1. Purpose:
The purpose of this Standard Operating Procedure is to establish a Raw Material Traceability Procedure that ensures traceability of all raw materials used in the manufacturing process.
2. Scope:
This SOP applies to all raw materials used in the manufacturing process, including but not limited to raw materials received from suppliers, in-process materials, and finished products.
3. Responsibilities:
The Quality Assurance Department is responsible for implementing this procedure and ensuring compliance by all personnel involved in the handling and use of raw materials.
4. Procedure:
4.1 Raw Material Identification:
All incoming raw materials must be identified with a unique code or batch number that provides traceability throughout the manufacturing process. The identification system must be approved by the Quality Assurance Department.
4.2 Raw Material Storage:
All raw materials must be stored in designated areas that are clearly labeled with the name of the material, the date of receipt, and the batch number. Raw materials must be segregated from each other to prevent cross-contamination.
4.3 Raw Material Usage:
Once a raw material has been issued for use, the Production Department must record the material’s batch number and quantity used in the batch record.
4.4 Recording of Usage:
Every production batch must have clear documentation indicating which raw materials were used in the process and their corresponding batch numbers. This documentation must be kept by the Production Department and made available to the Quality Assurance Department upon request.
4.5 Traceability:
If a quality issue arises during the manufacturing process, the Quality Assurance Department must be able to trace the affected batch number of the raw material back to the supplier and the specific lot number received.
4.6 Quarantine Procedures:
Any raw materials that have been identified as non-conforming must be placed in quarantine and isolated from all other materials until their disposition has been determined by the Quality Assurance Department.
4.7 Disposition of Non-conforming Raw Materials:
Non-conforming raw materials must be evaluated by the Quality Assurance Department to determine their disposition. The disposition may be to return the materials to the supplier or to discard them following appropriate procedures.
5. Records:
All records generated as part of this Raw Material Traceability Procedure must be maintained according to the company’s document control procedures.
6. Training:
All personnel involved in the handling, storage, and use of raw materials must be trained on this procedure and its importance in maintaining product quality.
7. Conclusion:
Following this SOP ensures traceability of all raw materials used in the manufacturing process. This procedure provides an effective tool to prevent non-compliance, minimize production losses, and protect consumer safety. The Quality Assurance Department is responsible for ensuring compliance with this SOP.