1.0 OBJECTIVE
To lay down a procedure for Rejection of Raw Materials and Packing Materials
2.0 SCOPE
This procedure is applicable to all Raw materials and Packaging materials that are analyzed and rejected in Quality Control .
3.0 RESPONSIBILITIES
Executive/ Officer QC shall be responsible for the Rejection of Raw Materials and Packing Materials
Head-QC/ Designee shall be responsible for review and ensuring compliance of Standard Operating Procedure.
4.0 DISTRIBUTION
Master copy : Quality Assurance Department
Controlled Copy – 1 : Quality Control Department
5.0 PROCEDURE
Team leader/Executive shall initiate the rejection procedure for raw materials and packing materials if the material is found out of specification.
- QC Executive/officer shall prepare the rejection report .
- QC executive/officer shall refer the GRN and Certificate of Analysis to prepare the rejection report.
- QC will issue the rejection report for raw and packaging material on the basis of physical verification during sampling, out of specification results and on-line rejection.
- QC executive/officer shall assign the rejection report no as follows:
- WWW/XX/YYY/ZZ-001,
- Where WWW represents Company.
- XX represents the rejected material. PM for Packing material ,RM for Raw material
- YYY represents the running serial number for the rejection report beginning with 001 at the start of each year.
- ZZ represents the last two digits of the year.
- Rejection report of material shall be record as per Annexure-2
- Team leader/Executive QC shall take approval of Head-QC/designee and authorization of Head quality/designee on the rejection report.
- A “REJECTED” label shall be affixed on the rejected material.
- Attach a copy of the rejection report to the analytical data sheet.
- A copy of the rejection report for raw and packaging materials shall be shared to QA and warehouse.
6.0 ANNEXURES
Annexure-1 : Rejection Report for Raw materials and Packaging materials.
Annexure-2 : Rejection Logbook.
7.0 ABBREVIATIONS
QC-Quality Control
QA-Quality Assurance
GRN- Good Receipt Note