Environmental-Monitoring-Program-Step-by-Step-guide
Environmental-Monitoring-Program-Step-by-Step-guide
ENVIRONMENTAL
ARTICLE #2
ENVIRONMENTAL PATHOGEN MANAGEMENT:
PATHOGEN TESTING IS DANGEROUS 07
MONITORING ARTICLE #3
Over the years, he rose through the ranks and ended-up managing pro-
duction, technical and food safety & quality teams. This cross-functional
exposure enabled him to find pragmatic solutions, that strengthened
food safety and quality systems in different multinational organizations.
During his career, he has not only advised small and medium-sized
businesses in the food industry in New Zealand, but has also managed
international consultancy projects in the United States, Europe and
China. His expertise has opened many doors for him, from leading
training in food safety and quality to mentoring many professionals in
the food industry around the world.
I’m really excited BioMérieux is sharing this short series For me, a positive environmental sample is a gift. It
of articles about environmental pathogen management means we can start investigating, look for the root
in the food industry. I have a real passion for this to- cause and strengthen our systems and controls, be-
pic and after visiting hundreds of food plants around fore any real damage happens.
ENVIRONMENTAL
the world, it is clear to me that a sound environmental
pathogen programme can protect your product, your 3. Your food business is more exposed than ever
customers and ultimately, your business. New diagnostic developments in microbiology have
PATHOGEN MANAGEMENT:
made a real difference in the investigations of food
Of course, being pragmatic, I’m also well aware that poisoning outbreaks. Investigators are now using a
running an environmental pathogen programme costs technology called Whole Genome Sequencing (WGS),
be cost-effective.
7 ENVIRONMENTAL MONITORING PROGRAM
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Following my first article, I hope you are all very excited the pathogen result comes back positive.
about environmental pathogen monitoring. So it’s time
to dampen some of that excitement and ring some As mentioned before, there is only one course of action
PATHOGEN MANAGEMENT:
The impact of a positive pathogen result is dramatic and prevent public exposure. We have to expect the
and can be very costly to your business. If a pathogen unexpected! Once the product has been released
is found in your product, you have to make a very into the market, our window for pathogen verification
PATHOGEN TESTING IS
quick decision about that product, as it can no longer testing has closed.
be sold. If a pathogen is found in your factory envi-
ronment, you may still have some time, but it often Fortunately, new accredited rapid test methods have
DANGEROUS
leads to a right panic. dramatically reduced the test turnaround times for
pathogens and we no longer have to wait for three to
So, before we pull out our swabs, I think it’s useful to five days to get a result.
reflect on some of the dangers with pathogen testing.
The “ticking timebomb”!
The “false alarm”! This situation occurs when factory management starts
I sometimes get asked how to deal with a “false po- accepting a low and sporadic level of positive environ-
sitive” result. A reasonable question, considering the mental detects as the “new normal” (another human
major business impact I have just mentioned. Interes- bias). It goes something like this: positive detect – let’s
tingly, I almost never get asked what to do about a “false clean; three months later: positive detect – let’s clean;
negative” result. I think this has to do with a human two months later: positive detect – let’s clean and on
bias: If we get a result we expect (i.e. no pathogens), and on it goes! You get the picture!? Unfortunately, a
we do not tend to challenge the outcome. persistent low level of environmental pathogen detec-
tions is not normal!
Both “false” results do happen, and the consequences
are dramatic either way. It could be argued that whilst Considering the difficulty of recovering and finding
a “false positive” is expensive due to product loss, a actual pathogens in your factory environment, repeat
“false negative” is worse, as contaminated product is hits only mean one thing: you have a contamination
released into the market. Take the 2017 infant formula somewhere and could be sitting on a ticking timebomb.
contamination in France. The company stated that
a large number of their samples tested negative for “We do not know, what we do not know”!
Salmonella. This would have given them a false sense Finally, a personal lesson! I have been in the food
of security and only when babies started falling ill, did industry for over 30 years and this comes at a price:
they realise something was seriously wrong. I have a tendency jumping to conclusions based on
experience (I suspect I’m not alone). This all changed
My only answer to the “false alarm” is this: in order to in 2015 with ice cream.
minimise the risk of a false pathogen result, testing for You see, I never thought of ice cream as a risky food (it’s
pathogens should only be conducted with an accredited frozen – what can go wrong!?). Hence, I was quite re-
method. In addition, sampling and sample handling (in laxed about the lack of environmental pathogen moni-
In this second article from our series your food plant as well as in the laboratory) needs to toring in some ice cream factories. That was of course,
about environmental pathogen be very well controlled and you should consider using
an accredited laboratory for this reason.
until the 2015 contamination incident in the USA, when
people got sick and died from eating ice cream!
management in the food industry, Jack During my global travels, I have seen food company
Turns out I was not alone in my assumption; following
the ice cream incident, a large number of ice cream ma-
van der Sanden exposes some potential laboratories, with no formal accreditation, testing for nufacturers changed their approach to environmental
pathogens like any other quality parameter. To me, this pathogen management and the USFDA initiated a full
mistakes companies make, when is asking for trouble because in the end, a pathogen “swabathon” of American ice cream factories.
result will stand! Even if you have every reason to doubt
embarking on pathogen testing. the result, there is no recourse. You may also recall the list of products in my first article
and the increasing number of new food groups linked
The “Russian roulette” test! to food poisoning (I have been told that in Australia,
When it comes to pathogens, an error is I understand working capital and shelf-life are impor-
tant considerations for any business and moving stock
rock melons are now classed as a “forbidden fruit” for
pregnant women). So, when it comes to food safety, I
usually dramatic and can be very costly quickly is key, particularly for FMCG manufacturers. now remind myself: “I do not know, what I do not know!”
(I recently learned this is called: “ intellectual humility”)
to your business. Jack reminds us that This can sometimes lead to an interesting situation For this reason, I recommend an environmental pa-
where product is shipped before the final product thogen monitoring routine for all food manufacturing
we have to expect the unexpected, test results are known. In the case of pathogen tests, plants. Because, even if you think your product is bullet
this is like playing “Russian roulette”. You essentially proof, your food factory should never be allowed to
avoid unnecessary recalls and that shoot yourself in the foot if the product has gone and become a pathogen breeding ground
pathogen testing can be dangerous if — Jack
So, after we have discussed “why?” (article 1) and you seek some expert advice).
issued some warning shots (article 2); it's time to For target pathogens, the purpose of your environ-
start designing our environmental pathogen pro- mental pathogen programme is to “seek and destroy”!
PATHOGEN MANAGEMENT:
Background Pathogens
Traditionally, foods have been classified as high or low Some food products have never been associated with
risk, based on the potential for pathogen contamina- a known pathogen, nor implicated in food poisoning
FOR?
like yoghurt, high heat products like UHT and dry
products were considered low risk. Whilst I understand this reasoning, I’m no longer
convinced any food is safe from pathogens. The fact we
Whilst some of the rationale for high and low risk food are now dealing with antibiotic resistant “super bugs”,
still stands, the boundary between this “black and shows the incredible adaptability of micro-organisms.
white” distinction has become somewhat blurred. My thinking is that a heavily contaminated factory
For example, following well documented pathogen environment may well lead to a “house bug” that
outbreaks, our views for foods like fresh and frozen could start contaminating your product at some point.
vegetables, ice cream, cereals and peanut butter have
well and truly shifted. As we improve our diagnostic I believe in a “safety first” approach; a food plant
capability with tools like Whole Genome Sequencing, should never become a breeding ground for pathogens
this list may well continue to grow. and for this reason I recommend all food plants to
have a programme for “background or secondary
I think it may be more useful to look at food on a grey pathogens”: pathogens that do not pose an immediate
scale when it comes to pathogens and I now routinely risk to your product.
talk about “higher” risk and “lower” risk foods.
The reason I raise this point, is that several food fac- Will we look as hard for background pathogens as for
tories I have visited do not monitor for environmental target ones? No! The purpose to monitor for back-
When it comes to pathogens, there have pathogens at all, based on the assumption that they ground pathogens is to keep an eye on your factory
produce a “low risk” food. My routine response is that environment and the focus of the programme shifts
always been two categories of food: low risk “we don’t know what we don’t know” (remember?) from “seek and destroy” to “seek and control”.
or high risk. Traditionally, this distinction and at least should be aware of what’s lurking in our
factory environment. In summary, regardless of your product, an envi-
was based on the potential of pathogens However, I do agree that an extensive, expensive
ronmental pathogen management programme can
provide very useful information. In both cases the
to contaminate and, subsequently, grow pathogen management plan for a UHT or yoghurt plant purpose of “seek” remains but our response will differ.
is counterintuitive, so let me introduce the concept of
in the product. “target” and “background” pathogens. For higher risk foods, an extensive environmental
management programme for target pathogens is
Target Pathogens strongly recommended, preferably combined with
However, an increased number of food Listeria monocytogenes in chilled and ready-to-eat
products, Salmonella in dry products, Cronobacter
a less frequent routine for the background one. For
example, a soft cheese plant may have an extensive
poisoning outbreaks have occurred with sakazakii in infant formula and E. coli in lettuce are
all examples of pathogens that are “hard linked” to a
programme for Listeria (Target) and a low-level pro-
gramme for Salmonella (background).
foods like, fresh and frozen vegetables, ice specific food group. We know, either through scientific
research or from experience that some foods can For lower risk foods, a low frequency environmental
cream, cereals and peanut butter, which has host/support particular pathogens. programme for Salmonella and Listeria will be useful
to understand your general factory condition.
challenged our view of “low risk” foods. When it comes to the food you make, you are probably Because you never know when to expect the unex-
very familiar with the pathogen(s) that are a risk to pected.
your product and I call these the target or primary
In this third article from our short series on pathogens. In a nutshell, “target” pathogens are the — Jack
pathogens that are known to be a risk to your product
environmental pathogen management in the and can make your customers sick. PS: Sometimes I get asked, why we are not looking for
Salmonella and Listeria in equal measure; because
food industry, Jack van der Sanden suggests Obviously, if you have a target pathogen associated they are both dangerous pathogens. However, please
with the food you make, your environmental pathogen consider that, by making no distinction between the
that no factory is truly safe, and that it monitoring programme should focus on this pathogen. two pathogens, every dollar that is spent on a back-
(If you make food and are unsure if your food category ground pathogen will not be spent on finding the real
is important to establish a tailor-made has been implicated and linked to a pathogen, I suggest “target” one.
pathogen surveillance program based on
the type of food that is being made.
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“A goal without a plan is just a wish” (Antoine de Saint-Exupery), result for a product contact surface swab during manufacture,
and this is no different for an environmental pathogen “hunt”. means our product is contaminated (we have moved from the
ENVIRONMENTAL
The goal of an environmental pathogen programme is to “seek” smoke into the fire).
the target and background pathogens; however, there is no
value in swabbing the factory without a clear rationale or plan. Something, which is not covered in the international guidelines, is
PATHOGEN MANAGEMENT:
If our programme is not designed to find pathogens, it will not the actual food process itself. Clearly, it is not possible for generic
be effective, or worse: a lack of pathogen detects may leave us pathogen guidelines to cover all the different food processes,
with a false sense of security (like having a smoke alarm with however, I believe it is really important to ask two very relevant
an empty battery). process questions for pathogen management:
PATHOGEN HUNT?
sential conditions to grow and thrive in a factory environment: ment following this kill step?
food – moisture – shelter. Of course, there are other conditions,
like oxygen and temperature, which differ between species, If we have a validated pathogen kill step in our process, we can
however, by controlling food, moisture and shelter in our factory, expect to find pathogens before this kill step (otherwise why
pathogens will struggle to get established. have a kill step?). Therefore, swabbing extensively before a kill
step will only confirm what we already know.
Food is minimised by having a clean plant, moisture is controlled
by keeping the factory as dry as possible during production and If our product is exposed following the kill step, the risk of envi-
shelter is eliminated by hygienic design and maintenance of our ronmental re-contamination of our product is high, and we should
equipment and buildings. definitely focus our pathogen hunt in this “post-contamination
zone” of our factory.
One way to hunt for pathogens, is to walk into the plant and
randomly swab the dirtiest spots you can find, targeting the When it comes to pathogens in the environment, the risk to the
areas where there is food – moisture - shelter (I call this: a worst- product increases depending how close we are to the product
case random sampling programme). Whilst this is the preferred and where we are in our food process.
approach for traceback sampling, for a routine programme, this
method tends to become a logistical nightmare, as we struggle If we combine proximity and process, and consider proximity
to remember where we swabbed, when we swabbed there last as likelihood and process as impact, we end up with something
and how to interpret our results. most people may recognise – a risk matrix, which shows: the
pathogen contamination risk to our product.
I once had a client calling me in despair. They kept finding
positives in a contaminated area of the plant, where the floors
3P MODEL
were in poor condition. They were on continuous traceback (and
spending an absolute fortune on testing). I suggested that, whilst
it was wonderful that they were finding pathogens; maybe, they
Going on a pathogen hunt without a plan could change their tactics and “stop sticking their swab in “a turd”
PROXIMITY/LIKELIHOOD
Close (zone 2) MEDIUM HIGH HIGH
to confirm it’s still “sh*t”! Perhaps they could focus their efforts
is like travelling without an itinerary: on isolating the area, fixing the floor and swabbing surrounding
areas to monitor whether the contamination was spreading?
In-between
(zone 3) LOW MEDIUM HIGH
you’ll never know where you end up. The moral of this story is that if we have a fully random pro- Far (zone 4) LOW LOW MEDIUM
Without a plan, you take the risk of setting We need a more structured plant monitoring programme, PLANT HYGIENE ZONE/IMPACT
up and paying for an environmental starting with the premise that the plant is clean (with no food –
moisture – shelter), because going pathogen hunting in a dirty
pathogen monitoring program, which plant is a bit like “shooting fish in a barrel”. This risk-based approach gives us a logical starting point and
guides our environmental pathogen monitoring efforts. The
may not detect pathogens and give you To design this programme, I have used risk management
principles.
colours can be used to establish our sampling numbers and
frequencies (more in red/less in green), but more importantly,
the illusion that your plant is healthy, The Pathogen Risk Matrix
they can guide our response in case of a pathogen detection.
(to be discussed in the next article).
when it may be contaminated. Most International guidelines on Salmonella and Listeria are
based on proximity: the closer you are to the product the higher Unfortunately, whilst the matrix will point us in the right direction
the risk for product contamination. Generally, four proximity and ensures our programme targets the right areas, it does not
categories are included: product contact surface, close, further tell us, how to pick our sample points. This activity requires an
In this fourth article in our short series and far. However, defining the difference between close, further
and far has been difficult to say the least.
initial plant risk assessment, which should include a review of
traffic flows, people movement and process access points.
on pathogen management, Jack van To deal with this issue, I suggest three proximity categories: To complete this risk assessment, I recommend using expert
der Sanden introduces a risk-based close (the outside of process equipment), far (floors, walls,
drains) and in-between (stuff that moves between far and close).
input (independent from the factory), because when it comes
to going on a pathogen hunt, nothing beats a fresh pair of
approach to set up your program ; how Please note that to me, product contact surface swabbing for
pathogens is the same as final product testing, because a positive
experienced eyes.
ENVIRONMENTAL So, we have designed our pathogen program, conducted a This is not easy; in a large number of cases, you will struggle
PATHOGEN MANAGEMENT:
risk assessment to determine our swabbing points, found an finding the pathogen again (only for it to pop up a few months
accredited laboratory and kicked-off the monitoring – PHEW later!). I think the main reason for this lack of success, is a
- peace of mind! That is of course, until that phone call on a Fri- response that is poorly co-ordinated and too fast. Evidence to
day afternoon, telling us that one of our environmental swabs date shows that one of the biggest advantages of an environ-
SURPRISE, WE FOUND A
has come back positive (It’s always a Friday afternoon!). mental pathogen management programme is: we have time
to do a proper job! (remember Company X in my first article?)
The most common reaction I have seen is: panic! A mad
PATHOGEN!
last-minute crisis meeting and some poor souls spending For this reason, I’m somewhat concerned about the latest
their weekend in the factory, running around cleaning and “instant” or “very rapid” testing technology for pathogens.
swabbing. I vividly remember my first Listeria hunt about 20 Whilst I can see the benefits for FMCG manufacture and
years ago (during the weekend!), as we were joint by a very traceback investigations, an environmental pathogen test
senior (and somewhat grumpy) manager to guide us and should never become a line clearance tool like ATP, because
keep an eye on proceedings. pathogens should by definition “not be” in your factory and a
positive result must always lead to a full investigation.
It doesn’t have to be this way!!!
A good environmental pathogen management program I would also like to reiterate my warning about “false” results.
should include a documented pre-determined response plan. Ideally, we should use the same accredited test method for all
Remember the reason we started our hunt for that pathogen? our pathogen testing (environmental as well as final product)
It was to find that pathogen in the environment, well before to prevent any test method debates (and believe me, they do
it sneaked its way into our product. So, we shouldn’t be sur- happen when it comes to a positive pathogen result).
prised if we get a positive result, instead we should congra-
tulate ourselves: Yippee, our monitoring program is working! A positive environmental pathogen result is a time to reflect
instead of panic (what’s going on!?). We need time to maxi-
Fortunately, we can use the colours in the risk matrix from my mise our chances finding the cause, so we can improve our
previous article to guide our response plans. Because, in my controls and systems. As I once said to the CEO of a large
view, a response to red, orange or green needs to be different. multinational food company: “I’m not concerned if we find
However, before we start writing down our actions for each a pathogen in one of the factories, but I do get concerned if
colour, I would like to introduce “risk appetite”. the response to that find is lacking.”
This is the last chapter of our short I’m not sure if you have ever spoken to a financial advisor? One So, here are some response plan tips:
of the first things they do, before they start talking investment • Grab your (pre-prepared) response checklist.
series on environmental pathogen options, is to gauge your risk appetite; whether you are risk • Bring in some fresh eyes (the hunt is on!)
averse or whether you are prepared to take the occasional • Conduct an environmental housekeeping inspection
management. The previous articles will loss on your journey towards financial freedom. first (identify the “food – moisture – shelter” spots)
• Review factory manufacturing records for unusual
have given you some insights for an When it comes to our pathogen risk matrix, this is no different. events/changes
I have sat in meetings where the different risk appetites of • Observe factory traffic movements for breaches
environmental pathogen management the various parties caused some real friction. Therefore, the • Include vector swabbing (has it spread? Where has it
first step is to determine the risk, acceptable to the business, come from?)
program in your factory. the regulator and the auditors. Once we have agreed on our • Do your traceback swabbing before your deep clean.
stakeholders risk appetite, we can lock in our pre-determined • Consider swabbing for hygiene indicators (EB, Coli-
response for each colour. form) as well
• Consider swabbing over several days
There is only one point left that has For example, I’m a food safety professional and conservative
when it comes to pathogens, so here’s my preferred response And the list goes on!
not been addressed: what to do if plan for a target pathogen:
I hope you have enjoyed this mini-series and I have shown,
you find a pathogen in your plant. Green: Expected – some traceback swabbing to determine that an effective environmental pathogen program is more
the size of the problem (and maybe find the cause). than a “swab here and there”.
Panic is often the first reaction, Orange: Surprise – more rigorous traceback swabbing and
increased final product sampling and testing moving forward. We have explored why we should have an environmental
but it shouldn't be if you have a Red: Scary – intensive traceback swabbing and additional pathogen program, what pathogens to look for, how to look
final product sampling before release from the date of the for them and what to do if we find them. I have also shared
predetermined response plan. last clear result (if possible, because your product needs to some personal lessons and experiences with you, because
be in your control). pathogen testing can be very costly to your food business – if
you get it wrong.
(Note that we are talking target pathogen. For the background
Jack van der Sanden, in this fifth and pathogens, only a traceback is recommended). Finally, if it all feels a bit overwhelming, please connect; I’m
more than happy to support your journey towards a robust
final article, explains what to do when To do a traceback, the worst-case random swabbing tech- pathogen program, so you can have a good night’s sleep!
nique (previous blog) is now appropriate, because we know
one of your pathogen samples comes the pathogen somewhere and we want to find the source. Thanks for reading!