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

[Paul Simpson]

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

4.1 General Requirements a) determine the processes needed..., and 4.2.2 Quality Manual c) a description of the interaction between the processes of the QMS. 5.6.2 c), 5.6.2 a)

I think on another thread I saw you mention you're off to join a CB. Good luck with that. Hopefully as part of your induction they will reinforce the need to present assessment of facts objectively and accurately.

Back to your comments. 'Determine the processes needed ...' allows a wide flexibility in approach so you might need to delve a little deeper into 4.1 but I'm betting you don't find a requirement there.

If, in addressing the requirements of 4.2.2 c, I have a paragraph in the manual that described in text format an outline of how my processes are structured and operated you would raise that as a NC? If the answer is no then the 'interaction of processes chart' listed as a 'must have' is but one way of meeting the 9001 requirement. I have seen many including a video!

In 5.6.2 c) the requirement is for top management to review process performance - not that all processes within the organization have KPIs. It is for the organization to decide where and how many objectives, process measures and KPIs they have - not for the CB to come in with an expectation.

 

[Kronos147]

I think on another thread I saw you mention you're off to join a CB. Good luck with that.

Thanks!

Hopefully as part of your induction they will reinforce the need to present assessment of facts objectively and accurately.

I have not done my training yet, but my understanding is that is their goal.

Right now I think I am answering from the perspective of I am a QA Manager who wants an effective QMS, not just compliant. Maybe I'm over the top, but I don't wait for the word "shall" to appear before I consider it a 'hard' requirement.

If, in addressing the requirements of 4.2.2 c, I have a paragraph in the manual that described in text format an outline of how my processes are structured and operated you would raise that as a NC? If the answer is no then the 'interaction of processes chart' listed as a 'must have'

I personally (at this point) don't see a reason to get hung up on the format a company decides to address a requirement. I am big on clause 0.1. The design and implementation (of the QMS) is influenced by... its particular objectives.

If a company is making a bunch of metrics and meausurements up to satisfy an auditor, it is ineffective. I walked into a company, and noticed right away that the metrics were nonsense. I questioned them and the answer was something about "bare minimal compliance."

The CB audit happened a couple of weeks later, with me in as an observer who would take over the role of MR after the audit. The auditor dug into Management Review, and none of the process owners could explain how they measured the process with the data presented at management review. They all discussed alternate methods of tracking their processes. Further examination of the management reports could not tie in to any definitive tracking (data accumulation) methods. Summary sheets indicated different scores than the actual results. In short, it was all make believe.

If the numbers matched, I could have argued that we meet the requirement by keeping metrics. I wouldn't argue the finding because it was beneficial and it led to making the system more effective.

 

[Paul Simpson]

Thanks, Kronos nad sincere good wishes for the new role. Auditors get a tough time on here when they start to bring in expectations that the standard does not require and you have to consider my response in the context of the OP - how to respond to an auditor NCR.

The value in discussing these findings is to evaluate whether a requirement actually exists and what an organization should do to meet the requirement. If someone draws a conclusion then they have to be able to justify it.

If you're the QM designing your organization's QMS then my first recommendation is don't start with the standard or an auditor's interpretation of it. I agree with Jim (shock horror) that a KPI can be used to satisfy a number of 9001 requirements and if you use them then draw as many links to requirements as you can when explaining your system to the auditor.

Where he and I tend to diverge is when this is presented as an expectation and 'the one way' of satisfying the standard and CB auditor.

 

[Kronos147]

Where he and I tend to diverge is when this is presented as an expectation and 'the one way' of satisfying the standard and CB auditor.

I see some people getting stuck on "the one way" idea too. Another good reason to read the Cove.

 

[Big Jim]

Thanks, Kronos nad sincere good wishes for the new role. Auditors get a tough time on here when they start to bring in expectations that the standard does not require and you have to consider my response in the context of the OP - how to respond to an auditor NCR.

The value in discussing these findings is to evaluate whether a requirement actually exists and what an organization should do to meet the requirement. If someone draws a conclusion then they have to be able to justify it.

If you're the QM designing your organization's QMS then my first recommendation is don't start with the standard or an auditor's interpretation of it. I agree with Jim (shock horror) that a KPI can be used to satisfy a number of 9001 requirements and if you use them then draw as many links to requirements as you can when explaining your system to the auditor.

Where he and I tend to diverge is when this is presented as an expectation and 'the one way' of satisfying the standard and CB auditor.

You and I are more alike than you realize.

Remember, I was in a hurry to provide some insight to the OP, who may by now stopped following the thread due to our internal bickering.

It was unfortunate that I chose the term "chart" when referring to the interaction of processes. I used that term because it is the most common form. I'm well aware that the correct wording from the standard is "description", and when I find a non-chart format for the interaction of processes I'm OK with it as long as it does the job effectively.

If you have not noticed, there has been a push for the last few years to audit to 8.2.3, something that wasn't done very well in the past. Organizations didn't understand it and when auditors didn't find much about it they ignored it. I think they didn't understand it very well either. My take on this is that we were shown how this could be done.

You may remember on one of my posts in the last few weeks I pointed out that organizations are expected to live to 8.2.3 and that the use of KPI is a way to do it. I challenged others to post how they were handling it by monitoring, not measuring. There was only one response, and the method presented seemed a bit awkward.

My point is that something needs to be done to monitor and measure your processes and an organization needs to be able to explain how they do it if an auditor asks.

The biggest sore spot of this whole thing to me is the lack of a clear definition of what is meant by a process. TC-176 has not adequately addressed this. The definition from ISO 9000 is basically that it is something with inputs and outputs to which value has been added. There are places in the standard where it seems clear that they are talking primarily about business processes, such as the lettered portion of 4.1. There are places they could be talking talking mainly about manufacturing processes, such as 7.5.2. There are places that it isn't at all clear which one they mean, such as 8.2.3 (although I believe it is mainly business processes intended). Peace

As long as there is no clear definition of what a process is, there will continue to be much confusion.

And thank you for un-knotting your knickers. You are much more pleasant this way.

Peace

 

[Paul Simpson]

You and I are more alike than you realize.

now you have me seriously worried.

Remember, I was in a hurry to provide some insight to the OP, who may by now stopped following the thread due to our internal bickering.

That can often be the case: 'Post in haste, repent at leisure.' I hope the OP has continued to follow the thread but the point is I thought the advice was poor. There is no bickering on my part. I may have pointed out that we often disagree.

It was unfortunate that I chose the term "chart" when referring to the interaction of processes. I used that term because it is the most common form. I'm well aware that the correct wording from the standard is "description", and when I find a non-chart format for the interaction of processes I'm OK with it as long as it does the job effectively.

OK. So we are agreed there are many ways of dealing with this requirement.

If you have not noticed, there has been a push for the last few years to audit to 8.2.3, something that wasn't done very well in the past. Organizations didn't understand it and when auditors didn't find much about it they ignored it. I think they didn't understand it very well either. My take on this is that we were shown how this could be done.

I think there have been a lot of people who have recognised flaws in the assessment process since the 2000 edition. I wouldn't say 8.2.3 is the main problem. The issue starts with process definition - clause 4.1 as you have mentioned. Unless you do a good job here then 8.2.3 is pretty meaningless.

You may remember on one of my posts in the last few weeks I pointed out that organizations are expected to live to 8.2.3 and that the use of KPI is a way to do it. I challenged others to post how they were handling it by monitoring, not measuring. There was only one response, and the method presented seemed a bit awkward.

I didn't see this. Or if I did I don't remember it. I under stand all organisations have to address 8.2.3 but not that they have to 'live to' it. So there may be many processes that don't need KPIs but that do require monitoring. A classic non-core process of auditing is one where the organisation looks to complete its annual audit programme but doesn't necessarily need a monthly or weekly KPI to track it.

My point is that something needs to be done to monitor and measure your processes and an organization needs to be able to explain how they do it if an auditor asks.

Agreed. So long as the auditor doesn't come in asking: 'Show me your audit KPIs'

The biggest sore spot of this whole thing to me is the lack of a clear definition of what is meant by a process. TC-176 has not adequately addressed this. The definition from ISO 9000 is basically that it is something with inputs and outputs to which value has been added. There are places in the standard where it seems clear that they are talking primarily about business processes, such as the lettered portion of 4.1. There are places they could be talking talking mainly about manufacturing processes, such as 7.5.2. There are places that it isn't at all clear which one they mean, such as 8.2.3 (although I believe it is mainly business processes intended). Peace

I'd agree that understanding of processes is poor. I don't lay all the blame at TC 176's door, though. Although the ISO 9000 definition is poor (inputs into outputs) clause 4.1 in 9001 and the guidance in 9000 and 9004 provide useful information that users can take and develop their QMS around.

As long as there is no clear definition of what a process is, there will continue to be much confusion.

Agreed. I don't think TC 176 will be able to come up with a definition that meaningfully addresses the full range of processes from document control through widget machining to business planning.

And thank you for un-knotting your knickers. You are much more pleasant this way.

Peace

while I am happy you are happy I don't post here to be seen as pleasant (but in fairness I don't post to be unpleasant, either). I tend to react unequivocally when I see posts that can create confusion and contradict that post specifically.

 

[drgnrider]

We have two of the same objectives at our factory as the OP, and three CB auditors have not had issues with them once they were explained. These are our ?high-level? objectives that everyone is made aware of, communicated, and progress is posted. What I see is that the OP has not really presented what the full objective is and the reason(s) ?why? these objectives, (there might be a valid explanation), and if there is a defined metric.

1) ?Absenteeism below 2%? - When people are not here, customer satisfaction falls. We missed a number of ship dates; a big part of the RCA: having to shift people from one project to another to get the one out... this in turn causes the other get behind... sloppy workmanship as it is rushed to meet the deadline... it is a vicious cycle. This has been set as a factory objective and deployed to the departments, it is on the managers to determine their individual fix.

Early shipping used to be a goal, but since we were unable to properly track all of our shipments (flawed corporate shipping system-very recently fixed), this was the next big hitter on our RCA. Even our ?on-time shipment? numbers fell off 30% when this new system went online? in the beginning, we had to manually do every shipment. So while corporate was fixing the software issue we tackled the next big item... the absenteeism.

2) Reduction of RMA?s, ours is ?15% reduction in NCR (non-conformance reports) costs? ? basically the part did not meet quality standards, either internal QA or was a valid complaint by the customer and it cost us $$$$ to correct it. This goal is now up to each production manager, with the aid of the CA?s and NCR?s, to determine what he is going to do with his department to reduce the department cost.


Roberto, as for how to handle this, the objectives belong to the business, not the interpretation of the auditor. As long as you can give a ?quality? reason why and a metric, there should not be an issue. If not readily understood from the audit report, I would ask for further clarification as to the why this was listed as an NC.
- As for your "sales per month", I agree with Sidney and Roxane, this is a stretch and you would have to show me how this relates to quality before I would accept it.



drgnrider

 

[Johnson]

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?

Setion 5.4.1 of ISO9001:2008 states:
Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
The easiest way to mee this requirements is to assign each of the company level objectives to department level.

 

[John Broomfield]

Setion 5.4.1 of ISO9001:2008 states:
Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
The easiest way to mee this requirements is to assign each of the company level objectives to department level.

Johnson,

By their nature most, if not all, processes involve two or more departments.

So, why have cross-functional processes compete with departmental objectives?

It's better for each process to have an objective and for the departments to collaborate in fulfilling their process objectives.

After all, the management system is meant to be process-based not department-based.

John

 

[Syed11]

1. Are SMART Objectives compulsory?

2. Can an auditor raise NCR for not having SMART Objectives?

3. If SMART Objectives are compulsory then what is the reference?