A confusing Non-conformity - No defined QMS processes intended for 'Management'

[tyolsal]

Hello there ,

Does anyone have an opinion about this non-conformity given to my one of supplier during their ISO 9001:2008 certification audit ?

The NC was given to item 4.1 .
Details of NC (word for word): "It's determined that the organization have not defined QMS processes intended for 'Management' and 'Provision of Resources' activities."

The Corrective Action recommended is simply : "Review your process documents according to standard"

Note: In their Quality Manual, it is explained how they carry out these activities with one or two paragraphs as usual in most quality systems.

My question ;
1) Is there any need for an additional explanation using a process map or a procedure for these processes as specially noted down in Item 4.1-Note 1 ?
2) How can be a process map for "Management Activities" and "Provision of Resources" ?

Thanks in advance

 

[SteelMaiden]

Re: A confusing Non-conformity

First and foremost - when there is confusion about an nonconformance, it is better to ask the auditor to explain it right then and there. We do appreciate that you quoted the nonconformance, that may help someone to see something out of line.

My feelings are that if the only place you talk about (they talk about) management processes or resource management is a paragraph or two in a quality manual, there may not be a very thorough, or concrete documentation of these two processes.

Please tell your supplier to contact their auditor as soon as possible and ask for clarification so they do not spend a lot of time chasing shadows.

 

[qusys]

Re: A confusing Non-conformity

I would like to know more on the collected evidences to issue this non conformity ( is it minor??): it seems vague without attending at the audit.
So I can assume but not sure on it.

Probably interactions between QMS process are not clear or decision making process for provision resources and management activities was not supported by data.
I think that these are aspects of management reviews process.
Generally speaking, having processing mappings for all key processes is not a requirement. The requirement for an organization is only to indentify the necessary processes for QMS and their application all over the organization: then establish the sequence and relations among them.

Another idea could be that outsourced processes coud not be well set in terms of control.

hope this helps

Hello there ,

Does anyone have an opinion about this non-conformity given to my one of supplier during their ISO 9001:2008 certification audit ?

The NC was given to item 4.1 .
Details of NC (word for word): "It's determined that the organization have not defined QMS processes intended for 'Management' and 'Provision of Resources' activities."

The Corrective Action recommended is simply : "Review your process documents according to standard"

Note: In their Quality Manual, it is explained how they carry out these activities with one or two paragraphs as usual in most quality systems.

My question ;
1) Is there any need for an additional explanation using a process map or a procedure for these processes as specially noted down in Item 4.1-Note 1 ?
2) How can be a process map for "Management Activities" and "Provision of Resources" ?

Thanks in advance

 

[AndyN]

Re: A confusing Non-conformity

It's simple!

If anyone, who (like us) was not present at the audit, cannot determine what is being reported, it's not a non-conformity!

It might be a 'finding', in other words there may be a real issue here, but unless it's been well communicated, it's not a non-conformity.......

 

[Marc]

Note the OP may not be a native English speaker so there may be language issues.

 

[Sidney Vianna]

Hello there ,

Does anyone have an opinion about this non-conformity given to my one of supplier during their ISO 9001:2008 certification audit ?

The NC was given to item 4.1 .
Details of NC (word for word): "It's determined that the organization have not defined QMS processes intended for 'Management' and 'Provision of Resources' activities."

The Corrective Action recommended is simply : "Review your process documents according to standard"

Note: In their Quality Manual, it is explained how they carry out these activities with one or two paragraphs as usual in most quality systems.

My question ;
1) Is there any need for an additional explanation using a process map or a procedure for these processes as specially noted down in Item 4.1-Note 1 ?
2) How can be a process map for "Management Activities" and "Provision of Resources" ?

Thanks in advance

What is missing here for this to be a valid non-conformity is the objective evidence that might have led the auditor to that conclusion. Having process maps for management and resource establishment processes (or any other type of process, for that sake) is NOT a requirement from the standard. From the Guidance on the Concept and Use of the Process Approach for management systems document, we read:

3.2 Typical types of processes that can be identified:

In accordance with 3.1 above, organizations have to define the number and types of processes needed to fulfil their business objectives. While these will be unique to each organization, it is however possible to identify typical processes, such as:

- Processes for the management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, ensuring communication, ensuring availability of resources for the other organization’s quality objectives and desired outcomes and for management reviews.

- Processes for managing resources. These include all the processes that are necessary to provide the resources needed for the organization’s quality objectives and desired outcomes.

- Realization processes. These include all processes that provide the desired outcomes of the organization.

- Measurement, analysis and improvement processes. These include the processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring, auditing, performance analysis and improvement processes (e.g. for corrective and preventive actions). Measurement processes are often documented as an integral part of the management, resource and realization processes; whereas analysis and improvement processes are treated frequently as autonomous processes that interact with other processes, receive inputs from measurement results, and send outputs for the improvement of those processes.

For the management process, if the auditor was able to find the objective evidence, which I colored in blue, s/he can not state that management processes have not been established. For the management of resources, until s/he can show objective evidence that something is not done for lack of resources, he can not write it up as a non-conformity. I would dare to say that the auditor in question is in the early stages of a learning process and still grasping to understand and properly interpret the standard at hand.

 

[JaneB]

Sidney,

I agree, both with your diagnosis and most likely cause.

What I would do is: take it up with the CB's management, pointing this out. An auditor must have evidence on which to base an NC. There isn't any. And as Sidney has rightly pointed out, there's no requirement in the Standard to document such processes.

 

[howste]

The organization shall
a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes...

NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.

I believe this is the requirement.

Without more evidence, I can only speculate what the auditor was thinking. Perhaps the problem is that the manual had a process map (or other method) showing other QMS processes, but didn't include processes for these two areas? Or perhaps the interactions with the other processes have not been identified in the manual?

How exactly does the manual describe the process interactions as required in 4.2.2?

 

[harry]

I came across a recent case over here where the auditor insist that one must have a policy section where you must have at least a few sentences to describe how you are going to address a particular clause of the standard. Without which, it will be interpreted that you had not met the requirements of the standard and an NC worded in the same manner as that brought out by the OP. (This was resolved after the auditee insisted that he gets a second opinion from head office). I am wondering if the original poster is facing the same issue.

From what I understand over here, this was the interpretation or way it was done for the pre-2000 versions and some auditors had not updated their knowledge since.

 

[JaneB]

Without more evidence, I can only speculate what the auditor was thinking.

And that's the difficulty. As you say, without clearer information, we can only speculate and guess.

A hallmark of a clearly expressed and effective NC or CA is that is very clear:
* what the problem is
* which requirement/s (policy, clause whatever) are not met
* what the evidence is that shows that.

This one doesn't do any of these.