5 replies to this topic

[mesophile]

Hi All,

So we all know there is high risk, high care and low risk facilities, however what is the ranking order of severity/risk? I know low risk is at the bottom! however what is deemed more important, a high risk factory or a high care factory?

I always thought high risk is more important than high care, however after thinking about this I am now not so sure:

For example: You can have a pasteurised high risk operation (cream deserts) however if you then add an unpasteurised fruit, i.e. strawberries, it becomes high care. Similarly, you can have a high risk cooked meat operation, add some bread and lettuce to make a sandwich and it becomes a high care operation.

Also, as a double whammy, you can have cooked sliced meat (high risk operation), put on a chilled pizza (high care operation), then freeze it and it becomes a low risk operation.

What are your thoughts?

Thanks,
Simon

[trubertq]

It never ceases to confuse and confound me....since both high risk ( with a cooking step) and high care ( no cooking step) can be ready to eat...

What if you have a raw product ? Where does that fit in?

[Charles.C]

Dear mesophile,

As you say, a much visited, and contentious, general topic. For the newcomers one example source is here –
http://www.ifsqn.com...dpost__p__50104

I assume we are focussing on BRC terminologies.

Personally I find a continuing element of uncertainty in this field due to the word "care" itself and particularly to use of all these "terms" for both process areas and products. I guess this dual usage is inevitable and must also not be (too) inconsistent with established (product) terminologies in the food arena. The result (eg compare 2. and 4. below) is IMO confusing.

The current BRC definitions AFAIK are -

1.High-care area - An area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by pathogenic micro-organisms.
2.High-care product - A product that requires chilling or freezing during storage, is vulnerable to
the growth of pathogens, received a process to reduce the microbiological contamination to safe levels (typically 1–2 log reduction) and is ready to eat or heat.
3.High-risk area - A physically segregated area, designed to a high standard of hygiene, where practices relating to personnel, ingredients, equipment, packaging and environment aim to prevent product contamination by pathogenic micro-organisms.
4.High-risk product - A chilled ready-to-eat/heat product or food where there is a high risk of growth of pathogenic micro-organisms.

(I presume the "minimise" in No.1 acknowledges the perceived operational limitation?)

In the same way, the OP's opening question is rather ambiguous to me (perhaps intentionally ). For example, are you asking (a) whether the output from a HR or HC is of (potentially) different safety risk to a consumer or (b) whether the implementation of a HR / HC operation requires more or less stringency with respect to ?? or ©…..?

I assumed (a). Of course, this could imply further criteria, eg any specific risks/pathogens are of interest, etc.

One response to (a) could be the BRC’s stated (microbiological) categorisation criteria (see attachment uu1) –

The guidelines for defining products to be considered for processing in high care or high risk areas are based principally on the ability of the food to support the growth of Listeria species.

Products have been further divided within the Standard into those requiring high care process environmental conditions and those requiring high risk environmental processing conditions. This is based on whether processing has eliminated Listeria through cooking or reduced the likely incidence through other control measures such as chlorine washing of vegetables. This ensures that products which have been processed are not placed at risk by other products within the same area which have only received a partial process.

(Operationally I predict that achieving BRC's stated “reduction” criterion regarding items such as raw vegetables is difficult to validate in practice [or to theoretically justify anyway?])

So from the POV of the probability of a later incident due to L.mono, I suppose, on average, HC products would be expected to be more “at risk”. Presumably some epidemiological data is required to validate or otherwise. Sandwiches for a recent UK example perhaps ??

(Also interesting to note that "Sandwiches" seems to have retained a classification of “high risk” in a recent UK operational manual [see uu2] as against No.2 although the couplet "high risk / high care" seems to occur almost everywhere else within the manual as an automatic duo. I presume this was to avoid any chance of users semantically underestimating the writers opinion of the statistical risk).

Other criteria / sub-criteria could obviously be evaluated, eg salmonella ?.

The list of interpretive caveats appended in the BRC guideline article is now substantial. I suspect BRC may not hv realised just how complex this issue could get when they attempted to unify / “Decision Tree” the subject.

I guess this whole "care" topic probably started with CFA’s pioneering studies into chilled foods. Related texts in this chilled field contain microbiological proposals for further (Process-oriented) Risk Classes within this specific genre. The surrounding text / distinctions seems more intelligible to myself than BRC's presentation. Other parallel approaches also exist such as an EC-inspired handling system for chilled foods.

I suppose the BRC drive to create a unified methodology to improve clarity/safety must be applauded but the practical useability remains to be confirmed IMO.

 uu1 - F048 - Understanding High care and High risk (june 2012) 3 28 5 12 Final.pdf   589.79KB   204 downloads
 uu2 - Food processors, suppliers 2011 COP public sector issue 7.ashx.pdf   134.87KB   129 downloads

Rgds / Charles.C

PS @trubertq - if you wish to be even more astounded, can try this short BRC discussion -

http://www.linkedin....ck=.gmp_4037619

PPS - just as a counterbalance, here is a recent, presumably (-) and (+) supportive of above respectively, L.mono disaster for hard-boiled eggs and canteloupe respectively -
http://www.mqmconsul...g/food-factory/

PPPS @mesophile, I hv obviously veered away from yr original examples due my interpretation. If I hv also completely moved away from yr originally intended direction of thrust my apologies in advance and please re-align the thread for successive posters.

It would be interesting IMO to compare the BRC vision with the Tesco viewpoint, I'm not a supplier but the latter embodies (I think) many similar concepts but implements them (I think) in a simpler fashion.

[mesophile]

Thank you Charles,

Your comments are always interesting to read.

You are correct, I was using the new BRC v6 interpretation guidelines on high risk and high care.

I come back to:

High Risk = Dairy desert or baked cheese cake
High Care = Dairy desert or baked cheese cake with topping

In the case of these products, you can alter (reduce) the risk category by adding non-pasteurised ingredients? this doesn't make sense?

Going by the terminology you stated above, without the topping there is "a high risk of growth of pathogenic micro-organisms", by adding the topping the products become "vulnerable to the growth of pathogens, to the received a process to reduce the microbiological contamination to safe levels (typically 1–2 log reduction)"

[Charles.C]

Dear mesophile,

It is maybe unreliable to use BRC's glossary definitions to make specific conclusions without consulting the full document.
(eg, anticipating further quotes below, the gloss.def. for HR area is curiously silent regarding the 70degC aspect, the def.for high risk product is apparently specific to chilled foods only, unlike the product referred to in the text quoted below.)

Maybe this paragraph also has some relevance -

Specific high-care and high-risk requirements The requirements relating to processing environment and general GMPs within the Standard are always expected to be adopted in relation to product risk. There are, however, some clauses within the Standard which identify particular and specific requirements applying to high-care or high-risk areas to ensure a consistent expectation.

It is possible that a cross-matrix showing the 1:1 relationships or otherwise between production zone Risk classification and product RC would be of some interest?

Returning to yr queried situation and applying a little editing (hopefully correctly?) -

Dairy desserts with uncooked components = high care
Dairy desserts with cooked components = high risk
(I assume the cooking matches the BRC / L.mono reqs)

the 2 results above match the BRC decision tree result as shown in the standard and as determined by the tree textbox query -

Have all vulnerable products received, prior to entry into the area, a heat treatment equivalent to 70ºC for 2 minutes?

Yes > HR
No > HC

The logic basis for the tree result above is, as far as I can see, typically inferred from standard's text below together with the L.mono comments in my previous post -

(A) Products requiring handling in a high-risk area have all of the following characteristics:
1. potentially vulnerable to the growth of pathogens, particularly Listeria species
2. all components have received a full cook process, minimum 70°C for 2 minutes or equivalent before
entry to the area
3. the finished products are ready to eat or heat** or, on the basis of known consumer use, are likely to be
eaten without adequate cooking (see HACCP 2.3.1)
4. the finished products require chilling or freezing during storage

(B )Products requiring handling in a high-care area have all of the following characteristics:
1. potentially vulnerable to the growth of pathogens
2. all microbiologically susceptible components have received a process to reduce the microbiological
contamination to safe levels (typically 1–2 log reduction of micro-organisms) before entry to the area
3. the finished products are ready to eat or heat** or, on the basis of known consumer use, are likely to be
eaten without adequate cooking (see HACCP 2.3.1)
4. the finished products require chilling or freezing during storage

the tree textbox obviously repeats A2. (B2 is apparently assumed to be automatically fulfilled which may be rather problematic in practice ).
Note that there are also various sub-codicils here and there in the standard’s text.

Assuming the BRC, L.mono. criteria quoted in my previous post, and that L.mono is in fact a pertinent (ie validatable) hazard, the tree result seems to make sense to me. If L.mono is not a pertinent hazard, I predict some further manouevring may occur.

Nonetheless, IMO there are unquestionably items in the table where the (zone) risk classification (RC) will not appear to concur with other sources' ideas for (product)RC , eg yoghurt is stated to be high care whereas it is almost invariably regarded as a low risk commodity IMEX. Moreover, L.mono. is not considered a potential hazard in this product (from memory).

Again, it's not my area but I noticed that cheese from unpasteurised milk is classified low risk. Hmmmmm.

Since 1949, the US government has forbidden the sale of cheeses made from unpasteurized milk unless the cheese is aged at least 60 days. The 60-day ban is meant to protect consumers from potentially harmful pathogens. After 60 days, the acids and salts in raw-milk cheese naturally prevent listeria, salmonella, and E. coli from growing.

http://cheese.about..../raw_cheese.htm

Risk assessment is likely to remain a highly subjective area of opinion for the foreseeable future IMO.

Rgds / Charles.C

[Charles.C]

Dear mesophile,

Since I found yr original posted queries of interest, I did some more digging. I should add that chilled foods are not my area of expertise although I do hv experience in frozen high risk foods. You are probably familiar with the history of this (mainly chilled) topic but have added a little background for other posters.

AFAIK, “high care” (HC) was a terminology invented by CFA around 1990s specifically for classifying hygiene control zones for chilled foods although perhaps not then exclusively to RTE products (unsure). “High risk” (HR) for both product and zonal classification was already globally well-used for frozen (chilled also maybe?), albeit in a variety of ways.

Historically, subsequent use of this HC terminology is evident in publications of organisations such as BRC, ECFF, EHEDG, FSA, Tesco. Some use only HC terminology, some use both HC/HR (in various linked interpretations), some use the terms interchangeably, others “convert” both to a secondary format so as to simplify (eg Tesco). The only common denominator (with 1 exception) in all these usages, I think, is that the term “high care” is solely used to specify a hygiene control area (two areas in case of ECFF). It’s double use by BRC for a product also seems to be innovatory. The expansion by BRC to frozen foods also seems to be innovatory. This manouevring has required BRC to make some interpretive/textual adjustments IMO although I think they hv tried to maintain alignment with CFA (the industry guide I guess) as far as possible (CFA do not offer any product defs AFAIK).

Frankly, the available permutations can be textually bewildering. To avoid further confusion, I will stick to current BRC requirements as far as possible with respect to yr OP.

So we all know there is high risk, high care and low risk facilities, however what is the ranking order of severity/risk? I know low risk is at the bottom! however what is deemed more important, a high risk factory or a high care factory?

I always thought high risk is more important than high care, however after thinking about this I am now not so sure

I think, as posed, this query is best interpreted in the sense of the hygiene "status" and associated requirements of the HC/HR zone.

This is from CFA (1997)(underlines are mine) –

A `high-care area' is an area designed to a high standard of hygiene where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by micro-organisms.
A `high-risk area' by comparison is a physically segregated area designed to a high standard of hygiene where practices relating to personnel, ingredients,equipment, packaging and environment aim to prevent product contamination by pathogenic micro-organisms (Chilled Food Association, 1997)

.

(I presume the non-cooked/cooked distiguishing feature already existed).

And similarly, a later comment talking about air-flow control –

There is a difference between high- care areas, where the aim is to minimize air contamination, and high-risk areas that are designed to prevent recontamination (Brown, 2003).

So I think yr own interpretation was in line with the original view.
Currently (BRC6 uu1 attachment) (my underlines) –

High risk areas require the highest levels of hygiene, working practices, fabrication, design of facilities and equipment to prevent product contamination with regard to microbiological hazards.
High care areas require high levels of hygiene, working practices, fabrication, design of facilities and equipment to minimise product contamination with regard to microbiological hazards.

And referring to para.4.3.6

The Standard requires that, ‘Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site’

Compare para 4.3.5 (note I am quoting uu1, not the standard itself)

It is important that the high care area is effectively protected from recontamination from the low risk zones. The segregation is most effectively achieved by full physical segregation by means of walls which separate the high care area from other factory areas. …….
Where a separate fully walled off area is not available for high care, alternative procedures shall be in place to segregate the high care area and prevent access to unauthorised people, transfer of materials or equipment (except via a controlled route) and microbiological contamination from airborne particles or water droplets. This may include time or space separation, control of movement or other restrictions.

Other examples can also be found, eg with respect to the air filter control.

So, with respect to the zonal implementation, it seems to me that status of HR > HC, ie you are correct again
----------------------------------------------
Just for comparison, here is the (somewhat different) Kraft procedure for risk assessment of production zones (not necessarily RTE) –

SECTION K: ZONING
Section 3.10 of the SQE Manual sets out requirements for a zoning program. Further requirements and guidelines include the following.

As a consequence of the product risk assessment to microbial contamination, the different areas (zones) of the production facility can be classified according to the microbiology risk.
Production zones should be classified based on the risk of cross-contamination:
Non-manufacturing zone:
• There is no open product in this zone.
• Product could be stored but not manufactured; also includes offices, cafeteria, locker room, laboratory, etc.
High risk zone:
• Areas, such as raw meat/raw milk/raw nuts receiving and storage, that are known to be contaminated and which require controls to prevent contamination of higher hygiene zones.
• These zones may have dedicated employees and may be physically separated from Controlled zone or high control zone.
Controlled zone:
• Product that are not highly sensitive can be exposed to the environment and the operators.
• GMP practices are implemented and Kraft Foods air requirements are met.
• The controlled zone may also serve as transition from non-manufacturing or high risk zone to high control zone.
• Products of higher sensitivity may be present if they are completely enclosed.
High control zone:
• Product of high sensitivity can be exposed to the environment and/or the operators.
• Additional GMP practices, such as captive footwear/clothing, may be required and more stringent equipment/building sanitary design requirements are followed
• When product of sensitivity 4 are exposed, additional production practices, such as preventing cardboard, wooden pallets, etc may be implemented

And here is an example of some results for a variety of products

 kraft prod.zone RA example.png   53.48KB   17 downloads

Rgds / Charles.C