306-1 - Internal Quality Audits
306-1 - Internal Quality Audits
306-1 - Internal Quality Audits
1.0 PURPOSE.....................................................................................................................................................3
2.0 SCOPE..........................................................................................................................................................3
3.0 REFERENCES...............................................................................................................................................
3.1 NATIONAL AND INTERNATIONAL STANDARDS............................................................................................
3.2 MANAGEMENT DOCUMENTS......................................................................................................................
3.3 QUALITY SYSTEM PROCEDURES................................................................................................................
4.0 DEFINITIONS...............................................................................................................................................
5.0 RESPONSIBILITIES....................................................................................................................................
6.0 INSTRUCTIONS............................................................................................................................................
6.1 QUALITY AUDIT SCHEDULING...................................................................................................................
6.2 PREPARATION AND PLANNING....................................................................................................................
6.3 PRE-AUDIT MEETING.................................................................................................................................
6.4 CONDUCTING THE AUDIT...........................................................................................................................
6.5 POST-AUDIT MEETING...............................................................................................................................
6.6 AUDIT REPORTING.....................................................................................................................................
6.7 FOLLOWING UP AND CLOSING OUT AUDITS...............................................................................................
7.0 ATTACHMENTS.....................................................................................................................................8
1.1 The purpose of this procedure is to define when, how and by whom internal Quality
Audits shall be performed.
2.0 SCOPE
2.1 This procedure applies to all departments covered by the Company Quality System.
2.3 Project Quality Systems shall be audited in accordance with the requirements of
Standard Project Procedure, GPP 7EG 302 - Quality System Audits.
3.0 REFERENCES
4.0 DEFINITIONS
MQA - Manager of Quality Assurance. Taken here to mean the Manager or his
nominated representative. In the New Delhi Execution Unit the
nominated representative is the Quality Assurance Manager for that Unit.
5.0 RESPONSIBILITIES
5.1 The MQA shall be responsible for the following aspects of Company Quality Audits:
5.2 The PQAM shall be responsible for 5.1 a-e above with respect to project Audits with
the exception that instead of the CMAS the Project Audit Schedule shall be prepared,
updated and controlled, and that the Audits will be performed in accordance with
GPP 7EG 302.
6.0 INSTRUCTIONS
The Company Master Audit Schedule (CMAS) covers the audit requirements of the
complete company quality system.
Reference is made to existing Project Audit Schedules when generating the CMAS to
avoid duplicating audits.
Project Quality Audits shall use a project specific numbering system such as three
letters followed by a sequential number (ie DUB-01 for a Dubai project).
6.2.1 The audit dates and details will be confirmed by memo with the auditee(s) no later
than five working days before the audit. A typical confirmatory memo and basis are
given in Attachments 1 and 2.
a) scope
b) areas to be examined
c) agenda
d) reference documents
e) names and details of audit team personnel
f) time and modes of arrival.
6.2.3 Where a preliminary review is considered desirable due to a large audit scope a
preliminary questionnaire will be sent to the auditee(s) for completion and return
prior to the date of audit commencement.
6.2.4 The MQA/PQAM will, for corporate/project audits respectively, either act as, or
nominate an Audit Team Leader.
6.2.5 The Audit team Leader shall ensure preparation of the quality audit checklist (QAC)
based on the following:-
a) scope
b) areas to be examined
c) agenda
d) reference documents
e) where applicable, questionnaire responses.
A brief pre-audit meeting shall be held at which the Auditor(s) and the Auditee(s)
shall agree on the following:
The Audit Team Leader is responsible for ensuring that notes of the meeting are
prepared, and attendance register - see attachment 4, is signed by the attending
members.
6.4.1 The auditor(s) shall conduct the audit of each item on the QAC by interviews and
examination of objective evidence, such as documents. The QAC may be extended if
additional questions become necessary to clarify the degree of conformance.
6.4.2 All original notes shall be made on a copy of the QAC. Details of the document
examined, giving file, number, section, page, paragraph and revision number and
whether an interview was carried out shall be entered in the 'REF/VERIFICATION'
column.
6.4.3 The 'COMPLIANCE - YES/NO' column shall be used to record whether the
information obtained is either compliant or not compliant with the requirement.
Wherever possible a 'NO' result shall be agreed at the time it is found by the
auditor(s)/auditee(s). Other entries in this column such as 'N/A' for 'Not Applicable',
and hyphens, shall be explained in the 'COMMENTS/REMARKS' column.
6.4.4 The 'COMMENTS/REMARKS' column shall record all findings, agreements and
deficiencies, including those which do not merit Corrective Action Requests (CARs)
and explain entries in the 'COMPLIANCE' column.
6.4.5 After the investigative phase of the audit the deficiencies will be separated into major
and minor. Corrective Action Reports shall be raised by the audit team for each
major deficiency (see Attachment 5 for a sample CAR).
6.4.6 An example of a major deficiency would be non-compliance with the procedure for
checking and approval of key engineering deliverables.
6.4.7 An example of a minor deficiency would be an isolated non key drawing that has not
been signed off as approved.
6.4.8 Where possible deficiencies will be grouped under common subject headings. The
CAR number shall be entered onto the CAR column on the QAC.
6.4.9 The CAR's shall be numbered in the following format XX-YY where XX is the audit
number and YY is the sequential CAR number. A suffix in the form XX-YY/1 shall
be allocated for CAR's in follow up audits.
6.4.10 Each member of the audit team shall prepare a summary of his findings and submit
these to the team leader for review prior to the post-audit meeting.
b) Discuss audit results, presenting a copy of any CARs to ensure that they are
understood by the auditees.
c) Agree any CARs together with the responsibilities and target dates for close-out
and follow-up audits, obtain the signature of the auditee(s) on each CAR and
provide the auditee(s) with the originals of the CARs.
d) In the event of disagreement over a CAR then the auditee shall be permitted to
submit documentary evidence relating to the validity of the CAR. This
evidence shall be reviewed with the auditee and the auditee's supervisor for
resolution. Where it is agreed that the CAR is valid, the supervisor shall sign
the agreed CAR to signify his agreement. Where it is agreed that the CAR is
not valid it shall be withdrawn.
e) Discuss the minor deficiencies and agree an action and time limit for resolution.
Follow up action to take place during the next audit. The agreed actions can be
documented in a Corrective Action Plan.
f) Agree the intended date for the audit report - see 6.6.1 below.
6.6.1 The Audit Team Leader shall prepare the audit report which shall be issued to the
MQA within an agreed timescale after the post-audit meeting.
Quality Audit Report (QAR) form - Attachment 6. This form shall give an overall
summary of the audit to describe its purpose, basis and audit results including the
number and brief details of CAR forms raised. This form shall be signed and dated
by the auditors.
For small projects, or audits with limited scope, and with the agreement of the MQA,
the narrative report may be omitted.
6.7.1 Corrective Action Requests (CAR's) shall be recorded on the Quality Audit Action
Schedule (QAAS) form (see Attachment 7) for the audit.
6.7.2 The Auditee responsible for the corrective action on a CAR shall complete boxes 11-
12 of the CAR form and return the original to the QA Group/MQA.
6.7.3 In the event of non-return of a CAR within the agreed date, then the matter shall be
raised with the auditee and auditee's supervisor. Reasons for the non-compliance with
the close-out schedule shall be documented together with a new agreed schedule
which shall be entered on the CAR and QAAS.
6.7.4 Follow-up to verify the implementation and effectiveness of the corrective actions
shall be carried out by the Audit Team Leader or his nominee within the agreed
period. If the action taken has been effective in correcting the deficiency and
preventing recurrence, the CAR, box 13, shall be completed, referencing
documentary evidence reviewed and signing and dating the form.
6.7.5 If the corrective action has not been effective in correcting the deficiency and
preventing a recurrence of the deficiency, then a new CAR shall be raised,
referencing the original CAR with the new CAR number recorded on the original. If
the new CAR is not closed-out at the second follow-up then the MQA shall review
the matter with Company Management for resolution which shall be recorded.
6.7.6 The QAAS shall be updated as the CARs are closed-out and cross-reference made to
any new CARs raised.
6.7.7 The Quality Audit Log - see attachment 8, shall be updated on close-out of all CARs
raised on an audit including follow-up audits.
6.7.8 Copies of follow-up audit reports and closed-out CARs shall be distributed by the
MQA as for initial audit reports.
7.0 ATTACHMENTS
1. Audit Memo
2. Quality Audit Basis
3. Quality Audit Checklist
4. Audit Meeting Attendance Form
Procedure Number QAP-306 Page 8 of 9
5. Corrective Action Request (CAR)
6. Quality Audit Report
7. Quality Audit Action Schedule
8. Quality AuditLog
Date:
From:
Copies To:
Of:
At: Ext:
Subject:
This memo confirms the arrangements for a Quality Audit on (Day, Date*).
Attached is the Quality Audit Basis defining the scope, areas to be examined, agenda,
reference documents and auditors.
The pre-audit meeting will be held at (time, location). On completion of the audit, a post-
audit meeting will be held and a date agreed for submission of the Audit Report.
To enable the audit to be conducted with the minimum of disruption to our normal work
programme, please arrange for suitable representation and assistance during the audit.
Regards,
(Auditor Signature)
Attachment 1
Additional Information: Quality audit checklist will take note of pre-audit questionnaire
responses
Attachment 2
QUALITY AUDIT CHECK LIST
1 Audit Process
Attachment 3
Audit Meeting - Attendance Form
Audit Dates:
Auditee: Auditor:
Auditee Representatives:
Other Attendees:
Attachment 4
Corrective Action Request (CAR)
Controlling Document:
Finding:
Attachment 5
Quality System Audit Report
Project Title: Audit No: Auditors:
Audit Date:
Project No:
Audit Scope:
Areas Examined:
Attachment 6
QUALITY AUDIT ACTION SCHEDULE (QAAS)
Attachment 7
QUALITY AUDIT LOG
Attachment 8