Purpose:
The purpose of this procedure is to define the process for reviewing Raw Material Certificates of Analysis (COA) to ensure that the raw materials received meets the required specifications and comply with regulatory requirements.
Scope:
This procedure applies to all raw materials received by the company.
Responsibilities:
The Quality Control (QC) team is responsible for the review of COAs for all raw materials received.
The Procurement team is responsible for ensuring that COAs are received for all raw materials received.
Procedure:
1. Upon receipt of a raw material, the Procurement team will ensure that a COA is received from the supplier.
2. The QC team will review the COA against the specification requirements for the raw material.
3. The QC team will verify that the COA contains all the required information, including the lot number, date of manufacture, expiry date, and test results.
4. The QC team will ensure that the test results meet the specification requirements.
5. If the test results do not meet the specification requirements, the QC team will initiate a Non-conformance report (NCR) and notify the Procurement team.
6. The Procurement team will investigate the non-conformance and take corrective actions as per the company’s standard operating procedures (SOPs).
7. Once the corrective actions have been completed, the Procurement team will provide evidence to the QC team of the actions taken.
8. The QC team will review the evidence provided and approve the raw material for use in production.
Abbreviations:
COA – Certificate of Analysis
QC – Quality Control
NCR – Non-Conformance Report
SOP – Standard Operating Procedure
Documents:
Raw Material COA
Standard Operating Procedures
References:
None
SOP Version:
1.0