ISO 9001: 2000 lists 3 types of actions, including Corrections, Corrective Actions and Preventive Actions. While the difference between a Corrective Action and a Preventive Action may be obvious, many quality personnel have difficulty distinguishing between a Correction and a Corrective Action. As a result, many organizations in the market have been treating these requirements as the same, therefore complying to one means violating another, and therefore implementing an ineffective management system.

So what is the difference? What advice do you give employees on distinguishing between the two?

Answer: A “Correction” is an action to eliminate detected nonconformities which have occurred, whereas a “Corrective Action” is an action to eliminate the cause of the nonconformity which has occurred.

GHTF has posted a proposed guidance document on Corrective and Preventive Action at http://www.ghtf.org/sg3/sg3-proposed.html The document is open for comment for 5 months.

Comments are to be sent to Egan Cobbold at Egan_Cobbold@hc-sc.gc.ca

Egan is the chair of SG3.

Please take the time to review and comment to help GHTF make a better document.

From the problem statement to root cause identification, corrective and preventive actions to effectiveness checking measures, many hours of preparation are needed to compile a strong CAPA project.

In your experience, what is the single item most companies forget to include or struggle with in their CAPA Projects?

Effectiveness Checking Measures
Documentation of Investigation
Identification of Root Cause
Corrective and Preventive Actions
Problem Statement