Preventative Action – what’s that then?

Preventative Action often confuses many people: see these threads

Preventive actions are of a pro active nature. They do not wait for nonconformances to occur. This is what wikipedia says:

A preventive action is a change implemented to address a weakness in a management system that is not yet responsible for causing nonconforming product or service.

Candidates for preventive action generally result from suggestions from customers or participants in the process but preventive action is a proactive process to identify opportunities for improvement rather than a simple reaction to identified problems or complaints. Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.

The focus for preventive actions is to avoid creating nonconformances, but also commonly includes improvements in efficiency. Preventive actions can address technical requirements related to the product or service supplied or to the internal management system.

Many organizations require that when opportunities to improve are identified or if preventive action is required, action plans are developed, implemented and monitored to reduce the likelihood of nonconformities and to take advantage of the opportunities for improvement. Additionally, a thorough preventive action process will include the application of controls to ensure that they the preventive actions are effective.

Still confused? This (pdf file) is the FDAs take on CAPAs.

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