STANDARD OPERATING PROCEDURE FOR PRODUCT RECALL

1.      Purpose:

1.1.The purpose of this document is to define procedure for product recall.  

2.      Scope:

2.1.It is applicable to head office and quality control departments.

3.      Responsibility:

3.1.Quality Control Manager

3.2.Quality Assurance Manager

3.3.Production Manager

4.      Procedure:

4.1. Quality assurance Department is responsible for follow up of Product Recall procedure.

4.2. QA dept.  Personnel receive the complaint from the head office, enter in complaint register, and issue a complaint number.

4.3. QA manager forwards the complaint to Quality Control Department.

4.4.  Quality Control Personnel analyze the product from the retained sample of the same batch and samples (5) of the same product from different customers/distributors to verify the complaint (Request for Analysis, Ref. Format # G/F/28).

4.5. If the complaint is verified as genuine then procedure A shall be followed and if the complaint is verified as false procedure B shall be followed.

4.5.1.       Procedure A:  if the complaint is genuine, SOP for product recall should be recommended by the QCM.

4.5.2.       Procedure B: if the complaint is false, Quality Control Manager issues a letter to the complainant, regarding non liability of the product quality to the company.

4.6. If the complaint is genuine and changes in the product have occurred then meeting of the head of Production, Quality Control and Quality Assurance Department shall be called upon and matter shall be discussed.

4.7. Decision on recall of product shall be taken and final approval shall be taken from Managing Director.

4.8. QA dept. shall forward the approved request of recall to the head office and inform Regulatory Authority.

4.9. Head office shall perform the following procedures for product recall:

A.     Inform distributors to collect the stock from retail outlets.

B.     Advertisement in print media.

C.     Prompt follow up of product recall.

4.10.  Head office shall provide a summary report of product recall to the QA department.

4.11.  Stock returned shall be counted and verified by QA dept.

4.12.  Destruction note shall be issued by the recall committee.

4.13.  Verification of product destruction shall be done by QA Dept. as per relevant SOP.

4.14.  Product Recall record shall be recorded in the product recall form (Ref. Format G/F/101) by the QA Officer.

4.15.  All record of product recall & destruction shall be maintained by Quality Assurance department.

5.      Attached Documents

5.1. Product Recall form