Operator Techniques in Manufacturing
While working through a cause-and-effect diagram, one often missed aspect is the operator technique. For example, a procedure might say “apply detergent” or “use sanitizer” as part of the operator's tasks. Other parts of the procedure would likely specify the exact materials to be used as detergent or sanitizer. It may also include details like a mixture ratio for dilution or a required hold time for effective surface contact. The specific amount of application may be left to operator judgment, influenced by which aspect of good manufacturing practice the operator prioritizes.
In one scenario, you might have an operator like Mr. Spritzer who aims to minimize time and material costs, applying just enough for the task. In contrast, another operator like Ms. Deluge may prioritize cleaning or sanitization effectiveness, applying a bit more with a safety margin. Depending on business and product risks, either Mr. Spritzer's or Ms. Deluge's approach could be suitable. However, without clear procedural definitions, variability could arise. This variability might lead to business risks due to high material costs or compliance risks due to contamination carryover. Understanding the process thoroughly helps pinpoint areas where risks can be mitigated or where additional controls are necessary.
Take control of your manufacturing process. Discover the impact of operator techniques. Strengthen your operations today!
About Brayearst Validation Consulting
Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.
