Title: Raw Material Change Request Procedure
Purpose:
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting and evaluating raw material changes in compliance with regulatory requirements and company quality standards.
Scope:
This SOP applies to all personnel involved in raw material change requests, approval, evaluation, and implementation at [Company Name].
Responsibilities:
The following responsibilities are defined in raw material change request procedure:
– The requester is responsible for submitting a change request and providing complete information regarding the raw material and the reason for the change request.
– The Quality Assurance (QA) department is responsible for evaluating the change request, determining potential risks, and ensuring that the proposed raw material meets the company’s quality standards.
– The Production department is responsible for implementing the approved raw material change with minimum impact on the production process.
Procedure:
1. Raw Material Change Request Submission:
– The requester shall complete and submit a Raw Material Change Request Form, including all necessary information regarding the proposed raw material change.
– The requester shall provide supporting documentation, such as supplier certifications, test results, and other relevant information to support the request.
2. Raw Material Change Request Evaluation:
– The QA department shall review the raw material change request and supporting documentation to determine the potential impact of the change on the product quality and performance.
– The QA department shall assess the potential risks and determine the need for additional tests and evaluations, such as stability testing, compatibility testing, and other relevant tests.
– The QA department shall document all evaluations and assessments in the Raw Material Change Request Evaluation Sheet.
3. Raw Material Change Request Approval:
– The QA department shall provide the approved raw material change request to the Production department.
– The Production department shall implement the approved raw material change in compliance with established procedures.
– The QA department shall monitor and document the implementation process.
Abbreviations Used:
QA – Quality Assurance
SOP – Standard Operating Procedure
Documents:
– Raw Material Change Request Form
– Raw Material Change Request Evaluation Sheet
Reference:
– Relevant regulations and guidelines.
– Company quality standards.
SOP Version Number: 1.0
Effective Date: [Date]