February 1, 2016

Using K2 for Non-Conformance

by Igor Jericevich in Whitepaper

This is quite a popular use case around K2 where we have quite a few customers taking advantage of K2 for things like Non-Conformance and CAPA ( Corrective and Preventative Actions ) within the manufacturing industry.

I built a small demo to show a use case around K2 and non-conformance.

The demonstration shows how a new submission can be completed and an approval process takes place. The process includes the ability to add preventative actions and each of these actions starts its own separately managed subprocess.



If you would like access to this and other K2 demos you can self-enroll into the environment here.  (Australia and New Zealand only at the moment)

For those that are interested this is a blurb from Wikipedia on CAPA:

“Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.[1] CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).

Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring such as would be identified by statistical process control (SPC). Preventive actions are implemented in response to the identification of potential sources of non-conformity.

To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS).”

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