1. Purpose
The purpose of this document is to outline the Raw Material Change Control Procedure followed by the organization to ensure that the raw material changes are managed in a structured and controlled manner.
2. Scope
The scope of this procedure covers all the raw materials that are used in the manufacturing of products at the facility. This procedure is applicable to all the departments involved in raw material procurement, storage, testing, and usage.
3. Procedure
The Raw Material Change Control Procedure is to be followed in the following steps:
Step 1: Change Request
Upon identification of a need to change a raw material specification or supplier, the concerned department personnel should complete the Raw Material Change Request form. This form should contain the details of the proposed change, the reason for the change, and the anticipated impact of the change.
Step 2: Review
The completed Raw Material Change Request form is then forwarded to the Change Control Committee (CCC) for review. The CCC will review the request and assess the potential impact of the change on the product quality and regulatory compliance. The review will include an assessment of alternative materials, suppliers, and impact on the manufacturing process.
Step 3: Approval
Upon approval
Step 4: Implementation
The implementation of the approved change will be initiated by the concerned department personnel. A plan should be developed for the implementation of the change, which should include the necessary testing and validation processes. The raw material supplier should also be informed of the change and the associated requirements for documentation, testing, and quality control.
Step 5: Verification
Upon implementation of the change, a verification process will be carried out to ensure that the change has been implemented as planned and expected. The results of the verification will be documented and reviewed by the CCC.
4. Documentation
All the steps involved in the Raw Material Change Control procedure should be documented. The following documents are to be maintained as a part of this procedure:
– Raw Material Change Request form
– Raw Material Change Control form
– Change Control Committee meeting minutes
– Verification report
5. Training
All the personnel involved in the Raw Material Change Control procedure should be adequately trained. The training should include an understanding of the importance of the procedure, the methods involved, and the documentation requirements.
6. Review
The Raw Material Change Control Procedure should be reviewed periodically by the Change Control Committee to ensure its continued suitability, effectiveness, and compliance with the applicable regulatory requirements.
7. Conclusion
The Raw Material Change Control Procedure ensures that any changes in raw materials used in the manufacturing process are managed in a structured and controlled manner. This approach helps to eliminate the risk of product quality issues and helps to maintain regulatory compliance.