Corrective and Preventive action:

A continuous improvement tool that can be extremely effective if used correctly. This tool is used not only for ISO 9001 organizations but also for organizations that comply to Cosmetics GMP ISO 22716, TGA GMP Pharmaceuticals, ISO 13485 medical devices etc. The definitions are as follows:

Corrective Action – action taken to eliminate the cause of an EXISTING nonconformance in order to prevent recurrence. This is pretty straight forward- an organization has a non-conformance and they implement training or a change to prevent recurrence.

Preventive Action – action taken to eliminate the cause of a potential nonconformance in order to prevent recurrence. If you are having difficulties identifying POTENTIAL non-conformances here’s a tip for you.

1) Using Risk Management tools, such as FMEA, can identify potential process failures. A FMEA will break down the process into individual components and identify potential failure modes.

2) Using Statistical Process Control (SPC control charts). Implement control charts in your process and monitor the process to identify drift. Take that extra step and adopt alert limits and not just alarm/specification limits. That way when your process breaches your alert limit you can implement action to bring the process back to target……added benefit – there’s no non-conformance  as you are still within specification.

Being PROACTIVE rather than REACTIVE is the key.

For more information on CAPA or any other continuous improvement tools contact Compliance Management Solutions.

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.