Essential Elements of Process Control and Quality Assurance

Process Control Elements

Raw Materials Management

Raw materials required for the process must be as specified in the transaction records, with checks on their source, condition, quantity, and production/receipt date. All details should be properly registered.

Labor Force and Training

Every process, regardless of its degree of automation, involves a quantitative and qualitative workforce component, which may be more or less specialized. The workforce employed in a process must be educated and trained in operations. They must be able to distinguish a good product from one that is not, know how to react to non-conformities, and maintain relevant operational records. Personnel can range from trainees requiring strong supervision to highly experienced staff with sufficient knowledge to train new operators.

Standardized Work Methods

Operations should not be arbitrary. Instead, they must follow established benchmarks and indicators outlined in the operational procedures, ensuring consistent results through repeatable actions. The method specifies the sequence of actions within an operation and the number of operators required.

Machinery and Equipment Checks

Machines and tools specified in the process documentation must be used. Before starting a process, the operator must perform a quick check, sometimes called a "dry run" or "pre-operational check." This verifies that the equipment is operable, free from strange noises, overheating, or leaks of liquids and gases, and that any necessary purging or cleaning has been completed.

Chemical Laboratory Sampling Protocols

1. Suitable statistical design for sample acquisition.
2. Required instruments for sample collection.
3. Design for sample preservation and transport.
4. Specific training for sampling personnel.
5. A written sampling plan to ensure quality results.
6. Verification of compliance with the above.

Key Considerations for Sampling

1. When, where, and how to collect samples.
2. Sampling equipment: inventory, calibration, and maintenance.
3. Sample containers: cleaning, stabilization, labeling, etc.
4. Sample transport.
5. Exclusion criteria for foreign objects.
6. Pre-treatment of samples (drying, blending, etc.).
7. Sub-sampling (only if necessary).
8. Laboratory information system (labels, forms, etc.).