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There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
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CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact that is true across multiple industries, including food, pharmaceuticals, and medical devices.
And it’s not just compliance that companies need to worry about. The truth is, effective CAPA management is a basic requirement for continuous improvement. Done well, CAPA management can lead to safer, higher quality products that delight customers. Poorly managed corrective actions, on the other hand, can lead to massive recalls, financial penalties, and reputational damage.
This article looks at 12 strategies for successful CAPA management using a quality management system (QMS), including:
• How to standardize workflows and processes
• CAPA metrics you should be tracking
• Root cause analysis best practices
• The essential role of risk in the CAPA process
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Comments
CAPA could well be your most important process
This is an important article because, as stated above, "CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact that is true across multiple industries, including food, pharmaceuticals, and medical devices." I looked up some sample FDA warning letters and this is very common. Inadequate CAPA also is a source of audit findings in automotive (IATF 16949) and elsewhere. If we don't remove the root causes, the problems will keep coming back and we will never be rid of them.
this article is excellent to…
this article is excellent to consider when evaluating your CAPA process, one additional element which it is significantly important is to Avoid recurrence, when failing you can be impacted with a major finding or 2.
Constantly evaluating your recurrency and escalating when solution has not been achieve
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