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SOP Control of Nonconforming Product

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20 views1 page

SOP Control of Nonconforming Product

Uploaded by

gadha peter
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GENIUS ORTHO Document No.

: QA/OP/019

Issue No.: 01
SURVEY NO 281/4, PLOT NO 1/2, NR.
UMIYA INDUSTRIAL ZONE 3, RIBDA,
Rev. No.: 00
RAJKOT, GUJARAT, 360311
Effective Date: 01/04/2018
TITLE: SOP CONTROL OF
Review Date: 01/04/2018
NONCONFORMING PRODUCT
Page No.: 1 of 1

Purpose This ensures effective management of products that do not meet specified
requirements, preventing unintended use or delivery, while maintaining
regulatory compliance and product quality standards.
Scope This covers the identification, control, documentation, and management of
nonconforming products, including processes for rework and concession.
Responsibility Q. C. Manager / Q. A. Manager / Departmental Head /

Procedure
1. Identification and Control:
o Identify and control nonconforming products to prevent unintended use or delivery.
o Define controls, responsibilities, and authorities in a documented procedure.
2. Actions for Nonconforming Products:
o Eliminate Nonconformity: Take action to address the detected nonconformity.
o Concession: Authorize use, release, or acceptance under concession if regulatory
requirements are met. Maintain records of authorization.
o Preclude Intended Use: Prevent the nonconforming product from its original
intended use or application.
3. Documentation and Records:
o Maintain records of nonconformities, actions taken, and any concessions granted.
o Document the identity of personnel authorizing concessions and the nature of
nonconformities.
4. Rework:
o Document the rework process in a work instruction, which must undergo the same
authorization and approval as the original work instruction.
o Evaluate and document any potential adverse effects of rework on the product.
5. Post-Delivery Nonconformities:
o If nonconforming products are detected after delivery or use has started, take
appropriate action based on the effects or potential effects of the nonconformity.

Function Prepared By Reviewed By Approved By

Designation

Signature

Date

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