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Preventative Action vs. Opportunity for Improvement
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Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
Preventative Action vs. Opportunity for Improvement
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Some Related Topic Tags
definitions, differences (general), opportunities for improvement (ofi), preventive action (pa)
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  Post Number #9  
Old 22nd March 2013, 06:58 AM
bikeshox

 
 
Total Posts: 30
Re: Preventative Action vs. Opportunity for Improvement?

We're working on an Opportunity for improvement, but I'm struggling on how to document the improvement. The only present place I can document the improvement is in our CAPA system.

The OFI came about as a cost savings, not as preventative action, as a CAPA would define.

How do i ensure that the OFI meets all of our quality requirements, and how should i document this?

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  Post Number #10  
Old 22nd March 2013, 08:12 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 790
Re: Preventative Action vs. Opportunity for Improvement?

IMO, it doesn't really matter so much HOW you document it, but that you DO document it. This is freedom.

If you have an OFI documentation or OFI mgmt system, use it.
I assume from you asking your question that you have no such system.
I, personally, would not build the system just for this...it is the cost savings that is important, not the type of documentation...so call it a PA and use your existing system.

PA: Preventing unnecessary expenditure.
Have someone in Mgmt declare it as a goal, document the goal, and then you are preventing non-compliance with that goal set by Mgmt. A stretch?...sure it is...using a wrench to drive a nail. But remember it is the saving money that is the important part...don't let the documentation run your life.

If things like this come up multiple times a year (I hope they do!)...build the OFI system. I would recommend that you simply add it on to the existing CAPA system. K.I.S.S.
Thanks to Ninja for your informative Post and/or Attachment!
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  Post Number #11  
Old 27th March 2017, 06:41 AM
Wolf.K

 
 
Total Posts: 19
Re: Preventative Action vs. Opportunity for Improvement?

Quote:
In Reply to Parent Post by Ninja View Post

If you have an OFI documentation or OFI mgmt system, use it.
(...) so call it a PA and use your existing system.
We are just discussing how to integrate OFIs, ideas suggested by employees, quality objectives and else into our existing system. To put all the things into the CAPA system does not sound like a great idea, because it would boost our # of CAPAs, which is not so good (looks as if we have quality problems).
  Post Number #12  
Old 27th March 2017, 07:43 AM
Pancho's Avatar
Pancho

 
 
Total Posts: 811
Re: Preventative Action vs. Opportunity for Improvement?

Quote:
In Reply to Parent Post by Wolf.K View Post

We are just discussing how to integrate OFIs, ideas suggested by employees, quality objectives and else into our existing system. To put all the things into the CAPA system does not sound like a great idea, because it would boost our # of CAPAs, which is not so good (looks as if we have quality problems).
Actually, CAPA is improvement. Lots of corrective or preventive actions only show that you have lots of improvement, not that you have low quality. In fact, it is likely that if you have and maintain world-class quality, you also have tons of improvement actions every period.
Thank You to Pancho for your informative Post and/or Attachment!
  Post Number #13  
Old 27th March 2017, 11:16 AM
Wolf.K

 
 
Total Posts: 19
Re: Preventative Action vs. Opportunity for Improvement?

So, e.g. every quality objective should get a unique CAPA number assigned?
  Post Number #14  
Old 27th March 2017, 12:32 PM
Bev D's Avatar
Bev D

 
 
Total Posts: 3,516
Re: Preventative Action vs. Opportunity for Improvement

you can think of it differently. QA doesn't have to track every improvement action. in our system we explain the various ways we engage in corrective actions, preventive actions and continual improvement. QA tracks all high risk items, supplier CAs as well as CAs from external auditors. All other activities are tracked at the local levels. in fact 'ideas' from employees are 'tracked' on the daily gemba boards. Managers are often completely unaware of them - they just see the results in their metrics. The Product and Process teams track their own quality metrics and initiate improvement activity and track progress on their own...again progress is seen by leadership in the higher level metrics.

all of this is described in our procedures and is easily auditable...but QQ is only knowledgeable or responsible for about 2% of all of the activity under this procedure.
Thank You to Bev D for your informative Post and/or Attachment!
  Post Number #15  
Old 28th March 2017, 07:05 AM
Wolf.K

 
 
Total Posts: 19
Re: Preventative Action vs. Opportunity for Improvement

Quote:
In Reply to Parent Post by Bev D View Post

in fact 'ideas' from employees are 'tracked' on the daily gemba boards. (...)

all of this is described in our procedures and is easily auditable...but QQ is only knowledgeable or responsible for about 2% of all of the activity under this procedure.
Well, we are a small start-up company, 8 people (growing, about 1 new colleague all 6 month), none of us has industrial experiences. We got our QMS from a consulting agency, and it works well, our notified body is always very happy. But we lack the day-to-day work routine and very often wonder "how should we do this?". Therefore I asked how we should integrate OFIs and Quality Objectives into the QMS, in a way similar to CAPAs.

I like the CAPA system. It guides you very well, has a timeframe, responsibilities and so on. Personally, I would just open a CAPA for every OFI, Quality Objective. Appoint someone responsible/process owner, and then I can sit and wait for the results. Currently, OFIs and QOs are just written somewhere, and nobody really cares about them. Because they are not in the CAPA system. And, as we are a medical device company planning to go for the US market, our CEO does not like to hear about "more CAPAs". Because he has heard, that the FDA does not like CAPAs...

Last edited by Wolf.K; 28th March 2017 at 09:32 AM. Reason: Typo, and added paragraph
  Post Number #16  
Old 26th July 2017, 11:08 AM
xfngrs's Avatar
xfngrs

 
 
Total Posts: 162
Re: Preventative Action vs. Opportunity for Improvement

Has this changed for ISO 9001:2015 or IATF 16949:2016?
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