SOP: Raw Material Rejection Procedure
1. Purpose:
The purpose of this SOP is to define the procedure for the rejection of raw materials that do not meet the required quality standards. This is to ensure that only high-quality materials are used in the manufacturing of products, thereby meeting customer requirements and improving product quality.
2. Scope:
This SOP is applicable to all raw material acceptance personnel, quality assurance personnel, and manufacturing personnel involved in the acceptance of raw materials and the production of products.
3. Responsibilities:
a. Raw material acceptance personnel are responsible for quality-checking incoming raw materials and identifying any discrepancies with the specifications.
b. Quality assurance personnel are responsible for approving or rejecting raw materials based on the provided specifications.
c. Manufacturing personnel are responsible for ensuring that only approved raw materials are used in the production of products.
4. Procedure:
a. Raw material acceptance personnel must conduct the necessary quality checks on the incoming raw materials against the provided specifications.
b. Any discrepancies identified must be recorded and reported to the quality assurance personnel.
c. The quality assurance personnel must then conduct a thorough examination of the raw materials and decide whether to accept or reject the material.
d. If the raw material is rejected, a Non-Conformance Report (NCR) must be raised, and the supplier must be informed.
e. The rejected raw material must be appropriately labeled and returned to the supplier according to the agreed return policy.
f. If the raw material is accepted, the raw material acceptance personnel must transfer the raw material to the manufacturing facility.
g. The manufacturing personnel must only use approved raw materials for the production of products.
5. Abbreviations:
NCR – Non-Conformance Report
6. Documents:
There are no specific documents required for this SOP.
7. Reference:
This SOP complies with the current Good Manufacturing Practices (CGMP) and the guidelines of the International Organization for Standardization (ISO).
8. SOP Version: 1.0