QA-M-019 Quality Assurance Manual Corrective Actions

Table of Contents

1. General
2. Recommendations
3. Verification of Corrective Action Performed
4. Client Detected Nonconformances
5. References

This section together with section 18, describes the nonconformance(NC)/corrective and preventive action system comprising the following steps:

• assessment and reporting of the nonconformance
• preparation of corrective action recommendation and disposition for follow-up
• verification of corrective action performed
• planned actions to avoid similar nonconformances
• direction for analyzing trends, processes, operations, quality records, service reports and client complaints
• direction for the establishment, documentation and maintenance of corrective actions, procedures and records

Corrective action shall be efficient not only in correcting the adverse condition but in eliminating the cause at source, if possi­ble.

Once the method of correcting the nonconformity has been determined, the corrective action shall be implemented immediately after approv­als (or waivers/concessions) of the recommendation have been obtained.

2. Recommendations

If NC's are detected during internal audits, an audit report with recommendations is prepared by the auditor (see section 22).

If a nonconformance is of a nature that a change in project produc­tion documents, drawings or calculations may be required, the audit report shall be forwarded to the Project Manager for his review and concurrence with the proposed recommendations.

Authority for the implementation of corrective actions may be by the General Manager, Manager Technical Operations, Project Manager and/or the Department Manager depending on the subject.

The implementation of corrective action on significant NC's shall be verified by the Manager of Quality Assurance by a follow-up audit.

Throughout the subdivisions as referred in section 18, alternative corrective/preventive actions and recommendations are given as described below:

2.1 Corrective/Preventive Action in Company Offices

If the cause of the nonconformity cannot be immediately determined, the Department Manager concerned shall instigate an investigation to determine the cause and the corrective action necessary to eliminate the cause of the nonconformity and to prevent recurrence of the condition in the future, if possible.

The corrective action may be:

• remedial work
• re-qualification of the process or supplier
• replacement of the product/material
• replacement/re-qualification of personnel
• revision of the Engineering, Procurement or Construction procedure
• revision of the contract requirements
• effective handling of customer complaints (ref.19.5.1)
• modification of the organizational structure
• waiver/concession from client and/or regulatory body
• revision of Company's QA Procedures and/or QA instructions (only after consultation with the Manager of Quality Assurance)

If a nonconformance is of a nature that a change in a project or Company standard document is necessary, the Project Manager, the Manager of Quality Assurance and/or the Department Manager is responsible for revising the document.

If required, relaxation or approval for project scope changes shall be obtained from the client. The procedure for Design Changes (section 9.3) shall be followed.

• after the issue of a nonacceptance note, remedial action shall be agreed to. Once the action has been completed, the Project Inspector shall issue a disposition memorandum.

• in OS & D reports no recommendations are given. The nonconformance is reported to the Project Manager for disposition. A nonconformance report may also be written if deemed necessary.

• nonconformance detected at supplier's premises during an audit after PO award, are to be corrected by the supplier to fulfil contract requirements. Recommendations are given in the external audit report.

2.3 Corrective Action at Site

The NC report recommendations will be made by the site quality representative. These recommendations are subject to agreement by all parties concerned.

Authorized requirements of the nonconformance report shall be strictly followed-up. The manager of the department, Project Manager or supplier/subcontractor involved, is responsible for implementation of the recommendations and for further prevention of reoccurrences.

Follow-up is verified by the nominated QA or QC representative that signs off the nonconformance/corrective action report if corrective action is satisfactory.

The completed report is submitted to the applicable QA representative to take care of further distribution.

All client detected nonconformances (or complaints) shall be given the highest priority for their resolution, to the satisfaction of the client (ref.19.5.1).

The Project Manager shall be immediately informed of any such nonconformance or complaint.

The Project Manager shall, on notification of the nonconformance/­complaint, agree with the client a definite time-frame for the resolution.

The Project Manager shall liaise directly with the client, keeping the client informed regarding the progress in resolving the non­conformance and/or complaint.