Quality Objectives and Monitoring & Measurement of Processes - Clause 8.2.3

Makrab

Involved In Discussions
#1
Is it right to apply ISO 9001:2008 Clause # 8.2.3 (Monitoring and Measurement of processes) to Quality Objectives measurement??

In this case, if target set (planned results) for a Quality Objective is not met (achieved) then Correction and Corrective action shall be taken.

Please advise.

Thanks!!
 
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John Broomfield

Staff member
Super Moderator
#2
Makrab,

Yes, monitoring and measuring processes per 8.2.3 is itself a process (or two). Implicitly though, the monitoring process is usually integral to the monitored processes themselves, instead of being separately analyzed and specified as a documented procedure.

But when setting objectives I would expect to see evidence of action on the system to ensure the objectives are fulfilled.

This is known as preventive action per 8.5.3. BTW, this preventive action may discover the objective is not feasible.

Once the objective is accepted and the action is taken, any trend towards nonfulfillment of an objective may invoke further preventive action.

Finally, if the objective is not met you could invoke corrective action. But as we know, preventive action should precede corrective action.

John
 
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kzachawk

Involved In Discussions
#3
This is where the 2000, 2008 and 2015 versions of the 9001 MSS muck up the water IMHO. They basically threw product and process development and implementation in with Supplier Management and Planning and turned on the mixer in order to attempt to be a one size fits all standard. The result has never been pretty.

I have had this very argument with Registrars and all I can say is "it depends" In the 2008 standard you might be able to argue your way round, if your high level objectives are not actually tied to your achievement of customer requirements (especially if the objectives are of some other discipline say Environmental or Financial etc.). I have heard of registrar auditors causing scope creep by interpreting statutory and regulatory in the ISO 9001 standard very broadly and attempting to include Environmental and Financial in their interpretation, of course the scope of the standard and other specific comments rules that out, but most people (including registrar auditors) don't read those parts of the ISO MSS.

However, if you have quality objectives and the intention is you meet them, and they are tied to the achievement of Customer or Regulatory requirements, that effect quality, then there should be evidence that your organization met the objectives or reviewed them and management took action as a result of the review (documented of course).
 
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Paul Simpson

Trusted Information Resource
#5
Makrab,

Yes, monitoring and measuring processes per 8.2.3 is itself a process (or two). Implicitly though, the monitoring process is usually integral to the monitored processes themselves, instead of being separately analyzed and specified as a documented procedure.
Not for the first time I will disagree. The understanding of the relationship between process measures and measurable objectives is not helped by the MSS wording but process measures are not necessarily directly linked to measures of achievement of the organization's policy and objectives. An example might help (later).

It is worth going back to clause 4.1 e in the context of the rest of 4.1 to frame this:
  • Any organization should be able to analyse its processes to identify what it needs to control and manage to ensure processes are delivering the outcomes they should
  • One part of this is to monitor and / or measure the process (4.1 e)

So the requirement to monitor / measure applies to all processes in the system. Where the organization decides a process needs to be measured then it is a straight line to 8.2.3.

<snip>But when setting objectives I would expect to see evidence of action on the system to ensure the objectives are fulfilled.</snip>
Often when setting objectives the organization's top management will look at the market and set objectives that do not relate to measures of internal processes but are nonetheless quality objectives and measures. For example the objective might be for the organization to be the supplier of choice for a particular product / service. There are a whole range of internal processes that may contribute to achieving this objective but no internal (8.2.3) process measure that does it.

This is where the 2000, 2008 and 2015 versions of the 9001 MSS muck up the water IMHO. They basically threw product and process development and implementation in with Supplier Management and Planning and turned on the mixer in order to attempt to be a one size fits all standard. The result has never been pretty.
As mentioned above the structure and language doesn't particularly help but I don't see the problem with identifying requirements and meeting them. Perhaps you can post an example of where you think the confusion lies? 9001 by definition has to be a 'one size fits all standard' but that doesn't mean we shouldn't be able to identify how the requirements apply to any organisation.

<snip>I have had this very argument with Registrars and all I can say is "it depends" In the 2008 standard you might be able to argue your way round, if your high level objectives are not actually tied to your achievement of customer requirements (especially if the objectives are of some other discipline say Environmental or Financial etc.). I have heard of registrar auditors causing scope creep by interpreting statutory and regulatory in the ISO 9001 standard very broadly and attempting to include Environmental and Financial in their interpretation, of course the scope of the standard and other specific comments rules that out, but most people (including registrar auditors) don't read those parts of the ISO MSS. </snip>
Your Registrar should be challenging your objective setting and how you can draw a line of sight to process measures because if your processes aren't aligned with objectives then there is a problem waiting to happen. I've also heard of auditors attempting 'scope creep' and it should be resisted but the also has to help itself and clearly demonstrate objectives that relate to quality and customer satisfaction.

Again I don't believe the standard is unclear.

There is nothing to keep from having your quality objectives serve TRIPLE duty. They can fulfill the requirements of 5.4, 8.2.3, and 8.4, and I encourage it.
It might just be terminology but the measures serve a single purpose (4.1 e) but in doing so they satisfy a number of requirements - including the ones you mentioned.
 

John Broomfield

Staff member
Super Moderator
#6
Paul,

I'd expect to see the system's processes (and departments) not fighting each other or tearing their system apart.

Indeed, you'd expect to see the organization's processes and their success criteria (see 4.1c) collaborating and interacting to fulfill the system's purpose or mission.

Your example quality objective of becoming a customer's favored supplier probably will need action on many parts of the system and its management system before use of that management system assures success.

The objective is fulfilled, or not, by the system's processes (possibly within a project) that will be monitored/measured for effectiveness and any necessary preventive action or, failing that: correction, or failing that: corrective action. All aided by the management system.

Only rarely have I seen clients analyze and define their process for monitoring the system's processes and that was because the supervisors had given their job to the internal audit team! Normally, the monitoring is implicit to each of the system's processes.

But here is an example of what I'm talking about.

John
 
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Paul Simpson

Trusted Information Resource
#7
OK. Again not for the first time, John, you miss my point. I nver said anything about processes fighting one another - although the concept is interesting. :)

You've repeated my point about multiple processes contributing to achieving an overall objective.

The rest of your point I didn't understand. :(
 
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