ISO9001 - Measurement Equipment records

[Randy]

Thanks Randy. To clarify, are you suggesting I keep up the certificates or cut back on the extra paperwork step?

Lay off the extra fluff, that's where everyone trips every time

 

[Katherine47]

Lay off the extra fluff, that's where everyone trips every time

Yeah thats what I was thinking. The more paperwork just leaves us open for more mistakes. why take the risk?!
Thanks for your help on this one!

 

[Randy]

Yeah thats what I was thinking. The more paperwork just leaves us open for more mistakes. why take the risk?!
Thanks for your help on this one!

Glad to help a bit.....Coincidentally, I had to issue a NC today mainly for the same reason which is putting more on yourself than necessary or what's required....They didn't do all the documentation they called out for in both their manual and in the specific procedure. Multiple pieces of "uh-oh" resulted in a self-inflicted wound.

Kinda go through your "stuff" and ask "Is it absolutely required, or do we really, really need it?" You'll be surprised.......In fact is there any reason why you couldn't make it an objective to help improve document control if nothing else? It's valid with any MS, and pay attention, that wasn't consulting, that was a question and I'm allowed to ask all of those I want.

 

[Big Jim]

Thanks everyone! It's nice to know I'm understanding the standard correctly and can eliminate this extra step. It's going to be a fun conversation trying to explain this to this person though!

Try reading that part of the standard to them.

 

[qualitymanagerTT]

Regarding measuring equipment the standard states:

8.5.1
ensuring that documented information for monitoring and measurement activity for product acceptance includes:
− criteria for acceptance and rejection;
− where in the sequence verification operations are to be performed;
− measurement results to be retained (at a minimum an indication of acceptance or rejection);
− any specific monitoring and measurement equipment required and instructions associated with their use;

Sorry - which standard says this?

...

My company has previously calibrated all measuring equipment in house at 6 monthly intervals IAW OEM recommendations (great). the results of this calibration are in a register detailing the equipment identification, the person who conducted the calibration, the results of the calibration, the date, extra notes etc. There is also an attached procedure which details how to calibrate and the acceptable tolerances.
...

Off topic, but I am curious about how you demonstrate measurement traceability, assuming you are using the term "calibration" as defined in VIM: https://jcgm.bipm.org/vim/en/2.39.html

 

[Big Jim]

Sorry - which standard says this?

AS9100D, it is part of an aerospace enhancement. It goes beyond what ISO 9001:2015 requires.

 

[Big Jim]

Regarding measuring equipment the standard states:

8.5.1
ensuring that documented information for monitoring and measurement activity for product acceptance includes:
− criteria for acceptance and rejection;
− where in the sequence verification operations are to be performed;
− measurement results to be retained (at a minimum an indication of acceptance or rejection);
− any specific monitoring and measurement equipment required and instructions associated with their use;

I am very green with Quality Assurance, and work for a very small company who has promoted me into sole QA role so please excuse if this is a silly question.

My company has previously calibrated all measuring equipment in house at 6 monthly intervals IAW OEM recommendations (great). the results of this calibration are in a register detailing the equipment identification, the person who conducted the calibration, the results of the calibration, the date, extra notes etc. There is also an attached procedure which details how to calibrate and the acceptable tolerances.
One person is convinced that we need to further support our calibration with a printed certificate stating the type of calibration conducted, and the signature of the boss (who did not actually perform the calibration), tool ID and date of calibration for each tool. I'm not joking when I say that is all the information on this certificate

This seems not only like overkill to me, but redundant information. The certificate sits in a binder, never to be looked at again, there is no new information on it. Everything is already accounted for in the Procedure and Register.

Have I missed something here? I want to stop doing this as it's a waste of time and paper. This is a weird hill that this person is willing to die on, but as I am the only person hired to do this role, I want to be able to show this person that this practice is not necessary.

What standard are you registered to? Has someone led you into doing more than is actually required by ISO 9001:2015? The requirements you cited are in AS9100D and are not included in ISO 9001:2015.

I'm wondering if whoever put together your quality management system was more familiar with AS9100D and steered you in that direction, making things more complicated than necessary.