Pre-Production Audit

International Quality Department

INDIA, August 2006
 Agenda

1. Principles
2. Application
3. Process explanation
4. Questionnary / Criteria Presentation
5. Questions / Answers

Based on Quality rules 00618-01-Q0102C00 Version 1

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 Principles

Pre-Production audit has to be performed during phase 4 of ANPQP.

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 Principles

Pre-Production audit is an examination carried out on the

manufacturing processes developed and implemented on
the production sites of the selected suppliers.

It is conducted in a preventive way, before the Supplier

Manufacturing Agreement for a new product or a modified
product, modified process.

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 Principles

It allows :

- The confirmation on site that the provisions laid down are implemented
in an efficient way and are suitable for reaching the quality and reliability
objectives that are required for mass production.

-The confirmation of the capability of the supplier to manufacture the

specified product according to the mass production condition and at the
nominal rate.

- The confirmation of the settings up of the production capacities.

-The confirmation that the planning of the means of production required

to ensure the increase rate, as planned, complies with the objectives
defined in the documents ANPQP Suppliers Plan.

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 Application

Manufacturing conditions necessary to perform on site

examination are as follows :

- according to mass production conditions,

- at the nominal rate,
- manufacturing of a minimum batch of 30 units,
- for a continuous production time of at least one hour,
- on each operational team at the time of production.

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 Application

Prerequisites :

- the action plan relating to process FMEA are settled,

- the definitive means of production and inspection and the
definitive handling and packaging equipment are installed
and operational,
- the product resulting from the process implemented is
compliant, (PSW accepted)
- the N-rank suppliers’ components have been approved.

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 Application
Audit reference base :

1/ Capacity analysis  9 criteria

2/ Product/process quality  12 criteria
3/ Procurement (materials and components)  6 criteria
4/ Means of production and inspection  6 criteria
5/ Instructions and documentation at the work stations  6 criteria
6/ Training and qualification of the operators  5 criteria
7/ Maintenance of the equipments  6 criteria
8/ Traceability/Identification/Packaging  9 criteria
9/ Logistics and production management  6 criteria

9 themes = 67 criteria
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 Process explanation

Diagram :

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 Process explanation

Stage 1 : Audit Preparation

Objectives :
- To give a reminder of the objectives of the pre-production audit.
- To define the audit scope : product audited and site.
- To specify the audit prerequisites and to make sure that they will be
satisfied by the date of the audit.
- To specify the modalities relating to the audit on the sites : date /
duration / attendees…
- To present the audit team.
- To set out the preproduction audit base-reference, the rating scale, the
decision rules.
- To define the report circulation conditions.

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 Process explanation

Stage 2 : Examination on the site

The purpose is to verify the manufacturing process in operation

ascertaining its consistency with the provisions laid down in document
“ANPQP-supplier plan”.
The managerial staff, the supervisory staff and the operators of the
audited site part in the examination.

The audit team :

- Examines, operation by operation, the whole set of criteria specified in
sheets ‘theme’ of the audit reference base.
- Notes down, for each criterion examined, the deviations from the audit
reference-base that are noticed.

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 Process explanation

Stage 3 : Rating and synthesis meeting

A synthesis is made by the audit team after examination on the site in

order to formalize the identified deviations and to draw-up the audit
rating.

3 possible results :
- Accepted
- Accepted with reservations (with a proposed action plan)
- Rejected (new audit must be preformed after analysis of the final action
plan.

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 Application

Criteria rating :

- Demerit rating from 0 to 3 on each criteria examined

- Criteria considered to be key points accept only values 0 or 3
- 3 criteria do not accept value 2

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 Application

Conformity Index :

The conformity index is the ratio of the number of criteria

rated at 0 to the number of criteria selected for the audit.

Its value (expressed as a percentage) is calculated as

follows :

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 Application

Decision rules :

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 Process explanation

Stage 4 : End of audit meeting

Objectives :
- Comment the deviation.
- Comment the rating decision.
- Define the correctives actions to be implemented immediately (rating at
3).
- Define the planning of a short term action plan (rating at 2).
- Define the planning of a medium term action plan (rating at 1).
- Clear up possible ambiguities on the deviation noticed.

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 Application

Stage 5 : Writing and circulation

Audit leader must write down all the remarks and supplemented by
possible additional information.

Report is communicated to :
- Project Leader,
- Engineering,
- ANPQP leader,
- Buyer,
- The supplier (not forget the quality manager and top management)
- The audit team

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