Corrective and Preventive Action – Background & Examples
• CAPA, nonconforming product, and complaints are all related to identified or potential nonconformances. • Nonconformances are: – A data source for the CAPA system – The basis of the nonconforming product requirements – A potential cause of complaints
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fmdic.org•Nonconforming Material Reports •Equipment Data •Scrap/Yield Data •Rework Data •Returned Product •Internal Audits •Process Control Data •Acceptance Activities EXTERNAL SOURCES INTERNAL SOURCES
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