1.0 Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidance on the verification of raw materials to ensure that only suitable raw materials are used in manufacturing processes.
2.0 Scope
This SOP applies to all employees involved in the receiving and verification of raw materials at the company.
3.0 Responsibility
Quality Control Department is responsible for verification of raw materials regarding their specification, identification, and suitability for use.
4.0 Procedure
1. Receiving
a. Raw materials must only be received from approved vendors.
b. Upon receipt, the delivery documents must be checked for accuracy and completeness.
c. Raw materials must be kept in a designated area until they are verified.
d. The received raw materials must be registered in a logbook for tracking and reference.
2. Initial Verification
a. The labels and documentation of the raw materials should be checked to confirm that it matches the purchase order.
b. The containers holding raw materials should be checked to confirm the material’s consistency, texture, and color.
c. Any visible damages or defects, such as dents, tears, or cracks on the packaging, should be noted.
d. If there is any deviation from the specifications or if the material appears damaged, the raw material should be quarantined, and the supplier notified.
3. Sampling
a. A representative sample must be taken from each lot/batch of raw materials.
b. Samples should be taken following the written procedure and using appropriate sampling tools.
c. The samples should be properly labeled and stored in a refrigerated or controlled temperature area.
4. Analysis
a. The samples must be analyzed according to the written protocol.
b. The analysis can be conducted in-house or by a contracted laboratory. If the contracted lab is used, the lab should be accredited, and the certificate of analysis should be available for review.
c. The lab analysis or microbiological results of raw material sample should be recorded.
5. Conclusion
a. After analysis, the samples are either accepted or rejected.
b. If the raw material is accepted, it must be properly labeled and stored in the appropriate location.
c. If the raw material is rejected, it must be returned to the vendor or destroyed according to the written procedure.
d. Raw material used for production must also be attached with QA Release label stating the raw material has been verified by the quality control.
5.0 Documentation
All procedures and results must be documented as per the company’s policy.
6.0 Training
All employees carrying out the procedure of Raw Material Verification must be trained in the correct handling, analysis, and documentation procedures required in this SOP.
7.0 Revision
This SOP shall be reviewed every five (5) years or earlier if necessary.
8.0 References
The SOP is based on ISO 9001:2015 requirements for raw material controls, quality standards, guidelines for raw material, certification of analysis, raw material receiving inspection checklist, and batch records.