1.0 Purpose:
The purpose of this Standard Operating Procedure (SOP) is to establish a Raw Material Specification Review Procedure to ensure that all raw materials received by our organization are within the defined specifications as per the supplier’s product data sheet and meet the intended use of our products.
2.0 Scope:
This procedure applies to all raw materials used in the manufacturing process.
3.0 Responsibilities:
• Quality Control Department is responsible for reviewing the specification of the raw materials.
• Procurement Department is responsible for obtaining the product data sheet from the supplier.
4.0 Procedure:
1. Procurement Department shall obtain the product data sheet for all raw materials from the supplier at the time of purchase.
2. Quality Control Department shall review the product data sheet of the raw material for its specifications.
3. The following parameters shall be reviewed for each raw material:
• Physical and Chemical Properties
• Appearance
• Solubility
• pH Value
• Identity
• Purity
• Microbial Contamination
• Heavy Metals
• Pesticides Residue
• Shelf-Life
4. If the raw material specification meets the required quality parameters, the Quality Control Department shall release the raw material for use.
5. If the raw material specification is not meeting the required quality parameters, the Quality Control Department shall reject the raw material and notify the Procurement Department of the non-conformance. Procurement Department shall contact the supplier for a replacement or refund.
6. If there is no product data sheet available for a raw material, the Quality Control Department shall take a sample of the material and send it to an accredited laboratory for testing.
7. The results of the laboratory test will determine whether the raw material meets the required quality parameters or not.
8. All raw material specification record shall be maintained by the QC Department for a minimum period of five years.
5.0 Revision History:
This SOP shall be reviewed and updated as necessary by the Quality Control Department to ensure continued accuracy and effectiveness.
