Doc. No. : NQAP 16.

01
CORRECTIVE ACTION PROCEDURE Rev. :1
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TABLE OF CONTENTS
1. Scope
2. Responsibilities
3. Classification the condition as significant or insignificant
4. Procedure
5. Follow-up action
6. Quality trend analysis
7. Exhibits
Document No.
Issued to
Controlled
Uncontrolled

Rev. Date Prepared by Reviewed by Approved by

NCQAE NCQAM NCQD

1 Dec.01.2019

Department name: Nuclear Department

Nuclear Quality Assurance Procedure
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Department name: Nuclear Department

Nuclear Quality Assurance Procedure
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1. SCOPE
1.1. This procedure describes the method of controlling the corrective action as a result
of quality deviations or audit findings (Internal or External).
1.2. A corrective action in accordance with this procedure is required for Significant
conditions adverse to quality, such as failures, malfunctions, deviations, defective
materials and equipment, nonconformance’s, audit findings and QA Program
deficiencies
1.3. It also describes the follow up required to assure the corrective actions has been
identified and applied correctly as soon as practical and the measures has been
taken to preclude recurrence
1.4. These requirements shall also extend to the performance of the approved
supplier’s corrective actions measures.

2. RESPONSIBILITIES
1.5. Lead Auditor has the responsibility to identify promptly the conditions
adverse to quality which may need corrective action through review of the
management review report, internal and external audits, nonconformance’s,
and customer complaints.
1.6. Nuclear Corporate Quality Assurance Manager (NCQAM) shall be responsible for:

 Review and approve the corrective action request.

 Review and approve the follow up done by the Lead Auditor.

1.7. The CAR issuer shall be responsible for :

 Preparation of Corrective action request, and to assure that the significant

conditions adverse to quality are identified promptly
 Follow up to assure that the nonconforming conditions has been properly

Department name: Nuclear Department

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corrected within the time scheduled and to assure that measures has been
taken to prevent their recurrence.

1.8. The responsible Manager for implementation of the corrective action shall have the
responsibility to analyze the cause of conditions adverse to quality and to take an
appropriate corrective action as soon as practical to preclude recurrence in
accordance with the Corrective Action Procedure

3. Classification the condition as significant or insignificant

1.9. The classification study of conditions adverse should consider the following
aspects:

a. Impact on reliability, availability, or maintainability of the equipment or

facility;
b. Importance in meeting regulatory commitments;
c. Consequence of recurrence;
d. The extent to which the adverse condition may apply to other items or
activities beyond the specific occurrence where it may have greater impact

1.10. The following conditions adverse to quality shall be classified as significant:

a. Process requiring substantial rework, repair, or replacement;

b. Damage to component requiring substantial repairs;
c. loss of essential data;
d. Repeated failure to implement a portion of an approved procedure.
e. Recurrent nonconforming condition(s) (Trend)
f. Condition(s) that could have a significant impact on Health and Safety or
cost and schedule would result in Quality Department with holding
acceptance of work

Department name: Nuclear Department

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g. A deficiency or findings identified in Orascom, third party or customer audit

4. PROCEDURE
1.11. When conditions adverse to quality are identified by any means such as
Nonconformance Reports, internal and external audits, customer complaints, and
other sources.
1.12. The Lead Auditor, NCQAM or SQCM as applicable shall initiate a Corrective
Action Request (Exhibit NQAME16.01) to the Manager who is responsible to
correct the conditions as soon as practical, and the CAR shall be approved and the
condition adverse quality shall be classified by the Nuclear Corporate Quality
Assurance Manager (NCQAM) (the Nuclear Corporate Quality Director (NCQD) in
case of the CAR is issued to QA Department).
1.13. The corrective action shall include the following:

a. Clear identification of the condition that adverse to quality and required

corrective action.
b. Suggestion of correction required
c. Classification the condition as significant or insignificant
d. Cause analysis
e. Evaluation of impact on generic implications
f. Notification of the conditions to the responsible department Manager
g. Proposal of corrective action to prevent recurrence by responsible
department Manager
h. Follow-up action for verification of effectiveness of the implementation of the
corrective action

1.14. The NCQAM shall maintain the CAR Log (Exhibit NQAME 16.02) for tracking and
follow-up of
1.15. The CAR, with identification of the quality problems to be corrected shall be

Department name: Nuclear Department

Nuclear Quality Assurance Procedure
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reviewed and approved by the NCQAM or by the NCQD in case of the findings is in
the NQA Department.
1.16. The CAR shall be forwarded to the applicable department Manager or vendor to
request response which include identification of cause, action to be taken to
prevent recurrence and a date when the proposed corrective action will be
completed.
1.17. The corrective action may require indoctrination and training including
requalification of the personnel accompanying the cause of the conditions requiring
corrective action and review of the needs of revision of related procedures or the
documents
1.18. The applicable Department Manager shall return the CAR with the proposed
corrective action and scheduled date to the NCQAM.
1.19. The CAR shall be responded to within ten days for internal corrective action and
within thirty days for external (vendor) corrective action.
1.20. When the proposed corrective action to be considered as inappropriate, the CAR
shall be returned to the applicable Department Manager or vendor for more
appropriate corrective action methods to be taken.

5. FOLLOW-UP ACTION
1.21. Follow-up action shall be conducted by the issuer within two weeks after the
scheduled implementation date to assure that corrective action is accomplished
properly as scheduled.
1.22. The verification shall be documented on the CAR with the issuer’s dated signature
and the CAR shall be reviewed and approved by the NCQAM or NCQD as
appropriate.
1.23. This follow-up action may be accomplished by audit or review of the objective
evidence provided.
1.24. When the corrective actions have not been effective, a revised CAR shall be

Department name: Nuclear Department

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issued to identify and correct the cause. In addition, the problem shall be reported
to the Nuclear Corporate Chief Operating Officer (NCCOO)
1.25. Upon completion of implementation and verification of the corrective action, the
CAR with the supporting documents, if any, shall be forwarded to the NCQAM
(NCQD in case of the CAR is issued to NQA Department) for final approval, and
close-out by sign and date on the CAR Log by the NCQAM.
1.26. If a qualified vendor fails to take the required corrective action, he will be
disqualified and removed from the Approved Vendors List.
1.27. The NCQAM shall review and update the CAR Log to assure close out status and
to take follow-up action.

6. QUALITY TREND ANALYSIS

1.28. The Nuclear Corporate Quality Assurance Manager (NCQAM) shall analyze the
NCR’s, CAR’s, and Customer complaints semi-annually.
1.29. The Quality Trend Analysis Report shall be prepared by the Nuclear Corporate
Quality Assurance Engineer and reviewed by the Nuclear Corporate Quality
Assurance Manager (NCQAM) and approved by the Nuclear Corporate Quality
Director (NCQD).
1.30. The Quality Trend Analysis Report shall be used as input for management review

7. Exhibits

Exhibit No. Exhibit Title

NQAME 16.01 Corrective Action Request
NQAME 16.02 CAR Log

Department name: Nuclear Department

Nuclear Quality Assurance Procedure