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SOP for Handling of Returned Material / Products

PURPOSE
To Lay down systematic procedure to establish handling of returned material/ products from market.

SCOPE
This method is applicable for the handling of returned material/products from market.

RESPONSIBILITY
Production Head / Tech. Director/ Head Quality Assurance

ACCOUNTABILITY
Head Quality Assurance

PROCEDURE
  • Any material or goods (Finished products &/or intermediates) returned from the market shall be stored in a separate area dedicated for storage of returned goods.
  • Record all the details in Returned Goods Record, as per the Annexure-II.
  • Inform the Quality Assurance department for evaluation of the returned goods.
  • The Quality Assurance chemist shall evaluate the returned goods for the following:
  1. Check the COA and other documents with the returned consignment.
  2. Condition of the Packaging, carton and container.
  3. Labeling details.
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  • If the returned materials has exceeded the labeled expiry period &/or the condition of the packaging, carton, container and storage condition of the material before returning/ shipping are doubtful, then destroy thematerial as per the XXX/SOP/QA/014 for control sample destruction.
  • If none of the above condition is apparent, then sample the material as per the XXX/SOP/QA/013 for sampling of the FG.
  • Analyze the sample as per the current approved product specification. If the product meets appropriate product specification, then the returned material/ product may be considered for reprocessing as per the SOP for reprocessing, provided the subsequent product meets the product specification.
  • In case the sample fails to meet the product specification, destroy the material/product as per the SOP for destruction, and initiate failure investigation.
  • Identify the batches manufactured during the same period &/or manufactured by using the same RM’s.Extend the investigation to these batches also.
  • Refer flow chart for handling of the returned material/ products as per Annexure I.
REFERENCES
NIL

ANNEXURES
Annexure I - FLOW CHART OF HANDLING OF RETURNED MATERIAL/PRODUCT
Annexure II - RETURNED MATERIAL/ PRODUCT RECORD

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ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
COA : Certificate of Analysis
FG : Finished good

REVISION HISTORY
Nil

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