CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9 P-007
1
1 Feb 03
2 of 25
REVISION CONTROL SHEET LATE LATEST ST REV REV
DATE DATE ISSU ISSUED ED
PREP PREPA ARED RED
REV REVIE IEWE WED D
APPR APPROV OVED ED
COMM COMMEN ENTS TS
0
1 Oct 2002
B. Burn
R.Ford
A.McIntosh
Issued For Use
1
1 Feb 2003
B. Burn
R.Ford
A.McIntosh
Department Name Change
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
3 of 25
TABLE OF CONTENTS
1.
SUMMARY
...................................................................................................... 4
2.
DEFINITIONS
...................................................................................................... 5
3.
AUDIT PLANNING ................................................................................................. 6
4.
AUDIT PREPARATION .......................................................................................... 7
5.
PERFORMING THE AUDIT.................................................................................... 8
6.
AUDIT REPORT ................................................................................................... 11
7.
FOLLOW-UP AND CLOSE OUT.......................................................................... 12
8.
DOCUMENTATION AND RECORDS................................................................... 12
9.
AUDITOR’S ROLES AND RESPONSIBILITIES .................................................. 15 APPENDIX 1
AUDIT AND REVIEW SCHEDULE ............................................ 17
APPENDIX 2
AUDIT REGISTER LOG............................................................. 18
APPENDIX 3
AUDIT CHECKLIST ................................................................... 19
APPENDIX 4
AUDIT REPORT SHEET............................................................ 20
APPENDIX 5
AUDIT ATTENDANCE REGISTER............................................ 21
APPENDIX 6
AUDIT NOTIFICATION .............................................................. 22
APPENDIX 7
AUDIT QUERY FORM ............................................................... 23
APPENDIX 8
C.A.R. STATUS LOG................................................................. 24
APPENDIX 9
C.A.R. FORM ............................................................................. 25
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
4 of 25
1.
SUMMARY
1.1
This procedure applies to all audit locations for:-
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: -
1.2.1 Determine the conformance or otherwise of the Management System Elements with the documented and agreed System requirements. 1.2.2 Determine the effectiveness of the System in meeting the specified Quality objectives and provide the Auditee with an opportunity to improve the System. 1.2.3 To provide objective evidence to Third Party Assessors of conformance to requirements. 1.3
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.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
1.8
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
5 of 25
The procedure outlined in Section 9.0 should be followed to:-
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:
1.9.1 Identification of non-conformity. 1.9.2 Documented agreement by Auditee of non-conformity. 1.9.3 Documented agreement on corrective action. 1.9.4 Documented closeout of action. 2.
DEFINITIONS Definitions, which are contained in ISO 8402, are as indicated: -
2.1
Quality Audit (ISO 8402) A systematic and independent examination to determine whether Quality Activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
2.1.1 Internal Audit Audits of a portion of the teams own organization. 2.1.2 External Audit An audit of portions of another organization’s Quality System not under the direct control or within the organisational structure of the audit teams own organization. 2.2
Auditor (Quality) A person who has the qualification to perform Quality Audits. Notes: -
a) To perform a quality audit, the auditor must be authorised for that particular audit.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
6 of 25
b) An auditor designated to manage a quality audit is called a “ Lead Auditor” 2.3
Auditee An organisation to be audited.
2.4
Non-Conformity (ISO 8402) The non -fulfilment of specified requirements.
2.5
Corrective Action Request (CAR) A document used to highlight and record any quality non- conformity and the proposed and actual remedial action.
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 CAR’s 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.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
7 of 25
3.2
In addition to audits of the Corporate System, Project specific audit schedules may have to be maintained including Vendor / Sub - Contractor audits. Third party audits will also be included in this schedule.
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
Planning the Audit
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. Specific details of the Audit Plan should only be communicated to the Auditee throughout the audit if the premature disclosure does not compromise the collecting of objective evidence.
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.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
8 of 25
4.5.2 Written confirmation ( letter, form or fax for external audits or form for internal audits see ( Appendix 6 ) shall include: •
Timetable for the Audit Reference number.
•
The Audit scope and objectives.
•
The Audit baseline documents :-e.g. Contractual
•
The Audit program.
•
Identification of Audit Team Members.
•
The date, duration and location of the Audit.
•
The time and location of the entry meeting, and a request.
•
Any special office facilities, e.g. office space.
4.5.3 For external Audits, at least seven (7) days notice in writing shall be given to the Auditee, if practical. 5.
PERFORMING THE AUDIT
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:
5.1.1 Introduce the Audit team. 5.1.2 Briefly discuss the Audit scope, objectives and proposed itinerary. 5.1.3 Confirm arrangements for any special resources or facilities, e.g. office space or escorts. 5.1.4 Establish the official communication links between the Audit team and the Auditee. 5.1.5 Confirm that the Audit reference documents are the specified revisions. 5.1.6 Agree on a time and a venue for the Audit Exit Meeting and issue an invitation to management representatives to attend. 5.1.7 Clarify any unclear details of the Audit plan. 5.1.8 Circulate an Attendance Register ( Appendix 5 )
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
5.2
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
9 of 25
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 Auditor’s 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: •
•
•
Evidence should be collected through interviews, examination of documents, and observation of activities and conditions in the areas of concern. Clues suggesting non-conformities should be noted, if they seem significant, even though not covered by the checklists, and should be investigated. Information gathered through interviews should be tested by acquiring the same information from independent sources, such as physical observation, measurement and records. Wherever possible, copies of relevant documents produced, as objective evidence should be obtained for inclusion in the report. Wherever possible, photographs of relevant acts witnessed, as objective evidence should be obtained for inclusion in the report.
5.2.5 The Auditor shall complete the Audit Checklist by stating under the heading “ Compliance” either: •
•
•
YES -Indicating complete acceptance. NO - Indicating evidence is not available to conform compliance of the Auditee. N/A- Indicating the Audit enquiry is not applicable.
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.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
10 of 25
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 t he 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
Audit Team Meeting
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
Analyse any non-conformities to confirm their validity as requiring Corrective Action Requests ( CAR's ) Ensure CAR’s are completed in accordance with Section 9.0 of this procedure prior to the Exit Meeting. Ensure that a list of Audit observations with brief detail is available. Agree on an objective overview of the Audit for presentation to the Auditee
Exit Meeting The Lead Auditor shall convene the Exit Meeting with Representatives of the Auditee organisation where he shall: •
•
•
•
•
Management
Present an objective overview of the Audit, making reference to satisfactory aspects of performance as well as to non-conformity findings and observations. The purpose is to ensure that the results of the Audit are clearly understood. Discuss each CAR and Audit observation to ensure they are fully understood by the Auditee and obtain his signature on the CAR. Present the Audit team’s conclusions regarding the Quality System’s effectiveness in ensuring that the Quality objectives will be met. Obtain copies of the CAR’s 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 CAR’s after receipt of the Audit Report. This should be within seven (7) days of the Exit Meeting.
•
Close the Meeting with the appropriate remarks.
•
Records of the Closing Meeting will be kept.
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
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
11 of 25
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
The Audit report shall comprise:-
6.3
-
Lead Sheet (Appendix 4)
-
Table of contents.
-
Audit Report Text.
-
Attendance Register.
-
Agreed CAR’s
-
Any attachments/photographs useful to the report.
The Audit Report text shall have the following sections:-
Audit scope and objectives.
-
Summary.
-
Basis of Audit (i.e. Listing of reference documents used in preparing Checklist.
-
Audit Program (i.e. Reference to Entry and Exit meetings, personnel involved, areas visited.
-
Details of Audit. (Including references to CAR’s and Audit observations, Audit team’s judgement of Audit’s compliance and the System’s ability to achieve defined quality objectives.
-
Copies of CAR’s.
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
The originals of any CAR’s shall be retained in the Q.A. files.
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
The Audit report distribution should always include the Auditee.
6.9
The Audit report shall be marked and transmitted as a Confidential Document. Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
6.10
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
12 of 25
Distribution of the Audit report will be as required but will normally be:-
Auditee
-
Specific project Quality Manager
-
Specific project Project Manager
-
Auditee’s Departmental / SHEA
The Quality Manager may make further distribution at their discretion. 6.11 Audit reports are considered to be controlled, copyright, confidential documents and should be treated as such by all recipients. 7.
FOLLOW-UP AND CLOSE OUT
7.1
The Audit Closeout shall be defined by the Lead Auditor, and will depend on the reasons for the Audit. -
If the Audit was “Assessment” of a potential supplier / subcontractor, the issue of the Audit report, with recommendations, can conclude the Audit.
-
If the Audit was carried out to identify non-conformities in a contractual situation, or as part of the project audit program, the Audit is not complete until all corrective actions have been carried out and verification of this has taken place.
-
The Lead Auditor shall monitor the progress of corrective actions on CAR’s in accordance with section 9.0 of this procedure.
-
At the due date, a follow up Audit to verify implementation and effectiveness of the corrective action may be performed. However, in the use of an external Audit where corrective actions are minimal, consideration may be given to obtaining documentation by post, obtaining written verification from a Specific project Inspector.
Completed Audit Documentation shall be filed in the Q.A. files. 8.
DOCUMENTATION AND RECORDS
8.1
After Audit Close-Out, the following documents shall be retained.
8.1.1 Audit Notification Document 8.1.2 The Audit Schedule. 8.1.3 Competed Checklists. 8.1.4 Originals of Corrective Action Requests
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
13 of 25
8.1.5 Audit Report and Transmittal Note. 8.1.6 Corrective Action Request Status Log. 8.1.7 Audit Follow- Up Report. 8.1.8 Other relevant correspondence, reports, etc. The C.A.R. Procedure 8.2
CAR Records
8.2.1 A Corrective Action Request Status Log shall be maintained (see Appendix 8) by the Quality Control Manager. 8.3
Raising the C.A.R.
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)
Recommended or proposed corrective action and scheduled start/completion shall be agreed jointly between the originator and Addressee. Corrective action shall include measures to prevent a recurrence of the deficiency. In the case of a Car raised during an Audit, the bottom portion of the CAR shall, wherever possible, be completed before the close of the Audit. The Addressee should be advised that his signature indicates that he understands and agrees with the stated Quality deficiency and corrective action and he agrees to carry out the stated corrective action.
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
Issuing the C.A.R.
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: -
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
14 of 25
-
Addressee
-
Specific Quality Manager
-
Specific Project Manager
-
Addressee’s Departmental Manager (Internal CAR’s only)
-
Project Q.A. file (ORIGINAL)
8.4.2 Following formal issue of the CAR, the status log shall be updated. 8.5
Addressee’s 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
Receiving the C.A.R. from the Addressee
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 CAR’s shall be filed in the Q.A. Department.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
15 of 25
9.
AUDITOR’S ROLES AND RESPONSIBILITIES
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
Lead Auditor’s Responsibilities
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 Auditor’s responsibilities also cover:-
9.3
-
Assisting with the selection of the Audit Team.
-
Preparation of the Audit Plan.
-
Representing the Audit Team with the Auditee’s Management.
-
Submitting the Audit Report.
Auditor’s Responsibilities
9.3.1 Auditors are responsible for:-
Complying with the applicable audit requirements.
-
Communicating and clarifying audit requirements.
-
Planning and carrying out assigned responsibilities effectively and efficiently.
-
Documenting the observations.
-
Reporting the Audit results.
-
Verifying the effectiveness of corrective actions taken as a result of the Audit (If requested by the client).
-
Retaining and safeguarding documents pertaining to the Audit.
-
Submitting such documents as required.
-
Ensuring such documents remain confidential.
-
Treating privileged information with discretion.
-
Co-operating with and supporting the Lead Auditor.
Check with Document Control for latest available Revision
CONOCO INDONESIA INC. LTD. PROJECTS DEPARTMENT SPECIFICATION TITLE QUALITY ASSURANCE AUDITS & CORRECTIVE ACTIONS
9.4
DOCUMENT NUMBER
REV
DATE
PAGE
84501-9200-9P-007
1
1 Feb 03
16 of 25
Independence of the Auditor Auditors should be free from bias and influences, which could effect the objectivity. All persons and organisations involved with an Audit should respect and support the Independence and integrity of the Auditors.
9.5
Auditors Objectives
9.5.1 The Lead Auditor should:-
Define the requirements of each Audit assignment, including the required Auditor Qualification.
-
Comply with the applicable Auditing requirements and other appropriate directives.
-
Plan the Audit, prepare working documents and brief the Audit Team.
-
Review Documentation on existing Quality System activities to determine their adequacy.
-
Report critical non-conformities to the Audit immediately.
-
Report any major obstacles encountered in performing the Audit.
-
Report the Audit results clearly, conclusively and without undue delay.
9.5.2 Auditors should:-
9.6
-
Should within the Audit scope.
-
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.
-
Be able to answer such questions, as: -
-
Are the procedures, documents and other information describing or supporting the required elements of the Quality System known, available, understood and used by the Auditee’s personnel.
-
Are all the documents and other information used to describe the Quality System adequate to achieve the required Quality Objectives.
-
Act in an ethical manner at all times.
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.
Check with Document Control for latest available Revision
84501-9200-9P-007
APPENDIX 1: -
AUDIT AND REVIEW SCHEDULE.
QUALITY AUDIT/REPORT SCHEDULE
Audit No.
Audit Subject
KEYS
Jan
P = PLANNED
Feb
March
T = TENTATIVE
April
May
2001 June July
E = EXECUTED
Aug
Sept
R = REPORTED
Approved By:
Oct
Nov
Dec
C = CLOSED
Approved By:
84501-9200-9P-007
APPENDIX 2: -
AUDIT REGISTER LOG.
AUDIT REGISTER / STATUS LOG CLIENT:
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 2: -
AUDIT REGISTER LOG.
AUDIT REGISTER / STATUS LOG CLIENT:
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 3: -
AUDIT CHECKLIST.
LOCATION: AUDITED ORGANIZATION:
REF.
AUDIT CHECKLIST
RAISED BY:
DATE:
PROCEDURE NO:
REQUIREMENT
AUDIT NO:
COMPLIANCE YES
NO
PAGE OF
NOTES/COMMENTS N/A
84501-9200-9P-007
APPENDIX 4: -
AUDIT REPORT SHEET.
CONOCO INTERNAL AUDIT REPORT CONFIDENTIAL AUDIT DATE: P.O. NO.: AUDITED ORGANIZATION: QUALITY DEPARTMENT: ENG. DEPARTMENT: FACILITY: TELEPHONE: FACSIMILE: TELEX: CONTACT NAME:
AUDT NO: PAGE OF AUDIT SUBJECT: AUDIT TYPE: PREVIOUS AUDIT DATE: PREVIOUS AUDIT REFERENCE: AUDIT TEAM: LEAD ASSESSOR: ASSESSOR: OBSERVERS:
CONTENTS SECTION SECTION SECTION SECTION
1 2 3 4
AUDIT OBJECTIVES SUMMARY AUDITEES DETAILED REPORT
84501-9200-9P-007
APPENDIX 4: -
AUDIT REPORT SHEET.
CONOCO INTERNAL AUDIT REPORT CONFIDENTIAL AUDIT DATE: P.O. NO.: AUDITED ORGANIZATION: QUALITY DEPARTMENT: ENG. DEPARTMENT: FACILITY: TELEPHONE: FACSIMILE: TELEX: CONTACT NAME:
AUDT NO: PAGE OF AUDIT SUBJECT: AUDIT TYPE: PREVIOUS AUDIT DATE: PREVIOUS AUDIT REFERENCE: AUDIT TEAM: LEAD ASSESSOR: ASSESSOR: OBSERVERS:
CONTENTS SECTION SECTION SECTION SECTION
1 2 3 4
APPENDIX 1 APPENDIX 2 APPENDIX 3 APPENDIX 4
AUDIT OBJECTIVES SUMMARY AUDITEES DETAILED REPORT 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: -
AUDIT ATTENDANCE REGISTER.
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.
CONOCO INTERNAL AUDIT NOTIFICATION An Audit is scheduled on the subject(s) listed below at the date(s) and time(s) shown. Those persons indicated as Auditees* are requested to confirm their availability to attend the Audit and opening meeting by signing against their name below. The detailed timetable showing the required involvement of individuals in the Audit will be presented and agreed at the meeting.
Timing of Audit
The Audit meeting is scheduled to commence at _________Hrs and will be held in ___________. It is anticipated that the Audit will then take approximately ________Hours/days.
The Audit subject is ______________________________________ and the following procedures have formed the basis of the checklists prepared for the Audit. No.
Procedure Title
Rev.
No.
Procedure Title
Rev.
Audit Scope
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 responsibl e 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:
Any person copied who wishes to attend the Audit or have others attend please inform the Lead Auditor.
Audit No.:
Quality Manager:Signature:-
Date:
84501-9200-9P-007
APPENDIX 7: -
AUDIT QUERY FORM.
AUDIT QUERY
CLIENT: DATE:
PROJECT:
CONTRACT NO:
AUDIT NO.:
PAGE ____ OF ____
AUDITEE:
AUDITOR:
CONTROL DOCUMENT, SECTION, PARAGRAPH, etc.
REQUIREMENTS:
QUERY:
RESPONSE:
ARRANGEMENTS CONFIRMED:
84501-9200-9P-007
APPENDIX 8: -
CAR STATUS LOG.
CAR STATUS LOG
AUDIT REPORT No.
BASIS OF AUDIT
TEAM LEADER
AUDITEE
Date
NO. OF C.A.R. Raised
Closed
NO. OF A.O. Raised
REPORT ISSUE DATE
Closed
84501-9200-9P-007
APPENDIX 9: -
CAR FORM.
CORRECTIVE ACTION REQUEST DATE:
AUDIT NO.
C.A.R. NO.:
DESCRIPTION OF NON-CONFORMANCE ( )
( )
( )
( )
A: Highly Critical
B: Critical
C: High Concern
D: Concern
DETAILS:
CONTROLLING DOCUMENTS, SECTION, PARAGRAPH.
QUALITY REQUIREMENTS:
84501-9200-9P-007
APPENDIX 9: -
CAR FORM.
CORRECTIVE ACTION REQUEST DATE:
AUDIT NO.
C.A.R. NO.:
DESCRIPTION OF NON-CONFORMANCE ( )
( )
( )
( )
A: Highly Critical
B: Critical
C: High Concern
D: Concern
DETAILS:
CONTROLLING DOCUMENTS, SECTION, PARAGRAPH.
QUALITY REQUIREMENTS:
QUALITY DEFICIENCY:
AUDITEE:
AUDITOR:
Sign:
Sign:
Date:
Date: CORRECTIVE ACTION TO BE TAKEN
ACTION TO BE TAKEN BY:
AUDITEE:
FOLLOW-UP
Name:
Name:
Date:
Date:
Date: FOLLOW-UP AND CLOSE OUT DETAILS
C.A.R. CLOSED-OUT