-bae” items
prevention (direct measurements, visual checks, pokayoke, for example)
- Methods for discharging defects. etc.
(4) Occurrence prevention level
Occurrence prevention levels shall be determined according to Table 3.
Table 3 Occurrence prevention evaluation criteria
Level １２３４
-Occurrence prevention -Occurrence prevention - Occurrence prevention relies - Difficult to follow
automatically carried in place but partially on human operation greatly standards.
out by machine. needs human but with limited - Not enough process
Machine detects intervention. amount of capability.
abnormality 100% by The 4M(NOTE) for normal KAN-KOTSU required. -Occurrence
itself. operation is - Occurrence prevention made prevention relies
Basic idea standardized and on heavily on KAN-
occurrence prevention machine not KOTSU.
is sufficient. sufficiently enough,
but there is enough process
capability.
If process capability is not sufficient enough and the following

jobs are not standardized yet, Level 4 shall be selected without exception.
Examples of jobs for standardization:
① Setup: jig change, change of condition-setting values, etc.
② Exchange: exchange of consumption materials such as cutters, electrodes,
inspection probes, etc.
③ Replacement: replacement of parts and subsidiary materials (grease, for
example), etc.
④ Check: check and maintain pokayoke, inspection jigs, equipment, measuring
instruments, etc.
⑤ Rework: jobs specified in “4.23 Rework operation procedure”
NOTE: 4M means Man, Machine, Method, and Material.

№ P_SQAM4
Chaper4
(5) Flow-out prevention level

Flow-out prevention levels shall be evaluated according to Table 4.
Table 4 Flow-out prevention level assessment criteria
Level <１> <２> <３> <４>
-Flow-out -Flow-out -Flow-out prevention -Standards not
prevention prevention in relies on human sufficiently
automatically place but operation greatly. specified/
carried out partially needs Some standards and followed.
Basic by machine. human procedures not -High potential of
idea Machine detects intervention. sufficiently defect outflow
abnormality 100% by specified/followed. from machine.
itself -Not sufficient flow-out
prevention on machine.
(6) General evaluation for a current rank
Each production assurance item shall be evaluated for both occurrence
(numbers: 1-4) and flow-out (numbers in bracket: <1>-<4>) prevention levels,
and then a current rank shall be represented by an alphabetical code A-F on
Table 5.
Table 5 General evaluation table
Occurrence prevention level

１２３４
<１> ＡＡＡＢ
prevention
Flow-out
<２> ＡＢＣ(*) Ｄ
level
<３> ＡＣ(*) ＤＥ
<４> ＢＤＥＦ
* How to judge rank of production guarantee items of QA network in the case of
pokayoke introduced
Please judge rank as follows where pokayoke introduced for production guarantee
items. A current rank shall be “B” in following case a) or b).
① Occurrence prevention level is “2” and flow-out prevention level is “<3>”
② Occurrence prevention level is “3” and flow-out prevention level is “<2>”
4.6.6.5 Kaizen for unachieved items

Unachieved items mean production assurance items which have not reached their
target ranks. They are considered as process weaknesses because they are not
sufficiently assured.
They shall be summarized on a QA network kaizen planning sheet and reviewed one
by one by the related sections (such as design, production engineering, production,
inspection, and QA). The related sections shall consider current technical capability
and cost, and then discuss optimal methods for Kaizen by looking over production
assurance items as well as process methods to decide on the necessity for the
Kaizen. After the discussion, if there are unachieved items that require more
enhanced pokayoke and/or control of work and checks, a section in charge of
promotion shall take responsibility to improve them. In terms of items which are
difficult to make Kaizen, constant discussions and reviews are required because it
may be possible to make Kaizen by some device becoming more popular lead to
lower cost to pay or drastic technique enable to adopt.

№ P_SQAM4
Chaper4
Fig. 1 Idea for improving unachieved items
Production Technical
assurance Cost
capability
Related sections: design, production eng., production, inspection, and QA
Judgment
QA network
Pokayoke Operation Manual
4.6.6.6 Preparation of QA network sheet/QA network kaizen planning sheet

① QA network sheet/QA network kaizen planning sheet shall be prepared for each
production line by using following form (Document No.5).
However, even in case of same production line, a lot of changeover operation
items required on part number basis or completely different process case
supplier shall prepare QA network sheets by part number basis.
② The creation procedure of QA network sheet/QA network kaizen planning sheet is
prepared according to the "QA network sheet/QA network kaizen planning sheet
(creation procedure)" (Document No. 5).
③ Enter the necessary information from process No. to a current rank into QA
network sheet and evaluate each production assurance item for its target
achievement.
④ Prepare a QA network kaizen planning sheet for unachieved items.
If there is no unachieved item, it is unnecessary to prepare QA network kaizen
planning sheet.
4.6.6.7 Remarks for preparing QA network sheet

(1) Necessary documents
The following documents shall be referenced to avoid missing reviewing
processes.
If there are any unavailable documents at the time of preparing a QA network
sheet, information shall be entered in the sheet with available documents only
and reviewed every time new documents come in.
- Products and parts
- Drawings
- QA process chart or relevant
- Inspection standards
- Process FMEA
- Causes and investigation results of field claims, customer returns, inspection
defects, and in-process defects of similar processes, etc.

№ P_SQAM4
Chaper4
(2) Key points for listing production assurance items

Production assurance items on a QA network sheet shall be represented with
“deki-bae” of products and parts, which shall be assured in a production process.
They however tend to become huge number if all deki-bae items are listed.
Therefore, it is strongly recommended to select items that can be controlled
within the processes only, since there are some relevant items that can be
covered if controlling with the representative items. See the following list for
examples.
The 4M items like process conditions shall be excluded because they are
occurrence prevention measures for the production assurance items.
① “deki-bae” items indicated on drawings
Items indicated on drawings shall be reviewed to select some which require
process control.
- Items of “Notification of QA Requirement”
- Remarks of manufacturing process on a drawing
- Items to help customer assembling such as set length and a name plate
② Possible defects in manufacturing
- Defects such as wrong parts, missing parts, wrong assembly, and process
skipping over
- Defects which could occur as a result of processing and handling damages
(burrs, scratches, nicks, and cracks, etc)
- Remaining fillers and grease
③ Potential defects
- Field claims, customer returns, inspection defects, and in-process defects etc.
of similar products
(3) Remarks for entering production assurance items
It is necessary to describe production assurance items in details in order to
capture defect status and their causes as well as to avoid missing reviewing
processes.
Example 1: Appearance defect
Since it is hard to specify what should be assured, an appearance defect shall
be described in a more specific term such as “scratches on the outside diameter,
“molten metal blanks around sealing area,” and “gloss (matt).”
Example 2: Screw tightening defect
Screw tightening defects include a “torque defect” and a “loosened screw” and so
on. Since they have different occurrence causes and need different flow-out
prevention measures, these items shall be separately taken actions as needed.

№ P_SQAM4
Chaper4
(4) Entry in “related control” space

Enter a control number, a procedure number, and an inspection number of a
manufacture control form to capture how occurrence and flow-out prevention
measures are reflected into the control form. Each department shall decide a
brevity code for each form.
① Pokayoke function check sheet
Fill in this space when pokayoke is used for the occurrence/flow-out
prevention.
② Operation manual sheet/check manual/others
As for occurrence/flow-out prevention measures with manual operations
involved, enter which step in which procedure sheet/manual these measures
are reflected into.
Example: operation manual sheet, check manual, machine condition setting
sheet, setup manual, partial part handling manual, material feeding manual, etc.
③ Control charts/recording papers/check sheets
Fill in this space when recording and managing a “deki-bae” checking result in
a data form.
④ Other check sheets
Fill in this space when inspecting and managing equipment and jigs with a form
other than the pokayoke function check sheet.
Example: jig and tool check list, etc.

№ P_SQAM4
Chaper4
4.7 Control plan procedure

4.7.1 Purpose
This procedure aims to clarify items to be controlled such as systems or processes
required to manufacture part/product which satisfy quality required.
4.7.2 Scope
Applies to all parts supplied to Denso.
4.7.3 Explanation
The Control Plan is a written description of the system for controlling parts and
processes that produce parts.
Process control relies upon control of the elements that drive the process, whereas
product control relies upon verification of the product as it emerges from the
process. In practice it is a combination of these that yields parts of consistent quality.
The control plan includes quality assurance process chart, shipping inspection standard,
etc.

1. The control plan format must meet all requirements in the drawing and NQAR etc.
from Denso. (See document No. 29).
2. The Control Plan the supplier uses must include all processes from Receiving Inspection
through to Customer Shipping.
3. The Control Plan shall be prepared under control of QA responsible personnel
4. Suppliers must verify and assure Control Plan contents of the process.
5. Check items according to standard test methods (ISO, DIN, JIS etc.) should be indicated.
6. The supplier shall revise the Control Plan when any quality concerns caused by design
change or process change, etc. are found.
7. The supplier shall update and re-issue the Control Plan to Denso for all revisions.
Denso may request other documents depend on the change content.
8. Please refer 4.7.5 and 4.7.6 about the procedure of QA process chart and shipping
inspection standard. (See document No. 6).

№ P_SQAM4
Chaper4
4.7.5 Quality assurance process chart

4.7.5.1 Introduction
This procedure specifies the preparation procedure of “Quality assurance process
chart” and describes how to fill out “Quality assurance process chart” in order to
promote quality assurance at the supplier and make effective use of “Quality
assurance process chart”.
4.7.5.2 Quality assurance process chart

“Quality assurance process chart” analyzes the part (product) production processes
from the first process to the final process in order of process, including the
subcontractor, receiving inspection, and shipping inspection, and specifies the
quality assurance items and their control methods in each process.
“Quality assurance process chart” clarifies who check quality, when and how to
check quality, how to record it, and whether the control method is appropriate or not
from relation with process capability. It is extremely important and indispensable in
quality assurance of parts (products).
4.7.5.3 Quality assurance process charts subject to submission

Denso’s Inspection Dept. or Quality Assurance Dept. in charge shall request for
related supplier by using“Notification of QA Requirement” (See document
No.29) to create and submit the quality assurance process of the following
by the deadline.
(1) Critical control designated parts
See “Control procedure of critical control designated parts” in Section 4.9 of
Chapter 4.
(2) For others specified by Denso’s Inspection Dept. or Quality Assurance Dept.
4.7.5.4 Submission timing and method

(1) Submission timing
Suppliers shall submit the chart by the due date that specified by Inspection
Dept. or Quality Assurance Dept.
(2) Submission method
Suppliers shall submit the original to Inspection Dept. or Quality Assurance
Dept. via Purchasing Dept. of Denso.
4.7.5.5 Check of quality assurance process chart

Inspection Dept. or Quality Assurance Dept. of Denso studies the contents, makes
necessary copies, and returns the original to suppliers via Purchasing Dept. within
one week after acceptance “Quality assurance process chart” from suppliers. If
there are any problems, Denso may ask suppliers to submit the chart again.
4.7.5.6 Change procedure of quality assurance process chart

In case of any changes in the submitted “Quality assurance process chart”, please
revise the applicable portions immediately and submit the revised original again.
For the submission method, follow the procedures described in Section 4.7.5.4 of
Chapter 4.

№ P_SQAM4
Chaper4
4.7.5.7 Explanation of quality assurance process chart

(1) Why is Quality assurance process chart necessary?
The objective of “Quality assurance process chart” is to specify the standard for
assuring the product quality and to check whether quality assurance is adequate.
It is indispensable in quality assurance. Use “Quality assurance process chart”
in the following cases after fully understanding its objective.
① Production preparation stage
1. Check whether there are any problems in process sequence, equipment,
measuring tool, and others.
2. Check which processes are important.
3. Check whether the quality assurance methods are appropriate by
specifying the control method.
4. Identify the process capability and check whether the equipment is
appropriate.
5. Find out problems such as inadequacy of standards or operation standards
by looking all processes from first to last when preparing the chart, and
improve prior to production.
② Mass production stage
1. It is used as check sheets when checking whether the operations are
performed as specified in “Quality assurance process chart”.
2. It is a clue as to find the cause and take measures effectively when a
problem occurred.
(2) Use of quality assurance process chart
Denso uses the quality assurance process chart submitted from suppliers for
the following purposes.
① Material to identify the whole picture of the process in advance and give
advice on defect prevention.
② Material to ascertain the actual control condition of suppliers and adjust the
inspection method of Denso.
③ Clue to determine the cause when a serious problem occurred.
④ To promote the maintenance of “Quality assurance process chart” at the
supplier.
⑤ To use as a check sheet for process diagnosis.
“Quality assurance process chart” includes a lot of company secrets.
Denso promises not to abuse these and bring disadvantages for suppliers.
Therefore, please present the actual conditions after understanding the
objective of submission.
(3) Preparation method of quality assurance process chart
① Form
As a rule, use the form *1 specified by Denso (See document No. 6). Format
of your own form may be used if the entry items are equivalent. In this case,
obtain an approval of Dept. in charge.
*1: Two types of forms are available. One is for general use and the other is
for Purchased Part Quality Assurance Center, Electronics Quality
Assurance Dept. of Denso.

№ P_SQAM4
Chaper4
② Range of entry
Enter all the processes from material receiving inspection to shipping
inspection, including subcontractors, in order of processes. Enter the
transfer and storage items important for quality assurance without any
omission.
③ Entry procedure
See the entry examples in Entry procedure of “Quality assurance process
chart” (See document No. 6).
④ Quality assurance process chart of similar parts
If there is no difference or there is only partial difference in the contents of
quality assurance process chart” of similar parts, prepare “Quality assurance
process chart” of representative part number, and enter the similar parts
numbers and their differences.

№ P_SQAM4
Chaper4
4.7.6 Supplier shipping inspection standard

4.7.6.1 Introduction
This procedure describes the submission method of the shipping inspection
standard that Denso requests suppliers to submit. Suppliers standardize how to
inspect and assure the quality requirements specified in the drawing of Denso or
“Notification of QA Requirement” (See document No. 29), into the inspection
standard and Denso checks these contents.
4.7.6.2 Definition of supplier shipping inspection standard

Supplier shipping inspection standard refers to the shipping inspection standard that
suppliers prepare for the part (product) ordered by Denso and that is approved
by Denso.
4.7.6.3 Request for preparation of supplier shipping inspection standard

Inspection Dept. or Quality Assurance Dept. of Denso requests to prepare the
inspection standard for the following items, with “Shipping inspection standard
preparation request” (See document No. 30) or “Notification of QA Requirement” .
① Critical control designated parts
② Other parts specified by Inspection Dept. or Quality Assurance Dept. of Denso
4.7.6.4 Submission timing and method

(1) Submission timing
Supplier who get request to submit shipping inspection standard from
Denso/Denso group companies shall respond within 5days after receipt of
“Shipping Inspection Standard (new / change ) Submission request or
“Notification of QA Requirement” based on due date of return suggested by
Inspection/QA section of Denso/Denso group companies. Please respond by
the date of submission schedule when instructed by Denso.
(2) Submission method
Submit “Request for inspection standard approval” (See document No. 11) and a
copy of the inspection standard（See document No. 12） to Inspection Dept. or
Quality Assurance Dept. via Purchasing Dept. of Denso. Depending on
4.7.6.5 Approval of shipping inspection standard

Inspection Dept. or Quality Assurance Dept. of Denso studies the contents of the
inspection standard submitted from suppliers and processes as follows along with
the reply to approval request.
If the inspection standard is acceptable, return the copy of the inspection standard
submitted via Purchasing Dept..
If the inspection standard cannot be accepted, request to resubmit a copy of the
inspection standard after modification.

№ P_SQAM4
Chaper4
4.7.6.6 Revision procedure of shipping inspection standard

When the approved inspection standard is changed, fill out “Inspection standard
approval request” and attach a copy of the revised inspection standard to obtain
an approval by Denso.
4.7.6.7 Other
If the inspection standard form is not specified at suppliers, use Denso’s form
“Inspection standard” attached to the end of this manual. (See document No. 13)
If the form is specified at suppliers, it is allowed to use it on the assumption that all
entry items of Denso are all included in this form. If you have any unclear points,
confirm with Inspection Dept. or Quality Assurance Dept. of Denso.

№ P_SQAM4
Chaper4
4.8 Work standard procedure

4.8.1 Purpose
In order to ensure quality assurance, ensuring safety and efficient work,
this procedure is intended to enable anyone to manufacture possibly best-quality products if they work
according to work standard in the same procedure.
Also this procedure is intended to be able to work in the best way even if worker is replaced by other person
or if time has passed.
4.8.2 Scope
This procedure is applied to work standards during the manufacturing process (including inspections and
shipments).
4.8.3 Explanation
The work standards are clearly indicated that the conditions and methods must be obeyed for the work
contents when the worker perform the work.
The work standards include job instructions, check instructions, etc.
4.8.4 Requests to supplier

Suppliers shall refer to section 4.8.4.1~4.8.4.2 and create work standards according to the actual situation
of the suppliers.
4.8.4.1 Items to be noted into job instruction and check instruction

Please state the following items according to the situation.
① Product number, product name, process name, mark indicating critical control designated parts
② Work procedures (including KAN-KOTSU work based on 5 senses and experience)
③ What is the problem if the procedure is not followed? (What effect may happen if it is not
followed?)
④ Standard time
⑤ Ensuring safety
⑥ PM (lubrication, cleaning, daily check, etc.)
⑦ Quality check (item, standard, interval, measurement instruments, management methods, etc.)
⑧ Work change over, adjustments (processing conditions, adjustment conditions, jigs and tools,
procedures for operating machines, etc.)
⑨ History of creation / revision
⑩ Trouble histories, points to consider, etc.

№ P_SQAM4
Chaper4
4.8.4.2 Points on creation

Please consider the following items.
① Work standards are set for each manufacturing process. (If a different work is required for each
product number, a work standard will be set for each product number.)
② As for control plan items requiring 100% check, the procedure must include a checking method
especially.
③ As for items which is "guaranteed by work procedure” under the QA network, the procedure
must include specific work procedures.
④ As for check items, critical control items must be checked first.
⑤ Regarding Trouble histories, write date of occurrence, type of trouble (market claim, customer
claim) and details of the defect.
⑥ Specify ensuring safety in detail and also write about the report of nearly-missed accident.
⑦ When work procedures are changed, opinions of affected workers must be reflected.
⑧ Work standard must be written by worker’s plain word so that workers can understand them.
⑨ As for quality assurance items, make a text as what action, what of where and how, to be a
good condition.
⑩ Unify proper nouns such as the name of a portion of the product, expression, the ending of the
word and defect condition etc..
⑪ Illustrations and photographs are supplementary, to make it clearly image and understand with
sentences only.

№ P_SQAM4
Chaper4
4.8.5 Points to consider before and after creating work standard

Please refer and consider to Table 1 before and after creating work standards.
《Table 1 Items to be Implemented before and after creating work standards (Cases)》
Job When considering When Operating

■Do not let the worker do the work which is not in the job ■Educate workers repeatedly to observe the basic
instruction. principle based on the work standards and confirm the
- When troubleshooting not covered by work standard or degree of comprehension. In particular, be careful if
irregular work becomes necessary, the worker shall not decide. the worker is a newcomer or a temporary worker.
Instead, the worker shall turn to supervisor for instruction and ■The manager / supervisor periodically checks that the
Common
ensure that 2 people work together (double-check). worker is carrying out the work according to the work
- In irregular work such as troubleshooting, a worker is likely to standards.
cause mistakes due to misunderstanding and common ■Listen to hard or difficult work to improve it.
mistakes.
When doing the work, clarify the work with the job instruction
written clearly even provisionally.
■Inspection items should be extracted without missing effective ■The place of inspection shall be the illuminance level
items for human judgment, and do not extract more than that can be judged as good or bad. (Excessive
necessary. brightness causes hard to see with reflection.)
Scratches, physical damages and foreign material on seal areas, - It is necessary to find light-source color and
design areas and coated surface must be checked. illuminating angle that improve detectability.
- Including problem histories etc. ■It is necessary to keep the temperature / noise
- For important part, to consider automatic judgment etc. by environment that the inspector does not feel
equipment as necessary. uncomfortable.
■A clear instruction must be given regarding the inspection - Consider air conditioning management / local air
portions to be checked visually. conditioning / blower etc. as necessary.
- Photo or illustrations must be used to avoid dispersion of - Ensure noise level that worker can concentrate
judgment among inspectors. during inspection.
- As for products with a design, the design area must be shown
■It is necessary to ensure inspection place where work
clearly.
can be smooth.
- As for “burr and short-shot of mold products” etc. that can
identify the defect occurrence portion, a clear instruction must - The place of inspection should be “Exclusive
be given regarding the location of possibly defect portions. inspection place" rather than at the end of an
Visual appearance inspection
assembly line where inspectors are rushed.

■If the judgment standard is not a yes-or-no question, boundary
sample must be prepared. ・It is desirable to adjust the height of a work desk to
- In addition to OK boundary samples, NG boundary samples the height of the worker, and make space that is
are also considered. easy to work.
- A boundary sample uses an actual product or photo (the size - It is advisable to lay “floor mat / back-resting board”
must be the same as an actual product). to reduce the worker’s tiredness.
■The order of inspection is performed in a flowing order, and ■It is necessary to set a training method
important items are prioritized. (program/time) that was reflected the job instruction,
- To avoid dispersion of judgment among inspectors, inspection when inspectors are assigned.
method must be considered how to handle the product and the - Inspectors’ abilities are evaluated by checking the
inspector’s eye line. level of skill.
■Too many inspection items should not be assigned to one - During the training period of inspectors, instructors
inspector. The inspection time is secured according to the double-check their abilities to detect problems.
inspection item. - Educate the Importance of inspection, influence
- It is necessary to ensure consistency with cycle time and tact upon overlooking etc..
time. ■Periodically plan awareness education for inspectors.
- If there are many items, consider the assignment of inspection - Periodically share failure cases of own department /
items. other departments.
- When adding inspection items urgently, such as at the time of - Have opportunity of discussion in the work.
failure in the own process, take into consideration the burden
on the inspector and not to add unreasonable items to
inspection time.

№ P_SQAM4
Chaper4
Job When considering When operating
■As part of inspection procedures, how to move and look at the ■Confirm "the judgment skill of the inspector" at
product to be inspected must be stipulated. every start of work.
- If it is difficult to locate the area of problems such as “scratch, - Confirm the judgment standard by boundary
physical damage and foreign material” etc., it is necessary to sample.
Visual appearance inspection
check the overall external appearance. - Confirm physical condition / fatigue feeling
- The final inspection should be considered not to be "two or more (interview etc.) of the inspector.
work" or “same-time work“. ■Implement measures to prevent drowsiness
- For the work involving many inspection checking points, it is and measures to recover from fatigue.
desirable to have an operation (finger pointing / mark) inspection - In order not to lose concentration, consider
that can monitor to skip inspection item. "refresh time" and "eyesight recovery
■When visual checking is difficult, prepare tools and stipulate it. exercise" etc..
- Prepare magnifier to check where things look small.
- Consider a colored back plate to make the detection easier. (for
example; Use blue back plate etc. when white-colored product is
checked.)
■When parts (products) box is moved, to check part number at three

points.
Example of three points check: box, parts (products), and shelf.
If an partial parts box is used, the changes in the number of products
Transportation / shipping
must be recorded.
■When part number of parts (product) is verified after inspection and
quantity management, use mechanized method.
For example of mechanized method
- Part number confirmation: QR code, bar code
- Quantity management: measurement instruments (scales)
■Human tasks that can not be mechanized are standardized as much
as possible.
- Make part number verification by symbol.

№ P_SQAM4
Chaper4
4.9 Control procedure of critical control designated parts

4.9.1 Purpose
This procedure specifies the control method that suppliers should comply with in order to
enhance the quality assurance of parts which may cause serious quality problems in the
market to prevent the problem.
4.9.2 Scope
Apply to parts which have critical control characteristics specified by drawing ,“Notification
of QA requirement” (Document No.29) from Denso.
4.9.3 Explanation
Critical control designated parts are those designated critical control characteristics (NOTE1)
affecting on vehicle safety (accidents, vehicle fire etc.), exhaust gas, regulation, and
driving function etc.. Therefore they are required special control at suppliers to prevent
any quality problems in the market.
Please implement control according to the purpose of each designation.
NOTE1: performance, mounting dimensions, strength, etc.
4.9.3.1 Definition
Critical control item is the generic name for the following five directive parts.
№ Type Definition
①Products with defects, failure, or handling errors which might lead to injury /
Safety Designation deadly accidents, vehicle fire, or other serious accidents.
１
Ｓ：Safety ②Products regulated by laws regarding safety.
③Designated products by customers.
①Products with defects or failure which might lead to inhibitions in exhaust gas
purification function as well as in perception / judgment function for exhaust-gas-
Emission Designation
２ related characteristics.
Ｅ：Emission
②Products regulated by laws regarding exhaust gas.
③Designated products by customers.
①Products which a responsible General Manager of Eng. Dept decides necessary

for the designation when considering prevention for lack of certification marks
Regulation Designation
３ and for incompatibility with legal regulations against products except Designation
Ｒ：Regulation
Types S and E.
②Designated products by customers.
Fahren (Driving)
Function ①Products with defects or failure which might lead to inhibitions of driving function.
４
Designation ②Designated products by customers.
Ｆ：Fahren
①Products whose effects of defects or failure are not defined by the above S, E, R,
Critical Designation
５ and F and which also need to go through critical control designation.
Ｃ：Critical
②Designated products by customers.

№ P_SQAM4
Chaper4
4.9.3.2 Indication mark

(1) Safety Designation indication (S: Safety)
diamond S double circled S circled S
S S S S
（Example of customer designation）
(2) Emission Designation indication (E: Emission)

diamond E double circled E circled E
E E E E
(3) Regulation Designation indication（R: Regulation）

diamond R double circled R circled R
R R R
R
(4) Fahren (Driving) Function Designation indication

diamond F double circled F circled F ( F: Fahren )
F F F
(5) Critical Designation indication (Ｃ：Critical)

diamond C double circled C circled C
C C C
4.9.3.3 Definition of ◇, ◎, and ○ designated

(1) ◇ designated parts/products
The ◇ designated is closely correspond with Result-Related Characteristics,
and normally result of the job such as performance, mounting dimensions,
strength etc which are described in Assembly drawings, Assembly reference
drawings etc.
Supplier shall assure all parts/products (100% guaranteed) to meet ◇
designated item’s requirement.
(2) ◎, and ○ designated parts/products
The ◎ and ○ designated is closely correspond with Factor-Related
Characteristics, and normally to be designated as follows;
① Result of the job such as performance, mounting dimensions, strength etc which
are described in Assembly drawings, Assembly reference drawings etc.
② Process conditions which affect result of the job described in Assembly drawings,
Sub-assembly drawings, and part drawing.
③ Material characteristics values described in Sub-assembly drawings and part
drawings.
Especially supplier shall assure all parts/products (100% guaranteed) to meet ◎
designated item’s requirement.

№ P_SQAM4
Chaper4
4.9.3.4 100% guarantee and designation

(1) Definition of 100% guarantee
Result-Related Characteristics 100% guarantee means to guarantee every
part/product to be good by meeting criteria that directly relate Result-Related or
Factor-Related Characteristics through all processes.
Prevent defects Impossible “Deki-bae”of No

with result-related Factor-related
characteristics characteristic
･One hundred(100)%
inspection cannot detect
items like destructive
Possible characteristics Yes
･Items like durability
characteristics cannot be
detected at an initial stage
Prevent defects Impossible
with factor-related
characteristics
Prevent defects with processing

conditions
Possible
“Deki-bae” of result- “Deki-bae” of result-related “Deki-bae” of result-related Completeness of result-related

related characteristics characteristics characteristics characteristics
⇒“◇ designation” ⇒“◇ designation” and then ⇒“◇ designation” and then sampling
⇒“◇ designation” and then sampling inspection
and then 100% sampling inspection inspection
“Deki-bae” of factor-related Conditions for manufacturing
inspection characteristics
“Deki-bae” of factor-related ⇒“○ designation” ⇒“◎ designation” and then 100%
and then sampling monitoring *2
characteristics The processing conditions for result-related
⇒“◎ designation” inspection
Characteristics are considered because
and then 100% inspection *1 Processing conditions
⇒“◎ designation” there is no “deki-bae” of factor-related
and then 100% monitoring *2 characteristics
＊1:“Deki-bae” of factor-related characteristics is designated as ◎,and then 100% inspection is carried out
If the “deki-bae” can be checked at all timings occurrence, it is considered as 100% inspection.
However, it is necessary to take additional to deal with defects which occurred at undetectable timings.
(Refer to the chart below)
＊2: Processing conditions are designated as ◎, and then 100% monitoring is carried out.
It is basically continuous monitoring which can also detect the defect of the product
Ex..）Press fitting: monitoring for press-fitting patterns （“Deki-bae” of the product: press-fitting dimension）
Welding: welding current, subducting patterns （ “Deki-bae” of the product: tensile strength,
nugget diameter and so on）
Sub-minimal factors should be satisfied in the continuous monitoring.
・When the monitoring data are out of specification of the processing conditions, the equipment should be
stopped automatically.
・Record regarding when the above problem occurred and what kind of actions are taken should be left.
〔 Supplement 〕 Checking Method When 100% Inspection

is Not Possible for Factor-related Characteristics
Defect Timing is not detectable

Occurrence
Timing is
detectable
<Changes in 5M1E> <Trend change> <Specific lot> <Unexpected occurrence>

Specify 5M1E and Check “deki-bae” at the Check the worst value Additional actions to deal
check “deki-bae” intervals when defects does of completeness per lot with defects which
Ex.) When changing not flow outside the company Ex.) Check samples by the occurred at undetectable
【Action】
tools, checking the initial/final Ex.) Regular dimension checks (1/100) batch from the center and the timings
product four corners Ex.)Add pokayoke
(2) Notification of critical control designation

Denso notifies by stamping the indication mark on “Notification of QA
Requirement”. Inspection Sect. or Quality Sect. explains the objective of
designation and the control points (function, cause-effect relationship,
importance…). If the already ordered part is newly designated as critical control
item, notify as mentioned above.

№ P_SQAM4
Chaper4
(3) Order of critical control designated parts (to recommended supplier )

① Denso orders the critical control designated parts to the preliminary approved
suppliers as recommended suppliers.
② Approval as the recommended supplier is based on the QMS audit results by
Denso.
Approval for recommended suppliers will be notified in writing by procurement
Dept. in charge of Denso.
③ The information of audit results of recommended suppliers by Denso or
Denso group manufacturing companies (prescribed in “Introduction” of page1
of this manual) to be shared by Denso and Denso group manufacturing
companies. And all recommended suppliers to be a candidate of supplier to
get order of critical control designated parts from Denso and Denso group
manufacturing companies.
Therefore, the list of recommended supplier name to be shared by Denso
and Denso group manufacturing companies.

4.9.4.1 Process study of critical control designated parts
Immediately after receiving the notification of critical control designation, suppliers
shall study the processes of critical control designated parts (NOTE1), clarify the
important points to be controlled, improve the control as well as prepare or modify the
quality assurance process chart (or equivalent) and the inspection standard and QA
network form. “Quality assurance process chart” (See Section 4.7.5) and
“QA network form” (See Section 4.6.5) requested by Denso shall be submitted
by the specified date to obtain an approval of Inspection Dept. or Quality Assurance
Dept. of Denso.
Inspection/QA section of Denso/Denso group companies conduct supplier process
audit at the trial stage of mass production before production as well as periodical audit
to confirm management condition.
Please talk and adjust schedule etc. of audit with Inspection/QA section in charge of
Denso.
NOTE1: Critical control designated items’ process capability :Cpk > 1.33
4.9.4.2 Signboard indication of critical control designated items

(1) Indication of S S E E R R processes
Following method shall be taken at the process including Inspection to guarantee
Safety, Emission, and Regulation ( symbolized by S S E E R and R )
designated characteristics to be well-controlled and encourage each related
member. ( S and S are case example )
◇ One side 100 mm ○ φ150mm,φ130mm

Indicate the process with a red mark and black letters on the white signboard.
It is discretional to display name of nominated operator of E E R and R
designated process.
№ P_SQAM4
Chaper4
（2） Indication of except S S E Eprocesses

R R
Indicate as needed at the discretion of suppliers. In this case, the indication
method should comply with Section 4.9.4.2 (1).
4.9.4.3 Indication of critical control designated parts on the standards and

forms
For the critical control designated parts, stamp the indication mark of critical control
item in red so that they can be controlled separately from the general parts.
- Job instruction sheet - Control chart - Check sheet - QA process chart
- Initial product inspection report - Inspection history - Inspection standard, etc.
For the cases other than those above, follow the instructions of Inspection Dept.
(or Quality Dept.) .
4.9.4.4 Inspection of critical control designated parts

Regarding 100% guarantee of products, please refer “4.9.3.4 100% guarantee and
designation”
(1) ◇ designated part/product
Please implement 100% inspection of ◇ characteristics.
In case it is impossible to implement 100% inspection, Denso indicates factor-
related process/condition to control by ◎ designation, so please guarantee 100%
based on 4.9.4.4 (2).
Even in that case, ◇ characteristics shall have sampling check.
(2) ◎ designated part/product
◎ characteristics shall be 100% guaranteed with following methods.
① To conduct 100% inspection.
② In case it’s impossible to implement 100% inspection, supplier shall continuously
monitor process condition which supplier can detect abnormal condition of
products
(3) ○ designated part/product
○ designation correspond to Factor-related Characteristics of critical control
designation. So please implement proper inspection for designated part/product.
4.9.4.5 Record of quality history

For the critical control characteristics, record the quality history with a control chart,
check sheet, inspection history, and others.
As for safety directive parts, Inspection Sect. or Quality Sect. will give instructions to
follow for the periodical submission of inspection history and control charts.
Please refer item no. 4.28 Quality Record Management procedure for details.
4.9.4.6 First delivery of critical control designated parts

(1) First delivery of safety directive part
Supplier shall indicate “Safety directive part” at the first delivery to Denso.
Please indicate by attaching “Initial product tag”(Document No.8) with red
stamping/rubricating Safety designated symbol on it.
(2) First delivery of directive parts other than those above
Indication above is only required when Inspection Dept./QA Dept. in charge of
Denso specified.

№ P_SQAM4
Chaper4
(3) Precautions on submission inspection of the initial product

As for the critical control characteristics of the critical control designated parts, in
principle, attach the data that indicates the process capability to the initial product.
However, this does not apply in any of the following cases. Consult with Inspection
Dept./QA Dept. in charge of Denso.
① The Inspection Dept./QA Dept. in charge of Denso has implemented a
process audit of the supplier and confirmed that there is no problem in the
process capability. (There shall be no changes in the audited process after .
audit)
② The data of the production resumption item is the same as that of the previous
lot that has already been submitted.
③ When it is impossible to calculate the process capability due to the small
production amount (N=20 or less), attach the actual measurement data of all the
products.
④ “Notification of QA Requirement” shows that there is no problem in the process
capability. However, it is only when there is no change in the process, etc. after
reply to the notification sheet until the initial product
4.9.4.7 Troubleshooting
If any problem requiring 100% sorting occurred in the ◇ and ○ directive parts,
immediately notify Inspection Dept. of Denso and follow the instructions.
4.9.4.8 Re-outsourcing of critical control designated parts

(1) Prohibition of self-procurement of critical control materials
(except for rubber and spring materials)
In principle, use the material supplied by Denso for the critical control materials,
and prohibit the self-procurement unless otherwise approved by Purchasing Dept..
(2) Prohibition of re-outsourcing of critical control designated parts
① Prohibit the re-outsourcing (secondary outsourcing) of all processes from the
initial process to the final process of critical control designated parts. However,
assembly parts other than the parts that affect critical control designated parts
can be re-outsourced.
(3) Critical control designated parts subcontracting application
① When re-outsourcing for special reasons, apply and get approvals by using
“Critical control designated parts subcontracting application” form (See
document No.16), “Subcontractor audit check sheet for Quality management
system” (See document No. 17) and “Quality assurance process chart” before
proceeding
（Even if the primary is a trading company, it is same.）
② For the approved suppliers for re-outsourcing, we provide this manual through
the Purchase Dept. upon request of supplier. (Please send email to the Section
with the supplier name and the supplier name of re-outsourcing)
(4) Reference information: Action of Denso after application
In principle Denso proceeds as follows when supplier submits application form.
① Denso/Denso group company judges OK or Not to go ahead with the results of
process audit by related members jointly.
② Denso will judge if the sub-supplier can be approved as recommended
supplier or not, based on QMS audit results by Denso.
However, in case the sub-supplier already approved as recommended
supplier, Denso may omit the QMS audit.
The supplier name of recommended supplier to be shared by Denso and
Denso group manufacturing companies.

№ P_SQAM4
Chaper4
4.10 Installation portion control procedure

4.10.1 Purpose
This procedure specifies the control method of installation portion in order to prevent
the occurrence of failures that installation is impossible at customer.
4.10.2 Scope
Apply to parts which have installation portion control characteristics specified by drawing
from Denso.
4.10.3 Explanation
4.10.3.1 Definition
(1) Installation portion
① The portion that Denso products are installed in mating parts such as vehicle,
engine and transmission etc. at customer.
② The portion that mating parts/products are installed in Denso products at
customer (such as fitting part with connector or pipe, sealing part of fuel or gas
etc., insert hole of filter etc.).
③ The portion that mating machine is installed in Denso products at customer
(fitting/connection part with filling machine or inspection tools etc.).
(2) Installation guarantee
① Denso products can be installed in mating parts such as vehicle and
engine etc..
② Mating products/parts and equipment can be installed in Denso products.
4.10.3.2 Procedure of Installation portion control

As to the control characteristics, in general, it shall be guaranteed 100% or controlled
to prevent failures from flowing outside company in inspection (including check by
installation tools out of inspection process) and production processes.
4.10.3.3 Designation code of Installation portion

The code which indicates installation portion is shown as (circle in) in drawing.
In
“In” means Install.
Addition: are used for the drawing that it has been already issued by
取 Mt I
Denso group company as symbol of the installation part.
Those will be unified into In in future.

4.10.4.1 Control method of Installation portion
About the installation control characteristic and the control method, Inspection Dept.
(or QA Dept.) notifies the supplier of “Notification of QA Requirement”
(Document No. 29).
After consider whether the requirements are feasible, reply it with "QA confirmation
results report" (Document No. 4).

№ P_SQAM4
Chaper4
4.10.4.2 Indication of Installation portion on the standards and forms

The designation code In indicated in the documents below.
shall be
(The size, color are optional.)
- Job instruction sheet - Control chart - Check sheet - QA process chart
- Initial product inspection report - Inspection history - Inspection standard, etc.
For the cases other than those above, follow the instructions of Inspection Dept.
(or Quality Dept.) .

№ P_SQAM4
Chaper4
4.11 The special process control procedure

4.11.1 Purpose
This procedure specifies control steps for special process parts (products).
4.11.2 Scope
Apply to parts/products of which manufacturing processes include “special process”
Denso defines following processes as “special process”:
Metal heat treatment, welding, rubber (vulcanization, adhesion), surface treatment
(plating, etc.), plastic molding(welding), plastic molding (annealing), soldering,
and electronic unit assembling (wire bonding process and the process where measures
against static electricity and foreign materials are performed).
4.11.3 Explanation
Different from a general assembly process, “special process” requires specific
engineering technology of the professional for process planning and securement of
quality, and also the characteristic is difficult to discriminate at first glance, therefore it is
required destructive test or any other special check. Even if there is a problem, it does not
come up to the surface immediately after processing, but might lead to a critical quality
problem later.

4.11.4.1 Manufacturing process control
The supplier shall keep records such as check results and also implement sure check
of manufacturing conditions and quality of the output including sub-suppliers.
4.11.4.2 Target parts/products of special control and items to be implemented

The following parts are targeted:
① Metal heat treatment: Newly ordered parts (products) that correspond to any of
Section 4.11.4.2. (1).
② Welding : Parts (product) which correspond to one of item 4.11.4.2.(2) among
the parts (product) which newly ordered with the welding item.
③ Rubber: Newly ordered parts (products).
④ Surface-treatment : Parts (product) which correspond to one of item 4.11.4.2.(3)
among parts (product) which newly ordered.
About above –mentioned parts, the team of related Denso members (Materials Eng.
R&D Div., Production Eng. R&D Div., Procurement group and Inspection Dept.,
Production Eng. Dept., QA Dept. etc. of each business unit,) may conduct audit of
relevant special process of the supplier from parts (product) ordering stage to a mass
production start or periodically as needed.
(1) Target for the process audit of metal heat-treatment parts (products)
The general heat treatment applied to the metal (iron/non-iron) shall be reported.
① Heat treatment pattern
1. Only the heat treatment is outsourced.
2. Assy, Sub Assy, and consistently processed parts of which heat
treatment is implemented at the supplier
3. Heat treatment of standard parts
Parts that include the heat treatment process and that have head part
number begins with 9 (Bolt, nut, washer, bearing, spring, etc.)

№ P_SQAM4
Chaper4
② Type of heat treatment

In heat treatment applying to metal (iron, non-iron),apply to heat treatment
that gives strength and abrasion resistance or determines the product
performance. Denso audits process shown below or required process
specially.
1. Quenching and Tempering (QT)
2. Carburizing (GC)
3. Carbonitriding (GNC)
4. Induction Hardening (IHA)
5. Tufftriding (TF-S､TF-G)
6. Nitriding (NH)
7. Austempering (HQA)
8. Sulphonitriding (SLT)
9. Stress relief Annealing (AN-S)
10. Magnetic Annealing (AN-M) (Hardness instruction is described on drawing)
11. Normalizing (NRO) (Hardness instruction is described on drawing)
12. Solution heat treatment and Age hardening
( Aluminium:T4,T6 SUS:631,630 BeCu etc.:AH )
13. Direct quenching from forging temperature
(Quenching in cooling process and hardness instruction is described on
drawing)
③ However, the following are exception.
1. Hydrogen removing treatment after plating
(Because this treatment is controlled through the plating process)
(2) Target for the process audit of welding parts (products).
Among welding, the following are targeted for process audit.
① Arc welding
② Spot welding
③ Projection welding
④ Fusion welding
⑤ Laser welding
(3) Target for the process audit of surface treatment parts (product).
Among surface treatment, the following are targeted for process audit.
① Plating
② Painting
③ Anodizing (alumite) processing
④Formation processing (phosphoric acid salt processing, black dyeing
processing)
However, when there is an individual request from our customer in addition to
this procedure, Denso will give instructions. Please follow them.

№ P_SQAM4
Chaper4
4.11.4.3 Cautions for plating process:

Removal of hydrogen embrittlement of the plated parts
The process of removing hydrogen embrittlement of the plated parts is extremely
important in quality assurance. Absolutely implement this process under the
specified conditions, complying with the drawing of Denso.
(1) Indication to plating code
For the part from which hydrogen embrittlement shall be removed, “H1, H2, or H3”
is added at the end of plating code.
When outsourcing the plating, make sure to indicate that to the plating plant.
Ex.) MFZn①H1C
(2) Conditions of hydrogen embrittlement removal
Keep the following conditions to remove hydrogen embrittlement.
① Remove hydrogen embrittlement within four hours after processing such as
plating.
② Processing time shall be at least 60 minutes for H1, at least 120 minutes
for H2, and at least 180 minutes for H3.
③ Processing temperature shall be 180 +20/-0 °C.
Use a constant temperature chamber dedicated for hydrogen embrittlement
removal, in which internal temperature distribution is even.
(3) Prohibition of reprocess of plating
Regarding hydrogen brittleness, “Safety designated part/product ( Item 4.9 critical
control designation management procedure) “ are prohibited to proceed plating
process twice or more. Therefore all plating defects shall be disposed.
(4) Prohibition of processing plating process three times
Other than “Safety designated part/product“ is allowed to plate after complete
removal of plating. But it is prohibited to remove plating and go through plating
process again.
Therefore all defects failed to rework described above shall be disposed.
4.11.4.4 Others
In addition to this procedure, when Denso customer request individually, Denso
instructs as required. Please follow the instruction.

№ P_SQAM4
Chaper4
4.12 Secondary supplier usage procedure based on pollution

prevention agreement.
4.12.1 Purpose
This procedure refers how to proceed to get approval when supplier plan to utilize
secondary supplier, categorized of plating, painting, and heat treatment process, which is
not designated by Denso from view point of prevention of pollution based on “Prevention
of pollution agreement”(Document No.2, item 7th (prevention of pollution at subcontractor))
or “Purchase agreement”(Document No.1) contracted between supplier and Denso to
prevent accidents of pollution.
4.12.2 Scope
Apply to the case when first tier utilize a secondary supplier which is not registered at
Denso for the process of plating, painting, and heat treatment.
Please contact relevant Purchase Dept. to check which subcontractors of plating, painting,
and heat treatment are registered.
4.12.3 Explanation
Denso conducts the audit to check if the sub-supplier can be qualified as a registered
supplier when Denso receives an application form described below.
4.12.3.1 Process audit

(1) Implementation timing
As a rule, conduct a process audit within one month after application.
(2) Audit result
① When it is judged that the level required by Denso is satisfied, make a special
approval of the subcontractor.
② When it is judged that the level required by Denso is not satisfied, request the
primary supplier to change the subcontractor without making a special approval.
However a special approval of the subcontractor can be made without process
audit in the following cases.
1. Other Division group of Denso has already approved the applicable
subcontractor.
2. The subcontractor is a specialized manufacturer of the standard part and
completed product, and the applicable supplier has been instructed and
controlled.

№ P_SQAM4
Chaper4
4.12.3.2 Notification to suppliers

Purchasing Dept. in charge of Denso notifies the primary supplier (1st tier) of
whether to use the subcontractor with “Application and response form of the
secondary supplier at the critical process for pollution prevention”
(See document No.18).
Note) In this notification, the control conditions regarding pollution control of the
subcontractor are deliberated from the viewpoint of pollution control, but the
quality of the part itself is not judged when the process is changed.
Therefore, the initial product procedure is separately required when a process
is established or changed.
4.12.3.3 Expiration date of special approval

Expiration date of special approval is two years and automatically renewed in
principal.
If a pollution problem occurred or a problem occurred in control conditions, perform a
process audit again to determine whether the special approval can be renewed or
not.

(1) Application
Issue “Application and response form of the secondary supplier at the critical process
for pollution prevention” (See document No. 20) when the supplier plan to utilize
secondary supplier for process of plating, painting, and heat treatment.
(2) Destination
Submit the original to Purchasing Dept. of Denso in charge.

№ P_SQAM4
Chaper4
4.13 Packaging specification preparation procedure

4.13.1 Purpose
This procedure aims to define the suppliers requirements for the safe transportation of
Denso parts.
4.13.2 Scope
Applies to suppliers of parts (products) to Denso.
4.13.3 Explanation
The supplier shall create a packaging specification for the safe transportation
of Denso parts to Denso. However, when Denso requests special requirements to the
supplier, the supplier shall reflect them on the packaging specification.

1. Please establish rules/procedure how to fix packaging specification which assure
Quality level of parts/products.
When the supplier establishes rules/procedure, please make consideration of
environment and operative efficiency.
2. When Denso has special requirement, Denso notifies the supplier. Please follow
the instruction.
3. Appropriate test methods shall be defined and carried out in order to assess the
level of protection from damage, contamination and adverse environmental
conditions during normal transportation.

№ P_SQAM4
Chaper4
4.14 Initial product inspection procedure

4.14.1 Purpose
This procedure explains the initial product inspection as part of the early-stage production
control to implement steadily.
4.14.2 Scope
Apply to parts/products which are delivered to Denso in following cases:
1. The part (product) that is newly traded or ordered and delivered from suppliers to
Denso. (Even if other Mfg. Dept. of Denso uses the same part (product), it is
treated as initial product at Mfg. Dept. that newly placed an order. The standard
parts, however are excluded.
2. The part (product) that is delivered again after delivery has been stopped for at least
one year.
3. Design change part (product)
4. Product whose component is newly established or changed such as approved
drawing type product.
5. Process change part (product) (See Section 4.25 Process change notification
procedure)
4.14.3 Explanation
(1) Definition of initial product
“Initial product” refers to the initial lot produced in the mass production process as
described above Scope 1-5.
(2) Difference between “initial product” and “first product”
The product subject to the following conditions refers to the first product, which is
distinguished from the initial product.
The part (product) produced just after the following cases:
① Machine adjustment
② Setup of jig and tool, die
③ Operation standard change
④ Operator change
⑤ Start of operation

(1) Outline of the initial product sample inspection
The supplier shall submit 3 items which are initial product sample, initial tag and
initial inspection record for inspection.
Regarding the electronic and electrical parts/product except print circuit board that
purchased Part Quality Assurance Center of Electronics Quality Assurance Dept.
is in charge of quality assurance, please suppliers shall submit only initial
inspection record to the Inspection Dept./QA Dept. in charge of Denso.
( Basically initial product samples and tags are not required. )
If required by Inspection Dept./QA Dept. in charge of Denso, follow the instruction.
( This only applied for suppliers who deliver parts/product to Denso )
When the parts/product that is delivered again after delivery has been
stopped for at least one year and that was approved by Inspection Dept./QA Dept. in
charge of Denso, the initial inspection may not be required.

№ P_SQAM4
Chaper4
① Submission inspection date ( Date is required to submit 3 items )

1. As a rule, the submission inspection date is at least 7 working days before
the official delivery date.
2. If required, Inspection Dept./QA Dept. in charge of Denso gives instruction.
3. If it cannot be submitted by the due date, inform Inspection Dept./QA Dept. in
charge of Denso of that effect in advance.
② Submission inspection quantity
1. Sample two initial products ( HAMANAKO DENSO CO., LTD is four ) and two per
cavity (cavity No.1 to n) for the part (product) produced by multiple (n) cavity die
or equipment, and clearly identify with tags to submit this for inspection.
2. Follow the instructions if particularly specified by Inspection Dept..
3. Sample ”Initial product samples” from the initial lot produced in the mass
production process.
③ Initial product inspection item
1. For the initial product inspection at suppliers, measure all the items described in
the drawing and specification
2. The items that affect quality due to change for the design change part or
the process change part
3. The items that affect quality due to rework for initial failure part.
In case that modify die, measure related point other than modification part also
because the point other than failure point may change by die modification.
To inform Inspection Dept./QA Dept. of the related point.
4.In case of similar parts/product, if approved by Inspection Dept./QA Dept. ,
a part of all inspection items may not be required.
(2) Outline of the initial inspection result
① Initial product inspection report
1. To submit original “Initial product inspection report” ( Document No. 7 ) .
2. If an approval was obtained from Inspection Dept./QA Dept., it is enough only to
transcribe the abnormal values in the “Initial product inspection report”
while entering the measurement results in the drawing. Attach that drawing to
“Initial product inspection report” (See document No. 7).
② Material test record
1. When the casting, die-casting, plastic, or rubber parts are newly delivered
(newly ordered part, design change part due to material change), prepare a test
piece based on the drawing or specification (including JIS), and submit it
together with the initial product with a copy of “Material test record” attached.
2. Follow the instructions if particularly specified by Inspection Dept./QA Dept..

№ P_SQAM4
Chaper4
③ No SoC containing evidence data registered list

1. Please follow DENSO CORPORATION Website ”Green procurement”,
and prepare documents ( evidence ) to submit with “Initial sample inspection
report “ to Denso to guarantee no SoC containing in parts/products.
Website URL:
https://www.denso.com/jp/ja/about-us/procurement/green/evidence/
2. When Denso finds any mismatch between report from supplier

and Denso’s analysis of SoC restricted 4 materials( mercury, cobalt, cadmium,
and chromium) , delivered parts/products to be rejected to accept. In principle no
deviation procedure for SoC restricted 4 materials Denso.
(3) Notification of the mass production go or no- go

Denso notifies the mass production go or no-go based on the result of initial sample
inspection report.

№ P_SQAM4
Chaper4
4.15 Production part approval process (PPAP) procedure

4.15.1 Purpose
This procedure give an explanation of Production Part Approval Process (PPAP) of
part/product purchased from supplier how to prepare and submit documents to Denso
based on customer’s special request to implement steadily.
4.15.2 Scope
Apply to parts/products, delivered to Denso, for which when Denso gets request PPAP
submission to its customer.
4.15.3 Explanation
(1) Denso requests PPAP submission by “Notification of QA Requirement”
(Document No.29)
(2) Suppliers may be asked to prepare PPAP in the following cases:
① Before the mass production of new part (product)
② Troubleshooting of current part (product)
③ Change of part (product) due to the technical change in drawings, specifications,
and materials
④ When different material / construction is applied to the conventionally approved
part (product)
⑤ When the mold, jig and tool, etc. are newly produced, added, or replaced
⑥ When modification or re-improvement is implemented to the existing mold, jig and
tool, and equipment
⑦ When the production process and method are changed
⑧ When the equipment, jig and tool are relocated to a different place
⑨ If there are any changes in the part, material, and service delivered from
the subcontractor
⑩ When the supplier restarts production after the process, equipment, mold, jig and
tool were not used in mass production for 12 months or more
⑪ When the supplier restarts production after Denso requests suppliers to suspend
the shipping due to the quality problem
⑫ If the test method and inspection method are changed to a new method

Prepare PPAP according to following production conditions when requested:
１. The part (product) shall be manufactured under the same condition as mass
production, which means the same manufacturing place, mold, jig and tool, operator,
and manufacturing environment.
2. For sampling, the parts (products) shall be manufactured in the time of 1 to 8 hours
by continuous production of 300 pieces or more. If the production quantity differs
from that mentioned above, a supplier needs to obtain documented agreement from
Inspection Dept./QA Dept. in charge of Denso.
3. If there are several lines for one part (product), or the shape of the part (product) is
determined by the mold, supplier must check it per line or per mold.

№ P_SQAM4
Chaper4
Table Required items for PPAP
No. Required item Contents

Parts shipping
1 Fill out and submit parts shipping warranty.
warranty
Appearance approvals
2 Fill out appearance approval report, and submit the approved report.
report
Sample the part (product) from completed products of tryout and submit it.
3 Sample products
However, select from the completed products measured in No.7.
Sample the part (product) from completed products of tryout. However, select
4 Master sample from the completed products measured in No.7.
Suppliers are required to store this sample.
5 Detail drawing Submit all the design drawings about the part (product).
When there is a change in the part (product) but a change in design

Record of design document
6 document is not implemented, submit substitute record of approval change, if
change
there are any.
Measuring results of part Select the part (product) from completed tryout products. Measure its weight
7
(product) dimensions and entered items on drawings.
Specifications of measuring When using unique tool and equipment for inspection and test, specification
8
tool for inspection and test of it needs to be submitted.
Results for material,
Submit test results of the material, performance and durability specified in
9 performance and durability
design document.
test
10 Process flow chart Prepare and submit the process flow chart.
Design failure mode and

11 Conduct failure analysis using FMEA method, and submit the results.
effects analysis (FMEA)
Process failure mode and

12 As above
effects analysis (FMEA)
13 Control plan Prepare and submit the quality assurance process chart for mass production
Process capability Investigate the completed products of tryout for its process capability for
14
investigation result important characteristics and special process. Report the results.
Bulk material requirement

15 Submit if there is a requirement for bulk material PPAP.
checklist
Measuring system Perform a statistical evaluation of measuring system analysis, and submit the
16
evaluation result results.
17 Acceptance of design Submit a record of agreement on Denso’s parts drawings and specifications.
Documentation of Submit the documents that certify the suppliers’ capability to perform required
18
laboratory inspection, test, or calibration of measuring devices.
Record of compliance with

19 Submit the record of performance on Denso’s individual requirements.
individual requirements

№ P_SQAM4
Chaper4
4.16 Part shipment notification procedure

4.16.1 Purpose
Part shipment notification is attached on part/product delivered to Denso to identify if the
part (product) is initial sample or special deviation acceptance etc.. (See document No.15).
4.16.2 Scope
Applies to following cases:
1.Screened part/product from nonconforming lot
2.New part/product
3.Design changed part/product
4.Process changed part/product
5.Restart production part
6.Special deviation acceptance for limited quantity
7.Die deviation accepted part/product
8.Temporary use part/product
9.Early stage control designated part/product
10.Any cases when Denso requests.
4.16.3 Explanation
The part shipment notification is used to identify the difference when parts
(products) delivered to Denso differ from previously accepted parts.

Please attach "Part shipment notification" in following cases.
Please attach "Part shipment notification" on each box.
1. For newly established part, design changes, process changes (permanent), resume
production part, die deviations, temporary use part, and early-stage production
control designated part, shipment notification sheet must be attached to the first
shipment of affected parts.
For Asmo to attach three lots every time.
However, when Denso has many "Next process", the supplier shall attach "Part
shipment notification" for each "Next process".
When Inspection Dept. /QA Dept. in charge of Denso instructs, please follow the
instruction.
After the initial shipment, it is not necessary for the supplier to continue
attaching part shipment notification sheet unless Denso requests the supplier
to continue doing so.
2. For checked/sorting of parts status as a result of a non conforming part and
special deviation accepted part of limited quantity, the supplier shall attach
the parts shipment notification sheet to the outside of every parts shipment
box/pallet until the final countermeasure completed.
However, duration to attach the part shipment notification shall be agreed with Denso.

№ P_SQAM4
Chaper4
4.17 Special deviation acceptance

4.17.1 Purpose
This procedure aims to implement surely by clarifying how to apply to Denso for special
deviation acceptance when the deviated part (product) occurred if they may be used as
they are or after modification.
NOTE: Special deviation acceptance is available only if there is no alternative.
Therefore, ensure the quality control so that special deviation acceptance does not
have to be applied.
4.17.2 Scope
Application for special deviation acceptance shall be made when suppliers study the
following items about the deviated part and judged that it could be used as it is or after
modification.
Inspection Dept./QA Dept. in charge of Denso approves the special deviation
acceptance when it was judged that the deviated part could be used after a study of the
following items and that it was preferable to use the deviated part in terms of delivery date
and economic aspects.
1. How much does it affect the function and performance of the product?
2. How much does it affect the durability of the product?
3. Does it interrupt the operations such as assembly, disassembly in the following
processes?
4. Is compatibility assured?
5. Can it be modified?
6. Are the measures taken to prevent a recurrence of deviation?
NOTE : In principle Denso do not accept deviation permit of critical control designated
items. However, if required special deviation of critical control designation item
necessarily, it is based on table-1.
4.17.3 Explanation
① Classification and criteria of special deviation acceptance are shown in table-1 below.
<Table-1: Classification and criteria of special deviation acceptance >
Classification Criteria
* In case some possibility to affect reliability, performance, and assembling at customer, and
special deviation acceptance (sda)
sda also reworks or additional adjustments of the relevant part or additional performance test
A required at following process.
* Items of critical control designated ( S E ).R F C
* In case some possibility to affect reliability, performance, and assembling

sda
at Customer.
B
* Items of critical control designated ( S E ). R F C
* In case some possibility to affect reliability and performance to some

sda
extent, but can keep production by paying special attention in assembling
C
process.
sda * In case out of inspection standard, but judged almost no affection to

D product performance and following processes.
* In case out of inspection standard, but relevant parts to sda C & D

die deviation
described above manufactured by using dies.

№ P_SQAM4
Chaper4
② Inspection Dept./QA Dept. in charge of Denso checks the “Deviation acceptance

request” form the supplier, and when judged to be accepted, it drafts a plan of special
deviation acceptance category, notifies the feasibility of acceptance and the
conditions for special deviation acceptance after necessary deliberation and
approval. Follow the instructions.
③ Prevent continuation of special deviation acceptance for one month or more for the
same reason by promoting the process improvement to finish special deviation
acceptance early.
However, the following cases are excluded.
1. Special deviation acceptance of die
2. Special deviation acceptance of in-process inventory that will be used up in over
one month.

When suppliers apply to Denso for special deviation acceptance, fill out “Special
deviation acceptance request” (See document No. 14), and submit it with the special
deviation acceptance sample to Inspection Dept./QA Dept. in charge of Denso.
Following items are also needed to respond:
1. For the initial product, attach “Initial product delivery inspection report”
(See document No. 7).
2. When applying for special deviation acceptance of the critical control item,
calculate the process capability index and attach it.
3. When applying for special deviation acceptance of die, attach “Initial product delivery
inspection report”.

№ P_SQAM4
Chaper4
4.18 Reporting procedure of contained substances (components)

associated with the substances of environmental concern
(SoC) regulation
4.18.1 Purpose
The purpose is to report substance contained in delivered parts (products) including
subsidiary materials.
4.18.2 Scope
Apply to cases below
1. All the parts (products) for which “New parts/products notification” is received.
2. The part (product) has change of contained substance (component)
by the design change or the process change.
3. The part (product) for which an individual reporting on contained substance is
requested from Denso.
4.18.3 Explanation
(1) Survey content
The materials used in part (product), also the name, mass or mass proportion of
substances contained in the materials. (Survey includes component parts
and surface treatment if there are any)
When reporting contained substances, it is necessary to divide material into units that
can be regarded as homogeneous (homogeneous material).
(2) Declarable substances

It is necessary to report substance contained in delivered parts (products) including
subsidiary materials.
①Regarding substances regulated by DDS 2004, it is necessary to report when it
contains. Excluding cases where the content rate is lower than the specified
threshold value.
② Denso may request reporting of substances that are not regulated by DDS 2004.
For confidentiality reasons, the total content of non-disclosure substances should
be 10% or less in homogeneous material for substances other than the DDS2004
regulation.
③ It is necessary to report substances contained in the final parts (products) state.
If reactive materials such as thermosetting resins, adhesives and coating materials
are included, please report the final material composition after the reaction.
(3) Use of the reported contents

Denso uses the reported contents to control the substances of environmental concern
and submits to customer in range of the purpose.

№ P_SQAM4
Chaper4

(1) Reporting forms and where to submit the report
① Automotive parts
Please report with JAMA/JAPIA unified data sheet (JAMA sheet) or IMDS
(International Material Data System).
1. Report by JAMA sheet
Please send csv file output from JAMA sheet which filled with necessary data
to procurement Dept. in charge of Denso.
Please download JAMA sheet from JAPIA homepage.
URL is http://www.japia.or.jp/.
NOTE: Please correct error before submission by inputting under macro activated
because JAMA sheet system has error check macro setting
2. Report by IMDS sheet
Please transfer IMDS data after enter the data in IMDS system.
Regarding with the forwarding company ID, confirm with procurement Dept..
When confirm transmission is complete, inform procurement Dept. of
“IMDS-ID/version”.
About IMDS system, please access IMDS homepage.
URL is http://www.mdsystem.com/.
② Non-automotive parts
Please report according to designated procedure of Denso.
(2) The report sheet preparation manual
According to the following manuals in Denso homepage, please make report
sheet (JAMA sheet or IMDS).
https://www.denso.com/jp/ja/about-us/procurement/green/datasheet/
① “The preparation manual of JAMA/JAPIA unification data sheet data”
② “The preparation manual of JAMA/JAPIA unification data sheet, IMDS report data”
(3) Report timing
① Regarding with the product received “New parts/products notification”, has
change of contained substance (component) by the design change or the
process change. In principle supplier shall report to Denso before delivery.
However, if required by relevant Dept., follow the instruction.
② If Denso requests individual reports, follow the report timing required.
(4) Basic caution point of report
①Investigation trace back to the supply chain
Regarding parts and materials purchased at supplier, please report the
contained substances with investigation trace back to the supply chain.
②Confirm the report data
Part/product shall be consistent with the reported data of contained
substance (component). Please don’t submit wrong data such as
copy from similar product, CAS No. of similar product, application code error.

№ P_SQAM4
Chaper4
4.19 Material control procedures

4.19.1 Purpose
This procedure aims to ensure quality control of materials which are used for parts
(products) delivered to Denso by describing items to be done.
4.19.2 Scope
Apply to materials of parts (products) delivered to Denso.
4.19.3 Explanation
As a general rule, supplier shall procure materials. But in case shown item 4.19.3.2,
please get materials supplied from Denso.
4.19.3.1 Self-procurement materials

Self-procurement materials are defined as materials what suppliers procure by their
own.
Meanwhile supplier shall have responsibilities for quality, ordering, procurement etc.
of materials of which unit price are set by Denso through central purchasing system
as well as self-procurement materials.
4.19.3.2 Supplied materials

Supplied materials are defined as materials supplied from Denso.
(1) Supplied materials intended
① Designated materials to supply from Denso
1. Critical control designated material (material of which characteristics or
composition etc. are critical control designated by drawing of Denso.
However, materials of rubber & spring are exempt.)
2. Materials designated by Denso
Surface-treated steel sheet (SECC-E、SGCC-E), Copper wire for coil
(flat-shaped and round-shaped wire)
② Materials of which negotiation with material manufacturer/agent is handled by
Denso.
In following case Denso Purchase Dept. will handle negotiation with material
manufacturer/agent in consultation with Material Procurement Section.
1. In case suppliers have difficulty to procure by their own.
2. In case unit price of their own procurement is much higher than Denso.
(2) Procedure to get supplied materials
① When supplier get supplied materials from Denso, please submit “Material
supply application form”(Document No.19) to relevant Purchase dept.
Please refer lead time following table and confirm Material Procurement
section individually when supplier submit application form.

№ P_SQAM4
Chaper4
Guideline of lead time of materials

Classification Material Lead time
Steel
4 months (start from melting process)
Require starting from first process of
3 months (start from melting process)
manufacturing. Non-ferrous metal
3 months (start from admixing process)
nonmetal
Steel 3 months (start from rolling process)
Require starting from intermediate process 2 months (start from rolling process)
of manufacturing. Non-ferrous metal 2 months (start from coloring/granulating
nonmetal process)
Steel 3 weeks
Existing materials but new dimension
Non-ferrous metal 3 weeks
nonmetal 3 weeks
Changes such as tolerance/ test methods/ After runout of stock or as soon as ready for
All materials
packaging. operation
② Procedure to cancel registration of supplied material.
When supplier does not need to get materials supplied from Denso, please
unregister the material promptly with “Material Supply Application Form” .

4.19.4.1 Material quality control
(1) Confirmation of material specification
① Self-procurement materials
Supplier shall confirm material specification and contract with material
supplier.
② Supplied materials
Denso shall contract with material supplier, therefore please get copy of
material specification from relevant Purchasing Dept. after application of
material supply.
(2) Material inspection record control
Supplier shall implement followings:
1. Please verify if shipping slip and identification tag are matched at Receiving
Inspection of materials and check if no damages/abnormality of package or
appearance.
2. In principle, please obtain material characteristics test report of each
production lot basis from material manufacturing supplier and check details
and keep them as suggested.
② Direct supplied materials
Direct supplied materials are defined that delivered to the supplier from
material supplier directly.
1. Please verify if shipping slip and identification tag are matched at
receiving inspection of materials and check if no damages/abnormality of
package or appearance and keep record of inspection.
2. Please obtain material characteristics test report of each
production lot basis from material manufacturing supplier and check details
and keep them as suggested.
3. Please perform receiving inspection. Please follow instruction from
material Inspection Dept. of Denso what & how to check.

№ P_SQAM4
Chaper4
③ Supplied materials
(Supplied materials refer to those materials delivered to Denso and then
supplied to each parts/products supplier)
1. Please verify if shipping slip and identification tag are matched at
receiving inspection of materials and check if no damages/abnormality of
package or appearance.
2. Supplier shall request material inspection Dept. in charge of Denso to
get copy of material characteristics test report of each production lot
when needed.
(3) Production Lot Control of materials
Please conduct production lot control system to minimize the loss such as
relevant parts/products sorting cost, claim cost etc. resulted by material
problem.
(4) Actions to be taken for material problems
Please make efforts to prevent reoccurrence by demanding to find real
cause and have countermeasure.
② Supplied materials
Please inform Material Inspection Dept. in charge of Denso of detail of
defect and fill in “Supplied material defect notification” (Document No.20) as
required, then submit it to relevant responsible section of material control.
Material classification and Sharing of responsibility for material quality assurance
Sharing of responsibility for material quality assurance
Obtainment and
Material classification Material spec
Quality check at retention of Taking
Material spec confirmation and
receiving material countermeasure for
pursuant to contract with material
inspection characteristic test material defect
supplier
report
Self- No indication in
procurement Supplier Supplier Supplier Supplier Supplier
the drawing
materials
(including
materials set Indicated in the
Denso
unit price by drawing Supplier Supplier Supplier Supplier
(DDS)
Denso)
Denso
Denso Denso
Direct supply Supplier Supplier (Material
(DDS) (Purchase Dept.)
Inspection Dept.)
Supplied
materials
Denso Denso Denso
Denso Denso
General supply (Material (Material (Material
(DDS) (Purchase Dept.)
Inspection Dept.) Inspection Dept.) Inspection Dept.)

№ P_SQAM4
Chaper4
4.20 Parts supply procedure

4.20.1 Purpose
This procedure clarifies the control procedure of the parts supplied by Denso and the
action when a defect is found, to implement steadily.
4.20.2 Scope
Apply to parts supplied by Denso.
4.20.3 Explanation
(1) Definition of supplied parts
Supplied parts are defined as follows.
① The parts that are supplied to suppliers after processing at Denso
② The parts that are supplied to suppliers through processing at Denso after they
are delivered from suppliers to Denso and accepted
③ The parts and raw materials that are supplied directly to suppliers after they are
delivered from suppliers to Denso
④ The parts that are directly delivered to supplier from another supplier without
involving Denso (hereafter, referred to as direct delivery to supplier from another
supplier).
NOTE: ①-③; call general supplied parts. ④; call direct supplied parts.

(1) Control of supplied parts
Specify the maintenance and control method for check and storage of the supplied
parts in the procedure manual to ensure control.
① Identify the whole of the supplied parts by a list and clarify its identification of each
supplied part.
② Perform receiving inspection for the supplied parts. Consult with Inspection Dept.
/QA Dept. in charge of Denso about the inspection methods and items.
③ Always stratify and control the supplied parts to ensure first-in first-out.
④ Make sure to check for defect such as deterioration of the supplied parts that have
been stored for a long time before usage.
(2) Actions to be taken for defective supplied parts
When a defective part was found in the supplied parts, follow instruction below.
① In case of general supplied parts, notify Inspection Dept./QA
Dept. in charge of Denso and get instructions.
② In case of direct supplied parts, follow instruction below.
1. If it is a critical defect that seriously interferes with the production of Denso,
notify Inspection Dept./QA Dept. in charge immediately and get instructions.
2. Other than No.1 , please handle between the suppliers.
NOTE: If supplier can’t judge, inform to Inspection Dept./QA Dept.

№ P_SQAM4
Chaper4
(3) Defect compensation of supplied parts

When the supplying destination found a defective supplied part, it can demand
compensation from Denso.
① Delivery of alternative parts
The supplying destination can demand the delivery of alternative part from Denso
for the supplied parts and from the supplier directly for the direct delivery parts.
② Screening and rework costs
When the supplying destination screened or reworked the defective parts, they can
demand the cost such as labor charge taken for these from Denso. The supplying
destination can order the supplier to screen and rework the defective parts with the
consents of Denso and the supplier.
③ Demand of defect compensation
The supplier fills all the necessary items [received date, received quantity, part
name, part number, defect occurrence date, defect contents, action conditions,
material cost, rework man-hour (assembly, reassembly), screening man-hour, and
others) in writing and makes an offer to Inspection Dept./QA Dept. in charge of
Denso.

№ P_SQAM4
Chaper4
4.21 Lot control procedure

4.21.1 Purpose
This procedure clarifies the procedure of lot control, what and how to do when any quality
problems of manufactured parts/products occur at following processes, to aim at prompt
countermeasures by finding its root causes and the range affected.
4.21.2 Scope
Apply to parts/products and also materials of parts/products delivered to Denso.
4.21.3 Explanation
(1) Definition of lot
The lot refers to a group of materials, parts, and products that are manufactured
under the same conditions (date, operator, equipment, manufacturing condition, raw
material, and others).
(2) Setting of lot number
The lot number is set to identify when the applicable material, part, or product is
received, processed, and assembled. The charge number and manufacturing number
of each supplier are used as lot number.
(3) Notification of lot control designation and required actions
When Denso request lot control designation, Purchasing Dept. in charge of Denso
notifies the supplier either of following 3 methods.
① ”Notification of QA Requirement” (Document No.29)
The suppler to reply with “QA confirmation results report” (Document No.4).
② “Lot Control requirement” with “Notification of Lot Control
Designation/Cancel/Draft/Approval)” (Document No.35).
The suppler to reply with “Lot Control Implementation Review Meeting Result
Report”. ( Document No.23).
③ Indicate or stamp an indication of “Lot control directive part” in the drawing or
specification supplied from Purchasing Dept. in charge of Denso to notify suppliers
of lot control designation.

1. For the lot control directive part, fill in the necessary items such as lot number in “Lot
control tag” (See document No. 13), perform first-in first-out, and deliver each lot with
lot control slip attached to the actual parts.
2. Keep a record for traceability.
3. Even if no request of lot control from Denso, if it’s judged necessary to do,
please implement the lot control.

№ P_SQAM4
Chaper4
pass etc.
next process H○○○
date
box Baｇ

№ P_SQAM4
Chaper4
4.22 Quality troubleshooting procedure

4.22.1 Purpose
This procedure clarifies the report and action methods to perform troubleshooting
immediately and reliably in case of problem.
4.22.2 Scope
Apply to all quality-related problems of products and parts, which are found in the
manufacturing and inspection processes.
4.22.3 Explanation
(1) “Problem” means the operation, process (5M1E) or deki-bae is different from usual.
* Defect is an item out of specifications in inspection / process check, so please
distinguish it from abnormality. (Even if a product satisfied all standards and
passed the inspection, it may be an abnormal).
Please refer to Table-1 “Problem details and concrete examples”
(2) “Troubleshooting” is activity secures product quality by quick report, investigation,
countermeasures of the cause, recurrence prevention when problem is found.
(3) “Delivery stop” is to stop delivery and transfer inside factory briefly in order to take
action such as verification, rework, sorting, replacement, etc. if quality problem or
suspect status is found.

№ P_SQAM4
Chaper4
<Table-1 Problem details and concrete examples>
Item Problem Concrete example
When the physical

·Jobs cannot be performed properly any longer.
Man condition of worker get
·The work pace has become slower.
worse
·The equipment fault lamp often lights

up.
·Water or oil leakage was found.
·Short time machine down times is increase
When an unusual or decrease.
Machine phenomenon occurred in ·The jig was damaged or worn out.
(1)When the operation or equipment and jig ·Operation of the equipment became slower
process (5M1E) is than usual.
different from usual ·Some parts are left in the equipment.
(Abnormality of the ·The number of dropped parts has increased.
causes)
·The charge amount of sealing agent is different from usual.
When an unusual amount,
Material ·There was missing part(s) or excessive part(s)
weight, hardness, or
5M1E is (parts) when assembling.
accuracy was felt
·It is hard when setting the parts on the jig.
Man
·The part cannot be completed within
Machine the specified time.
Material When the operation ·Actual steps of a job are different from job
Method cannot be performed
Method instruction standard.
even if it is done as
Measuring ·Input value is different from the processing
mentioned in the manual
Environment condition table.
·The shape of soldering fillet is unsatisfactory.
When ·Judgment is difficult with the boundary sample.

Measuring acceptance/rejection
judgment is difficult ·The NG master is not judged as “NG”.
When an unusual noise, ·Pump noise is higher than usual.

·An abnormal noise was heard while
Environ-ment color, touch, or smell was assembling.
felt ·Broken pieces of the part scattered around.
·The dots went over the limit line.

When a pattern of dots in
·The central value deviated, and points
the control chart shows a
concentrated near the control limit line.
problem ·The trend of pattern is unusual.
When the defect which

·A defect not included in P chart occurred.
never occurred was found
·An occasional defect continuously occurred.

When more defects than ·Defect ratio on P-chart became high.
usual occurred ·The number of rework in the reworking record
sheet has suddenly surged.
(2)When the integrity of product is
different from usual When a chronic defect
·A chronic failure suddenly stopped to occur.
(Abnormality of the results) stopped to occur
·The defect of critical control designated item occurred.

When a critical defect ·Although a pokayoke and an inspection are
occurred implemented in the previous process, a defect
has been occurred.
·Although a countermeasure was taken,

When a defect similar to
a defect is occurred again.
that occurred in the past
occurred ·A defect similar to the past one which
a countermeasure was taken is occurred.

№ P_SQAM4
Chaper4

Suppliers are asked to specify the concrete problems based on the Table-1 above.
( The contents of problem is recommended to be described by concreate phenomenon
which is intelligible for associate.) Establish the rules suited to the actual conditions of
suppliers, perform immediately and surely, referring to 4.22.4.1- 4.22.4.3.
When a problem occurred, when acceptance/rejection judgment is difficult, and when a
defective part may outflow, immediately inform Inspection Dept./QA Dept. in charge of
Denso.
4.22.4.1 Reporting and handling route when a problem was detected

Please make report/action rules for finding problem based on chart below.
ＢＣ
(Example) Ａ Managenal class who Upper QA responsible
Detector
received a report managenal class personnel
(Operator) （Supervisor） (Manager)
ＦＧ
Ｈ
Managerial class Upper managerial class
can be taken is necessity In following case, to inform related
Denso group company's inspection
Notification of fact Ｄｄｅ dept. as soon as possible.
Ｅ
* Defects could have been
Instructions for delivered to Denso group
troubleshooting company.
Troubleshooting Dept.
Report of results * New type defect was found,
but its real cause unknown.
* Defects increased unusually.
Managerial class can be taken ･･･Ａ→Ｂ→Ｄ→Ｅ→Ｆ
Upper managerial class is necessity･･･Ａ→Ｂ→Ｃ→ｄ→ｅ→Ｇ
№ Item Contents
Ａ Report of problem The detector reports to the supervisor (managerial class).
Report to the upper The managerial class who receives a report, reports to the upper managerial class about
Ｂ managerial class the problem and own troubleshooting plan.
Report to the QA The upper managerial class who receives a report, checks the problem contents, and
Ｃ responsible personnel reports to the QA responsible personnel about the problem and its troubleshooting plan。
Instructions for Give the related person (Dept.) the instructions for troubleshooting after checking the
Ｄ･ｄ troubleshooting actual part at site.
Report of troubleshooting
Ｅ･ｅ results
Receive the troubleshooting results from the related person (Dept.).
Report to the upper

Ｆ managerial class
Report the troubleshooting results to the upper managerial class.
Report to the QA
Ｇ responsible personnel
Report the troubleshooting results to the QA responsible personnel.
In case of potentially defective part/product flow-out risk or critical issue, supplier shall
Ｈ Report to customer
urgently notify Inspection/QA section of Denso/Denso group companies.

№ P_SQAM4
Chaper4
4.22.4.2 Troubleshooting implementation items

Please make troubleshooting implementation items based on Table-2 below.
<Table-2 Troubleshooting implementation examples>
Step Implementation Concrete example
･When a problem is found, stop the process and equipment,

and stop work.
･Treat it as a problem when it is unclear if it falls under a category
of problem.
･In case of stopping the process, maintain “1 cycle stop” policy.
(1) Action taken when Follow the practice of
･Report the discovery of problem to the Managerial class.
a problem is found “Stop”, ”Call”, ”Wait”
･Maintain the present condition of the equipment and the defective
products, and do not change them.
･Do not restart production until Managerial class instructs.
･When there are problems with the equipment, put up a notice
not to operate the equipment.
･Confirm that the process and the equipment have stopped.

Go and see on site to confirm
･Sort out the situation in which the problem is found.
a. Sort out the the situation and determine if it
(Product or part name, problem’s phenomenon,
situation falls under a category of
date and time, location and discoverer etc.)
problem
･Determine whether it falls under a category of problem.
･Confirm whether the products/parts are satisfying the drawing or standard work.
･Do not determine that there is no adverse influence on quality just by passing the
(2) Primary decision
b. Confirm the Go and see on site to confirm inspection or following the standard work, make a judgment based on the problem’s
influence on the influence on the product phenomenon. (There are problems that can not be detected by the existing
quality quality inspections or
the standard work as well)
･If it is difficult to make a judgment, make a judgment in stricter manner.
･if there is a problem of an adverse influence on product quality, do not restart

production, and make a judgment of production stop.
Make a primary decision of
(Do not expect that all defect products are rejected by inspection
“production stop” or “restart
c. Primary at post process)
production” based on the
decision on ･Determine whether the operation can be continued based on the possibility of
quality and equipment aspect,
hold or not equipment problem.
and instruct the result to
･Do not make a decision based on a production plan.
discoverer
･If the decision can not be made, report it to the upper managerial class and ask for
their decision.
･Make the prompt report directly and quickly based on

the actual problem product.
･If the 1st managerial class is not available, report it to
Directly and quickly report the
upper managerial class
(3) Prompt report of problem situation and the
･When working on the night shift or on a holiday, report to
problem result of the primary decision
responsible person who has been designated as the report
to the upper managerial class
destination.
･If there are possibility of an adverse influence at next process,
notify to managerial class of next process.
(4) Investigation
･Classify the cause into either “own process” or “parts or materials” that go into the
process. Request cooperation from the related sections if needed.
･Proceed with the investigation by comparing with the change
a. Cause
Investigate the problem cause history of the parts and the process (5M1E).
investiga-tion
･The factor of equipment wear out failure is hardly seen in the control characteristic,
and it easily leads to long term and large volume failure, investigate it without over
looking.

№ P_SQAM4
Chaper4
･Identify the range of the suspect lot based on the problem

cause.
･Do not exclude the product from suspect lot just by passing the
inspection or following the standard work, make a judgment based
Identify the range of the on the problem phenomenon. (There are problems that can not be
suspect lot based on the detected by the existing inspections or the standard work as well)
b. Identification
cause, and instruct its ･Determine the initial products of the suspect lot, and stop their
and Sorting of
classification (If there is outflow to outside of company with the utmost priority.
suspect lot
an adverse influence on If the initial products have already gone to the next process,
product quality) work on the issue with managerial class of next process.
(4) Investigation
･If they have already been shipped to outside of company,

notify Quality Assurance Dept. immediately.
･Products of the suspect lot shall be marked and sorted by storage location, by returnable
container or by product so that anyone can recognize them.
･Do not work on all issues by oneself, proceed with the allocated
plan with managerial class.
Develop a
･Confirm that temporary countermeasure does not have
countermeasure plan
c. Instruction of an adverse influence on the quality.
against the problem cause,
countermeasure ･If the countermeasure falls into a category of process change control (5M1E) or process
and proceed with the
s for the cause change, perform the procedure depend on change point and confirm quality.
allocated plan with the
･In case of equipment repair, identify the task allocation for the section in charge of the
related sections
repair and production section.
Especially proceed with the task of quality check after completing the repair.
･Confirm that the problem cause is identified, furthermore

confirm that countermeasure is based on logic.
･Do not let the product pass by the temporary inspection
without identifying the cause.
･If the defective phenomenon is the same as a single failure from the past, do not judge it
Go and see on site the
as a single failure as long as its cause is not identified.
a. Verification of content of the primary
･Confirm the quality from both sides of causes and results.
whether to decision of the managerial
･Confirm by oneself that the outflow prevention is implemented
restart class, and determine the
without failure.
production validity of restart
･If changes are made in the process by the countermeasure, determine whether it is
production possibility
necessary to inform of the process change. (Consult with Quality Assurance Dept. as
(5)Judgment on initial response
needed)
･Do not make a decision based on product shipping or
production schedule.
･Obtain approval of the managerial class by status above.
･If the shipping parts include quality failure or a possibility of quality failure, report it to
Determine the shipment managerial class and obtain an approval for shipment stop.
b. Shipment stop
stop based on the ･Announce the shipment stop and request the related sections for actions.
judgment
condition of product ･Confirm by oneself that the shipment stop is implemented
without failure.
･Determine the initial products of the suspect lot, and stop their
shipment with the utmost priority.
Stop shipment and sort ･Products of the suspect lot shall be marked and sorted by
c. Shipment stop the products storage location, by returnable container or by product
(When shipment ･Do not ship the shipment stop products until they are
stop is approved by managerial class .
announced)
･Stop the transfers inside of factory and identify the initial
Stop the transfer inside of
products of the suspect lot.
factory and sort the
･Products of the suspect lot shall be marked and sorted by
products
storage location, by returnable container or by product

№ P_SQAM4
Chaper4
･Confirm that "Since when" the products have been shipped to

outside of company and "Its reasoning".
Materialize the method for
･Determine the method for handling the shipped products from
handling the products that
a "Customer's perspective".
a. Examine the have already been
･Determine the necessity of replacement, sorting and rework,
handling of the shipped to outside of
etc. and materialize their methods.
shipped products company. (When the
･Do not make a snap judgment based on past quality results
suspect lot have already
and case examples, and judge that the products/parts
been shipped)
satisfy the drawing specifications.
･Confirm that the problem cause is identified, furthermore

confirm that countermeasure is based on logic.
Materialize the criteria for
･Based on the countermeasure content, materialize the quality confirm items that
whether or not to ship the
determine the good or NG of the product quality
products after restarting
･Determine if it falls into a category of process change and if it is necessary to report to
production
the customer.
b. Examine the
condition for
･Based on the problem cause, logically examine whether the suspect lot (shipment stop
cancelling
products) can be shipped or they should be 100% scrapped.
(6) Examination of actions
shipment stop.
･When shipping the suspect lot products (shipment hold products), determine the
(When shipment
necessity of sorting and rework. etc. and materialize their methods.
stop is Materialize the criteria for
･Do not determine just by the result of the existing inspection,
announced) whether or not to ship the
make a judgment based on the problem’s phenomenon.
products from the suspect
(There are problems that cannot be detected by the existing inspections as well)
lot (shipment stop
･Do not make a decision based on product shipping or
products)
production schedule.
･When rework or deviation is necessary, proceed with
following the related regulations for each.
･Determine whether it is necessary to call a countermeasure meeting.

･At a countermeasure meeting, related parties get together to share information, conduct
investigations and make decisions by utilizing the specialty of each section.
･Confirm and take corrective actions on the contents of "Primary decision", "Investigation",
"Judgment on initial response“
and "Examination of actions", and determine how to proceed
Confirm the progress of
c. with the action.
problem handling, and
Countermeasure ･The matters related to drawings and design quality (strength, reliability, etc.) must be
discuss the incomplete
meeting consulted with the management of the section that is in charge of the design.
items of the problem
･If there is a possibility of having an adverse influence on other production lines or other
handling
products due to problems with the purchased parts, etc., request its related sections to
take actions.
･Forward the meeting minutes to the related sections and
store them as a record.
･When it is determined that the matter does not require a countermeasure meeting,
forward the information to the related sections.
･Report the result of the actions to the managerial class

by document or electronically.
Put together the overall ･The report item are “Situation when problem is found”, ”Investigation
(7) Reporting and actions of the problem result”, ”Condition of shipment stop announcement”, “Result of restart
recording of results handling, report and production”, “Result of cancelling shipment stop”, “Result of the
record actions taken on the shipped products”, “Standardization plan”, etc. .
･Forward the report results to the related sections,
and store them as a record.
･Review to strengthen the control in order to prevent the occurrence

of problem cause.
Standardize the lessons
･Review the addition of quality check items that can detect problems.
learned from problem
(8) Standardization ･Standardize the action detail when an identical phenomenon occurs.
handling to prevent their
･Standardization shall reflect not only the on-site standards
recurrence
(operation manual, processing condition chart, etc.) but also the
quality process control plan and the inspection standard.

№ P_SQAM4
Chaper4
4.22.4.3 Training and instruction for problem report

Ensure training and instruction so that the operator and the managerial class can
immediately report when a trouble was found as well as can fully understand the
definition of problem.
position Training details
1. Make sure to teach the operators the correct operation (standardized

operation) and its workmanship. Especially when 5M1E (Man, Machine, Method,
Material, Measuring, and Environment) was changed, train the operators to pay
attention because a trouble easily occurs.
2. Check whether the operators operate as specified in the standard, consciously
and on purpose, to find and correct a deviation from the standard.
Supervisor
3. Evaluate and train the operators about the problem for following issues.
① Detection ability
② Accustom operator to report immediately (Do not blame the operators even
if there is a mistake in the report.)
4. Post the action standard of problem reporting at each work site to enhance the
consciousness.
Evaluate the supervisor about standard compliance training and problem report training, and implement
Manager
training for the unsatisfactory items to level up.
4.22.4.4 Procedure of the case of defect flow out to customer of Denso or

found at Denso
(1) Continue production activities
Supplier shall conduct sorting/rework operation for stock (parts/products) at
Denso or customer of Denso under close liaison with Inspection Dept./QA
Dept. of Denso to keep production activities at customer of Denso and
Denso.
(2) Determine cause and tentative countermeasure
Supplier shall take prompt action to find out real causes and check flow out of
nonconformity and also take proper tentative countermeasures under indication of
quality responsible personnel.
Note: Please keep records of finding out real causes and tentative
countermeasures.
(3) Procedure of countermeasures for nonconformity (recurrence prevention)
Supplier who received “Quality problems report“ (Document No.26/27) shall fill in
the form such as nonconformity real causes of occurrence, flow out,
countermeasures and those results concretely, then please submit Inspection
Dept./QA Dept. of Denso by due date.
(4) Quality check and delivery procedure of parts/products produced after
countermeasures for nonconformity
In case implemented countermeasures for nonconformity accomplished with
design change or process change, please follow procedures “ 4.14 Iinitial sample
inspection procedure “ and “ 4.25 Process change application procedure “ as well.
4.22.4.5 Application procedure of deviation permit

In principle supplier cannot deliver parts/products those are out of spec. However, as
a special exceptional case that means potential serious risk such as line stop at
customer of Denso, in addition when Denso and supplier judge that they can be
used after rework due to the degree of nonconformity, supplier can deliver them to
Denso after getting approval by submitting deviation permit application for limited
term or limited quantity.
Please refer “4.17 Deviation permit application procedure” for details.

№ P_SQAM4
Chaper4
4.23 Rework procedure

4.23.1 Purpose
This procedure clarifies implementation items to prevent quality problems caused by
rework operation.
4.23.2 Scope
Apply to rework operation of parts/products.
4.23.3 Explanation
It is a policy that no rework shall be done. However, if there is no choice but to rework the
product, it is required to ensure same quality of the reworked parts/products as
parts/products in the regular process.
(1) Rework shall correspond to any of the following three items[(1)～(3)].
However, rework done in the normal process without changing the product/part (like
resetting when setting error occurs), recheck, and adjustment work without
disassembly such as performance adjustment shall be excluded from rework.
① Work performed to make the rejected product into the good one
Ex.) - To add the part that is missing
- To correct the insufficient insertion of the connector or hose
- To disassemble the product and replace the defective part with the good one
② Work performed to take only the good parts out of the rejected product and to put
them into the normal line.
Ex.) - To disassemble the product and dismount the part or sub-assy that can be
used then put it into the line
③ Assembling/machining work performed by the operator, which shall be done in
the automated process.
Ex.) - To tighten the screw manually with the screwdriver instead of the automated
process.
(2) Rework in the line is likely to cause operational errors, thus avoid it as much as possible.
Rework in the line means rework in the normal process and rework outside the line
means rework are done at the special workplace for rework.

(1) Study and approval of whether the rework should be done or not
① When a defect occurs at a new line or a new type of defect occurs at an existing
line, ascertain whether rework of defect shall be done or not.
② Create a process that satisfies the rework requirements shown on [Table-1 below]
and get approval from QA responsible personnel.
③ Periodically review whether there is a rejected product that shall be disposed
without rework under the basic policy of “no rework”.
④ Get instruction by E-mail/written application form from Inspection Dept./QA Dept.
in charge of Denso when supplier plan to rework the area where related critical
control designated items （refer item 4.9 ) prior to rework.
(2) Rework record

① As for the reworked product, record the rework details such as lot,
and quality check result of the reworked product.
② Follow the instruction for identification etc. when the supplier got instructions from
Inspection Dept./QA Dept. in charge of Denso.

№ P_SQAM4
Chaper4
(3) Key points of Rework operation

① Basically, “Rework operation shall be accomplished once it is started” in order to
prevent the nonconforming product, missing parts, unfinished product, etc. from
flowing out. Thus, pay attention not to bring the unfinished rework product to the line
while the line is running.
② Always perform 5S thoroughly at the place where rework is implemented, and be
extremely cautious about any flaw, dent, deformation, foreign materials etc. not to
occur on not only reworked area but also other sections of part/product.
Table 1: Rework requirements
Item Requirement
1. There shall be a special workplace for rework, and a sign, etc. shall
indicate the workplace.
Workplace 2. The product before rework, the reworked product, and the product to dispose shall be sorted by allocating the
(Except rework different space for the workpiece, separating boxes by color, identification of the actual product, etc.
in the normal 3. Necessary equipment and tools for rework shall be provided.
(Necessary equipment and tools shall be specified on the rework instruction sheet.)
line)
4. Workplace environment like lighting shall be provided as needed so
that the work and its check can be ensured.
1. There shall be the rework instruction sheet.

For the work at the special place for rework, it is essential that the rework instruction sheet is prepared. For
the rework in the line (however, it shall be minimized), it is possible to add the instruction to the normal work
instruction sheet.
2. The item that can be reworked (= reworkable item) shall be specified.
3. Work steps and work details shall be specified for each rework item.
Rework (Potential negative influence by rework operation shall be considered)
4. The non-reusable part and the reusable part shall be predetermined.
instruction
5. Check items and criteria for the reusable part shall be specified.
sheet 6. Inspection items and criteria for the reworked product shall be specified.
7. When, where, and how to put reworked products into normal line to be specified.
8. All the items of the reworked product shall be inspected at the normal inspection
process.
9. When the product is disassembled and reloaded, checking method for preventing
wrong parts shall be clarified (like identification, indication and controlling methods of
the extra parts and space).
1. The operator certified for rework* shall be predetermined and indicated.

(This can be omitted for the rework in the normal line.)
*The highly skilled operator has been trained.
2. The operator can work (tell) according to the work instruction sheet and shall actually works.
Operator
3. The operator shall understand that “unusual failure mode different from the usual one shall not be reworked
and shall be reported and shared with supervisor”.
4. The operator shall understand that a special action is necessary like using the identification control tag if it is
inevitable to interrupt the rework operation.
Identification , 1. The rework record shall be included part No., date, reworking detail, product quantity, and operator name.
indication / (This step can be omitted for the rework inside the line.)
Record 2. Control the reworked products so that they can be sorted with clear identification etc.

№ P_SQAM4
Chaper4
4.24 Boundary samples/Master samples preparation procedure

4.24.1 Purpose
This procedure aim to share exactly same quality criteria of parts/products between the
supplier and Denso for them Denso or Denso’s customer has visual quality
requirements.
4.24.2 Scope
Applies to parts/products from supplier to Denso with appearance criteria of quality etc.
4.24.3 Explanation
(1) Boundary samples
① Boundary samples are used to define the boundary level of characteristics which
are difficult to define by quantitative methods.
② Boundary samples may be temporary or permanent.
Denso normally operates using boundary acceptable samples, however
boundary non-acceptable samples may be used as well when requested by
Denso.
(2) Master samples
① Master samples define the expectations of Denso or the customer of Denso for
part visual characteristics.
② Master samples to be used to inform suppliers of Denso's QA requirement items
to be followed by the supplier.

1. If Denso requests boundary or master sample(s), the supplier must submit sample(s)
for mass production level parts. When the sample is so small that difficult to see or
check, please submit magnified photograph instead of the sample.
2. Boundary samples are created on an “as needed” basis when acceptance judgment
questions arise.
3. Boundary samples and master samples must be submitted to Denso under approval
of the supplier’s quality assurance engineer or manager.
4. At least two sets of samples must be submitted to Denso.
One set will be retained by Denso and the other returned to the supplier.
5. Each part must be clearly labeled using an identification form.
The form shall be used defined by each Dept. in charge of Denso.
6. For sub-supplier appearance items, the supplier must develop agreeable samples
with the sub-supplier for Denso approval.
If necessary, the sample(s) can be developed with Denso and negotiated and
approved by all three parties (Denso, supplier, and subsupplier).
At least three sets of samples are required, and each one shall be kept at each
related Dept..
7. The sample form must be filled out with all descriptive information, however
control number and period of validity of the form to be instructed by Denso.
8. Temporary Boundary samples may be approved.
In such cases, a countermeasure plan must be submitted detailing the problem and
corrective actions.

№ P_SQAM4
Chaper4
9. Master sample approval is based on visual and/or numerical evaluation.

Emphasis is given to visual comparison of the master color and/or
mating components.
The method used for numerical data collection must be the one which best replicates
the operative technique or visual standard required by the customer.
10. Revisions, changes or renewals must be resubmitted according to the above
guidelines.
11. Suppliers are responsible for maintaining color control with a system which
documents the color history of parts provided to Denso and which is in
accordance with the Master sample.
12. When the sample(s) reach the expiration date, the supplier must resubmit the
sample(s) to Denso.
13. Boundary samples/ Master samples are to be stored to protect the condition of
the parts for the life of the parts supply, as a quality record.

№ P_SQAM4
Chaper4
4.25 Process change notification procedure

4.25.1 Purpose
This procedure describes the notification method to Denso and related items when
suppliers change the process to implement accordingly.
4.25.2 Scope
Apply to changes of 5M1E (Man, Machine, Method, Material, Measuring, and
Environment) comprising the process.
Note) For the change related to the drawing descriptions, notify using “Application form
for revision of the items of purchased product and part”
Please refer “4.26 Design change request” for details.
4.25.3 Explanation
① Regarding changes of 5M1E (Man, Machine, Method, Material, Measuring, and
Environment) comprising the process, Denso specified the control target and method
of such process change, considering the past record, and the degree of influence on
quality. It is required control according to the procedure.
② The items to be definitely notified when the process change plan is determined are
set based on the following concepts. (See “Table 1: Items requiring process change
notification" for details)
1. Change of the conditions that cannot be easily detected by visual inspection or
measurement of the completed product
2. Change of the items such as die that decide the fate of quality
3. Change of the items that mainly caused the past quality problem
4. Change in shape required of the part whose design and manufacturing are left
entirely up to suppliers
5. Process change at secondary and subsequent suppliers
6. Other items approved as especially required
③ Action of Denso after notification
1. Inspection Dept./QA Dept. in charge of Denso judges if initial sample
inspection report required or not by confirming process change details at supplier
based on application form from supplier.
Denso may request supplier to review process change details when judged it’s
required.
Thereby, Denso notifies supplier of necessary data to submit and caution points
of quality check to change process with “Process change response form”
(Document No.10) in writing via relevant Purchase Dept.
(In some case, Denso may reject the process change at supplier.)
2. For those to which it is replied that the process investigation to be implemented,
follow up the notification items.
3. For those to which the submission of inspection of the initial products is
determined to be required, Denso performs inspection according to the initial
product inspection procedure (See 4.14).
4. When it is judged that the change shall be reflected into the drawing, Denso
may contacts suppliers to request to submit “Purchased product and part
description revision application”.

№ P_SQAM4
Chaper4

4.25.4.1 Creation of process change notification
① Format
Please use “Process change request and notification sheet” (Document No.10)
② Creation procedure
Please refer to the procedure in “Process change request and notification sheet”
4.25.4.2 Submission of process change notification

① Process change application to Denso shall be applied 3 monthsNOTE-1
prior to the planned date of change with “Process change request and notification
sheet” (Document No.10)
Please submit documents described above to Purchase Dept. in charge of
Denso. However, in case of less than 3 months, the supplier shall submit a
Process change application as soon as it is clear that the supplier would like to
have a process change considered by Denso.
Notes-1:Denso need to get approval from customer in some case of change. In
such case, please follow the instruction of our section in charge
The following are the case required customer approval described above.
1. Change of manufacturing place (new plant/process, other plant/process,
oversea plant included)
2. Change of any supply chain (sub-contractor change or new subcontractor case)
3. Introduction of new equipment in process, process capacity increase, any
change of pressing die/molding die, production system change, restart of
process after long cessation which may connect to quality change of
parts/products)
4. Change of manufacturing methods/ process condition (in case Denso notify
customer of manufacturing methods/process condition)
5. Process change of critical control designated part (please refer item 4.9)
including inspection method change.
6. Process change of Metal heat treatment, welding, rubber
vulcanization/adhesive bonding, etc.(please refer item 4.11) including
inspection method.
7. Material change
8. Process change of Denso brand parts/products delivered to auto
manufacturer (customer) via system manufacturer.
Other than those above cases, some case may require to get approval from
customer. Therefore please consult Inspection section of Denso when supplier
plan to change process as soon as possible.
Note) Please be aware that it may take more than 3 months to reply from Denso.
In such a case Denso informs the supplier about the situation.
② “Process change request and notification sheet “ (Document No.10) shall be
approved by QA responsible personnel/empowered personnel by QA responsible
personnel before submission to Denso.

№ P_SQAM4
Chaper4
4.25.4.3 Cautions for process change notification

① In case supplier cannot follow procedures as suggested due to emergency,
please get instruction from Inspection Dept./QA Dept. by contacting verbally or by
phone call. However even in this case, please follow procedures as suggested
afterward as soon as possible.
② If it cannot be judged whether the change notification is required or
not, contact and follow the instructions of Inspection Dept./QA Dept. of Denso.
③ In the case where there is no countermeasure method if the change is not
accepted (discontinuance of sub supplier, etc.), prior consultation with the
Inspection Dept.(QA Dept.) and the procurement Dep. shall be conducted
beforehand and supplier submit the notification based on the result.
4.25.4.4 Cautions for process change

Ensure thorough control of the following points when changing the process in order
to prevent serious troubles caused by inadequate control.
1. Are the purposes and effects of process change confirmed?
2. Are all effects of process change confirmed?
3. Are disadvantages as well as advantages considered?
4. Is there any other characteristic and part that are affected?
5. Is there any influence on other function and shape?
6. Are safety and reliability confirmed?
7. Is there any problem in the process organization?
8. Is there any problem in the processing method?
9. Are the timings of design change and process change clear and are the parts
changed accordingly ?
10. Are the initial product inspection standard and the inspection method
determined?
11. Is the initial product inspection surely implemented, and are the products
accepted?
12. Are the operation standard, equipment, die, and jig and tool arranged?
13. Is the operation training implemented?
14. Are the old material, old part, drawing, operation standard, die, jig and tool
collected and disposed?
15. Submit “Purchased product and part description revision application”
(See document No. 9.) for the items to be reflected into the drawing such as
material change.
16.Change of material supplier may lead to change of material’s DDS number in
Denso drawing. This case shall be treated as Design Change. Please confirm
how to treat as required.
4.25.4.5 Voluntarily control of process changes

In case any changes which are not listed in “Table 1: Items requiring process
change notification" and the supplier does not need to notify Denso, the supplier
shall voluntarily control those changes so that the supplier can prevent quality
problems or promptly find a root cause and affected lots when quality problems
occurred.

№ P_SQAM4
Chaper4
4.26 Design Change Request procedure

4.26.1 Purpose
This procedure clarifies what to be done when the supplier request Design Change to
Denso to be implemented surely.
4.26.2 Scope
Applies when following cases occurred.
1. When the supplier want to change written items on the drawing.
2. When the supplier want to change written items on the specification agreed with
Denso.
4.26.3 Explanation
1. "Application form for revision of the items of purchased product and part" is used
by suppliers to request a design change to parts manufactured for Denso.
(See document No. 9).
2. Denso will check and verify the contents of "Application form for revision of the
items of purchased product and part", then fills in Denso's related Dept.'s
comments and send its copy to the supplier. The supplier shall respond for the
comments.
3. The supplier shall fill in all columns with bolded borderline of "Application
form for revision of the items of purchased product and part"
4. Denso will decide to approve or reject "Application form for revision of the items
of purchased product and part" submitted to Denso after investigation and
assessment of the contents.

1. The supplier must submit a "Application form for revision of the items of purchased
product and part" to Denso contact as soon as it is clear that the supplier would
like to have a design change considered by Denso.
2. A minimum of 6 months is recommended in advance of the proposed design change.
However, depend on change details or customer, it may take more than 6 months
to complete.
3. The supplier must attach any additional supporting documentation and an draft of
implementation schedule with "Application form for revision of the items of purchased
product and part" submission to Denso.
4. The "Application form for revision of the items of purchased product and part"
and draft of implementation schedule must be approved by the supplier’s QA
responsible personnel/empowered personnel by QA responsible personnel.
5. Once the "Application form for revision of the items of purchased product and
part" is received at Denso, it will initially be reviewed for acceptability and
may be additional requirements determined. The supplier shall follow the instruction
from Denso.
6. When Denso approved "Application form for revision of the items of purchased
product and part", Purchasing Dept. in charge of Denso will send Engineering
Change Instruction with drawings and specifications after change.
The supplier shall treat the first shipment as initial product. Please follow
initial sample inspection report procedure (Please refer 4.14).
7. If rejected, the supplier must correct the relevant information when the
supplier judge that it is necessary to review and resubmit, resubmit the complete
"Application form for revision of the items of purchased product and part" pack
to Denso.

№ P_SQAM4
Chaper4
4.27 Audit inspection receiving system procedure

4.27.1 Purpose
This procedure clarifies request items of Denso for suppliers when Denso implements
“Audit inspection receiving system”.
4.27.2 Scope
Applies to parts/products which satisfy specified conditions of Denso.
However, audit inspection receiving is not applied to the initial products and the
early-stage production control parts. Audit inspection receiving is not also applied to the
critical control designated parts in principle.
For the items other than the critical control designated items, audit inspection receiving is
applied.
4.27.3 Explanation
Audit inspection receiving is to eliminate the prescribed inspection if the quality and
delivery result of delivered parts(products) are good a longtime because the process is
controlled very well.
There are two ways of audit inspection receiving methods: interval inspection and
direct loading
(1) Specified conditions of audit inspection receiving
Denso judges following thing generally to ensure securement of the Quality.
① The past receiving inspection result
② The past quality failure result
③ Detection capability of defective part in the following processes of Denso
④ Effect to following process
⑤ Quality assurance systems of suppliers
(2) Suspension or cancellation of designation
When a quality problem occurred and the audit inspection received part is involved or
when the audit inspection directive part satisfies one of the following conditions,
Inspection Dept./QA Dept. in charge of Denso suspends or cancels the designation.
① When the specified conditions of audit inspection receiving are not satisfied
② When a change such as design change or process change subject to initial product
inspection is made, and Inspection Dept./QA Dept. in charge of Denso judged
that audit inspection receiving was inappropriate.
③ As a result of process audit, Inspection Dept./QA Dept. in charge of
Denso judged that audit inspection receiving was inappropriate.

(1) Notification of designation
When applying the audit inspection receiving, “Notification and agreement of audit
inspection receiving application and inspection consignment.” (See document No.34)
will be submitted to the supplier from Denso. Upon agreement, please fill-in and seal
the agreement, and submit to Denso’s Purchase Dept. in charge.
The notification form is different by Denso group company. Please refer to attached
table 2 “Document list of quality assurance”.
Note) Denso informs the supplier of "Designation of audit inspection receiving" with
supplier Kanban also.

№ P_SQAM4
Chaper4
(2) Process audit

Inspection Dept./QA Dept. in charge of Denso periodically performs a process audit
of suppliers about the following items to identify whether audit inspection receiving
designation is appropriate or not.
① Are the quality requirements assured for the important characteristics of part
(product)?
② Are there any problems in the manufacturing process and its management, and is
the process stable?
③ Is the quality assurance system of whole company (plant) adequate?
④ Is the control good after process change?

№ P_SQAM4
Chaper4
4.28 Quality records control procedure

4.28.1 Purpose
This procedure clarifies actions to be done by supplier for quality records and records
retention to be followed.
4.28.2 Scope
Applies to (documented) records of activities according to this manual (Common edition
& Parts/Products edition) or evidences that show performance of activities.
< (Documented ) records include electronic media. >
4.28.3 Explanation
① Suppliers need to retain (documented) records at dedicated store place (filing cabinet,
storage place etc.) under well controlled condition.
② The retention period consists of retention and storage periods.
1. “Retention” refers to keep categorized documents by function or classification, at
dedicated store place (filing cabinet, storage place etc.) under well sorted
condition.
2. “Storage” refers to keep required documents to a minimum in the archive.

(1) Control items etc. at supplier
Supplier shall set procedures for control, acquisition, filing and header label of quality
records and conduct according to procedures.
(2) Retention period of quality records
①The retention period of quality records is the following period after the date of
manufacture (or the date of creation)
Category Retention period

Quality records of “★”mark on Table 1 15 years
Quality records other than Critical control parts 10 years

“★”mark on Table 1 General parts 3 years
② If supplier set storage period, the retention period is the total of storage and
retention.
③When Inspection Dept. /QA Dept. in charge of Denso instructs via the
“Notification of QA Requirement”(Document No. 29), etc., please follow the
instruction.

№ P_SQAM4
Chaper4
Table 1 “the type of quality records”
SQAM related
Quality record Remarks
№ No.
●Drawing design review

2.4.1 ●Process design review
1 ★ Record of review
etc. ●Review meeting prior to mass production
etc.
2 ★ Reliability test results In case supplier conducted reliability test
2.8.3.4.4
3 ★ Record of PPAP Record of implemented results requested by Denso.
4.15
●record of design change done at supplier

●drawing revision/change application form
2.8.3 etc.
4 ★ Records of design change with approval stamp of Denso.
4.26
●design change notification issued by
Denso.
2.8.3
5 ★ Record of process capability study 2.9.1
4.4.4
2.8.5.2
6 ★ Record of production lot control
4.21
●Initial sample inspection record

Record of inspections and inspection 2.8.6
●Receiving inspection record
7 ★ history 2.9.1
●In-process inspection record
(including records of defects) 4.14
●Shipping inspection record
Record of control chart and various 2.8.2
8 ★
quality control 2.9.1
Record of continuous monitoring of
9 ★ process condition of ◎designated 4.9.3.4
part/product
●Process change implementation record
and process change notification form with
2.8.5.6
10 ★ Record of process change approval stamp of Denso.
4.25
●Implementation record of process change
by supplier (exempt case to notify)
2.8.7 Implementation record and special deviation acceptance

11 ★ Record of special deviation acceptance
4.17 application form with approval stamp of Denso
●Quality trouble notification issued by

Denso, investigation results, and
Investigation results of defect real countermeasure record
12 ★ 2.10.2
causes ●Defect cause investigation records and
countermeasure implementation record
carried out by supplier own
13 ★ SOC data sheet 4.18

№ P_SQAM4
Chaper4
SQAM related
Quality record Remarks
№ No.
14 Record of management review 2.9.3
15 Records of education & training 2.7.2
Design planning sheet (new product control

16 2.8.3
chart)
17 Input record to design 2.8.3.3 In case of product(part) design
Notification of QA Requirement QA 4.3

18
confirmation item check results report form etc.
●Design FMEA (in case of product (part)

4.6.5
19 FMEA design)
etc.
●Process FMEA
20 QA network 4.6.6
21 List of subcontractors 2.8.4.1
●Assessment result before business

22 Records of subcontractor assessment 2.8.4.2 ●Assessment result after business
connection
Record of equipment daily check and

23 2.8.5.1.5
periodical check
Record of measuring tool inspection and

24 2.7.1.5
calibration
Record of measurement system analysis
25 2.7.1.5.1.1 Implemented record of MSA requested by Denso.
(MSA)
26 Implemented record of internal quality audit 2.9.2
Boundary sample/ actual sample ●Confirmed and approved by Denso.

27 4.24
(Include color sample) ●Prepared and provided by Denso.
Critical control parts/products subcontractor

28 4.9.4.8 ●The form with approval stamp of Denso
utilization application and response form
29 Record of rework 4.23

№ P_SQAM5
Chapter 5
Chapter 5 Request for compliance with the rules
5.1 Action when this manual is not adhered to

Suppliers are requested to abide by all the rules as well as fully understand the basic
concept of quality assurance described in this manual. Unfortunately, a problem due to
incompliance with the rules occurs.
Consequently, if the rules are not adhered to, Denso takes the following actions.
(1) If a quality problem occurs because the rules are not complied with, the following
actions are taken according to the standard specified by Denso.
① All compensation expense
② When it is judged that the level required by Denso is not satisfied in terms
of corporate culture, Denso considers changing the supplier or the volume of
business.
(2) If the rules are not adhered to although a quality problem does not occur, the actions
in accordance with ② of (1) are taken.
5.2 Examples of the problems due to incompliance with the rules

Below is past examples of defects caused by incompliance of the rule.
Please refer to it and prevent recurrence of the defect.

№ P_SQAM5
Chapter 5
(1) Is the stratification control good?
Put the indication tags of accepted part, uninspected

part, in-process part, design change part, rework
<Example 1>
completed part, part requiring rework, screening
Although the defective lot was once
completed part, part requiring screening, part requiring
screened, the separated part was mixed in
study, and partial part in each part box, and indicate the
the good parts due to insufficient
stratification indication. storage place as well. It is necessary to perform
stratification indication so that a third person can
understand just by looking.
Make sure to implement the formal shipping inspection

<Example 2>
again for the reworked part after rework was completed.
Although a defective part was reworked,
In this case, the quality of the part needs to be assured
other defect could not be detected
by implementing more careful inspection than that of
because the usual shipping inspection
the normal current product (for example, increase of
was not implemented for other defective
sampling rate and inspection item).
(2) Is the check method good?
<Example 1>
It is necessary to ensure the stratification control at the
One lot has been shipped with the nut
work site and to enhance the detection ability of
temporarily tightened.
shipping
<Example 2>
A defect of certain die number could not For stratification and sampling inspection for each die
be detected because random sampling number, it is necessary to sample and check the parts
was performed from the multiple-cavity of all die numbers.
molded parts.
<Example 3>
Sparks inevitably occur during welding. It is necessary
When brazing the space collar to the iron
to use a spark adhesion prevention jig for the important
plate with a burner, sparks adhered inside
portions and to clearly specify the check points in the
the space collar, and a bolt does not go
operation manual.
through it.

№ P_SQAM5
Chapter 5
(3) Is the incorrect part delivery prevention good?
<Example 1> It is necessary to indicate the part number on each

A wrong part was delivered by mistake part box for the actual parts or on each part when
because no part number is indicated on the partial parts were taken out from the part box so
the actual part. that everyone can check the part number.
<Example 2>
Not only 10-digit number but the foolproof by
The part number was mistakenly read as
combination such as picture matching or color
similar part number in which only one digit
matching or the two-person check are necessary.
of 10-digit part number is different.
It is necessary to provide a foolproof to prevent a

<Example 3> right-left error (for example, the best ways are to
The part numbers were mistakenly make the parts for right and left same, to change the
indicated for right and left. plating color, or to stamp the part number.) or call
attention by posting a picture or the actual part.
Anyway, to prevent wrong part delivery, it is desirable to limit the handlers as less as possible and place a seal on
the part to find who handled that part later.
Special attention is needed in the case of urgent item or non-routine.
(4) Is the check good in non-routine operation?
<Example 1> The more urgent the part, the more the person
Shipping inspection was not done for the responsible for quality needs to request the
urgent item and the defective part was cooperation of the related persons and to check
delivered. carefully.
<Example 2>
The material was purchased at the shop It is necessary to adequately check the material or
instead of normal route because of small dimensions of the materials purchased at the
volume, and thus a wrong material defect shop.
occurred.

№ P_SQAM5
Chapter 5
(5) Is the quality assurance good when the manual operation was automated?
<Example 2>
<Example 1> Although the curing agent compounding filler that fills epoxy
Manual soldering was changed to soldering resin into the parts was additionally installed due to rapid
by the automated soldering device, resulting production increase, a failure of this device changed the
in a soldering failure. compounding ratio, resulting in a crack of epoxy resin due to
aging.
When the manual operation was automated, or a machine was newly or additionally installed, frequently check
the actual parts until the quality is stabilized as well as implement reliability test of the parts (products).
(6) Is rework procedure OK ?
<Example >
In case rework appearance defect,
①Assembled incorrect (similar) part due to misconception of operator
②Incorrect part was not detected after rework operation because only appearance
check was implemented and not put into regular inspection process.
①Please prepare “operation instruction sheet” of rework and let familiarize operator with
it and follow.
②All reworked components shall be inspected through regular inspection process.
(7) Is the receiving inspection of the standard parts good?
<Example >
The rivet with 1 mm shorter length under head was mixed, resulting in a caulking failure.
Although many of the standard parts are received without inspection, it is necessary to always perform receiving
inspection for the parts other than those for which measures are taken so that a defect can be detected in the
process even if it flows, and to record the inspection results.

№ P_SQAM5
Chapter 5
(8) Is the receiving inspection of the direct delivery parts and materials good?
<Example >
When a cavity defect was found in the noncutting portion of the casted part during receiving inspection or in the
process.
It is necessary to always perform receiving inspection for not only the self-procured parts and materials but the
direct delivery parts, and to record the inspection results. It is apt to consider these parts as the parts supplied by
Denso and to misunderstand that their quality are assured by Denso. Although Denso implements the initial
product inspection, the quality of each mass production part is not assured by Denso. With this point in view,
Denso asks suppliers to be responsible for implementing quality assurance.
Do not shift the responsibility for the reason that “it is not our fault because the direct delivery parts are
defective.”
(9) Is the quality assurance of the secondary and tertiary supplier parts good?
<Example>
When visiting the supplier to investigate and diagnose the cause of defective part, sometimes it is not the in-
house product of the primary supplier but the subcontractor product. At the subcontractor, it is found to be the
tertiary supplier product.
The critical control designated parts, the parts whose inside are difficult to be checked because of taping etc, A
parts (that are directly delivered to the customer not through the process of Denso), the products or semi-
products that are directly delivered to Denso not through the process of your company), and the parts that are
important in quality assurance, principally need to be manufactured in house.
Especially when outsourcing the manufacturing of the critical control designated parts to subcontractors by
necessity, this manual specifies that a special approval application shall be made to Denso. Please note that the
following rule is made. The primary supplier shall enter where the part is processed in “Initial product delivery
inspection record” (See document No. 7 in Section 6.3 of Chapter 6.) and submit it, and also shall notify with
“Process change notice” (See document No. 10 in Section 6.3 of Chapter 6.) when the processing manufacturer
is changed.

№ P_SQAM5
Chapter 5
(10) Is the stratification of the design change parts good?
<Example>
Stratification between the old and new parts is not sufficient after design change, causing a trouble in the
delivered parts.
It is necessary to clarify the timing of change and to stratify the parts by giving an indication on the actual design
change parts and old parts.
A rule is made that the design change parts are delivered to Denso with “Stratification control tag” (See
document No. 15, in Section 6.3 of Chapter 6.) attached.
(11) Are the quality assurance rules specified by Denso adhered to?
<Example 1>
The punch was processed at the work site without <Example 2>
permission because the press die punch was broken. A defect could not be detected by each Dept.
A defect could not be detected because no report was because no report was given about the change of
given to the supplier and each related Dept. of Denso in the subcontractor and the dimensional failure,
spite of dimensional failure, resulting in a serious quality resulting in a serious quality failure.
problem.
These are all caused by that the process change notice was not issued in advance.
As you know, Denso specifies the minimum items to be complied with by suppliers in this manual.
On this occasion, the related Sect. shall read this manual once again and conduct a study meeting about the
related items in the QC circle. This is a way to ensure observance of the rules.

№ P_SQAM6
Chapter 6
Chapter 6 Quality assurance related documents
The documents required to smoothly implement quality assurance are listed in Section
6.3 Quality assurance related document list.
The category column is set in the table to indicate when these documents are necessary.
Please implement the prescribed procedures after carefully checking this table
6.1 Classifications for the category column

(1) When starting business … When receive an order of the part (product) of the
manufacturer that newly start business with Denso.
(2) New product … When the manufacturer that has an account with Denso receive an
order of new product.
(3) Design change and process change … When a design change or process change
are implemented.
(4) Continuos production … When orders are continuously received and production
continues.
(5) When delivering the product again … When there is no order for the past one year or
more and the part (product) start to be delivered again
(6) When a defect occurred … When a defect occurred in the delivered parts (products)
6.2 Symbols in the category column

Item marked with ○ … Task that suppliers shall implement
Item marked with … Task
☐ to implement based on Denso’s request
Item marked with △ … Task to implement due to supplier’s needs
6.3 Document list of quality assurance

Please refer to attached table 2-1 to 2-15
“DENSO Quality assurance related document list”.

Attachment
Attachment A
Definition of Terms
IMDS
IMDS is shared data system of raw materials. Motor-vehicle manufacturing companies
use the system to control all aspects of environment conservation of individual
part/product adopted in motor-vehicle.
Perfection can be reproduced by using this system in the automotive industry they are
used, and what kind of materials are finally incorporated in which component in which
parts.
Environment
“Environment” refers to the process conditions surrounding or influencing a particular part
or product’s production and quality. Environments differ with each site, but generally
involve air conditioning, noise, lighting and facilities management.
Measurement System
Statistical evaluations shall be performed in order to analyze fluctuations among the
various systems of measuring and testing devices. (For example, investigate bias,
linearity, stability, regular consistency / repeatability.)
Inspection
・Receiving Inspection
The inspection for the parts(products) are delivered from supplier
・In-process Inspection
The inspection is performed in process based on standard work.
・Shipping Inspection
The inspection is performed after finish production based on shipping
inspection standard.
Calibration
Calibration refers to all tasks where a value measured by a gauge, inspection, measuring
or testing device is compared with a designated, standardized device placed under
regulated conditions.
New Edition Control

Refers to systems for using new documents (publications).
Generally speaking, new edition control requires clarifying issue dates on new
regulations, job instructions, inspection regulations, etc., and entering them into a log for
distribution that contains new publication dates. Additionally, information about new
publications can be made accessible by computer.
Suppliers Quality Assurance Manual (Parts (Product) Edition) A-1

Attachment
Job Standards
Job standards are the models and patterns that support various operations.
Corrective action
Corrective actions are the Kaizen and countermeasures developed to handle faulty or
defective items and it typically consists of five types of items. They are: 1) immediate
treatment, 2) finding root cause, 3) temporary treatment, 4) retroactive treatment, and 5)
recurrence prevention (permanent treatment).
Master schedule
Basic process chart based on the main project, targeting the period from the start to
the completion.
Checking Instructions
Instructions for checks contain written procedures and methods to verify important areas,
key points, and generally perform checks well.
Procedures
Procedure forms are the documented processes regularly used for the multiple functions
of the organization or group. This is a generic term for documents containing procedures
for regulations, standards, job instructions, etc.
Trace-ability
Trace-ability is the ability to use recorded classifications (markings) to follow a certain
product, such as its history, use and location. For example, it allows an operation to track
and investigate where delivered parts and materials were used. “Trace-ability” in the
case of measuring devices provides a recorded evidence of path that connects the device
in question to the national standard devices.
Internal Quality Audit

Internal quality audits are systems for making planned and comprehensive assessments
of quality management systems by internal auditors authorized by the company.
First-products
This term refers to parts and products produced directly after a change in job standards,
job start time (start of the day, start after lunch break, etc.), replacements of jigs, tools or
dies/molds, operator replacements or adjustments to machinery.
Standards
Standard items refer to the supporting models (patterns) for performing operations.
Quality System
This is a generic term for the structures designed to build quality into the organization and
its processes. Quality systems refer to the 5 M’s (Machine, Materials, Man, Method,
Measuring), and include operational resources (the budget).

Attachment
QA Structure
Refers to the entire unified structure for ranking individual items required by quality
assurance.
Process
Refers to courses, treatments, progress conditions, and processes.
Parts Submission Warrant (PSW)

A document representing the whole production part approval process (PPAP), the part
number, the name, the drawing number and the revision number etc. are described.
Document
This term refers to all documents (including electronic data) containing job procedures
and standards that are repeatedly used to perform a certain task. The term covers
regulations, standards, instruction sheets, drawings, inspection regulations, logs
(formats), etc.
Pokayoke / Error proofing

Pokayoke denotes (mechanical) systems to prevent the creation or escape of quality
failures (defects) at the design and production phases. Typically, error-proofing involves
a device or jig.

Attachment
Attachment B
History of Revision
No. of
Contents Date
revision
First edition Issued Chinese edition Apr 1, 2005
1,Add DENSO(CHANGZHOU) Fuel Injection Systems Ltd.

2, Change The early-stage production control procedure
3, Changes in elements of controlling critical control designated parts
1st Apr. 1, 2008
4, Add Special process usage procedure
5,Add Reporting procedure of contained substances (components)
Etc.
1,Add 3.4.7 Subcontractor Process Audit prior to mass production
4.10 Rework procedure. 4.13 Material control procedures
2,Simplify 4.1Notification procedure of QA related responsible personnel, 4.2The
early-stage production control procedure ,4.3Control procedure of critical control
designated parts,4.5 QA network,4.6 Control Plan procedure, 4.7 Supplier shipping
2nd inspection standard, 4.8 The special process control procedure,4.11 Quality Sep. 1, 2012
troubleshooting procedure,4.15 Submission of process change notification,4.16
Production part approval process (PPAP) procedure,4.17 Reporting procedure of
contained substances (components) chapter 5 Request for compliance with the
rules
Etc.
1,Add 4.2Functional Safety operation procedure，4.3Notification of QA Requirement
procedure ，4.5 Quality Assurance Schedule preparation procedure，4.6.5
Preparation method of process FMEA ，4.9 Installation portion control procedur
4.11 procedure based on pollution prevention agreement ，4.13Packaging
specification preparation procedure，4.15 Part shipment notification procedure
4.23Boundary sample / Master sample preparation procedure，4.25 Design
Change Request procedure，4.26Quality records control procedure
2,Unify the text structure as Purpose Scope Explanation Supplier responsibilities
3,Add content of 3.4 Audit of quality assurance conditions ，chapter4 4.1Notification
procedure of QA related responsible personnel，4.4The early-stage production
3rd Oct 1, 2017
control procedure ，4.6.6QA network，4.7Control Plan procedure，4.8Control
procedure of critical control designated parts，4.10 The special process control
procedure，4.13 Initial product inspection procedure，4.14Production part
approval process (PPAP) procedure，4.16Special deviation acceptance，
4.17Reporting procedure of contained substances (components) ，4.18 Material
control procedures，4.19Parts supply procedure，4.20Lot control procedure
4.21Quality troubleshooting procedure，4.22Rework procedure，4.24Submission
of process change notification，chapter 6Quality assurance related documents
4,Add Attachment A
Etc.
Suppliers Quality Assurance Manual (Parts (Product) Edition) B-1

Attachment
Attachment B
History of Revision
No. of
Contents Date
revision
1,Changed the automotive QMS standard,
ISO / TS 16949 → IATF 16949.
2,Describe constraints of accreditation bodies in "ISO 9001
certification acquisition request".
3,Describe the final goal of IATF 16949 certification acquisition.
4,Add "Survey dating back to the supply chain" to the procedure
at the time of preparing the report form in "Reporting procedure
of contained substances (components) associated with the
substances of environmental concern (SoC) regulation".
4th 5,Work standard procedure :New establishment Oct. 1, 2018
6,”Cautions for process change notification” Added newly
7,Added the date of manufacture (or the date of creation) for
retention period of quality records .
8,Delete the unused tables in appendix 2,and revies file NO.
9,Added creation procedure into “Process FMEA form”, ”QA
network sheet” and “Process change request and notification sheet”.
Suppliers Quality Assurance Manual (Parts (Product) Edition) B-2

Denso SQAM Rev4

Uploaded by

Copyright:

Available Formats

You might also like

Denso SQAM Rev4

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Denso SQAM Rev4

Uploaded by

Copyright:

Available Formats

Suppliers Quality Assurance

Revised 4th revision, Oct. 1. 2018

Parts (Product) Edition

About this publication

Suppliers Quality Assurance Manual (Parts (Product) Edition)

＜Basic requirements； ＜Individual requirements；

Parts （Product） Edition

tems and their definitions

Expressions and their definitions

Suppliers Quality Assurance Manual (Parts (Product) Edition)

Chapter 3 Items to be implemented by Denso and items to be complied with

Chapter 4 Individual Requirements ･･･ 5

Suppliers Quality Assurance Manual (Parts (Product) Edition)

4.4.4.1 The maintenance of the early-stage production control system ･･･ 9

Suppliers Quality Assurance Manual (Parts (Product) Edition)

4.7.6.3 Request for preparation of supplier shipping inspection standard ･･･35

Suppliers Quality Assurance Manual (Parts (Product) Edition)

4.11.4.3 Cautions for plating process:

Suppliers Quality Assurance Manual (Parts (Product) Edition)

4.19.4 Supplier responsibilities ･･･66

Suppliers Quality Assurance Manual (Parts (Product) Edition)

4.27 Audit inspection receiving system procedure ･･･87

Chapter 5 Request for compliance with the rules ･･･92

Chapter 6 Quality assurance related documents ･･･98

Suppliers Quality Assurance Manual (Parts (Product) Edition)

DENSO （CHINA）INVESTMENT CO., LTD.

Suppliers Quality Assurance Manual (Parts (Product) Edition) 1

Chapter 3 Items to be implemented by Denso and items to be

3.1 Indication of control category by importance

Category Type Control code

Critical control designated Regulation Designation R R R

Installation portion of the customer mating In

3.2 Implementation of receiving inspection

3.3 Disposal of defective part found in the process of Denso

3.4 Audit of quality assurance conditions

Suppliers Quality Assurance Manual (Parts (Product) Edition) 2

3.4.2 QA audit of special process

3.4.3 Process audit of new product prior to mass production

3.4.4 Periodical process audit

3.4.5 Process audit when the process was changed

3.4.6 Process audit when a defect occurred

3.4.7 Subcontractor Process Audit prior to mass production

3.4.8 Quality Management System audit

3.4.9 Temporary process audit

3.5 Issuance and follow-up of Defective Corrective Action Request

Suppliers Quality Assurance Manual (Parts (Product) Edition) 3

3.6 Supplier performance monitoring

3.7 Quality management system architecture / audit of compliance

3.7.2 Compliance with IATF16949

Suppliers Quality Assurance Manual (Parts (Product) Edition) 4

Chapter 4 Individual Requirements

4.1 Notification procedure of QA related responsible personnel

4.1.4 Supplier responsibilities

Suppliers Quality Assurance Manual (Parts (Product) Edition) 5

Suppliers Quality Assurance Manual (Parts (Product) Edition) 6

4.2 Functional Safety operation procedure

4.2.4 Supplier responsibilities

＜Basic requirements；＜Individual requirements；