Evaluating Effectiveness of a Preventive Action after Closure

Q

QAMTY

#1
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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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
You can not evaluation effectiveness of a preventive action, not are preventive actions "closed out".

Do you mean effectiveness of a Corrective Action?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
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 3[sup]rd[/sup] party auditors went along with.
 
R

randomname

#5
Only things you can verify are:

- the controls were put in place
- the controls worked if the trigger event occurred
 
Q

QAMTY

#6
Thanks Marc, Sidney and randomname.

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

Thank you so much.
 
J

Julie O

#7
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.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
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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