Jump to content

  • Quick Navigation
Photo
- - - - -

SQF Metal detection size requirements for large Products


  • You cannot start a new topic
  • Please log in to reply
7 replies to this topic

dsarapin

    Grade - Active

  • IFSQN Active
  • 9 posts
  • 1 thanks
0
Neutral

  • Earth
    Earth
  • Gender:Male

Posted 11 February 2020 - 08:23 PM

I am in a USDA inspected facility which has no size requirements for metal detection standards (accept that the process is validated, and effective for the size products) Recently the facility had points taken away on question 11.7.6.2 of the SQF 8.1 standard because it did not meet the FDA size standard of 7 mm. (my facility has been using 8mm for years)  I am looking for anyone who may have had to appeal a question such as this, and what documentation or evidence would support the decision to use 8mm instead of the 7mm. The argument that the USDA doesn't require the size restraints, nor that my facility does large items that are to large to effectively detect a 7mm SS standard, worked with the auditor. The process is validated, and the metal detectors are calibrated annually, and verified every 2 hours for effectiveness. I would not like to be forced into using a smaller size detection standard that will cause too many false positives due to the type and size of my products.

 

Any advice or evidence that would help in the appeal process would be greatly appreciated.



Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 18,859 posts
  • 5248 thanks
1,226
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 11 February 2020 - 09:32 PM

I am in a USDA inspected facility which has no size requirements for metal detection standards (accept that the process is validated, and effective for the size products) Recently the facility had points taken away on question 11.7.6.2 of the SQF 8.1 standard because it did not meet the FDA size standard of 7 mm. (my facility has been using 8mm for years)  I am looking for anyone who may have had to appeal a question such as this, and what documentation or evidence would support the decision to use 8mm instead of the 7mm. The argument that the USDA doesn't require the size restraints, nor that my facility does large items that are to large to effectively detect a 7mm SS standard, worked with the auditor. The process is validated, and the metal detectors are calibrated annually, and verified every 2 hours for effectiveness. I would not like to be forced into using a smaller size detection standard that will cause too many false positives due to the type and size of my products.

 

Any advice or evidence that would help in the appeal process would be greatly appreciated.

 

Hi dsarapin,

 

The typical FDA absolute criterion/objective is that the product should contain no detectable metallic contamination.

 

I deduce you are claiming that for yr product/MD the minimum detectable SS test strip is  8mm, ie it will detect 8mm but not detect 7mm. So it's maximum capability is then not compliant with

 

  FDA Compliance Guide 555.425, ie -

 

REGULATORY ACTION GUIDANCE:
The following represent the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and direct reference import detention to the appropriate Field Offices within the Human and Animal Food Program*.

a.  The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length.

 

 

Tricky.

 

Some more context might help -

 

RTE product ?.

Pack Unit size/height entering MD = ?

For "sensitive" customers ?

 

I assume you have checked/failed repeatedly with a certified 7mm test strip. How do you test ?

 

You might consider checking MD supplier to see if the machine setup cannot be "tuned" slightly to increase SS sensitivity from 8 to 7mm ?, eg aperture, test location, etc


Edited by Charles.C, 12 February 2020 - 05:05 PM.
edited, expanded

Kind Regards,

 

Charles.C


SQFconsultant

    SQFconsultant

  • IFSQN Fellow
  • 3,772 posts
  • 947 thanks
840
Excellent

  • United States
    United States
  • Gender:Male
  • Interests:American Patriot
    WWG1WGA
    Never give up, never give in - always win!
    Martha's Vineyard Island, Massachusetts

Posted 12 February 2020 - 10:37 PM

So, just so I understand - the SQF Auditor cited you for an FDA requirement?


Kind regards,
Glenn Oster
 
GOC BUSINESS GROUP | SQF System Development, Implementation & Certification Consultants
Internal Auditor Training - eConsultant Retainer Subscriptions - Pre & Post SQF-GAP Audits - Consultant Training
Visit us @ http://www.GlennOster.com  or call us @ 772.646.4115 US-EST 8am-4pm Anyday except Thursday
 
 

Slab

    Grade - SIFSQN

  • IFSQN Senior
  • 424 posts
  • 200 thanks
98
Excellent

  • United States
    United States
  • Gender:Male
  • Location:The Heel of the Boot
  • Interests:Reading (history, science fiction), Photography, drawing,food safety, metrology, TQM, hoplology, etc.

Posted 13 February 2020 - 05:03 AM

If you are poultry:

 

Attached File  QAD 609 - Metal Detection.pdf   583.39KB   23 downloads
 

 

It's my understanding for SQF that you are required to meet regulatory standards for your industry, of which the FDA does not have jurisdiction, unless you also process non-specified meats (the "fog of regulation" can be aggravating).

 

So, if you are confident of your regulatory compliance I would challenge them on it.

 

 

 


Food Safety News  Marine Stewardship Council

 

"Some people freak out when they see small vertebra in their pasta" ~ Chef John


Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 18,859 posts
  • 5248 thanks
1,226
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 13 February 2020 - 09:22 AM

If you are poultry:

 

attachicon.gif QAD 609 - Metal Detection.pdf
 

 

It's my understanding for SQF that you are required to meet regulatory standards for your industry, of which the FDA does not have jurisdiction, unless you also process non-specified meats (the "fog of regulation" can be aggravating).

 

So, if you are confident of your regulatory compliance I would challenge them on it.

 

Hi Slab,

 

Thks for yr interesting file.

 

As yet, the actual product/process is unfortunately unknown.

 

TBH, I had understood that USDA (referenced [somewhere])  had  harmonised their Regulatory requirements in line with FDA's famous metal contamination document  However yr attachment appears to indicate otherwise, eg zero cross-referencing to FDA's document and curiously no comments as to the basis of the USDA's recommended sensitivity test strips fpr poultry testing in section 3..

 

The USDA document seems to imply that the OP's implemented (SS) test strip should have been supplied from USDA/QAD after consultations with the latter. Unclear whether this was the procedure as described in  opening line of OP.

 

Regardless, based on the (not directly OP-related) "hints" in section 3 of attachment, it, offhand, looks to me rather improbable that USDA would have recommended/supplied an 8mm test strip.

 

Nonetheless I guess it all depends on what the actual  USDA Regulatory situation was/is. If the latter is similar to attachment + USDA's supervision had been routinely OK with the ongoing 8mm set-up I agree yr comment.

 

@ dsarapin - can you clarify any of above comments ?

 

PS -  strangely, the attached  USDA/FSIS 2019 training document contains some haccp examples utilising  FDA's metal contamination document  and one example more aligned to data in the QAD609 file.

 

Attached File  FSIS 21_IM_HAV_Methodology.pdf   1.12MB   13 downloads


Edited by Charles.C, 13 February 2020 - 09:55 AM.
added

Kind Regards,

 

Charles.C


dsarapin

    Grade - Active

  • IFSQN Active
  • 9 posts
  • 1 thanks
0
Neutral

  • Earth
    Earth
  • Gender:Male

Posted 13 February 2020 - 02:13 PM

Thank you for all the advice..We produce a variety of RTE meat products such as a full hams/turkey's and sausages. It is the larger items that are causing the 7mm testing to have multiple false positives, due to the size and variation to the product. My auditor mentioned that the FDA regulation of 7mm was the the industry standard. Is that true?



QAGB

    Grade - PIFSQN

  • IFSQN Principal
  • 671 posts
  • 255 thanks
107
Excellent

  • Earth
    Earth

Posted 13 February 2020 - 02:42 PM

Thank you for all the advice..We produce a variety of RTE meat products such as a full hams/turkey's and sausages. It is the larger items that are causing the 7mm testing to have multiple false positives, due to the size and variation to the product. My auditor mentioned that the FDA regulation of 7mm was the the industry standard. Is that true?

 

I can't answer this question for USDA regulated facilities. I can, however, say that FDA facilities tend to use that 7mm as a criteria for foreign material. Most facilities I know set critical limits well below 7mm.


Edited by QAGB, 13 February 2020 - 02:43 PM.


Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 18,859 posts
  • 5248 thanks
1,226
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 13 February 2020 - 04:42 PM

Thank you for all the advice..We produce a variety of RTE meat products such as a full hams/turkey's and sausages. It is the larger items that are causing the 7mm testing to have multiple false positives, due to the size and variation to the product. My auditor mentioned that the FDA regulation of 7mm was the the industry standard. Is that true?

 

Hi dsarapin,

 

False positives can be due to various interference factors from either product or machine. IMEX this kind of problem requires calling in the representative of the MD supplier to discuss.

 

Please supply a little more context, eg - 

 

MD sensitivity is strongly related to factors like product size / MD  instrument aperture dimension, packaging, presentation (eg frozen), product food matrix.

 

I assume this is a horizontal conveyor feed.

 

(1) What kind of packaging  around product being tested, eg only plastic wrap, included finished cardboard carton ? or ?

 

(2) Is the product frozen ? chilled ?

 

(3) What is the maximum size, ie height of the (packed [?]) hams/turkeys entering the MD ?

 

(4) What is the approx. aperture diameter/height of the MD  in use ?

 

(5)  Will the MD consistently detect test strips < 7mm when (ideally) appropriately located/embedded in the product itself or (alternatively) embedded in a dummy unit of similar dimensions to the Product ? (the MD should of course readily detect < 7mm when a test strip on its own is axially passed thru MD).

 

As I understand the USDA inspector has no problems with your 8mm critical limit for the metal detector. Correct ?

 

Re ^^^^(blue) if you are USDA controlled, their opinion may supercede the SQF auditor's interpretation from a Regulatory POV.


Kind Regards,

 

Charles.C





0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users