2.3.5.1 Microbiological & Chemical

"2.3.5.1 Finished product specifications shall be documented, current, approved by the supplier and their customer, accessible to relevant staff and may include:

i. Microbiological and chemical limits; and

ii. labeling and packaging requirements."

When the code says 'may include' does that mean it's highly recommended? Can an auditor give a non-conformance if we do not include micro & chemical limits?

"2.3.5.1 Finished product specifications shall be documented, current, approved by the supplier and their customer, accessible to relevant staff and may include:

i. Microbiological and chemical limits; and

ii. labeling and packaging requirements."

 

When the code says 'may include' does that mean it's highly recommended? Can an auditor give a non-conformance if we do not include micro & chemical limits?

Hi Lacey,

As per SQF Code Edition 7.1 Module 2 Guidance Document Clause 2.3.5 Auditing Guidance - Evidence of conformity
'Specifications include all significant parameters required to ensure the safety and quality of the product'

So the answer is yes if the specifications don't include a maximum level for micro and/or chemical hazards that can affect your product.

Regards,

Tony

Anyone else have thoughts on this?

Dear lacey,

The absolute minimum appears to be -

The supplier  must develop  a written finished  product  specification for  each  product  (or  group of  similar products) covered under the scope of certification.  The specification must, as a minimum, comply with the appropriate food safety legislation (including labeling requirements) and must be updated as required.  The supplier must keep a copy of all finished product specifications and a register of all versions of these documents.

 

 

As per Tony, the rest appears to be dependent on what SQF will regard as "significant" at the time of audit. perhaps you should ask SQF  how this will be (consistently) done ?

Rgds / Charles.C

PS - It seems rather bizarre to me that SQF seemingly do not consider physical factors as being potentially related to product safety for the finished product. At least  to an extent worthy of inclusion in the Code at this point anyway.?! 

Hi Lacey,

 

As per SQF Code Edition 7.1 Module 2 Guidance Document Clause 2.3.5 Auditing Guidance - Evidence of conformity
'Specifications include all significant parameters required to ensure the safety and quality of the product'

 

So the answer is yes if the specifications don't include a maximum level for micro and/or chemical hazards that can affect your product.

 

Regards,

 

Tony

How should I go about setting the max micro levels? Is there a written standard anywhere? Annual verification of these too, I assume?

You'll find this document to be helpful with 2.3.5.1 --

How should I go about setting the max micro levels? Is there a written standard anywhere? Annual verification of these too, I assume?

How should I go about setting the max micro levels? Is there a written standard anywhere? Annual verification of these too, I assume?

Dear Lacey,

It might help if you mentioned the type of product involved ? :smile:

I think yr general query  has another thread somewhere here with several compilation links. The ICMSF vol6 is a famous encyclopedical source. Plus the Canadians have published another compendium of (mainly) hazardous parameter settings. Plus uncountable issuances from country-by-country Public Health representatives, undoubtedly existing in yr case i expect ex FDA, USDA, whatever.

The specifics initially depend on whether a regulatory data set exists or not. If not, the priority is typically first given to safety related, zero-tolerant items (SRZTI), followed by SR non-ZTI items, then other non-safety values derived often from  experience of realistic usage.

Rgds / Charles.C

PS (added) - you may find these threads / post of interest -

http://www.ifsqn.com...not/#entry40993

http://www.ifsqn.com...ods/#entry34086

http://www.ifsqn.com...ion/#entry59495

(Canadian link)

How should I go about setting the max micro levels? Is there a written standard anywhere? Annual verification of these too, I assume?

Hi Lacey,

Please confirm the product.

Regards,

Tony

Hi Lacey,

 

Please confirm the product.

 

Regards,

 

Tony

The products are RTE sandwiches, Freezer to oven pizzas, frozen raw pizza crusts, breadsticks, and the like.

The products are RTE sandwiches, Freezer to oven pizzas, frozen raw pizza crusts, breadsticks, and the like.

This includes USDA & FDA regulated product.

This includes USDA & FDA regulated product.

Dear Lacey,

And do these bodies also regulate the micro.safety / quality ? If so, end of search unless you disagree with them for other non-regulated products ? if so, perhaps you could elaborate a little ?

Offhand i think i can predict 3 product candidates for regulatory (or non-regulatory) RTE maxima without much fear of contradiction from any textbooks for a USA scenario (except a possible distinction for No.1 if USA follows the EC, [I believe they choose not to]) -

(1) L.mono. = ND / reference sample size / reference sampling plan / reference procedure

(2) Salmonella spp = ND / reference sample size / reference sampling plan / reference procedure

(3) E.coli O157: Hxyz (and maybe other serological variants) = ND / reference sample size / reference sampling plan / reference procedure

ND = not detected. Do note that a sampling plan is relevant. Also note that not all of (1-3) will be relevant to every product.

Values for (4) APC, (5) (generic)E.coli, (6) coliform, (7) S.aureus will probably occur and may well appear to be "picked out of a hat" . Limits probably vary with product type and also randomly with state. Other species may pop up depending on the individual product composition / sources, eg Campylobacter, various spore-forming types. Frankly, the total possibilities are legion but most commercial specifications limit to, maybe, (4-10) favorites. On-line links obviously offer search possibilities . haccp designed lists per product type also exist in specific (extended) journal reviews but many need money.

.

A great source of ideas is the ICMSFv6 (+v2,v8?) volumes  I referred previously ( v6, v8 are  google preview available on-line I think, v2 [the relevant part] is downloadable free). Another renowned micro. data source is the massive Compendium of Microbiological Methods for examination of Foods (approx.) also viewable on-line (especially the older editions IMEX).

Then there are the other non-bacterial microbes which I won't get into here.

For the raw item, nos (1-3) should hold again, (4-7)  likely to be a free-for-all.

If you are having to design the specs yourself and the product not regulated, many people choose (1-3) +  (4-7) as above (including the caveats) using a "reasonably typical" limit for latter  and then add (8-X), usually around 0-4 items  depending on product, etc, eg marine items get vibrio species thrown in. :smile:  some people tend to go a bit wild and end up with 15-20 which can look a bit ridiculous, albeit comprehensive.

It would be nice if  straight  compilations of lists existed with, say,  top 10 health related microbes for a huge range of product/sub-product categories. They do but AFAIK most are in the private sphere due to their being commissioned or require some access permissions, eg Codex database, maybe.

Rgds / Charles.C

PS - The attachment given in post 7 is helpful. There is additionally an impressive indexed list of RTE foods / similar limits in its, i think,  original ca.2001 source edition due to  PHLS / UK (a magnificent organisation now apparently renamed as HPA). Both the 2001 document and a, IMO, sometimes less user-friendly ca.2010 update which is  "EC compliant"  are available on-line and variously posted on this forum. The extensive data given may clash with US ideas of course. No accounting for "taste". :smile:

I work for FDA/USDA RTE plant.

Our limits:

Microbiological Standards:  Target   Maximum

Total Aerobic Plate <100/g <10,000/g

E.Coli / Coliform <10/g <100/g

Staphylococcus Aureus <10/g <100/g

Mesophilic Anaerobes <3/g <3/g  

Listeria Negative Negative

Salmonella Negative Negative

Just a suggestion.

I work for FDA/USDA RTE plant.

 

Our limits:

 

Microbiological Standards:  Target   Maximum

Total Aerobic Plate <100/g <10,000/g

E.Coli / Coliform <10/g <100/g

Staphylococcus Aureus <10/g <100/g

Mesophilic Anaerobes <3/g <3/g  

Listeria Negative Negative

Salmonella Negative Negative

 

Just a suggestion.

Dear Destinee,

I assume this is some form of cooked meat.

The numerically different double "<"s seem to defy mathematical logic ? :smile:

My guess is that mM are being quoted? Although the APC looks rather atypically demanding compared to most RTE micro.standards IMEX. Special consumer perhaps ?

Rgds / Charles.C

I just copied and pasted, the forum text box removed the formatting.  The top line states "target" and "maximum" which is the reason for the two sets of numbers.

I just copied and pasted, the forum text box removed the formatting.  The top line states "target" and "maximum" which is the reason for the two sets of numbers.

Thks.

Ok,  this is equivalent to mM. (sorry, didn't notice the target / maximum line).  I don't think "negative" can numerically be a target or a maximum but I understand the intention. :smile:

I am impressed if you can routinely achieve a value of APC for cooked meat of < 10,000/g. (I assume incubation ca.37degC / 2 days), and amazed if routinely < 100/g.

Rgds / Charles.C

PS No spec. for E.coli O157 (+ other "O"s ?) Surprising  omission for meat ? Or perhaps this is handled by USDA on site ? Another "Neither Neither".

I work for FDA/USDA RTE plant.

 

Our limits:

 

Microbiological Standards:  Target   Maximum

Total Aerobic Plate <100/g <10,000/g

E.Coli / Coliform <10/g <100/g

Staphylococcus Aureus <10/g <100/g

Mesophilic Anaerobes <3/g <3/g  

Listeria Negative Negative

Salmonella Negative Negative

 

Just a suggestion.

Hi Destinee,

I am assuming that these are for product on day of production, is your standard the same for end of life?

Regards,

Tony