Calibration requirements for ISO 9001:2000 - We do not conduct GRR studies

G

Graeme

#11
Leonardo Lopez said:
Does this means that the studies have to be done only on that measurement equipment used for a PPAP product?
As far as I know, nothing in ISO 9001:2000 has any requirement relating to PPAP. Isn't that requirement something in QS9000 or ISO/TS 16949? If so, it's a different standard with different requirements.

ISO 9001 says that measurements that affect product quality must be made with calibrated instruments, states a few other requirements, and refers you to ISO 10012:2003 (the current version) for guidance on a measurement management system. (Clause 7.6) Any other requirements are either internal to your organization or come from the customers -- they are not in the ISO 9001:2000 standard.
 
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Govind

Super Moderator
Staff member
Super Moderator
#12
sbickley said:
Hi Everyone,

We currently use many measuring instruments in our First Article and repeat inspection processes. This equipment is currently calibrated by an outside part once per year and we do not conduct GRR studies. We also do not conduct daily tool checks when they are checked out, etc.

Is this acceptable or should we be doing more to ensure conformance with the standard?

Please give me some ammunition if we need to do more so I can sell this to management.

Thanks,
Scott
Previously, I was answering this thread from the software point of view.Later, reading this post more carefuly, I myself started to have more questions.

See below the ISO9001: 2000 requirement:
“The organizations shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements”I referred to ISO9001: 2000 handbook. :read: Refer Page: 348 last paragraph,
The book says that is requirement is not specified in the new standard however estimation of measurement uncertainty cannot be avoided. This is also required in the documentation of traceability of measurement results.

We typically use the GR& R result for the “Random Error” value in the measurement uncertainty calculations. (To calculate Measurement Uncertainty, we require both Systematic Error and Random Error).

This book, which is an authority in ISO9001 guidance and interpretation lean towards measuring Uncertainty to meet this requirement. Yet, many of us do not conduct GR & R or Measurement uncertainty calculations.

How is this requirement being addressed by all the organizations? How are you convincing your auditor about this requirement? :confused:

I did a lot of thinking and I decided to ask our knowledgeable community a follow-up question:

Calibration requirements for ISO 9001:2000 - We do not conduct GRR studies
How is this possible without conducting the GR & R , Measurement uncertainty to come to a conclusion that the measurement is carried out in consistent with monitoring and measurement requirements?


Thanks,
Govind.
 

Govind

Super Moderator
Staff member
Super Moderator
#13
Ok, Let me further jog your memory. ;)

From my experience, here are various examples how many organization try to meet the requirement.

Some organizations create a Generic Table that will provide details
Accuracy of Equipment Vs Applications used and gets it documented as a Work instruction.

Some Organizations actually list all equipment within the system and link one on one with the application being used and maintain it as a record.

Some organization just go by the least count Vs tolerance zone and justify the auditor that the equipment far more adequate for the application. ( I don’t think this approach is correct).

How do you meet this requirement? Any different? One of the above?

Govind.
 
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