Requirements for Calibration of Temperature Recorder During Transport?

We are a distributor of packaged food products.  We do not do any manufacturing or packaging, but we do handle some herring products packaged in glass jars and thus we have a Seafood HACCP program.

Our supplier (the manufacturer of the Seafood Product) includes a Ryan CR1 temperature strip recorder (manufactured by Sensitech) with each shipment to verify temperature during transport.  Our process is to review the recorder strip to verify temperature during transport, along with our own measuring of the product temperature and box temperature at the time of receiving.

During a recent SQF audit, our auditor told us that we were required to maintain proof that each recorder was properly calibrated.  We have checked with the manufacturer, and they have given us a letter stating that all devices are calibrated at the factory.  The devices are not field-calibratable and the temperature cannot be read without opening the device and breaking the seal so

My questions are:

• Does the Seafood HACCP standard really require that the receiving party positively verify the calibration status of each recording device?
• Since the device is not calibratable and cannont be opened to be read, what method is there to aquire this proof of calibration?

If we were held to this standard, our only option would be to convince our supplier to use another device entirely, but they are reluctant to do that saying that they use this same device with all customers currently and have never run into this issue.

Thank you for any help you can give.

It has been a while since I have worked with seafood, but think the auditor is being a little over the top.   You have a letter from the factory stating the units are calibrated at the factory.Your reviewing the temperature strips and checking the temperature at receiving, if there are not large differences, don't see his point.    Especially since this unit is designed to be single use. 

Dear gw redmond,

I presume by "Seafood HACCP Standard" you are still referring to SQF.?

You omitted to state the type of instrument you are using to measure the temperature.

The point is that the instrument may no longer be performing as per at the time of original calibration, ie yr temperature measurements could be in error. And a similar comment could apply to the transport system.

If it is a portable thermocouple instrument it is usual IMEX (production) to routinely  "re-check" the original calibration as a part of haccp verification. This typically does not require breaking an original calibration seal.

IMEX, this is typically unrelated to the type of product but will be related to the relevant standard.

Rgds / Charles.C

I presume by "Seafood HACCP Standard" you are still referring to SQF.?

The SQF code in this area really relies on the HACCP guidelines heavily, rather than re-stating all of the HACCP standards.  In the case of Seafood, the FDA has specific mandates requiring HACCP plans for Seafood and specific guidelines are published.  That is what I was referring to when I said "Seafood HACCP Standard".

You omitted to state the type of instrument you are using to measure the temperature.

I did omit the type of instrument we are using, but that wasn't really the topic of my question.  For our own physical temperature checks at the time of receiving we use regularly calibrated temperature probes and are confident that part of our process is proper.  What we are really interested in is the proper procedures related to the Ryan CR1 Temperature Strip Recorder placed in the truck by our supplier at the time of shipping.

It has been a while since I have worked with seafood, but think the auditor is being a little over the top.   You have a letter from the factory stating the units are calibrated at the factory.Your reviewing the temperature strips and checking the temperature at receiving, if there are not large differences, don't see his point.    Especially since this unit is designed to be single use. 

Thanks Snookie.  This certainly matches our feeling, but our auditor has been pretty firm when we have challenged him on this so we are trying to gather some more opinions on the subject.  Thus our desire to reach out for some other outside feedback.

That particular strip chart recorder comes with a product specification that proves that it is NIST traceable. This should suffice as there is no way to verify calibration otherwise. 

 http://www.sensitech...oducts/ryancr1 

That particular strip chart recorder comes with a product specification that proves that it is NIST traceable. This should suffice as there is no way to verify calibration otherwise.

Yes, we have come across that also, although if you try to "trace it", Sensitech says they are not able to provide specific calibration certificates or documentation on a device by device basis (i.e. by serial number or something)

http://seafood.orego...5th-Ed-2011.pdf

See chapter 10

This is a single use item, which is factory calibrated even if it does track it by serial number.  If your calibrated thermometers are reading in the temperature tolerances of the individual devices  then it shows the product is performing correctly.  To require that we all calibrate our shippers equipment and maintain records is a new requirement to me.   This  really add to the expense of what we do.  Herring will soon be 10.00 dollars a fish, which will break my husband's heart. 

Think it is important to note that at the time I write this there have been 139 views of this topic and not one person has said......Yes I do this.....and there are some very smart diligent people in this group. 

Since this is an SQF audit then auditor is probably working under a recognized certification body.  It may be necessary to take this question up the chain within their organization. 

Since this is an SQF audit then auditor is probably working under a recognized certification body.  It may be necessary to take this question up the chain within their organization. 

Agreed. I hate to sound like "that guy," but it sounds to me like an auditor that doesn't fully grasp the scope of the device and what it would mean to actually attempt to calibrate it in the traditional sense.

Agreed. I hate to sound like "that guy," but it sounds to me like an auditor that doesn't fully grasp the scope of the device and what it would mean to actually attempt to calibrate it in the traditional sense.

I agree that I hate to be "that guy" as well.  With as many audits as I have done and some have been brutal, only once I have had to go above the auditors head.  I hated doing it, but auditor was really being difficult and was just plain wrong.  But it was that or have our customers think we were incompetent. 

Dear gwredmond,

I'm still not entirely clear which standard is being audited. It matters.

Many people who viewed this thread may well have been re-processors, like myself. IMEX (not NZ), lot acceptance at reception is then often based on one's own temperature control data plus evaluation of the product itself. This may relate to Snookie's 139. But not feasible in the current case of course. The significance may depend on the (unknown) temperature limits involved in this specific product case also.

IMO it is undeniable that the use of data such as derived from a temperature measurement is questionable if the accuracy is unknown. I deduce from above link that the strip chart recorder is thermocouple based. ? If so, it must surely have been calibrated (sometime) ? (and apparently to NIST).

The OP was - 

(1) Does the Seafood HACCP standard really require that the receiving party positively verify the calibration status of each recording device?

(2) Since the device is not calibratable and cannont be opened to be read, what method is there to aquire this proof of calibration?

for (1) it obviously, strictly, depends on the text of particular standard. IMO yr auditor should have defined the text location related to his criticism if requested ? My expectation is that the answer will be either explicitly yes, or yes by interpretation from another codicil. The latter may be debatable of course. Maybe consider a consultant's advice before you launch a protest to a higher level ?.

for (2) IMO calibration data should exist, it is possible that  the recorder supplier is "prevaricating" for (unknown) reasons ?.

Regarding (1) i would have challenged at the time of audit but i personally think the auditor was anyway in error to not specify?

Rgds / Charles.C

Dear gwredmond,

 

I'm still not entirely clear which standard is being audited. It matters.

 

Many people who viewed this thread may well have been re-processors, like myself. IMEX (not NZ), lot acceptance at reception is then often based on one's own temperature control data plus evaluation of the product itself. This may relate to Snookie's 139. But not feasible in the current case of course. The significance may depend on the (unknown) temperature limits involved in this specific product case also.

 

IMO it is undeniable that the use of data such as derived from a temperature measurement is questionable if the accuracy is unknown. I deduce from above link that the strip chart recorder is thermocouple based. ? If so, it must surely have been calibrated (sometime) ? (and apparently to NIST).

 

The OP was - 

 

(1) Does the Seafood HACCP standard really require that the receiving party positively verify the calibration status of each recording device?

(2) Since the device is not calibratable and cannont be opened to be read, what method is there to aquire this proof of calibration?

 

for (1) it obviously, strictly, depends on the text of particular standard. IMO yr auditor should have defined the text location related to his criticism if requested ? My expectation is that the answer will be either explicitly yes, or yes by interpretation from another codicil. The latter may be debatable of course. Maybe consider a consultant's advice before you launch a protest to a higher level ?.

 

for (2) IMO calibration data should exist, it is possible that  the recorder supplier is "prevaricating" for (unknown) reasons ?.

 

Regarding (1) i would have challenged at the time of audit but i personally think the auditor was anyway in error to not specify?

 

Rgds / Charles.C

Very good points as always. 

Thank you again for the feedback.

IMO yr auditor should have defined the text location related to his criticism if requested ?

The auditor did quote the "Fish and Fishery Products Hazards and Control Guidance Document" published by the FDA.  Specifically page 137 of the most recent edition (Fourt Edition - April 2011).  In reading that section extensively, for our product (Scombrotoxin-forming fish delivered refrigerated (not frozen)), the document says:

1. Each load must be accompanied by transportation records that show the fish was held at an ambient temperature of 40 degrees F
2. Monitoring must be done with a continuous temperature recording device measuring the internal product temp OR the ambient air temp
3. Establish Verification Procedures: Before a temperature-indicating device is put into service, check the accuracy of the device to verify that the factory calibration has not been affected.  This check can be accomplished by:
   1. Immersing the sensor in an ice slurry if the device will be used at or near refrigeration temperatures
   2. Comparing the temp reading with a known accurate reference device
   3. Following the manufacturer's instructions.

This is where the "interpretation" comes in.  Our position is that the manufacturer's instructions say that they device is calibrated at the factory and guaranteed accurate for a period of one year, thus the device is "verified" by following this instruction.

In addition, our supplier who is shipping us the product periodically tests the devices to establish a "track record" of accuracy of the devices.  This testing process renders that particular device unusable because it has to be opened up to be read, but it helps confirm the manufacturer's statements.

Maybe consider a consultant's advice before you launch a protest to a higher level ?.

We have spoken to a HACCP consultant who will also be coming on-site next week for some training and further consulting.  His advice was to perform and document a hazard analysis on the risk of the devices not performing properly which would essentially prove that the risk is extremely low.

Thanks again for all the feedback.

Dear gwredmond,

I would opine that yr auditor had/has a strong case unless some quantitative evidence can be  provided to verify the manufacturer's calibration claim.

Validation is unfortunately often as simple as that.

Definitely Interested to see if the consultant can suggest a validation without data. Perhaps no historical evidence of any subsequent safety issues regarding the specific hazard** / transport issue in current case, the so-called negative release gambit. i got away with that for one audit but only once.

Personally i would continue pushing hard at the recorder supplier, eg problem further business due audit hassles. (Hopefully ths is a competitive situation and alternative carriers is an option ?).

Rgds / Charles.C

** PS, added - personally I've never worked with herring and was unaware it has scombroid issues. I presume this is well-documented in the detailed list of fish species hazards within yr previously referenced text.

We actually operate under the Seafood HACCP Plan as well. We do have to prove to our inspector that the TTR's that we are using are properly calibrated so we can trust the readings that we are gathering from the device. in order to do this we have the certificates on the device stating its been calibrated by the manufacturer but then we also leave the TTR in a warm room for 30 minutes to ensure the device shows the temperature increase. We take the last recording on the TTR device and compare it to our Atkins Thermocouple which is checked for calibration daily against a NIST certified thermometer. As long as the two temperatures are within our spec of 2F + or - then the TTR is within calibration.

Hope this helps!