PROCEDURE NUMBER

PMP2-07-4




TITLE



EXTERNAL QUALITY AUDITS




Copy ________

Controlled ......

Uncontrolled ...

23 May '96	Use of Checklist and Attendance sheet made optional	G North
15 Sept '95	Deleted Auditmaster	A Nolan	P S Wilton
25 July '94	Minor Changes Throughout	A Nolan	P S Wilton
25 Feb '94	Amended	N Travaglini	P S Wilton
12 Nov '93	Revamped	N Travaglini	P S Wilton
26 Oct '92	Delete CAR Issue	N Travaglini	P S Wilton
3 Jan '91	Form no Corrected, Alt.	P S Wilton	P S Wilton
23 Jan '90	Issued	D V Baker	P S Wilton
DATE	RE-ISSUE DETAILS	BY	APPROVED

1.0 PURPOSE

The purpose of this procedure is to define a standardised approach towards the performance of external audits on behalf of client companies.

2.0 SCOPE

This procedure applies where QA Management Services has been engaged by a Client to ascertain if an organisation's Quality System is compliant with a specified Quality System Standard or the organisation's own Quality Documentation.


3.0 REFERENCES
PMP2-13-1 Internal Quality Audits
PMP2-03-1 Tender and Contract Review.


4.0 DEFINITIONS
Nil

5.0 RESPONSIBILITIES
5.1 Company Director
The Company Director is responsible for:
a) Reviewing client requirements and appointing suitable personnel to perform the assignment.

6.0 PROCEDURE DETAILS

6.1 A Company Director reviews the requirements with the client in accordance with PMP2-03-1.

6.2 Upon acceptance of the assignment the Director appoints an Auditor adequately qualified by training and experience to properly conduct an assessment.

6.3 The Auditor notifies the auditee of the intention to perform the audit and discuss and agrees the scope and the auditee's responsibilities during performance. Preliminary discussions may be held informally but confirmation of all agreements is made in writing.

6.4 The Auditor may obtain from the auditee, (for the purpose of a desktop review), documentation pertaining to the agreed scope of the audit.

6.5 The Auditor reviews the auditees's proffered documentation to determine if the system described will meet the requirements of the specified quality system standard and any other specified supplementary requirements.

A formal Critique Report of the desk top audit, detailing any deficiencies, is forwarded to the client if requested.

6.6 Upon reviewing the auditee's documented system, the Auditor establishes the resources necessary to assess the compliance of the quality system with the agreed documentation.



A preliminary visit to the auditee's premises may be needed in order to properly determine the requisite resources.

The resources to be considered include :-
a) the number of audit team members
b) the requisite capabilities of the team members
c) the duration of the audit
d) team travel and accommodation
e) administrative assistance (secretarial, photocopying etc)

6.6.1 As well as having qualified auditors in the team, personnel having sufficient technical expertise to permit evaluation of technical functions peculiar to the auditee's organisation may need to be arranged as observers or team members.

6.7 An Audit number is assigned to each audit carried out by Q.A. Management Services. This is the same as the job number. Additionally, any client reference numbers are recorded onto all pertinent documentation.

The Auditor shall, if warranted by the size of the auditee's organisation, prepare a schedule showing the proposed times and duration for the audit of each element of the quality system and include the names of those team members as applicable to each phase of the audit. The Auditor forwards the schedules to the auditee early enough to permit the auditee to arrange for appropriate personnel and facilities to be available.

6.8 The Auditor may wish to prepare an audit checklist or questionnaire based on the auditee's quality documentation in order to facilitate the gathering and recording of information.

6.9 The Auditor convenes an informal meeting of all of the audit team members to brief them on the objectives and scope of the audit and on their roles.

6.10 Each team member is provided with applicable sections of the audit checklist or questionnaire for their comment and the inclusion of specific technical questions as applicable to their field of expertise.

6.11 The audit shall comprise:
- An entry meeting
- Audit performance and data gathering
- Exit meeting

6.11.1 An 'Attendance Sheet' (attachment 1) may be circulated to record the names of the attendees at both the entry and exit meetings as an alternative to recording attendees in the audit report.

6.11.2 The audit is conducted by each of the team members in accordance with the audit checklist and by seeking objective evidence of compliance.

6.11.3 At the end of the audit the lead auditor convenes a meeting of the audit team to review the findings of each team member.

The categorising of the audit results is discussed by the team but it is the final responsibility of the nominated lead auditor to decide the category rating which shall be one of :-


'A' = Acceptable
'O' = Observations noted but acceptable
'C' = Corrective Actions required - NOT ACCEPTABLE


6.11.4 Following the meeting of the audit team the lead auditor convenes an 'Exit Meeting' to present an objective overview of the audit, summarising the results and highlighting and need for corrective action.

6.12 The report of the findings recorded is produced by the lead auditor using, wherever possible attachments as per PMP2-13-1 Internal Quality Audits.

6.13 The audit report shall include :

a) An Audit Report Lead Sheet on which is included a brief summary of the findings.

b) Audit Report on which the audit is reported in narrative form eg:


INTRODUCTION

- reason for and background to the audit

ENTRY MEETING

- minutes of the meeting; including list of attendees

QUALITY SYSTEM/SCOPE

- identification of the reference documents used for the audit (Quality system Standard, Quality Manual .... etc.)


AUDIT FINDINGS

- a summary of the findings including corrective action and observations

EXIT MEETING

- minutes of the meeting; including list of attendees

FOLLOW-UP

- describe any follow up actions taken or to be taken

GENERAL/CONCLUSIONS

- detail observations not included elsewhere and any conclusions which may be offered.

ATTACHMENTS

- List of attached documents. (Eg. copies of C.A.R.'s, completed checklist).

6.14 The audit report is signed by the lead auditor and reviewed by the Managing Director before forwarding to the Client.

Any full follow-up audits requested to verify the implementation and effectiveness of corrective actions are carried out in accordance with this
procedure.

7.0 DOCUMENTATION
Form No.
PMP2-07-4.01 Attendance Sheet

PMP2-07-4.01 Version