19 replies to this topic

[dl1888]

I am in a little bind and looking for help on 11.2.10 CALIBRATION. It states you have to have a procedure for when calibration is found out of compliance. We calibrate scales and temperature reading devices on a monthly basis, which is compliant with the SQF code. But now they want a procedure for when the calibrated equipment is found out of compliance, what will your product disposition be.

Do I need to calibrate my scales and temperature devices everyday to ensure my calibrated equipment is always in compliance. I do not want to have to recall a monthly worth of product if I find my calibration out to compliance if I continue to calibrate on a monthly basis.

Any help would be great. Thank you,

[Bawdy01]

Hi DL1988



I suggest you do a risk assesment (if you havent already) surrounding your items to be calibrated. Those measuring CCPs should get a higher frequency than those doing CPs for instance, but this then needs to be balanced against the likelyhood of the instrument going out of calibration and the frequency of its use and if there are any other "indicators" that could alert you to an out of calbrated piece of equipment. If you have a good history of the equipment holding calibration then monthly or even quarterly may be okay. I am a lazy so and so, i hate doing extra work unless there is good reason or value in doing so. You may find that some need more frequent testing, others can be relaxed a little. I too would hate to have to recall a months worth of stock just when a simple calibration check could have prevented it.

For example, i used to work in a cannery, the pH meter was calibrated daily as the pH is very important to ensure the correct thermal process and there was only the one pH check, but the Mercury in Glass (MIG) thermometers on the retorts themselves were calibrated only twice a year, as these rarely drifted out of calibration, there was a digital thermometer on the retort as well, (which was cross referenced to the MIG on every cook cycle and recorded) as well as a pressure reading (which gives a ball park idea of internal retort temps). So there was ample opportunity to catch if the MIG was out of calibration.

Hopefully to help answer your question re a procedure for out of calbration - Your corrective actions needs to be determined in line with what the item was measuring and its impact upon the products safety, quality and or regulatory compliance. It can be difficult to write as the amount of deviation is also significant/important in deciding how to act. If the scale is out by 0.9 gm and you are using it to measure 10kg bags of flour, then it is probably not signifcant as opposed to being out by 1.0kg.

In the past i have managed to get away with a fairly generic sentence along the lines of "the HACCP team or QA Manager shall be immediately made aware of the calibration results so that they can meet to risk assess the likely impacts of any deviation and take any necessary actions as determined." Seems to cover most of the likely issues that can arise if equipment went out of calibration, and reflects what would happen in reality anyway.

As an aside, and i do not know how you could possibly write this into any manual, it is surprising how often the operators themselves pick up issues before the calibration checks do, the bag doesnt feel the correct weight, the valve/lever is open as far as normal, doesnt look, smell feel right etc. Particularly the experienced long term ones, i have often been amazed at what some of them can detect.


Hope that helps.

Bawdy.

[Urban Explorer]

Our CCPs are temperature and pH.

pH meter is calibrated daily via buffer solutions. (requirement by USDA/FDA) - however, the actual "real" calibration of the machine is determined by the manufacturer, not you. Our manufacturer recommends yearly on it.

Bimetallic Thermometers are calibrated daily against a mercury thermometer (again, requirement for daily check) which is calibrated annually per manufacturer (acceptable to SQF). These bimetallics do not have a calibration date on them (which is acceptable) as long as the range between their reading and the mercury is not greater than 2°F (plus or minus). In which case, the thermometer must be hand calibrated (via a nut or sensor), removed from service, or sent to the manufacturer for repair. (look up Kansas State University's thermometer calibration guide)

Our scales are checked daily also by certified weights. The same principle applies, manufacturer recommends twice a year on those. The percent variation from the weight and the reading is a maximum of 2 percent (plus or minus). When out of range, the scales are either fixed or thrown out.

I write these notes directly on the daily calibration sheets. if you need an example, let me know.


I suggest if any of your scales or thermometers relate to CCPs that you do it daily. sometimes doing the basics is not financially savvy when it relates to food recalls, etc.

I keep a spreadsheet of the equipment, when it was calibrated, and when it needs to be calibrated again. If you have a hard time remembering like I do, set up a date in your Outlook calendar or a regular old wall calendar.

[Madam A. D-tor]

Dear Destinee,

You have written down in a procedure what you will do if the device is out of control --> repair or throw away.
You also need to decide/assess if your products have been at risk.
Is it for example traceable wich products and processes are checked with the non-conforming equipment?
In most monitoring systems there is build in some tolerance. Make sure the tolerance of your measuring equipment is smaller than the one of your CCP.
If the measuring device is out of control, check if there were products at risk.

E.g. temperature requirement (CCP) is > 73 °C with critical limit = 72 °C.
First, due to the tolerence of 1 °C, you should specifiy the tolerance for the thermometer < 1 °C. For example 0,5 °C. I am sure that you have done this in the past, but please check this for all your measuring equipment. I have found more than once that the CCP tolerance was 1 °C and the equipment tolerance was 2 °C. You can imagine the food safety risks of such methods.
If the thermometer you use for checking this CCP is out of specification, you need to check if your product have been at risk. Say the thermometer was out of spec for 0,7 °C. You take all the products or processes (In the example: products) that have been measured with this equipment and check if these are with or within specification. If you calibrate once a year, you then check the records of the whole year.
For example the following values have been measured:
73,4
73,8
73,1
74,2
72,9
72,8
73
73,1
73,3
73,2
If the thermometer is +0,7 out of spec, all measurings < 72,7 have exceeded the critical limit and are at risk.
In this example none of the measurings has exceeded the critical limit.

This exercise should be done everytime a measuring device is out of spec and this is what you should write down in a procedure. And indeed it can be as simple as: "when measuring device is found out of control QA department will check if products have been at risk and if needed take action to the products and initiate recall procedure".
If records of checks are communicated to e.g. customers, these should get the amended results.

Be aware of operators borrowing devices of colleagues. If you think operator has used thermometer A and in real he has been using thermoter B to cunduct the checks, you might correct the wrong results.

Non-conformities I have observed regarding this issue:
- tolerance of device to large for the to be measured values;
- calibration performed by maintenance department, which only send the devices to external organisation and put the results in a folder. No one with knowledge checked the results coming back and during audit it was found out that device exceeded the limits and no actions have been taken (PT 100 in pasteurisation process);
- measuring devices not calibrated according the own procedure;
- measuring equipment used not traceable.

Good luck with your procedure.

[Charles.C]

I am in a little bind and looking for help on 11.2.10 CALIBRATION. It states you have to have a procedure for when calibration is found out of compliance. We calibrate scales and temperature reading devices on a monthly basis, which is compliant with the SQF code. But now they want a procedure for when the calibrated equipment is found out of compliance, what will your product disposition be.

Do I need to calibrate my scales and temperature devices everyday to ensure my calibrated equipment is always in compliance. I do not want to have to recall a monthly worth of product if I find my calibration out to compliance if I continue to calibrate on a monthly basis.

Any help would be great. Thank you,

Dear DL,

The audit query is calibration procedural 101.

For any relevant answers, more info. is necessary.

What is the product / process and the specific use of the items you refer ?

Rgds / Charles.C

PS - IMEX, most factories do check the accuracy of their scales every day for obvious reasons (eg claims). This is not necessarily the same (eg via sub-master checkweights) thing as a "full" external calibration although it can be equivalent.

[dl1888]

The product is Shell Eggs. We have a USDA guideline of keeping our CCP (our cooler) at 45 degrees F. of less. I have a thermometer in the cooler which is calibrate on a monthly basis against a NSIT certified thermometer. I have a tolerance of +/- 1 Degree F. for the temperature reading device in the cooler. What I do not have is a procedure for if my tolerance is exceeded outside the +/- 1 degree F. How do I ensure my product is still safe? What should my disposition of the product be?

[Charles.C]

The product is Shell Eggs. We have a USDA guideline of keeping our CCP (our cooler) at 45 degrees F. of less. I have a thermometer in the cooler which is calibrate on a monthly basis against a NSIT certified thermometer. I have a tolerance of +/- 1 Degree F. for the temperature reading device in the cooler. What I do not have is a procedure for if my tolerance is exceeded outside the +/- 1 degree F. How do I ensure my product is still safe? What should my disposition of the product be?

Dear DL,

Thks for input.

This looks more like a HACCP Plan question, eg relating to failure of a critical limit (?).

The haccp plan content is typically based on requirements such as -

Whenever there is a deviation from established critical limits a corrective action must be instituted to ensure that defective products do not reach the consumer. These actions should include the following (NACMCF, 1997):

1. determine and correct the cause of deviation
2. determine the disposition of products that were produced during the process deviation
3. record the corrective action taken.

Some typical options for product include:

1. isolating and holding products for safety evaluation
2. reprocessing
3. rejecting and/or destroying of product
4. use as by-product (animal feed).

(eg http://www.fao.org/d...3e/y4743e0i.htm )

I believe egg production is controlled by legislation in USA, eg
http://www.fda.gov/F...n/ucm170746.htm

I'm not familiar with US egg standards but I would expect that (automatic?) corrective actions are spelled out somewhere in the rules (?).

(The corrective action may depend on specific details. IMEX, this kind of difficulty is one reason why many haccp plans include an "operational limit" in addition to a critical limit.)

Maybe there are some US egg processors reading this thread ?

Rgds / Charles.C

PS - Yr query about "safety" would presumably involve some level of (eg Salmonella) microbiological sampling / analysis but possibilities are likely to be defined by legislation / specific details.

[TheDude]

Our scales are checked daily also by certified weights. The same principle applies, manufacturer recommends twice a year on those. The percent variation from the weight and the reading is a maximum of 2 percent (plus or minus). When out of range, the scales are either fixed or thrown out.
 

 

We check our scales 3 times a shift with a certified weight and also send certified test spheres through the metal detectors at least every hour. The scales are professionally calibrated bi-annually and the metal detectors are annually. We received a minor because we did not have a procedure addressing the disposition of potentially affected products should the equipment be found out of calibration state. We have a procedure addressing when our checks fail, but nothing for when the professional calibration fails. It doesn't make much sense to me. If the machines are not professionally calibrated properly, our checks would show it. Any thoughts?

[Urban Explorer]

We check our scales 3 times a shift with a certified weight and also send certified test spheres through the metal detectors at least every hour. The scales are professionally calibrated bi-annually and the metal detectors are annually. We received a minor because we did not have a procedure addressing the disposition of potentially affected products should the equipment be found out of calibration state. We have a procedure addressing when our checks fail, but nothing for when the professional calibration fails. It doesn't make much sense to me. If the machines are not professionally calibrated properly, our checks would show it. Any thoughts?

 

hmm, that sounds like just some minor wording.  Oh those auditors, looking for any little thing.

 

Can you paste the actual wording from your procedure?  It may shed some light on what it should say to appease your corrective actions.  Your "checks" are basically calibrations because the procedure is the same as a professional technician, but you need that official certificate biannually to show that you are doing things properly.

 

Maybe put a line in saying if a professional certification notes deficiency, then your certified weights shall be recertified and samples of in house products reweighed to verify you are within allowable limits.  ??? I've never had to write that in, but every auditor is different.  I'm assuming you are running a top rate facility and he was grasping.

 

I've seen minors for operators not having the scale level bubble exactly in the middle.  But others don't even look at that!

[Charles.C]

Dear leesqf,

 

It sounds to me like the auditor is, for some reason, not satisfied with the methodology used to certify yr standard weight(s). ? Hence the unique (IMEX) follow -up question (assuming the auditor was referring to this step).

 

Was he satisfied ?

 

If not, this would usually invalidate yr own internal calibration procedure (I agree with Destinee's terminology) which was apparently found satisfactory (presumably  including yr internal corrective action [usually involving a repeat of some weight checking + appropriate disposition of any defective scale]).

 

Rgds / Charles.C

[TheDude]

He was satisfied with everything other than the fact that we do not address what to do with product if the professionals find a problem with equipment upon performing the calibration. My reply was that our checks prove the equipment is working properly so the professionals will not find any deficiencies. We have a procedure stating how to handle product if our checks note deficiency but not if the professionals do. Even though I do not agree with this non-conformance, I will amend our policy as has been recommended to satisfy the auditor.

[tadelong]

Sometimes you have to wonder what kind of quota the auditors have to meet.  We calibrate most things monthly, using a variety of methods (a certified hygrometer in the egg cooler, for instance). Our digital scale we use for checking the graded eggs (a small sample, mind) is checked and calibrated every day, but not against certified weights. Main reason for that being cost and bother, but since the regulations allow for a 0.5 g variance, why would we expend the resources?

 

I'm sure the next auditor will find and grab me on this, but I try to come armed for bear on audit day.

[Charles.C]

Dear leesqf,

 

professionals find a problem with equipment upon performing the calibration.

 

Sorry but I don't understand how this relates to an external certification of yr checkweight(s). Who are these mysterious  "professionals?"

Are you saying that the auditor, for some reason, mistrusts the external certification facility which you are using ? If so, the auditor's mistrust should be justified to you.

 

@tadelong

 

but not against certified weights

 

Well, at least you appreciate yr weight control process  is defective. i guess the rest is a commercial, non-safety, decision.

 

I presume you have decided that the risk from a wrongly calibrated hygrometer is less readily argued.

 

Regardless, I congratulate you on yr auditorial debating skill or ability to be assigned unusually, user-friendly auditors.

 

Rgds / Charles.C

[TheDude]

Who are these mysterious  "professionals?"

Are you saying that the auditor, for some reason, mistrusts the external certification facility which you are using ? If so, the auditor's mistrust should be justified to you.

 

 

 

The manufacturer of our metal detectors come in to calibrate them annually. The auditor stated we must have a procedure documenting what we do if the "professionals" notice something was calibrated incorrectly. This doesn't make sense to me because we do the same calibration at least every hour and our test spheres are NIST certified.

[Urban Explorer]

Having had a round of jerk auditors, I can tell you that each one claims you must do this or must do that.

What you could do is appeal the minor on the basis that you need another opinion on how to interpret the code.

I really think SQF needs to step in and give auditors ground rules. It is absolutely ridiculous how they treat companies as though we are too stupid to read the code and that they know better. Show me proof of what I "have" to say and I'll accept it.. Otherwise they are talking out of their ass, to put it bluntly.

Sorry, most of these guys have been dinosaurs of the industry for 20-30 years and have prejudices against younger professionals. Maybe that's not always the case, but this has been my experience. They believe they know everything but the food industry has changed since 1965.

We as companies are spending thousands of dollars to auditors to be disrespected and made out to be fools.

[Charles.C]

Dear leesqf,

 

There appears to be consideable confusion between yourself, the auditor and possibly the manufacturer of yr equipment(s?) as to the meaning and sqf requirements concerning "calibration". Unfortunately I find it rather difficult from preceding posts to sort out the actual basis of the disagreement.

 

I deduce there was in fact no problem over the weight control procedure, or perhaps two identical complaints?. Hopefully the former.

 

Rgds / Charles.C

[TheDude]

Destinee,

Wow. It sounds like you have had some bad experiences. I have only dealt with 1 auditor and he has been very nice.

I am most likely going to take the minor and slightly adjust our procedure to satisfy them even though I don't really understand.

 

Charles,

It very well could be confusion (different interpretation). The auditor and I discussed it for quite some time but ultimately he "won".

[markjoelangeles]

Having had a round of jerk auditors, I can tell you that each one claims you must do this or must do that.

What you could do is appeal the minor on the basis that you need another opinion on how to interpret the code.

I really think SQF needs to step in and give auditors ground rules. It is absolutely ridiculous how they treat companies as though we are too stupid to read the code and that they know better. Show me proof of what I "have" to say and I'll accept it.. Otherwise they are talking out of their ass, to put it bluntly.

Sorry, most of these guys have been dinosaurs of the industry for 20-30 years and have prejudices against younger professionals. Maybe that's not always the case, but this has been my experience. They believe they know everything but the food industry has changed since 1965.

We as companies are spending thousands of dollars to auditors to be disrespected and made out to be fools.

I agree!

[LostInTheWoods]

Resurrecting this zombie thread, but I'd like to clarify something. I'm new to Food Safety, but come from a Quality and Measurement background.

 

Calibration and Verification are 2 different things, but often confused (likely because they are performed at the same time). Calibration is setting a measurement instrument's output to match a known standard. Verification is checking to make sure the calibration is still correct. I'll illustrate this through the aforementioned scales.

 

I'll call in an outside vendor to calibrate my scales. The vendor should first verify the scale's accuracy and list the "as found" condition by weighing known weights and listing the error (this is really validation). They will then adjust the scale so that it is as accurate as it can be, noting the "as left" condition. All this says is that the scale is good, right now (this is very commonly misunderstood, many people take it to mean that it will be good for a whole year). I'm supposed to base my calibration interval on risk, but usually I take the accepted default of 1 year.

 

If I don't perform any verification, then 1 year from now, the vendor comes back, and reports the "as found" as + 1kg, I need to consider everything I've used that scale for in the past 1 year is suspect. I would need to analyze the risk and make appropriate decisions regarding recall and traceability, etc. However, if I'm performing verification with a certified check weight weekly, I would have records showing that the scale was measuring correctly each week, and the only suspect product would be that produced between my last verification and my calibration.

[jfrey123]

Nice resurrect LostInTheWoods lol.  Since it got bumped, I'll share that I've always had production verify scales are accurate at the start of each shift.  Finding out a scale was out of calibration at some point over a week is a lot of potential product that could've shipped, and becomes a liability to the traceability program.  I've always had a scale check as part of the pre-op or start-up documentation, trained operators required to record the scale they're checking and the certified weight they're using for the check.  The SOPs should state a scale failing a verification is to be placed on hold until it can be serviced/calibrated, and all material run past the scale should be checked for accuracy.

 

Also, since we're talking about it now, don't forget to have your weights recertified when you have your scales officially calibrated.  I've run annual calibration frequencies on both, basically calling out a company that is qualified to issue calibration certs for both my scales and my weights.  No SQF auditor has ever found fault with that (knock on wood).