ISO TS 16949:2002 Lead Auditor Course - PPAP Audit Process

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

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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

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
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
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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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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• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Sample product {sample production parts}
– Quantities as requested by the customer

34
• 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
• 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
• 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
• 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
• Level 3
is the default value if a customer
has not yet defined a
submission level for your
company

40
For
bulk material
suppliers the
default value is
level 1

41
NOTE:
• Different customers
may
assign different submission levels

42
• 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
Product is
NOT
to be shipped unless
customer approval is received.
Verbal approval is unacceptable

46
• Full Approval
– This indicates that the part meets all of the
customer requirements. The supplier may
then proceed to supply product as
required.

47
• 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
• 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

ISO TS 16949:2002 Lead Auditor Course - PPAP Audit Process

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