Effectiveness of Preventive Actions

H

Hanr3

#41
The ISO standard describes Preventive Action using mostly the same requirements as Corrective Actions. Some preventive things fit better under preventive maintenance, under training, under safety or other sections of the ISO standards.

.
Doesn't matter which section or activity you label it, it is still a preventive action.
 
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S

samsung

#42
Changing the oil in your car every 5,000 miles is no garuntee your engine wont fail from an oiling issue.
However if you dont change the oil, it will most certainly fail.

The standrad states; "The organization shall determine action to eliminate the causes of potential nonconformities..."
Yes the standard does say " The organization shall determine action to eliminate the causes of potential nonconformities..." and in the context of this statement why should 'oil changing' be construed as a PA. Who has determined the need for changing the oil - car owner or the manufacturer? I'm sure it's the car manufacturer who, based on design parameters and having analyzed the data collected over the years from various sources, arrived at this 'oil change' recommendation. The owner is simply doing what s/he is recommended to do. I don't understand what role does the car owner's management system have in this instance? He would be changing the oil even without having a QMS in place.

Everything that prevents something can't be considered as a PA (with particular reference to PDCA based management systems).

To me the best approach is some sort of alarming step. SPC is an alarming step, if you approach the upper or lower limit, your almost out of tolerance, action is taken to correct the situation and bring you back to normal readings. Your preventive action was effective, and you have evidence of it. This by no means quarantees you will never have a failure because your out of tolerance.
Yes, I do agree. :agree1:
 
J

Juliette

#43
I think the point you have made is that preventive action is necessary but that it is difficult to assess whether it is effective.

My problem is this: how far would I have to go to prove to an external auditor that we have assessed our preventive action for effectiveness? At what point can I close the preventive action form and say "Yes that's effective, now I can file it"?

Thanks for any clarity that you can bring to a newbie.
 
S

samsung

#44
I think the point you have made is that preventive action is necessary but that it is difficult to assess whether it is effective.

My problem is this: how far would I have to go to prove to an external auditor that we have assessed our preventive action for effectiveness? At what point can I close the preventive action form and say "Yes that's effective, now I can file it"?

Thanks for any clarity that you can bring to a newbie.
The standard requires to establish a documented procedure to define requirements for "e) reviewing the effectiveness of the preventive action taken."

The auditor would first look at the way you determined the need for preventing a potential problem. The assessment may include how you analysed the data/ causes of the potential problems (e.g., application of some problem solving technique etc.), implementation of actions, records of your observations & review if a nonconformance was really prevented and the management is satisfied with the actions taken & the likes.

Any PA doesn't have to be virtually 'closed' just like actual nonconformities. However, the most important thing is the requirement of your own documented procedure that you will have to adhere to.

P.S.: You may also wish to take into account the following points (for guidance while dealing with PAs) taken from ISO:9004:
— use of risk analysis tools such as fault mode and effects analysis,
— review of customer needs and expectations,
— market analysis,
— management review output,
— outputs from data analysis,
— satisfaction measurements,
— process measurements,
— systems that consolidate sources of information from interested parties,
— relevant quality management system records,
— lessons learned from past experience,
— results of self-assessment, and
— processes that provide early warning of approaching out-of-control operating conditions.
 
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#45
I think the point you have made is that preventive action is necessary but that it is difficult to assess whether it is effective.

My problem is this: how far would I have to go to prove to an external auditor that we have assessed our preventive action for effectiveness? At what point can I close the preventive action form and say "Yes that's effective, now I can file it"?

Thanks for any clarity that you can bring to a newbie.
Hello Juliette (in my Dad's part of England)

Well, to me it's very simple. If I know that jumping in front of cars is dangerous, and I put in place controls to prevent me from doing that (based on risk etc) then, if I don't get run over, I believe I can say those controls are effective. After all it's not as if cars are no longer on the roads, or they've got accident avoidance technology or something like that!

If an auditor couldn't accept that - particularly if I showed the use of an effective prevention tool such as a PFMEA to identify the controls, risks etc, then I'd be asking the auditor to leave...

Actually, prevention and associated risks are never 'filed' as such, a PFMEA is a 'live' document, modified in response to changes, new things etc.
 
J

Juliette

#46
So, provided that our procedure states that we only 'close' a PA once management are satisfied, and that we record all the information which the management uses to determine whether it is satisfied, we can justify closing / no longer looking at them on a regular basis?
 
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S

samsung

#47
So, provided that our procedure states that we only close a PA once management are satisfied, and that we record all the information which the management uses to determine whether it is satisfied, we can justify closing / no longer looking at them?
Ofcourse you can. After all it's the management (not the auditor) who has to decide whether or not they are satisfied/ benefited with the actions implemented by their team.
 
Q

QCAce

#48
Another helpful tip for identifying preventive action opportunities and measuring their effectiveness is to make use of internal audit 'observations'. Observations are usually recorded when the auditor has concerns but no nonconformance has occurred yet. These can be great preventive action opportunities. Also, you can also measure effectiveness of implementation based on reduced observations of future internal audits.
 
S

samsung

#49
Another helpful tip for identifying preventive action opportunities and measuring their effectiveness is to make use of internal audit 'observations'. Observations are usually recorded when the auditor has concerns but no nonconformance has occurred yet. These can be great preventive action opportunities. Also, you can also measure effectiveness of implementation based on reduced observations of future internal audits.
While I agree to using IA reports for identifying PA opportunities, I am unsure of 'reduced number of observations' being a reliable indicator of effectiveness. If we talk in terms of the entire organization, a reduction in no. of observations as compared to the past results, can simultaneously result from many other factors such as lack of auditors' understanding of the process or not devoting sufficient time & interest to the auditing process, low frequency of planned audits etc. etc.

However, if none of these or similar attributes exist, I will have to accept that the resultant improvements are assignable to the proactive approach of people towards finding and working on potential problems as well as the effectiveness of the actions they implemented.

Thanks.
 
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Q

QCAce

#50
While I agree to using IA reports for identifying PA opportunities, I am unsure of 'reduced number of observations' being a reliable indicator of effectiveness. If we talk in terms of the entire organization, a reduction in no. of observations as compared to the past results, can simultaneously result from many other factors such as lack of auditors' understanding of the process or not devoting sufficient time & interest to the auditing process, low frequency of planned audits etc. etc.

However, if none of these or similar attributes exist, I will have to accept that the resultant improvements are assignable to the proactive approach of people towards finding and working on potential problems as well as the effectiveness of the actions they implemented.

Thanks.
While I agree that not all reductions in observations may be attributable to certain preventive actions, I am unsure as to why you are unsure whether they could be used as an indicator of effectiveness.

However, I will have to agree with your acceptance that preventive actions can result in improvements.
 
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