1. Purpose of Retesting Schedule of Raw Material
The purpose of this Standard Operating Procedure (SOP) for Retesting Schedule of Raw Material is to establish guidelines and procedures for determining the retesting schedule of raw materials used in [Company Name]’s production processes. This SOP for Retesting Schedule of Raw Material ensures that raw materials consistently meet quality standards and comply with regulatory requirements.
2. Scope of Retesting Schedule of Raw Material
This SOP for Retesting Schedule of Raw Material applies to all personnel involved in the procurement, testing, and quality control of raw materials within [Company Name]. It encompasses procedures for assessing raw material stability, establishing retesting intervals, and maintaining accurate records.
3. Definitions involved in Retesting Schedule of Raw Material
3.1 Raw Material:
Any substance or component used in the manufacturing of products before any processing or conversion.
The process of periodically assessing the quality and suitability of raw materials to ensure compliance with established specifications.
3.3 Retesting Schedule:
The predetermined frequency at which raw materials are subjected to retesting.
4.1. Quality Control Manager
4.1.1 Oversee the implementation of the raw material retesting schedule.
4.1.2 Approve deviations from established retesting schedules based on risk assessments.
4.2. Procurement Officer
4.2.1 Provide procurement data and information to support the retesting schedule.
4.2.2 Collaborate with suppliers to obtain necessary documentation related to raw material stability.
4.3. Laboratory Analysts
4.3.1 Conduct testing and analysis of raw materials in accordance with the retesting schedule.
4.3.2 Report any deviations from specifications to the Quality Control Manager.
5. Raw Material Retesting Schedule
5.1. Initial Stability Assessment
5.1.1 Upon the receipt of a new raw material, conduct an initial stability assessment.
5.1.2 Consider factors such as storage conditions, supplier history, and regulatory requirements when determining the initial retesting frequency.
5.2. Establishment of Retesting Frequency
5.2.1 Determine the retesting frequency based on the initial stability assessment.
5.2.2 Utilize relevant industry guidelines and regulatory requirements as references.
5.3. Retesting Intervals
5.3.1 Establish clear retesting intervals, which may vary depending on factors such as material type, criticality, and stability data.
5.3.2 Document the retesting intervals for each raw material.
6. Deviations and Adjustments
6.1.1 Document any deviations from the established retesting schedule.
6.1.2 Investigate and assess the impact of deviations on product quality.
6.2.1 Adjust the retesting schedule as needed based on investigation outcomes, stability data, or changes in regulatory requirements.
6.2.2 Ensure that adjusted schedules are reviewed and approved by the Quality Control Manager.
7. Record Keeping
7.1.1 Maintain accurate records of raw material retesting schedules, results, and any deviations or adjustments.
7.1.2 Retain records for the specified retention period in compliance with regulatory requirements.
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