ISO 9k2k 8.2.3

[GARY MOORE - 2009]

Are initiatives such as, through put yield, sampling plans IAW ANSI/ASQC Z1.4, and auditing, cover this clause and the need for statistics without performing SPC on every lot of products?

We also perform lean black belt programs at our facility.

 

[db]

Process monitoring

Gary, first of all welcome to the Cove!

8.2.3 does not specify the "how" or "how much" to monitor or measure your processes. That is up to you. If the methods you choose demonstrates the ability to achieve planned results then they should be good enough.

SPC is NOT required. Now, if you are looking at TS, the rules are different.

 

[GARY MOORE - 2009]

Thanks for the info and welocme Dave B.

 

[M Greenaway]

Gary

As db has stated SPC is not mandated by the ISO9001 standard, which is one of the worst crimes commited by the writers of this document.

My humble opinion for what its worth is that in order to understand the performance of your processes you MUST analyse them using proven statistical techniques. ISO9001 harps on about the importance of process management, yet fails to highlight the crucial part of process management, i.e. the understanding of variance, and need for statistical analysis of process performance.

 

[M Greenaway]

Jim

Yes the standards do hint at the use of such techniques - I really think they should have driven the message home by making it into real requirements of the standard. But again I guess this is beyond the remit of ISO9001, as it doesnt actually tell us HOW to do anything.

 

[Mike S.]

Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?

 

[M Greenaway]

Mike

If mom and pop are going for ISO9001 certification then they must have quantifiable quality objectives and they must monitor, measure and analyse their processes. Now whatever it is they are measuring I would say it must be done statistically. Your measurement of capability can be done against your quality objectives.

 

[energy]

I hear you

Mike S. said:

Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?

Mike S.

They do not have full blown complicated industry sanctioned statistical techniques employed. It can be real simple. Like this:

# of complaints vs number of orders....Goal 3%
# of complaining customers vs total customer base....Goal 2%
Average order filling time....Goal 2 minutes
stale returns vs total number of orders...Goal 2

Nothing fancy...use a Pie Chart

 

[db]

KISS

From energy (welcome back!)

Nothing fancy...

Many times we tend to put more focus on the tool than we do the analysis. I agree w/energy use the KISS (keep is simple stupid, or political correct...keep is short and simple). Don't confuse statistical techniques with SPC.

 

[Mike S.]

I was kinda thinkin' along the same lines as db and Energy. IMO, Mom and Pop don't need to calculate their CpK or have a bunch of x-bar/R charts hanging around. But it was sounding to me like Martin and Jim were sanctioning formal SPC as the only way to go in every circumstance (maybe I misunderstood), so I wanted to see what their actual ideas were. I'm still kinda unsure what exactly they would use for Mom and Pop. Can you be more specific Martin and Jim?

Maybe part of the confusion is what, exactly, represents a "statistical technique"? Is a pie chart a statistical technique? Is calculating an average of orders per month a statistical technique simply because "average" is a statistical term?