Hello forum

Some of you might remember me posting under the nickname "atetsade" around 2003, seeking help and advice in creating and ISO 9001:2000 QMS for my father's screw machine shop.

I've moved on from there, and have just joined a company as a CNC machinist.

This company is in the final stages of ISO 9001:2000 implementation and has a registration audit in one month. They have impressed me with their dedication and top management commitment to ISO 9000. Today they brought the entire company of 20 persons to a hotel conference room to discuss the standard and to do implementation training.

The presenter was a consultant for the company, and walked us all through the entire standard, section by section.

I was surprised when we reached section 8.2.3, Monitoring and Measurement of Processes. The discussion was not what I expected. The discussion was about tumbling or "rock shaking" parts, and how this was a process that needed to be monitored. The explanation was that we needed to monitor the parts tumbler so that the parts weren't over-tumbled.

This worried me quite a bit, since 8.2.3 is obviously talking about monitoring and measurement of the quality management system processes defined in section 4.1. I thought, well, maybe the consultant was trying to skip going into the process approach, believing it would confuse the employees.

I approached her after the meeting and told her of my concern. She really didn't understand what I was asking about at first, and she tried to explain about the parts tumbling again.

I asked her if she had advised our company of the process approach and the need to identify key processes, as in the plan-do-check-act cycle. She seemed to reply that this was not necessary, and that the company flow-chart was sufficient to satisfy the requirements of 4.1.

Their flow-chart is a traditional sort of chart showing all the steps that product takes through the company, but it does not show inputs and outputs of steps along the way. There didn't seem to be any real key processes defined, nor means to measure and improve the macro-level processes of the company.

Should I be concerned about this? I try to stay out of people's QMS efforts. Most of the time, my inputs seem unwelcome, and besides, I have more fun making parts. However, there seems to be a real lack of understanding about the process approach in this company's QMS, and given their take on 8.2.3, it seems they may have an issue coming up in their registration audit with Perry Johnson.

Would this be a major finding during registration audit?

So it sounds like the only processes the company has defined are the "product realization" processes? There is a note below 4.1 that clearly shows that there need to be more QMS processes defined than these:
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
This is clarified further in the draft of the new ISO 9001:2008 standard:
NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.(my bold showing changes)

You are spot on, explaining that 8.2.3 isn't just for product realization processes. It sounds like you were explaining to her that clause 8.2.3 is for all QMS processes. I believe 8.2.3 gives more detail of what is required in 4.1e:
The organization shall...
e) monitor, measure and analyse these processes...

Should you be concerned? As an employee who knows better, yes. But more importantly, top management should be concerned.

Whether this will this lead to a nonconformity is a different question. If I interpreted what you said correctly, I believe it should be a nonconformity. The draft standard shows the intended interpretation of the current version, that processes other than product realization must be defined. Also the quality manual must show the interactions between the processes, which appears to be missing. However, I've seen too many auditors that either don't understand it that way or shy away from writing this for some reason.

Chances are that even if the organization doesn't understand 8.2.3 as intended, they may still meet the requirement because of business metrics and the requirements of 5.6 and 8.4.


By the way, why the user name change? I remember you were a pretty frequent poster before...

Hello forum

Some of you might remember me posting under the nickname "atetsade" around 2003,

Hi, we could change your user name from "atetsade" to "apestate" - thus your previous posts shall also refer your new name.

Just let us know and we could change it - no need to create a new user name :)

I've seen too many auditors that either don't understand it that way or shy away from writing this for some reason.

We do have such auditors around here also. I think these are the people who do not see the need to apply the principle of continuous improvement - they choose to remain with the 1994 version.

Thank you for your extended explanation howste. You have put my concerns into precise terms.

You are correct that the company's flow chart is limited to product realization processes. That is something almost tangible that I can approach the company with. That is exactly the root of the problem.

This gives me something specific to bring to their attention. I will try to present the process approach principle in the best way I can, and bring along my own documentation to make it look easier for them. It'll be a good chance to do a refresher on ISO 9000, and I'll have done my best to help the company out.

I think you guys are correct that some people shy away from the process approach because they don't understand it, or wish to avoid it. Hopefully that changes with the 2008 revision!

Ajit Basrur, thank you for the offer. I would like to change my name from atetsade to apestate. atetsade was simple "apestate" upside down / umop apisdn.

So it sounds like the only processes the company has defined are the "product realization" processes? There is a note below 4.1 that clearly shows that there need to be more QMS processes defined than these:

This is clarified further in the draft of the new ISO 9001:2008 standard:
(my bold showing changes)

You are spot on, explaining that 8.2.3 isn't just for product realization processes. It sounds like you were explaining to her that clause 8.2.3 is for all QMS processes. I believe 8.2.3 gives more detail of what is required in 4.1e:


Should you be concerned? As an employee who knows better, yes. But more importantly, top management should be concerned.

Whether this will this lead to a nonconformity is a different question. If I interpreted what you said correctly, I believe it should be a nonconformity. The draft standard shows the intended interpretation of the current version, that processes other than product realization must be defined. Also the quality manual must show the interactions between the processes, which appears to be missing. However, I've seen too many auditors that either don't understand it that way or shy away from writing this for some reason.

Chances are that even if the organization doesn't understand 8.2.3 as intended, they may still meet the requirement because of business metrics and the requirements of 5.6 and 8.4.


By the way, why the user name change? I remember you were a pretty frequent poster before...

I agree with everything that Howste has here and would like to add something to it. I read in your post that "They have impressed me with their dedication and top management commitment to ISO 9000." If your impression is correct then it is unlikely that it would generate a major or minor NC, more likely an opportunity for improvement of the QMS. But keep in mind what Howste said "it should be a nonconformity," and he is an expert at this. :agree1: Please let us whether this is identified during the Certification audit as an issue or concern of some type. I would be surprised if they even note it consedring it is with PJ. ;)

...You are correct that the company's flow chart is limited to product realization processes. That is something almost tangible that I can approach the company with. That is exactly the root of the problem.

This gives me something specific to bring to their attention. I will try to present the process approach principle in the best way I can, and bring along my own documentation to make it look easier for them. It'll be a good chance to do a refresher on ISO 9000, and I'll have done my best to help the company out...

…I guess, this will be the best approach you can do as of now… I’m sure your company is somehow adopted an improvement scheme where employee can suggest or recommend something for correction, corrective action, preventive action and/or continual improvement… use this scheme…

…whatever happens, at least you did your part…

Thank you for your extended explanation howste. You have put my concerns into precise terms.

You are correct that the company's flow chart is limited to product realization processes. That is something almost tangible that I can approach the company with. That is exactly the root of the problem.

This gives me something specific to bring to their attention. I will try to present the process approach principle in the best way I can, and bring along my own documentation to make it look easier for them. It'll be a good chance to do a refresher on ISO 9000, and I'll have done my best to help the company out.

Good luck! Please let us know how it all turns out...

Thanks all

I will let you guys know what the outcome is. It will be interesting.

Incidentally, thanks Marc and Ajit for merging my login accounts. Worked perfectly. :D

Thanks all

I will let you guys know what the outcome is. It will be interesting.

Incidentally, thanks Marc and Ajit for merging my login accounts. Worked perfectly. :D

So you have a bigger karma now ;)

Tricky situation, but you're definitely right on the money.

Howste has given you very good advice.

This whole thing of a process approach is still badly understood/misunderstood/not understood in a lot of quarters, alas.

Once I had the problem clearly defined by howste, I was able to look at their documentation more closely and get a better picture of the issue at hand.

They have included the four key processes ISO 9001:2008 notes in their process interaction flowchart.

Better not to mention this, I think, since I am new in the company and they are a bit frazzled by a rushed implementation and no one else in the company has the benefit of first-hand experience of getting through a registration audit, yet.

It would be an excellent suggestion for continuous improvement, though, and thank you for that idea.

Now I am single-handedly doing all their internal calibration! I asked if I could help out after showing the owner some of my credentials, and was handed the whole job. Then I noticed none of their thread gages have been calibrated, and all the calibrations they've done internally are just on micrometers, and nobody wrote down results of before/after tests and measurements. And, the procedure is just some copied thing. :rolleyes:

Oh well, it's a nice little company and I like the people there :D

Oh well, it's a nice little company and I like the people there :D

What a great opportunity to make a dramatic difference and gain the trust of the owner to support the implementation of other improvement initiatives.

Good luck!

Stijloor.

What a great opportunity to make a dramatic difference and gain the trust of the owner to support the implementation of other improvement initiatives.

Indeed yes. Sounds like you could be there for a while, Apestate.