Handling of return or rejected goods.

1.0 OBJECTIVE

To lay down a procedure for handling of return or rejected goods.

 2.0 SCOPE

This procedure is applicable for handling of return or rejected goods at company.

3.0 RESPONSIBILITY

3.1 Head-Production

3.2 Head-Quality Control

3.3 Head-Quality Assurance

3.4 Head-Warehouse

4.0 PROCEDURE 

4.1 Ensure that all returned products are handled in the following manner 

4.1.1 There are no mistakes in identity for products and batch numbers. 

4.1.2 Defective or substandard products should not get mixed with good products and become liable to be offered for sale. 

4.1.3 The handling and disposition of returned products should not contravene any statutory requirements. 

4.1.4 Complete documentation is available on all operations on returned products from receipt to final disposal. 

4.2 Any goods which have returned from the market for any one of the following reasons are treated as a returned good: 

4.2.1 Returned goods on advice of Drug Control / Regulatory Authorities from the market customers. 

4.2.2 Returned stock from distribution office, due to:

4.2.2.1 Date Expired Products 

4.2.2.2 Damaged of Broken Primary Containers.  

4.2.2.3 Leaky or Broken Seals of Closures of Primary Containers. 

4.2.2.4 Mutilated or smudged labelling rendering the product unidentifiable of its name, or batch number. 

4.2.2.5 Soiled labelling rendering the products unassailable or un-presentable aesthetically, but otherwise clearly identifiable for product name and batch number. 

4.2.3 Returned goods for any voluntary reason.

4.2.3.1 Returned goods for any impairment in analytical report reported by customer. 

4.3 The returned goods will be received by Finished Goods Warehouse. The stock will be placed in the Secured area under lock and key which is adequately segregated and labelled with the reason for return as per the reasons mentioned in above, by Executive or above, Warehouse. 

4.4 Record the returned goods in the register as given the Annexure-1. 

4.5 A description of the condition in which the goods will be entered in the Returned or rejected Good Report by Executive- Finished goods as given in Annexure-2. 

4.6 The returned or rejected goods report will be sent to QA Executive. QA Executive will physically inspect the condition of the returned goods and enter observations in the returned or rejected goods report   and send the report to Head – QA as given in the annexure-3 

4.7 Based on the above observations , Head - QA will decide whether: 

4.7.1Re -Analysis is required to consider for reuse or rectification.

4.7.2  The material should be destroyed. 

4.8 If re-analysis is required, the QA-Executive will send the Returned Good- Assessment Report to QC- Executive for arranging for sampling and analysis of the material. 

4.9 QC will collect sufficient sample (Sufficient to perform 3 analyses) individually from each container if required or a representative sample from all the containers as per the requirement of the parameters to be checked and also send the same sample to the external authorized autonomous Laboratory. 

4.10 The QC will test the material as per the laid down specifications. 

4.11 An analytical Report with relevant details will be prepared by QC Executive as well as by external laboratory to explore the possibilities of consideration for reuse / destruction. 

4.12 Based on the analytical report, Head - QA decides whether the returned good can  be reused or destroyed. 

4.13 If the Head-QA decides the reuse then document the same in the Annexure-4. 

4.14 The Return Good - Assessment Report will be approved by Head - QA. 

4.15 The Report is then sent to the Ware House - Head who will prepare and co-ordinate for the action plans drawn .The action plan should be approved by Head - QA.

4.16 QA will monitor action plan throughout the operations till the returned good is re- worked or disposed off. 

4.17 In case of destruction, the ‘returned goods register  ’ shall be filled in the format and filed with QA along with returned or rejected goods report   . 

5.0 ABBREVIATIONS 

5.1 WH-Warehouse

5.2 QC-Quality Control

5.3 QA-Quality Assurance

6.0  ANNEXURE 

6.1Annexure-1: Returned Goods Register 

6.2 Annexure-2: Returned Or Rejected Goods Report  

6.3 Annexure-3: Goods Inspection Record 

6.4 Annexure-4: Product Release Sheet For Returned Goods