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This document outlines the procedure for identifying and controlling potentially unsafe or non-conforming products to prevent their unintended processing or release. It details the responsibilities of various personnel, the steps to address nonconformities, and the importance of maintaining records of actions taken. The procedure includes guidelines for handling nonconforming products at different stages, from raw material inspection to post-delivery actions.

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sandeep
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16 views

DOC.5

This document outlines the procedure for identifying and controlling potentially unsafe or non-conforming products to prevent their unintended processing or release. It details the responsibilities of various personnel, the steps to address nonconformities, and the importance of maintaining records of actions taken. The procedure includes guidelines for handling nonconforming products at different stages, from raw material inspection to post-delivery actions.

Uploaded by

sandeep
Copyright
© © All Rights Reserved
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Title: PROCEDURE FOR CONTROL OF POTENTIALLY

UNSAFE/ NON - CONFORMING PRODUCT


1. PURPOSE
To ensure that product which does not conform to specified requirements is identified and controlled
to prevent its unintended further processing or release for use or delivery.

2. SCOPE
This procedure covers all nonconforming products appearing in raw material, in process and/or in
final products.

3. RESPONSIBILITY
The responsibility for satisfactory performance of this procedure lies with:
a) Head QA has the responsibility to identify & control, and suggest corrective action plan based
on root cause analysis for non-conformity identified.
b) GM- Operations for authorizes the corrective action.
c) Head-QA to verify conformity of the product prior to its release.

4. PROCEDURE
4.1 The organization shall ensure that product which does not conform to specified requirements is
identified and controlled to prevent its unintended further processing or release for use or delivery

4.2 The nonconforming products shall be dealt with the following way:
4.2.1 By taking action to eliminate the detected nonconformity; AND
4.2.2 By authorizing its use, release or acceptance by customer under concession. In such cases a
pre-shipment certificate of analysis and / or pre-shipment sample may be sent to the customer
for approval. OR
4.2.3 By taking action to preclude its original intended use or application for alternative use. OR
4.2.4 Disposition of product in accordance with any relevant regulatory & legislative guidance.
4.3 The organization shall maintain records of the nature of nonconformities and subsequent actions
taken including concession/compensation given.
4.4 When nonconforming product is reprocessed, it is subject to re-verification to demonstrate
conformity to the requirements.
4.5 When nonconforming product is detected after delivery or use has started, the organization takes
action appropriate to the effect, or potential effects, of the nonconformity as per procedure for
product recall.

Title: PROCEDURE FOR CONTROL OF POTENTIALLY


UNSAFE/ NON- CONFORMING PRODUCT

4.6 Nonconforming product may be detected at various stages:

a) Nonconformity identified during incoming raw material inspection,

b) Nonconformity identified during processing,

c) Nonconformity identified during final inspection and testing,

d) Nonconformity identified after delivery or during use of product,

e) Nonconformity identified during quality audits.

4.7 Whenever nonconformity appears at any of the above situations, it shall be identified by status label
and segregated from conforming products. However, this is needed only when reprocessing of the
nonconforming product is not taken up immediately. A Nonconformity, Correction and Corrective
action report (NCR) is generated indicating actions taken.

4.8 Nonconformity, Correction and Corrective action report shall be initiated as per the procedure for
corrective and preventive action.

5. REFERENCES
Procedure for corrective action (N_APX/P/06))

6. RECORDS
Nonconformity, Correction and Corrective action report (N_QA/F/07)

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