Reviewing Effectiveness of Corrective Actions

[sathishthantri]

A good discussion.
Corrrective actions are actions taken to eliminate the effects of causes.
It may so happen that there are some causes which were missed in the analysis or new causes come in picture (due to changes).
So, RCA changes with new additions, thereby triggering new actions.

 

[Sidney Vianna]

A good discussion.
Corrrective actions are actions taken to eliminate the effects of causes.

I believe that true corrective action eliminates the (root) causes of a problem, not the effects. The analogy is if a patient goes to see a doctor with a severe fever, the doctor has to diagnose the reason for the fever and not simply tell the patient to take cold showers in order to lower his body temperature.

It may so happen that there are some causes which were missed in the analysis or new causes come in picture

Indeed, many times, there are contributing/multiple causes for a problem. That's why one of the "changes" in the 2008 edition of ISO 9001 is the word causes (plural) under 8.5.2.

The organization shall take action to eliminate the cause causes of nonconformities in order to prevent recurrence.

 

[kgott]

In my previous organization, we did not typically close the CA until the review was complete, thus negating options (a) and (b). This would usually lead to (d), which was documented on the corrective action paperwork, so that we had the "lifecycle" of the issues, root cause analysis (even if wrong), actions taken, etc. It also showed how long the issue the remained truly open..

This raises the issue of how many opportunities should a CA be given to be proven to be either effective or ineffective?

Obviously; this can depend on factors such as how long it takes for the CA to be put to the test, how long the cycle takes etc but if the CA holds once is that enough to be considered to be effective?

If it holds 10 times but fails again on the 11th time is that a recurrence or is it a new event and is managed with a new CA.

Any thoughts on how to manage this aspect of the CA issue?

 

[qusys]

This raises the issue of how many opportunities should a CA be given to be proven to be either effective or ineffective?

Obviously; this can depend on factors such as how long it takes for the CA to be put to the test, how long the cycle takes etc but if the CA holds once is that enough to be considered to be effective?

If it holds 10 times but fails again on the 11th time is that a recurrence or is it a new event and is managed with a new CA.

Any thoughts on how to manage this aspect of the CA issue?

You should investigate root cause of the last one, if it is an outlayer or it is aa sympthom of a new problem, where you should repeat the whole cycle of the corrective action activity.

 

[optomist1]

John,

Sorry here is the correct link for CMU Software training/certification..

http://seicertification.clearmodel.com/

Regards,
Optomist1

 

[John Broomfield]

John,

You seem to have posted your question twice.

I recommend option d) do something else.

That something else is to delay invoking the corrective action.

Your management system should separate correction from corrective action.

Two examples:

1. Correct the product nonconformity using your documented procedure for control of nonconforming product (see 8.3).
2. Correct your nonconforming process using your undocumented procedure for monitoring [and correcting] processes (see 8.2.3).

Invoke corrective action, to stop recurrence by removing the root causes, only after you (or your competent auditor) evaluates the benefit of investing in corrective action.

John

 

[Bev D]

Actually - Optimist 1 posted a correction to today's post by John in an older thread from the same person. teh threads are coincidentally 2 years apart...

 

[normzone]

All of the above contains useful advice.

In my experience there are sometimes occasions where it is not possible to accurately assess the effectiveness of the corrective action - there may be issues where you would have to wait for an event pattern to play out again to verify that your precautions put in place were effective.

And if that event pattern only recurs once in a blue moon, or never, you can make reasonable assumptions about the effectiveness of your action but without a test case to verify you are only making assumptions.

Other times it is likely that you'll have a chance to experience the event again in a year or so. How valuable is it to keep the CA open and review it then? To me, that depends on how much resource you have dedicated to monitoring events and linking to open CAs.

Sometimes I will close CAs with the effectiveness noted as apparent, but contingent upon no further recurrences of this issue. We can split hairs all we like, but the value of me (an army of one, small company) maintaining a list of CAs open for years and feverishly monitoring them on the chance that I may find incontrovertible evidence of full effectiveness does not seem like an effective use of resources.