11.2.10.2 Disposition of Potentially Affected Product

Hello,

I am having difficulty in 11.2.10.2 Procedures in place to address the disposition of potentially affected product when equipment is found out of calibration.

If scales are found out of calibration would you have to conduct a recall for products that have left the facility already?  Weight is more of a quality issue than a food safety issue but, I'm having difficulty figuring out what to do with potentially affected product if the scales are found out of calibration.

If thermometers are found out of calibration I'm assuming we would have to put all product in house on hold and recall all product that has left the facility since we pasteurize and use our thermometers for pasteurization which is a CCP.  So, we would place all product on hold since the last good check and recall product that has left the facility and analyze and investigate it's disposition since this would be a food safety issue.  Does this sound correct?

I'm unsure if we would need to do that for scale calibration being out of tolerance because it isn't a food safety issue but, I don't know what else we would do and I don't want to state we would put the product on hold and conduct a recall if it is not necessary.  Any help would be greatly appreciated.

Thank You

I'm in the same boat with scales. Had a minor over it and the procedure just doesn't give enough details about what to do and how much product should be involved. Will need to resolve it soon, once I do I'll come back to post :)

Hello jportz,

It seems out of calibration scales could only affect quality. But it also actually affect the safety and legality of your product. An over packed product/over weight could possibly be underpasturized because its core temperature can't be achieved on your scheduled process time/temperature. An underweight product could be a violation on legality. So much so with the out of calibration thermometer.

regards,

redfox

We pasteurize before we weight the final product.  I talked to the company that calibrates our scales and he said if we are buying and selling off the scale that we have to go by the state tolerances and that is what they use.  He didn't think we were doing that but, we weigh our final product then add the brine and label it and ship it to the customer.  We don't do in house scale calibration, our scales are only calibrated by an outside company every 6 months.  I did past trending of the outside scale calibration company's results and some of our scales have been out of state tolerance.  If the tolerance was 5 pounds I have that it was off by -6.8 pounds and another that should have a tolerance of 2 pounds was off by 3 pounds.  Our scale's that are used for ingredients he said isn't for sale by trade so I can set my own tolerances.  I have a lab scale that was off by plus 2 grams and is used to weigh product for plating, the tolerance from the state is 1 gram.  I am unsure on what to do with the affected product in this situation.  These were years ago but, I am worried what to do if it happens again.  If we had to recall 6 months of product a lot of it would be gone and used by then.  We don't have weights to check scales in house.  Any suggestions on what I do with the affected product? 

Perform a risk analysis on what would happen if the scale was inaccurate. 

Hi portz,

You omitted to mention whether yr SQF is Lvl 2 or 3.

I assume any legality issues in Lvl2 are confined to safety -related factors. (?)

If Lvl2, IMO weight-related defects are normally irrelevant to safety (I guess canning might be an exception as per redfox's comment) so the most likely (non-SQF-related)  factors would be regarding customer contractual / legality aspects. I deduce the latter are customer / State related so would depend on the specifics.

The typical options for "rejected" product are (a) dumping, (b) re-processing, (c) sell to someone who will themselves presumably re-process or have alternative utilization routes. There may be local restrictions on the available options.

PS - IMEX it is "best practice" to do daily "self-calibration" of scales with check weights

Hello jportz,

Buying a test west and sending it to an ISO-17205 accredited calibrator for your internal calibration/verification used is much cheaper than a recall. Even it is not a requirements by a specific standard, doing an internal calibration is quite beneficial to product safety, quality and legality and to your business. An overweight product for example might not be a legal issue but it surely hurts your business.

regards,

redfox

• Weight: depends on if it is under or overweight.  Underweight could be a legal issue, and a quality issue.  Depends on if you pack for retail or for industry and if you pack by a standard weight/volume or not.
  • If you need a product disposition, I would write the SOP as "evaluated by management".  Specifically, you would likely conduct further weight checks of the product and cull out anything out of spec from the last "good known scale calibration check".  Anything within spec could be sold.  Final disposition would be determined if you can rework the product/material or not.

We check our scales at the beginning of each day with a calibrated weight. If anything is out of tolerance, we call the calibration company and fix it immediately. What's the worse case scenario from a health and safety perspective if your scales are not calibrated correctly?