Quality Process Plan
1. Product Specifications
Communicate with clients and determine their requirements. Receive purchase orders from the client and create work orders. Samples can be tested by the client for final confirmation.
2. Operations Management and Planning
Coordinate with operations and procurement departments to secure raw materials and initiate production processes.
3. Raw Material Quality Control
Inspect raw material quality according to raw material specifications and inspection plans. Ensure compliance with import health requirements, including the quality certificate, raw material conformity certificate, and program documentation.
4. Warehouse Management
Implement and monitor warehouse health requirements.
5. Production Stage(s)
Verify quality and conformity to client specifications through laboratory testing and the final product inspection plan. Quality checks are conducted separately at each production stage.
6. Quality Control and Assurance
Review daily production reports, implement production instructions for each stage, and verify GMP compliance.
7. In-Process and Laboratory Quality Control
In-Process quality tests are conducted at the beginning of production and continuously throughout each production stage according to inspection plans. All tests are subject to final confirmation through laboratory testing.
8. Packaging and Labeling of the Finished Product
Pack finished products onto pallets according to customer specifications. Label each product to identify the job number, production date, batch number, and production and quality personnel.
9. Storage in the Finished Product Warehouse
Follow instructions for storage and segregation of different types. Implement and monitor health requirements and execute shipping and loading plans.
10. Shipping to the Customer’s Warehouse
Inspect quality before shipment to ensure compliance with specifications and health requirements. Attach the Certificate of Analysis (CAA) and FDA approval when required. Inspect shipping trucks or containers to ensure compliance with health requirements and adherence to shipping and handling instructions.
