ISO 9001 Clause 7.6 Measuring Devices cannot be excluded!?

[MikeL]

I had a manufacturing client who does not have any measuring devices yet the assessor said we could not exclude 7.6 because it always applied! (see attached doc).

My client makes headlight and bonnet protectors. They make a master sample and use this for visual inspection. There are no verniers, mics or any thing else like that in production.

We now have a policy and procedure for calibration and a register (which is blank).

(My client wanted this assessor so swapping to a more rational CB was not an option)


I regularly exclude 7.6 for service industry.

I notice it can't be excluded from TS

 

[D.Scott]

I think you may have misinterpreted the document. It is not saying you can't exclude the calibration portion of 7.6. It is saying you can't exclude 7.6 in its entirety. You must address the portions of it that do apply. You can certainly exclude calibration if your client has nothing to calibrate but you also must control however the process is monitored.

Dave

 

[Cari Spears]

As the last couple of paragraphs of the document state:

"Where it is not possible to calibrate monitoring and measuring devices they should be verified or validated. Examples include: a pilot study for a survey questionnaire, comparisons for sensory testing, etc.

From the description of monitoring and measurement, devices and equipment above it can be seen that it is unlikely that an organisation will be able to exclude the whole of clause 7.6 from the scope of its quality management system. If it explicitly does not use “measuring equipment” the organisation may be able to exclude the requirements of the third paragraph, bullets a) to e) and the first two sentences of the fourth paragraph."

How do they validate the master samples they use for visual inspection currently, for example?

 

[Justin]

the organisation may be able to exclude the requirements of the third paragraph, bullets a) to e) and the first two sentences of the fourth paragraph."

Right on Cari, couldn't have said it better myself.

 

[MikeL]

I know I'm nuts but...

My clients get a car.

Sometimes just the right bit of a car.

The process involves melting a cut out piece of acrylic plastic into a mould in an oven. The moulds were set up by "reverse engineering" off the car faces. I was sure I would find at least some verniers in the place but no.

I can understand that para 2 applies although it is basically the same as 8.2.4.

But the whole section (7.6) is called Control of Measuring and Monitoring Devices ..... and they have none!

 

[The Moose]

My clients get a car.

Sometimes just the right bit of a car.

The process involves melting a cut out piece of acrylic plastic into a mould in an oven. The moulds were set up by "reverse engineering" off the car faces. I was sure I would find at least some verniers in the place but no.

I can understand that para 2 applies although it is basically the same as 8.2.4.

But the whole section (7.6) is called Control of Measuring and Monitoring Devices ..... and they have none!

Is the oven temperature important to the process?
What happens to the material if it is overheated (does it become brittle?)
Therefore should you have a process (either internal or external) for measuirng the temperature of the oven?

 

[Sidney Vianna]

#9, grasshoper

I think you may have misinterpreted the document. It is not saying you can't exclude the calibration portion of 7.6. It is saying you can't exclude 7.6 in its entirety. You must address the portions of it that do apply. You can certainly exclude calibration if your client has nothing to calibrate but you also must control however the process is monitored.

Dave

Example #9 of the Application Document supports that position.

 

[JRKH]

How is the process monitored

I had a manufacturing client who does not have any measuring devices yet the assessor said we could not exclude 7.6 because it always applied! (see attached doc).

My client makes headlight and bonnet protectors. They make a master sample and use this for visual inspection. There are no verniers, mics or any thing else like that in production.

We now have a policy and procedure for calibration and a register (which is blank).

(My client wanted this assessor so swapping to a more rational CB was not an option)


I regularly exclude 7.6 for service industry.

I notice it can't be excluded from TS

Obviously your client is manuacfuring a product.
This product must be monitored/measured to a assure fitness for use.
So how is the process monitored?

You state that they make a master.
How is the master verified?
How is it controlled to assure it remains intact and correct?
Are the molds monitored for wear?
What would happen if the master were destroyed?

These are the questions that I would want answered if I were conducting the audit. It may be that you have a somewhat unusual situation that requires a creative way to resolve it. I don't thinke just creating a calibration procedure for non-existant tools is going to do it. It wouldn't satisfy me.

James

 

[vanputten]

Hello MikeL:

I have a hard time beleiving that an organization melts acrylic into a mold and never measures or monitors the product. If they can turn acrylic to a molten state, mold it, and get good product every time without any measuring or monitoring, I want to invest in this company.

I know of no injection, blow, or extrusion molding where no measuring or monitoring is done.

When the organization starts a production run, do they get good parts from the first cycle? How do they know? They must have amazing die set ups, temp controls, process controls, etc. The die never wears. The temp is always exactly right. The supplied acrylic is always exactly the same. Cooling times are always exactly right. Wow!

Please tell us more.

By the way, isn't the master sample a monitoring device?

Thank you, Dirk

 

[MikeL]

Thanks Guys

After having had a look at all the posts and some of the other threads I am happier now to include it for this client. In other words you've changed my mind, particularly one of the ISO documents which gave a broader definition to the concept of "device".

What was interesting in this case was that the assessor who did both the pre-assessment and certification agreed with excluding 7.6. It was only when it went to the big boss in Sydney that it was flagged.

(by the way now working with a table cloth manufacturer and assessor, same company, agreed with exclusion of 7.6)