AS9100 Calibration Register

bguarino

Starting to get Involved
#1
Our company is ISO9001 and is moving towards AS9100 compliance. Our current system for production equipment that can inspect, measure, or test production materials is to identify its status with a unique number and a calibration label. This equipment is then tracked and recalled thru a calibration database.

Equipment (that can inspect, measure test) that is not used on production materials is just tagged with an "Engineering Use Only" label. No unique number. Not tracked in the database.

As we move to AS9100 our QC Manager is stating that all equipment needs to be numbered and tracked in the calibration database regardless of where it is used. They have issued a corrective action to the entire site to do an inventory of all equipment (thousands of pieces) to update the database and label everything.

However, AS9100 states "When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: " And then goes on to list A, B, & C requirements.

If measurement traceability is not a requirement for an engineering lab, then all the requirements that follow this statement would not apply?
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#2
A properly issued CA in this case should clearly state the requirement that is not being followed. What are they saying is wrong about your current practice?

If they are saying Management has determined that the measurements made in the Eng lab require the added confidence provided by calibrating those instruments, then it makes sense to proceed down that path.

But if they are only doing it because of some perceived need in AS9100 they may be misunderstanding the requirements. The clause you quoted is ISO9001.
 

John Predmore

Trusted Information Resource
#3
The first sentence under AS9100 7.1.5.2 contains a qualifying clause, "When measurement traceability is a requirement...". The sentence after a,b,c contains a qualifying clause, "for ... measuring equipment requiring calibration or verification." The third sentence states, ""The organization shall maintain a register of the monitoring and measuring equipment.", with no qualifying clause. Taken literally, the third sentence says anything that is measuring equipment must be listed in the register. I can see your interpretation, as well, that the qualifying clause in the first sentence applies to every sentence in the section . From a quality assurance perspective, it is probably safer to list all equipment in the register, because sometimes gauges and portable tools move around without the quality department's knowledge, and then you would know where the device came from.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
The third sentence states, ""The organization shall maintain a register of the monitoring and measuring equipment.", with no qualifying clause. Taken literally, the third sentence says anything that is measuring equipment must be listed in the register.
Going further the entire clause is:

The organization shall maintain a register of the monitoring and measuring equipment. The register shall include
the equipment type, unique identification, location, and the calibration or verification method, frequency, and
acceptance criteria.


How could you list a "calibration or verification method, frequency, and acceptance criteria" if it is not to be calibrated or verified? You can't. This is why I believe tools not needing calibration do not need to be in the register. But I agree the clarity is lacking from AS writers. I have never had that interpretation challenged. :cfingers

It would be interesting to see of 3rd party auditors like Randy would write a NC in that case.
 

dwperron

Trusted Information Resource
#5
The interpretation I have always seen used is based on the first sentence: "When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:....."

There is a differentiation made between equipment that requires calibration and equipment that does not.
The organization shall determine which is which, and establish a recall system.
A register shall be maintained of the calibrated equipment. This is for calibrated equipment, as the elements required in the register include "calibration or verification method, frequency, and acceptance criteria" - things that do not apply to uncalibrated equipment.

There is no AS9100D requirement for the register to contain all measuring and test equipment, but some companies force this upon their calibration organization as an asset management function. That should not end up as an AS9100D CAR, but it could be a finding if your command media requires that all T&ME be recorded in your calibration register and you don't.
 
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