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Evaluating Effectiveness of a Preventive Action after Closure
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Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
Evaluating Effectiveness of a Preventive Action after Closure
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preventive action (pa)
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  Post Number #1  
Old 2nd October 2016, 12:46 PM
QAMTY

 
 
Total Posts: 489
Please Help! Evaluating Effectiveness of a Preventive Action after Closure

Hi everybody
A silly question about preventive actions, regarding the closure

When do you consider the action was effective?
When it happened what you wanted to eliminate (a potential failure) and plans you suggested worked fine.

but what happens if potential failure didnt occur ?

and it is needed the closeout.
How do you manage this issue?

Or you determine a frametime for the closeout and if didnt occur, it can be closed?

Regards

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  Post Number #2  
Old 2nd October 2016, 12:55 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,029
Re: Evaluating Effectiveness of a Preventive Action after Closure

You can not evaluation effectiveness of a preventive action, not are preventive actions "closed out".

Do you mean effectiveness of a Corrective Action?
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  Post Number #3  
Old 2nd October 2016, 01:15 PM
QAMTY

 
 
Total Posts: 489
Re: Evaluating Effectiveness of a Preventive Action after Closure

I refer to PA, you mean doesnt apply closeout?
Thanks
  Post Number #4  
Old 2nd October 2016, 01:56 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,937
Re: Evaluating Effectiveness of a Preventive Action after Closure

Quote:
In Reply to Parent Post by QAMTY View Post

When do you consider the action was effective?
When it happened what you wanted to eliminate (a potential failure) and plans you suggested worked fine.

but what happens if potential failure didnt occur ?
Some of these questions go to the core of the reason why the TC 176, after reading numerous threads in this space, have decided to get rid of the silly preventive action requirement in ISO 9001:2015.

Technically, you can never completely verify the effectiveness of preventive action, since you are trying to verify that a POTENTIAL problem does not happen. In order to "comply" with that requirement in 9001:2008, most organizations did "mickeymouse" verification of PA implementation and effectiveness and 3rd party auditors went along with.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 2nd October 2016, 02:22 PM
randomname

 
 
Total Posts: 84
Re: Evaluating Effectiveness of a Preventive Action after Closure

Only things you can verify are:

- the controls were put in place
- the controls worked if the trigger event occurred
Thanks to randomname for your informative Post and/or Attachment!
  Post Number #6  
Old 2nd October 2016, 05:39 PM
QAMTY

 
 
Total Posts: 489
Re: Evaluating Effectiveness of a Preventive Action after Closure

Thanks Marc, Sidney and randomname.

For us, as ISO newbies, your feedback, really clear up a lot of doubts

Thank you so much.
  Post Number #7  
Old 1st November 2016, 11:29 AM
Julie O

 
 
Total Posts: 221
Re: Evaluating Effectiveness of a Preventive Action after Closure

In your CAPA plan, specify a period of time over which the matter will be monitored for recurrence. Include some type of justification for the amount of time specified (eg, risk associated with recurrence, the amount of time the process ran without the trigger event occurring, etc).

Include language saying that the PA will be closed out if the event does not recur during that period, to be reopened it if occurs again after that period. Closing out the action item is not the same as saying you will turn a blind eye to the problem forever and ever amen.
  Post Number #8  
Old 1st November 2016, 12:35 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,937
Re: Evaluating Effectiveness of a Preventive Action after Closure

Quote:
In Reply to Parent Post by Julie O View Post

In your CAPA plan, specify a period of time over which the matter will be monitored for recurrence. Include some type of justification for the amount of time specified (eg, risk associated with recurrence, the amount of time the process ran without the trigger event occurring, etc).

Include language saying that the PA will be closed out if the event does not recur during that period, to be reopened it if occurs again after that period. Closing out the action item is not the same as saying you will turn a blind eye to the problem forever and ever amen.
The OP was asking about preventive action. So, there can't be recurrence, just occurrence.

Recurrence implies an existing nonconformities and, by definition, we would be talking about corrective (not preventive) action.
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