Some departments don't have Quality Objectives - Non Conformity?

[AndyN]

5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.


My question is this :

Are the "relevant functions " necessary to meet product requirements a subjective notion ?

can a company that sells to a customer a product X really pretend that the function (purchasing) that allows it to BUY product X from its supplier is not "relevant" to meet product requirements ?

i find that hard to understand

furthermore how can HR not be a "relevant" function to meet product requirements when HR is in charge of recruitment and training of employees??? Even more so when the product is a service like support ?

I'm really having a hard time understanding

Another question :

If my Quality Manual says that quality objectives must be created at the HR and purchasing levels , would the absence of quality objective constitute a non conformity then ?

Let me answer the last question first, yes it would be an nc - but against your QMS manual!

It may be in some businesses that HR and Purchasing have a significant role in the overall achievement of objectives, but - equally - in some organizations the roles are quite limited. We don't make shouldn't assumptions, in answering because we don't know which is which for your business! You have told us some things, but really insufficient to allow us to give you an answer pertinent to your situation.

From my reading of what you wrote, the auditors didn't do a very effective job, because they were probably auditing from ISO 9001 and not the manual - which you indicate (now) may have the requirements for objectives. The manual would have been a better document to audit from. Had this been the case, the auditors would have written their findings and the point wouldn't be discussable.

Let's not forget that the QM is a keystone in the quality system. If it doesn't say that objectives are established in some of these departments/functions/processes, then you will have a nightmare - as indeed these posts have shown!:mg: Why didn't these places have any objectives, anyways?

Perhaps your organization should go back to basics of understanding what the quality system is there to achieve and get everyone aligned...

 

[Sardokar]

Why didn't these places have any objectives, anyways?

...

because the department manager cant be ***** to create them

having a wee bit of trouble getting everyone on board the quality system train

 

[AndyN]

because the department manager cant be ***** to create them

having a wee bit of trouble getting everyone on board the quality system train

Aha! Hence my comment regarding revisiting the whole thing!

 

[AndyN]

Going back over some of your previous posts it appears the HR manager has been the proverbial 'fly-in-the-ointment'. Many managers rail against objectives, because they fear being held to account for their process performance. So, this is a reflection of the most senior manager's attitudes. IS this person clear about what the management team have to achieve? Maybe it's time for a heart to heart with both of them - and you might need to enlist the help of a consultant.

It might be worth going back to basics with them. Do they understand 'S.M.A.R.T.' as applied to objectives (do you?). Once it's clear it's the process performance that's under scrutiny and that the HR manager has to be accountable, after that you get to find out if they're really management material after all...this can be fun!

 

[Big Jim]

Let me answer the last question first, yes it would be an nc - but against your QMS manual!

From my reading of what you wrote, the auditors didn't do a very effective job, because they were probably auditing from ISO 9001 and not the manual - which you indicate (now) may have the requirements for objectives. The manual would have been a better document to audit from. Had this been the case, the auditors would have written their findings and the point wouldn't be discussable.

Should not the auditor be auditing against both the quality manual / procedures and the ISO 9001 standard?

 

[AndyN]

Should not the auditor be auditing against both the quality manual / procedures and the ISO 9001 standard?

Emphatically, No! Let me explain:

The ISO standard is the reference/requirement for the design of the quality management system. Once the system is designed and meets the relevant requirements, it's implemented and the auditors verify that implementation. If they discover an implementation issue, they will report it and it will automatically become a non-conformity to the standard, won't it?

To audit to the design, once the system is built is like checking a house for building regs. after the owner moves in and lives there! Too darned late!

We read here, daily, about internal auditors who get all wound around the axle about what ISO says, then management don't understand, or take corrective actions and on and on - in the main because they have been taught, at a Lead Auditor course, to audit to the standard - and that's all they know!

 

[Rameshwar25]

If my Quality Manual says that quality objectives must be created at the HR and purchasing levels , would the absence of quality objective constitute a non conformity then ?

Let me answer the last question first, yes it would be an nc - but against your QMS manual!

Andy, My opinion is that if Quality Manual says that quality objectives must be created at the HR and purchasing levels, their absence will be NC against the process owner and not against Quality Manual (or against MR in most of the cases).
The process owner must have read the controlled copy of quality manual requiring q.objectives in his deptt. If he could not make objectives, this is problem with the process owner.
Moreover, i would again say, during internal audit absence of the q.objectives in both processes should be raised as NC. The intent during internal audit is to raise max number of NC to keep the QMS healthy and to prevent any major NC arising during external audit.
If all department would take advantage of words 'relevant functions' then system will be too dilute to be effective.

Rameshwar

 

[Big Jim]

Emphatically, No! Let me explain:

The ISO standard is the reference/requirement for the design of the quality management system. Once the system is designed and meets the relevant requirements, it's implemented and the auditors verify that implementation. If they discover an implementation issue, they will report it and it will automatically become a non-conformity to the standard, won't it?

To audit to the design, once the system is built is like checking a house for building regs. after the owner moves in and lives there! Too darned late!

We read here, daily, about internal auditors who get all wound around the axle about what ISO says, then management don't understand, or take corrective actions and on and on - in the main because they have been taught, at a Lead Auditor course, to audit to the standard - and that's all they know!

What is your source for this revelation? That certainly is against my understanding. My understanding is that internal auditors are to audit against both. A great deal of effort is made during internal auditor training on teaching the requirements of the standard first and formost as it is, as you say, the reference standard.

Actually, audits have still another dimension to it as well, and that is to audit the auditee's practice against the standard, and whatever documentation they may have. There is no requirement to have a documented procedure that covers every requirment in the standard. Often the auditee's documentation is silent about how they will meet certain requirements. In that case an auditor must audit the standard against their practice. Internal auditors need to audit in that manner too.

Please see 8.2.2 a:

"The organization shall conduct internal audits at planned intervals to determine the quality management system a) conforms to the planned arrangements, to the requirements of this international standard, and to the quality management system requirements established by the organization . . . "

(emphasis added)

Too late for what? If a building inspector found a code violation that impacted the safety of the inhabitants, should he keep his mouth shut because it is too late? I think not!

 

[AndyN]

What is your source for this revelation? That certainly is against my understanding. My understanding is that internal auditors are to audit against both. A great deal of effort is made during internal auditor training on teaching the requirements of the standard first and formost as it is, as you say, the reference standard.

Actually, audits have still another dimension to it as well, and that is to audit the auditee's practice against the standard, and whatever documentation they may have. There is no requirement to have a documented procedure that covers every requirment in the standard. Often the auditee's documentation is silent about how they will meet certain requirements. In that case an auditor must audit the standard against their practice. Internal auditors need to audit in that manner too.

Please see 8.2.2 a:

"The organization shall conduct internal audits at planned intervals to determine the quality management system a) conforms to the planned arrangements, to the requirements of this international standard, and to the quality management system requirements established by the organization . . . "

(emphasis added)

Too late for what? If a building inspector found a code violation that impacted the safety of the inhabitants, should he keep his mouth shut because it is too late? I think not!

Jim, you clearly have your views on many topics. They don't agree with mine - we've taken differing stances on many topics and I know well enough that whatever I post, you have a different viewpoint. My position has long been that, for example, just because a course teaches internal auditors to 'interpret' the standard doesn't mean it was the effective thing to do! As I've posted many, many times before here, we read daily about people who can't relate their audit findings in a manner that management understand. Where did the training stand on that? Do we expect management to know the words of ISO? I hope not!

Furthermore, the course content requirements of accredited auditor courses, hasn't changed in eons, based as it was on second party techniques. Where's the improvement in that? I could go on.

I've had too many experiences of ineffective audits, to agree with your approach, Jim. I can't imagine what yours has been, but we won't see eye to eye, clearly!

 

[AndyN]

Andy, My opinion is that if Quality Manual says that quality objectives must be created at the HR and purchasing levels, their absence will be NC against the process owner and not against Quality Manual (or against MR in most of the cases).
The process owner must have read the controlled copy of quality manual requiring q.objectives in his deptt. If he could not make objectives, this is problem with the process owner.
Moreover, i would again say, during internal audit absence of the q.objectives in both processes should be raised as NC. The intent during internal audit is to raise max number of NC to keep the QMS healthy and to prevent any major NC arising during external audit.
If all department would take advantage of words 'relevant functions' then system will be too dilute to be effective.

Rameshwar

Rameshwar - I may not have been too clear in my statement. The internal audit should have used the Quality Manual as the audit criteria. That would make it very clear to management that if the manual has been authorized by the most senior manager, then the process owner is in non-compliance! Not the manual!
It is a fact of management that they are accountable for their responsibilities to comply with the requirements of the quality management system, aren't they? So, the NC will paraphrase the requirement for all departments to establish objectives and they will be held accountable for corrective actions! You understand this part.

I cannot agree with your statement about raising the maximum ncs to keep things healthy. That is not correct! Internal audit is there to act as an independent verification for management, not to burden them with actions!