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Production Part Approval Process
PPAP
ISO TS 16949:2002 Lead Auditor Course
2
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
3
So what is PPAP?
• PPAP
– Production Part Approval Process
“PPAP defines the requirements for
production part approval, including
production and bulk materials”
4
Applicability
• PPAP applies to all internal and
external suppliers of;
– bulk materials
– production materials
– production parts
– service parts
5
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
6
PPAP Third edition
Effective date
February 1, 2000
7
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
8
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
9
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
10
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
11
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 period
7. Product and process changes that affect fit, form,
function, durability or performance requirements of
the saleable product
Other instances when submission may
be required
12
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
13
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
14
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..
15
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
16
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.
17
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
18
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
19
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.
20
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
21
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!
22
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
23
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!
24
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
25
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
26
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
27
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
28
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
29
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
30
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.
31
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
32
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
33
PPAP - Definition of Requirements
• Sample product {sample production parts}
– Quantities as requested by the customer
34
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
35
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
36
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
37
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
38
PPAP - Submission Levels
• Submission levels are ranked
from
1 to 5,
the customer will identify the
submission level.
39
PPAP - Submission Levels
• Level 3
is the default value if a customer
has not yet defined a
submission level for your
company
40
PPAP - Submission Levels
For
bulk material
suppliers the
default value is
level 1
41
PPAP - Submission Levels
NOTE:
• Different customers
may
assign different submission levels
42
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
43
Submission Levels and Retention Requirements
Requirement 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 * R
3 Cust Engineering approval, if rqd R R S * R
4 Design FMEA R R S * R
5 Process flow diagram R R S * R
6 Process FMEA R R S * R
7 Dimensional results R S S * R
8 Matl, performance test results R S S * R
9 Initial process study R R S * R
10 Measurement Systems Analysis R R S * R
11 Qualified lab. Documentation R S S * R
12 Control Plan R R S * R
13 Part Submission Warrant (PSW) S S S S R
14 Appearance Approval Report (AAR) S S S * R
15 Bulk Matls. Reqmnts. Checklist R R R * R
16 Sample product R S S * R
17 Master Sample R R R * R
18 Checking aids R R R * R
19 Records of Customer compliance R R S * R
S = Submit to customer & retain copy
R = Retain on site and make readily available to customer
* = Retain on site and submit to customer upon request
44
PPAP - Part Submission Status
• Suppliers will be notified by the
customer
as to the disposition
of the submission
45
PPAP - Part Submission Status
Product is
NOT
to be shipped unless
customer approval is received.
Verbal approval is unacceptable
46
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.
47
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
48
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.
49
Record Retention
• PPAP records shall be retained for;
– length of time part is active, including service
requirements
– plus one year
50
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
51
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

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Ppap la

  • 1. Production Part Approval Process PPAP ISO TS 16949:2002 Lead Auditor Course
  • 2. 2 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
  • 3. 3 So what is PPAP? • PPAP – Production Part Approval Process “PPAP defines the requirements for production part approval, including production and bulk materials”
  • 4. 4 Applicability • PPAP applies to all internal and external suppliers of; – bulk materials – production materials – production parts – service parts
  • 5. 5 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
  • 6. 6 PPAP Third edition Effective date February 1, 2000
  • 7. 7 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
  • 8. 8 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
  • 9. 9 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
  • 10. 10 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
  • 11. 11 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 period 7. Product and process changes that affect fit, form, function, durability or performance requirements of the saleable product Other instances when submission may be required
  • 12. 12 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
  • 13. 13 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
  • 14. 14 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..
  • 15. 15 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
  • 16. 16 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.
  • 17. 17 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
  • 18. 18 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
  • 19. 19 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.
  • 20. 20 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
  • 21. 21 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!
  • 22. 22 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
  • 23. 23 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!
  • 24. 24 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
  • 25. 25 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
  • 26. 26 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
  • 27. 27 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
  • 28. 28 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
  • 29. 29 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
  • 30. 30 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.
  • 31. 31 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
  • 32. 32 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
  • 33. 33 PPAP - Definition of Requirements • Sample product {sample production parts} – Quantities as requested by the customer
  • 34. 34 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
  • 35. 35 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
  • 36. 36 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
  • 37. 37 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
  • 38. 38 PPAP - Submission Levels • Submission levels are ranked from 1 to 5, the customer will identify the submission level.
  • 39. 39 PPAP - Submission Levels • Level 3 is the default value if a customer has not yet defined a submission level for your company
  • 40. 40 PPAP - Submission Levels For bulk material suppliers the default value is level 1
  • 41. 41 PPAP - Submission Levels NOTE: • Different customers may assign different submission levels
  • 42. 42 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
  • 43. 43 Submission Levels and Retention Requirements Requirement 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 * R 3 Cust Engineering approval, if rqd R R S * R 4 Design FMEA R R S * R 5 Process flow diagram R R S * R 6 Process FMEA R R S * R 7 Dimensional results R S S * R 8 Matl, performance test results R S S * R 9 Initial process study R R S * R 10 Measurement Systems Analysis R R S * R 11 Qualified lab. Documentation R S S * R 12 Control Plan R R S * R 13 Part Submission Warrant (PSW) S S S S R 14 Appearance Approval Report (AAR) S S S * R 15 Bulk Matls. Reqmnts. Checklist R R R * R 16 Sample product R S S * R 17 Master Sample R R R * R 18 Checking aids R R R * R 19 Records of Customer compliance R R S * R S = Submit to customer & retain copy R = Retain on site and make readily available to customer * = Retain on site and submit to customer upon request
  • 44. 44 PPAP - Part Submission Status • Suppliers will be notified by the customer as to the disposition of the submission
  • 45. 45 PPAP - Part Submission Status Product is NOT to be shipped unless customer approval is received. Verbal approval is unacceptable
  • 46. 46 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.
  • 47. 47 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
  • 48. 48 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.
  • 49. 49 Record Retention • PPAP records shall be retained for; – length of time part is active, including service requirements – plus one year
  • 50. 50 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
  • 51. 51 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

Notas del editor

  1. Notes