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2018 - CAPA: Corrective and Preventative Actions and Addressing Non-Conformances



VenueAurora, USA - United States USA - United States

KeywordsCapa compliance; Capa courses; Capa format


Topics/Call fo Papers

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fail; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Or do you stop to consider whether there's actually a deeper problem that needs your attention? If you only fix the symptoms – what you see on the surface – the problem will almost certainly happen again... which will lead you to fix it, again, and again, and again. If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.
An ounce of Prevention is worth a pound of Cure; but, when a non-conformance does occur it is critical to get to the real origin of the problem. Root Cause Analysis uses a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can:
• Determine what happened.
• Determine why it happened.
• Figure out what to do to reduce the likelihood that it will happen again.
CAPA assumes that systems and events are interrelated. An action in one area triggers an action in another, etc. If you cannot prevent a problem from occurring, by tracing back these actions, you can discover where the problem started and how it grew into the symptom you're now facing and take appropriate corrective action.
• Taking pro-active preventative actions
• Identifying a non-conformance
• Examining the Data
• Identifying Possible Causal Factors
• Identifying the Root Cause(s)
• Taking Corrective Action
• Verifying the effectiveness of the corrective action
• Defining a non-conformance
• Developing a Non-Conformance Report (NCR)
• Investigating and documenting a non-conformance
• Resolving a non-conformance by RCA
• Taking appropriate corrective action
• Verifying the effectiveness of corrective actions
• QA managers
• Laboratory managers/supervisors
• QC practitioners.
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Last modified: 2018-04-06 15:50:12