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Control of Non-Conforming Products Procedure

This SOP establishes methods for controlling non-conforming products from identification to disposal. It applies to non-conforming products identified during and after production. The QA manager is responsible for overseeing the process which includes submitting a non-conformance report, evaluating if rework, customer concession or discard is appropriate, and initiating corrective actions to prevent future issues. Non-conforming products must be clearly identified, addressed promptly and handled according to applicable regulations.

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Solomon Gamanuel
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998 views

Control of Non-Conforming Products Procedure

This SOP establishes methods for controlling non-conforming products from identification to disposal. It applies to non-conforming products identified during and after production. The QA manager is responsible for overseeing the process which includes submitting a non-conformance report, evaluating if rework, customer concession or discard is appropriate, and initiating corrective actions to prevent future issues. Non-conforming products must be clearly identified, addressed promptly and handled according to applicable regulations.

Uploaded by

Solomon Gamanuel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SOP for Control of Non-Conforming Products

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
The purpose of this procedure and its related instructions is to establish the methods employed for
controlling non-conforming product starting from segregation to its final disposal.
2. Scope
This procedure is applicable to any non-conforming product identified both in process and at the final
stages before and after delivery.

3. Validity
This SOP is valid only until next revision date and if it bears control seal

4. Responsibility
QA manger
5. Material and Equipment
None
6. Procedure
6.1. Non-conformance report can be submitted by anyone who has identified the non-
conforming product(s). The product shall be immediately identified by suitable means
and segregated in order to prevent unintentional use or delivery.
6.2. Identification of Non conforming (NC) product is the result of one or more of the
following reasons.
- Failure of product to comply with the specification as a result of QC
testing.
- Routine IPQA process monitoring
- Routine supervision of production staff like managers, Production
Pharmacist, supervisors etc.
- Compliant from customer
6.3 QA personnel pastes “NC Product” slips on each container/bag of the product
6.4 If NC product belongs to R&D upscale batch then R&D manager pastes “NC Product”
slips on each container/bag of the product & segregates from other products.
6.5 Once the non-conforming product has been identified it shall be registered into a Non-
conforming Product Registration Form by QA personnel.
6.6 The nature and the extent of the non-conformity shall be described by assigned and
competent team against specified requirements for the product. The team member
consists of experts from QA and production departments.
6.7 The non-conforming product shall be evaluated whether the non-conforming can be
eliminated by rework, delivered to customers by concession or discarded.
6.8 The non-conforming product shall be delivered to the customer only when the customer
has full understanding on the nature and extent of non-conformity of the product and
agrees to accept by concessions.
6.9 Delivery decision shall be made by the Quality Assurance and Production Departments.
6.10 The non-conforming product shall be reworked to the extent of fully complying with
the pre-determined requirements.
6.11 If the customer rejects concession, the product shall be discarded immediately.
During discarding, all procedure set by food, medicine and health care administration and
control authority shall be followed.
6.12 After re-working on the non-conforming product it shall be verified for full
conformance with pre-determined requirements.
6.13 Corrective action shall immediately be initiated in order to prevent its re-occurrence.
6.14 Follow the standard operating procedure for product Recall (SOP/ /QA/006) if the
compliant is raised from customers.
6.15 If non-conformance occurs when the product is within the finished goods store, the
QA department shall post a label clearly indicating that this products are Non-
Conforming.

6. Abbreviations:
 SOP Standard Operating Procedure
7. Related Documents /Applicable document/

Related
Title
Documents.
SOP/QC/006 SOP for Product Recall

8. Revision History

Version
Revision Description
No.
1 New

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