9200 9P 007 - R1
9200 9P 007 - R1
9200 9P 007 - R1
PROJECTS DEPARTMENT
SPECIFICATION
TITLE
QUALITY ASSURANCE AUDITS &
CORRECTIVE ACTIONS
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DATE ISSUED
PREPARED
REVIEWED
APPROVED
COMMENTS
1 Oct 2002
B. Burn
R.Ford
A.McIntosh
1 Feb 2003
B. Burn
R.Ford
A.McIntosh
Department Name
Change
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TABLE OF CONTENTS
1.
SUMMARY
......................................................................................................4
2.
DEFINITIONS
......................................................................................................5
3.
4.
5.
6.
7.
8.
9.
APPENDIX 2
APPENDIX 3
APPENDIX 4
APPENDIX 5
APPENDIX 6
APPENDIX 7
APPENDIX 8
APPENDIX 9
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1.
SUMMARY
1.1
1.1.1 Internal and external audits performed by suitably trained and experienced
personnel.
1.1.2 The planning, preparation, performance, reporting, follow up and close out of
audits.
1.2
Objectives
The prime objectives of audits are to: -
The requirements of this procedure shall not limit the freedom of the QA Auditors
to perform spot audits not included in the original audit program, if questionable,
Quality related activities are observed at any time.
1.4
This procedure is based on the ISO 10011 Auditing Standards and forms part of
the Project Quality Plan 84501-9200-9R-010.
1.5
The Quality Assurance Department are responsible for co-ordinating all audits
and ensuring that they are undertaken by acceptably qualified personnel and that
Corrective Actions raised are cleared in a timely manner.
1.6
The Project Quality Control Manager will ensure that an audit schedule is
maintained for each Operating Unit and actively followed.
1.7
Corrective actions raised as the result of an audit are intended to record quality
non-conformities identified during audits. For non-conformities identified during
ongoing surveillance of inspection, or by other Department personnel, refer to the
EPCI Contractors Quality Plan Procedures for Non- conformances and Corrective
action.
1.8
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1.8.1 Obtain and record agreement on action to be taken to correct the nonconformities and prevent recurrence.
1.8.2 Verify and record that the agreed corrective action has been implemented.
1.8.3 Provide a CAR Status log (Appendix 8) as a means of monitoring and recording
follow up action and providing a basis for analysis of quality trends.
1.9
In the case of internal audit observations, the CAR form (Appendix 9) may be
replaced by narrative text within an audit report, or memorandum, provided that
the following activities are clearly identifiable:
DEFINITIONS
Definitions, which are contained in ISO 8402, are as indicated: -
2.1
Auditor (Quality)
A person who has the qualification to perform Quality Audits.
Notes: -
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Auditee
An organisation to be audited.
2.4
2.5
2.6
Corrective Action
Measures taken to rectify conditions adverse to quality and, where necessary, to
preclude their repetition.
2.7
Observation
A statement of fact made during an audit and substantiated by objective
evidence.
2.8
Objective Evidence
Qualitative or quantitative information, records or statements of fact pertaining to
the quality of an item or service or to the existence and implementation of a
quality system element, which is based on observation, measurement or test and
which can be verified.
2.9
Addressee
The person, organisation, unit or company to whom the CAR is addressed and
who is responsible for ensuring that corrective action is carried out. In the case of
CARs raised during formal audits, the addressee will be the Auditee.
3.
AUDIT PLANNING
3.1
Each manufacturing outlet engaged in producing items for the Specific Project
will establish and maintain an overall schedule for planned audits of the quality
system at that location. This will be prepared by their local Quality Manager and
approved by the Specific project Quality Manager.
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3.2
3.3
The audit schedule will be established listing the audit subjects against schedule
dates (Appendix 1) .The schedule should allow for follow up audits and be
updated regularly as information becomes available. Any unscheduled audits
undertaken will be included in this schedule.
3.4
Audit report numbers shall be allocated and registered by the Lead Auditor, and
shall be proceeded by the year, i.e. AR 01/01, AR 02/02 etc and location.
4.
AUDIT PREPARATION
4.1
At least two weeks before a scheduled Audit, the Quality Manager or his
designee shall nominate a Lead Auditor and Auditor(s) for the audit, and shall
inform them of the scheduled audit date, the Auditee organisation, contact
names, Audit scope and elements to be audited.
4.2
The auditors, excepting technical specialists, shall be staffs who have been
trained in Auditing techniques.
4.3
Technical specialists may be selected to supplement audit activity but must not
be responsible for the specific activities being audited.
4.4
4.4.1 The Lead Auditor will obtain the next available number from the audit register.
4.4.2 The Lead Auditor, will assign responsibilities to he audit team and ensure that the
checklists are prepared ( Appendix 3 ) based upon a review of:-
4.5
Audit planning this will also include any special arrangements for
observing work in progress or specific practices or procedures selected for
detailed review.
Notification of Audit
4.5.1 The Lead Auditor shall contact the Auditee organisation to discuss the audit,
agenda and location, and to arrange a mutually convenient date and time within
the period allocated in the Audit Schedule.
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4.5.2 Written confirmation ( letter, form or fax for external audits or form for internal
audits see ( Appendix 6 ) shall include:
4.5.3 For external Audits, at least seven (7) days notice in writing shall be given to the
Auditee, if practical.
5.
5.1
Entry Meeting
The Lead Auditor shall convene a brief meeting between the audit team and the
nominated representatives of the Auditee organisation at which the Lead auditor
shall:
5.2
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The Audit
5.2.1 For external Audits following the entry meeting, it is sometimes of value for the
Audit Team to undertake a familiarisation tour of the facility prior to commencing
the Audit. This will be at the discretion of the Lead Auditor, bearing in mind that a
tour of the facility will, in any case, be required during the Audit.
5.2.2 The Lead Auditor will co-ordinate and directs the course and pace of the Audit,
The Lead Auditor may make changes to the Auditors work assignments, if
necessary.
5.2.3 Each Auditor shall use the checklist as an enquiry aid. Checklists shall be based
on requirements contained in the audit baseline documents (Section 4.5.2).
5.2.4 The Auditor is concerned only with objective evidence and on examination of this
will record in the appropriate space on the checklist essential information, e.g.
identification of the evidence examined and specific details of any nonconformance together with applicable references:
5.2.5 The Auditor shall complete the Audit Checklist by stating under the heading
Compliance either:
Details of all observations and non-conformances will be recorded. Nonconformities should be identified in terms of the specific requirements of the
standard or other related documents against which the Audit has been
conducted.
5.2.6 If the Auditor suspects Quality deficiencies during the course of the Audit, the
checklist may be expanded with additional questions.
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5.2.7 In cases, where queries cannot be answered on the spot, Auditors may provide
an Audit Query Form (Appendix 7) for the use of the Auditee Representative.
This form allows the Auditee to obtain information to answer the query without
delaying the Audit, for review later in the Audit.
5.2.8 Where non-conformities are identified, the Auditor and Auditee shall agree on a
statement defining non-conformity and shall both sign the agreed statement.
5.3
5.3.1 On completion of the Audit and prior to the Audit Exit Meeting, the Audit team will
meet in order to:-
5.4
Exit Meeting
The Lead Auditor shall convene the Exit Meeting with Management
Representatives of the Auditee organisation where he shall:
Discuss each CAR and Audit observation to ensure they are fully
understood by the Auditee and obtain his signature on the CAR.
Obtain copies of the CARs and leave them with the Auditee for his
initiation of corrective action prior to receipt of the Audit report.
Advise the Auditee organisation of the intended date of the issue of the
Audit Report and state the expected response to complete and return all
CARs after receipt of the Audit Report. This should be within seven (7)
days of the Exit Meeting.
5.4.1 If requested, the Auditor may also take recommendation to the Auditee for
improvements to the Quality System. Recommendations are not binding on the
Check with Document Control for latest available Revision
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Auditee. It is up to the Auditee to determine the extent, the ways and the means
of actions to improve the Quality System.
6.
AUDIT REPORT
6.1
Following the Audit, the Lead Auditor, with assistance from the Audit Team and
using the completed Checklist, shall prepare the formal Audit Report.
6.2
6.3
Table of contents.
Attendance Register.
Agreed CARs
Summary.
Copies of CARs.
6.4
The existence and use of Checklists should be referred to in the Audit Report but
the Checklists should not be distributed with the report.
6.5
6.6
The Audit Report shall be signed by the Lead Auditor and reviewed / approved by
the Specific project Quality Manager.
6.7
The Audit report shall be issued within seven (7) days of the Audit. The covering
letter or memo shall indicate the date by which the responses are required.
6.8
6.9
6.10
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Distribution of the Audit report will be as required but will normally be:-
Auditee
7.
7.1
The Audit Closeout shall be defined by the Lead Auditor, and will depend on the
reasons for the Audit.
-
8.1
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CAR Records
8.2.1 A Corrective Action Request Status Log shall be maintained (see Appendix 8) by
the Quality Control Manager.
8.3
8.3.1 Corrective Action Requests shall be implemented by completing the CAR Form
(see Appendix 9). This is generally self-explanatory but the following notes are
given for guidance.
a)
First part of the form to be completed by the Originator of the CAR (by the
Auditor in the case of a CAR raised during an Audit) and signed by the
Auditee.
b)
8.3.2 Having completed the first part of the CAR, a copy shall be passed to the
Addressee for his records and to enable him to implement the agreed corrective
action (This does not constitute formal issue of the CAR but speeds up the
corrective action.)
If at any time of raising the CAR, it is not possible to agree on the corrective
action to be taken, the form with the first part completed should be passed to the
Addressee for him to complete the corrective action to be taken and return at a
later agreed date.
8.4
8.4.1 The originator shall retain the original form and formally issue a copy to the
Addressee.
In the case of a CAR raised outside an audit, copies will be distributed as
required but will normally be as follows: -
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Addressee
8.4.2 Following formal issue of the CAR, the status log shall be updated.
8.5
Addressees Response
8.5.1 The addressee has responsibility for promptly completing applicable sections of
the form to the originator by the date requested.
8.5.2 If not already done during the Audit, the Addressee shall state the intended
corrective action together with the proposed date by which such action shall be
accomplished, and shall sign and date this statement. A copy of the CAR
completed to this stage shall be returned to the originator.
8.5.3 When the specified corrective action has been implemented, the Addressee shall
complete the bottom portion of the form and return a copy of the CAR to the Q.A.
Department.
8.6
8.6.1 On receiving the CAR, the originator shall record in the CAR Status Log the given
information and shall determine what action is required.
8.6.2 If a follow up Audit is required, the originator shall contact the Addressee and
agree on a date for the follow up meeting.
8.7
Follow-up Action
8.7.1 Follow up action or Audit to verify the implementation of corrective action shall be
performed as detailed in Section 7.0 of this procedure.
8.7.2 When the follow-up action confirms that the corrective actions taken are
satisfactory, the originator shall complete the close out section of the CAR form,
making reference to relevant documents reviewed, and signing and dating the
CAR. The Lead Auditor shall finally sign the CAR as closed out.
8.7.3 Originals of CARs shall be filed in the Q.A. Department.
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9.
9.1
Audit Team
9.1.1 Whether an Audit is carried out by a team or an individual, A Lead Auditor should
be placed in overall charge.
9.1.2 Depending on the circumstances, the Audit Team may include experts with
specialised background, auditor trainees or observers who are acceptable to the
client, Auditee and Lead Auditor.
9.2
9.2.1 The Lead Auditor is ultimately responsible for all phases of the Audit. The Lead
Auditor should have management capabilities and experience and should be
given authority to make final decisions regarding the conduct of the Audit and
Audit Observations
9.2.2 The Lead Auditors responsibilities also cover:-
9.3
Auditors Responsibilities
9.4
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9.5
Auditors Objectives
Plan the Audit, prepare working documents and brief the Audit Team.
Report the Audit results clearly, conclusively and without undue delay.
9.6
Exercise Objectivity.
Collect and analyse evidence that is relevant and sufficient to permit the
drawing of conclusions regarding the Audited Quality System.
Remain alert to any indications of evidence that can influence the Audit
results and possibly require more extensive Auditing.
Are all the documents and other information used to describe the Quality
System adequate to achieve the required Quality Objectives.
All Lead Assessors are required to have undertaken an IQA Approved course
and passed the examination. Internal Auditors are required to undertake an IQA
approved Auditing course for internal audits and will not be allowed to participate
in external audits until they have passed the Examination.
84501-9200-9P-007
APPENDIX 1: -
Audit No.
KEYS
Approved By:
Audit Subject
Jan
P = PLANNED
Feb
March
T = TENTATIVE
April
May
2001
June
July
E = EXECUTED
Aug
Sept
R = REPORTED
Approved By:
Oct
Nov
C = CLOSED
Dec
84501-9200-9P-007
APPENDIX 2: -
LOCATION:
PROJECT:
REV:
CONTRACT NO:
SHEET:
BY
OF
DATE:
AUDIT NO.
DATE
TEAM
AUDITEE
SUBJECT
CONT. NO.
REPORT
ISSUE
DATE
NO. OF
FINDINGS
DATE
CLOSED
REMARKS
84501-9200-9P-007
APPENDIX 3: -
AUDIT CHECKLIST.
LOCATION:
AUDITED ORGANIZATION:
REF.
DATE:
AUDIT CHECKLIST
RAISED BY:
PROCEDURE NO:
REQUIREMENT
AUDIT NO:
COMPLIANCE
YES
NO
PAGE OF
NOTES/COMMENTS
N/A
84501-9200-9P-007
APPENDIX 4: -
AUDT NO:
PAGE OF
AUDIT SUBJECT:
AUDIT TYPE:
PREVIOUS AUDIT DATE:
PREVIOUS AUDIT REFERENCE:
AUDIT TEAM:
LEAD ASSESSOR:
ASSESSOR:
OBSERVERS:
CONTENTS
SECTION 1
SECTION 2
SECTION 3
SECTION 4
AUDIT OBJECTIVES
SUMMARY
AUDITEES
DETAILED REPORT
APPENDIX 1
APPENDIX 2
APPENDIX 3
APPENDIX 4
AUDIT NOTIFICATION
ATTENDANCE REGISTER
SUMMARY OF ACTIONS/RECOMMENDATIONS
DOCUMENTS SAMPLED DURING AUDIT
DISTRIBUTION
Q/A
AUDITEES
PREPARED BY:
ORIGINAL
READ AND RETURN
APPROVED BY:
(Signature)
(Signature)
(Date)
(Date)
84501-9200-9P-007
APPENDIX 5: -
LOCATION:
DATE(S)
AUDIT NO.:
AUDIT
ATTENDANCE
REGISTER
AUDITEES:
OF AUDIT:
ENTRANCE MEETING
LOCATION:
DATE:
NAME:
ORGANIZATION:
TITLE:
EXIT MEETING
LOCATION:
DATE:
NAME:
ORGANIZATION:
TITLE:
84501-9200-9P-007
APPENDIX 6: - AUDIT NOTIFICATION.
Timing of
Audit
Name
Confirming Signature
Name
Confirming Signature
Auditees*
Please ensure
that all relevant
personnel are
available on the
date(s) shown.
Audit Team
Lead Auditor-
Auditor(s)-
Note: The Lead Auditor is responsible for ensuring that signatures of Auditees are obtained above to
acknowledge their agreements and for leaving a copy of this notification with each Auditee.
Copies to:
Audit No.:
Quality Manager:Signature:-
Date:
84501-9200-9P-007
APPENDIX 7: -
AUDIT QUERY
CLIENT:
DATE:
PROJECT:
CONTRACT NO:
AUDIT NO.:
AUDITEE:
AUDITOR:
REQUIREMENTS:
QUERY:
RESPONSE:
ARRANGEMENTS CONFIRMED:
84501-9200-9P-007
APPENDIX 8: -
AUDIT REPORT
No.
Date
BASIS OF AUDIT
TEAM LEADER
AUDITEE
NO. OF C.A.R.
Raised
Closed
NO. OF A.O.
Raised
Closed
REPORT
ISSUE
DATE
84501-9200-9P-007
APPENDIX 9: -
CAR FORM.
AUDIT NO.
C.A.R. NO.:
DESCRIPTION OF NON-CONFORMANCE
( )
( )
( )
( )
A: Highly Critical
B: Critical
C: High Concern
D: Concern
DETAILS:
QUALITY REQUIREMENTS:
QUALITY DEFICIENCY:
AUDITEE:
AUDITOR:
Sign:
Sign:
Date:
Date:
CORRECTIVE ACTION TO BE TAKEN
AUDITEE:
FOLLOW-UP
Name:
Name:
Date:
Date:
Date:
FOLLOW-UP AND CLOSE OUT DETAILS
C.A.R. CLOSED-OUT