SQ-2102

PROCESS AUDIT Rev.: 8

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Index Modification Description Date

General Review vs. International Stds. (VDA 6.3, IATF 16949)

8 2017/08/30
Integration of App. 1, 2 & 5 in the procedure (updates identified in blue)
CAR updated including request of Root Cause of Non Conformity
7 2012/01/31
Comment on Q70 of App 4 updated
6 Process Audit Questionnaire Updated including CCL assessment 2012/01/02
Updated according to last version of Supplier Quality Manual – SQA
5 2010/04/30
2104.
Clarification of guidelines for rating of conformity - Definitions of capability
transferred in appendix 5 - Questionnaire becomes revision 4 due to
additional questions # 8 and # 9 for Initial Samples and for Quality
4 Monitoring File - Questions # 100 and # 101 modified to better integrate 2007/01/09
ISO 14001 requirement - Question # 104 added to integrate ISO/TS
requirement about verification of performances of processes - Various
clarifications added in comments on the questionnaire.
To take into account evolution of requirements linked to ISO/TS 16949
ed.2002, FIEV audit, evolution of VAQ 2104 procedure. To add
comments about Full Day Production Run (FDPR) - Audit questionnaire
3 2005/03/04
(appendix 4) moves to Rev. 3 (participation of Valeo to audit of tier 2
supplier in case of S/R characteristics + adaptation of rating of non-
conformities to ISO/TS ed.2002. and to FIEV recommendations
To take into account ISO/TS 16949 and V1000 ed.V - Appendix 1 moves
2 to rev.2 (systematic CAR if CRI > 0 - Questionnaire (appendix 4) moves 2003/10/01
to rev.2 (rating of non-conformities according appendix 2).
Clarification of statistical definitions - Update of French version versus
1 English version - Update of required level for Ppk 2000/07/01

Update of format and codification according to procedure VAQ 2201 -

0 Update according to evolution of SQA manual VAQ 2104 - Definition of 1999/10/28
different types of process audits and of technology family

Written / Revision
Name Function Date
D. MASUCCI / Group SQA Methodology Director /
August 2017
G. GOMEZ VLS PG Quality System

Approval
Name Function Date

D. Dimur SQA Group Director August 2017

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Contents

1 PURPOSE OF THE PROCEDURE ....................................................................... 3

2 APPLICATION FIELD ............................................................................................ 3
3 REFERENCE DOCUMENTS ................................................................................ 5
4 DEFINITIONS ........................................................................................................ 5
5 OPERATIONAL MODE ......................................................................................... 6
6 FLOWCHART ........................................................................................................ 7
7 APPENDIXES........................................................................................................ 7
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1. PURPOSE OF THE PROCEDURE

This procedure provides a baseline document for a process audit system to evaluate manufacturing processes
performed externally or internally at Valeo sites.
The aim of the audit is the Process Qualification, i.e. authorization of volume production for the product or
products concerned, under the conditions defined in the Project or AQP.pp and required during the audit.
Note: The process audit, together with the Full Day Production Run, constitutes the output for the validation of
the milestone “Supplier Process Validated” in the AQP.pp procedure.
The detail of applicable tasks is defined in the Supplier Quality Manual – SQ 2104.

2. APPLICATION FIELD

 External (Suppliers Sites)

All manufacturing processes carried out by Suppliers of Valeo with the aim of achieving product / process
qualification under the AQP.pp procedure (ref Supplier Quality Manual – SQ 2104, as well as to ensure that the
process maintains the respect of standards (Periodic Audit)
 Internal (Valeo Sites)
All manufacturing processes carried out at sites within the Valeo Group with the aim of achieving product /
process qualification for a given Project and to ensure that our processes remain permanently under control in
serial production (Periodic Audit).

A process audit is carried out on a volume production process under Full Day Production Run (FDPR)
conditions. The audit shall be carried out before the Initial Samples (IS) submission. The IS shall be produced
by a process qualified by the audit. The parts produced during the FDPR cannot be submitted as Initial
Samples unless the process is qualified at the end of the FDPR.
It is recommended to perform production trials, before Full Day Production Run (FDPR), in order to
progressively adjust the process, prepare the FDPR and ensure right first time approval of the FDPR.
For External Suppliers it is required to do a preparation of the FDPR by using the FDPR Preparation Form and
to perform a self process audit evaluation based on the VALEO standard (Appendix 5, 6 & 7 of the procedure
SQ - 2104) prior to VALEO official audit.

Within these two fields of application (Internal or External), this procedure applies to the following types
of audit:

- Audit to qualify a new process (Internal or External)

The audit questionnaire is fully completed and the associated components (authorized for volume production)
shall be clearly specified.
Scoring: The score depends solely on the audited criteria. The rules for qualification are defined in Appendix 2.
The audit report shall be archived in the Initial Samples file and the electronic file of the Process Audit Report
must be attached in the corresponding database (PQA Module of SRM Portal for External Audits) and
according with the local QMS for serial production process audits.

- Audit to qualify a transferred process (Internal or External)

As described above, after verifying that the procedure for the Transfer of a Process SQ 2103 has been applied
correctly.
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- Audit to requalify a process following a modification to the product or process (Internal and
External)
Specific procedures shall be in place at each site to deal with any modifications (IATF 16949 - 8.3.6). These
modifications shall follow the same stages as are applied to a new development in design. The audit team shall
review the questionnaire and define the criteria to be audited in relation to the extent of the modification and the
risks that may arise from it. The audit team should also determine the process / component pairs to be
requalified.
Scoring: The score depends solely on the audited criteria. The rules for qualification are unchanged (ref
Appendix 2). The formal report of the partial requalification audit must be archived with the initial process
qualification report in the Initial Samples file (PQA Module of SRM Portal for External Audits and local QMS for
Internal Audits)

- Audit to qualify an existing process for a new component (Internal or External)

If the component concerned belongs to a technology family (see item 4. Definitions)
The common process audit for a technology family may only be taken into account if the process has been
formally qualified within the past two years (ref Qualification criteria - Appendix 2). If this is not the case, the
full process must be reaudited.

If the component or components concerned do not belong to a technology family for which the process
is already qualified
The audit questionnaire shall be fully completed, and the associated component or components shall be clearly
specified.
The audit team shall review the questionnaire and define the criteria to be audited.
Scoring: The score depends solely on the audited criteria. The rules for qualification are unchanged (see
Appendix 2).

- Periodic Audit (Internal or External)

This type of audit is carried out in order to ensure that the manufacturing process continues to conform to the
product and process specification documents and the Quality Assurance File (QAF). The period between these
audits is specified in Appendix 1, paragraph III.

- Selective Audit (Internal or External)

This type of audit must be carried out:

 Each time that a specific point in the process fails to conform to the QAF / PPAP and / or is likely to lead to
the manufacture of non-conformant products.
 After a quality incident (rejected delivery, rejection during processing at the customer's premises, etc.). The
audit shall be sufficient to verify the effectiveness of the corrective actions implemented to resolve the
problem detected.
The audit team shall review the questionnaire, and define the criteria to be audited.
Scoring: The score depends solely on the audited criteria. The rules for qualification are unchanged (ref
Appendix 2).
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- Follow-up Audit (Internal or External)

This type of audit is carried out in order to ensure that the Corrective Action Plan (CAP) has been correctly
implemented following an audit.
When CAR’s are issued, a follow-up audit must be carried out after any of the above audits.
In case of critical CAR’s, the implementation of corrective actions and follow-up audit has to be done within 20
calendar days after the audit when the critical non conformities were detected.
A follow up audit to close all CAR’s (Critical and Non Critical) has to be done within 3 months after the audit
when the non conformities were detected.
The audit team evaluates the progress made in relation to each CAR; and providing that the corrective actions
are in place and effective, closes the corresponding CARs. A new score is calculated taking the closed-out
CARs into account.
If the process is not qualified, a complete process audit has to be redone during a new FDPR.
NB: For External Suppliers, if the process is qualified (PI > 80% without critical CARs), Valeo delegates the
closure of non critical CARs to the supplier to be submitted in the PQA Process in SRM for the validation of the
milestone “PQA Status Granted”.
In the cases where the PQA Process is linked to a Project with a Customer SOP agreed, the deadline to close
the CARs within 3 months has not to exceed the date of the Customer SOP + 2 months.

3. REFERENCE DOCUMENTS

- ISO 9000: 2015 Standards

- QS-9000 Standard, Issue 3, 1998 - Chrysler-Ford-GM grouping “PPAP” (Production Part Approval Process)
- IATF 16949 Oct. 2016
- VDA 6.3 July 2016
- FIEV Reference Document “Process Audits”, Document: F6
- Renault Quality Institute Reference Document “Process Audits” Q0053C, October 1992
- ISO 19011 Guidelines for Quality and Environmental Management Systems Auditing
- Supplier Quality Manual - SQ 2104 – August 2017
- Procedure “Transfer of a Process” - SQ 2103 – December 2015

4. DEFINITIONS

- Process Audit: An in-depth analysis of the product manufacturing process, with a view of establishing a list
of actual or probable causes of dysfunction. The audit enables the identification and measurement of any
deviations from the requirements of the QAF, including the adequacy and effectiveness of these
requirements.

- Technology Family: A Technology Family is a set of components manufactured by the same Valeo /
Supplier site achieving the same technical function, and which rigorously follow the same flow using same
specific tooling.
Components have to be produced from the same assembly line, using the same tools; following the same
production flow to be considered as “technology family”… the change only concerns the dimensional aspect
of the component (setting of components has not to be considered as “technology family”).
Some examples:
VCC: “technology family”: aluminium pipes / not “technology family”: TxV (setting is different)
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- CAR: Corrective Action Request

- CAP: Corrective Action Plan

- QAF: Quality Assurance File of the product/process. List of the items and its deliverables to define all
necessary means and resources to comply with the mandatory requirements and to ensure the agreed
quality level
NB: for External Suppliers see the summary of the items to achieve the milestone “Component Design
Validated” in Appendix 1 of SQ Manual - SQ 2104

- AQP.pp: Advanced Quality Planning for product and process pp (SQ Manual – SQ 2104). It follows all
activities, tasks and deliverables to prevent the creation of defects, since the Supplier selection until the
mass production. Some of the deliverables are:
- S-VRF: Specific Valeo Requirement File: Summary of Mandatory Requirements from Purchasing,
Logistic, Quality and R&D.
- QAF: Quality Assurance File
- ISR: Initial Samples Report
- Performance Monitoring Files (tasks to be done during Ramp Up and Serial Life)

- PQA: Product Quality Assurance

- SPPC: Special Product & Process Characteristics

- RPN: Risk Priority Number

- Process Flow: Operations through Goods Inwards, inspection, production, handling, storage, and shipping.

- R&R: Repeatability / Reproducibility

- S&R: Safety and Regulatory Characteristics

- DDR: Daily Delivery Request

- Flexibility (Polyvalence): The ability to carry out a number of different tasks.

- Multi-competence: The ability to carry out a number of different functions at a given workstation (multi-
skills).

- FDPR: Full Day Production Run

Production run to validate the "full capacity / quoted rate" conditions. A sufficient quantity of components
shall be manufactured during this day to be considered statistically significant. It shall extend for a period
between 1 hour and 8 hours (one shift). At least 300 components shall be manufactured unless a specific
quantity is specified in relation to the rate of manufacture.
Objective is to ensure that human and material means are ready for serial production within Q,C,D, targets
of the project and has to include one or several change-overs (if applicable), allow to check all versions of
tools and the training of all operators. Where multiple tooling is used (moulds, dies, cutting tools, etc.), parts
from each mould, cavity, or position must be measured, tested, and used in the assembly of a finished
product.
For Internal FDPR, if the customer has more rigorous requirements, they have to prevail over internal ones.
The quantity to be manufactured shall be formally specified in the Quality Assurance File (in the
validation plan).

N.B.: When an additional shift has to be set up, a FDPR must be organized to validate proper running of the
line with the new team, particularly to check training of operators and availability of support resources.
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Rules for the organization of Full Day Production Run, with assignment of objectives, approval of these
objectives by manufacturing, and recording of results are described in the GST- Full Day Production Run
Report for Internal processes or Appendix 5 of SQ Manual 2104 for External Supplier processes.
The conditions of the FDPR must fix minimum quantity to be produced and ensure that forecasted quantity is
representative of forecasted volume for serial production. In the definition of objectives for the FDPR, the
following criteria must be taken into account when applicable:
- Hourly rate of the line and Kosu
- Reliability of equipment (e.g.: number of breakdowns, number of micro-stoppages, MTBF, ...)
- Capability measurement (Cmk for equipment, Ppk for the process at the end of the FDPR)
- Number of shifts
- Number of references and change-overs
- Measurement of Total Process Line Rejects (TLR ppm) and End Of Line Rejects (EOL ppm)
- Number and type of reworks
- Identification and recording of all losses of TRP
- Identification of products (labelling)
- Traceability of Initial Samples against FDPR
- Internal transfers and logistic items (stock, transportation, ...)

- Customer: The Valeo Site that purchases the component (in the case of a process audit carried out on an
Internal or External supplier); or the Project Manager (in the case of an internal process audit for a new
product); or Management (in the case of a periodic internal audit).

- Control Parameters: Parameters that shall satisfy specific conditions if the process is functioning correctly.
These conditions may be internal (e.g. start-up conditions…) or external (e.g. power supply parameters,
ambient conditions, etc.).

Additional glossaries can be found in Supplier Quality Manual – SQ 2104, and in ISO 8402 Standard.

5. OPERATIONAL MODE

A process audit typically consists of 6 (details in Appendix 1):

1- Preparing for the audit
2- Performing the audit
3- Scoring (ref Appendix 2)
4- Report (Result - Summary - Qualification - Distribution)
5- Audit follow-up
6- Periodic audit

6. FLOWCHART

(Not applicable)
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7. APPENDIXES

External (Supplier Sites) Internal (Valeo Sites)

Appendix 1 Method for a Process Audit SQ 2102

Appendix 2 Scoring SQ 2102

Sheet SUMMARY of App. 7 of SQ Manual Sheet SUMMARY of Process Audit

Appendix 3.1
- SQ 2104 - Rev. 8.2 (Excel file of procedure SQ 2102)
Sheet AUDIT RESULT of App. 7 of SQ Sheet AUDIT RESULT of Process Audit
Appendix 3.2
Manual - SQ 2104 - Rev. 8.2 (Excel file of procedure SQ 2102)
Sheets CAR of App. 7 of SQ Manual - Sheets CAR of Process Audit
Appendix 3.3
SQ 2104 - Rev. 8.2 (Excel file of procedure SQ 2102)
Sheet CAR’s FOLLOW-UP of App. 7 of Sheet CAR’s FOLLOW-UP of Process Audit
Appendix 3.4
SQ Manual - SQ 2104 - Rev. 8.2 (Excel file of procedure SQ 2102)
Sheet QUESTIONNAIRE of App. 7 of SQ Sheet QUESTIONNAIRE of Process Audit
Appendix 4
Manual – SQ 2104 – Rev. 8.2 (Excel file of procedure SQ 2102)

Appendix 5 Definitions of capability SQ 2102

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APPENDIX 1: General Method for a Process Audit

Type of Audit Responsibility

I – Process Audit
1- Preparing for the Audit
 Conduct Pre-audit / Initial meeting with auditees.
 Formally accept the QAF:
In case of an External Supplier component, the milestone “Component Design Validated” - Valeo SQA
of the PQA process has to be approved. team for
In the case of an Internal audit, the QAF may be accepted in one of two ways: By the external audits
Customer (at their request); or according to an internal procedure. - Quality team
 Define the scope of the process audit. for internal
 Establish the audit team (Lead auditor + Assistant + Specialist (could be one of the audits
auditors).

The Audit team must include a specialist in the process being audited.

 Prepare the questionnaire, including any specific criteria.

 Confirm the audit schedule with the auditees.

2- Performing the Audit

 Conduct introduction meeting with all personnel concerned (in meeting room). Audit team
 Review the QAF in the meeting room (Chapter 1 of the questionnaire).
 Proceed with the audit in the plant following the production process flow diagram and the
surveillance / control plan (Chapters 2 to 6 of the questionnaire).

3- Scoring Audit team

 Follow the scheme outlined in Appendix 2.

4- Report (Results - Summary - Qualification - Distribution)

 Prepare the report, including:

Audit team
 A Summary of the Audit (ref.:Tab Sheet SUMMARY of Appendix 7 of SQ Manual 2104)
 The overall Audit Result (ref.: Tab Sheet AUDIT SUMMARY of Appendix 7 of SQ Manual
2104)
 An individual corrective action request (CAR) for each Criterion Risk Index CRI > 50
(ref:Tab Sheet CAR (N) of Appendix 7 of SQ Manual 2104)
 A CAR will be issued with specific comment for each criterion with a CRI > 0.
 A specific comment if the Progress Indicator PI < 80%.
 A tentative date for an audit follow-up to verify that all the corrective actions have been
Audit team +
carried out (if necessary).
auditees
 Conduct closing meeting to present the results of the audit.
Note: A copy of the report, signed by the Lead Auditor and the auditee, shall be left
with the auditee.
Audit team
 Distribute the final report.
The Audit report is a formal document and must remain with the documents for the
product / process under consideration in the Initial Samples file.
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Type of Audit Responsibility

II- Follow-up Audit

A Follow-up Audit is mandatory, when CARs have been issued.

1 – Corrective Actions Plan (CAP)

 All CARs shall be subject to an audit follow-up. Audit team +

 A Corrective Action Plan relating to the Corrective Action Request(s) shall be submitted to auditees
the auditors within the time limit agreed upon during the process audit.

2 – Report (Results – Summary – Qualification – Distribution)

 The CAR follow-up audit is intended to verify that the CAP has been applied effectively. Audit team +
The report should identify any remaining deviations; and confirm that all the deviations auditees
initially identified have been closed.

The progress report is a formal document and should be retained with the
documents in the Initial Samples file.

 The Follow-up Audit Results and Summary documents are completed indicating the
process qualification status. These documents are distributed to all applicable personnel.

III – Periodic Audit

A full process audit is performed periodically on at least a technology family in order to verify
that the process / product continues to conform to the product specifications and the QAF.

A periodic audit shall be performed whenever a modification is made to a Product / Process

Audit team +
which would have an impact on the surveillance / control plan.
auditees
Periodic audits are typically performed every two years, providing that no major
incidents have occurred in relation to deliveries of the product; and that no modification
has been made to the Product / Process.

The effect of periodic audit results on the PQA status of products delivered by the supplier:

 If the audit has not revealed any Quality deficiencies, the process remains qualified.
- An action plan is set up to address any non-critical CARs issued during the audit.

 If the audit has revealed critical non-conformances, the process is no longer

qualified.
- A rigorous action plan is set up to address the critical CARs issued during the audit. Auditees
- In case of Supplier components, PQA status is temporary suspended. The resumption Auditees
of PQA deliveries for products may occur after the non conformities have been solved,
initial samples submitted, new probationary period…(ref SQ Manual 2104)
IV – Selective Audit
A selective audit shall be performed for any requirement of the AQP.pp which appears to be Audit team +
nonconforming; especially as a consequence of an incident (refused delivery, return from auditees
customer…). A selective audit is also performed to verify the implementation and
effectiveness of corrective actions.
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Appendix 2: SCORING
Scoring is a method of quantifying quality risks. Two parameters, Risk (R) and Conformance (C), are calculated
and used when preparing the audit report.

1- RISK (R):
Two scores may be given: R = 5 → “Medium” risk; and R = 10 → “Major” risk
A risk score is allocated to each criterion that is audited. It enables the quality risks of unsatisfactory criteria to
be prioritized.

When quality risk concerns a critical characteristic, the risk is always considered to be major.

Examples of Medium and Major Risk…

Medium Risk (R = 5):

This is applied to criterion that could generate a non-Quality situation in the short to medium term with the risk
of an incident occurring.

For example…

 Absence of written procedures or documents at the workstation

 Absence of a flowchart
 Unsuitable handling equipment
 Unmarked storage area
 Incomplete record documents, gaps in the record sequence, etc.

Note: If the criterion could generate the non-conformance of a critical characteristic, the risk score
shall = 10.

Major Risk (R = 10):

This is applied to any criterion that will definitely generate a non-Quality situation in the short term, and that will
result in an incident if not addressed. (This is the case for all criteria relating to a SPPC).

For example…

 Elements of QAF missing

 Non-validated initial samples
 Non-conformant process capability
 Poka-yoke not in operation
 Unsuitable measurement equipment
 Measurement equipment not at the workstation
 Non-adherence to instructions
 Operators not trained
 Absence of a surveillance / control plan
 Lack of identification marking, etc.
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2- CONFORMANCE (C):
One of four scores may be given: 0, 4, 7, or 10. The score is determined by the auditor based on observations
during the plant visit.

 Score 0: Conformity to requirement (*)

 Score 4: The requirement is taken into account but implementation is not systematic or not
effective. Risk of failure not completely eliminated; corrective and preventive action must be
implemented.
 Score 7: The requirement is taken into account but solution is not implemented or without real
application. Important risk of failure (product or process). Corrective and preventive action must be
implemented.
 Score 10: The requirement is not taken into account or, non conformity with a direct effect on the
product; immediate countermeasure, corrective and preventive action must be implemented.

(*) : Conformity to requirement of Quality Assurance File (solution planned in the QAF is implemented,
is sufficient, is applied without deviation and is followed up).

Scores of 4, 7, or 10 must be accompanied by COMMENTS / FINDINGS.

3- CRITERION RISK INDEX (CRI):

This is calculated by multiplying R x C = CRI.

A CRI may have seven possible values:

R C CRI
5 0 0
10 0 0
5 4 20
5 7 35
10 4 40
5 10 50
10 7 70
10 10 100

4- USE OF R AND C PARAMETERS AND OF THE CRI INDEX

These values shall be used to determine the two indicators (PI and LI) needed to qualify the process:

Progress Indicator (PI):

Number of CRI = 0
__________________
PI = x 100
Total number *CRI

* Some chapters (such as chapters 3 and 6) may be evaluated several times during an audit.
- In this case, the number of CRIs is increased proportionally.
- PI scores the process over a range of 0 to 100.

A PI of at least 80% is one of the two conditions for the qualification of the process.
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Level Indicator (LI):

The number of CRIs > 50 is an indicator of the Quality level of the process in terms of weaknesses.
It should be equal to zero.

If LI > 0:

- THE PROCESS CANNOT BE QUALIFIED…

- Corrective actions must urgently be put in place, within specified lead time, in response to each
individual CAR (ref Tab Sheet CAR (N) of Appendix 7 of SQ Manual – SQ 2104);
- A strengthened surveillance/control plan must be established (100% inspection, for example).
- All corrective actions must be checked during the follow-up audit.

5- PROCESS QUALIFICATION

CRI AND PI PROCESS

CORRECTIVE ACTIONS
VALUES QUALIFICATION
- Immediate implementation of
definitive corrective actions or
implementation of temporary
1 CRI > 50 corrective actions (e.g. 100%
and / or NO automatic inspection) pending
PI < 80% approval of definitive corrective
actions.
- A follow-up audit shall be
performed.
- Submission of a corrective action
All CRI < 50 plan for the auditee checked by the
YES
and PI > 80% auditor. Audit follow-up at the
auditor’s discretion.
All CRI = 0 - Continuous improvement and
YES
( PI = 100% ) internal surveillance.

Appendix 3:and 4: Process Audit Templates

Internal – Valeo Sites

Appendix #3&4 - SQ 2102 Rev.8.xlsm

File available in SQ Portal  Standard Documents and Procedures  2102 - PROCESS AUDIT

External – Suppliers Sites:

App. 7 of SQ Manual - SQ 2104 - Rev. 8.2

File available in SRM – page Reference Documents
(also available in SQ Portal  Standard Documents and Procedures  2102 - PROCESS AUDIT)
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Appendix 5: Definitions of capability

This appendix is defining the capability indices Cm & Cmk, Pp & Ppk and Cp & Cpk.

USL = Upper Specification Limit

LSL = Lower Specification Limit

1/- Machine capability (Cm, Cmk):

For characteristics following a normal law, the 2 machine capability indices are Cm and Cmk, defined as
following:

Cm 
(USL  LSL)
and Cmk 

min (USL  X ), ( X  LSL) 
6S 3S
Cm: machine capability index
Cmk: machine capability and centring index

With X average value of the sample and S = standard deviation of the sample, based on individual readings.

For calculation of Cm and Cmk, the trial shall consist of at least 50 parts sampled during a single trial on the
machine, using a single lot of raw materials, and under identical operating conditions.

Valeo requirement is: Cmk  2.

2/- Preliminary process capability (Pp, Ppk):

For a stable process and for characteristics following a normal law, the 2 preliminary process capability indices
are Pp and Ppk, defined as following:

Pp 
(USL  LSL)
And Ppk 

min (USL  X ), ( X  LSL) 
6e 3e

Pp: preliminary process capability index, measured during the Full Production Day.
Ppk: preliminary process capability and centring index, measured during the Full Production Day.

With X average value of the sample and σe = standard deviation of the sample, based on individual readings.
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For calculation of Pp and Ppk, the sample shall consist of at least 100 parts, sampled in a minimum of 25
subgroups at different times during the Full Production Day. These samples shall be representative of the
various mould cavities, tool positions, raw material lots, and operating conditions.

Valeo requirement is: Ppk  2.

3/- Process capability Cp, Cpk:

For a stable process and for characteristics following a normal law, the 2 process capability indices are Cp and
Cpk defined as following:

Cp 
(USL  LSL)
and Cpk 

min (USL  X ), ( X  LSL) 
6 3

With X average value of all the individual readings and σ = estimated standard deviation of the process,
based on individual readings.

Cp and Cpk can be calculated when historical of the process is sufficient to allow a good confidence level
(typically, several days, with several raw material batches and several operators), depending on the quantity of
parts.

Valeo requirement is: Cpk  1,67

Detailed statistical definitions and interpretations for applications may be found in AIAG reference manuals.