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DietCoke1953
We had a goal to close 85% of all CAR's in less than 30 days. We only reached a level of 75% closure rate.
Could an auditor consider this a Major non-conformance?
Could an auditor consider this a Major non-conformance?
Re: Is Failure to achieve Goal a Major Non-Conformance?
Meeting a goal or not is a result, the issue is not closing nonconformances within their planned date.
To be of more use to you there is so much left to understand here, such as:
1) Did any of these NCs involve product to customer or risk of sending bad product to customer?
2) How many NCs were included in the goal?
3) How far past their due date are they?
4) What kind of evidence was available to the auditor to show there was due diligence in pursuing the issues?
5) What was the exact write up of this major nonconformance?
Meeting a goal or not is a result, the issue is not closing nonconformances within their planned date.
To be of more use to you there is so much left to understand here, such as:
1) Did any of these NCs involve product to customer or risk of sending bad product to customer?
2) How many NCs were included in the goal?
3) How far past their due date are they?
4) What kind of evidence was available to the auditor to show there was due diligence in pursuing the issues?
5) What was the exact write up of this major nonconformance?
Re: Is Failure to achieve Goal a Major Non-Conformance?
DietCoke,
It depends on whether you prioritized action on the vital few...
...and if your haste to close CARs caused root causes to remain in your system.
Between us we may find the objective itself was a bigger nonconformity "failure to evaluate the time needed for effective corrective action".
John
DietCoke,
It depends on whether you prioritized action on the vital few...
...and if your haste to close CARs caused root causes to remain in your system.
Between us we may find the objective itself was a bigger nonconformity "failure to evaluate the time needed for effective corrective action".
John
Re: Is Failure to achieve Goal a Major Non-Conformance?
Only if they were grasping at straws. If they were "good" they'd suggest removing the goal, since closure of corrective actions cannot be completed within 30 days for a proportion and that, as a result, you'd never make 100%
Only if they were grasping at straws. If they were "good" they'd suggest removing the goal, since closure of corrective actions cannot be completed within 30 days for a proportion and that, as a result, you'd never make 100%
I hate day based "goals" for closing corrective actions. They are arbitrary and have no basis in reality. Many times, it could take a month to determine the root cause, let alone figure out how to fix it.
IMO, not achieving a goal should be just that. A failure to achieve it. It should have nothing to do with a "non-conformance." All this does it set a mindset to make sure your goals are "achievable" so you don't get dinged. As an owner/manager I prefer goals that are hard to meet. I certainly don't want someone coming in from the outside and telling me we have a non-conformance because we did meet our stretch goal.
IMO, not achieving a goal should be just that. A failure to achieve it. It should have nothing to do with a "non-conformance." All this does it set a mindset to make sure your goals are "achievable" so you don't get dinged. As an owner/manager I prefer goals that are hard to meet. I certainly don't want someone coming in from the outside and telling me we have a non-conformance because we did meet our stretch goal.
Major nonconformance are generally the result of a couple things: 1) failure to establish a process to meet a standard requirement (blatant omission) 2) blatant failure to comply with your prescribed program and standard requirements. Severity of a nonconformance can play into how an auditor views an issue. Single point failures are uncommon, but not out of the question (e.g. health risk items that appear ignored). As Jennifer notes, there are other things that can exacerbate a situation.
Missing by 10 points is hardly cause to issue a major NC by itself. There would have to be other factors that would be considered to have that happen in my opinion. And as noted, putting things to 'hard numbers' isn't my normal cup of tea. For CAPAs/CARs, having soft dates based on established risk is a better practice, to help guide things along to a loose schedule. That, along with the due diligence Jennifer mentions, is essential in giving auditors a warm fuzzy that things are being attended to. Even if you miss the 'goal' by 10 points, a solid record of reviews and extensions, etc. should keep things from ending up bad.
I think our colleagues above got the gist of things just right! Good luck!
Missing by 10 points is hardly cause to issue a major NC by itself. There would have to be other factors that would be considered to have that happen in my opinion. And as noted, putting things to 'hard numbers' isn't my normal cup of tea. For CAPAs/CARs, having soft dates based on established risk is a better practice, to help guide things along to a loose schedule. That, along with the due diligence Jennifer mentions, is essential in giving auditors a warm fuzzy that things are being attended to. Even if you miss the 'goal' by 10 points, a solid record of reviews and extensions, etc. should keep things from ending up bad.
I think our colleagues above got the gist of things just right! Good luck!
Exactly. Why did you pick 30 days for a goal? Why not 35? or 25? Why not some other number?
(an P.S. - nice to have a Kevin Mader sighting.)
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Why choose any specific number of days? That's inappropriate AND an external type of requirement. Anyone who understands how CA works would set a goal of within "+/- 1 day of target for the specific CA issue". That way, it's appropriate to the individual needs of that CA and holds people to their planned actions...
Randy
Super Moderator
If you are aware of your inability of not meeting your goal and do nothing....Shame on you....But not to the tune of a Major
It's your objective and maybe it was unreasonable, you don't have the resources or whatever...Change it...but not to 75%....Initiate an internal corrective action and fix the problem....
USE THE SYSTEM!!!!!!!!!
Some target is generally expected as you know, lest actions be left with a vague finish goal that too easily slips to the back burner as it were.
Two unanswered questions are at issue here. Are the targets unreasonable? Or, do people not make serious effort to close the actions?
I didn't include in my list earlier, but you and our fellow Covers have pointed out its relevance:
6) Does the procedure allow for extensions? And if so, were these actions extended?
There is just too little to go on here to decide how to feel. I have lots of clients who don't have problems with assigning target finish dates. If they get it wrong, they extend as long as they need to get it right without undue delay.
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