9 replies to this topic

[kloon]

I am ordering new digital temperature and humidity monitoring devices for the warehouse and calibration is an additional charge. The devices come with a certificate of conformance certifying " the product was manufactured to and is warranted to strictly comply with the accuracy and resolution specifications as published on the manufacturer's website" Is this sufficient documentation? As part of our calibration schedule, these devices will be sent for calibration on an annual basis.

[Brothbro]

Hi Kloon and welcome to the forum. I would pay for the calibration. "Manufactured to comply with" may only mean that the manufacturer followed their own instructions to create a device they're confident will work. It does not explicitly state that any testing/calibration was actually performed.

[jfrey123]

Thermometers should be calibrated.  If it's cheaper for you to send them out for third party calibration versus getting the first one from the manufacturer, then that would be fine, but you always want to have a valid calibration for the thermometers before you add them to your plant's use, and from there you can start your own verification process at your plant's specified frequency.

[Charles.C]

I am ordering new digital temperature and humidity monitoring devices for the warehouse and calibration is an additional charge. The devices come with a certificate of conformance certifying " the product was manufactured to and is warranted to strictly comply with the accuracy and resolution specifications as published on the manufacturer's website" Is this sufficient documentation? As part of our calibration schedule, these devices will be sent for calibration on an annual basis.

Hi kloon,

 

"Calibration" has a variety of meanings.

 

The answer to your query  depends on -

 

(1) Sufficient to whom ?

(2) what the Certificate says ?

(3) what you are using the thermometer for ?

 

For example the Certificate may state something like accurate to within +/- 0.5degC at ice temperature. This is insufficient  if used for monitoring steam in a cooking process at 90degC.

[kloon]

Hi kloon,
 
"Calibration" has a variety of meanings.
 
The answer to your query  depends on -
 
(1) Sufficient to whom ?
(2) what the Certificate says ?
(3) what you are using the thermometer for ?
 
For example the Certificate may state something like accurate to within +/- 0.5degC at ice temperature. This is insufficient  if used for monitoring steam in a cooking process at 90degC.

Is it sufficient enough to satisfy the FDA. They are digital data loggers that transmit temperature and humidity via Wi-Fi to a web based database. They are used strictly for monitoring of ambient conditions.

[Charles.C]

Is it sufficient enough to satisfy the FDA. They are digital data loggers that transmit temperature and humidity via Wi-Fi to a web based database. They are used strictly for monitoring of ambient conditions.

 

Hi kloon,

 

(2) = ? (temperature -wise )
ambient = approx ? degC (a unit calibrated at 0degC typically shows increasing errors with operational temperature difference although I daresay FDA might not demand re-calibration if the "ambient" difference was within "X" degC)

 

There is a difference between COCs and COAs since the latter typically include actual data rather than "Assurances").

 

I have limited experience with data loggers but, ex-google -

 

How Accurate Are Data Loggers? There are loggers with accuracy specifications from basic but useable accuracy; 1-2% full scale, to high accuracy specialized units; in the 0.01% full-scale range. A temperature logger used for warehouse monitoring would typically have 1-2 degrees Fahrenheit accurac

 

and, JFI -

 

https://www.alliance...-my-data-logger

[kingstudruler1]

my opinion is that even a new thermometer / measuring device even with a cert should be checked prior to use.  you would typically want a NIST or similar certificate of traceability as well.  the statement that they provided is meaningless. 

 

however, in your case, as Charles stated, monitoring ambient conditions that aren't critical to food safety -  it's probably overkill. 

 

 

BRCGS states:

 

All identified measuring devices, including new equipment, shall be checked and, where necessary, adjusted: • at a predetermined frequency, based on risk assessment • to a defined method traceable to a recognised national or international standard where possible. Results shall be documented. Equipment shall be readable and be of a suitable accuracy for the measurements it is required to perform.

[Charles.C]

I am ordering new digital temperature and humidity monitoring devices for the warehouse and calibration is an additional charge. The devices come with a certificate of conformance certifying " the product was manufactured to and is warranted to strictly comply with the accuracy and resolution specifications as published on the manufacturer's website" Is this sufficient documentation? As part of our calibration schedule, these devices will be sent for calibration on an annual basis.

 

^^^(red) -To summarize, the basic answer is simply, probably, NO, unless perhaps the measurement is considered by FDA to have no relevance to their assessment.

[Utama]

I am ordering new digital temperature and humidity monitoring devices for the warehouse and calibration is an additional charge. The devices come with a certificate of conformance certifying " the product was manufactured to and is warranted to strictly comply with the accuracy and resolution specifications as published on the manufacturer's website" Is this sufficient documentation? As part of our calibration schedule, these devices will be sent for calibration on an annual basis.

Yes, you should 

[Charles.C]

I am ordering new digital temperature and humidity monitoring devices for the warehouse and calibration is an additional charge. The devices come with a certificate of conformance certifying " the product was manufactured to and is warranted to strictly comply with the accuracy and resolution specifications as published on the manufacturer's website" Is this sufficient documentation? As part of our calibration schedule, these devices will be sent for calibration on an annual basis.

Hi kloon,

 

Note that, in Principle, for temperature, you may not need to have all the units externally calibrated. It should be possible to designate one unit as a Master thermometer and calibrate the others against this. The choice depends on, for example, cost of calibration, whether any CCPs are involved, necessity (if any) for routinely, frequently (eg monthly), re-checking the calibration. If you believe only annual  external checking required at low cost, probably the preferred option.

(Routine checking at 0degC is typically fairly simple/rapid  however I am unsure about a Procedure for humidity).