1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the risk assessment procedure of raw materials used in the production of products to ensure the safety, quality and legality of the final products.
2.0 Scope: This procedure applies to all raw materials used in the production of products at [Company Name].
3.0 Responsibility: The Quality Assurance (QA) department is responsible for the implementation and maintenance of the Raw Material Risk Assessment Procedure.
4.0 Procedure:
1. Raw Material Evaluation: The QA team shall evaluate the raw material used in the production of products based on the following parameters:
a. Regulatory compliance – The raw material must be in compliance with local and international regulations and standards.
b. Source of the raw material – The source of the raw material must be from reputed suppliers with a good track record.
c. Physical and chemical properties- The physical and chemical properties of the raw material must be analyzed to ensure that it is appropriate for the intended use.
d. Safety data sheets – The supplier must provide a safety data sheet for each raw material used.
2. Identify potential risks: Based on the evaluation, the QA team shall identify potential risks associated with the raw material used. Risks may include contamination, adulteration, or mislabeling.
3. Conduct a Risk Analysis: The identified risks shall be analyzed for the likelihood of occurrence and severity of consequences. This helps determine the risk level.
4. Determine risk level: The QA team shall determine the risk level for each potential risk, and categorize them into high, medium, or low risk based on the probability of occurrence and severity of consequences.
5. Develop and implement risk mitigation strategies: The QA team shall develop and implement risk mitigation strategies for each identified risk. Strategies may include testing the raw material for contaminants or verifying the supplier’s certification.
6. Review and update: The Raw Material Risk Assessment Procedure must be reviewed periodically to ensure its effectiveness and update it if necessary.
Conclusion: By adhering to this Standard Operating Procedure, we will ensure that raw materials used in the production of products are of high quality, safe, and compliant with regulatory standards.
