SOP for Raw Material Investigation Procedure
Purpose:
The purpose of the Raw Material Investigation Procedure is to ensure that all incoming raw materials meet the required specifications, minimize the risk of contamination, and prevent the usage of non-conforming raw materials in manufacturing.
Scope:
This SOP applies to all raw materials that are acquired for the manufacturing process.
Responsibilities:
A designated Raw Material Investigator will be designated to conduct investigations on any non-conforming raw materials. This individual will be responsible for conducting the investigation and determining the root cause of the issue.
Procedure:
1. Receipt of Raw Materials: Raw materials will be inspected upon arrival at the facility. Samples will be taken from each material and immediately sent for testing.
2. Testing Raw Materials: All raw materials must meet the predetermined specifications outlined for each product. If any material fails the testing, a report of non-conformance will be created by the Raw Material Investigator.
3. Investigation: The Raw Material Investigator will launch an investigation into any non-conforming raw material. This will include reviewing manufacturing records, conducting interviews with employees, and performing any necessary tests.
4. Corrective Action: After concluding the investigation, the Raw Material Investigator will develop a corrective action plan and share it with all appropriate staff members.
5. Documentation: All testing and investigation results shall be recorded and kept in the company’s database.
Abbreviations used:
N/A
Documents:
– Raw Material Testing Results
– Report of Non-Conformance
– Corrective Action Plan
References:
N/A
SOP Version:
This is the initial version of the Raw Material Investigation Procedure.