1. Purpose of Raw Material Release
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the release of raw materials for use in manufacturing processes within [Company Name]. This procedure ensures that all incoming materials meet quality standards and regulatory requirements before use.
2. Scope of Raw Material Release
This SOP applies to all personnel responsible for receiving, inspecting, and releasing raw materials within [Company Name]. It encompasses procedures for inspection, sampling, testing, and documentation.
3. Definitions involved in Raw Material Release
3.1 Raw Material:
Any substance or component intended for use in the production of finished products.
3.2 Quality Control (QC):
The department responsible for assessing and ensuring the quality of raw materials and finished products.
4. Responsibilities
4.1. Receiving Personnel
4.1.1 Inspect incoming raw materials for visible damage, contamination, and adherence to shipping documentation.
4.1.2 Notify the QC department of any discrepancies or issues with received materials.
4.2. Quality Control (QC) Personnel
4.2.1 Perform sampling and testing of raw materials based on predefined specifications and testing protocols.
4.2.2 Approve or reject raw materials based on test results and quality standards.
5. Raw Material Inspection and Testing
5.1. Visual Inspection
5.1.1 Conduct a visual inspection of each incoming raw material container or package.
5.1.2 Look for signs of damage, contamination, or improper labeling.
5.2. Sampling
5.2.1 Follow approved sampling procedures to obtain representative samples of raw materials.
5.2.2 Ensure proper labeling and handling of samples to maintain integrity.
5.3. Testing
5.3.1 Perform required tests on sampled raw materials using approved analytical methods and equipment.
5.3.2 Record test results and compare them to established acceptance criteria.
6. Raw Material Release Process
6.1. Release Decision
6.1.1 QC personnel review the inspection and testing results to make a release decision.
6.1.2 Approve the release of raw materials that meet all quality criteria.
6.1.3 Reject materials that do not meet specifications, and follow the defined non-conformance process.
6.2. Release Documentation
6.2.1 Document the release decision, including approval or rejection, and record the batch/lot numbers.
6.2.2 Maintain release records in a secure and organized manner.
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