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Major NC 2.5.2.2, no additional checks of metal detector on changeover

recent SQF level 2 audit

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#1 emdurkin

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Posted 30 August 2018 - 10:45 PM

I need some advise...our facility got a Major NC at our recent SQF audit. While performing a vertical audit of items it was noted that a product had not gone through the Metal Detector. This product is a short run for our facility and was complete within 30 minutes, so it did not show up on the CCP log for that day. Our CCP procedures state that we run a verification check every 90-120 minutes and note it on the log. SQF 2.5.2.2 states that "the methods, responsibility, and criteria for verifying monitoring is implemented and documented". No where does it state that if a changeover occurs before the scheduled verification time, that an additional check needs to be done. The auditor wrote " when the changeover occurred the check of the metal detector using the 3 test wands had not occurred as required by the metal detector protocols". This is not our protocol nor can I find an SQF protocol that makes this statement. I want to appeal this major NC. We are a small bakery making crackers, cookies and small amounts of granola. HELP!



#2 Dr Vu

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Posted 30 August 2018 - 11:11 PM

Load all the protocols you have on your form or procedure.maybe you have other protocols somewhere

Mostly you wanna challenge these during the audit

 

 

If nothing then you need to challenge..


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#3 FurFarmandFork

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Posted 31 August 2018 - 12:05 AM

when the changeover occurred the check of the metal detector using the 3 test wands had not occurred as required by the metal detector protocols". This is not our protocol nor can I find an SQF protocol that makes this statement. I want to appeal this major NC. We are a small bakery making crackers, cookies and small amounts of granola. HELP!

 

Simple, if your food safety plan didn't require the check, then no check was required and the finding is false. If your food safety plan DOES say that a check needed to occur, then you're a bit hosed and need to modify your paperwork to require checks at changeover.

 

If they just want to see it on the paperwork, maybe attach the previous/following runs so that all the checks are visible on the primary paperwork.


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#4 FSQA

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Posted 31 August 2018 - 01:46 PM

Do you have fixed Metal detectors or mobile/removable metal detectors (as mobile units can be rotated between several lines and might have been checked some time ago)?

 

If you are using a fixed metal detector, you can challenge the NC and show documentation of pre and post metal detection verification, of this production run. As FFF mentioned above, it primarily depends on your FSP.



#5 Ryan H.

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Posted 31 August 2018 - 03:37 PM

Typically it's "best practice" to perform metal detector checks for each change-over, regardless. Whether or not that is part of your policy, i do not know, however that might be why your auditor is giving you a NC here. Auditors like to see the same practices across the industry.. 

 

Good Luck to you. 


All the best, 

 

Ryan Heavner 


#6 SQFconsultant

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Posted 31 August 2018 - 04:45 PM

Based on what you said I think it should be in there, there should be a changeover check as well.

 

However, the Auditor had no call to make it a MAJOR finding.

 

If anything, it should have been written up as an opportunity for improvement, thus putting you on notice but no grade or points off.

 

I find that Auditors (having been one of the first SQF Auditors in the USA) need to be firm but fair - this was not a fair call.

 

You need to put a challenge in and at best get it wiped off or at least get an opportunity for improvement.

 

Make the improvement however now.


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#7 EvanAUS

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Posted 05 September 2018 - 05:51 PM

If metal detection is listed as a CCP in your HACCP plan, then I agree with the Auditor that this is a Major NC - any time that a failure in CCP monitoring occurs, it is automatically a Major NC.
Your description confirms that an entire product was produced without a CCP check.
However, frequency of CCP monitoring is based on risk and I believe you could have argued that if your next scheduled CCP verification check of the function of the metal detector failed to detect the test pieces, your corrective action would have been isolation of all product back to the last successful check - including the entire (short) run of the product described.
As already mentioned, challenge of the NC should have been while the auditor was on-site. Sadly, I think you’ve left it too late to successfully challenge now.
Closure of the NC is a relatively simple matter - simply update your HACCP Plan to include at least one CCP monitoring check at the start of each product run.


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#8 Scampi

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Posted 05 September 2018 - 06:14 PM

Double check that you haven't stated this as your protocol anywhere, then challenge hard.....it's not even listed in the auditing "guidance" I just checked


Because we always have is never an appropriate response!


#9 jcieslowski

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Posted 06 September 2018 - 12:36 PM

If metal detection is listed as a CCP in your HACCP plan, then I agree with the Auditor that this is a Major NC - any time that a failure in CCP monitoring occurs, it is automatically a Major NC.

 

Where is there a failure in monitoring?  It was properly checked in the morning, run for a while, and then checked again and still running.  No product was run without the benefit of metal detection.  

 

We might say it is foolish to wait so long to do the 2nd test because if it doesn't detect the metal test sample they've opened up a big window of implicated product, but that's apparently an economic risk the company is willing to take.  Who are we to argue? 



#10 EvanAUS

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Posted 06 September 2018 - 07:42 PM

Yes, the CCP was monitored at the documented frequency, but there was an entire product run without a CCP check.


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#11 FSQA

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Posted 06 September 2018 - 08:40 PM


 

 it was noted that a product had not gone through the Metal Detector.

 

EvanAUS, after re-reading the initial post, I agree ( IMO) this is a CCP violation, as the product was ran without CCP monitoring (Metal Detector).

 

P.S: Based on some of the earlier post: i assumed it was about the CCP monitoring for changeovers, but in this case it seems like the product was never ran through a detector. 



#12 FSQA

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Posted 06 September 2018 - 09:05 PM

*CCP Monitoring Checks.



#13 Charles.C

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Posted 06 September 2018 - 09:09 PM

Hi emdurkin,
 

 

2.5.2.2  The methods, responsibility and criteria for verifying monitoring of Good Manufacturing Practices, critical control  points  and  other  food  safety  controls,  and  the  legality  of  certified  products,  shall  be  documented  and implemented.    The  methods  applied  shall  ensure  that  personnel  with  responsibility  for  verifying  monitoring activities authorize each verified record.

 

3.7.5.2     Metal  detectors  or  other  physical  contaminant  detection  technologies  shall  be  routinely  monitored, validated and verified for operational effectiveness.  The equipment shall be designed to isolate defective  product and indicate when it is rejected.

 

I deduce there are more product lines than metal detectors so some sharing is inevitable.

 

(1) I see no SQF requirement that all product must pass through a metal detector. Similarly I assume no legal requirement. (Although best practice yes of course.)

 

(2) I also see no SQF/legal requirements that every lot must be monitored somewhere. (Best practice beginning/ end of a Production Lot in addition to appropriate routine time-based Validations of sensitivity).

 

The SQF Guidance afai can see offers no restrictions with respect to (1,2) above.

 

So -

 

(a) It depends on actual FSP text.

(b) If (a) not in disagreement with actual results, should have challenged the auditor's "protocol".

 

PS - Of course numerous positive metal detections would also influence the above comments. CCPs/monitoring are risk-based.


Kind Regards,

 

Charles.C


#14 012117

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Posted 06 September 2018 - 11:23 PM

Hi, Emdurkin.

 

If it is not written in any protocol then the rating of major could be challenged provided that during the validation of the CCP plan, the every 90-120 as defined, can demonstrate effectiveness and confidence on the functionality of the metal detector. This can be supported by stating that on this changeover, the metal detector is not movable (that it will alter signal), that during changeover there are no equipment that will be placed near metal detector that its frequency can be affected (e.g metal free zone or frequency generating equipment with frequency similar to your MD), that the product setting before and during changeover is similar in all aspect (including speed and reject settings).

 

Since there might be insufficient context as I am only basing on what you have said that "the product might not have gone through MD", is there also no start up check? As the auditor might have not seen any evidence on the logsheet or the MD log that during that no time, no functionality check were made.

 

In addition, to emphasize, validation of HACCP plan should consider all the possible scenario.



#15 Dr Vu

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Posted 07 September 2018 - 01:15 AM

On further reading this...auditor may be right but may have written it to make it easier for you to correct the issue

Basically the rule is if it's not documented ,it's not done. Your protocol is to run product thru metal detector on a time based basis... But there is no evidence anywhere within the facility that the product went thru metal detector at all.

 

Maybe that's the issue.The metal detector could be functioning but did that batch go thru it or not?  There is no evidence.

On future short runs that don't meet your timelines..maybe you need to sticker it with  Green dot or check mark or 'passed thru md'...some evidence that it went thru.


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#16 Charles.C

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Posted 07 September 2018 - 01:46 AM

On further reading this...auditor may be right but may have written it to make it easier for you to correct the issue

Basically the rule is if it's not documented ,it's not done. Your protocol is to run product thru metal detector on a time based basis... But there is no evidence anywhere within the facility that the product went thru metal detector at all.

 

Maybe that's the issue.The metal detector could be functioning but did that batch go thru it or not?  There is no evidence.

On future short runs that don't meet your timelines..maybe you need to sticker it with  Green dot or check mark or 'passed thru md'...some evidence that it went thru.

 

Hi Dr Vu,

 

I think I half-agree.

 

IMO there is a documentation error + a possible issue of Best Practice vs Protocol but, as I understand, that was not the cause of the NC.

 

For example, here is a MD Verification counter-example to the NC( ex-CFIA). (also note the specific protocol in "Critical Limit" column).

 

Attached File  HACCP Generic Model for Fresh produce, Ready-To-Eat Fresh-Cut Vegetables, CFIA.pdf   427.04KB   8 downloads

 

PS - I think I misunderstood the OP in my previous post. I deduce that all the production passed the MD but the relevant batch was simply not logged as such. This would be a documentation error.


Edited by Charles.C, 07 September 2018 - 02:00 AM.
revised, hopefully corrected

Kind Regards,

 

Charles.C


#17 jcieslowski

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Posted 07 September 2018 - 01:04 PM

I also misunderstood the complaint.  I too assumed every item passed a metal detector and there was simply no metal detector verification check performed during a specific item run.

 

emdurkin, why can't / don't you pass all product through a metal detector



#18 Scampi

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Posted 07 September 2018 - 01:12 PM

The issue is the LANGUAGE the auditor used. Period.  PP stated auditor mentioned "metal detection protocols" and no such document exists in SQF land

 

The auditors are supposed to enforce and follow the code; not make up things as they go along

 

The only way this could be a MAJOR NC would be if the metal detector had not been checked all day (according to information OP provided)

 

We can all agree that the way the metal detector is being monitored is not best practice, but none the less, is conforming to both the HACCP plan and SQF code

 

The PP stated that their program had no requirement to check metal detector at batch change, but rather every 90-120 minutes. According to that, just because product went through it and the bars were not passed with said product does not mean product failed (according to poster)

 

To the OP, I do suggest that you change your CCP anyway, you really should be checking the metal detector at change over............remember, the packaging could also have metal material in it, and you have no other way of knowing


Because we always have is never an appropriate response!


#19 Charles.C

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Posted 07 September 2018 - 01:33 PM

Hi emdurkin,

 

Any more thoughts / clarifications ?


Kind Regards,

 

Charles.C


#20 Dr Vu

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Posted 07 September 2018 - 11:34 PM

Hi emdurkin,

 

Any more thoughts / clarifications ?

You are right to ask Charles.i think emdurkin gave us the NC and his explanation in one paragraph.so we can't really give advice based on that.its difficult.

 

Finding:during vertical audit of product it was found that product x did not pass through metal detector.there was no record of product having passed through one .even when the changeover occurred the check of the metal detector using the 3 test wands had not occurred as required by the metal detector protocols

 

emdurkin?


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#21 emdurkin

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Posted 21 September 2018 - 09:15 PM

Good Afternoon Everyone,

I just wanted all of you who relied to my Major NC issue....I appealed this issue and after mush back and forth with our CB...We were granted the appeal!!!!! Thank you for all of the advise and support!

Yay US!!!! Grateful for this community of my peers 






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