SQF 11.2.10.3 - Protection of calibrated equipment

Has anyone had any experience with this specific part of the code? We're working on development of this program but weren't sure how to go about "protecting" calibrated equipment. Do we need only worry about protecting CCPs or are we supposed to address all equipment?

Specifically, protected from unauthorized adjustment.

Specifically, protected from unauthorized adjustment.

I'd have to interpret that as CCP related equipment (metal detectors, etc).

And that was acceptable to the auditor?

Just like it says ... how do you protect the equipment from unauthorized adjustment?

For our metal detector, for instance, it has an operator password and a technician password, and only the technician can actually change phase/sensitivity/etc settings within the machine, while the operator is allowed only to switch between products. Only one person here knows the technician password - me, so unless they are doing some hacking, I am assured that no one who is not authorized is changing sensitivity settings within the machine.

Hi Cheeseman


For my metal detector I have passwords on the equipment that allows access to the control panel. Only authorised operatives are given the password and these people are trained and authorised to adjust the program.


For other things like thermometers and pH meters there is nothing practical to be done in protecting from adjustment.


That is what I shall be saying in my upcoming SQF audit (5th March) - I will let you know if that flies with the auditor!



Kind regards,



Sarah

Hi Cheeseman


For my metal detector I have passwords on the equipment that allows access to the control panel. Only authorised operatives are given the password and these people are trained and authorised to adjust the program.


For other things like thermometers and pH meters there is nothing practical to be done in protecting from adjustment.


That is what I shall be saying in my upcoming SQF audit (5th March) - I will let you know if that flies with the auditor!



Kind regards,



Sarah

For equipment like thermometers, meters, etc., although you can never fully protect against unauthorized adjustment, you can limit the possibility by:
a. keeping them locked up when not in use
b. providing regular access to only trained, responsible individuals
c. scheduling calibration verification at regular intervals to ensure they are still properly calibrated

Just a thought.

Thanks for the input Sarah and Marshenko! Like each of you said, the critical equipment shouldn't be a problem to regulate (metal detector, htst equipment). It's the everyday equipment that is used constantly throughout the day (thermometers, ph meters, pipettes) that don't seem realistic to lock up.

For equipment like thermometers, meters, etc., although you can never fully protect against unauthorized adjustment, you can limit the possibility by:
a. keeping them locked up when not in use
b. providing regular access to only trained, responsible individuals
c. scheduling calibration verification at regular intervals to ensure they are still properly calibrated

Just a thought.

We work 24/7 so locking up thermometers is not really practical and we are a small factory so access cannot be limited to certain areas or individuals.

We do weekly calibrations - that is a good point that I will bring up at the audit.



Thank you!

For tools and instruments look to see if where the adjustment is if a paper adhesive seal can be placed on/over it maybe. Like the tamper proof seal type thing then you would know if someone changed it because it would be broke.

Not sure if that's feasible but it's just an idea.

Has anyone had any experience with this specific part of the code? We're working on development of this program but weren't sure how to go about "protecting" calibrated equipment. Do we need only worry about protecting CCPs or are we supposed to address all equipment?

Yes, I have experience with this section of the code -- very simple, you need to protect all equipment that can be "calibrated". Show it in writing and prove it in action. Thus for instance you might store all of your stick thermometers under lock in the QA department, or your PH meter equipment may be passcode protected, or your metal detector requires a code to test/check/re-calibrate, etc.

So run a check on what items you have that require calibration and then go about writing your documentation on it and implement same.



Glenn Oster

http://www.GetGoc.com