ISO 9001 calibration question please

Moncia

Quite Involved in Discussions
#1
Good morning

I have not been here in a while - I hope every one is well

I started new job last may but taking over the existing ISO 9001 and 14001 now on top of my original duties

I have a question on calibration requirements - I have questioned the past due date on our log sheet with the QA manager and he told me this
"The calibration schedule is not dictated by the day, it is by the month. This is to allow for workload and demands on the QA Dept and availability of resource. To suggest if a piece of equipment is out of calibration by one day I feel is incorrect. For example the vacuum gauges, if the due date is the 03/03/21 and it still hasn’t been calibrated as of today, it is within calibration until the end of the month."

Is that acceptable - the log has specific due dates on ( I always had specific due dates on both log and stickers) - but before i go and start changing it to month and year only - I'd like your opinion please
 
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chris1price

Trusted Information Resource
#2
I would clearly define the requirement in your Calibration SOP. If the SOP says the equipment is acceptable until the end of the month, than that's ok. I would also make a note on the Log to this effect. If it doesn't say this, then the actual date on the label should be applied.
 

Ron Rompen

Trusted Information Resource
#3
I agree completely with Chris. Make a note in your SOP/Process description. I would suggest modifying it so that it allows plus OR MINUS 30 days from the 'due date'. I have done this for the last 20+ years, and have never had a nonconformance raised against it.
 

Randy

Super Moderator
#4
Instrument manufacturer's recommendation, industry specific requirements, your organization requirements...Most everything else is BS especially opinions, so do what works for you
 

Scanton

Wearer of many hats
#5
As long as whatever self imposed requirement is documented and you are meeting that requirement, there should be no issues. I have a six monthly calibration cycle on my held held devices such as calipers and micrometers which has a +/- 3 days on the due date, and I am comfortably able to meet this.

I calibrate these every six months due to the gauges being used in a dirty/oily environment. The original 12 month cycle meant too many gauges were coming back heavily contaminated, so I give them a little TLC every six month, which increases their serviceable life and dramatically reduces the number of gauges failing calibration.
 

Ooi Yew Jin

Starting to get Involved
#6
When there is a due date to be a criteria or requirement, it is motiving us to be more proactive to plan, do, check and act.
Bias or linearity test can be performed for justification to apply deviation ~ may be 1 month in period to recover the calibration missing date.
 
#7
I would clearly define the requirement in your Calibration SOP. If the SOP says the equipment is acceptable until the end of the month, than that's ok. I would also make a note on the Log to this effect. If it doesn't say this, then the actual date on the label should be applied.
Good advice as well as the other comments. I might add only that even a statement on your calibration log about the flexibility of the due date would suffice.
 
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