14 Points (Deming's 14 Points)

A set of management principles developed by W. Edwards Deming to guide organizations in improving quality and productivity. The points emphasize leadership, continuous improvement, training, and a systemic approach to management.
See also: W. Edwards Deming, Total Quality Management

21 CFR Part 11

A section of the U.S. Code of Federal Regulations that sets requirements for electronic records and electronic signatures in FDA-regulated industries, ensuring data integrity, security, and traceability.
See also: FDA Compliance, Electronic Records

21 CFR Part 210

Regulations from the U.S. FDA covering current Good Manufacturing Practice (cGMP) for manufacturing, processing, packing, or holding of drugs.
See also: cGMP, Pharmaceutical Quality

21 CFR Part 211

FDA regulations specifying cGMP requirements for finished pharmaceuticals, including quality control, documentation, and manufacturing processes.
See also: cGMP, Pharmaceutical Quality

21 CFR Part 820

FDA regulations outlining the Quality System Regulation (QSR) for medical device manufacturers, covering design, production, and post-market requirements.
See also: QSR, Medical Device Quality

5 Whys

A root cause analysis technique that involves asking "why?" five times (or as many as needed) to drill down to the underlying cause of a problem.
See also: Root Cause Analysis, Problem Solving

5S

A workplace organization method from Lean manufacturing that stands for Sort, Set in order, Shine, Standardize, and Sustain. It aims to improve efficiency, safety, and cleanliness.
See also: Lean Manufacturing, Visual Management

8D (Eight Disciplines)

A structured problem-solving methodology used to identify, correct, and eliminate recurring problems, especially in manufacturing. The eight steps include team formation, problem description, containment, root cause analysis, corrective action, and prevention.
See also: Corrective Action, Root Cause Analysis