Monitoring and measurement of processes - How do you comply? ISO 9001 Clause 8.2.3

[Sidney Vianna]

Normally, my participation in this forum is more along the lines of answering questions, but I am very interested to learn more about the participants, that are willing to share their way of satisfying one very important requirement of the Std.

8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. . . .

For example, how do you monitor/measure your design and development processes? what about your purchasing process, supplier monitoring process, etc . . .

I see many times that organizations are still focusing solely on the product realization processes, by using yields, scrap rates, etc . . . but the standard goes beyond product realization and broadens it to include the rest of the QMS proocesses.

Sidney

If I were permitted to add a supplementary question it would be "how do people differentiate between 'monitoring' and 'measuring'? The official ISO/TC176 definitions seem not to be very helpful!

[Laura M]

I used "internal audits" as one way to monitor processes that do not have obvious measures. You monitor them at a frequency you determine. You can also used # of corrective actions as a result of the process.

I have several small companies that I work with. Therefore monitoring is often much more useful than measuring. For example, one company decided to look at "% turnover" - both management initiated and employee initiated as a measurement of employee satisfaction and also the management hiring process. When the data was actually plotted it was either "0" or "1" or as a percentage '0%" or '3%' so kindof irrelevant to plot. So now, each quarter, we look at the same data - more for information - Who quit and why? - as a monitor of HR practices.

I'd appreciate any feedback on this approach.

I have a chart in the quality manual that lists each process and whether its 'monitored' or 'measured (listing the metric) or both.

Laura

[Shaun Daly]

Sidney, I have recently come across the "6 Sigma" concept.

To be a "6 Sigma" company you have to have only 3.4 defects per million opportunities.

But dont just apply that to product quality.

Lets take purchasing; Say your company rule is "All purchase orders must be approved & faxed to the supplier within 2 days of the raised date".

Now, over a month you review your PO's, and send 150 out. 148 of them go out within 2 days, and 2 do not.

So 2/150*1000000=13,333 "Failed" PO's per million opportunities.

You cross reference that with a table to get your Sigma number.

This can be applied to any process to measure its efficiency.

I think I have explained it right, someone please correct me If I am wrong, its my birthday tomorrow & I am plastered

[edward.gibbs]

I agree that Six Sigma is an extremely powerful tool for meeting the Monitoring and Measurement requirement.

As one of our Six Sigma initiatives we developed a dashboard system. Each organization in the company identified their key processes and developed measures for those processes. For manufacturing it is yields, defects, SPC type stuff. For other organizations it is things like proposal capture rates, turn around time for Purchase Orders, training completed versus plan, etc.

Each organization has 5 or 6 key metrics, and they are posted in chart form on a dash board as you enter the area for all to see. Our senior staff does monthly walkarounds where they stop in front of each dashboard and quiz the managers on any issues the dashboard reveals, as well as compliment outstanding performance.

We had no trouble at all explaining to our auditor how we are monitoring and measuring our processes. In fact he wrote a nice complimentary observation regarding how we were using Six Sigma to great effect to satisy an ISO requirement.

Ed Gibbs

[Marc]

In Reply to Parent Post by Shaun Daly

Sidney, I have recently come across the "6 Sigma" concept.

To be a "6 Sigma" company you have to have only 3.4 defects per million opportunities.

But dont just apply that to product quality.

Six sigma is nothing more than using statistical techniques. I think the point is - or as I understand the 'new' ISO focus to be - Does each 'department' have objectives. Objectives imply a measureable (no measureable, how can you tell if you are meeting your objective?).

"To be a "6 Sigma" company you have to have only 3.4 defects per million opportunities." Ummm, well, I guess that depends on how you look at that and I suspect those companies are few and far between. Is that high volume manufacturing? What about job shops? Can purchasing be held to that 'standard' with regard to their obectives / measureables? In what process in a job shop of 40 people would one apply a requirement of < or = 3.4 defects per million opportunities? How would this apply to a trucking company where their main objectives relate to on-time pickup and on-time delivery? Can they only be late 3 or 4 deliveries out of a million deliveries? Can that even be achieved? Theory is nice. But then Reality rears its ugly head.

Every company is different. Some companies are very small where there are no departments per se.

I believe the factor here is to look at the company and their structure. From that determine what objectives are set and how they measure them. If it's a small, simple company, there won't be a whole lot of objectives. If it's a company of 20,000+ employees there are going to be (or should be) lots of objectives (many different departments, systems, even locations).

As to Sidney's original question, it is the whole of the new ISO requirements. Objectives and measureables. From those come the ability (without numbers, you're just guessing) to 'continually improve'. I see this as a QS-9000 off-shoot.

The rest of the stuff to me is what I call "Oh, my!". Take the 'new' theme of a 'Process Based Approach'. That is only so much hubris. I remember back around 1995 during an implementation at a large multi-national they were doing internal audits. I got a call. There was a complaint from a department that the auditors had come without notice. And they had. They had followed a trail from one department to another and wanted to see the followup. The complaining department was not on the audit scope so they got a surprise.

The failure was in the auditors planning. They were *supposed* to plan their audits so that inputs to what they were auditing (in this case a system in a department) and their outputs were verified. Simply said, they had to verify the interactions of each system (sound familiar?) including records and procedural interactions. The intent was not to take the whole company and do an internal audit of every department in the same audit. The audit team should have planned the paper trails they planned to follow. So - if a system (procedure, department, whatever) was being audited, had the auditors done their homework, they would have planned to follow specific paper trails and as such they should have included that department in the scope of the audit. Then, if they found somethiing outside the scope of the audit that they wanted to look at, they should have noted it for a future audit. Again, we're talking internal audits here - not registration audits where the whole company is fair game.

My point here is that the 'process' approach is neither new nor novel. The 'new' part is objectives and measureables being required throughout the company. I believe, at least to some degree, every company does have objectives or measureables - but maybe not the ones one might expect. Most of the clients I have worked with had appropriate measureables - often to the personel level. Most personnel have yearly reviews or similar where objectives are set to be reviewed in the next review. Departmental objectives generally exist.

Yet, I still run into companies which have no way of tracking scrap. Umm, Hello! This is 2003! The importance of tracking scrap has been known for many, many years. The 'new' requirements of ISO *may* help companies like that, but then I wonder where their management has been for the last 20 plus years.

[edward.gibbs]

I guess I see Six Sigma as a road to walk, rather than a destination to be reached.

You are of course correct that in many real world situations the goal of Six Sigma quality is un-acheivable. That doesn't negate the value of applying the process as a continuous improvement tool. You are also right that much of Six Sigma is simply SPC, but I do think it helps to drive the SPC concept into areas that traditionally were not considered as candidates for SPC.

The key is, as you said, to take a process approach, determine your KPI measurables, and set goals for those measurables that drive continuous improvement. For some of us that is not news, but for others it is.

An organization that is already effectively implementing a Six Sigma strategy should have to do little or nothing additional to meet the ISO requirements for monitoring and measurement. The only real issue is to ensure that your Quality Policy and Quality Objectives are really supported by the KPI measurables and associated goals the organization is using.

Note that I am NOT advocating adopting Six Sigma in order to satisfy 8.2.3 - that would be using a tactical nuke to kill a gopher. Six Sigma should be (or not be) adopted by an organization for valid business reasons that stand on their own merit. But if you are lucky enough to be in an organization that has decided to walk the Six Sigma path, 8.2.3 is a no-brainer.

Ed Gibbs

[Marc]

In Reply to Parent Post by edward.gibbs

I guess I see Six Sigma as a road to walk, rather than a destination to be reached.

I agree 100% that statistical techniques should be utilized whenever possible and where appropriate.

I have no complaint with six sigma per se other than I think it is being sold as something it isn't - which is the answer to about everything.

In my opinion a six sigma black belt is valuable more as a project management tool for improvement in large company environments.

I looked at project management back around 1998 - http://PMI.org I was doing a lot of implementations in large companies and viewed the project management aspect as the most important part of my function. Interpreting the standard was the easy part. Planning what had to be done, assigning resources, figuring costs and tracking progress was the hard part. What I found was that, like with the six sigma program, there was a minimum project size (including a minimum project cost) to qualify for the top grades. You have to be in a pretty big company to meet some of the requirements.