Standard Operating Procedure for Handling of Rejected Material in QC Lab

1.0 Purpose:

To lay down a procedure for Handling of Rejected Materials.

2.0 Scope:

The scope of this procedure is applicable to all Raw Material, Packaging Material, Semi – Finished and Finished Product in Quality Control Department.

3.0 Responsibility:

QC-Personnel: To Analyze all Raw Material, Packaging Material, Semi – Finished and Finished Product. To Initiate the Rejection Report.

Head QC/ Designee: To Check the Rejection Report.

Head QA/ Designee: To Approve the Rejection Report.

4.0 Definitions:

5.0 Procedure:

5.1 All materials shall be tested as per their respective specifications.

5.2 In the case of raw materials and packaging material, a copy of the Rejection Report shall be sent to the Purchase Department and Stores. The original copy shall be retained by the Quality Control Department.

5.3 In the case of semi-finished and finished products, a copy of the Rejection Report shall be sent to the Quality Assurance Department. The original copy shall be retained by the Quality Control Department.

5.4 The Manager – QA/Designee shall approve the Rejection Report.

5.5 A Rejection Logbook shall be maintained for raw material, packaging material, semi-finished, and finished products.

5.6 In the case of valid OOS, material/product shall be rejected as per the procedure defined below.

5.7 Raw Material and Packaging Material:

• Raw material and packaging material shall be rejected due to quality issues, defects in packaging, and damaged containers.

• If the material does not comply with the specification, inform the Manager – QA/Designee and Warehouse Department for further necessary action.

• QC personnel shall issue the rejection report from QA.

• Fill out the Rejection Report and mention the details of rejection.

• Enter the details of rejection in the Rejection Logbook.

• After filling out the complete observation in the rejection report, Manager – QC/Designee shall check the compiled data.

• Manager – QA/Designee shall approve the rejection report.

5.8 Finished and Semi-Finished Product:

• Finished products and semi-finished products shall be rejected due to quality issues.

• If the material does not comply with the specification, inform Manager – QA/Designee and Production Department for further necessary action.

• QC personnel shall issue the rejection report from QA.

• Fill out the Rejection Report and mention the details of rejection.

• Enter the details in Rejection Logbook.

• After filling out the complete observation in rejection report, Manager – QC/ Designee shall check the compiled data.

• Manager – QA/Designee shall approve the rejection report.

• The Rejection Report Number shall be assigned as per [Company specific numbering system].

6.0 Acceptance Criteria:

Not Applicable

7.0 Frequency:

As and when required.

8.0 Format for recording:

8.1 Rejection Register for RM, PM, Semi-finished and Finished Product.

Sr. No.	Date	R. R. No.	Material Name	Control No.	Challan No. & Date	Manufacturer & Vendor	Qty. Received	Qty. Rejected	Reason for Rejection

8.2 Rejection Report.

RM/ PM/ SFP/ FP REJECTION REPORT

Rejection Report: ______________ Date: _______________

Name of Material / Product
Item Code / Product Code
Control Number
Batch Number
Quantity Received
Quantity Rejected
Reason for Rejection
Manufacturer
Supplier
Challan No./ Date
Action desired
Initiator Sign
Checked by QC Dept.
Sign of QA Dept.

FOR PURCHASE DEPARTMENT

Action taken :

Sign of Purchase Department

CC : QC / Stores /Purchase Department