Monitoring... what is it?

M

MD

Definitions 101 - Measuring and Monitoring

This day i spent reading ISO 9001 clause 4.1. and as you could see (if you wanted, but you dont :) and i understand you) from my posts there are lots of things that are not clear enough for me...

So 4.1. d) "Organization shall ensure the availability of resources and information necessary to suport operation and monitoring of these processes"

process monitoring... who performs process monitoring in an organisations? I mean if there are no technical monitoring devices? Could we say Quality manager performs monitoring of a processes? (Not the direct owner of a process! I.e. Procurement manager dont monitor purchasing process but MANAGE purchasing process!)

I define term monitoring (it is not mentioned in ISO 9000:2000, but i think it should be): interventionless observing.

So some explanations (do you agree with them)

1. Process Monitoring: interventionless observing of a process (on my definiton basis);

2. Process Audit: systematic, independent documented process for obtaining audit evidence and evaluating it objectively to determine the extent to wich audit criteria stated for this process are fulfilled (on ISO 9000 basis);

3. Process Management: coordinated activities to direct and control (intervent into) a process (on ISO 9000 basis).

Summary:

1. Who performs monitoring of a precesses in an organization?
2. What types of resources (please give an example) should be used to perform monitoring (see 4.1.D))?
3. How do you monitor you processes (SHOULD YOU BE "General Motors" OR "Mr. Little & Sons Inc.")???
 
R

Russ Kochis

MD,
The WHO & HOW of process monitoring would largely be dependent on the size, structure, product/service and type of process.

How do you monitor the internal audit process? Most organizations use management review, comparison of internally identified N/C’s to externally identified N/C’s, Organizational feedback, etc. Who does it? QA manager, mgmt rep, exec mgmt?

You probably have a lot of the monitoring in place now, as you look at the various processes ask yourself what information is generated and who reviews it. The standard does not specify the who or how, so you can define this within the needs of the organization. Look at existing information and see if it can be used for the monitoring. Can minor change be done to forms, records and procedures to easily meet these requirements? Most of the stuff I have done to meet this requirement was in better definition of responsibility since we were doing most of the monitoring anyway.

Hope this helps,
Russ
 
G

Graeme

Re: Re: Monitoring... what is it?

Jim Wade said:

Measure (verb): ascertain or determine the spatial magnitude or quantity of (something); ascertain or determine (a spatial magnitude or quantity) by the application of some object of known size or capacity or by comparison with some fixed unit

Jim,

I am really amazed at the definition of "Measure" you found in the TC 176 Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000! That definition excludes over 90% of the work I do as an electronic metrologist! It also probably excludes most of the "measurements" that are typically made as part of a quality management system! All because of that word "spatial", which means "pertaining to or involving or having the nature of space" (https://www.dictionary.com) I take it to mean, then, that one is "measuring" only when determining how much volume a thing occupies, or counting how many things are in a given volume. Personally, I deal mostly with electrons. Sure, they have volume when in their particle mode (any physicist will sometimes agree with that) but not enough for you or I to notice. Besides, I am more interested in how many are flowing per second, or what force they exert, or how many times per second their flow oscillates. According to TC 176, none of that is "measuring" becasue none of the dimensions are "spatial".

But enough absurdity.

I like the definition you use in your manual and will (with permission, I hope) swipe something like it for the upcoming revision of mine.

To measure means to collect data (in the form of ‘quality records’) about the degree to which something is being done well.

Thank you for the reference. I will try to get a copy of that document for use when I need a good laugh.
 

E Wall

Just Me!
Trusted Information Resource
Size consideration

Depending on your company size you may handle this any number of ways.

At our location the process operators is responsible for the first level of monitoring and measuring. We also have shift QA Auditors that perform process audit, verifying critical characteristics at intervals (since they can show up in any dept at any time - no planned set pattern - integrity is maintained). The QA Engineer performs a monthly audit on QA Auditor records, and does walkthroughs each week (again no set plan so keeps everyone on their toes).

Any problems are immediately reported to the process Leadmen or Supervisor and the QA Manager. This works great for us.

Eileen
 
C

Chris May

The way of monitoring/measuring

If you can express "something" in numbers you can measure it.

If you can measure it you can control it.

If you can control it you can improve it.

We are using SPC techniques such as control charts. tally charts. pareto analysis etc.
It very much depends upon your industry, product base, customer base.

At a factory level, we monitor the first time pass rate of each product from the test equipment.

In real timeon the shop floor, the various processes involved (flowsoldering, manual assembly, surface mount paste, placement, reflow) are monitored using control charts which are completed by the process owner (operator) every so many PCB's or every time period depending upon the product complexity. Alarm bells ring when the plotted sample is outside of the control limits.

Our process data are also analysed by a multifunctional team or teams (we have 4 or 5 at any one time). This is for continual improvement benefits to reaffirm the various control limits or better still change/improve them. These teams gather the daily data and brainstorms/cause & effect these data for wider trends and problems and improvement opportunities

The teams consist of typically 2 people from the assembly cell or process area, one test/repair technician and an Engineer from QA, Production Eng. Two of our teams each have a Director involved.

Nuts & Bolts time:

Process:- Flow Solder Machine

I had to break this system down into its main elements.
Flux
Preheat
Solder Pot
Conveyor Speed

Sample measurements were taken of each element over a period of two weeks. Preheat and pot wrer temperatures, conveyor speed was ft/min and flux deposition was weighed.
Using these samples, I was able to arrive at the achievable upper and lower control limits for each element.

At certain time periods, the flow solder operator(s) will measure each element and plot this value on its relevant control chart. If the value is within the control limits, then everything is fine. If the value is outside of either limit then something has changed/gone wrong. STOP THE PROCESS
Also, if a certain number of values ( I forget at the moment) are creating a trend, then there is going to be a problem (preventive)


Anyway, enough blathering.

Who does it?
Multifunctional teams with a more technical facilitator to mentor the team. This guy is NOT the leader, he is just the driver.
How do you do it?
Mathematically, I am afraid.

There is a great forum here at the cove covering SPC/6 sigma with good links.

Hope you haven't gone to sleep.

Regards,

Chris May
 
J

JodiB

I can't

Jim Wade said:

Can someone please explain that to me with an example: a process that can't be measured but which can be monitored (including an explanation of what is monitored if there is no measure)?

When I was putting together the criteria for success and the methods of measure for each of our processes, the ones that I had the most difficulty with were management review and internal audit. In fact, I almost came to the Cove for assistance. But I was finally able to come up with things. Not great criteria, but they were there.

So I can't think of anything that you couldn't come up with a measurement for, even if all you identified was the number of nonconformances that the process generated!
 

Mike S.

Happy to be Alive
Trusted Information Resource
A couple comments:

Graeme said: "I am really amazed at the definition of "Measure" you found in the TC 176 Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000! That definition excludes over 90% of the work I do as an electronic metrologist!" Graeme -- I think the defintions will make more sense if you separate "spatial magnitude" from "quantity" -- by that I mean don't assume it means " spatial magnitude or spatial quantity" but rather assume it could mean any quantity all by itself, such as those electrons you speak of. Does it make sense then? To me it does, but maybe that means I'm as nuts as the guys who wrote this "ambiguous" stuff!:bonk:

Jim said: "Can someone please explain that to me with an example: a process that can't be measured but which can be monitored (including an explanation of what is monitored if there is no measure)?" Jim -- This may be reaching a bit, but here's what I think those writers may have been thinking: Maybe monitoring can be an informal, non-standardized, qualitative measurement. For example, I know machinists who can tell pretty positively if their machines are running correctly and everything is being machined okay by the sound of their machine from across the room. They may be completing paperwork and just listening. Is it formal, foolproof, quantitative, or standardized measurement such as actually reading the RPM of the wheel or the size of the machined part? No, but the operator could reasonably say he was "monitoring" the process without taking a measurement in the traditional sense. Likewise, someone could look at hundreds of parts flowing by on a conveyor and, not seeing any obvious problems, say he/she was monitoring the process but it would be impossible or impractical to measure each of those hundreds of parts in the traditional sense.

Don't get me wrong -- I can't say these definitions by ISO are good ones or well explained, because they're not. This is just me trying to rationalize what they might have thought that they weren't able to explain well. Or, maybe it means I really am going nuts faster than I thought.

Comments?

Mike S.
 
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