Galaxy Chemicals (Egypt) S.A.

Procedure for Control of Document No. APEX/GCE/GMP/MOGP – 5.0

nonconforming product Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 1 of 2
Operating Process : Manual of General Procedures

Title: Procedure for Control of nonconforming product

Purpose: To define and document the procedures specific to the Control of nonconforming
product.

Scope: All processes.

Responsibility: Location MR and related Process Heads / Leaders

Procedure:

1. Documented evidence is maintained to ensure that any product which does not conform to specified
requirements is prevented from inadvertent use. Control for identification is maintained, by putting
‘HOLD’ or ‘Rejected’ labels over such materials. After documentation, evaluation and segregation,
disposition of non-conforming product is dealt with.

2. The concerned departments are informed about the nonconformity. The matter is reviewed and
corrective action to be taken is communicated. The concerned processes or sub-processes are IMS
for incoming material, Production for in-process material and Warehouse Management for finished
material.

3. The responsibility for review of any nonconforming product rests jointly with the quality assurance and
production.

4. Authority for disposition of any nonconforming product lies with following members of the NCP
committee of the respective unit :

 Leader- Quality or Location Quality Assurance in-charge or as per NCP authorization matrix
 Leader- Conversion Process of respective location or as per NCP authorization matrix
 In absence of above, the approval is given by Head Quality Process (India / Egypt) or Managing
Director (Egypt).

5. Any nonconforming product, is disposed by any of the following alternatives :

 The product is re-worked to meet the specified requirements
 Dispatched with customer’s prior consent against written communication from customer or
Business Creation Process.
 Accepted as a special case after getting an undertaking from vendor.
 Re-graded for alternate application.
 Rejected or scrapped.
Note : Acceptance under special concession for raw material is approved by Head Quality or Head
Conversion Process.

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.:
 Galaxy Chemicals (Egypt) S.A.E

Procedure for Control of Document No. APEX/GCE/GMP/MOGP – 5.0

nonconforming product Revision No 04
Issue Date 30.03.2023
Effective Date 05.04.2023
Date of next review 29.03.2026
Page No. 2 of 2
Operating Process : Manual of General Procedures

6. If necessary, product which does not conform to specified requirements, same is reported for
concession to the customer or customer’s representative through the Business Creation
Process. The description of the non-conformity that has been accepted and of re-process, is
recorded to denote the actual condition.

7. Reprocessed or reworked product is re-inspected in accordance with the documented procedures.

8. The records of the activities mentioned above are maintained by the Quality Process.

References:
1. Respective Process / Sub-Process Manual.
2. NCP record
Records: Are maintained by related Process Heads or Process Leaders.

Sr.
Revision No. Date of issue Reason for change
No.

1 0 01.08.2012 Original issue of Document

2 1 01.04.2015 All the documents revised in line with global change of

documentation system.

3 2 01.04.2018 Entire manual revised as per ISO 9001 :2015

requirements.

4 3 01.04.2020 Entire manual revised as per ISO 22716 :2007

requirements.

5 4 30.03.2023
Entire manual issued as per EFfCI GMP requirements

Owned by Approved by Issued By

Leader-Quality Process Head-Quality Process / Managing Director Management Representative

GMP/MOGPMANUAL/30.03.2023 Rev04 Approver’s signature not required unless the document is printed
Copy No.: