Clause No.

Wise Format with Purpose & Process Owner

Clause Number Name Purpose Process Owner

To identify the internal & external issue throughout
4.1_List of External the organization and prioritize the weak area (in Managmement /
4.1
Internal Issue general) for focus , can be made deparment wise. All HOD's
SWOT method is a populary used
To find out and integrate the requirements in our
4.2_Needs Expectations of
4.2 own QMS as they could impact or have potential to Respective Process Owner
Interested Parties
impact our QMS
To find out the product and service for which
4.3.1_Determine the scope organization is responsible & inclusion or exclusion
4.3.1 Quality System
of QMS of design with justification with details of remote
location (if any)
To make sure that the customer specific
requirements are linked with organization QMS
4.3.2 4.3.2_CSR Matrix requirements (Procedure, Work Instruction, Quality Assurance
formats,etc). Easy to refer by respective process
owner without looking everytime at customer
4.3.2_Master List of To make sure that we have LATEST / UPDATED
4.3.2 Quality Assurance
Customer SQM version of Customer SQM with us
To make sure that NO product safety reguirements
4.4.1.2_Product Safety
4.4.1.2 are missed out and those requirements are Engineering
Characteristics
cascaded down the line in various requirement
To understand the process requirements (input,
output, method, etc) for effective procedure making
4.4.1 4.4.1_Turtle Diagram Process Owner
and audit. It give us the overall view / mapping of
process structure
To establish the corporate policies regarding
5.1.1.1_Corporate
5.1.1.1 employee code of conduct, ethics esclation, anti- HR
responsibilities policy
bribery, etc to maintain the authenticity & prevent
So that NOT to miss the efficiency (Output w.r.t
5.1.1.2_Process
5.1.1.2 Input) related objectives (as required) when Process Owner
Effectiveness & Efficiency
estabilshing the objectives
5.1.1.3_List of Process To identify & designate the process owner of each
5.1.1.3 Quality System
Owner process to avoid the ambiguity (confusion)
To make sure that the competent personnel are
5.3.1_Roles,
hired as per job roles (useful at the time of hiring).
5.1.3 Responsibilities & HR
Also, the respective Process Owner have clarity of
Authorities
role and avoid any ambiguity
6.1_Risk & Opportunity To identify the gaps in the QMS and mitigate (take
6.1 Process Owner
Analysis action) those which could impact QMS
To avoid interruption in the key areas (Key
Equipments, Utility, Cyber attack, etc.) and make
6.1.2.2 6.1.2.3_Contingency Plan Process Owner
sure that alternate option is available and working
so tested at regular frequency
To ensure that quailty objectives are established
6.2.1 6.2.1_Quality Objectives All HOD's
and monitored to verify the health of QMS
6.2.2_Action Plan for To ensure that the set targets are achieved with
6.2.2 All HOD's
quality objective step by step action plan with responsibilties
To avoid the unauthorized alterations or changes in
6.3 6.3_System Change Note Quality System
the QMS
7.1.3.1_Manufacturing To identify the risk and feasibility of making a
7.1.3 Engineering
Risk Assessment product during new development / changes
7.1.5.1.1_Measurement To ensure that MSA is carried out for respective
7.1.5.1.1 Quality Assurance
System Analysis Plan instruments (family wise) as per plan
To ensure that Calibration of measuring
7.1.5.2.1 7.1.5.2.1_Calibration Plan equipments are carried out for as per the defined Quality Assurance
frequency and no instrument is left out
error) for traceability. Also, In the case of
instrument found NOT okay during calibration or
7.1.5.2.1_Caibration otherwise, refer the last calibration date to findout
7.1.5.2.1 Quality Assurance
History Card the suspected lot

To prserve the internal (experience,

7.1.6_Organization standardization,etc) & external knowledge
7.1.6 HR / Process Owner
Knowledge Library (academic, trainings,etc) of employees. Avoid
organization brain drain and over dependency on
7.2.1 7.2.1_Training Need To identify the gaps in the skill as per required job HR
 Clause No. Wise Format with Purpose & Process Owner
Clause Number Name
7.2.2_Competence - On the
7.2.2
job training
7.2.3_a_List of Internal
7.2.3
Auditors_QMS
7.2.3_b_List of Internal
7.2.3
Auditor
7.2.4_List of second party
7.2.4
auditors
7.4 7.4_Communication Matrix
7.5.1.1 7.5.1.1_Process Interaction
7.5.3.2.1_list of
7.5.3.2.1
documented information
7.5.3.2.2 7.5.3.2.2_ECN Note
7.5.3.2.2 7.5.3.2.2_ECN Summary
8.2.3.1.3_Manufacturing
8.2.3.1.3
Feasibility
8.2.3_APQP Tracking
8.2.3
Sheet
8.3.2.3_software
8.3.2.3 development capability
self assessment
8.3.2_Master Development
8.3.2
Schedule Example
8.3.3.1_contract review
8.3.3.1
checklist
8.3.3.1_Design Input &
8.3.3.1
Verification Sheet
8.3.3.2_Process Design
8.3.3.2
Input & Verification Sheet
8.3.3.3_Master List of
8.3.3.3
special characteristics
8.3.4.4 8.3.4.4_a_PSW Format
8.3.4.4_b_Checklist for
8.3.4.4
PPAP.xls
8.4.1.2_a_Supplier
8.4.1.2
registration form
8.4.1.2_b_Master List of
8.4.1.2
Supplier & Control
8.4.2.2_Statutory and
8.4.2.2
regulatory conformity
8.4.2.4.1 Second-party
8.4.2.4.1
audit plan
Purpose Process Owner
To achive the competency through practical
shopfloor training so personnel knowledge gap HR
does NOT have impact on product quality / ouput
To know the numbers of certified auditors at given
Quality System
time and deploy them in their audits as per the
To know the numbers of certified auditors at given
Quality Assurance
time and deploy them in their audits as per the
To know the numbers of certified auditors at given
Quality Assurance
time and deploy them in their audits as per the
To know who willl communicate to whom along
with frequency and method of communication. To Qualty System
avoid any confusion for responsibility
To know the process linkages along with remote
Quality System
location and outsourced process
To understand the required documentation and
Process Owner
control them (identification, revision, rentention,
To record and control the changes in the product in
a planned way (study, old stock availability, etc) Engineering
with standardization (as required)
To see the overall summary of ECN (date, customer,
review date,etc) and their current status (approved, Engineering
under progress, rejected ,etc)
To make sure that our organization is capable of
meeting customer requirements, identify risk, Engineering
capacity and propose any changes as required
To make sure that we meet and track development
status of product under development (including
transfer or modify product) so that the deadlines
Engineering
are NOT delayed and we meet customer
requiements on timely basis
To make sure that organization are capabale for
making embedded software and so that that it does Engineering
NOT cause any issue (complaint / issue in the main
Macro level monitoring of key milestone in the
Engineering
project (development)progress
To make sure we have understood the customer
requirements correctly and there is NO ambuiguity Engineering
(agreement with customer)
To make sure we have understood the design
requirements and it help us in the establish design Engineering
output (DFMEA, Drawing, Material Standard, etc.)
To make sure we have understood the process
requirements and it help us in the establish process Engineering
output (FMEA, Control Plan, PFD, etc.)
You can coherence audit (linkages verification) with
other documents (control plan, fmea, pfd,etc) and Engineering
also help us in establishing SPC Plan
Evidence of final PPAP approval and sign off with
Engineering
customer indicating the reason of submission,
submission level, run at rate and final status
To make a summary of requirements NOT appicable
or the status of any pending 18 documents are easy Engineering
to identify
To get the first hand information about supplier
(details like sale, customers, machines, team, etc)
Purchase
so that his infrastructure and capabilities can be
judged for further engagement
To keep a track of all customer key details along
Purchase
with contact and ISO / IATF status
To make sure that the supplier adhere to statutory
and regulatory requirements so that later it could Purchase
not create trouble during regular production/
To know which supplier needs to be be audited at
decided frequency and intimate them in advance for Quality Assurance
audits
 Clause No. Wise Format with Purpose & Process Owner

Clause Number Name Purpose Process Owner

So that ALL key requirements (as per checkpoints)
are covered for effective supplier initial or regular
8.4.2.4.1_Supplier Audit assesment to find out the gaps and opportunities
8.4.2.4.1 Quality Assurance
Check points for improements. Also, categorized them as per
rating system (e.g A,B,C,etc)
To know the status of real performance of supplier
8.4.2.4_Supplier
8.4.2.4 & update them about regular performance (with Quality Assurance
Monitoring
rating system) to initiate timely action for
Inspection, Regular Assessment, Certification
8.4.2_Type & Extent of Requirement, etc) is to be kept on each category
8.4.2 Purchase
Control supplier

8.5.1.1_a_Control Plan To ensure all changes are updated in the control

8.5.1.1 Quality Assurance
Review Frequency plan
8.5.1.1_b_Format for To establish product & processes characteristics
8.5.1.1 Engineering
Control Plan along with control at various stages of production
To make sure that shutdown does not have an
8.5.1.4_WI for Verification
8.5.1.4 adverse effect on meeting product requirements (as Process Owner
After Shutdown
per standard)
8.5.1.5_a_Machine history
8.5.1.5 card study for periodic To identify the repeated failures and plan for root Maintenance
overhaul cause analysis and periodic overhaul as required
To know when machines or parts of machines to be
8.5.1.5_b_Format_Periodic
8.5.1.5 taken out for overhaul in coordination with Maintenance
Overhaul Plan
production planning to reduce unplanned
To assess the condition of stock (damage, rust,
8.5.4.1_Stock Condition
8.5.4.1 dusty,etc) and take timely action for negative Store
Verfication
impact or line stoppage
To avoid the adverse impact of any change and
8.5.6.1_4M Change Control make sure we meet product conformity
8.5.6.1 Quality Assurance
Management requirements. Also, it helps in the investigation of
root cause (to identify if any change resulted in to
To know the different alternate processes in the
8.5.6.1.1_List of Alternate organization incase of non-availabiilty of primary
8.5.6.1.1 Engineering
Process Control control and to ensure the control for alternative
process to avoid any negative effect on product
8.6.2_Format for Layout
8.6.2 To know the frequency of layout inspection activity Quality Assurance
Ins Plan
and we don't miss the layout inspection
8.6.2_Format for Layout
8.6.2 To act as a proof / record of layout inspection Quality Assurance
Ins Report
covering all product dimension as per the drawings
To meet the product specific statutory and
8.6.5_Statutory and regulatory requirements so that later at any stage
8.6.5 Engineering
regulatory conformity no surprise (product must NOT get hold or rejected
at customer end / end user / designated country)
To act as authorization of deviation from approved
authority (top mangement / customer) for
8.7.1.1 8.7.1.1_Deviation Note production not meeting specification requirements. Quality Assurance
Also, specify the deviation quantity and time limit of
deviation
To know the status of any deviation note (open /
closed) and act as a quick reference for key details
8.7.1.1 8.7.1.1_Deviation Logbook Quality Assurance
regarding deviation

To keep track for rework details (carried out date,

who was responsible, identifcation, quantity, etc) so
8.7.1.4_Format_Rework that it's supply to customer or disposition is always
8.7.1.4 Quality Assurance
Log traceable.

To keep track for repair details (carried out date,

who was responsible, identification, quantity, etc)
8.7.1.5 8.7.1.5_format_Repair Log along with deviation reference so that it's supply to Quality Assurance
customer or disposition is always traceable.
 Clause No. Wise Format with Purpose & Process Owner

Clause Number Name Purpose Process Owner

It is formal methodology (authorization system) for
declaring the parts to be disposed in case of not
8.7.1.7 8.7.1.7_Format_Scrap Note Quality Assurance
repairable or reworkable. And this way parts are not
reused and scrap value can be calcuated easily
To identify the present customer satisfaction level
9.1.2.1_Customer and identify customer dissatisfaction indicators
9.1.2.1 Quality Assurance
Satisfaction Survey prior and work on the resolution of them to
maintain and enhance customer satisfaction
9.2.2.2_A Internal Audit To make that all process are covered as per plan
9.2.2.2 Quality Assurance
plan_QMS and at decided frequency
NOT to miss any key requirements as per the
9.2.2.2_B_IATF_Internal
9.2.2.2 standard / procedure and NEW personnel can also Quality Assurance
Audit Checksheet
participate / do audit easily

9.2.2.2_C_Audit NC Format To identify the root cause analysis and appropriate

9.2.2.2 Quality Assurance
QMS corrective action by auditee and act as a NC
evidence and verification by auditor
9.2.2.3_A_Process Audit To act as a monitoring for Plan vs Actual status for
9.2.2.3 Quality Assurance
Plan ALL manufacturing process (in all shifts)
So that we don't miss any key process audit
9.2.2.3_B_Process Audit checkpoint and make sure that the process
9.2.2.3 Quality Assurance
Sheet parameters are as per the control plan to meet
product specification requirements
9.2.2.4_A_Format_Product To act as a monitoring for Plan vs Actual status for
9.2.2.4 Quality Assurance
Audit Plan ALL products
9.2.2.4_B_Format_Product
9.2.2.4 To confirm all product parameters at all stages of Quality Assurance
Audit Sheet
production are under control as per the control plan
All concerned personnel inlcuding top management
9.3.1.1 9.3.1.1_MRM Plan are aware about frequency, timings and duration of Quality System
MRM plan
So that NOT to miss any key agenda as per the
9.3.2.1 9.3.2.1_MRM Agenda Quality System
standard requiements and keep meeting as agenda
Act as a evidence of meeting along with discussion
9.3.3_MRM_Minutes of
9.3.3 points, actionable points with responsibility and Quality System
Meeting
target date with any resource requirements.
A structured methodology for effective resoultion of
10.2.2 a_8D Problem a problem and avoid the re-occurence of a problem.
10.2.2 Process Owner
Solving Also, act as a evidence of action and add to
understanding and customer satisfaction
10.2.4_pokayoke To make sure that the pokayoke itself are in the
10.2.4 Quality Assurance
verification sheet working condition