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Corrective and preventive action (CAPA or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems ...
Preventive actions rely upon on the consequences of change. Once changed, inevitably, risks should be taken into consideration. In this case preventive actions aim to minimize or, where possible, eliminate the risks. Risks arise when little is known and understood about a particular situation. The chances of risk are minimized whilst one has ...
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
For example, an "Is/Is Not" worksheet is a common tool employed at D2, and Ishikawa, or "fishbone," diagrams and "5-why analysis" are common tools employed at step D4. In the late 1990s, Ford developed a revised version of the 8D process that they call "Global 8D" (G8D), which is the current global standard for Ford and many other companies in ...
Zero Defects is a management tool aimed at the reduction of defects through prevention. It is directed at motivating people to prevent mistakes by developing a constant, conscious desire to do their job right the first time."
Action for Improvement – How are corrective and preventive action created, managed and closed out; what processes are in place to ensure the continual improvement process. Although other occupational safety management models may use different terminology, the basic components and workflow for occupational safety management systems will be the ...
Hazard analysis critical control points, or HACCP (/ ˈ h æ s ʌ p / [1]), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level.
Good manufacturing practice covering other industries; Corrective and preventive action (CAPA) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme; Validation (drug manufacture) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)