Production Part Approval Process

PPAP
Fourth Edition
 sitleo62@Gmail.com

¡Les deseo un exitoso 2019!

Leonel Quintanilla Aguilar

PPAP PPAP

IATF 16949:2016
PSW
PPAP

PSW
PPAP
 Table of Contents
INTRODUCTION
SECTION 1 - GENERAL
SECTION 2 - PPAP PROCESS REQUIREMENTS
SECTION 3 - CUSTOMER NOTIFICATION AND
SUBMISSION REQUIREMENTS
SECTION 4 - SUBMISSION TO CUSTOMER
- LEVELS OF EVIDENCE
SECTION 5 - PART SUBMISSION STATUS
SECTION 6 - RECORD RETENTION

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PPAP Process Flow Chart
 INTRODUCTION
PPAP defines generic requirements for production part
approval for production and bulk materials
PURPOSE:
 To determine if all the customer engineering design
record and specification requirements are properly
understood
 To ensure that the manufacturing process has the
potential to produce parts consistently during a
significant production run at the quoted production
rate

7
 INTRODUCTION
APPLICABILITY:
 PPAP shall apply to internal and external organization
sites supplying production parts, service parts,
production materials, or bulk materials
 For bulk materials PPAP is not required, unless
specified by the authorized customer representative
NOTE 1: See customer specific requirements for additional information
NOTE 2: A customer can formally waive PPAP for an organization
NOTE 3: A waiver of a PPAP requirement should be requested through the
authorized customer representative
NOTE 4: Catalog parts are identified and ordered by functional specifications
or by recognized industry standards

8
 INTRODUCTION
APPROACH:
 The word “shall” indicates mandatory requirements
 The word “should” indicates a recommendation
 NOTES are for guidance in understanding or clarifying
the requirements
 For the purpose of PPAP, terms and definitions given
in IATF 16949 apply

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 SECTION 1 - GENERAL
1.1 Submission of PPAP:
1. A new part or product
2. Correction of a discrepancy on a previously
submitted part
3. Product modified by an engineering change to
design records, specifications, or materials
4. Any situation required by section 3 (Customer
Notification and Submission Requirements)

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.1 Significant Production Run:
 For production parts:
– From one hour to eight hours
– Minimum of 300 consecutive parts
– Conducted at the production site, under production
conditions
– Parts from each unique production process shall be
measured and tested
 For bulk materials:
– No specific number of parts is required
– Sample shall be taken from a “steady state” operation

11
 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2 PPAP Requirements:
 Organization shall meet PPAP requirements listed
and all customer specific requirements
 Production parts shall meet engineering design
record and specification requirements
 PPAP requirements are defined in Bulk Material
Requirement Checklist
 If specifications cannot be met, problem solving
methods shall be used and corrective actions shall
be taken (8Ds)

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.1 Design Record:
 Organization shall have the design record for the
product/part, including components
 When the design record is in electronic format
(CAD/CAM math data), a hard copy shall be produced
2.2.1.1 Reporting of Part Material Composition: Provide data
showing compliance with customer requirements
2.2.1.2 Marking of Polymeric Parts: Shall be identified with
symbols specified in ISO 11469 and/or ISO 1629

13
 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.2 Authorized Engineering Change Documents:
 All authorized change documents for changes not
documented in the design record but incorporated in
the part
2.2.3 Customer Engineering Approval:
 Evidence of customer engineering approval if
specified
2.2.4 Design Failure Mode and Effect Analysis (DFMEA):
 The product design responsible organization shall
develop a DFMEA

14
 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.5 Process Flow Diagram(s):
 Process Flow Diagram in a format that describes the
production process steps and sequence
2.2.6 Process Failure Mode and Effect Analysis (PFMEA):
 Organization shall develop a PFMEA
2.2.7 Control Plan:
 CP defines the methods used for process control
2.2.8 Measurement System Analysis Studies:
 MSA studies for all new or modified gages,
measurements, and test equipment

15
 Process Failure Mode and Effects
Analysis (PFMEA) Exercise

Focus on prevention actions

(Poka Yoke Methods)

16
 Gage Studies Exercise
(MSA)

Accuracy and Precision

Gage Studies

17
 Classification of MSA Issues
1. Instrument characteristics (Basic equipment):
– Application
– Operating Range
– Discrimination/Resolution/Sensitivity
2. Location Variation (Accuracy):
– Bias
– Stability
– Linearity
3. Spread or Width Variation (Precision):
– Repeatability
– Reproducibility
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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.9 Dimensional Results:
 Evidence of dimensional verifications according to
the design record and the Control Plan with actual
results in compliance with specifications
 Dimensional results for each unique process
 Identify one of the parts measured as the master
sample
 Use of Geometric Dimensioning and Tolerancing
(GD&T) on dimensional reports

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.10 Records of Material/Performance Test Results:
 For all tests specified in the design record and/or
Control Plan
2.2.10.1 Material Test Results:
 For all parts and product materials with chemical,
physical, or metallurgical requirements
2.2.10.2 Performance Test Results:
 For all parts and product materials with performance
or functional requirements

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.11 Initial Process Studies:
2.2.11.1 General:
 To determine if the production process is capable of meeting
customer requirements (Special Characteristics)
 The level of initial process capability or performance shall be
determined with the customer prior to submission
 The focus is on variable data, attribute data is not acceptable
for PPAP
 MSA shall be performed prior to initial process studies to
understand measurement error
 If control charts are used, a minimum of 25 subgroups and 100
consecutive readings shall be collected

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.11.2 Quality Indices:
 Initial process studies shall be summarized with capability or
performance indices
 Statistical Process Control techniques shall be used
 Initial process studies are used to understand variation in
terms of Cpk (Capability index for a stable process) and Ppk
(Performance index)
 If the process has several streams, appropriate statistical
methods shall be used (SPC)

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.11.3 Acceptance Criteria for Initial Study:
Evaluation of processes that appear stable

RESULTS INTERPRETATION

Index > 1.67 Process meets the acceptance criteria

Process may be acceptable

1.33 < Index < 1.67 Review results of study

Process does not meet the acceptance criteria

Index < 1.33 Review results of study

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.11.4 Unstable Processes:
 An unstable process may not meet customer requirements
 Special causes shall be identified, evaluated, and eliminated
and a corrective action plan shall be submitted prior to PPAP
2.2.11.5 Processes with One/Sided Specification or Non/Normal:
 The organization shall determine with the Authorized
Customer Representative the acceptance criteria
2.2.11.6 Actions to be Taken when Criteria are not Satisfied:
 Contact the ACR if PPAP is compromised
 Submit a corrective action plan and a modified Control Plan
 Process shall be improved until acceptance criteria is met

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 Machine Capability Exercise
(SPC)

Short term study to determine

machine capability

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.12 Qualified Laboratory Documentation:
 PPAP inspection and testing shall be performed by a
qualified laboratory, internal or external
2.2.13 Appearance Approval Report (AAR):
 AAR applies to color, grain, or surface appearance
 If appearance requirements are specified on the
design record, a separate AAR shall be submitted for
each part or family of parts
 Complete and authorized AAR shall accompany the
Part Submission Warrant (PSW)

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.14 Sample Production Parts:
 Sample products shall be provided
2.2.15 Master Sample:
 A master sample shall be retained for the same time
as the PPAP records or:
a. A new master sample is produced
b. If the master sample is required as a reference or
standard by the design record, CP, or inspection criteria
 A sample part shall be retained for each position of a
multiple production process

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.16 Checking Aids:
 If requested, part assembly or component checking
aids shall be submitted
 Checking aids can include fixtures, gages, templates,
mylars specific to the product
2.2.17 Customer-Specific Requirements:
 Records of compliance to customer requirements
shall be kept

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.18 Part Submission Warrant (PSW):
 Upon completion of PPAP requirements, a PSW
shall be completed
 A separate PSW is required for each part number
 A PSW shall be submitted for each position of a
multiple production process
 A responsible official shall approve the PSW

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 SECTION 2 – PPAP PROCESS REQUIREMENTS
2.2.18.1 Part Weight (Mass):
 The part weight of the parts as shipped, in kilograms
to four decimal places, shall be recorded in the PSW
 The weight shall not include shipping protectors,
assembly aids, or packaging materials
 Ten randomly selected parts shall be weighted and
the average shall be reported, including parts from
each position of a multiple production process
 Weight is used for vehicle weight analysis and does
not affect PSW approval

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 Part Submission Warrant (PSW)
Exercise

Document requirements

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 PSW Document Submission
Phase 1. Program Planning:
• Quote Package
(Response to RFQ)
• Program Plan (MS Project)
• Conceptual Product Design
• Special characteristics
• Preliminary BOM
• Conceptual Process Design
• Preliminary List of M&E
• Test Plan
• Process Capability Plan
• APQP team members and contact
directory
Phase 2. Product Design and Development:
• Engineering Drawings
• BOM
• Material Test Results
• List of certified suppliers
• DVP&R
• Design FMEA
• Appearance Approval Report (AAR)
• Inspection Report
• Dimensional Results
• Performance Test Results
• IMDS Package
• Packaging and shipping standards
 PSW Document Submission
Phase 3. Process Design and
Development:
• Process Flow Diagram
• Process Layout
• Control Plan
• Work Instructions
• Machine Capability Study
• MSA Studies
• Process FMEA
• Engineering Changes
• Labeling & Packing
• Suppliers PPAPs
• IMDS Package
Phase 4. Product and Process
Validation:
• Operator Certification Matrix
• Maintenance Program
• Functional Test Report
• Dimensional Test Report
• Appearance Approval Report
• Process Capability Studies
• MSA Studies
• Run at rate results
• Safe Launch Plan
• Sample Parts Inspection Reports
• PSW
Retention/Submission Requirements Table 4.2
 SECTION 3 – CUSTOMER NOTIFICATION
3.1 Customer Notification:
 Any planned changes to the design, process, or site
shall be notified (12 weeks before)
 Upon notification and approval of the proposed
changes, PPAP submission is required after the
implementation
 ECR/ECN System

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 Supplier Initiated Changes

Changes in product design,

process design, production
facilities, or logistics

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 SECTION 3 – SUBMISSION REQUIREMENTS
3.2 Submission to Customer:
 PPAP approval shall be submitted prior to the first
production shipment
 PPAP file shall be updated to the current production
process
 PPAP shall contain the name of the Authorized
Customer Representative

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 SECTION 4 – SUBMISSION TO CUSTOMER
4.1 Submission Levels:
 Items and/or records shall be submitted according to
the level of evidence
 Level 3 shall be used as the default level for all
submissions
 The ACR may identify a different submission level
 Different locations may be assigned a different level
of submission

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 Submission Levels:

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Retention/Submission Requirements Table 4.2
 SECTION 5 – PART SUBMISSION STATUS
5.1 General:
 Upon approval of submission, future production shall
continue to meet customer requirements
5.2 Customer PPAP Status:
5.2.1 Approved:
– Part or material meets all customer requirements
– Authorized to ship production quantities, subject to
releases

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 SECTION 5 – PART SUBMISSION STATUS
5.2.1 Interim Approval:
 Permits shipments for production requirements on a limited
time or piece quantity basis
 Interim approval will be granted if:
– Non-compliance preventing approval has been clearly identified
– Action plan has been agreed upon by the customer
– PPAP re-submission is required to obtain approval
5.2.3 Rejected:
 PPAP submission does not meet customer requirements
 Not authorized to ship production quantities
• Process shall be corrected and PPAP re-submission is required
to obtain approval

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 Production Part Approval Process
PSW Submission

Plan & implement

countermeasure actions to
obtain full approval (8Ds)
Commence
shipment of
Complete and
Identify reason product
Supplier

submit the PSW

for failure to
with all
achieve full
necessary
approval (8Ds)
supporting
documentation

Part Submission Warrant

& Supporting Documents

Rejection Interim Approval Approval

OEM

Review
 SECTION 6 – RECORD RETENTION
 PPAP records, regardless of submission level, shall
be maintained for the active life of the part plus one
year
 PPAP records from a superseded PPAP file shall be
included in a new part PPAP file

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 Facility Transfer Exercise

Activities before and after a

facility change is made

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 Exercise
Process / Facility Site Change Management

List items to consider:

Before a change takes place

After a change takes place

 Activities BEFORE the change
– Engineering Change Request
– Quote File Review & Letter of Intention
– Detailed Project Plan
– Risk and Contingency Plans
– Updated Capability, Process Flow, Floor Plant Layout
– Updated Control Plan and PFMEA
– Validation Test Plan
– Translations of documents
– Hiring and Training Plan
– Safety Stock Build Requirements
– Ramp-up plan
– Packaging specifications
– Engineering Change Notification (Customer approval)
 Activities AFTER the change
– Customs documentation
– Transfer of production line
– Preparation of installation
– Hire and train personnel
– Order materials
– Functional Trial Run (if required)
– Official Run at Rate
– Run at Rate Reports (MSA, SPC, Capacity Plan, Functional,
dimensional and appearance)
– Supply Chain Management (Suppliers)
– Ramp-up Plan
– PPAP Package & Part Submission Warrant (PSW)
– SOP (Customer approval)