Are we spending enough time and resources on effective Preventive Actions?

Bev D

Heretical Statistician
Super Moderator
There are two issues at play: compliance to a standard and doing the right thing. The fact that some auditors struggle with preventive actions (outside risk management in medical devices) is appalling. Sad but true I suppose. We shouldn’t let compliance be the peak of our efforts tho; it really is the minimum. I don’t know why preventive actions like SPC, 5S, PM or predictive maintenance, one piece flow, error proofing, etc. aren’t used more…and I think that is the real issue: Why settle for mere compliance?
Just more of my :2cents:

-- Is there (or should there be) a fundamental difference between CA and PA?
Reactive vs proactive; that is the difference. For corrective action, you are required to take action because you are out of compliance. For preventive action, you are not required to take action, but you are being proactive and taking action anyway to ensure continued compliance.

-- Why are the two bundled together (in standards, conceptually, and in practice)? Should they?
Because both have a root cause and are managed as an improvement project in a similar way.

-- Is there really a distinct and unique kind of activity worthy of the title "PA"?
In my mind, it is more of a category of improvement actions rather than a unique activity.

-- Why is PA implemented relatively little in orgs (is it?), and should it be different?
Because many orgs are reactive instead of proactive. If the company I work for was previously able to close out complaints in two weeks, and now it is taking two months, I might get concerned that the quality system is not as effective as it could be. I also might get concerned that this could cause medical device reports (or vigilance reports) to be submitted late. That could be a big problem. I could decide to open a preventive action to figure out what is causing these delays and to determine appropriate actions to get our complaint closure time back in line.

-- If indeed PA is unique and should be implemented "more", does it need verification and what should this verification include?
It depends on the actions. Most preventive actions are able to be verified as effective, but this may not be possible for some.
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