Pharma Definition/Abbreviation, Pharma Beginners
ISO 9001:2015 isΒ an international standard for a quality management system (QMS) that helps organizations consistently provide products and services to meet customer and regulatory requirements.
ISO 13485:2016 vs ISO 9001:2015
The PDCA (Plan-Do-Check-Act) cycle isΒ an iterative, four-step process for continuous improvement of products and processes. It involvesΒ planningΒ a change,Β doingΒ the change on a small scale,Β checkingΒ the results, andΒ acting on the learnings by standardizing or making further adjustments.
The “5 Whys” isΒ a problem-solving technique used to identify the root cause of an issue by repeatedly asking “why?” to get to the bottom of the problem.
It involves starting with a problem statement and then asking “why” five times, with each answer forming the basis for the next question. The process is designed to move past surface-level symptoms to uncover the underlying cause.
Quality Assurance vs Quality Control
FMEA techniquesΒ involve a systematic, step-by-step process to identify potential failure modes in a product or process, analyze their effects, and calculate a Risk Priority Number (RPN) to prioritize actions.
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