1.7: Quality Systems and Approaches
- Page ID
- 39744
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Many companies follow quality systems and standards to help them meet the needs of the customer. We will go in-depth into the quality methodologies, which are important in the biosciences in a later chapter. Below is a brief mention of some common quality methodologies found in biomanufacturing. Note – not all quality systems are mandated by law – some are voluntary! We will explore why a company would take on additional quality systems beyond what is required by law!
- Current Good Manufacturing (CGMP) is a set of FDA-enforced manufacturing guidelines, which oversee the production of biotechnology products. The goals of CGMP regulations are to ensure product quality, safety, and regulatory compliance.
- ISO9000 is a quality standard that has been developed to provide guidelines for improving quality management systems. Eight key principles are integrated into ISO9000 standards: customer-focused organization, leadership, involvement of employees, process approach, systems approach to management, continuous improvement, factual decision-making, and mutually beneficial supplier relationships.
- Six Sigma is a methodological strategy that deals with product and system failures. To increase system reliability and reduce failure, companies utilize a rigorous process improvement methodology, Define-Measure-Analyze-Improve-Control, which encourages management decisions based on data.
- Lean production focuses on removing waste from production processes. Lean workers recognize the seven forms of waste: Producing defective parts, producing more parts than needed, excessive inventory, unnecessary activities, unnecessary movement of people, unnecessary transportation or handling of materials, and people waiting.