11 replies to this topic

[JorgeCompres]

Hi,

Our company has a huge amount of thermometers and pressure gauges. Do they all have to be calibrated or only the important ones located in the process area such as the CCP's?

Thank you!

[Charles.C]

Hi,

Our company has a huge amount of thermometers and pressure gauges. Do they all have to be calibrated or only the important ones located in the process area such as the CCP's?

Thank you!

The general answer is that it depends on how much you wish to believe the temperature / pressure as indicated by a particular unit. If > Zero, there is a need for (repetitive) calibration by "somebody". The procedure, frequency and "somebody" may depend on various factors, eg history, status ( eg master, sub-master), etc.

You do not mention if query relates to certification to a specific standard. This (and any legislatory requirements) may be relevant regarding yr query as to CCPs +?.

Rgds / Charles.C

[JorgeCompres]

Thank very much for your answer!

We are applying for the SQF certification.

On the standard does not specificate what kind of therrmometers and/or gauges you have to calibrate thats why im confused. In our company we have more than 100 so before we make the investment in calibration we want to know if all of them have to be calibrated.

The general answer is that it depends on how much you wish to believe the temperature / pressure as indicated by a particular unit. If > Zero, there is a need for (repetitive) calibration by "somebody". The procedure, frequency and "somebody" may depend on various factors, eg history, status ( eg master, sub-master), etc.

You do not mention if query relates to certification to a specific standard. This (and any legislatory requirements) may be relevant regarding yr query as to CCPs +?.

Rgds / Charles.C

[George @ Safefood 360°]

GFSI requires all calibrations to be risk assessed. In other words each device and its application should be RA and an appropriate calibration plan put in place to reflect this. For example a device used to monitor a CCP would IMO be high risk and require more frequent calibration or checking.

For thermometers I have seen regimes whereby the company maintains a set of certified thermometers which are not used in monitoring activities but only for the checking of operational thermometers on a scheduled basis. The higher the risk the more frequent the checking against these standard certified thermometers.

I am not saying this is what you should do. I do not have enough information about your operations. But I would suggest you explore such an option and put all the required procedures, documentation, risk assessments and validation in place if you decide to go down this road.

100 thermometers!?! I would love to be the local calibration lab in your area

George

[JorgeCompres]

jajaja!! thank you!

GFSI requires all calibrations to be risk assessed. In other words each device and its application should be RA and an appropriate calibration plan put in place to reflect this. For example a device used to monitor a CCP would IMO be high risk and require more frequent calibration or checking.

For thermometers I have seen regimes whereby the company maintains a set of certified thermometers which are not used in monitoring activities but only for the checking of operational thermometers on a scheduled basis. The higher the risk the more frequent the checking against these standard certified thermometers.

I am not saying this is what you should do. I do not have enough information about your operations. But I would suggest you explore such an option and put all the required procedures, documentation, risk assessments and validation in place if you decide to go down this road.

100 thermometers!?! I would love to be the local calibration lab in your area

George

[Tony-C]

100 thermometers!?! I would love to be the local calibration lab in your area

George

Yep but not unusual in high temperature processes that require steam barriers

[Tony-C]

Hi,

Our company has a huge amount of thermometers and pressure gauges. Do they all have to be calibrated or only the important ones located in the process area such as the CCP's?

Thank you!

In effect your Hazard Analysis/Assessment etc. will have done your risk assessment for you. As this is an ISO 22000 forum I am assuming that you have CCP’s & OPRP’s. In both cases you may have determined the key control measures and monitoring procedures which are dependent on your temperature and/or pressure gauges being accurate. You will also have determined critical limits for your CCP’s.

Relevant parts of the ISO 22000 standard:
7.5 Establishing the operational prerequisite programmes (PRPs)
The operational PRPs shall be documented and shall include the following information….:
b) control measure(s)
c) monitoring procedures

7.6.1 HACCP plan
The HACCP plan ….. shall include the following information for each identified critical control point (CCP):
b) control measure(s)
c) critical limit(s)
d) monitoring procedure(s)

7.6.4 System for the monitoring of critical control points
A monitoring system shall be established for each CCP to demonstrate that the CCP is in control including.
c) applicable calibration methods

8.3 Control of monitoring and measuring
Where necessary to ensure valid results, the measuring equipment and methods used
a) shall be calibrated or verified at specified intervals

So in summary you need to or should have already identified the critical instruments to your process/product by identifying CCP’s and OPRPs. These are the ones to focus on in terms of priority for calibration. In addition to this there may be prerequisite programmes where you will decide that calibration of instruments is also important such as a thermometer monitoring coldstore temperature.

TECHNICAL SPECIFICATION ISO/TS 22002-1 Prerequisite programmes on food safety — Part 1: Food manufacturing
16.2 Warehousing requirements
Effective control of warehousing temperature, humidity and other environmental conditions shall be provided where required by product or storage specifications.

Regards,

Tony

[Charles.C]

Dear JorgeCompres,

As per yr original post, it appears that yr selection of iso22000 as the FSMS system is a (calibration) bonus as compared to BRC (and also SQF/IFS ?) which (annoyingly IMO) sucks in some specific non-safety related activities. (does GFSI really demand calibration of items such as balances used for product net weight purposes ?).

The necessity of calibration for monitoring instruments associated with CCPs and OPRPs (pseudo-critical limits?) as detailed in the nice previous post seems unquestionable.
However the scope of calibration activities associated with PRPs appears IMO rather “loose” in the iso22000 standard. The involvement is presumably via monitoring instruments / the Verification function. I noted Tony’s use of the word “important”. The closest, official, generic equivalent I could see is “calibrating thermometers or other critical measuring equipment” in iso22004/8.4. At least there is no explicit use of the dreaded "risk assessment" (another bonus ).

I hope that yr experiences when categorizing CCPs / OPRPs do not dampen yr satisfaction over the choice of iso22000 .

Rgds / Charles.C

[George @ Safefood 360°]

. (does GFSI really demand calibration of items such as balances used for product net weight purposes ?).

Charles I think the need to calibrate balances used in net weight purposes comes from the GFSI requirement relating to meeting national / international legislation requirements - which usually covers weight and measure, declared net weights etc.

George

[Charles.C]

Charles I think the need to calibrate balances used in net weight purposes comes from the GFSI requirement relating to meeting national / international legislation requirements - which usually covers weight and measure, declared net weights etc.

George

Hi George,

Thanks for input. Apologies, my text was poorly written , i was primarily criticising the inclusion of weight control in a FS system, and thereby necessitating calibration of balances.

My own theory is that “due diligence” is the primary driving force for BRC’s intrusiveness.

I had a look at the 2012 version (6th ed., ver. 6.2) of GFSI guidance document.

The only directly relevant GFSI (calibration) text I could find seemed to be –

The standard shall require that the organisation identify the measurement of parameters critical to ensure food safety, the measuring and monitoring devices required and methods to assure that the calibration of these measuring and monitoring devices is traceable to a recognised standard.

(FSM20, Pg105)

Perhaps GFSI’s document is only setting the minimum requirements within its interpretation of FS scope, any additional content being outside the scope, ie “not their business”.?

I also noticed these chunks in GFSI document –

2.2.4 a scheme’s standard may incorporate requirements other than those related to food safety, but only those requirements relating to food safety shall be assessed by GFSI for the purpose of recognition and the scheme’s standard shall have a significant proportion of its overall requirements as food safety related
requirements. For the application process the scheme owner will clearly identify and cross-reference those requirements to be put forward for the scope of GFSI recognition (Reference Part I Annex 1 - Scheme Application Guidelines).

In the event that a scheme is recognised by GFSI and the scheme’s standard incorporates requirements other than food safety criteria, the scheme owner shall clearly define within any communication the scope of GFSI recognition with respect to food safety.

2.6.6 The scheme owner shall only make claims regarding the conformity in respect of the scope for which recognition to the GFSI Guidance Document has been granted.

Hmmmm.

I also did a quick search for "weight / quantity" within the IFS (2012) and SQF (2012) food standards.

The results were that -

(a) IFS seems to be similar to BRC regarding requirement of weight control details.
(b) SQF only includes “weight” in the level3 section (ie Food Quality Plan). No mention in the Level2-Food Safety Plan. This is reasonable IMO although some people might regard “Weight’ as outside “Quality” also.

I believe IFS is not driven by the same requirements as BRC as far as due diligence is concerned.

So maybe it’s all just random nosiness. Kudos to iso22000, SQF; at least with regard to calibration / weight.

Rgds / Charles.C

[Charles.C]

Dear JorgesCompres,

Humble apologies for earlier mis-clicking and moving yr topic to iso22000 forum. Shows the possible side-effects of over-exposure to iso standards.

Regarding SQF, the appropriate answer depends on which module yr process is in, eg 2 + 7/10/11. And what level you are interested in.

As per location in SQF forum, George's post #4 is probably most appropriate as you no doubt already realized. Some reduction in work is possible if level 2 rather than level 3.

The details will depend on yr actual flowchart + (presumably) your choice of Level. A look at relevant SQF Guidance documents (if still existent/downloadable) is also suggested.

You are potentially involved with sections like 2.4 (1/2/3), 7.2.8, 10.2.10, 11.2.10.

@George – now I better appreciate yr erudite comments in posts #4 and #9.Thks.

Rgds / Charles.C

PS - generalised Guidance document (2008) is attached -
 SQF guidance 6th ed 2008 - 2000-Guidance-General.pdf   1.33MB   54 downloads

+ packing house guidance
 sqf guidance packing house (2010).pdf   882.47KB   53 downloads

[Tony-C]

Dear JorgesCompres,

Humble apologies for earlier mis-clicking and moving yr topic to iso22000 forum. Shows the possible side-effects of over-exposure to iso standards.


Rgds / Charles.C

..........so please disregard my previous references to ISO 22000 & 22002 & OPRP's

As you have indicated I believe GFSI guidance requires calibrations related to food safety and not national / international legislation requirements specifically.

Calibration is covered in SQF Good Manufacturing Practice Modules and requirements in each of these modules are fairly similar:
The methods and responsibility for the calibration and re-calibration of measuring, test and inspection equipment used for monitoring activities outlined in pre-requisite program, food safety plans and food quality plans and other process controls, or to demonstrate compliance with customer specifications shall be documented and implemented.

Regards,

Tony