sop for non conformance of RM PM and finished product
1.0. OBJECTIVE:
The objective of this SOP is:
1.1 To describe a procedure for Handling of Non Conformance (NCR) of Raw Material (RM) / Packaging Material (PM) and Finished Product (FP).
1.1.1 Raw material / finished product which conforms to Regulatory specifications but does not conform to in house specifications.
1.1.2 Non- critical defects in packaging material, which does not affect finished product quality.
2.0. RESPONSIBILITY:
2.1 Head of the Concerned Department shall be:
2.1.1. Responsible for Non-Conformance report.
2.2 Quality Assurance shall be:
2.2.1 Responsible for investigating and approving the Non-Conformance Report.
3.0. ACCOUNTABILITY:
Head – Quality Assurance
4.0. PROCEDURE:
4.1 On receipt of the rejection test reports of the Raw material / Packaging materials / Finished products from
the Quality Assurance Dept., the Dept. Head of the affected Department shall decide whether a request can be made for review of rejection decision.
4.2 The request for review shall be made in triplicate in Non- conformance Report (NCR) as per Annexure – 1
4.3 The Head of the affected Dept. or his representative shall specify the reason (s) for review in the NCR. The affected Dept. shall
send the NCR to General Manager for his recommendation to.
4.4 Quality Assurance – Head shall decide to Accept or Reject the NCR based on the risk evaluation.
4.5 If necessary, Quality Assurance – Head before taking the final decision may consult Research & Development Head / President – Technical Operations.
4.6 On absence of Quality Assurance Head, President – Technical Operations shall decide to Accept or Reject the NCR.
4.7 The NCR shall be distributed for final disposal as under, the original NCR shall be filed in the Documentation room
along with the QC report of the respective Batch / AR no.
4.8 One photocopy shall be forwarded to the Head of the originating Dept. for reference.
4.9 One photocopy shall be retained by QA for Annual Product Review.
5.0. REASON FOR REVISION:
This SOP is revised due to revision due date.
6.0. TRAINING:
Trainer — Head – Quality Assurance
Trainee — All departmental heads / Quality Assurance Personnel
Period — One day
7.0. DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 4 : Head of Department – Warehouse
Certified Copy No. 5 : Head – Plant Operations
Original Copy : Head – QUALITY ASSURANCE
8.0. ANNEXURE:
Nil.
9.0. REFERENCE:
In-House
ANNEXURE – 1
FORMAT FOR NON-CONFORMANCE REPORT
NON-CONFORMANCE REPORT
(For Non-Regulatory Reasons Only)
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