1. Purpose
  2. General
  3. Responsibilities
  4. Procedures
  5. Flowchart
  6. References
  7. Attachments

1.Purpose

1.1 Objectives

The system of Internal Quality Audits must ensure that:

  • the Quality System of Company complies with all clauses of the ISO 9001 standard and applicable contractual/legal requirements;
  • the Quality System is understood and used through all levels of the organization;
  • the Quality System is functioning efficiently and has the ability to achieve defined quality objectives;
  • it can identify potential problems and resolutions to ensure a more effective quality management system is operative.

1.2 Scope

This procedure describes the responsibilities for organizing, executing, reporting and follow-up of:

  • scheduled internal quality audits on departments
  • scheduled internal quality audits on projects

Next to mentioned scheduled Internal audits also unscheduled audits or surveillances may be performed on request of the client, the general manager, the department manager or the quality assurance manager as a result of a complaint, observation or expected area of concern.

2. General

This procedure describes the responsibilities (who is doing what and when) and provides also some instructions on how to perform an audit.

Additional information on how to perform an audit is given in ref.6.8 and 6.9.

Standard checklists have been developed as a guidance for auditing a certain department or discipline (see ref.6.4 and 6.7).

Definitions of terms used can be found in ref.6.6.

3. Responsibilities

The Management Quality Team (MQT) is responsible for:

  • the selection and assignment of the auditor(s) for auditing the QA Department;
  • the review of and agreement on the departmental quality audit schedule;
  • the periodic review of the analysis/trends of audit results;
  • corrective actions with respect to intra-departmental Quality system aspects. (split of departmental responsibilities).

The Department/Discipline Managers are responsible for:

  • the review of and agreement on the established project quality audit schedule;
  • the selection and assignment of the project auditor(s);
  • corrective action on nonconformances, related to the standard Company Quality System and implementation thereof.

The Manager of Quality Assurance is responsible for:

  • the establishment of a departmental quality audit schedule;
  • the review of and agreement on the established project quality budget and the audit schedule;
  • monitoring and central coordination/organization of the departmental and project audit schedules;
  • the selection and assignment of auditors for departmental audits (except Quality Assurance audits);
  • the selection and assignment of the lead auditor for project audits;
  • follow-up and monitoring of Quality System nonconformances;
  • the review and analysis of all audit reports;
  • organization of the periodic management review.

The Project Manager is responsible for:

  • the establishment of an appropriate project quality budget;
  • the establishment of a project audit schedule;
  • informing the Manager of Quality Assurance on the progress per discipline, to enable execution of audits at the proper time;
  • corrective actions on project specific Quality System aspects;
  • follow-up and monitoring of project nonconformances.

The Discipline Lead Engineer on the project is responsible for:

  • Corrective actions on (product) nonconformances.

The Auditor is responsible for carrying out an objective audit in accordance with this procedure and for reporting accordingly.

The Auditee shall cooperate to enable an effective execution of the audit and is responsible for the correctness of all information given.

4. Procedures

4.1 Planning

Departmental Audits shall be planned annually. The Manager of Quality Assurance shall maintain, in agreement with the MQT, a departmental audit schedule.

Project Audits shall be planned and scheduled by the Project Manager in agreement with the QA and involved Department Managers at the time of preparing the Project Procedure and Execution Manual (ref.6.1 and 6.3).

The number, timing and expected duration of audits shall be based on the expected critical aspects and related risks. In principal three audits will be executed on every discipline. The first audit will normally focus on the documented procedural system (completeness, correctness, distribution and awareness) and the following audits will normally focus on product quality and effective implementation of the quality system by carrying out sample checking.

For more detailed planning criteria see ref.6.7.

The Project Manager shall revise the project audit planning in line with the established progress and inform the Manager of Quality Assurance to ensure an effective timing of audits.

4.2 Monitoring Timely Execution of Internal Audits

The Manager of Quality Assurance shall monitor the internal audit schedules regularly and communicate with the responsible Department/Discipline Manager to ensure timely assignment of auditors.

4.2.1 Selection of Auditor(s)

Audits may be carried out by one auditor or by an audit team under the guidance of a lead auditor.

Auditors shall be suitably qualified and experienced personnel and independent of those having direct responsibility for the work being performed (ref.6.2).

The Manager of Quality Assurance shall select the departmental auditor(s) except for audits of the QA department for which the MQT shall select the auditor(s).

A project audit team will in principal consist of the project QA Engineer (acting as lead auditor) and the discipline manager or a senior engineer (acting as auditor, selected by the Department/ Discipline Manager). Audits may also be performed by an auditor of another department or discipline (e.g. an internal client).

The Manager of Quality Assurance shall ensure that the assigned auditors are properly instructed about the objectives of the audit.

4.2.2 Notice of Audits

Audits will be announced approximately one week in advance by the Manager of Quality Assurance or the assigned auditor(s), as appropriate by means of a written notice. The following parties shall be informed as a minimum:

  Departmental Audit Project Audit
General Manager X  
Director of Projects   X
Project Manager   X
Project QA Engineer   X
Manager QA Department X X
Department Manager X X
Discipline Manager   X
Main Auditees X X

The assigned auditor(s) shall address the following audit program aspects:

  • project documentation that will be assessed;
  • audit date(s), schedule (timing) and location;
  • name(s) of auditee(s);
  • name(s) of auditor(s);
  • name(s) of possible observer(s);
  • proposed timing and location of post-audit meeting.

and inform all concerned to ensure that required resources, facilities, informants and project documents needed for the document review and the audit are available.

4.2.3 Document Review/Preparation

The auditor(s) may select random product examples to study them in advance, if appropriate.

The auditor shall prepare himself adequately for the audit by means of studying for example the following documents:

  • Project Procedures and Execution Manual;
  • governing procedures and work instructions;
  • contractual requirements;
  • legislative requirements;
  • previous audit reports;
  • standard question lists (ref.6.4 and 6.7);
  • examples of product documents.

To enable an effective audit it is advised to prepare a specific question list. This list shall contain relevant questions to meet the audit objectives, reflect important aspects of above mentioned documents and the process to be audited. This specific question list can be used as an "aide memoir" during the audit and can supplement the standard question list.

4.2.4 Pre-Audit Meeting

The auditor(s) shall hold a short meeting with the main auditees prior to commencing the audit interviews. During this meeting the following points shall be dealt with:

  • introduction of auditor(s) and any observer(s);
  • the scope and objectives of the audit;
  • the assessment criteria (norm, procedures, etc.);
  • the people expected to be interviewed;
  • the proposed schedule for the interviews;
  • the method of reporting and distribution;
  • timing of the post-audit meeting;
  • the auditee's right of appeal (see section 4.2.8);
  • remaining questions.

Any objections to the audit plan shall be made known to the auditor(s) and solved before executing that part of the audit.

Specific details of the audit plan shall only be communicated if their premature disclosure does not compromise the collection of objective evidence.

4.2.5 Audit Interviews

Audit interviews shall be carried out to verify the extent to which the quality program and/or project requirements are being satisfied. The interviews shall also be used to verify the extent to which Company's Quality System satisfies the quality objectives.

Wherever possible, objective evidence shall be sought to demonstrate that activities have been correctly carried out. Documents seen during the audit must be noted, especially those that are related to an observed non-conformance.

During this phase of the audit, an observer shall only have the right to ask the auditee(s) questions, if given specific permis­sion by the (Lead) auditor(s).

The auditor(s) shall summarize at the end of the interview, the subjects the auditee can expect to be reported.

4.2.6 Post-Audit

A post-audit meeting shall be held as soon as possible after the audit, to ensure proper understanding of the findings by those responsible for taking corrective action. The following agenda will in principal be followed:

  • audit scope and objectives
  • audit assessment criteria
  • explanation of method used
  • summary of main positive findings
  • raised nonconformances
  • summary of main observations
  • summary of main recommendations
  • agreement on corrective actions
  • outstanding questions

Corrective actions and due dates are to be agreed upon by the assigned person to take corrective action or his responsible manager. In case it is not possible to reach agreement during the post audit meeting on corrective actions (and timing) the responsible manager shall submit within one month an action program to the Manager of Quality Assurance, describing what corrective actions will be taken, the assigned responsible person and an expected date of implementation.

4.2.7 Reporting

The audit report shall be issued as soon as possible after the audit (preferably not later than one week). It is up to the auditor(s) to decide whether he/they will issue the audit report "for comments" before, during or after the post audit meeting.

Project Audits shall be reported in standard format (ref.6.10).

Departmental Audits shall be reported in a standard format (ref.6.5).

A clear split shall be made between findings based on objective evidence and findings based on subjective information/opinions.

The main findings in the audit report shall be split in the following two categories for actions to be taken:

  • Nonconformances: These are reported on a separate sheet (ref.6.10 for projects and 6.11 for departments) and present either a major deviation from a quality system requirement that require corrective action or a preventive action to assure quality (e.g. formalization is required, procedure needs to be updated or disciplinary action is required to ensure effective implementation).
  • Observations/additional recommendations: These are reported in the form of an action list and present minor deviations from a project or system requirement and/or possibilities for improvement to be decided upon by responsible management.

The auditor identifies the person(s), responsible to take corrective actions, if possible.

The auditor may propose recommendations to solve nonconformances and/or observations/additional recommendations.

Major obstacles encountered in performing the audit shall be reported.

In case another department/discipline manager is responsible to take corrective action on a certain nonconformance, the auditor shall ensure adequate acknowledgment by invitation to the post audit meeting , a separate memo and/or explanatory meeting.

The completed audit report shall be issued for comments to all auditees and action assignees. If the auditee does not agree with any part of the report, he/she shall take the matter up promptly with the auditor.

If the auditor agrees with received comments (on paper and/or during the post audit meeting), he/she shall incorporate these and the audit report shall then be issued for information/action with the following distribution:

Distribution Departmental Audit Project Audit
General Manager X  
Director of Projects   X
Manager Technical Operations X
Project Manager   X
Project QA Engineer   X
Manager QA Department X X
Department Manager X X
Discipline Manager   X
Main Auditees X X

In principle Company does not distribute the project audit reports to the Client, however should the client want to see the results of the audit, he may be invited to review the Company Project Manager's copies of the audit reports.

4.2.8 Right of Appeal

If any auditee has complaints about the way an audit has been performed, he/she shall have the right to appeal to his/her Manager and/or the MQT.

4.3 Follow-up

The responsible Department Manager/Project Manager shall ensure that corrective actions are taken promptly and that preventive actions are taken in time to prevent reoccurrence.

The Manager of Quality Assurance/Project QA Engineer shall maintain a record of nonconformances and agreed actions for subsequent follow-up and resolution monitoring. For specimen of a departmental nonconformance report see ref.6.11.

The Department Manager/Project Manager shall acknowledge the Manager of Quality Assurance/Project QA Engineer as soon as nonconformances have been solved and will provide him with relevant evidence (e.g. back-up information).

The Manager of Quality Assurance shall analyze all (departmental, project and third party) audit reports. Outstanding nonconformances will be addressed regularly in the MQT meeting.

The Manager of Quality Assurance/Project QA Engineer shall verify that corrective actions to solve nonconformances have been implemented effectively. (e.g. by means of an unscheduled follow-up audit or during a scheduled audit).

4.4 Records

The nonconformance tracking reports will contain the following information:

  • nonconformance identification number;
  • nonconformance description;
  • responsible department/project;
  • responsible person for corrective action;
  • due date for corrective action;
  • status.

All original project audit reports shall be retained by the Project Quality Assurance Engineer. Department audit reports shall be retained by the Manager of Quality Assurance. The Quality Assurance Department shall maintain a file of all audit reports. Evidence and/or back-up information shall be noted on, and/or filed together with the original nonconformance notes. The Project Manager's copy of all project audit reports shall be retained in the project file, until job close-out.

The Department Manager shall keep his copy of the audit report until all agreed corrective actions, for which he/she is responsible, have been effectively implemented.

5. Flowchart

6. References

 

7. Attachments

None

  Document Number Title Level

6.1

CM-PE-303

Project Procedure and Execution Manual

2

6.2

BN-G-UK002

Qualifications of QA (audit) Personnel

5

6.3

BN-S-UK001/9

Audit Schedule

5

6.4

BN-G-UL001

Department Audit Checklists

5

6.5

REC28002

Departmental Quality Audit Report

5f

6.6

BN-G-U001

Terminology

5

6.7

BN-G-UK003

Guide for Project Audits of All Disciplines

5

6.8

IA-Course

Handout Internal Audit Course 1993

-

6.9

ISO 10011-1, 1990(E)

Guidelines for Auditing Quality Management Systems

-

6.10

REC28001

Project Quality Audit Report

5f

6.11

REC28003

Nonconformance Report

5f

7. Attachments

none