QA-M-022 Quality Assurance Manual Quality Audits

Table of Contents

1. General
2. The Auditor
3. Audit Planning
4. Performance
5. Reporting
6. Follow-Up
7. Standard Checklists
8. References

1. General

Quality Audits are executed to assess the overall effectiveness of the Quality Program of Company, suppliers and subcontractors.

The following main audit types are distinguished:

• internal audit, performed within the Company organization.
• external audit, performed by Company in the organization of a supplier or subcontractor.
• extrinsic audits, performed in Company by an external body (e.g. client).

The following scopes of audits are distinguished:

• systems audit, focused on the Quality System, comprising the documentation, processes and working methods.
• product/service audit, focused on the resulting quality of the product and/or service.

Internal Audits shall be planned, as found necessary, for each project. System audits within Company's organization, not related to projects, shall be performed biannually as a minimum.

External Audits may be performed:

• prior to placing a purchase order, so as to assess an organiza­tion's capability to perform the intended work.
• after placing a purchase order, so as to evaluate the organization's performance and compliance with contracted requirements.

The type, extent and frequency of audits is dependent on Company's experience with the suppliers or subcontractors, and/or client's requirements.

Extrinsic Audits may be requested by a client so as to assess/evaluate Company’s Quality system and/or products.

Extrinsic audits may also be requested by Company to be performed by a recognized authority (e.g. Lloyd’s) for the purposes of evaluation or accreditation of Company’s Quality system.

During extrinsic audits, the auditor(s) shall be provided with all necessary assistance, guidance and facilities. However the proprie­tary nature and confidentiality of Company's products and data, as well as those of Company's clients, shall be strictly observed.

This section further describes the requirements in relation to Company's internal and external auditing activities.

2. The Auditor

The audit shall be performed by qualified/experienced personnel (preferably recognized by an international certification body) that are not directly responsible for carrying out or checking/inspecting the activity being audited.

If deemed necessary audits may be performed by an audit team conducted by a Lead Auditor.

3. Audit Planning

System audits shall be planned to ensure that each department is audited, at least biannually.

Project audits shall be scheduled, as far as possible, in phase with the status and importance of the project activities to assurethe adequacy of and adherence to the applicable Quality Program and/or Plan.

Unscheduled audits may be executed on departments and/or projects on request.

4. Performance

To initiate the planned/requested audit, the Auditor shall notify the auditee(s) and their Manager(s) prior to commencing the audit activities.

Prior to performing the audit, the Auditor shall arrange a pre-audit conference with the designated individuals from the organization to be audited. The pre-audit conference provides for:

• explaining the audit scope and methods
• agreeing audit sequence and involved individuals
• agreeing times for the sequence of activities and the post-audit conference.

The Auditor shall conduct the audit in accordance with procedure (ref.22.8.1). See also section 11.2.

The Auditor shall conduct a post-audit conference with the designat­ed individuals from the audited organization and identify specific audit findings and/or nonconformances.

Recommendations for corrective actions to resolve the audit findings and/or nonconformances should be discussed during this conference.

5. Reporting

The Auditor shall issue an audit report as soon as possible after the audit. The audit report shall include a summary of audit find­ings and/or nonconformances, conclusions and recommendations.

6. Follow-Up

The audited organization, department or task force group is responsible to ensure that the agreed corrective actions, recommended in the audit report, are carried out. The Auditor is responsible for a follow-up on the deficient area. This may be done during the next scheduled audit or an additional "follow-up audit".

7. Standard Checklists

Standard checklists that identify documents and subjects to be audited are maintained (ref.22.8.2 and 22.8.3).

These checklists may be used as a guidance for preparing the specific audit checklist.

8. References