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Production Part Approval Process PPAP ISO TS 16949:2002 Auditor Course Supplement

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Production Part Approval ProcessPPAP

ISO TS 16949:2002 Auditor Course Supplement

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Course Objectives

• By the end of the course the participant should be able identify the following;– How to audit PPAP· When PPAP submission is required· The requirements for part approval· Submission levels and the retention

requirements· Definition of requirements· Part Submission status

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So what is PPAP?

• PPAP – Production Part Approval Process

“PPAP defines the requirements for production part approval, including production and bulk materials”

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Applicability

• PPAP applies to all internal and external suppliers of;– bulk materials– production materials– production parts– service parts

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Foreword to PPAP Third Edition

• Inclusion of requirements for bulk material• Bulk material-specific appendix• Industry specific appendix• Tire industry specific appendix• Cpk/PpK = Initial process studies• Clarification

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PPAP Third edition

Effective date

February 1, 2000

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Production Part Approval Process

PPAP is a mandatory requirement of

ISO TS 16949:2002

Element 7.3.6.3

so is Supplier PPAP requirements

7.3.6.3

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PPAP - When Submission is required

• A full Production Part Approval is always required before shipment of the first production in the following situations;1. A new part or product - something not previously

supplied before

2. Correction of discrepancy on a previously submitted product

3. Engineering change on part or product

4. Other

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Definition of “Other” In any of these “other” situations the

supplier is required to notify the customer who may subsequently elect to require a submission for

PPAP approval.

Driven by design and/or process changes

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Other instances when submission may be required

1. An alternate construction method or material is now used

2. When a tool is modified or completely replaced

3. Refurbishment or re-arrangement of existing tooling

• Refurbishment = the reconstruction or modification of a tool or machine to to increase capacity or change its existing function

• Re-arrangement = A deviation from the process described in the process flow diagram

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4. Transfer of tooling and equipment to a different plant/location

5. Change of subcontractor for parts, non equivalent materials or services that affect fit, form, function, durability or performance requirements

6. Tooling inactive for a twelve month period7. Product and process changes that affect fit, form,

function, durability or performance requirements of the saleable product

Other instances when submission may be required

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8. Change in the test/inspection method - new technique

9. For bulk materials only

– New source of raw material with special characteristics from new or existing subcontractor

– Change in product appearance attributes, where there is no appearance specification

– Revised parameters in the same process– Change outside of the DFMEA of the approved product

Other instances when submission may be required

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PPAP - When Submission is required

• If there is any question concerning the need for

Production Part Approval - contact the customer

and obtain any agreement in

writing

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PPAP - Definition of Requirements

• Design records of saleable product– These typically include the following;

• CAD/CAM Math Data• Part Drawings• Specifications

– For bulk materials design records may include;• raw materials list• formulations• processing parameters etc..

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PPAP - Definition of Requirements

• Engineering Change Documents– Any documents authorised by a customer’s

representative that may affect the product but has not yet been incorporated in the design record or drawing for that product

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PPAP - Definition of Requirements

• Customer Engineering Approval– Customer Engineering approval may be

required for a product or associated documentation relating to that product, if this is required it will be stated on the customer’s drawing or similar.

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PPAP - Definition of Requirements

• Design FMEA– If the supplier is design responsible a

Design FMEA must be developed– For bulk materials, a design matrix shall be

developed prior to developing the Design FMEA

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PPAP - Definition of Requirements

• Process flow diagrams– A process flow diagram defines the

sequence of operations utilised to manufacture a product

– Process flow diagrams are mandatory for each product - Not Negotiable

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PPAP - Definition of Requirements

• Process FMEA– The process flow diagram should be the

basis of commencing a Process FMEA.– Generic FMEA’s are acceptable if there is

evidence of review and approval that is part specific.

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PPAP - Definition of Requirements

• Dimensional results– Dimensional results must reference part drawings

and should include cross sections, tracings and sketches as applicable

– The part number, change level, drawing date and supplier’s name must be shown on all supplementary documents

– The supplier shall identify one of the measured parts as a Master Sample

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PPAP - Definition of Requirements

• Material & Performance Test Results– Material Test results (chemical, physical,

metallurgical) for all parts/materials denoted on the design record

– Blanket statements of conformance are unacceptable

– All tests on the design record must be conducted, not just those you agree with!

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PPAP - Definition of Requirements

• Material Test Results cont..– The Material test report must contain;

• design record change level, date, specification level

• Date of testing• Material subcontractors name and supplier

code if required is they are a customer approved subcontractor

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PPAP - Definition of Requirements

• Material & Performance Test Results– Performance Test results (functional,

reliability, etc..) for all parts/materials denoted on the design record

– Blanket statements of conformance are unacceptable

– All tests on the design record must be conducted, not just those you agree with!

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PPAP - Definition of Requirements

• Performance Test Results– The Performance test report must contain;

• design record change level, date, specification level

• Any authorised engineering change documents not yet incorporated in the design record

• Date of testing

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PPAP - Definition of Requirements

• Initial Process Studies– Initial process capability results are required for each

special characteristic and must conform to customer requirements

– Unless otherwise specified, default values are:• Index value > 1.67 = process meets customer

requirements• Between 1.33 & 1.67 = acceptable, but may require

improvement, contact customer to review

• Index value < 1.33 = process does not meet customer requirements, contact customer

to review

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PPAP - Definition of Requirements

• Initial Process Studies cont..– If an X bar & R chart is used for the study a

minimum of 25 subgroups are required containing at least 100 readings from consecutive parts.

– If <100 parts are available contact customer to develop a suitable plan.

Initial Process Studies can only be conducted on stable

& normal processes

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PPAP - Definition of Requirements

• Measurement System Analysis Studies– For each measurement device,

Measurement System Studies must be conducted.

– Measurement System Studies include;• Repeatability and Reproducibility Study• Bias study• Linearity study• Stability study

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PPAP - Definition of Requirements

• Qualified laboratory documentation– A qualified laboratory is one that complies to the

requirements of 4.10.6 of QS 9000 rev 3– External laboratories must be accredited to ISO

Guide 25 or equivalent– If an independent lab conducts the testing, the supplier shall submit the

tests on the labs letterhead or the standard lab report format. The name of the lab that completed the tests, date(s) of test(s) and standards used shall be indicated.

Blanket statements of conformance are not acceptable

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PPAP - Definition of Requirements

• Control Plan– The control plan must include reference to all

special characteristics that are determined by the customer or supplier.

– Approval of the control plan may be required by the customer prior to submission of PPAP documents

Check with the customer

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PPAP - Definition of Requirements

• Part Submission Warrant– A document that is used to indicate the

reason for submission, the level of submission and the submission results

– This document is signed off by a designated official within the company, typically the Quality Manager.

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PPAP - Definition of Requirements

• Appearance Approval Report– A report which identifies the disposition of

a product in terms of Appearance evaluation and colour evaluation

– This report must initially be approved by the customer’s representative, typically the styling department, and then sent in conjunction with the Part Submission warrant to the customer

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PPAP - Definition of Requirements

• Bulk material requirements checklist– The composition of the checklist must be

agreed with the customer. All specified requirements shall be completed unless indicated “Not Required” on the checklist

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PPAP - Definition of Requirements

• Sample product {sample production parts}

– Quantities as requested by the customer

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PPAP - Definition of Requirements

• Master Sample – A master sample is a part that has been already

been verified (refer dimensional results). If this part serves as the basis for an acceptance criteria, it should be identified as such and identify customer approval date together with a reference to the design record

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PPAP - Definition of Requirements

• Master Sample cont..– A master sample is required for each position of a

multiple cavity die, mold, tool, pattern or production process.

– If the type of product makes storage difficult, this requirement can be waived by the customer, but,

Obtain Customer Approval in Writing

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PPAP - Definition of Requirements

• Checking Aids– Examples of checking aids are; fixtures, mylars,

fibreglass splashes, templates etc.. - something that is used as a comparative reference

– Checking aids must reflect the latest engineering design level of the product

– Measurement System studies must be

conducted on these checking aids

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PPAP - Definition of Requirements

• Records of compliance with customer specific requirements– Example

• GM requires two(2) sample parts from level 2 or 3 suppliers. All sample parts are to be labelled with part number, change level and supplier name.

• Ford requires all materials to comply with WSS-M99P9999-A1

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PPAP - Submission Levels

• Submission levels are ranked from

1 to 5,

the customer will identify the submission level.

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PPAP - Submission Levels

• Level 3

is the default value if a customer has not yet defined a

submission level for your company

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PPAP - Submission Levels

For

bulk material

suppliers the

default value is

level 1

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PPAP - Submission Levels

NOTE:

• Different customers

may

assign different submission levels

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PPAP - Submission Levels

• The submission levels are:

Level 1 Warrant only and Appearance Approval Report if required

Level 2 Warrant with product samples and limited supporting data

Level 3 Warrant with product samples and complete supporting data

Level 4 Warrant and other requirements as defined by the customer

Level 5 Warrant with product samples and complete supporting data reviewed on-site

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Submission Levels and Retention RequirementsRequirement Level 1Level 2 Level 3 Level 4 Level 5

1 Design records of saleable product R S S * R

:for proprietary components/details R R S * R: for all other components/details R S R * R

2 Engineering change docs. If any R S S * R3 Cust Engineering approval, if rqd R R S * R4 Design FMEA R R S * R5 Process flow diagram R R S * R6 Process FMEA R R S * R7 Dimensional results R S S * R8 Matl, performance test results R S S * R9 Initial process study R R S * R

10 Measurement Systems Analysis R R S * R11 Qualified lab. Documentation R S S * R12 Control Plan R R S * R13 Part Submission Warrant (PSW) S S S S R14 Appearance Approval Report (AAR) S S S * R15 Bulk Matls. Reqmnts. Checklist R R R * R16 Sample product R S S * R17 Master Sample R R R * R18 Checking aids R R R * R19 Records of Customer compliance R R S * R

S = Submit to customer & retain copyR = Retain on site and make readily available to customer* = Retain on site and submit to customer upon request

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PPAP - Part Submission Status

• Suppliers will be notified by the

customer as to the disposition

of the submission

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PPAP - Part Submission Status

Product is

NOT to be shipped unless

customer approval is received.

Verbal approval is unacceptable

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PPAP - Part Submission Status

• Full Approval– This indicates that the part meets all of the

customer requirements. The supplier may then proceed to supply product as required.

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PPAP - Part Submission Status

• Interim Approval– This indicates that shipment of material may

proceed for a specified period of time or piece quantity.

– Interim approval is granted when a product does not meet all customer requirements but the supplier has

• Clearly defined the root cause and• has provided an interim action plan that is approved by

the customer. Re-submission is required

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PPAP - Part Submission Status

• Rejected– This indicates that the product and/or

associated documentation does not meet customer requirements and therefore production quantities are not permitted to be shipped until all issues are resolved.

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Record Retention

• PPAP records shall be retained for;– length of time part is active, including service

requirements– plus one year

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Auditing PPAP

1. Is the organisation using PPAP rev 3?

2. How does the organisation identify which level they are?

3. Is this level consistent with the PPAP they are supplying to their customer(s)

4. Review several PPAPs to ensure all of the applicable 19 requirements are covered

5. Review lab documentation and ensure the scope of accreditation of the lab is consistent with the testing/inspection they are doing for the organisation.

6. How does the organisation define compliance with customer requirements

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Auditing PPAP

7. Verify that the date of the PSW is before the initial delivery date to the customer for production volumes

8. Verify the contents of the PSW, ensure correct level, part number, change level etc..

9. How does the organisation deploy PPAP with its suppliers?

10. Take a sample of part numbers, obtain the BOM and verify that all suppliers have submitted PPAP