5.4.1 Quality Objectives - Nonconformity: The process was not fully effective

[Roberto Vigo]

During a previous surveillance audit, the auditor wrote a Minor CA for us not having relevant objectives. The Auditor wrote:

Nonconformity: The process was not fully effective in that objectives weren’t at relevant functions and levels.
Evidence: There were quality objectives, however they weren’t at relevant functions and levels within the organization (only three top level objectives).

Our objectives were, Percentage RMA's per month, Sales per month, Tardies percentage per month (we have a tardiness problem).

The auditor then went on dictating what relevant objectives we should have. I feel that this should have been an observation, versus a CA. Is anyone in agreement? Disagreement?

 

[ScottK]

Re: 5.4.1 Quality Objectives

Hi Robert - is this in reference to ISO9001 or ISO13485? - asking so it can be placed in the right sub-forum.

I think we need more info to judge.... are those the only three objectives for the whole company?
As far as an auditor recommending objectives, that's fine but you are not obligated to use their recommendations as long as your make sense for your business.

 

[Roberto Vigo]

Re: 5.4.1 Quality Objectives

ISO 9001-2008

 

[Helmut Jilling]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

During a previous surveillance audit, the auditor wrote a Minor CA for us not having relevant objectives. The Auditor wrote:

Nonconformity: The process was not fully effective in that objectives weren’t at relevant functions and levels.
Evidence: There were quality objectives, however they weren’t at relevant functions and levels within the organization (only three top level objectives).

Our objectives were, Percentage RMA's per month, Sales per month, Tardies percentage per month (we have a tardiness problem).

The auditor then went on dictating what relevant objectives we should have. I feel that this should have been an observation, versus a CA. Is anyone in agreement? Disagreement?

This is a misinterpretation and misapplication of the requirement. The auditor made an error. The requirement is that Objectives which are defined must be COMMUNICATED to the relevant levels. That means if it is a maintenance objective, it must be communicated to and known by the relevant maintenance personnel, but not necessarily by the purchasing people, because it may not be relevant to them.

The clause in no way specifies what your objectives should be. It is useful to look up the clauses during an audit, to see what the actual wording is... You may want to discuss this finding with the CB. It is not appropriate in its current form.

PS: based on the objectives you do cite, there is probably room for improvement in this area of your system. But the finding as written may not be valid.

 

[Big Jim]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

This is a misinterpretation and misapplication of the requirement. The auditor made an error. The requirement is that Objectives which are defined must be COMMUNICATED to the relevant levels. That means if it is a maintenance objective, it must be communicated to and known by the relevant maintenance personnel, but not necessarily by the purchasing people, because it may not be relevant to them.

The clause in no way specifies what your objectives should be. It is useful to look up the clauses during an audit, to see what the actual wording is... You may want to discuss this finding with the CB. It is not appropriate in its current form.

PS: based on the objectives you do cite, there is probably room for improvement in this area of your system. But the finding as written may not be valid.

I'm not sure that I fully agree with the auditor in that I suspect there could have been more and perhaps should have been more.

I don't agree with Helmut's intrepretation either.

What the standard says is that quality objectives need to be established at relevant functions and levels within the organization. To me, establish is not a matter of employee knowledge and maintenance of that knowledge.

Back to the OP. What the certification bodies (and they are pushed by the accreditation bodies) are driving for today is developing KPI for each of your core processes. There is nothing to keep you from using any one KPI for more than one process or more than one KPI for any one process.

Guidance for what to use for quality objectives / KPI can be found in element 8.4 where you are told you need to do analysis of data to determine the health of your system, and goes on to give you four topics that must be covered with them; customer satisfaction, product quality, process conformity (often shown overall as on-time delivery), and supplier performance.

Go to your interaction of processes chart and determine what you say your core processes are, and line them up to the above KPI.

A typical example could be:
Management Process - Customer Satisfaction
Sales - Customer Satisfaction and On-time Delivery
Production Planning - Product Quality and On-time Delivery
Purchasing - Supplier Performance
Manufacturing - Product Quality
Quality - Product Quality
Shipping / Receiving / Warehouse - On-time Delivery

Of course, you need to set goals for each of those and your mix of core processes are likely to be different.

I have a plane to board or I would say more but best of luck.

 

[Randy]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

Objectives belong to the organization

Relevance belongs to the organization


Have objectives been established? YES or NO ..... If YES, move on. If NO, then why not?

Are objectives being achieved? YES or NO..... If YES, move on. If NO, why not? (Lots of questions here with 100 potential answers)


If both are YES, then who or why give a krap about relevance because success is presenting itself.........Move on!

 

[Sidney Vianna]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

Have objectives been established? YES or NO .....

Not so simple. Is "sales per month" an objective? Maybe. Is it a QUALITY objective? Most likely, not. Especially because, as discussed numerous times, increased sales CAN have a negative impact on product quality and customer satisfaction, if not properly managed.

While increase sales is a (very important) business objective, in my opinion, it does not satisfy the definition of a quality objective, thus, it should be rejected by an auditor assessing the system against ISO 9001.

Of course, you need to set goals for each of those

I agreed with everything you posted, but not this. Goals are optional. ISO 9001 does not mandate quantitative goals associated with the objectives.

 

[Big Jim]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

I agreed with everything you posted, but not this. Goals are optional. ISO 9001 does not mandate quantitative goals associated with the objectives.

I see your perspective, but let me point out that I am encouraging the use of KPI to fulfill three elements of ISO 9001: 5.4 about quality objectives, 8.2.3 about monitoring and measuring your processes, and 8.4 about analysis of data.

Looking specifically at 8.2.3, "These methods shall demonstrate the ability of the processes to achieve PLANNED RESULTS. When PLANNED RESULTS are not achieved, correction and corrective action shall be taken, as appropriate". (emphasis added)

I submit that planned results are goals.

On further reflection, goals are built into objectives by the very definition of an objective. The Merriam Webster Dictionary defines objective as "something you are trying to do or achieve: a goal or purpose" and "something toward which effort is directed: an aim, goal, or end of action".

 

[RoxaneB]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

During a previous surveillance audit, the auditor wrote a Minor CA for us not having relevant objectives. The Auditor wrote:

The process was not fully effective in that objectives weren?t at relevant functions and levels.

There were quality objectives, however they weren?t at relevant functions and levels within the organization (only three top level objectives

Our objectives were, Percentage RMA's per month, Sales per month, Tardies percentage per month (we have a tardiness problem).

The auditor then went on dictating what relevant objectives we should have. I feel that this should have been an observation, versus a CA. Is anyone in agreement? Disagreement?

In line with Sidney's thoughts, how are your objectives related to Quality? I have no clue what an RMA is. Sales does not equate to better quality or meeting customer requirements - especially if I'm an existing customer and now you've increased your sales to other people potentially resulting in a longer lead time to meet my requirements. Tardiness, as well, has a very blurred and uncertain connection to quality - unless you mean it's resulting in a high turnover so the existing employee base has less experience and requires more time to complete a product or provide a service. Still, I'm really having to work at trying to see the connection Quality.

Next point...relevant functions and levels. How are your objectives communicated to the appropriate people? More than that, how are actions developed to address the objectives? Who is involved in these actions (both the development and execution and monitoring)?

So, let's go back to tardiness. If the auditor was speaking to an employee about the objectives and the employee had no clue about the tardiness issue or the actions or the goals or the objective or what his/her role was in helping support the achievement of the tardiness objective, then, yes, there is a gap here.

You've provided us with the auditor's nonconformance but what is your organization's argument against it? Is there evidence to the contrary of what was written by the auditor?

 

[Kronos147]

Re: 5.4.1 Quality Objectives - Nonconformity:The process was not fully effective

FWIW, I see the situation as Big Jim see it.

The metrics are more effective when it's clear to what process they pertain. They metrics may reflect up the performance of more than one process.