Sanity Check on ISO 9001 Pre-Assessment Findings

[Jim Wynne]

OK, you have a point.

But IF not... and IF we only need to be accurate within, ooh, let's say a couple of inches (she says, bowing to the imperial measurement system still in use by you guys), would you still argue that tape measures need calibration?? I sure wouldn't.

Yep, IF the measurement is specifically documented and required

From whence comes this requirement?

 

[Randy]

From whence comes this requirement?

It's a challenge because one really has to understand a system approach, but look at 7.6a to begin with...then think 7.2.1, 8.2.3, 8.2.4 and how they can apply to having measure something....There's a difference between taking a measurement for self assurance and taking a measurement that has been specifically defined by a customer, a regulation or the organization itself.

"Customer X says......no longer than 63 or shorter than 58" then measuring is necessary and the instrument used falls under 7.6

If a measurement, any measurement MUST be taken then the instrument used has to be either individually calibrated or verified against something else that is calibrated and traceable to either a international or national measurement standard (like NIST) or in the absence of some standard then the calibration process itself must be recorded.

It's all very plain in balck and white...No interpretation needed

It is touchy ground at times though because sometimes we see ambiguous requirements such as "Grey" in color....Colors can be measured, but how many different "colors" of Grey are there? Which Grey is the correct Grey?

 

[cereo]

Again, this is not a customer requirement, nor a regulatory requirement. The shipping company (a supplier, not a customer) charges extra if we exceed 20 feet (no acceptance limits provided) so our procedure states to verify that the load is under 20 feet. We are careful to stay well under that. Nothing falls out of the sky, nobody gets hurt, product isn't affected and the customer never knows, we just lose some profit margin if we get careless and don't check before shipping.
We DO calibrate our scales as these are used to meet DOT requirements.

 

[JaneB]

Sheesh Randy. I think we're on the same page.

Did you go right past these 3 words in my previous post??

But IF not...

 

[Randy]

Again, this is not a customer requirement, nor a regulatory requirement. The shipping company (a supplier, not a customer) charges extra if we exceed 20 feet (no acceptance limits provided) so our procedure states to verify that the load is under 20 feet. We are careful to stay well under that. Nothing falls out of the sky, nobody gets hurt, product isn't affected and the customer never knows, we just lose some profit margin if we get careless and don't check before shipping.
We DO calibrate our scales as these are used to meet DOT requirements.

YOUR PROCEDURE SAYS? Guess what? Self inflicted wound and you've got to control the measuring tapes.

Your procedure is a "Self Created" requirement that must be fulfilled and verifiable as to its accomplishment and the shipping companies requirement must also be accomplished and verifiable as well.

Why?

Because if you don't meet it, the customer doesn't get their stuff! UH-OH, you didn't achieve CUSTOMER SATISFACTION because the shipping load was tooooooo long by %age of an inch.

 

[JaneB]

YOUR PROCEDURE SAYS? Guess what? Self inflicted wound and you've got to control the measuring tapes.

Your procedure is a "Self Created" requirement that must be fulfilled and verifiable as to its accomplishment and the shipping companies requirement must also be accomplished and verifiable as well.

Randy is completely, utterly, 100% on the money here (as so often).

A requirement is a requirement. It doesn't matter in a sense who created the requirement, as currently it is a requirement in your system. And thus you must control the tapes.

Sensible solution: change that requirement. (Assuming you can, of course).

 

[JaneB]

If a measurement, any measurement MUST be taken then the instrument used has to be either individually calibrated or verified against something else that is calibrated and traceable to either a international or national measurement standard (like NIST) or in the absence of some standard then the calibration process itself must be recorded

I agree that in such a case the equipment comes under 7.6.

But what about the:

Where necessary to ensure valid results

bit in the 3rd para of 7.6?

If there's fairly wide latitude / tolerance (eg, measurement can be + or - a couple of inches or so) and one is using regular, everyday tape measures, say, then are you still holding that ALL equipment must be calibrated as you describe?

 

[ChrissieO]

Haven't been on the cove for a few weeks and just catching up. I have read the first two pages of responses to this and as usual agree mostly with Jane, Randy, Marc, Andy and the rest of the usual suspects.

Just to put my "twopenneth" (its a brit thing) in. The first thing that hit me from the OP is that the auditor is a typical "tick box" auditor with no signs of thinking outside the box or evaluating the processes.

Yes he has made some valid points but he has also made some points that are abosultely meaningless and of no added value.

As Randy pointed out, some of this is self inflicted injury. Are your procedures written for a perfect "ISO" world and then you are expected to follow them? If they are not realistic, revist them and update them to what you actually do. Were they written by some quality geek that trained in the dark ages or were they written by the people that actually use them.

Paper stamped documentation - do still people still use paper

But as it is the companies own standard there is not much the OP can do apart from ensure that the dinasaur of an auditor is put out to grass very soon.

Sorry about my rant but I fed up of seeing thread after thread about auditors in the world of 9001 and TS who are still nit picking at minor issues and using check box mentality auditing..................thought this went in to "Room 101" (is that another brit thing?) with QS9000!!!!!!!

Get over it move on and worry about things that actually effect the business.....thay are called PROCESSES!!!!!!!!!

ok rant over....honest

Cx

 

[Jim Wynne]

It's a challenge because one really has to understand a system approach, but look at 7.6a to begin with...then think 7.2.1, 8.2.3, 8.2.4 and how they can apply to having measure something....There's a difference between taking a measurement for self assurance and taking a measurement that has been specifically defined by a customer, a regulation or the organization itself.

"Customer X says......no longer than 63 or shorter than 58" then measuring is necessary and the instrument used falls under 7.6

If a measurement, any measurement MUST be taken then the instrument used has to be either individually calibrated or verified against something else that is calibrated and traceable to either a international or national measurement standard (like NIST) or in the absence of some standard then the calibration process itself must be recorded.

It's all very plain in balck and white...No interpretation needed

It is touchy ground at times though because sometimes we see ambiguous requirements such as "Grey" in color....Colors can be measured, but how many different "colors" of Grey are there? Which Grey is the correct Grey?

I agree that it's very plain. We won't get into the interpretation thing again, but the plain language of 7.6 says that calibration is required when necessary to ensure valid results and nowhere in the standard does it say that calibration is required if a measurement is required.

 

[Randy]

Let me put it real, real simple. The need for calibration or validation of devices in instances exactly like described has been appealed to an accreditation body by an organization that was audited and the appeal was lost. The NC stood as written