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Expired Calibration Certificates

#calibration #COVID19 #CCPs

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Lelouch_rayne

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Posted 08 February 2021 - 08:20 AM

Dear all, we have upcoming BRC audit on March, 2021. Our last year calibration certificate expired last October 2020, meaning our equipment was not calibrated since October 2020 up until now. Unfortunately, our external calibration will be scheduled on April 1st week. The delay was mainly because of the travel restrictions imposed in our country aside from being expensive – technicians need to quarantine for 14 days before they enter our facility and we still need to pay them while being quarantined. Btw, measuring devices need to be calibrated are all part of CCPs. So far, all devices are in good condition and working perfectly - within operational range. So, how do I explain this to the auditor? Is the COVID stuff enough as reason for such thing? I’m afraid that this is going to be a major non-conformance, the fact that we allowed to operate the line without being calibrated. Lelou

 



Raj21

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Posted 08 February 2021 - 08:47 AM

Dear Lelou,

 

You may need to explain the auditor on other criteria such as verification methodologies and tools you used to assess the CCPs in control. Supporting evidences of final product conformity results could be provided in addition. Visually you may not see the difference and the equipment still could be seen to be operating within the range they do usually. But then, this is the purpose of calibration to see whether it actually is showing the correct results as per the master.

The restrictions of travel and related costs could be explained with supporting data or government order , to sound genuine. If the travel restrictions are lifted and the auditor can travel on-site in March, why not the calibration agencies before April ? This could be a question I feel.



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Scampi

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Posted 08 February 2021 - 02:21 PM

Did you do any in house verifications for the claim that they are working fine?  If yes, than a deviation explaining the delay should suffice

 

If NOT then you may be in bigger trouble..........how do you know everything is ok if you have not verified in house?  ON a CCP technically you'd be in a recall situation

 

Need more info to advice correctly


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SQFconsultant

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Posted 08 February 2021 - 03:01 PM

you can use an explanation with the auditor, however i doubt that it will fly given the excessive length of time where a something could have been worked out. Sometimes we need to work around, go under and move mountains in order to get things done.


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Lelouch_rayne

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Posted 09 February 2021 - 01:05 AM

Dear Lelou,

 

You may need to explain the auditor on other criteria such as verification methodologies and tools you used to assess the CCPs in control. Supporting evidences of final product conformity results could be provided in addition. Visually you may not see the difference and the equipment still could be seen to be operating within the range they do usually. But then, this is the purpose of calibration to see whether it actually is showing the correct results as per the master.

The restrictions of travel and related costs could be explained with supporting data or government order , to sound genuine. If the travel restrictions are lifted and the auditor can travel on-site in March, why not the calibration agencies before April ? This could be a question I feel.

 

The only verification method I have so far are: final product analysis, review of monitoring records and IQA. Is this enough already?

 

 

The restriction of travel in our country ended several months ago already. This is another reason why I'm reluctant with this setup because I know the management could really push the calibration schedule last year (4th quarter) but they didn't. The reason it was schedule on April is because we have a new line that needs also to be calibrated, so to save money they decided to calibrate both equipment at the same time.

 

I know this sounds absurd.  :helpplease:


Edited by Lelouch_rayne, 09 February 2021 - 01:07 AM.


Lelouch_rayne

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Posted 09 February 2021 - 01:13 AM

Did you do any in house verifications for the claim that they are working fine?  If yes, than a deviation explaining the delay should suffice

 

If NOT then you may be in bigger trouble..........how do you know everything is ok if you have not verified in house?  ON a CCP technically you'd be in a recall situation

 

Need more info to advice correctly

 

No, we didn't. We are not capable enough to do such activity.

 

This is what I'm afraid of. Because technically speaking all the products produced on the period where the calibration expired should be non-conforming product already. So what if the auditor ask: how come we release those batches, what's our basis?

 

Would finished product analysis be enough?



Raj21

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Posted 09 February 2021 - 10:17 AM

The only verification method I have so far are: final product analysis, review of monitoring records and IQA. Is this enough already?

 

 

The restriction of travel in our country ended several months ago already. This is another reason why I'm reluctant with this setup because I know the management could really push the calibration schedule last year (4th quarter) but they didn't. The reason it was schedule on April is because we have a new line that needs also to be calibrated, so to save money they decided to calibrate both equipment at the same time.

 

I know this sounds absurd.  :helpplease:

 

Final product analysis if it validates the parameters controlled by the CCP may be acceptable. Again it is case to case basis and completely depends upon the auditor.

But as you mention that travel restrictions ended much earlier, in this case delaying calibration for the purpose of clubbing of visits may not be acceptable. BRC is very clear with its norms for such cases though it is implied.

It directly shows up on resource provision in clause 1 "Senior management commitment". 



Scampi

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Posted 09 February 2021 - 01:05 PM

What kind of equipment specifically are you talking about?  X-ray, thermometres, metal detection?


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Lelouch_rayne

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Posted 10 February 2021 - 03:53 AM

What kind of equipment specifically are you talking about?  X-ray, thermometres, metal detection?

 

Aseptic Filler (ready-to-drink):

 

- temperature sensor

- pressure sensor

- flow meter



Scampi

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Posted 10 February 2021 - 01:00 PM

oh dear

 

have you sent any of the finished goods to a certified 3rd party lab?

 

Those items are important to your process, particularly temperature and pressure

 

BTW, you CAN verify a thermometer in house and it's better than nothing. Currently you have no idea how close to bang on it is.  You also could have

A) purchased a new calibrated thermometer

B) sent yours out for calibration via the mail (that's what we do)

C) purchased calibrated NEW pressure sensor/flow meter

 

https://globaltemp.c...the thermometer.

 

My gut is recall...............you're company determined those were CCPs and did not follow the deviation procedures. Just because something is "operational" that you determined requires calibration probably isn't going to cut the mustard with your auditor

 

Not the answer you're looking for I'm sure, but you can still do A/B/C before April.................


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caroline2771

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Posted 11 February 2021 - 02:24 PM

We had the same kind of problem last year although it wasn't because of COVID ..

Our frequency was set to be in March but our audit was an unannonced one and we had it in February. 

 

The auditor gave us a minor because she said we showed her the same calibration paper the year before and she absolutely needs to see a new one when auditing.

 

Learning from this mistake, what I can tell you to do since the COVID is not a common situation, you could open a corrective action plan that states why it hasn't been calibrated this year, and when is your time limit to do it.. Also, you could make ''submission'' with other companies to see if someone else could do it for this year.

I also recommend to do an intern calibration (maybe more often until the audit) to make sure you have something on file to show.

You could also purchase new certified calibrated weight 

 

Hope this helps!

 

Good luck :) 



Scampi

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Posted 11 February 2021 - 02:28 PM

I would have fought that caroline........the auditors job is to ensure you program meets requirements and that you're doing what you said you would do. Since you were meeting requirements, and you did not exceed the time limit imposed for recalibration............auditor was wrong in issuing a minor----show me where is says "they must see a new certificate"  you can't, case closed


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caroline2771

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Posted 11 February 2021 - 04:38 PM

I would have fought that caroline........the auditors job is to ensure you program meets requirements and that you're doing what you said you would do. Since you were meeting requirements, and you did not exceed the time limit imposed for recalibration............auditor was wrong in issuing a minor----show me where is says "they must see a new certificate"  you can't, case closed

 

You are absolutely right !

I wasn't the SQF practitoner back then, but you have a point !

 

thanks 






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