Manufacturing

Title Group Quality Capability Targets

Reference FAU-S-PSG-0235

Purpose Define Process Capability Targets and Reaction Rules if not

achieved
Scope GROUP

Related documents FAU-S-PSG-0221 Process Capability Analysis

FAU-S-PSG-0223 Inspection Process Capability
FAU-S-PSG-0226 Control Charts
Issue n° 03

Description of changes - Full review to fit to FAU-S-PSG-0221 and FAU-S-PSG-0226,

- Update DLP Template,
- Change Owner and Approver - names and functions,
Specific protection for FCP documentation is applied to this document according to the icons’ information.

- Modify Purpose
Cancels and replaces FAU-S-PSG-0235 – Issue 02 – 09/08
- Requirements for non-key characteristics on drawing
FAU-S-PSG-0235 – Issue 01 – 10/06

Author Mathilde CARRE – FAS Master Black Belt

Owner Eric JACQUOT – Group End-to-End Quality Director

Approved by Agustin LOPEZ DIAZ - Group Senior Vice President TCS, Quality,
Health, Safety & Environment Care

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 This document specifies mandatory rules of process capability studies:

✓ Which capability should be calculated from 1st production trial up to serial life,
✓ Which minimal sample sizes should be used?
✓ Which target to be reached and consequently-
✓ What are the corresponding reactions rules?

It is to be applied for variable Characteristics (e.g. weight, length, diameter…). It does not
apply in the following cases:

a) Attribute data (e.g. OK / NOK)

b) The external Customer stipulated its own requirements (see CSR),
c) A reliable product or process Poka-Yoke is in place to avoid or catch all non-
conformities,
d) Specific requirements defined in Standards (e.g. special processes like Heat
Treatment, special tolerance management like Tolsys…).

First ensure the capability of the inspection process (refer to FAU-S-PSG-0223).

Second ensure process stability: capability studies do not make sense for unstable
processes. If the process is unstable, eradicate special causes before any calculation of
process capability index.
Specific protection for FCP documentation is applied to this document according to the icons’ information.

Depending upon special characteristic type, capability targets to be reached are:

Safety/ Regulation Characteristics ≥ 1.67

Functional Characteristics ≥ 1.33

For other characteristics shown on the drawing, conformity must be assured all along the
product life cycle. In particular: PPAP, engineering change, production transfer and
process change.

Capability target values are the same regardless of the life phase. However, the type of
capability study to be carried out differs, as shown hereunder:

Reaction Rules according to

Type of Minimum Capability Study Result (2)
Program Phase Capability Sample
Study (1) Size (1) Below Target Above Target

Before & during 1st Machine 30 parts in a 100%

Production Trial Capability row Inspection or
Mass & Extended Batch
Short Term 25 samples Use Control
Mass Production Acceptance
Capability of 2 parts Charts
Trial with
Acceptance
Long Term 50 parts at
Serial Life Control Limits
Capability random

(1) See FAU-S-PSG-0221 Process Capability Analysis for details

(2) See FAU-S-PSG-0226 Control Charts for details

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