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Getting Started With Food Safety Packet

The document is a resource packet on food safety covering various topics such as pesticides, blockchain technology, food tolerances, GFSI certification, and food safety culture. It provides essential information on the role of pesticides in agriculture, the importance of blockchain for traceability in food supply chains, and the challenges faced in implementing food safety measures. Each section aims to educate readers on best practices and regulatory requirements to ensure food safety and quality.

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Mohamed Gomaa
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© © All Rights Reserved
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0% found this document useful (0 votes)
24 views45 pages

Getting Started With Food Safety Packet

The document is a resource packet on food safety covering various topics such as pesticides, blockchain technology, food tolerances, GFSI certification, and food safety culture. It provides essential information on the role of pesticides in agriculture, the importance of blockchain for traceability in food supply chains, and the challenges faced in implementing food safety measures. Each section aims to educate readers on best practices and regulatory requirements to ensure food safety and quality.

Uploaded by

Mohamed Gomaa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Getting Started With

Food Safety
Resource Packet

1
Table of Contents
- Pesticides 101............................................................................................................................3

- Blockchain: What is is and does it live up to the hype?........................................................... 9

- Takingth "Labor" out of Selecting a Third-Party "Labor"atory................................................. 13

- The Basics of Food Tolerances and Maximum Residue Limits................................................ 18

- The Roadmap to GFSI Certification......................................................................................... 22

- Writing Corrective Actions for Your Food Safety Audit.......................................................... 37

- The Importance of Food Safety Culture.................................................................................. 42

2
Pesticides 101
Pesticides can be confusing. Companies create new ones every day, the rules are ever-
changing, and to top it all off, every country has its own set of standards. How can one person
possibly keep up?

Well, luckily for all of us, there are great resources online to help like Bryant Christie, a free
online database with global MRLs and rules. But before we get too far down the rabbit hole
with these more advanced concepts and tools, it’s crucial to get a firm understanding of the
fundamentals.

LET’S BEGIN.
The word pesticide is a general term for a substance used to destroy or control pests. A pest
can be anything from a mouse, an insect, or a bacteria, to an unwanted plant or weed.
Pesticides play a considerable role in the success of an agriculture company because they are
involved in multiple steps of the process from the farm to the storage of the harvested
product. When choosing which pesticide to use, it is essential to remember that each pesticide
is designed to eradicate certain pests and has a specific way of doing so. If you don’t do your
due diligence before application, you may accidentally eliminate something you didn’t want
to.

3
Pesticides can be broken down into several groups:

1. Insecticides – used in insect control: miticides, larvicides, ovicides, pheromones,


termiticides.
2. Herbicides – used in algae or plant control: algicides, brush killers, defoliants (a
pesticide that kills leaves), desiccants (a pesticide that causes the plant to dry out),
plant growth regulators (PGR), and weed killers.
3. Fungicides and antimicrobials – used to control bacteria and fungus that infect
plants: bactericides, disinfectants.
4. Vertebrate poisons – used to kill higher level animals: piscicides, rodenticides.
5. Fumigants – used to disinfect or purify an area. Fumigants are usually biocides.

UNDERSTANDING THE TYPES OF PESTICIDES


As we discussed, there are many types of pesticides. The two examples that you will test for
most often are insecticides and herbicides.

Insecticides
Insecticides affect the insect’s endocrine system, nervous system, and digestive system. They
do this by “tricking” the insect to killing it or keep it off your crop, see Figure 1 below. These
various methods of removing the pest or (modes of action) can be anything directly sprayed
onto the insect, to something that is sprayed onto the leaves and eaten by the insect.

[Link]

4
Insecticides in the Real World
One of the most modern examples of the ingestion aided mode of action is to spray the
pesticide Bt on corn and cotton. Bt or Bacillus thuringiensis is a bacterium that produces a
toxic crystal (Cry), with proteins that have been known to be insecticidal. In the past, farmers
sprayed Bt on fields as an organic pesticide, but with difficulty and high expense. As a result,
scientists took the genetic information for Bt Cry genes, extracted them from the bacteria, and
inserted into the genome of the corn or cotton. Thereby allowing the plant to produce the
effects itself.

When the plant produces the Cry in the tissue makes it more effective. The gene protects the
plant from the sun instead of leaving it in the environment. Once the caterpillar ingests the
Cry, it is solubilized and activated. The toxin binds to the gut cells, and through a series of
biochemical reactions causes the cells to die and eventually the caterpillar.

Common Pesticides Used on Insects


Some of the most common insecticides which affect the nervous system of insects are DDT*,
fipronil*, pyrethroids*, and neonicotinoids*. Neonicotinoids, such as Imidacloprid*, harm the
insect by paralyzing the mouthparts of the insect. While Thiamethoxam*, another
imidacloprid, paralyzes the muscles of the insect after direct application.

Herbicides
Herbicides affect the plant directly and are the most commonly used pesticide by
homeowners. The mode of action for herbicides is dependent on the absorption (where it is
applied to the plant) and translocation (how it moves through the plant) (Fig 3).

[Link]
stmanagement/pesticides/[Link]

• Foliar-Translocated Pesticides: applied to leaves and are distributed in the plant via
the phloem (a transport system in plants for sugars). This pesticide goes through the
entire plant, starting at the leaves and goes down to the roots.
o Ex: Glyphosate*

5
• Foliar-Contact Pesticides: applied to the leaves and causes the leaves to die.
o Ex: Diquat
• (3 and 4) Foliar or Root Uptake Pesticides: applied to the roots or leaves and
transferred to the rest of the plant. The pesticide is translocated via the phloem and
xylem.
o Ex: Tebuthiuron, Picloram, Metsulfuron

Interested in learning more about pesticides like glyphosate? Read Testing Your Product For
Glyphosate

WHAT’S HAPPENING INSIDE THE PLANT


Once inside the plant, the pesticide works on various cellular functions, affecting the light
systems, cell metabolism, or growth/cell division of the plant and eventually breaking it down.
Below are some examples of each:

• Acetyl CoA carboxylase Inhibitors: Inhibit a protein that works in the generation of
fatty acid synthesis inside of the cells. Downstream it blocks the building blocks for
the membranes of the cell walls. (Ex: cyclohexanedione)
• ALS Inhibitors: Inhibits the production of a key enzyme that is used to build
branched-chain amino acids. Amino acids are essential in the formation of many
components, including DNA. (Ex: Imidazolinones, pyrimidinylthiobenzoates)
• Photosystem II Inhibitors: This group of pesticides affects everything from the
CO2 fixation and stopping the production of ATP (cellular energy) to inhibiting
carotenoid biosynthesis or anthocyanin and RNA synthesis. (Ex: nitriles, and
phenylpyridazines, Phenylcarbamates, pyridazinones, triazines, triazinones)
• Photosystem I Inhibitors: PSI inhibitors accept electrons from the photosystem and
are reduced (electron is removed) to form hydrogen peroxide and are further
combined with lipid radicals which form a compound that destroys the integrity of the
cell membrane and allows the cells to leak. (Ex: Bipyridyliums)
• PPO Inhibitors: Protoporphyinogen oxidase (PPG Oxidase) is an enzyme of
chlorophyll. As downstream actions are taken, lipids (fats) and proteins are attacked
and result in loss of chlorophyll and carotenoids. This leads to leaky membranes and
the cells and organelles drying and disintegrating rapidly. (Ex:oxadiazoles,
oxazolidinediones, phenylpyrazoles, pyrimidindiones, thiadiazoles, and triazolinones)
• EPSP Synthase Inhibitors: This group of herbicides inhibits 5-enolpyruvylshikimate-
3-phosphate synthase (EPSP), an enzyme that is important in the production of
aromatic amino acids needed for further protein synthesis or biosynthetic pathways
for growth. (Ex: glyphosate*)
• Microtubule Inhibitors: Pesticides found in this category inhibit the formation or
polymerization of microtubules. Microtubules are fundamental structures in the
creation of cell walls and chromosome separation in mitosis (cell division). Without
microtubules, the cells cannot divide nor elongate. This is also important in seed
germination. (Ex: Benzamide, benzoic acid (DCPA), dinitroaniline, phosphoramidate,
and pyridine)
• Synthetic Auxins: This group is closely associated with plant growth regulators. At
low levels, once inside the plant, this pesticide stimulates RNA polymerase, an enzyme

6
that makes RNA, resulting in increases in RNA, DNA, and protein biosynthesis. As these
cellular products increase, it leads to uncontrolled cell division and growth, which
results in vascular tissue destruction. On the other hand, at high concentrations,
auxins inhibit cell division and growth, usually in meristematic regions (growth
regions). (Ex: Benzoic acids, phenoxy carboxylic acids, pyridine carboxylic acids)

How Each Herbicide Affects the Plant

[Link]

WHY IS THIS IMPORTANT?


Many different outcomes can happen when pesticides are applied. It is essential to know the
effects, as well as the targets when using pesticides. You want to be confident the pesticides
you apply are going to give you the intended outcome you are looking for (control of a pest,
regulation of plant growth, defoliation of a plant). Pesticides must also be applied according
to the label and done according to state and local laws. An excellent resource for pesticide
application is an Agricultural Pest Control Adviser (PCA). A PCA will be able to give you
recommendations based on your commodity and needs.

After you complete pesticide application and need to test your product for pesticide residue,
send your samples to Safe Food Alliance for analysis. We can also assist you with drift
validation and documentation for FDA detention or exports.

7
How We Can Help You
At Safe Food Alliance, we analyze a wide variety of pesticides with technical expertise and
certification from the state of California. Our lab is ISO 17025 accredited utilizing the most
cutting-edge methods and instrumentation to deliver you speedy results to help you make the
important decisions. To make things simpler, the pesticides with an asterisk (*) denote
pesticides we can test or have the ability to analyze an analyte in the group.

If you would like to get started with pesticide testing or have questions about the article, I can
be reached at josephn@[Link].

8
The easiest way to understand blockchain technology is to think of it as an electronic notary. A
notary protects the integrity of a document by verifying the signer’s identity, making sure they
aren’t being forced to sign under duress or intimidation and making sure they’re aware of the
contents of the document or transaction. So, when a document is notarized, you can feel
confident the document is legitimate.

Blockchain serves a very similar function.

A blockchain is a growing list of records, called blocks, which are linked using cryptography.
Each block contains a cryptographic hash of the previous block, a timestamp, and transaction
data. By design, a blockchain is resistant to modification of the data. It is “an open, distributed
ledger that can record transactions between two parties efficiently and in a verifiable and
permanent way.”

Therefore, like a notary, Blockchain protects the integrity of the information stored within
each block.

9
During a foodborne illness outbreak, one of the biggest challenges is determining where the
contaminated food originated from and where it was distributed/served/sold. There is not an
easy way to track down this information; which makes managing a recall, or an outbreak,
incredibly tricky, time-consuming, and dangerous.

Blockchain technology can keep a record of the entire supply chain. If Blockchain were
implemented across the food industry, it would be possible to see everywhere a single piece
of produce has been — from farm to plate. Consumers and food industry professionals alike
would be able to see if a recall had impacted their produce or if it was from the same farm that
is being investigated for a foodborne illness outbreak. Cool, right? It doesn’t stop there! This
enhanced traceability could also help protect against food fraud by providing a verifiable
record or every stage in the supply chain.

It isn’t that easy. There are a lot of very real obstacles in the way, and there is no easy
solution.

In a dream world, when helpful technology is created, people rush to adopt it because they
know it is valuable. In the world we actually live in, the reality is much different. Many key
stages of the food supply chain operate with very low margins. Growers, packers,
slaughterhouses, wholesalers, and harvest companies have very manual processes – and they
don’t always have the capital to invest in technology. The other thing these companies are
short on is time for training. Successful implementation of a new system requires time,
money, and desire. When you’re operating with a shortage of time and money, desire is hard
to come by as well. Transparency and traceability are popular ideas throughout the food
industry, but when it comes time to actually turn that idea into reality, many companies have
an “if it ain’t broke, don’t fix it” attitude.

The unfortunate reality is that people often pay the cost of food traceability at the early stage
of the supply chain (growers, packers, processors) and the benefit is felt the strongest by
those at the end of the supply chain (retailers and consumers). What this means is that we are
asking the companies with the smallest margins to make the most significant investments –
which they are often unwilling or unable to make. It is a fair point, outside of altruism, there is
not a clearly defined business benefit to growers — so we are asking them to complicate their
process, invest time and money, for little direct benefit.

10
This is particularly damaging because Blockchain won’t be revolutionary if it is only protecting
part of the food supply chain. To be completely effective, every piece of the food supply chain
needs to be on board.

Experts estimate that food fraud is now a $40 billion-dollar business. Unfortunately, the
people committing food fraud are making a lot of money, and they are likely to be involved at
some point in the supply chain. Blockchain and traceability technology threaten this business
because of the technological ability to sound alarm bells and alert the world to food fraud. So,
to protect their business model, these criminals will fight traceability implementation tooth
and nail.

There are a lot of small-to-mid-sized companies offering traceability solutions, but


unfortunately, these systems don’t always talk to each other. Blockchain success is heavily
dependent on private tech companies being open to working together and sharing their data
— which historically, they are not.

Traceability varies by industry and product. For example:

• Agriculture/Farming: Identification starts with the birth of livestock or planting and


moves through the growth process, use of pesticides, nutritional records, vet records,
and transportation records;
• Food Processors: Identification starts at the source of each ingredient and follows
through the processing, packaging, distribution, and transportation process;
• Retail and Food Service: Identification starts with receiving receipts/invoices to
identify the lot and batch information with regulations not requiring tracking “one-
up” to the final consumer;
• Transportation and Distribution: Commingling points of contact are vectors for the
spread of disease. Waybills should contain source party and target party
identification. Specific locations are needed for livestock in most countries. If products
are disaggregated for smaller shipments, then records need to reflect lot/batch codes
of the manufacturer or processor.

Different groups have different motivations, and it may be difficult for a system to
accommodate the needs of each industry or product.

The short answer is maybe. Blockchain represents immense possibility, but it also comes
with equally immense challenges. If the food industry doubles down on Blockchain and can
secure engagement at every phase of the supply chain, the results would be revolutionary.
However, if there is only partial adoption of traceability technology, it will be far less
successful.

11
There is a reason to be optimistic, however! The FDA recently launched the New Era of Food
Safety program that looks ready to move the food industry forward into new traceability
technologies.

12
Taking the “Labor” out of
Selecting a Third-Party
“Labor”atory
The need for a third party or contract laboratory is almost a must in today’s marketplace. The
word laboratory, first used in the 1600’s, comes from the Latin laboratorium, a place that is set
apart for scientific experiments, a place for labor and work. Today, we continue to see
laboratories as scientific epicenters, only with much greater capacities to test things like our
food supply. If you are a food processor, you know that many customers buying food
products, regulations, and most Global Food Safety Initiative (GFSI) benchmarks require
testing. The role of a laboratory is to preserve your reputation and integrity. You want to have
the confidence that your testing is getting done quickly, and done right the first time. But
finding the right fit for your company is easier said than done.

CHOOSING A LABORATORY
What qualities should you look for when selecting a lab?

13
First you need to figure out what your needs are as a company. What type of testing do you
need? Microbiology? Chemistry? Pesticides? If you need multiple types of testing, do you want
to work with one lab who can do both? Most labs specialize in multiple areas.

Second, consider the specific requirement of your customers. At the end of the day, you need
to create a product that you can sell to your customers. Ask your customers if they have a
preference. Many customers will have a list of approved laboratories. This will help with
overcoming any questions that may arise in the future with your client.

Choosing and committing to one lab can reduce administration costs, improve efficiencies,
and decrease stress. That being said, your choice should be constantly reassessed to ensure
they are meeting your company’s needs. Most labs are not created and operated equally. That
is why I have created a list of considerations to help you make the right choice.

MAKING THE RIGHT CHOICE


When choosing a laboratory there are many factors to consider. Below is a list of 6 areas to
focus on when making yours.

Accreditation
ISO 17025 or A2LA is an accreditation that establishes that a laboratory has an established
documented way of doing things or procedures. This is an accreditation that takes in every
aspect of the sample including arriving and sample receipts, all aspects during the testing,
and the final report. Labs which are ISO 17025 have undergone an extensive audit that
encompasses: management, quality systems, document control, subcontracting, complaints,
nonconformance issues, calibrations, equipment, and service to clients. The lab should be
able to provide its ISO/A2LA Certificates, it’s important to make sure they are not expired. The
lab can also provide you with an approved scope of methods which have been approved
under ISO.

Often, not all tests needed are covered under the scope. Labs will short cut on specific tests
because of costs, equipment or another reason, so it is important to check the ISO 17025
scope. The lab can also provide you supportive analytical proficiency data especially for the
matrix you are having tested.

Ability and Experience


The lab you chose should use official and recommended methods. They should also be able to
explain how they came to their results, with analyses that are repeatable and reproducible.
Having consistency in preparation of the sample, analysis, certificates of analysis,
troubleshooting and communication, all aid in minimizing variability and help give you piece
of mind. Different matrix (whole almonds in shell, whole, blanched, flour, oil, butter, and
pastes) may react differently under testing conditions leading to a false positive or negative.
Review the proficiency data and make sure it is done at multiple times during the year or at
least if methods are being changed.

14
It will also be incredibly helpful for you if the laboratory has experience testing your product.
With this industry knowledge, they will have a better understanding of how your product is
manufactured and the known issues associated with it.

Laboratories have a vast and deep connection throughout the industry and can help support
you if the need arises. They are usually involved with trade meetings and technical sessions
and can support you through technological advances and regulatory changes. It’s also good to
select a lab that isn’t overstretched and ends up subcontracting work out to another lab.
Some labs overcommit or accept samples and send the samples to another laboratory to be
processed. You cannot be certain if these labs are handling your sample in the same manner
as your primary lab. If you need a specific test and it needs to get subcontracted out, just find
another lab. You want the laboratory to inspire confidence in their expertise.

Customer Service
Good customer service should drive you to good results and make working with a lab a very
easy task. Make sure the lab you choose is courteous, available, and timely in meeting your
expectation. You should lay out what you expect from the lab upfront. Question the
laboratories rush policies, how long it takes from a sample being submitted to a report being
generated (turn-around time). You want them to be able to work with you and not take
advantage of your needs. A good lab will assist you with all the testing you need and make
suggestions for other tests if they have knowledge about it.

Labs can suggest and consult about environmental monitoring programs, including sampling
sites, how to collect the samples and provide you with the materials to collect the samples. If
you don’t have a technical expert on staff it is important to make sure they are able to
interpret the data they provide you. This information should not only be used as a tool in your
decisions but also be based on your company’s standards. Most laboratories offer couriers so
you can have your samples picked up saving you money in shipping and letting you know the
analysis will begin the same day. Look for hidden courier fees and flexibility in the lab to come
to your facility when you need them there.

Drop In
You want to make sure “big customers” are being serviced the same way as “small
customers.” Send a comparative test of your own. Show up in person and evaluate how you
are treated. It is recommended to send in samples with known results to see if you get
comparable results. The best way to audit the lab is to schedule a visit. The laboratory should
welcome a visit, during the visit you can meet the technicians you’re working with, evaluate
the facility, and explain any questions or concerns you have. If they don’t want you to visit you
don’t want to be doing business with them.

You Get What You Pay For


It is good to shop around and see the cost of the testing you need, but the cost should be one
of the last things you should think about. You want to make sure you are getting the quality

15
analysis, with great customer service and everything is done in a reasonable amount of time
without being taken advantage of.

Other Considerations
It is important to make sure the lab you choose expresses confidentiality while processing
your samples. You shouldn’t see a competitor’s data, or product laying around if you visit the
lab. If a testing laboratory tells you who they are working with they are most likely releasing
your information too.

Working with a lab that also has a certifying body or training and consulting department can
give you a broader picture of food safety and quality. If you are having an issue with a specific
test, they might be able to provide you references or connect you directly with their training
and consulting branch. A laboratory should always be innovative and looking for the future of
testing needs. A strong research branch should be constantly validating and moving the
company forward into new more sensitive areas while helping with unique needs of the
industry.

Choosing a laboratory can be a daunting task, but with this article, you can begin to find clear
distinctions between labs. Take your time and remember they will be representing your
brand, while preserving your reputation and integrity. They could prevent a recall or be the
reason for one. Working with Safe Food Alliance brings you all of this and more. Our goal is to
partner with you and help you make the safest food possible.

16
LABORATORY SELECTION CHECKLIST:
□ Accreditations
ISO 17025 A2LA ELAP USDA Approved/PEC
□ Approved Scope/Copy of Certificates
□ Proficiency Data
□ Capability
□ Knowledge with your commodity
□ Equipment that is able to meet needed Limit of Detection (LOD)
□ Trained staff
□ Experience
□ Method Knowledge
□ Consistency
□ Proficiency Testing
 Date sent:
 Results/Notes:
□ Customer Service
□ Available to answer your questions
□ Quick Turn Around Time
□ Open and Upfront
□ Data guidance (if needed)
□ Environmental Monitoring Services

PROVDE SWABS PERFORM SWABBING

□ Courier Services
FIXED TIMES CUSTOM PICK-UPS
□ Confidentiality
□ Innovation
□ Rush Policy
□ Locally tested
□ Research options
□ Online Laboratory Information Management System (LIMS)
 Provides you update of sample progress YES NO
 Easy to use YES NO
 Provides Historical Samples YES NO
 Presentable Certificate of Analysis YES NO
□ Priced Accordingly
□ Meets your customers’ needs
□ Hidden Fees YES NO
□ Access to additional resources

TRAINING CONSULTING AUDITING

17
The Basics of Food Tolerances
and Maximum Residue Limits
An MRL (Maximum Residue Limit) or a food tolerance, as it is known in the USA, is the
maximum amount of a pesticide residue that can be found in or on food. While any food with a
pesticide residue under an MRL should be safe to eat, it is important to remember that an MRL
is not a safety limit. That being said, a residue over an MRL is not necessarily a safety hazard,
but rather a violation of good agricultural practices (GAP).

If you are growing, packing, importing/exporting, or otherwise involved in the domestic or


global trade in agricultural commodities, it is critical that you be aware of any MRLs that may
affect your commodity and the regulations around them. This article is meant to give you a
basic introduction of pesticides and their limits, but no single article can cover all the
complexities and local variations in MRLS. If you have questions about your specific situation,
reach out to your PCA, local farm advisor, grower group, or a Safe Food Alliance
representative.

18
LET’S START WITH SOME DEFINITIONS.
Pesticide
A pesticide is defined by the EPA as: “Any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest.”, “Any substance or mixture of
substances intended for use as a plant regulator, defoliant, or desiccant.” or “Any nitrogen
stabilizer”.

Active Ingredient
The active ingredient (AI) in a pesticide is the chemical or chemicals that actually have the
desired effect and do the heavy lifting (the AI in Round Up is glyphosate). The rest of a
pesticide product is the inert ingredients such as solvents (e.g. water) and adjuvants which
are additives that improve pesticide performance (spreaders, wetting agents).

Pesticide Residue
A pesticide residue is the trace amount of any pesticide remaining on the crop after
treatment (and any post treatment steps required by the label, such as a reentry period). It is
important to note that an MRL may refer to an AI, adjuvant, or any other residue that results
from a pesticide application, like metabolites. Remember, all MRLs are specific to a pesticide
and crop combination. For example, if you find the fungicide Imazalil on oranges, and the
market does not have an MRL for it, then any Imazalil residue found on an orange is illegal
(a positive list system or PLS).

Default MRLs
Some markets, like Europe or Japan, have default MRLs where if there’s no specific MRL for a
given crop/pesticide, but the pesticide isn’t specially banned, the MRL defaults to a given
value (usually 0.01ppm). These default MRLs are generally set to around the current limit of
detection for most pesticides, though, so there’s often little difference between a default MRL
and no MRL.

Residue Definition
The last important definition we’ll discuss is the residue definition. The residue definition
tells you what chemicals need to be measured to determine if your commodity conforms with
the MRL. For example, the residue definition for the herbicide oxyfluorfen is just the chemical
oxyfluorfen, but for fosetyl-aluminum both the parent compound, fosetyl-aluminum and the
chemical it degrades into in the environment, phosphonic acid, needs to be measured. This
can also change based on the commodity and market: the residue definition for glyphosate
for wheat in the United States is different than the definition for almonds in Australia.

HOW ARE MRLS MADE?


While an MRL is not a safety limit, the setting of an MRL begins with safety testing.

19
How It’s Done

1. The registrant of a pesticide performs animal studies to determine the smallest


amount of the active ingredient that the animal can be exposed to before having an
adverse reaction. This amount is the no observable adverse effect level or NOAEL.
2. From there, they take the NOAEL and multiply it 100 times to give a range (Safety
Margin) to include as much of the population as possible.
3. The safety margins and two toxicological values are then applied: the smallest amount
that it is acceptable for humans to consume at one sitting (acute reference dose
or ARfD) and the smallest amount that it is acceptable for humans to consume on a
long-term basis (acceptable daily intake or ADI) are calculated.
4. The registrant carries out field trials, where the pesticide is applied to the commodity
at the highest proposed rate and the crop is then handled according to GAP.
5. Finally, the MRL is set based on statistical analysis on the range of pesticide residues
found on the crop from the field trials, after all applicable harvest activities. What that
means is they analyze how much of the crop is left after harvest and measure if it
might get people sick.

Following the Directions

Again, while the MRL needs to be at a safe level (all sources of consumption are summed and
the MRL is only approved if the public’s estimated consumption is under the ADI and ARfD), it
is really a way of ensuring that GAP was followed in the application of the pesticide. If the
instructions in the pesticide label are followed, the pesticide residue, by the time the
commodity reaches the consumer, should be under the MRL. It is important to follow the
label, as an MRL violation is a sign that GAP was not adhered to, possibly risking harm to the
environment, workers and those who live nearby the spray site.

HOW TO STAY INFORMED ON MRLS


The world of pesticide regulations is large and constantly changing. Even the basic
information covered in this article may seem like a lot to have to keep track of, without getting
into the specifics of how MRLs work in each individual market. Europe alone is worth its own
(much longer) article, one that might go out of date in the time between writing and reading.
The good news is that all the information you need to stay informed on the state of MRLs is
publicly available if you know where to look.

For the most up to date information, make sure to stay in communication with any PCAs, farm
advisors, or grower groups who may have firsthand knowledge of your crop, growing
methods, and target market. Second, visit an online database where you can find information
on what MRLs there are for your crop and market. Online databases are available for
the United States, Europe, Japan, Korea, Canada, for starters, but that can still be a lot to have
to keep straight. Bryant Christie Inc. keeps an excellent MRL database that covers over
“…1000 pesticides, 875 commodities, and 125 markets”; due to a grant from the federal
government. Access is free to users within the United States.

20
Remember, the key to avoiding pesticide residue issues is to stay informed. By knowing where
there may be potential issues ahead of time and testing for residues before you ship your
commodity, you can manage your pesticide risk.

21
The Roadmap to
GFSI Certification

22
Introduction
Global Food Safety Initiative (GFSI) certification. Where do we even begin? If
you find yourself getting overwhelmed by all of the acronyms, regulations,
and customer demands, don’t worry you are not alone. GFSI certification is
complicated. That’s why we’ve created an easy guide to help you navigate GFSI
certification.
In this guide you will find an introduction to GFSI, an explanation of HACCP,
and guidelines to GFSI certification, all to assist you in determining which audit
scheme is right for your company.

WHAT IS GFSI CERTIFICATION?


GFSI is a benchmarking organization that works to create consistency in food
safety rules to allow for more effective food safety plans. The objectives of
GFSI are to:
1. Reduce food safety risks by delivering equivalence and convergence
between effective food safety management systems
2. Manage cost in the global food system by eliminating redundancy and
improving operational efficiency
3. Develop competencies and capacity building in food safety to create
consistent and effective global food systems
4. Provide a unique international stakeholder platform for collaboration,
knowledge exchange and networking
GFSI stands for Global Food Safety Initiative and was created “in 2000 to find
collaborative solutions to collective concerns, notably to reduce food safety
risks, audit duplication and costs while building trust throughout the supply
chain” [Link] .

23
GFSI

SCHEMES
Within GFSI certification, there are many “schemes” or “platforms” as they are now called to choose from.
When choosing a scheme, it is important to pick the one that is going to work best for your company.
Those offered under the GFSI umbrella are:

• Primus GFS • Canadagap


• Global Aquaculture Alliance Seafood • SQF
• Global Gap • BRC Global Standard
• FSSC 22000 • IFS International Featured Standards
• Global Red Meat Standard • Japan Food Safety Management Association

24
UNDERSTANDING
HACCP
T H E FO U N DAT I O N O F G FS I

HACCP, short for Hazard Analysis Critical Control Points are where it all begins. Without
HACCP, you won’t be successful in your food safety program, so make sure you take a
class to get educated on everything there is to know about this fundamental piece of
food safety. On top of being extremely helpful, HACCP training is required under many
GFSI schemes.

Fun Fact *According to a study conducted by the Food Marketing Institute (FMI) and the
Grocery Manufacturers Association (GMA), food recalls cost companies an average of $10
million per incident.

25
THE HISTORY OF HACCP decided that NASA’s engineering management
Shortly after NASA was established in 1958, requirements, Critical Control Points, would be
the prospect of manned spaceflight raised an used as a guideline for this food safety initiative.
important concern: how could they be sure the Critical Control Points (CCP) were used to test
food astronauts would be eating was safe? If food weapon and engineering system reliability and by
poisoning is bad on terra firma, the possibility of using CCPs, NASA and Pillsbury were able to hire
such an infection in a Gemini capsule could prove contractors to identify and eliminate the “critical
fatal. The process had to change. When food failure areas” in the food processing procedures.
safety practices first began, they relied heavily on This new approach focused on preventing
product testing. Samples would be extracted from the introduction of hazards in the process of
the processed foods and tested for contamination. manufacturing food, rather than looking for the
While useful in many ways, testing only a small effects of those hazards in the finished product.
portion of the product could not guarantee that The system they developed revolutionized safe
the entirety of a batch of food was safe to eat. In food production, and by the 1990s, would come to
fact, such a huge portion of each batch needed to be the internationally recognized HACCP approach
be tested that very little final product would be left to food safety. HACCP is included in the Codex
over for consumption. Alimentarius that is recognized by both the World
As a result, NASA partnered with the US Army Health Organization and World Trade Organization
Laboratories and the Pillsbury Company to develop for the merit of its guidance on food safety.
a more reliable approach to food safety. It was
26
UTILIZING HACCP WHY IS A HACCP PLAN
HACCP remains the foundation for all food safety IMPORTANT?
plans because of the focus on avoiding hazards in
Bottom line, proper implementation of a HACCP
production before the product is finalized.
program will revolutionize your company.
This is accomplished through seven key steps: A successful HACCP plan reduces customer
complaints and the likelihood of a recall by
1 Conduct a hazard analysis identifying and controlling potential hazards which
may come from raw materials, facility processes,
2. Identify Critical Control Points
and the always terrorizing human error.
3. Establish critical limits for each critical control With a functioning HACCP plan, you achieve greater
point employee awareness and buy-in. Empower your
employees to be part of the food safety process
4. Establish critical control point monitoring and show them that they too are helping to create
requirements safe food.
5. Establish corrective actions Last but certainly not least, HACCP principles are
in alignment with the requirements of the FDA’s
6. Establish verification procedures Food Safety Modernization Act (FSMA) rule for
food processors — Hazard Analysis and Risk-
7. Establish record-keeping and documentation
based Preventive Controls (“HARPC” or “Preventive
procedures Controls”). Although a HACCP plan does not meet
8. Reviewing every step in the entire all of the requirements, it meets the majority of the
requirements and is the best platform from which
manufacturing process (from raw material
to build an FSMA-compliant management system.

?
production, procurement, and handling, to
manufacturing, distribution, and consumption Many food processors first hear of the
of the finished product) allows you to consider
the potential risks for biological, chemical, and
physical contamination. What you want to be
able to do is identify risks and then effectively
control them. That is what a HACCP plan will
do for you.

One of the defining factors of a CCP is that the


process has measurable results that are regularly
monitored. Monitoring allows you to be proactive.
The process also ensures that if your process has
gone out of control by deviating from the critical
limit, you will be alerted that the product is at
risk and needs corrective actions. Monitoring
wouldn’t be possible without record keeping! Clear,
consistent records make it possible to demonstrate
that the food you manufacture was produced
safely.
Don’t forget that critical limits must be science-
and evidence-based!

27
GFSI
CERTIFICATION
WH AT YO U N E E D TO K N OW

Global Food Safety Initiative when a customer asks for a copy of their GFSI Certificate.
Because GFSI is such a large and complicated institution, it can be difficult to grasp what
exactly GFSI certification means on your own.
It is most easily explained by telling the history of the organization.

28
THE HISTORY OF GFSI RETAILERS THAT
RECOGNIZE GFSI
In the 1990’s, food processing and manufacturing
businesses around the world began to realize that
the state of food safety was not what it should be.
With food supply rapidly globalizing and a string
of well-publicized food safety crises, consumer
confidence was falling fast. In an attempt to
address the issue, the numbers of food safety
audits ballooned as retailers found themselves
needing food safety audits for their customers.
No good solutions were at hand.

LEADING INDUSTRY ISSUES


• First-party audits presented a major conflict
of interest and were not consistent from one
supplier to the next
• Second-party audits were expensive for
retailers and onerous for suppliers who had a
different audit for each customer
• Third-party audits were all across the board
as each type of audit had its own expectations
and auditors had widely variable expertise
and credentials
Recognizing this, the heads of many global
corporations met in 2000 and agreed to create the
Global Food Safety Initiative or GFSI. This Initiative
would provide a benchmark against which third
party food safety standards could be judged. The
standards that were approved would be recognized
and accepted by major retailers around the world.

This market-driven approach meant that just


one GFSI-benchmarked audit each year could
satisfy a food processor’s various customers
by demonstrating that they had been found
acceptable by a credentialed auditor to a known
standard. In English this means that with a GFSI
audit, you only need one annual audit instead of
having different audits for each retailer you were
trying to sell with.

29
UNDERSTANDING GFSI
Every GFSI standard effectively reviews three
things: Putting all of these elements together, a GFSI audit
ensures that a supplier is producing safe food year
1 Does the supplier say what they do? round.
(Reviewing policies and procedures)
While it can be stressful for a supplier to learn
2. Does the supplier do what they say? that an important contract hinges on obtaining
(Observing processes while they run, a certification they’ve never heard of before,
suppliers who successfully pursue GFSI certification
interviewing employees, inspecting the facility) generally find that the effort invested leads to
3. Does the supplier track that they do what they significant rewards.
say? (Reviewing records)

THE BENEFITS OF GFSI


In general, companies who have adopted GFSI certification have seen incalculable rewards. If you are
interested in becoming GFSI certified, you can use the information below to assist in your decision
process.
Improved Margins – When food is consistently produced safely and processes are under control, there
are far fewer recalls, product holds, reworks, and wasted product headed for the landfill.
• 72% of food safety professionals say GFSI has enhanced food safety practices at their facilities
• 61% say GFSI has improved their ability to produce safe food
• 90% say GFSI has helped to increase employee food safety knowledge
• 68% say GFSI is helping to prepare them for forthcoming regulatory changes
Attractive Marketing – Many major retailers will not even consider buying from suppliers without GFSI
certification. Even those who do not currently require it recognize the significance of such certification as
an important asset. If your customers are currently not requiring GFSI from your facility, you can count
on the fact that they eventually will be.
Consistent Systems – A well-implemented GFSI system is just that: a system. Instead of having one or
two people who are essential to keeping a plant running, a food safety system helps to ensure that the
plant can keep running and producing safe food even when the QA manager is out sick, on vacation, or in
meetings.
Brand Protection – Safer food production will help prevent a facility experiencing a product recall or
receiving an FDA Form 483. Such crises can cause long-lasting harm to a brand’s appeal, doing incredible
damage to a supplier’s ability to remain open and operational.
Safe Food – Most importantly, a GFSI food safety system helps keep your food safe. You want those who
eat the food you produce—your own families, friends, and neighbors, as well as people you may never
know—to safely enjoy it. A GFSI system empowers you to keep consumers healthy and safe.

30
MANAGEMENT Quick Facts &
COMMITMENT
As you consider GFSI Certification, you should bear
Figures
in mind that there is one key factor for every facility

61%
that helps determine whether or not implementing
a GFSI standard will be successful: Management
Commitment.
In every facility, upper management always
effectively chooses to view GFSI Certification in one
GFSI certification increases the
of two ways: ability to produce safe food

72%
1 As a hoop they have to jump through to keep
their customers
2. As a necessary system for producing safe food
for consumers
Would choose to become GFSI
For those holding to the perspective that GFSI certified if they were not already
Certification is a required necessity to do

90%
business with some customers; you will find
customers increasingly viewing GFSI Certification
as fundamental necessity for their suppliers. But
those who see it primarily as an obstacle to cross,
may end up communicating this attitude to their
employees and find themselves with a facility full GFSI raises awareness and
of people who do the right and safe thing when knowledge about food safety
someone is watching.

72%
In contrast, those who recognize that GFSI
Certification is not only a necessity to retain and
attract customers but also an essential tool in
producing safe food will communicate this attitude
to their employees with a very different outcome. GFSI certification increases the
When everyone in a facility understands that best ability to produce safe food
practices are essential because they keep real
people like their own families healthy, when they
recognize that their jobs are more secure when the

68%
facility is less likely to suffer a major recall, people
do the right and safe thing whether or not anyone
is looking.
Management Commitment is not just a feeling, but
an attitude that leads to action by using resources GFSI-recognised certification
to ensure that all employees have proper training, helps to prepare for
that equipment is safely maintained, and that forthcoming regulatory changes
hazards are effectively removed from the finished
product.
Furthermore, Management Commitment is an
essential requirement for GFSI and is verified in
every GFSI audit.

31
The Major Players
As explained in the introduction, there are ten different platforms under the GFSI umbrella. But when it
comes to Food Processing, two of the largest are BRC and SQF. Globally SQF has 6588 certified sites and
BRC has 20903 certified sites, showing the footprint that the two platforms have.

WHAT IS BRC?
The British Retail Consortium (BRC) is a trade association for the UK food retail industry created in 1992.
The BRC has published standards for best practices for the food and manufacturing industries for two
decades, and also publishes the On-Pack recycling standards for the UK. The BRC Global Food standard
has been in existence since 1998, and in 2000 was the first food safety standard to be recognized by
the GFSI organization, which means the standard meets their “benchmark” criteria for acceptance.
The standard is designed as a “total quality management” program, and includes both food safety
requirements and quality requirements which food manufacturers must meet in order to be certified. As
of December 2018, BRC has 20903 global certified sites under the platform.

WHAT IS SQF?
The SQF food safety standard, first developed in Australia in 1994, has been owned and managed by
the Food Marketing Institute (FMI) since 2003; it is recognized as Safe Quality Foods Institute (SQFI).
The SQF food safety standard has a unique structure which includes a modular approach. Module 2 of
the standard is applied to all food manufacturers, and applies to basic management requirements and
application of the HACCP process. In addition to Module 2, the other Modules of the standard are applied
which contain industry-specific GMP and Prerequisite programs based on what the company produces
(such as meats, beverages, grains & nuts, produce, etc.). As of September 2018, SQF has 6588 global
certified sites with 4648 of them in the United States.

32
BRC OR SQF? • The Desk Audit is a review of only your
policies and procedures, whereas the Facility
Many facilities considering GFSI certification for Audit involves inspection of the facility and its
the first time find themselves asking whether they processes while they are running, employee
should pursue BRC or SQF. Ultimately, there is interviews, and reviews of your records.
no wrong choice, as both standards are equally Basically, the Desk Audit answers the question
benchmarked to the Global Food Safety Initiative “Do you say what you do?” while the Facility
Guidance Document and both are designed to be Audit answers “Do you do what you say and
used by food processors and manufacturers. Even track that you do what you say?”
so, there are a few key considerations that might
• The Desk Audit is not graded and does not
help facilities determine which direction they want
impact the final grade on your SQF Certificate
to pursue.
the first year. It is included in the final report
which will be seen by SQF and your customers
upon request. All non-conformities from the
KEY CONSIDERATIONS Desk Audit must be closed out with Corrective
Actions before the Facility Audit can take
1 Because GFSI is largely driven by retailer place.
demand, it is never a bad idea to ask your
• The Facility Audit can be performed any time
biggest customers if they have a preference from 4 weeks after up to 6 months after the
between the two certifications. In broad Desk Audit, but is usually completed within 6
strokes, BRC tends to be more familiar in the to 8 weeks.
United Kingdom and Western Europe, while • Once your facility is certified, your annual
SQF tends to be more familiar around the recertification audits will combine the Desk
Pacific. If you export to either of these regions, and Facility into a single visit.
this should be something you consider. BRC Certification
Since both standards are GFSI Benchmarked,
• The initial BRC audit all takes place on one
should mean that both standards are equally
visit, so effectively it combines the Desk and
accepted anywhere. the Facility into one visit from the first year
2. SQF requires each certified site to have an on.
unannounced audit for one out of every 5. Practically speaking, this difference your first
three annual audit cycles. At present, this year can have an impact in a few ways:
is not a requirement of BRC although this
• Because SQF breaks the Desk Audit and
may change in the near future as the code Facility Audit into different visits, the initial
is updated. Note* A BRC certificated site can SQF Certification tends to cost a bit more than
choose to have their BRC audit performed as the initial BRC audit. This difference does not
unannounced if they would like to. persist after the first year, as both codes use
just one visit for annual recertification audits.
3. Both SQF and BRC have introductory programs
• Because the SQF Desk Audit gives you a
that do not meet the full requirements of
chance to catch problems in your policies
GFSI but that can help get your facility on and procedures before the graded Facility
the path toward full certification. BRC has Audit, it can help you to ease your way into
the BRC START! Program while SQF has SQF the process, as any non-conformity in your
Fundamentals. policies and procedures will likely lead to
more non-conformities downstream in your
4. The two codes take different approaches to actual practices. By catching them at the
your initial certification audit: policy stage, you might be able to fix the
issues before the facility audit.
SQF Certification
• With SQF, your initial certification audit is
broken into two separate visits: the Desk
Audit and Facility Audit.
33
Even so, it should be noted that both BRC and SQF
audits could be preceded by HACCP Verification
CHOOSING A CB
Audits, or BRC or SQF Pre-Assessments which Choosing the certification body or (CB) that is right
can bring in an auditor to conduct a mock audit for you can seem daunting at times. Which one do
beforehand to help catch any issues. you choose? What is the difference amongst them?
While one standard or the other may be preferable Step one will be to choose a scheme that works for
for your specific facility, you really can’t go wrong you. Once that is done the options for certification
with either. bodies gets smaller. Luckily most schemes provide
a list of all the certification bodies that audit to that
specific standard. Here are links to a few:
UNDERSTANDING THE • SQF: [Link]
ADDENDA certified/find-a-certification-body/
First and foremost, what is an addendum? • BRC: [Link]
An addendum is an additional audit component • Primus GSF: [Link]
that can be added to a larger audit. This is very [Link]
common with big retailers like McDonalds and
When selecting the right certification body, you
Costco.
need to make sure that the company audits to the
One of the benefits of a GFSI audit is that you standard you are interested in utilizing.
can include an addendum with the audit to help
The next thing you need to consider is what are the
evaluate your facility in additional ways. It’s also
most important things for your organization. Is it
usually less expensive than paying for the two
customer service? Is it price? Proximity? Access to
audits separately.
resources? Create a list in order of priority of what
With the Costco Addendum--a simple document are the most important attributes you would like
filled out in addition to a SQF or BRC audit—you to see in the certification body you work with. Find
can easily demonstrate that your facility meets the a certification body that will help explain how the
requirements to supply food products to Costco. certification process works, answer quick questions
This is a necessity for any current or prospective about your facility, and be there to guide you
Costco supplier and can only be performed by a through the auditing process.
handful of approved Certification Bodies, including
Tip* Use the completed matrix when you call
Safe Food Certifications. If your facility currently is
potential certification bodies to ensure that they
required to conduct a 1 day Costco Audit each year,
can meet al of your needs.
that audit would be replaced by an SQF or BRC
audit combined with the Costco Addendum. Keep track of how long it takes for them to get back
to you and how helpful they are with getting you
With the FSMA Module, an auditor can take a
certified. The process of becoming GFSI certified
special look at those requirements of the Food
can be difficult. You need a certification body who
Safety Modernization Act that are not already
is going to be your partner in the process.
covered by GFSI. This does not impact the result
or grade of the GFSI audit, but it can help you to
ensure your facility is in compliance with federal
law.

The selection matrix on the following page was created using feedback from
our clients, however, every organization is different; so, you may want to
create your own matrix using evaluation criteria more closely aligned with
your organization.

34
Criteria CB 1: CB 2: CB 3:

Size
Smaller CB’s can give
more personal attention,
but a larger CB has more
auditors
Schemes
Do they have the
schemes you need?
Are they
responsive?
If a CB isn’t responsive
during the quote process
they definitely won’t be
responsive during the
audit process
Are they local?
If they have auditors in
your state you will save
money on travel
What is their
KPI Rating?
Some schemes, such as
BRCGS, offer CB ratings
Price?
Are they affordable?
What is included in the
quote? Do they offer
discounts?
Partner or
Customers?
Do they take the time to
understand your unique
needs? Do they work
with you? Or do they
treat you like a number?

35
WHY WORK WITH SAFE FOOD CERTIFICATIONS?
As an organization, Safe Food Certification’s main priority is you. When we work together, we both
succeed. What sets us apart?

• Approachability
When you call Safe Food Certifications, you get a real person on the phone every time.
• A Go to Resource
When you work with us, you have access to great resources like this E-book. We are here to help you
at every step of the way. You get the services you want, when you need them.
• Top Quality
Safe Food Certifications is one of two West Coast 5-star BRC certification bodies.
• Excellent Staff
With our sister company Safe Food Alliance, you have access to auditors that are also trainers,
bringing unsurmountable industry experience with them.

Becoming certified for the first time can be intimidating but you don’t have to do it alone. We understand
the liabilities and the worries. In order to smooth out your learning curve, contact Safe Food Certifications
to help you establish a road map for pursuing GFSI certification for your facility. No matter your level of
preparedness and scheme-specific requirements, we will help you meet you food safety goals.

On hold is not an option, reach a real


person every time.

Narayan Patil, Ph.D. | 916.223.5164 | NarayanP@[Link]


Sam Greenlee | 916.246.2806 | SamG@[Link]

‘The Safe Food Certifications auditors are very professional and experienced. I
appreciate your guidance throughout the certification process and being able to
reach someone every time I contact the organization.’

[Link]
36
Writing Corrective Actions for
Your Food Safety Audit
You have just been audited, by a customer or by a third-party, and are now facing a Corrective
Action Request (CAR). What is a Corrective Action Request? What do you do? Your first instinct
should be to ask why.

Why?

Exactly!

When you understand what caused the problems, you can create long-term solutions to
prevent them from happening again or negatively impacting other processes. Why—again—is
this important? The bottom line is that every business is run on revenue, margins and overall
profitability. Top management meetings are inundated by numbers. Certainly, your work is
important on many levels, but underlying every other aspect of your work is your
responsibility to help improve food safety and quality. A simple mistake means time and
money is spent to rework or destroy product. CAPA (Corrective action and Preventive
Actions) derived from 5 Whys or fishbone are tools that can be used to address a systemic

37
issue, control processes, and ultimately help prevent a costly food safety or quality
incident.

So, what should you do after you clearly defined why this corrective action was issued?

INVESTIGATE
Find out what caused the problem. Not just what happened, but what started the problem. In
order to find the right solution, you must first identify the root cause of the issue.

The 5 Whys Method


The 5 Whys, a root cause analysis method, is just one tool that can be used to better
understand the root cause of a problem. In this method, you ask “why” as many times as you
can until the root cause is determined—not necessarily just five times.

The Fishbone Method


Another simple root cause analysis tool is called the Fishbone (Ishikawa) Diagram. In this
methodology, factors are broken into categories. This is also known as the 6M: Manpower,
Method, Machine, Materials, Measurements, and Mother Nature. These are commonly-used
categories for manufacturing environments, and each likely cause is assigned to the
appropriate category.

Manpower
To determine the root cause, start an investigation that includes the people involved in the
process. Interview them, discuss the process together, and let them help you understand what
may have led to the issue in the first place. It’s critical that the focus be on gaps in
processes and systems, rather than individuals, as a problem is seldom isolated to an
individual. Focusing on the individual also puts them on the defensive. If the lines of
communication are not as open as we would like them to be, the employees are less likely to
discuss what they need or why they do the things that they do for a procedure.

Method
Next look at the standard operating procedure and verify that what you say is indeed what
you do. Variation, inconsistency or discrepancy in systems and practices play a very
important role in the outcome of the process, as do the practices of employees who are
directly involved in executing the technical aspects of the job. Resources are important to
consider as well; if your team members are not provided with what’s needed to do their job
properly, they will find ways to improvise.

The company values set by the leaders of the organization in terms of food safety and quality
can also greatly influence the decision-making process of your team. We must ask our team to
answer this: Is it more important to make product on time, which may need to be re-
worked; or is it more important to make good product the first time around? To be fair
this is a challenging question to grapple with. There are often internal pressures, such as the
production department’s demand to meet the daily quota in accordance with the shipping

38
schedule. These pressures can result in higher prices if output is given higher priority than
food safety and quality. It won’t matter that you were able to meet your production schedule,
if the product does not meet defined food safety and quality specifications, and ultimately
customer expectations.

Machines, Materials, Measurements, and Mother Nature


The rest of the categories laid out in the fishbone format relate to issues other than personnel
activities such as equipment, materials, product specifications, and the environment. Even
the different seasons and changes in weather can play a role in how agricultural raw materials
may impact process. The equipment used to measure product specifications can prove to be
out of calibration and incorrect readings at times. That’s why it’s so important to calibrate at
least annually by a third party and verify measuring devices daily or at frequencies deemed
appropriate for product specifications. A lot of these things can go back to policies laid out in
the prerequisite programs set in place by the facility. The development of PRPs (prerequisite
programs) and effective execution of those program can a play a pivotal role.

The items noted above are just a few examples of what to look for when conducting your
own investigation for determining root cause and developing corrective actions to
prevent it from reoccurring.

AFTER ROOT CAUSE – FIXING THE PROBLEM


Once a root cause is identified, make sure you find a solution that thoroughly addresses the
issue. If you don’t, it is very possible the problem will happen again. CAPA investigators
frequently identify non-conformity as a root cause, thus leading to develop an ineffective
solution.

Example
Let’s say that there’s a specific area of the facility where you frequently find trash on the floor.
The non-conformity is that the trash on the floor may pose a risk for pest harborage and
provide unhygienic conditions for the facility that can lead to product cross contamination. If
the ‘fix’ that the company applied was to train people to pick up the trash and dispose of it in a
different location, and this non-conformity still continues to occur, then the solution did not
permanently address the problem. It may have been just a correction.

The corrective action in this simple scenario may be to place an appropriate trash receptacle
in this location or in the close proximity, assign responsible personnel as when to remove the
trash and verify during the pre-op and throughout the day. It is important to know the
difference between a correction and a corrective action, that way your CAPA responses
will be more likely to be effective, and less likely to reoccur.

FINAL THOUGHTS
In developing CAPAs, there are two important things to document:

39
1. Provide a summary of the root cause of the problem. The summary must identify the
main cause(s) of the problem and should also lead to corrective actions which will
prevent the problem from happening again.
2. Provide evidence of the solution. Justify that the solution works by documenting
pictures, revised documents or records, training records, etc. It is not only important
to find the cause of the issue but to also prove that your team efficiently
implemented a solution to prevent the non-conformance from recurring.

If you would like more information about how to correctly write corrective actions, contact
Sam Greenlee, Safe Food Certifications, LLC (samg@[Link]; Tel: 916-246-
2806).

40
Corrective Actions
Worksheet

Why was this corrective action issued?

What caused the problem, what started the problem?

Which method did you choose? 5 Whys Fishbone Method

What were the results? Who was involved?

What did you learn from the


interview process? Who was involved?

41
The Importance of Food
Safety Culture
In my role, I routinely work with facilities pursuing a third-party food safety certification audit
for the first time. After four years of assisting and educating people about the audit process, I
have noticed that you can recognize early on whether a company’s pursuit is focused more on
obtaining the necessary certificate or in ensuring that their products are safe.

Most facilities fall somewhere in the middle of the spectrum, balancing the desire for food
safety with legitimate concerns about profitability. It is not difficult, however, to identify
whether a facility sees a food safety audit as another bureaucratic hurdle or an opportunity for
growth. That attitude often acts as an indicator of how the company will perform on their
audit. Sites that prioritize safety and continuous improvement are likely to have better audit
outcomes.

Of course, this is not news to many people. GFSI-benchmarked schemes intentionally look for
this quality through objective evidence, with SQF emphasizing “Management Commitment”
and BRC clauses mentioning “Food Safety Culture.”

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Food Safety Culture refers to the specific culture of a facility: the attitudes, beliefs,
practices, and values that determine what is happening when no one is watching. If you
want to gauge a site’s Food Safety Culture, try asking yourself how the site typically responds
to food safety concerns. Does the staff take potential problem seriously, as if its importance is
obvious? Or do they view food safety practices as just one more hoop they need to jump
through in order to stay in business? Is their response to simply ask, “How much is this going
to cost?”

Food Safety Culture refers to the specific culture of a facility: the attitudes, beliefs,
practices, and values that determine what is happening when no one is watching. If you
want to gauge a site’s Food Safety Culture, try asking yourself how the site typically responds
to food safety concerns. Does the staff take potential problem seriously, as if its importance is
obvious? Or do they view food safety practices as just one more hoop they need to jump
through in order to stay in business? Is their response to simply ask, “How much is this going
to cost?”

In 2012, the Food Marketing Institute and the Grocery Manufacturers Association found that
“the average cost of a recall to a food company is $10M in direct costs, in addition to brand
damage and lost sales[SK1] according to a joint industry study.” The costs were significantly
higher for larger manufacturers as seen below.

While it is common for there to be tension between Quality Assurance and Operations teams
over the allocation of resources in a plant, the data suggests that it is in the interest of both
departments to develop a strong Food Safety Culture. Doing so ensures the integrity of food
products and protects the bottom line.

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HOW, THEN, CAN YOU CULTIVATE FOOD SAFETY
CULTURE IN YOUR FACILITY?
As suggested by the SQF scheme approach, a change to company culture always begins at the
top. Because senior management has final control over resources, their buy-in on food safety
is absolutely essential. Ways management commitment can be seen include:

• proper money and time are allocated to staff receiving necessary food safety training
• machinery and tools are repaired and replaced accordingly to decrease the risk of
health hazards for the product and employees
• a food safety plan is well developed and acts as a living document that is regularly
updated

Management commitment is also apparent when senior management regularly participate in


routine food safety meetings; reviewing customer complaints, results of recent inspections,
food safety issue in the industry, corrective actions from previous audits, and progress toward
new food safety goals.

Beyond the above listed actions, a truly robust Food Safety Culture requires creative thinking
to help the entire staff understand the importance of food safety. At the root, you want the
people in your facility to understand not just what they are doing and how they are supposed
to do it, but why. Why does an employee need to follow their assigned procedures and
protocols? Why should they report any concerns to supervisors? Most importantly, why does
their job matter?

For instance, it is possible people on the floor of your facility think of their work as tedious or
insignificant. How can you help every member of the staff understand their role in
manufacturing safe food? How can you can help them to see that their work helps keep
people alive and out of the hospital? Changing a company culture is never easy. It takes time
and knowledge to move forward. The eight step process featured below acts a helpful first
step towards your adoption of a more food safety focused company culture.

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It is important to remember that creating this type of culture is only truly effective when it is
backed up with action. Are employees provided with an effective anonymous way to share
safety concerns with management? Do they see maintenance and repair tickets being
addressed promptly? Are they penalized for doing things right even when that slows them
down?

Cultivating a Food Safety Culture is a never-ending process of continuous improvement, but


commitment to this area yields benefits for the bottom line, for employee satisfaction, and for
the families who eat your product. You can’t afford to neglect it.

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