Product Recall

PURPOSE

• The purpose of this SOP is to describe the procedure for product recall from the customer end in case of any emergency.

SCOPE

• This procedure is applicable to all products manufactured by Shakambhari Ispat & Power Ltd.

REFERENCE(S) & ATTACHMENTS

• References
  • In-house
• Attachments
  • Attachment I: Mock Recall Format - SIPL/QAS/010/F01/00

RESPONSIBILITY

• Head-QA – to initiate and inform statutory bodies if required.
• Production and QA – to investigate.
• Sales – to discuss the matter with clients.

DISTRIBUTION

• Quality Assurance
• Quality Control
• Production

DEFINITION(S) & ABBREVIATION(S)

• Definitions
  • Recall: to enable and facilitate the complete and timely withdrawal of lots of end products which have been identified in point 7.1 of this procedure.
• Abbreviations
  • QA: Quality Assurance
  • QC: Quality Control
  • SOP: Standard Operating Procedure
  • cGMP: current Good Manufacturing Practices

PROCEDURE

• Product recall will be considered under the following circumstances:
  • Mislabelling of the product.
  • Contamination, which may cause serious hazards.
  • Recall ordered by any regulatory agencies due to any specific reasons.
  • Recall necessitated due to product not conforming to the quality attributes.
  • Mix-ups of different items.
• Evaluation of the information: Head QA will evaluate the information and initiate investigation into the complaint as per SOP No. SIPL/QAS/005/01 'Customer Complaint Handling', comprising:
  • Re-evaluation and retesting of the retained sample.
  • Review of BPR and testing & release documents.
  • Send, if required, QA / marketing personnel to the complainant to ascertain the facts.
• After obtaining the approval, Head QA will inform the Marketing & Warehouse departments about the decision to recall the product.
• Head QA will immediately advise the Marketing / Warehouse department to hold further distribution and/or sale of the product and batch(es). Speedy and clear directives to this effect shall be given to all concerned with the distribution. Marketing will in turn inform the customer about the same.
• Head QA will draw a time frame for recalling the product in consultation with the Managing Director and Operation Head.
• The Warehouse department shall reconcile the quantity of the recalled product against the quantity dispatched. This shall be verified by QA. The recalled product shall be kept under quarantine until the entire sold / unsold quantity is received.
• QA / Production shall carry out a detailed investigation on the recalled product to ascertain the reasons. After completion of the investigation, the decision to destroy / retest / reprocess / re-sort the recalled product shall be taken in consultation with the Managing Director. The re-labelling, re-sorting or disposal of the recalled product shall be carried out, and this shall be monitored by QA.
• Handling of the recalled products: Reason for Recall Handling Method Mislabelling of the product Re-label under supervision of QA personnel and document the details. Mix-up / Contamination % sorting of the material under supervision of QA personnel and document the details. Product not conforming to quality attributes or specifications Destroy the material under supervision of QA, take approval from statutory bodies wherever required, and document the details.
• Mock Recall
  • Head QA will initiate a mock recall to check the preparedness of the recall procedure. The following persons will take part in the mock recall process:
    • Operation Head
    • Head QA / Sr. Executive Quality
    • QC In-charge
    • Head Production
    • Head Dispatch
  • Time limit: the time limit to complete the mock recall will be 2 hours from the time of announcement.
  • Mock recall shall be carried out once in a year. Records of mock recall will be kept.

REVISION HISTORY

Revision No.

Effective Date CC No. Details of revision: New SOP