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Preventive Action should not / cannot be taken when rectifying a problem

Preventive action should not / cannot be taken when rectifying a problem

  • True

    Votes: 12 44.4%
  • False

    Votes: 15 55.6%

  • Total voters
    27
C

ChrissieO

#21
But you can prevent it from happening again,

To me that is all part of the corrective action, putting controls in place to correct the process so re-occurance does not happen

but that's not prevention in the eyes of the standard. If you're dealing with ISO/TS 16949 instead of ISO 9001,

I have to deal with both as some of our locations are 9001 and others 16949

the efforts extended to processes other than the one in which the nonconformity occurred can't be characterized as preventive either.
That all said, I do agree with an earlier post that said that it doesn't matter what its called, it needs addressing. From now on I shall call them "Strawberries & Rasberries":yes:


Chrissie
 
Elsmar Forum Sponsor
S

samsung

#23
I don't see it like that, your preventive action would come from your FMEA & control plan at planning stage in the same way you would look at a risk assessment in safety or environmental impact.
None of the PDCA based MS standards I'm aware of, have ever indicated (or mentioned) the Preventive Actions as part of planning as you mentioned. Whatever actions that one takes during the initial planning to 'prevent' something aren't the preventive actions defined and required by most standards including those concerning safety or environment.

ISO 9001 has put 'Preventive Actions' under the title 'Improvement' (check but not planning) phase whereas ISO 14001 & OHSAS both have placed it under 'Checking' where it's expected that a PA must emanate from Performance measurement & Monitoring only. Other supporting guidelines also advocate the same thing.

Risk assessment (e.g in OHSAS or EMS) is an activity conducted during the initial (planning) phase and that's why it's kept under 4.3 (Planning) whereas the PAs are part of Check phase and hence placed under clause 4.5.3 (Checking) and 8.5.3 in 9001.
 
C

ChrissieO

#24
None of the PDCA based MS standards I'm aware of, have ever indicated (or mentioned) the Preventive Actions as part of planning as you mentioned. Whatever actions that one takes during the initial planning to 'prevent' something aren't the preventive actions defined and required by most standards including those concerning safety or environment.

ISO 9001 has put 'Preventive Actions' under the title 'Improvement' (check but not planning) phase whereas ISO 14001 & OHSAS both have placed it under 'Checking' where it's expected that a PA must emanate from Performance measurement & Monitoring only. Other supporting guidelines also advocate the same thing.

Risk assessment (e.g in OHSAS or EMS) is an activity conducted during the initial (planning) phase and that's why it's kept under 4.3 (Planning) whereas the PAs are part of Check phase and hence placed under clause 4.5.3 (Checking) and 8.5.3 in 9001.
I don't get too wrapped up about where things appear in the standard and our procedures and manual are not written around the standards, they just happen to conform. I think maybe preventive action should be part of planning.

I think it comes under clause 8 "because it always has" and doesn't it wind you up when you are auditing and you ask someone "why do you do that" and they reply "because we always have" and you can fathom no rhyme nor reason why they should perfom a task or create duplicate information etc.

If a process is planned properly you will prevent failure - preventive action.

Gosh, I am begining to sound like a heratic. Our preventive action procedure documents our planning and risk management and niether our 9001, 16949 or FDA auditors have a problem with it, so that's fine by me.

Chrissie
 
Last edited by a moderator:
S

samsung

#25
Our preventive action procedure documents our planning and risk management and niether our 9001, 16949 or FDA auditor had a problem with it, so that's fine by me.
Chrissie
It's totally a different thing what's fine for you. It may be fine with you now and possibly in future as well but may not be fine for all since evaluations are based on standards and all the standards, insofar, Preventive Actions matter, are on the same page.
 

Jim Wynne

Staff member
Admin
#26
It's totally a different thing what's fine for you. It may be fine with you now and possibly in future as well but may not be fine for all since evaluations are based on standards and all the standards, insofar, Preventive Actions matter, are on the same page.
Preventive action exists on a continuum that begins with the initial planning for a product or service and continues so long as the process(es) in question continue to operate. The fact that preventive action isn't mentioned per se in some sections of the standard (ISO 9001:2008 specifically) doesn't mean that preventive action in the early stages of product/service development shouldn't be considered preventive action.

Look at 8.5.3 and you'll see that the requirements are such that they may be implemented at any point in the aforementioned continuum. There are no restrictions given in that regard.

Preventive actions should be identified and implemented as early as possible.
 

Randy

Super Moderator
#27
Chrissie!

The problem is...there is a potential for a bigger problem. The problem is the existance itself of POTENTIAL, RCA if done properly, will identify the cause of the POTENTIAL so that a solution to its resolution can be arrived at and implemented.
 
S

samsung

#28
The fact that preventive action isn't mentioned per se in some sections of the standard (ISO 9001:2008 specifically) doesn't mean that preventive action in the early stages of product/service development shouldn't be considered preventive action.
If it's so, why all the standards have excluded it from the (standard's) planning part? One can also maintain that 'planning' on and itself is a 'Preventive Action' because it prevents one from experiencing blind deviations in future but how can these early preventions satisfy the requirements of e.g. 8.5.3 which are largely associated with monitoring and measurement of processes & products.

Look at 8.5.3 and you'll see that the requirements are such that they may be implemented at any point in the aforementioned continuum. There are no restrictions given in that regard.

Preventive actions should be identified and implemented as early as possible.
I agree that actions 'to prevent something' can be taken at any stage of project i.e., conception, execution, development or operation but the intent of clause 8.5.3 or 4.5.3 (in OHSAS & 14001) is 'evaluating the need for action to prevent occurrence ............" and this evaluation must be based upon data/trend analysis, measurement of processes and products, audit results, monitoring of customer perception etc.

You may also wish to look at the following requirement of 8.4 (c) (ISO 9001)

c) The analysis of data shall provide information relating to:
characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4),
and 4.5.1 from OHSAS

The organization shall establish, implement and maintain a procedure(s) to monitor and measure OH&S performance on a regular basis. This procedure(s) shall provide for:

f) recording of data and results of monitoring and measurement sufficient to facilitate subsequent corrective action and preventive action analysis.
 

Jim Wynne

Staff member
Admin
#29
If it's so, why all the standards have excluded it from the (standard's) planning part? One can also maintain that 'planning' on and itself is a 'Preventive Action' because it prevents one from experiencing blind deviations in future but how can these early preventions satisfy the requirements of e.g. 8.5.3 which are largely associated with monitoring and measurement of processes & products.
The fact that preventive action isn't mentioned in "the planning part" is irrelevant. Look at 8.5.3 and tell us where it says that preventive action, as described therein, can't be used in the development stage. Just because it's in the back of the standard and not the front doesn't mean that there's some kind of exclusive wall between the front and the back.

I agree that actions 'to prevent something' can be taken at any stage of project i.e., conception, execution, development or operation but the intent of clause 8.5.3 or 4.5.3 (in OHSAS & 14001) is 'evaluating the need for action to prevent occurrence ............" and this evaluation must be based upon data/trend analysis, measurement of processes and products, audit results, monitoring of customer perception etc.
You're reading too much into it. Are you saying that because the standards reference certain methods of evaluating processes, that other methods, such as history and experience, are barred from consideration? I don't think so. What you're saying is that processes must be actually operated before we can invoke preventive action, which makes no sense.
 
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