Calibration of equipment
1) Who should define the frequency of calibration? a) The manufacturer of equipment b) The organization c) Outside laboratory (third party) 2) Should verification process determine if equipment is out of tolerance before the time of the certificate expiration? I think the answer is "yes" and ISO 22000 prescribes:8.3 Control of monitoring and measuring 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, b) shall be adjusted or re-adjusted as necessary, c) shall be identified to enable the calibration status to be determined, d) shall be safeguarded from adjustments that would invalidate the measurement results, and e) shall be protected from damage and deterioration. Records of the results of calibration and verification shall be maintained.
And if the appropriate action is "recalibration" and doesn’t fall any of the options (a to d). <BR><BR>3) If we prefer to do the calibration internally, can certificate of master gauge suffice, or the personnel who will do the calibration should be certified by a authorized body?8.4.2 If verification does not demonstrate conformity with the planned arrangements, the organization shall take action to achieve the required conformity. Such action shall include, but is not limited to, review of a) existing procedures and communication channels (see 5.6 and 7.7), b) the conclusions of the hazard analysis (see 7.4), the established operational PRP(s) (see 7.5) and the HACCP plan (see 7.6.1), c) the PRP(s) (see 7.2), and d) the effectiveness of human resource management and of training activities (see 6.2).
In their Code of Practice they state that the calibration frequency is a minimum of annually for all equipment requiring calibration.
We have a certified, calibrated thermometer that we then use to calibrate the temperature probes and displays in our Cool Rooms, Freezers and delivery vans. This method was approved by the BRC accreditation auditor when we were successfully audited, for the first time, last week.
If the instrument is found to be out of calibration then our corrective actions include reviewing all of the temperature records since the last successful calibration to ensure that correct storage temperatures have been maintained.
We have external calibration companies to calibrate our pasteuriser temperatures, holding times and plate integrity.
I hope that this helps you.
ISO 22000 requires 1) Who should define the frequency of calibration? a) The manufacturer of equipment b) The organization c) Outside laboratory (third party) 2) Should verification process determine if equipment is out of tolerance before the time of the certificate expiration? I think the answer is "yes" and ISO 22000 prescribes: And if the appropriate action is "recalibration" and doesn’t fall any of the options (a to d). <BR><BR>3) If we prefer to do the calibration internally, can certificate of master gauge suffice, or the personnel who will do the calibration should be certified by a authorized body?
We have a State authority who inspect our domestic dairy industry.
In their Code of Practice they state that the calibration frequency is a minimum of annually for all equipment requiring calibration.
We have external calibration companies to calibrate our pasteuriser temperatures, holding times and plate integrity.
I hope that this helps you.
Sounds reasonable. I have always calibrated pasteuriser thermometers quarterly.
You may find this useful:
FDA Equipment Checks.pdf 366.35KB 440 downloads
Regards,
Tony
However, it is only a code of practice, but if you are wanting to do it more frequently than once pwer annum then one can, but the code of practice is only a guide to ensure that the calibration should be conducted at least annually. I hope this helps.
Regards
Ajay
Sounds reasonable. I have always calibrated pasteuriser thermometers quarterly.
You may find this useful:
FDA Equipment Checks.pdf 366.35KB 440 downloads
Regards,
Tony
Dear,
File is password protected.
Faisal Rafique
ISO 22000 requires 1) Who should define the frequency of calibration? a) The manufacturer of equipment b) The organization c) Outside laboratory (third party) 2) Should verification process determine if equipment is out of tolerance before the time of the certificate expiration? I think the answer is "yes" and ISO 22000 prescribes: And if the appropriate action is "recalibration" and doesn’t fall any of the options (a to d). <BR><BR>3) If we prefer to do the calibration internally, can certificate of master gauge suffice, or the personnel who will do the calibration should be certified by a authorized body?
Question 2. Validation of a process is when you design a process and you trial that process to prove that it will perform in a certain way. Then you start up producing something ( a product or service). After some time, you will like to check if your process design is still performing as planned. That is verification. There are many tools to verify a process. Of course the audit process is one of the most used but there are many more.
Verification process could determine if equipment is out of tolerance but this too late, very reactive and this strategy could have terrible consequences depending on the process (e.i.: recall or withdrawal of product). If you want to determine if equipment is out of tolerance, you need to be preventive. Control charts are excellent tools for that purpose.
Please tell me if this info helped you. Thanks.
Yes, it is. I appreciate your answers. It’s very helpful. There’s still unanswered question (question #3) regarding internal calibration – certificate of master gauge vs certified internal calibrator. Any thoughts?Question 1. You should define the calibration frequency based on different factors or criteria like regulatory requirements but also based on your equipment performance. For example: same equipment won’t perform in the same way in a dusty environment than in a wet one, etc. Control charts will also be a good tool to monitor the process and show trends. This will also allow you to be preventive.
Question 2. Validation of a process is when you design a process and you trial that process to prove that it will perform in a certain way. Then you start up producing something ( a product or service). After some time, you will like to check if your process design is still performing as planned. That is verification. There are many tools to verify a process. Of course the audit process is one of the most used but there are many more.
Verification process could determine if equipment is out of tolerance but this too late, very reactive and this strategy could have terrible consequences depending on the process (e.i.: recall or withdrawal of product). If you want to determine if equipment is out of tolerance, you need to be preventive. Control charts are excellent tools for that purpose.
Please tell me if this info helped you. Thanks.
Regards
Ajay
ISO 22000 requires 1) Who should define the frequency of calibration? a) The manufacturer of equipment b) The organization c) Outside laboratory (third party) 2) Should verification process determine if equipment is out of tolerance before the time of the certificate expiration? I think the answer is "yes" and ISO 22000 prescribes: And if the appropriate action is "recalibration" and doesn’t fall any of the options (a to d). <BR><BR>3) If we prefer to do the calibration internally, can certificate of master gauge suffice, or the personnel who will do the calibration should be certified by a authorized body?
Dear MOM,
I agree with Carlos regarding the frequency of calibration, so that is is proactive but not unecessarily excessive. Use of a control charts on the drift observed in every verification cycle will provide you with info if the Instrument is drifting so fast as to need more frequent calibration OR if it is remaining stable and you can decrease the frequency.
In my experience I have considered the manufacturers recommendation and then monitored drift to ensure the Calibration schedules are adequate.
Indeed, modern instruments with better temperature compensation etc and better electronic components seem to be very stable compared to 15 years back!
Still, sometimes to satisfy sceptical auditors, i have had to do a verification more frequentlly and record that a claibration was not needed as the verification indicated absence of a "zero' or "span' drift of the instrument, to any significance.
With regards to your internal calibration query, the standard requires the Calibration to be traceable to national and international standards. So firstly, you will need to ensure your "master" gauge is calibrated by an agency that can provide traceability with regrads to it's own Master used and also the methodology used.
Now, you need to maintain your master in a manner that prevents damage or drift in your site master.
Finally, your operator needs to have knowledge of how to use the "master' to calibrate, i.e., he is trained by the equipment suppliers in the use of the master instrument and has been trained how to calibrate the local instrument. I am making an assumption here that the opeartor has been appointed to the job with minimum qualifications needed to operate/ calibrate the instrument.
For e.g. If it was simply a :"weighing scale" he could be any lab tech, but if we were talking about calibration of some Biomedical instrumentation then, yopu would be looking at an suitable engineer.
In summary, Internal calibration - master needs to have traceability to standards, and staff needs to be trained ( appropriately )
Thanks for the great replies. How about my last question? What do you think about it? If we prefer to do the calibration internally, can certificate of master gauge suffice, or the personnel who will do the calibration should be certified by a authorized body?
You can make any master instrument and do internal calibrations but training of personnel is important for this purpose.
Faisal