Does anyone have an example calibration procedure covering disposition of product for SQF 11.2.11?

Does anyone have a example of a calibration procedure for SQF 11.2.11 - specifically the disposition of product?  We are a dry blending company. How do I know if my metal detectors are not calibrated? We test them every morning & every 3 hours.  

Are you just talking about metal detectors or all equipment. you verifying the metal detector daily is proof that the calibration of the metal detector is working properly. What is it that you do if you check the metal detector and it does not reject your test wands? That would be the disposition of the product. Did I answer your question?

It looks like you are asking two questions.

As to calibration - we also test our detectors with 3 calibrated sample cards prior to run and every hour, after coming back from break and at end of day.

We have the local rep come in every 6 months to tune the system or if there are issues (there never has been.)

Great.  So when it is asking for procedure on disposition of product is this from the last test of testing wands or back to rep certification? What would happen if a rep said that there was an issue? 

I think I am over thinking it....

Great.  So when it is asking for procedure on disposition of product is this from the last test of testing wands or back to rep certification? What would happen if a rep said that there was an issue? 

 

I think I am over thinking it....

I think you might be hahaha

Procedures shall be documented and implemented to address the disposition of potentially affected products should measuring, test and inspection equipment be found to be out of calibration state 

 What does this mean? If the equipment wasn't working for a period of time what will you do with the product that could have been contaminated?

Overthinking, yes -

You are trying to determine what to do with product if test fails or during the day the alarm/light goes off?

If that is the case and you don't currently have a disposition (what you are going to do when the alarm goes off) we need more details - for instance is this an inline tube, how does the product run, etc. A photo would help.

Our calibration procedure is just a couple pages long and makes general statements about how we handle calibrations on various equipment in the plant and lab - who schedules them, who reviews them, what kind of documents we require, what to do if something is found to be out of calibration, etc.  We then have a spreadsheet listing each piece of equipment, model and SN, where it is located, what it's function is, whether it is an internal calibration or external calibration, date of last calibration, due date of next calibration.  

Below is an excerpt from our SOP which discusses doing a risk assessment when something is found to be out of calibration:

1. If a piece of equipment is found to be out of calibration:
   1. The equipment will be re-calibrated as soon as possible.  If not possible to re-calibrate immediately, the equipment will be taken out of service.
   2. The Maintenance Manager, Quality Management, and the Plant Manager will be notified.
   3. A risk assessment of potentially affected product will be done, going back in time to the last good calibration.  The assessment will be done by the Quality Management, Maintenance Manager and Plant Manager.)  The purpose of this evaluation is to determine if further action is needed (product put on hold, etc.).
      1. The risk assessment will include consideration for the following:
         1. What the equipment is being used to measure.
         2. How far the calibration is out and how significant the impact is.
         3. Does the equipment monitor or measure a control point or regulated characteristic?
         4. Review of previous calibration records for that equipment –internal and external.

The discussion here so far has been related to a metal detector (CCP), but there may be other equipment you need to consider.  Many of us already have clearly defined actions to take when the metal detector is found to not be working properly (when a test piece fails) such as:  stop the line, put product on hold back to the last good check, repair or replace the detector, can re-run product on hold through a work MD at later time, etc.  

However, there may be other equipment in the plant or lab that gets calibrated such as weigh scales for example.  When an outside service comes in once a quarter or once a year to calibrate them, and they find a scale out of calibration that you use to weigh ingredients, products, other... this is when a risk assessment needs to be done.  It's possible that scale has been used for an entire quarter, or entire year and wasn't giving accurate weights.  What is the significance of that?  That depends on how far it was off, what it is used for, was it reading too low or too high, etc.  The risk assessment should be documented with the answers to the those type of questions, and your conclusion as to if product is at risk or not.  

This has been my experience with that part of the standard, and I hope you find this helpful.