Quality Assurance Terms Glossary/Numbers

From Elsmar Cove Quality Assurance and Business Standards Wiki

• 1st-Party Audit - A Quality Audit performed by the organization itself.
• 2nd-Party Audit - A Quality Audit performed by a customer of the organization.
• 3rd-Party Audit - A Quality Audit performed by a body that is independent of both the organization and customer.
• 3 M - Muda, Mura, Muri - Waste, Unevenness, Overburden - Japanese terms used as "check points" for identifying the areas in need of improvement. See also TPS (Toyota Production System)
• 5 M - Machines, Manpower, Methods, Materials, Measurement. See also Fishbone Diagram
• 5S - see Five S
• 6 Sigma - see Six Sigma
• 8D - see Eight Disciplines Problem Solving
• 21 CFR Part 820 - Section of the Code of Federal Regulations dealing with medical devices.