Subject Page

Introduction 2
Advance Planning for PPAP 4
Submission Warrant 5
Appearance Approval Report 7
Parts, Drawings & Inspection 8
Results
Checking Aids 9
Material Certifications/Test 11
Results
Failure Mode & Effects Analysis 13
(FMEA)
Process Flow Diagram 14
Process Control Plan 15
Initial Process Studies (Capability 16
Analysis)
Measurement Systems Analysis 17
Contact Information for Publishers 19
of Standards

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E
xperience has shown that introduction of the PPAP process has helped
customers to a more comprehensive understanding of suppliers’
capabilities in providing products that satisfy design requirements. We
have also seen, however, that many suppliers—especially those for whom
PPAP is a new experience—have had a difficult time in supplying submission
packages that can be expeditiously approved.

Perhaps the most significant misunderstanding of our intentions for PPAP

lies in the popular (and erroneous) perception that a PPAP submission is an
independent entity or a paperwork exercise. On the contrary, a PPAP
submission is the output of a process intended to provide objective evidence
that suppliers are capable of providing products that will consistently meet
our requirements. Unless the Advanced Product Quality Planning (APQP)
process is conscientiously adopted and followed by suppliers, the value
added by supplying a PPAP submission package is negligible.

All of the elements of PPAP are, individually, the output products of

individual processes which, when combined, form a cohesive chain of
evidence that all specifications have been met, and that the supplier is
capable of producing conforming product—at quoted rates—on an ongoing
basis.

Because the integrity of PPAP submissions—and the processes represented

by the submissions—is considered a critical factor in our continuing
relationships with suppliers, submissions are carefully evaluated. The
purpose of this guide is to supplement the AIAG documentation so as to
provide guidance in specific areas where we have noticed that suppliers
seem to have the most questions. This guide is not intended to be a
comprehensive “how-to” manual. Suppliers are urged to begin the
APQP/PPAP process as early as possible, and to contact the customer
representative for guidance as need be.

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Many of the issues that delay PPAP approval may be attributed to lack of planning, and
failure to begin the PPAP process early enough. PPAP is not a bundle of paper, or a
digital file to be hurriedly compiled in the shadow of an imminent deadline. It’s evidence
of successful completion of a carefully organized and executed APQP process. Here are
some of the things that suppliers can do to insure that PPAP submissions that meet
expectations are completed on time:

 As soon as drawings are received, they should be carefully reviewed to determine

what’s necessary to complete the job. If there are custom or other published
standards called out, do you have the most recent copies of them? Do
subcontractors have copies and understand the requirements? Is there any special
inspection equipment that will have to be purchased or fabricated? Are the drawing
specifications clearly understood?

 Make sure that everyone in your organization who might contribute to PPAP
documentation is aware of the impending requirement for submission, and
understands the requirements for the elements they’re responsible for producing.
For example, those responsible for material procurement must be aware of the
requirements for material test reports, and make sure that sub-suppliers are also
aware and are prepared to provide PPAP-compliant documentation in a timely
manner.

 It’s helpful to have a single person who’s responsible for tracking PPAP
requirements, making associates aware of deadlines and in general managing the
process from beginning to end. It’s nearly always detrimental to assign this
responsibility to a person whose time is already accounted for by existing duties.
Making sure that there are enough resources to get the job done, including human
resources, is an important part of a conscientious APQP process.

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The submission warrant must be completed correctly in order for the submission to be
approved. It is permissible to use either the AIAG warrant form (found in the AIAG
PPAP manual or in AIAG-compliant software) or a form that includes all of the same
information. Whatever form is used, it’is important that the current version is used and
the following requirements are fulfilled:

 A completed warrant form should never have blank spaces—enter “NA” for those
items that do not apply to the submission. Contact your customer representative if
unsure about what information is required in a particular field.

 Dedicated inspection devices must be identified on the warrant in the “Checking

Aids” field. See page 9 for the PPAP definition of “checking aid.” Checking aids
must be revision-controlled.

 Under “Reason for Submission”, any entry other than “Initial Submission” that is not
self-explanatory should be explained. It is permissible to append an explanation on
a separate page that references the warrant. The “Other” option may be used in
addition to one of the specific choices. There may be more than one reason for
submission.

 “Requested Submission Level” must be the level specified on the purchase order or
by the customer representative.

 There should be only very rare instances when Submission Results is marked “No.”
As is clearly stated in the AIAG PPAP manual, nonconforming conditions should
preclude submission until they are officially reconciled. This means that suppliers
must be in possession of engineering change or deviation documentation prior to
PPAP submission, and the document(s) must be referenced on the warrant in the
Additional Engineering Changes field.

 Make sure that the warrant is dated, and the printed name, title and phone number
appear in the appropriate spaces.

 The Mold/Cavity/Production Process field in the Submission Results area of the form
must be completed. Tooling such as molds and stamping dies must be explicitly
identified, and the number of mold cavities must be given, using an additional sheet
if necessary. In cases where there is no specific tooling in use, and the nature of
the production process is apparent, the field may be left blank, or “See Process Flow
Diagram” may be entered when a flow diagram is being submitted.

(Continued on next page)

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  The production rate field under Declaration must be completed. This production
rate applies to the rate of the PPAP production run, and may be different from
the quoted production rate.

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 Sample parts (if required) must be provided in accordance with the PPAP level being
submitted, or special instructions from your customer representative. If you’re
unsure about how to deliver sample parts, contact the customer representative
before proceeding. Please be aware that the supplier is required to retain master
samples in accordance with the requirements specified in the AIAG PPAP manual
unless the requirement has been waived in writing by the customer.

 When the AIAG documentation refers to the “design record(s)”, it normally means
the customer’s controlled drawing. The “design record(s)” may also include
supplemental specifications that are given to the supplier, such as appearance
(cosmetic) requirements. Submissions must be based on the customer design
records when such records exist. Even though the supplier might have design
responsibility and has created design records for the part(s) in question, customer
design records are the controlling documents, both for PPAP approval purposes and
for verification of ongoing compliance. If you are not sure about whether a given
customer design record exists, or whether you have the current issue, please
contact the customer for guidance. If there are supplier drawings, they must be
submitted as well, unless otherwise specified.

 For inspection results, although format is optional, the following guidelines apply:

1. Although permissible, the practice of writing inspection results directly on the

drawing is discouraged. It is preferred that the drawing be “ballooned” and
results reported on a separate sheet showing specification, tolerance, and
number of parts checked. Out-of-tolerance items should be highlighted or
otherwise specifically identified.
2. It is expected that the submission dimensional report will include results for all
specifications, dimensions, and notes on the design record.
3. Multiple-cavity tools?

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Definition: A checking aid is a dedicated gage, fixture or other device used to verify
compliance of design record specifications. Use the following criteria to determine
whether a particular device qualifies as a checking aid for PPAP purposes:

1) If the device is specially made for the part(s) being verified, and is not available as a
catalog item elsewhere, it is a “checking aid.”
2) Standard items, such as plug gages, which are dedicated for use on a particular part
feature, but do not qualify under criterion #1, are not checking aids. For example, if
a standard pin gage is put into a handle, numbered, and dedicated for use on a
particular part, the result should not be considered a checking aid, because the pin
gage being used is a standard catalog item. On the other hand, if it is necessary to
have a pin gage or set of pin gages custom-made for use on our part due to the fact
that the size required is not available as a catalog item, the result is a checking aid
for PPAP purposes.

Other types of devices that might qualify as checking aids are optical comparator
overlays, special CMM holding fixtures and welding/assembly fixtures that are also used
for part verification. Please consult with your customer representative if you are unsure
about whether a given device qualifies as a checking aid.

Checking Aid Requirements

 The checking aid must be assigned a gage control number in accordance with the
supplier’s gage control system. Revision control is required also, so that checking
aids are reviewed when design records change.

 The checking aid(s) must be identified (by gage control number, revision level and
revision date) in the appropriate space on the part submission warrant. A list that is
referenced from the warrant may be used if the space allotted on the warrant is
insufficient.

 In the PPAP submission, the supplier must present evidence that the gage is capable
of performing as intended, and is capable of discriminating to the extent required by
the design record tolerance for the characteristic or feature in question. This may
require submission of a drawing of the device, or other objective evidence that the
device operates in accordance with design record specifications.

 MSA is required in accordance with the appropriate requirements shown in the most
recent issues of the AIAG PPAP and MSA manuals. Keep in mind that attributes
gage analysis requires the use of nonconforming parts, and that the nature of the
nonconformity be identified in quantitative terms.

(Continued on next page)

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 The checking aid(s) must be identified on the control plan, or in controlled part-
specific instructions referenced from the control plan.

 Because the need for a checking aid should be identified during the APQP process, it
should normally be mentioned in the PFMEA either as an improvement item (a
recommended action) or as a Current Control Method.

 The checking aid must be made available to the customer upon request, and may be
required as a submission item for PPAP purposes.

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 Material Certifications

Objective evidence of compliance with all material specifications shown in design

records or otherwise communicated to the supplier is required. “Blanket” certificates
of conformance that are not specific as to the following requirements are not
acceptable:

 Specification(s) as shown in the H-D design record. The reference must

exactly match the drawing callout.
 If published standards are referred to, (e.g., ASTM or SAE documents),
testing must be in accordance with the referenced standard, and results must
be recorded and reported accordingly. The change level of the standard(s)
must be shown.
 When actual test result values are reported, the specified value and
tolerance/limits must also be shown.
 There should never be handwritten (or other) additions to printed material
test reports.

Performance Test Results

Performance test reports are required for all performance specifications shown
on (and referred to in) design records. When a specification shown on the
design record requires performance reportable in numbers, testing must be
performed and results must be reported in the PPAP submission.
Exceptions to performance testing/reporting requirements must be arranged with
the customer before initial PPAP submission and written permission from H-D to
deviate from requirements must be included in the PPAP submission. This is true of
every PPAP submission; deviations from requirements for testing apply to only the
current part number and submission. Test results that indicate failure should
preclude PPAP submission until the situation has been reconciled by the supplier
and customer.

Published Standards and Specifications

Copies of customer documents may be obtained from your customer

contact. Suppliers are responsible for obtaining copies of other published
standards (ASTM, SAE, ANSI, etc.) from the publisher. Contact information for
some major publishers of standards may be found on page 23.

(Continued on next page)

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Qualified Laboratory Documentation

When this element is required in a PPAP submission, the supplier must submit
evidence that the laboratory performing the required testing has been recognized as
accredited by a nationally recognized laboratory accreditation body such as A2LA.
There are two forms of documentation required: a current certificate of accreditation and
a scope of accreditation. The laboratory scope document details the tests and activities
the laboratory is accredited to perform, the equipment used, and the standards for
which the laboratory is qualified to perform testing.

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Harley-Davidson requires that FMEA, in accordance with the AIAG requirements, be
performed for most submissions. It is critical for the supplier to integrate FMEA into the
normal preparations for producing new parts. H-D reviews all FMEAs very carefully,
and expects that all reasonably anticipated potential failure modes will be addressed. It
is also very important to integrate and link FMEA with the APQP process—there must be
a logical, connected relationship between the process flow diagram (PFD), the FMEA,
and the Process Control Plan (PCP). The following guidelines should be followed when
preparing the FMEA for a PPAP submission:

 Do not set “trigger” Risk Priority Numbers (RPN’s). In other words, setting an
arbitrary RPN level for taking preventive actions (e.g., actions required only if an
RPN is x or higher) is not acceptable. See the most recent edition of the AIAG FMEA
manual for guidance on when actions should be taken to reduce risk.

 The failure mode might pertain to a description of a potential failure of the process,
or a manifestation of a process failure in the output. In other words, the mode
might refer to how the process itself might fail, or to output defects.

 If there are no “recommended actions” for a given potential failure mode, enter
“None”.

 If actions are recommended, a target completion date must be entered, along with
the name(s) of the person(s) responsible for initiating the action(s). If the date for
completion is after submission, The customer may follow up and expect an updated
FMEA document at the appropriate time.

 In most cases, the value assigned to “severity” will not change because of actions
taken to reduce risk. This is because the severity of the failure mode in question
will not change, even if it is made less likely to occur or easier to detect.

 Special attention should be paid to reducing “occurrence” factors (a function of

prevention activities.)

 Instances where there are no recommended actions to reduce risk on a FMEA

should be rare. If the analysis is done conscientiously as a team effort,
improvements can nearly always be devised. Pay special attention to past failures,
and look at similar parts/processes for history that might be helpful in identifying
opportunities for improvement.

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Process Flow Diagram (PFD)

The flow diagram is the foundation document for quality planning (APQP) activities. It
provides the source for both the FMEA and the control plan. No particular format or
method for creating flow diagrams is prescribed, but the contents of the diagram are
critical to the success of process improvement activities. The following guidelines will
help suppliers to create flow diagrams that contribute to successful PPAP efforts, and
ongoing quality performance.

 Include all discrete steps in the diagram, from receiving and verifying raw materials
to shipping or storage of the end product. Show each step in the process in the
order that it actually occurs during normal production.

 Develop a standard format for flow diagram symbols and methods, and make sure
that the methods are used uniformly each time a flow diagram is created.

 Flow diagram creation, as with all of APQP, must be a team effort.

 Number the individual steps in the diagram to facilitate linking them to the FMEA
and control plan.

 The PFD should be revision-controlled and must show the customer part number
and revision level.

 For processes that are identical for more than one part, a generic flow diagram is
permissible. Individual diagrams are required, however, when any unique step or
operation is required, or when special characteristics have been identified.

 Flow diagrams need not be graphic; shop routings that show all operations in order
might suffice for simple processes.

 Try to keep the PFD as simple as possible—save detail such as document numbers
and other references for the control plan.

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The control plan is part of the output of the APQP process. It must be devised in strict
conformance to AIAG requirements. It is expected that the control plan will be
designed as a team effort by the supplier, and that the finished document will be
available to operators in the supplier’s production areas. Here are some guidelines for
successful control plan design:

 Make sure that the control plan is logically linked to the PFD and PFMEA.
Operations shown on the FMEA as having relatively high risk values (RPN’s) must
be addressed on the control plan.

 Be specific as to specifications and tolerances for individual control items such as

dimensions to be measured. If the supplier uses another document system for
specifying control methods, it may be explicitly referenced from the control plan,
but such documents must be revision controlled and the supplier’s quality system
must include methods to insure that documents are reviewed when customer
specifications change.

 Process characteristics must be shown, along with the methods used to control
them. Control of process characteristics is what distinguishes a process control
plan from an inspection plan.

 For all “special characteristics”, specific gages or gage types must be specified on
the control plan. If dedicated devices are used, they must be identified on the
submission warrant. If a generic gage type is identified, (e.g., “6-inch caliper”)
measurement systems analysis (MSA) data must be available—and included in
the submission—that demonstrates the efficacy of the gage type for verification
of the characteristic in question.

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It is of critical importance that initial process studies are performed in strict accordance
with AIAG requirements, including the requirements shown in the PPAP manual for a
“significant production run.” Any deviation from the requirements must be approved
and documented by the customer in advance of PPAP submission. The following
requirements must be satisfied in order for initial process studies to be considered
acceptable:

 It will be assumed that the supplier will use standard X-bar and Range charting and
that the data will include at least 100 parts in at least 25 subgroups from the
“significant production run.” Samples must be taken at regular intervals as
production is running; post-production selection of samples is not acceptable. If the
supplier believes that a different method of statistical analysis will be more
efficacious, the method must be approved in advance by the customer.

 If process distributions appear significantly non-normal, consult the AIAG PPAP

manual for requirements.

 Make sure that the calculations used to determine Cpk/Ppk values are correct for the
application; don’t use a formula intended for bilateral tolerances for a specification
with a unilateral tolerance and don’t use Ppk when Cpk is appropriate, and vice-versa.

 Review the capability report(s) carefully prior to submission. Make sure that control
limits have been properly calculated, and that aside from points outside the control
limits there are no other apparent signs of non-normality such as “runs” on either
side of the centerline.

 A well-developed capability report should be self-explanatory and not require

assumptions about the samples, the population, or any other pertinent factors.

Remember—Process capability is a critical component of the PPAP process.

Submissions with capability reports that do not strictly adhere to all requirements are
cause for PPAP rejection. Please contact your customer representative if you have any
questions about capability reporting.

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It is a common misconception that traditional gage reproducibility and repeatability
(GR&R) and MSA are synonymous. In fact, GR&R is a component of MSA, a process
that helps to insure that measurement variation is identified and quantified in
manufacturing processes. Here are some guidelines for successful MSA performance
and reporting:

 Because the purpose of MSA is to determine how measurement error affects total
variation in critical characteristics, it is mandatory that the study uses production
parts that represent the operating range of the process. Device-specific GR&R
studies that were not performed on the PPAP parts will not be acceptable except in
special circumstances.

 The preferred method to use is the AIAG average and range method using ten
parts, three operators and three trials. It is strongly suggested that at least two of
the three operators in the study are people who will normally use the measuring
device in production or inspection.

 For attributes-type specifications, see the AIAG MSA manual for requirements. Keep
in mind that attributes studies must include nonconforming parts, as the goal is to
show that the device will always identify nonconforming parts and always accept
good ones. If an attributes device is used, keep in mind that the study must
demonstrate that the device is capable of discriminating to the level of the design
record tolerance for the part in question.

 The output criterion for the study will be GR&R expressed as a percentage of total
tolerance, although percent of total variation is acceptable if the variation value is
derived from the capability study (i.e., the variation value represents total process
variation, and not within-study variation). It is expected that all relevant
worksheets will be submitted (as opposed to summary reports) and that
all reported values will be within the expected limits. For example, when
evaluating the results of an average-and-range study, averages and
ranges must be as expected with regard to control limits.

 It is expected that the output value will not exceed 30%. If the value is greater
than 10% but less than 31%, evidence of management review and approval of the
results must be provided in the submission. Every effort should be made to insure
that GR&R values are as low as possible. There is no level of performance that
should be considered unconditionally acceptable in all cases. Judgments regarding
the fitness for use of a measurement system must take other factors into account,
such as the amount of tolerance being consumed by the process.

(Continued on next page)

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 Worksheets are available for use in the AIAG MSA manual, and the necessary
formulae and instructions are included. If the supplier chooses to do MSA
calculations manually, it is strongly suggested that the work be double-checked
before submission.

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Note: This information was verified to be accurate at the time it was written. Phone numbers and
addresses may have changed since then. The supplier is ultimately responsible for locating sources for
standards and specifications.

American National Standards Institute (ANSI)

11 W. 42nd Street
NY, NY 10036
(212) 642-4900
www.ansi.org

American Society for Quality (ASQ)

P.O. Box 3005
Milwaukee, WI 53201
(800) 248-1946
www.asq.org

American Society for Testing and Materials (ASTM)

1416 Race Street
Philadelphia, PA 19103
610-832-9500
www.astm.org

Automotive Industry Action Group (AIAG)

Suite 200
26200 Lahser Road
Southfield, MI 48034
(248) 358-3003
www.aiag.org

Society of Automotive Engineers (SAE)

400 Commonwealth Drive
Warrendale, PA 15096-0001
412-776-4841
www.sae.org

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