Advanced Product Quality Planning

APQP

QUALITY PRODUCTIVITY MANAGEMENT CONSULTANCY

(QPMC)

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 Advanced Product Quality Planning (APQP)

Synopsis:
Advanced Product Quality Planning (APQP) is the technique, adopted by most of the
companies, which helps to establish the steps necessary to assure that a product satisfies the
customer.
The goals of product quality planning are effective communication in a team with everyone
involved, on time completion of all required steps, minimal or no quality problem.
APQP should be used as a guideline to utilize the resources towards customer satisfaction, to
identify the required changes early, to provide a quality product on time at competitive cost.
Effective product quality planning depends on a company’s top management commitment to the
effort required in achieving customer satisfaction.

Purpose
The purpose of this workshop is to provide individuals and teams with the knowledge and skills
to the different phases of APQP requirement. The training program covers Plan and Define
program, Product design and development, Process design and development, Product and
Process validation, Feedback assessment and Corrective action.

Objectives:
After completion of this workshop, participant will be able to:
1. Explain the importance of thinking.
2. Understand different stages of APQP
3. Able to take decision fast

Precaution:
The participant manual was designed for use in the context of an instructor-led workshop and as
a reference outside the workshop. All presentations are in transparent sheet material. It was not
designed as a self-study text.
This material should not be photocopied without the permission of author. Also this material
should not be shown or given to any Consultant or Consultancy Organization.

Dr. S Bhuniya

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 Advanced Product Quality Planning (APQP)
What is APQP?
Advanced Product Quality Planning (APQP) is a structured method of defining and establishing the steps
necessary to assure that a product satisfies the customer.
Effective product quality planning depends on a company’s top management commitment to the effort required
in achieving customer satisfaction.

Objectives of APQP
The goals of product quality planning are
* effective communication in a team with everyone involved
* on time completion of all required steps
* minimal or no quality problem.
* minimal product launch quality risk

Benefits of APQP
* Resources are directed towards customer satisfaction
* Required changes are identified early
* A quality product on time at competitive cost.

Phases of APQP
Phase I- Plan and Define program
Phase II- Product design and development
Phase III- Process design and development
Phase IV- Product and Process validation
Phase V- Feedback assessment and Corrective action.

Phase –I ( Plan and Define the Program)

1. Organization will interface with the customer& get all the necessary customer inputs like customer drawings,
specifications, sample parts etc. to enable to do a preliminary feasibility study.

2. An initial feasibility study, preliminary process flow & risk assessment are done based on the checklist to
evaluate the suitability of designing and manufacturing the new product. This initial feasibility and risk
assessment will be done in a team.

3. In some cases, when the customer requires some sample parts before submitting the quotation, the same is
submitted.

4. Based on the initial feasibility studies, the new product development will be considered. The cost estimation
will be done for the new product.

5. The quotation package will be prepared & submitted to the customer for acceptance. The qualities planning
activities starts once the customers conforms the orders either verbally or give it in writing.

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6. The team will do a detailed contract and feasibility review based on the customer confirmation and order
placement.

7. Organizer will conduct a Quality system requirements review with the customer to ensure that all TS
16949:2002 system requirements are clarified and any additional customer specific requirements are
required. Organizer will ensure that all customer standards like packaging standards, engineering standards;
inspection standards are received from the customer.

8. Organizer will combine feasibility review & quality system requirements review.

9. Organizer will prepare a detailed Product quality planning and introduction Gantt chart. This chart will
show all the activities of APQP in detail along with the responsibilities, start-date and end-date. The
progress of the product introduction is also monitored using this chart.

10. Organizer will initiate the APQP Status reporting form. The program need dates and the supplier timing
dates are planned depending on when the customer requires the product. If the customer requires the APQP
status reporting form to be sent to him at a determined frequency, Organizer will ensure that the status
reporting form are sent to the customer as per the agreed frequency.

11. Organizer will prepare the Bill of Material for the new product. Based on the BOM and the similarity of the
new product components with the existing ones, Organizer will review the existing Family data sheet and
decide the part families for the new product for all components made in-house.

12. Organizer will select the subcontractors from the Approved subcontractors list. If any new subcontractors
are required, then the selection will be done. Quality system development of existing subcontractors will be
done. Product development with the subcontractors (new/existing) will be done.

13. The following are the outputs are the end of phase-1 of APQP:
* Customer inputs like drawings, specs, and correspondences
* Initial feasibility and risk assessment checklist
* Quotation
* Customer’s Purchase order
* Contract and feasibility review checklist
* Quality system review checklist
* New product planning and introduction Gantt chart
* Bill of Material
* Family data sheet
* APQP status reporting form
* List of subcontractors
* Customer specified special characteristics

14. Management review will be conducted by organizer to ensure the adequacy of all the activities conducted
during Phase-1.

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Phase II- Product design and development

15. Product design and development will be done ( only for design-responsibility organization)
* Design FMEA
* Design for manufacturability and assembly
* Design Verification
* Design reviews
* Prototype build
* Engineering Drawing
* Engineering specification
* Material specification
* Drawing and specification changes

16. Organization prepares detailed drawing using customer drawing / sample wherever required and make
tooling drawing accordingly.

17. A detailed plan for any new facilities, equipment or tool if required will be prepared by organization.
Facilities planning and review will be done.

18. Organization will ensure that the existing gauges/measuring equipment is capable of measuring the
characteristics for the new product made. If any new gauges/measuring equipment is required, then team
will prepare a list of new gauges/measuring equipment for procurement and to be procured.

19. Organization will review whether any customer specified testing is needed and any additional test
equipment are required for doing the testing. If any new test equipment is required, team will prepare a list
of test equipment for procurement.

20. Organization will review the tooling/die/fixture requirements and identifies the existing tools/dies/fixtures
and the tools/dies/fixtures to be manufactured for making the new product. This also includes any
tooling/dies/fixtures, which have to be given to the subcontractor.

21. The following are the outputs at the end of Phase-2:

* Drawings, specs
* Design FMEA
* Preliminary list of special characteristics
* Prototype control plan (if contracted to produce prototype parts)
* Design verification plan
* Design verification test results
* Design reviews
* List of new equipment/facilities (if required)
* List of new gauges/measuring equipment (if required)
* List of new test equipment (if required)
* List of tool /die/fixture

22. Management review will be conducted at the end of Phase-2 to ensure the adequacy of all the activities done
during phase-2.

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Phase III- Process design and development

23. The APQP team will prepare Process Flow Diagram, Process FMEA, Special characteristics & Pre launch
Control, Tool/ Die/ Fixture Drawing.

24. Organization will prepare work / operation instructions based on the activities required

25. Process development and Qualification will be done.

26. Organization will prepare floor plant layout.

27. Packaging drawings and specifications will be done as per the customer specified packaging standard (if
provided) or internal standards by organization.

28. Any training required for the operators as part of the new process are identified by team and provided.

29. Prepare sample and submit to customer for initial verification with dimensional report.

30. Conduct MSA study (Bias, Linearity, Stability, Gage R & R) for similar type of components or have the
plan for those studies at the time of PPAP sample.

31. Prepare preliminary capability study plan for special characteristics.

32. At the end of Phase-3, Leader along with the APQP team ensures that the following are available for
conducting the Production part approval process.

TYPE REQUIREMENTS
Man 1. Trained operators
Machine 2. Facilities/equipment (including facilities at subcontractor)
Method 3. Validated tooling (including tooling at subcontractor)
Measurement 4. Calibrated gauges/measuring equipment
5. Test equipment
Material 6. Raw materials
7. Subcontractor processes developed and qualified.
8. Packaging requirements
Atmosphere 9. Good housekeeping
10. Any other environmental conditions (if any)
Documents 11. Drawings/specifications
12. Process flow chart
13. Process FMEA
14. Control plans/any other customer equivalents
15. Customer standards
16. List of special characteristics
17. Work / Operation instructions

33. Review is conducted at the end of Phase-3 to ensure the adequacy of all the activities done during phase-3.

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Phase IV- Product and Process validation
34. Production Part Approval Process will be followed as per the PPAP reference manual after tool/die/fixture
validation or those can be verified thoroughly by lay out inspection of component.
If the customer wants a different process to be followed, then it will be agreed during Quality systems
review with the customer.

35. PPAP sample (quantity as agreed or 300 nos minimum) will be produced as per Pre launch Control plan,
Work/ Operations instruction.

36. MSA studies (Bias, Linearity, Stability, Gage R &R) to be carried out, if it was planned in Phase 3.

37. Preliminary process capability studies ( Pp, Ppk) will be carried for special characteristics as per plan.

38. Dimensional, Performance testing or Production validation testing will be carried out.

39. One master sample of PPAP, will be kept.

40. Packaging evaluation will be done

41. PPAP sample will be sent to customer for approval with PSW (Part submission warrant).

42. If customer approves the PPAP part for regular production, then APQP team prepares the Production
control plan and releases it to the shop floor.

43. Quality Planning sign off will be done.

44. Changes for which as agreed with the customer during Quality systems review, PPAP has to be submitted

Phase V- Feedback assessment and Corrective action.

45. If customer has not accepted the PPAP part, then relevant above activities have to be reviewed and make
those effective for approval of customer.

46. Product quality planning data and experience will be used as an input for the future same type of product
development.

Common activities:
47. APQP timing plan initiated during Phase-1 will be reviewed and updated. and the progress of the product
planning tracked. The review frequency will depend on the following:
* Type of the new product
* Difference in the processes from the existing processes
* Customer requirement date

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 Failure Mode & Effects Analysis (FMEA)
Definitions & Types
FMEA is an analytical technique, which combines the technology and experience of several engineering
disciplines in identifying foreseeable failure modes of a product or process and planning for its elimination.
Mainly FMEA are Design FMEA and Process FMEA.

What FMEA will do:

* Identify known and foreseeable failure modes.
* Rank failures according to relative impact on the product.
* Help to establish priorities based on expected failures and severity of those failures.
* Help to uncover oversights, misjudgments and errors that may have been made.
* Help to reduce development time and cost of manufacturing process by eliminating many potential failure
modes prior to operation of the process and by specifying the appropriates tests to prove the designed product.

What FMEA will not:

* Will not fix the identified problems.
* Will not define the action that needs to be taken.
* Will not replace the PDCA (Plan, Do, Check, Act) plan, which should be used to track major potential
problems to resolution.

How to get started:

Select 4 to 8 people who are knowledgeable of the process or the design to be used for a new process.
* Always best to include end users in the process.
* Should be a team effort.

Design FMEA Process FMEA

Customer End user, Design responsible End user, Subsequent or
engineers or Higher downstream
assemblies or Mfg. Process Mfg. or Assembly operation
responsible engineers in
activities such as Mfg.,
Assembly, Service
Assumptions Takes the technical / physical The product as designed will
limits of a Mfg. / Assembly meet design intent
process into consideration

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 PROCESS FMEA
What is it?
A process potential FMEA is an analytical technique, utilized primarily by Manufacturing Responsible
Engineer / Team as a means to assure that, to the extent possible; potential failure modes and their associated
causes / mechanisms have been considered and addressed.

What it does?
It
- Identifies the process functions and requirements.
- Identifies potential product and process-related failure modes.
- Assesses the effects of potential failures on the customer.
- Identifies the potential manufacturing or assembly process causes and identifies process variables on
which to focus controls for occurrence reduction or detection of the failure conditions.
- Develops a ranked list of potential failure modes, thus establishing a priority system for preventive
/corrective action considerations.
- Documents the result of the manufacturing or assembly process.

Which customer is to be considered?

“Customer” for a Process potential FMEA is seen as the ‘Next Process (NP)’, ‘Assembly’, ‘OEM’ and
‘Application / Vehicle’ or ‘government regulation’.

Team Effort
During the initial process potential FMEA process, the responsible engineer is expected to direct and actively
involve representatives from all affected areas.

Development of a Process FMEA

FMEA begins by developing a list of what the process is expected to do and what it is expected not to do i.e.
process intent.

FMEA details should include:

* FMEA Number
* Item
* Process Responsibility
* Prepared by
* Model Year (s) / Vehicle (s)
* Key Date
* FMEA Date
* Core Team

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Process Function/ Requirements
* What is the process?
* What is it supposed to achieve?

Potential Failure Mode

* How can the process / part fail to meet the specification?
* List each potential failure mode for the particular operation in terms of a component, subsystem, system or
process characteristic.
* Typical failure modes could be bent, Cracked, Handling damages, Surface too rough, Open circuited, Burred,
Hole too shallow, Dirty, Deformed, Short circuited, Hole off-location, Hole missing, Hole too deep, Surface too
smooth, Mis-labeled etc.

Potential Effect (s) of Failure

* In what form, would the customer define the failure?
* What are the effects of this failure mode that the customer sees?
* Typical failure effects could be
- Noise, Erratic operation, Effort, Operation impaired, Intermittent operation, Leaks, Rework /Repairs,
Scrap, Rough, Excessive, Unstable, Inoperative, Draft, Poor appearance, Vehicle control impaired,
Customer dissatisfaction etc., in case of final operation.
- Can not fasten, Does not fit, Does not connect, Does not match, Can not mount, Can not bore/tap,
Cannot face, Damages equipment, Causes excessive tool wear, endangers operator etc., in case of
customer being next operation or subsequent operation.

Severity
Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer.
Severity applies to the effect only.
A reduction in Severity Ranking Index can be effected only through design change.
Severity should be estimated on a “1” to “10”scale.

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Effect Criteria: Severity of effect
(Customer Effect)
Hazardous Very high severity ranking when a
without potential failure mode affects safe
warning vehicle operation and / or involves
noncompliance with government
regulation without warning
Hazardous Very high severity ranking when a
with potential failure mode affects safe
Warning vehicle operation and / or involves
noncompliance with government
regulation with warning
Very High Vehicle / item inoperable, with loss of
primary function.
High Vehicle / item operable, but at a
reduced level of performance.
Customer very dissatisfied.
Moderate Vehicle / item operable, but comfort /
convenience item (s) inoperable.
Customer dissatisfied.
Low Vehicle / item operable, but comfort /
convenience item (s) operable at
reduced level of performance.
Very Low Fit & Finish / Squeak & Rattle item
does not conform. Defect noticed by
most customers (greater than 75%).
Minor Fit & Finish / Squeak & Rattle item
does not conform. Defect noticed by
50% of customers.
Very Fit & Finish / Squeak & Rattle item
Minor does not conform. Defect noticed by
discriminating customers (less than
25%)
None No discernible effect
Classification
Classify any special product characteristics (e.g. Critical, Key, Major/ Significant) for components, subsystems
or systems that may require additional process controls.
If a classification is identified in the process FMEA, notify the design responsible engineer since this may affect
the engineering documents concerning control item identification.
Criteria: Severity of effect Rank
(Manufacturing / Assembly Effect)
May endanger operator (machine or assembly) 10
without warning
May endanger operator (machine or assembly) 9
with warning
100% of product may have to be scraped. Or 8
Vehicle / item repaired in repair dept. with a
repair time greater than one hour.
Product may have to be sorted and portion 7
(less than 100%) scrapped. Vehicle / item
repaired in repair dept. with a repair time
between a half-hour and an hour.
A portion (less than 100%) of the product may 6
have to be scrapped (no sorting) or Vehicle /
item repaired in repair dept. with a repair
time less than a half-hour.
100% of the product may have to be reworked. 5
Or Vehicle / item repaired in offline but does
not go to repair dept.
The product may have to be sorted, with no 4
scrap and a portion (less than 100%)
reworked.
A portion (less than 100%) of the product may 3
have to be reworked with no scrap, on-line but
out-of-station.
A portion (less than 100%) of the product may 2
have to be reworked with no scrap, on-line but
in-station.
Slight inconvenience to operation or operator, 1
or no effect
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Potential Cause (s) / Mechanism (s) of failure
* What are the ways in which this process failure could occur?
* Describe in terms of something that can be corrected / controlled.
* Typical failure causes may be Improper torque (over, under), improper weld (Current, time, pressure),
Inaccurate gauging, Improper heat treatment (time, temperature), Inadequate gating / venting, Inadequate or no
lubrication, Part missing or mislocated, Worn locator, Worn tool, Chip on locator, Broken tool, Improper
machine set up, Improper programming etc.

Occurrence
Occurrence is how frequently the specific failure cause / mechanism will occur.
Occurrence should be estimated on a “1” to “10” scale.
Probability of Failure Likely Failure Rate Ppk Rank
Very High: Persistent Failure ≥ 100 per thousand pieces < 0.55 10
50 per thousand pieces ≥ 0.55 9
High: Frequent Failures 20 per thousand pieces ≥ 0.78 8
10 per thousand pieces ≥ 0.86 7
Moderate: Occasional Failure 5 per thousand pieces ≥ 0.94 6
2 per thousand pieces ≥ 1.00 5
1 per thousand pieces ≥ 1.10 4
Low: Relatively Few Failures 0.5 per thousand pieces ≥ 1.20 3
0.1 per thousand pieces ≥ 1.30 2
Remote: Failure is Unlikely ≤ 0.01 per thousand pieces ≥ 1.67 1

Current Process Controls

What are the existing process controls that:
* Prevent to the extent possible the failure mode or cause/ mechanism of failure from occurring.
* Detect the failure mode or cause / mechanism of failure
Controls can be process controls such as error / mistake proofing or Statistical Process Control (SPC) or can be
post-process evaluation.
Two types of process controls to be considered
* Prevent the cause / mechanism of failure or the failure mode from occurring, or reduce their rate of
occurrence
* Detect the cause / mechanism of failure or the failure mode, and lead to corrective action (s).
Once the process controls have been identified, review all prevention controls to determine if any occurrence
rankings need to be revised.

Detection
Detection is the rank associated with the best detection control listed in process control column. In order to
achieve a lower ranking, generally the planned process control has to be improved.

Detection should be estimated on a “1”to “10” scale.

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 Detection Criteria: Insp Suggested Range of Detection Methods Rank
Types
A B C
Almost Absolute certainty X Cannot detect or is not checked 10
Imposs of non detection
ible
Very Controls will X Control is achieved with indirect or random checks 9
Remot probably not detect only
e
Remote Controls have poor X Control is achieved with visual inspection only 8
chance of
detection
Very Low Controls have poor X Control is achieved with double visual inspection only 7
chance of
detection
Low Controls may X X Control is achieved with charting methods, such as 6
detect SPC.
Moderate Controls may X Control is based on variable gauging after parts left the 5
detect station, or Go / No Go gauging performed on 100% of
the parts after parts left the station.
Moderate Controls have a X X Error detection in subsequent operations, or gauging 4
High good chance to performed on setup and first piece check (for setup
detect causes only)
High Controls have a X X Error detection in-station, or error detection in 3
good chance to subsequent operations by multiple layers of acceptance:
detect supply, select, install, verify, and cannot accept
discrepant part.
Very High Controls almost X X Error detection in-station (automatic gauging with 2
certain to detect automatic stop feature). Cannot pass discrepant part.
Very High Controls certain to X Discrepant parts cannot be made because item has been 1
detect error-proofed by process/product design.
A- Error Proofed, B- Gauging, C- Manual Operation

Risk Priority Number (RPN)

RPN = SEVERITY (S) * OCCURANCE (O) * DETECTION (D)
Within the scope of the individual FMEA, RPN will be between “1” and “1000”.
For higher RPN, the team must undertake efforts to reduce through corrective action.
Regardless of the resultant RPN, special attention should be given when severity high.

Recommended Action(s)
Intent is to reduce the severity, occurrence, and / or detection ranking
Action such as following should be considered
- Only a design and or process revision can bring about a reduction in the severity ranking.
- To reduce the probability of occurrence, process and / or design revisions are required. An action-oriented
study of the process using statistical methods could be implemented for continuous improvement and defect
prevention.

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- To increase the probability of detection, use of error / mistake proofing / process and / or design revisions are
required.
Generally, improving detection controls is costly and ineffective for quality improvements. Increasing quality
controls inspection frequency is not positive corrective action, should only be utilized as temporary measure,
permanent corrective action is required.
If engineering assessment leads to no recommended actions for a specific failure mode / cause/ control
combination, indicate this entering “None” in this column.

Responsibility (for recommended action)

Enter the organization and individual responsible for the recommended action and the target completion date.

Action taken
After an action has been implemented, enter a brief description of the actual action and effective date.

Resulting RPN

Follow up
The process responsible engineer is responsible for assuring that all the actions recommended have been
implemented or adequately addressed.

The process responsible engineer has several means of ensuring that concerns are identified and that
recommended actions to be implemented. They include
* Ensuring that process / product requirements are achieved
* Reviewing engineering drawings, process /product specification, process flow
* Confirming the incorporation of changes in assembly/ manufacturing documentation
* Reviewing control plans and operation instructions.

______________X______________

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 Guidelines for preparation of “Process Flow Diagram”
1. Mention Serial No.

2. Mention Operation Description .

3. Mention Flow diagram with symbol

4. Mention Operation Sketch

5. Mention incoming source of variation

6. Mention Process Characteristics

7. Mention Product characteristics

Sl No. Operation Flow Flow Incoming Source Process Product

description diagram Sketch of Variation Characteristic Characteristic

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 Guidelines to Carry out PFMEA
Corrective action (CA) for existing problem
Preventive action (PA) for potential problem
(1) Failure Mode
• Opposite of desired outcome of that process
• Mention oversize / undersize in case of dimensional (if effect is same then no need to
differentiate)
• How much?
• Last six months problem should be covered.
(2) Effect
• Effect to be written for
o Next process (NP)
o Assembly
o OEM
o Vehicle / Application
o Government Regulation
(3) Severity
• Follow guide lines for ranking severity number
• Circle the max no., which will be used for RPN calculation.
(4) Class
• Corresponds to product characteristic
• For those product characteristic having effect on Application or Customer
o Severity ranking 10, 9 - Critical , Safety, Government regulation
o Severity ranking 8,7 – Significant / Major
(5) Cause
• Cause related to failure mode.
• Write those, which are related Incoming source of variation, mentioned in Process Flow
• Write those, which are related process characteristic
(6) Occurrence
• Check the data related to causes
o If exists, then straightway go to the Occurrence table and rank accordingly
o If it is not there,
 Depending on the probabilities, give the ranking
 Not able to take decision in the meeting / confusion, then go to failure mode
data and give the same ranking to all causes
• Check the rejection percentage corresponding to that failure mode
o If it exists, then straightway go to the occurrence table and rank accordingly
o If it is not existed, then go by probability
• For each cause, there will be one occurrence no.
(7) Current process Control
• If the cause happens then what is the method, we have to detect the cause?
• What is the method do we have to prevent the cause?
• What is the method; do we have to detect the failure mode?

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Note: Difference between prevention and detection:
Example: There is a sensor to stop the production process, if anything goes wrong- Detection
If something goes wrong, but sensor doesn’t allow to stop the production or no inconsistency in production
criteria, then it is ’Prevention’.

(8) Detection
• Whenever cause occurs, would it detect?
• Rank as per table

(9)Risk Priority Number (RPN)

RPN = S X O X D

(10) Recommended Action

• To be taken, only when occurrence no. is more than 3, preferably; because our ultimate aim
is to reduce the frequency of cause’s occurrence.
• It should be completed within target date

Outcome of the PFMEA

• List of critical, significant or major and key characteristics of the part
• List of recommended action to be implemented

Customer Complaint & Rejection Analysis

Customer Complaint Rejection

Directly from customer Field failure

Effect on Application / Vehicle

Failure Mode Identify failure mode Failure mode

Identify Causes

Look for Preventive control

Look for Detection control

Corrective Action
Corrective Action Impact
------------------------X------------------------

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 Guideline to carry out CONTROL PLAN
1. Copy the Process No. and Process Description from Process Flow.

2. Write the Process machine/ Device/ Jig/ Tool used for doing that Process.

3. Go to the Process FMEA. Copy the first product characteristics for that process into Product characteristic
column of Control Plan.

4. Copy the Potential Causes of FMEA into Process characteristics of Control Plan.

5. Copy the Class Column of FMEA into Special Characteristics column of Control plan.

6. Write Product specification from drawing against Product characteristic.

7. Write the Process specification if applicable in the same column.

8. Write the evaluation / Measuring Equipment used for controlling Product and Process characteristic.

9. Write control method (prevention and detection) used for controlling product and Process characteristic.

10. Write Reaction Plan for Product and Process characteristic when it goes out of specification.

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 Production part Approval Process (PPAP)
Purpose:
To determine whether all customer engineering design record and specification requirements are properly
understood by the organization &
whether process has the potential to produce product consistently meeting the requirements during an actual
production run as quoted production rate.

Section I
I.1 General
Organization shall obtain full approval from the customer for
• A new part or product
• Correction of a discrepancy on a previous submitted part
• Product modified by an engineering change to design records, specification or materials

I.2 PPAP Process requirements:

I.2.1 Significant Production Run:
Product run shall be from 1 hour to 8 hours of production with 300 minimum consecutive parts or specified by
customer. Run shall be manufactured at the production site using productionised tooling, gaging, process,
materials and operators from the production environment.

I.2.2 PPAP requirements

Organization shall meet all specified requirements. Blanket statements of conformance are unacceptable for any
test results. All records shall be in a PPAP part file or referenced in such file, which will be readily available.

I.2.2.1 Design Records

Organization shall have all design records.

I.2.2.2 Any authorized Engineering Change Document

Organizer shall have any authorized engineering change documents not yet recorded in the design record but
incorporated in the product, part or tooling.

I.2.2.3 Engineering Approval, when required

Where specified by the design record, organization shall have evidence of customer engineering approval.

I.2.2.4 Design FMEA (for design responsible)

I.2.2.5 Process Flow Diagram

Process flow diagram in organization-specified format that clearly describes the production process steps and
sequence, as appropriate and meets the specified customer needs, requirements and expectation.

I.2.2.6 Process FMEA

As per PFMEA manual

I.2.2.7 Dimension Results

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Organization shall provide the evidence that dimensional verifications required by the design record (Layout
inspection) and Control Plan has been completed and results indicate compliance with specified requirements.
Organization shall identify one of the parts measured as the master sample.

I.2.2.8 Record of Material / Performance test result

Organization shall have records of material / performance/ functional test specified on design records or Control
Plan.
In Material test result, wherever chemical, physical or metallurgical requirements specified by design record or
control plan to be verified form in-house laboratory or outside-accredited laboratories. Material test report shall
indicate
• Design record change level of parts tested, number, date, change level of specification
• date on which the testing took place
• material subcontractor’s name
In Performance test result, whatever specified by design record or control plan to be verified form in-house
laboratory or outside-accredited laboratories. Performance test report shall indicate
• design record change level of parts tested, number, date, change level of specification
• any authorized engineering change documents that have not yet been incorporated in the
design record.
• date on which the testing took place

I.2.2.9 Initial Process Studies

I.2.2.9.1 The level of initial process capability or performance to be evaluated for special characteristics only.
Organization shall use calibrated measuring instrument with permissible measurement uncertainty.

I.2.2.9.2 Quality Indices

Cpk – Capability Index for a stable process
Ppk performance index
Short-term studies

I.2.2.9.3 Acceptance Criteria for Initial Study

For appearing stable process (Ppk) or stable process (Cpk)

Results Interpretation

>1.67 Process currently meets Customer requirements. After approval, begin production and follow
control plan
1.33 to Process is currently acceptable, but may require some improvement
1.67
<1.33 Process does not currently meet the acceptance criteria

I.2.2.9.4 Unstable process

An unstable process does not meet customer requirements. Supplier shall identify the nature of instability,
evaluate and wherever possible eliminate special causes of variation prior to PPAP submission.

I.2.2.9.5 Process with one-sided specification or Non Normal Distribution

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Organization shall establish an alternative acceptance criterion or different type of index or some method of
transformation data for special characteristics which are not bilateral equidistant tolerance or non normal
distribution.
I.2.2.9.6 Strategy when acceptance criteria are not satisfied
Organization shall submit corrective action plan and a modified control plan providing 100% inspection.
Continue variation reduction efforts till Cpk greater than equal to 1.33.

I.2.2.10 Measurement System Analysis Studies

Organization shall carry our Bias, Linearity, stability, gage R & R for all equipment used for measurement or
performance test.

I.2.2.11 Qualified laboratory Requirements

Organization shall have laboratory scope, policy and documentation as per QS 9000 (4.10.6 and / or 4.10.7)

I.2.2.12 Control Plan

I.2.2.13 Part Submission Warrant (PSW)

Separate PSW shall be completed for each customer part number
If production parts will be produced from more than one cavity, mould, tool, die, pattern or production process
(e.g. line or cell) organization shall complete dimensional evaluation on one part from each with identified
“Mold/ Cavity/ Production Process”.

I.2.2.13.1 Part Weight

Organization shall record part weight upto 4 decimal places unless otherwise specified by customer.

I.2.2.14 Appearance Approval Report (AAR)

Appearance approval report to be completed for each part or series of parts for which submission required for
parts with color, grain or surface appearance requirements.

I.2.2.15 Bulk Material Requirements checklist (apply only to bulk material only)

I.2.2.16 Sample Production Parts:

Organization shall provide sample product as requested by the customer and as defined by the submission
request.

I.2.2.17 Master Sample:

Organization shall retain a master sample for the same period as the production part approval records, or until a
new master sample is produced for the same customer part number for customer approval or where a master
sample is required by design record, control plan or inspection criteria, as a reference or standard.
Master sample shall be identified with approval date on the sample.
Organization shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern or
production process unless otherwise specified by customer.

I.2.2.18 Checking Aid:

Organization shall certify that aspects of the checking aids agree with part dimensional requirements.

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I.2.2.19 Customer-Specific Requirement:
Organization shall have the records of compliance to all applicable customer specific requirements.

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