10 replies to this topic

[Byrlan]

Hi everybody, I have question relate to clause 8.3 Control of Monitoring and Measuring (ISO 22000). The clause said that : The organization shall provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.

Where necessary to ensure valid results, the measuring equipment and methods used.

a. shall be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded,


etc…

If my Ice Cream Manufacture have a freezer equipment that borrowed to our customers (stores ), Whether the freezer (its thermometer) have to be calibrated and verified at specified intervals and who is responsible for that, my company or the store? If yes, wow it so expensive because it so many. Is calibrated mandatory?

Thank you

[Charles.C]

Hi everybody, I have question relate to clause 8.3 Control of Monitoring and Measuring (ISO 22000). The clause said that : The organization shall provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.

Where necessary to ensure valid results, the measuring equipment and methods used.

a. shall be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded,


etc…

If my Ice Cream Manufacture have a freezer equipment that borrowed to our customers (stores ), Whether the freezer (its thermometer) have to be calibrated and verified at specified intervals and who is responsible for that, my company or the store? If yes, wow it so expensive because it so many. Is calibrated mandatory?

Thank you

Dear Andya,

Not quite sure if i hv fully understood yr question but I deduce that you are renting equipment to customers.
It seems logical that it is your responsibility to ensure that the equipment functions correctly, ie is accurate.
Calibration is required to ensure such accuracy.

Rgds / Charles.C

[HPG]

Hi everybody, I have question relate to clause 8.3 Control of Monitoring and Measuring (ISO 22000). The clause said that : The organization shall provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.

Where necessary to ensure valid results, the measuring equipment and methods used.

a. shall be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded,


etc…

If my Ice Cream Manufacture have a freezer equipment that borrowed to our customers (stores ), Whether the freezer (its thermometer) have to be calibrated and verified at specified intervals and who is responsible for that, my company or the store? If yes, wow it so expensive because it so many. Is calibrated mandatory?

Thank you

Dear Andya,
Yes, you have to calibrated all your freezers.
You can buy a master thermometer then you have to calibrated it at external calibration company.
And then you can use the master thermometer to calibrated internally all the freezers that your company has

Regards,
Hadi

[Byrlan]

Dear Andya,
Yes, you have to calibrated all your freezers.
You can buy a master thermometer then you have to calibrated it at external calibration company.
And then you can use the master thermometer to calibrated internally all the freezers that your company has

Regards,
Hadi

Hi Mr. Hadi


I’m not clear with statement : .........., Where necessary to ensure valid results, the measuring equipment and methods used...... , I think the preventive maintenance-inspection is compulsory to guarentee the equipment (freezer) will be working proper. And it can provide evidence for the specified monitoring and measuring methods.

[zue_rais]

a calibration masterlist is required with review of all calibration results, be it internally and externally

[Charles.C]

Dear Andya,

I agree with you that the words you underlined are rather poorly chosen. It is regrettable IMO that the standard's text has never been revised / corrected in any way since the original publication in 2005.

However the real key words in the clause 8.3 are in the opening paragraph - “evidence” and “adequate”.

For a thermometer this means demonstrating that the indicated temperatures are accurate. Such a procedure is called “calibration”. Preventive maintenance is (of course) necessary but not sufficient.

Nonetheless, if you can prove that the indicated thermometer values invariably conform to yr contracted accuracy, the interval between calibrations can be lengthy. The corresponding guidance para.8.3 in ISO 22004 explains typical requirements for thermometers, etc in some detail.

In practical terms, it is highly unlikely IMO that an ISO 22000 auditor will approve a response to para. 8.3 unless it includes the implementation of a calibration procedure.

Rgds / Charles.C

[HPG]

Just like Mr. Charles' post, for par 8.3, the best option is calibration.
I think it will satisfy the auditors.

Regards,
Hadi

[tsmith7858]

Hi everybody, I have question relate to clause 8.3 Control of Monitoring and Measuring (ISO 22000). The clause said that : The organization shall provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.

Where necessary to ensure valid results, the measuring equipment and methods used.

a. shall be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded,


etc…

If my Ice Cream Manufacture have a freezer equipment that borrowed to our customers (stores ), Whether the freezer (its thermometer) have to be calibrated and verified at specified intervals and who is responsible for that, my company or the store? If yes, wow it so expensive because it so many. Is calibrated mandatory?

Thank you

From a strictly ISO 22000 point of view the calibration of any equipment is only mandatory if the equipment is part of your CCP (ie: your CCP would be violated if equipment was not functioning correctly) or there are regulatory requirements that dictate it must be done (ie: temp of product must be maintained above or below a certain target). If the equipment that you are speak of does not involve a CCP and is not regulated than it is not mandatory.

On the quality side of things, one would feel that anything that impacts your quality should be calibrated.

[Charles.C]

From a strictly ISO 22000 point of view the calibration of any equipment is only mandatory if the equipment is part of your CCP (ie: your CCP would be violated if equipment was not functioning correctly) or there are regulatory requirements that dictate it must be done (ie: temp of product must be maintained above or below a certain target). If the equipment that you are speak of does not involve a CCP and is not regulated than it is not mandatory.

On the quality side of things, one would feel that anything that impacts your quality should be calibrated.

Dear tsmith,

I understand yr logic but I think yr conclusion is contrary to the intention of ISO 22004 / 8.1.

I would make the opinion that with a deliberate avoidance of calibration, the freezing temperature is permanently of unknown validity. This would certainly influence my hazard analysis.

Regardless, I’m happy for the auditor (and the customer) to decide.

(I guess it’s fortunate that FSSC 22000 is not involved ).

Rgds / Charles.C

[tsmith7858]

Dear tsmith,

I understand yr logic but I think yr conclusion is contrary to the intention of ISO 22004 / 8.1.

I would make the opinion that with a deliberate avoidance of calibration, the freezing temperature is permanently of unknown validity. This would certainly influence my hazard analysis.

Regardless, I’m happy for the auditor (and the customer) to decide.

(I guess it’s fortunate that FSSC 22000 is not involved ).

Rgds / Charles.C

Perhaps I should have stretched my argument to include everyone's favorite friend from ISO 22000, the OPRP!

[HACCP Mentor]

From an auditors perspective, wherever you see the words "SHALL" "WILL" or "MUST" written in an audit criteria (ie standard) these requirements are mandatory.