Seafood HACCP Alliance Training Course 3-1

Introduction
In Module 1 you were introduced to the HACCP
concept. In Module 2 you learned about the
potential food safety hazards that could be
associated with seafood products. Now it's time to
start learning about what you need to have in place
before you develop your HACCP plan.

First, you'll need to be sure that all of the

necessary Prerequisite Programs are in place.
You'll also need to complete several Preliminary
Steps that involve gathering the information and
resources that are needed to begin the process of
developing your HACCP plan. There are 23 pages
and 5 questions in this Module.
 Seafood HACCP Alliance Training Course 3-2

Prerequisite Programs
Let's start by learning about the Prerequisite Programs.

HACCP is not a stand-alone program. It is one part of a larger system of

control procedures that are necessary to ensure the safety and wholesomeness of
the food you handle or process. For HACCP to function effectively, it must be built
on a solid foundation. That foundation is made up of what we call Prerequisite
Programs.

Prerequisite programs are procedures that need to be in place to ensure that your
HACCP program works. For example, compliance with Good Manufacturing
Practice regulations, maintaining acceptable sanitation conditions, and having
equipment maintenance programs are all necessary to ensure that you have an
adequate environment for your food handling or processing operation. All of these
programs and procedures provide the foundation for your HACCP system.

Let's take a look at some of the specific Prerequisite Programs that you need to
have in place.
 Seafood HACCP Alliance Training Course 3-3

Good Manufacturing Practices

Good
Manufacturing
Practices
FDA's Good Manufacturing Practice regulations, commonly called the GMPs,
describe the conditions and practices that must be met for food handling and
processing operations or activities. These regulations are codified in federal
regulations and can be found in Title 21, Part 110 of the Code of Federal
Regulations. The GMPs describe measures of general hygiene as well as measures
that prevent food from becoming adulterated due to unsanitary conditions. They
are broadly focused and encompass many aspects of the plant's physical
structure, plant operations, and personnel practices and hygiene.

GMP regulations have been in effect for over 30 years, and they have been
revised periodically during that time. Most state and local laws or codes are also
based on these federal GMPs.

To see a copy of the Good Manufacturing Practice Regulations from Part 110 of
Title 21 of the Code of Federal Regulations go to page 259 of the Seafood HACCP
Alliance training Manual “blue book”.
 Seafood HACCP Alliance Training Course 3-4

GMP’s and Your Sanitation Program

Because the GMPs are so broad based and only
describe the general conditions or practices for
a food handling or processing facility, it may be
necessary to define your sanitation program
more specifically. This can be accomplished by
developing your own Sanitation Standard
Operating Procedures, commonly called
SSOPs—another Prerequisite Program. It is up
to each individual firm to develop the specific
procedures or SSOPs that ensure that the
conditions prescribed by the GMPs are met.
Typically, SSOPs describe a particular set of
objectives associated with the sanitary handling of
food and the cleanliness of the plant environment
as well as the activities that will be conducted to
meet these objectives.

Take a look at the diagram to the left—it provides a

visual representation of the relationship between
HACCP, GMPs and SSOPs. Note that the base or
foundation of the pyramid includes GMPs and
SSOPs—both of which are Prerequisite
Programs.
 Seafood HACCP Alliance Training Course 3-5

Sanitation Standard Operating Procedures

Sanitation
Standard
Operating
Procedures
Contrary to popular perception, sanitation control is not limited to cleaning
equipment. Although clean equipment and a clean working area are essential for
producing safe foods, so are personnel practices, plant facilities, pest control,
warehouse practices, and equipment and operation design.

Sanitation Standard Operating Procedures or SSOPs describe how to clean and

sanitize equipment and work areas, control pests, and maintain building and
grounds. In addition to describing the expected procedures, SSOPs should also
describe when these procedures will be conducted, who has the responsibility to
ensure that they are followed, what personnel practices are acceptable, and any
other parts of the GMPs that apply to your operation.

Written SSOPs describe all of the sanitation procedures needed to ensure that
your plant facilities and operations comply with GMPs. They are valuable to both
management and employees because they clearly describe what must be done to
maintain clean and sanitary conditions and practices in your plants.
 Seafood HACCP Alliance Training Course 3-6

Sanitation Monitoring
An important component in a sanitation program is
monitoring. Methods for monitoring sanitation
practices will vary according to the type and size of
your processing operation. Typically a checklist can
be used to record conditions and verify that
sanitation procedures are conducted properly.

The frequency of sanitation monitoring will also

vary depending on your operation. For example, if
you process a cooked, ready-to-eat product,
employee practices will need to be monitored more
often throughout the day than in plants that
produce raw products which will be cooked by the
consumer. Another example is monitoring for
pests. The grounds around your plant may require
monthly monitoring to assure that vegetation is
not overgrown and attracting pests. However, the
areas inside your plant may need to be inspected
daily to ensure that there are no pests in food
handling or storage areas.
 Seafood HACCP Alliance Training Course 3-7

Sanitation Requirements of the

FDA Seafood HACCP Regulation
For seafood processors, sanitation monitoring and record keeping is mandatory
for eight key areas of sanitation identified in the FDA's Seafood HACCP regulation.
FDA now requires that you monitor and keep records of your monitoring
observations for these eight key sanitation conditions and practices.

The 8 key sanitation conditions and practices are:

1. The safety of water used with food, food contact surfaces, or for making
ice
2. Condition and cleanliness of food contact surfaces
3. Prevention of cross contamination
4. Maintenance of hand-washing, hand-sanitizing, and toilet facilities
5. Protection from adulterants
6. Labeling, storage, and use of toxic compounds
7. Employee health conditions
8. Exclusion of pests
 Seafood HACCP Alliance Training Course 3-8

In addition to monitoring records, if a deficiency in

any of the sanitation areas is observed and
recorded, a correction will be necessary to
maintain control of that area or condition. The
correction that is taken then needs to be
documented on your sanitation record to
demonstrate that control of that area or condition
has been re-established. Monitoring, record
keeping and correction can also help you identify
trends and problem areas. Space for noting
corrections should be included on monitoring
forms. An example of an SSOP checklist that
includes the eight key areas of sanitation is
provided in the next module (4).

The Seafood HACCP Alliance has developed a one-

day Sanitation Control Procedures (SCP) training
program that focuses on control procedures,
monitoring, and record keeping for each of these 8
areas of sanitation. To see a list of Alliance SCP
courses scheduled in the U.S., visit this web site:
http://seafood.ucdavis.edu/Events/sanitation.htm

Additional information on these sanitation

requirements is available in other Seafood HACCP
Alliance training courses. Monitoring frequencies
for each of these 8 areas of sanitation are
recommended in the Seafood HACCP Alliance
"Encore" course.

For a more in depth view of sanitation monitoring,

frequencies of monitoring and record keeping from
the Seafood HACCP Alliance "Encore" course, visit
this website:http://distance-ed.arme.cornell.edu/
seafood/Module3/UCDavisSanit.html
 Seafood HACCP Alliance Training Course 3-9

Sanitation Controls and

Food Safety Hazards
When SSOPs are in place, HACCP can be more
effective because it can concentrate on the hazards
associated with your food or processing operations
and not on the processing plant environment.

Well-designed SSOPs that are fully and effectively

implemented can be valuable in helping to control
hazards like bacterial pathogens. Identification of
critical control points may be influenced by the
effectiveness a company's sanitation program. For
example, SSOPs can help control bacterial hazards
by specifying procedures to:
1. avoid product cross-contamination by proper
product flow and limiting employee tasks and
movement;
2. locate handwashing and sanitizing stations
near the processing area to facilitate proper
handwashing;
3. ensure appropriate equipment maintenance
and cleaning and sanitizing procedures.

SSOPs can likewise be used to help control

chemical contamination from sanitizers and other
chemicals found in food processing operations.
 Seafood HACCP Alliance Training Course 3-10

Sanitation Controls and HACCP

Controls
Hazards which are inherent to the product or
are associated with a discrete processing step
must be controlled with HACCP. Hazards
associated with the processing environment or
personnel are usually better controlled with
sanitation procedures.

The distinction between CCP's and sanitation

controls is not always clear. For this reason
sanitary controls can be included in the HACCP
plan. However, in most situations processors
should not complicate their HACCP plan with
sanitation monitoring requirements.

In some situations, effective SSOPs may reduce the number of critical control
points in HACCP plans. Relegating control of a hazard to SSOPs rather than the
HACCP plan does not minimize its importance or indicate lower priority. In fact,
some hazards are typically controlled by a combination of SSOPs and HACCP
critical control points. For instance, plant sanitation, employee hygiene and strict
handling procedures are often as important for controlling the bacterial pathogen
Listeria monocytogenes in cooked food operations as the actual cooking and
refrigeration steps that are likely to be identified as critical control points in a
HACCP plan.

If sanitation controls are included as part of a HACCP plan, they must lend
themselves to all aspects of a critical control point (CCP) such as establishing
critical limits, monitoring, corrective actions, verification and record-keeping
procedures. A Clean-in-Place (CIP) system for equipment is a good example of
sanitation controls that could be handled as a CCP within a HACCP plan. A CIP
system's effectiveness can be monitored, critical control points can be
established, monitoring records can be maintained, and appropriate corrective
actions can be established when the critical limits are not met. On the other
hand, a processor's pest-control program should be included in its SSOP rather
than its HACCP plan.
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Other Prerequisite Programs

We've discussed two important Prerequisite
Programs that must be in place: a sanitation
program or SSOPs and GMPs. Now let's look at
some other Prerequisite Programs that may be
needed for certain types of operations.
• Facilities - There may be specific state or
local code requirements for food handling or
processing establishments in your area that
specify where your operation should be
located, and how it is constructed and
maintained. You may also need to obtain
specific permits or licenses from state or local
authorities.
• Production Equipment - All equipment
should be constructed and installed according
to established sanitary design principles,
manufacturer recommendations, and any state
or local codes. Preventive maintenance and
calibration schedules should be established
and documented using manufacturer and other
information as appropriate.
• Standard Operating Procedures -
Procedures that describe how routine
operations such as receiving, storage, labeling,
shipping etc. are to be conducted may need to
be established to ensure that products and
packaging materials are handled and
processed appropriately to ensure their safety
and wholesomeness.
 Seafood HACCP Alliance Training Course 3-12

Other Prerequisite Programs

(continued)
• Supplier Controls - You may need to establish
controls to ensure that your suppliers have
effective GMP, HACCP, or other food-safety
programs in place.
• Product Specifications - You may need to
develop written specifications for all ingredients,
products and packaging materials and send them
to your suppliers. These specifications may
include quality requirements, acceptable portion
sizes, or other requirements not related to safety.
• Personnel Policies - Policies and procedures for
employees and other persons who enter the
manufacturing plant should be established. These
policies may cover a variety of things related to
employee behavior and performance and could
include training requirements for GMPs, sanitation
procedures, personal safety, HACCP etc.
• Traceability and Recalls - Procedures that
ensure that raw materials and finished products
are coded and labeled properly and meet the
requirements of all appropriate federal, state, and
local food labeling and/or weights and measures
regulations. A recall system should also be in
place so that rapid and complete traces and
recalls can be done when product retrieval is
necessary.

Other examples of prerequisite programs might

include quality-assurance procedures, standard
processing procedures, and product formulations and
recipes.
 Seafood HACCP Alliance Training Course 3-13

Preliminary Steps for Developing a HACCP Plan

Whew! Now that we've described the programs that provide the foundation for
your HACCP plan, let's get started developing your plan. Before you start to apply
the 7 principles of HACCP, you need to complete some Preliminary Steps.
Failure to properly address these Preliminary Steps may lead to ineffective design,
implementation and management of the HACCP plan.

There are five Preliminary Steps:

1. Assemble the HACCP team,
2. Describe your food product(s) and how they are distributed
3. Identify the intended use and the consumers of your food product(s)
4. Develop and verify your process Flow Diagram
5. Obtain training and a management commitment

Lets take a look at each one individually.

 Seafood HACCP Alliance Training Course 3-14

Develop Your HACCP Team

The first preliminary step is to decide who will develop your HACCP plan.
Although one person may be able to analyze hazards and develop a HACCP plan
successfully, many industries find it helpful to build a HACCP team. When only one
person develops the HACCP plan, some key points can be missed or
misunderstood in the process. For small companies, the responsibility for writing
the HACCP plan may fall to one person. This is acceptable, but opportunities to
involve employees and to seek outside assistance from universities, Sea Grant or
Cooperative Extension programs, consultants, or other resources should be used
as needed.

The team approach minimizes the risk that key points will be missed or that
important parts of the operation will be misunderstood. It also encourages
ownership of the plan, builds company involvement, and brings in different areas
of expertise. The team should consist of a variety of individuals with different
specialties, and individuals who are directly involved in the plant's daily
operations. The team may include personnel from maintenance, production,
sanitation, quality control and laboratory.

The team develops the HACCP plan, writes SSOPs, and verifies and implements
the HACCP system. The team should be knowledgeable about food-safety hazards
and HACCP principles. When issues arise that cannot be resolved internally, it may
also be necessary to enlist outside expertise.

Go ahead now and make a list of who you think should be on your HACCP team.
Seafood HACCP Alliance Training Course 3-15

Describe Your Product(s) and

How They are Distributed
The 2nd Preliminary Step asks you to
identify what products you handle or
process and how they are distributed. To
adequately describe your products you
need to think about and make a list of the
species of fish and shellfish that you handle
or process as well as the various product
forms for each of these species. You will
use this list to properly identify all of the
potential species-related food safety
hazards that could be associated with your
products when we show you how to conduct
your Hazard Analysis (HACCP Principle #1
in Module 5). For specialty firms such as
molluscan shellfish processors or
distributors their species list may only
include 2 or 3 different species. Other firms
such as full service wholesalers may handle
50 to 100 different species of fish and
shellfish over the course of a year.
 Seafood HACCP Alliance Training Course 3-16

You also need to consider how your products are received, handled or processed,
and distributed. An important factor to include in your product description is
whether or not each species is refrigerated, iced or frozen in your operation and
during distribution. This information will be important to consider when
determining if certain types of hazards are reasonably likely to occur for your
operation. You also need to consider how your products are packaged. Specific
food safety hazards such as the bacteria that can cause botulism are associated
with products that are vacuum packed or packed in containers with reduced
amounts of oxygen.

The FDA and the Seafood HACCP Alliance developed a worksheet for their Encore
HACCP training course that can help you develop your species list. This worksheet
includes a list of items for all of the factors related to product form (refrigerated,
iced or frozen), packaging, and source that you will need to consider in your
Hazard Analysis. A copy of this Species List Worksheet is shown below. You can
print as many copies of this form as you need from your computer.

Where Where How How How How

Purchased Received Stored Shipped Packaged Consumed
Refrigerated

Refrigerated

Refrigerated
Fisherman

Species
Processor

Reduced
Air Pack

Oxygen

Cooked
Grower

Frozen

Frozen

Frozen
Iced

Iced

Iced

Raw

Now that you've printed the form, go ahead and fill it out, listing all of the fish or
shellfish species and products that you handle or process. Then mark each box to
indicate how they are purchased, received, stored, shipped and packaged.

Voila! Your second Preliminary Step is now completed.

 Seafood HACCP Alliance Training Course 3-17

Identify the Intended Use of Your

Products
The 3rd Preliminary Step asks you to identify how
each of your products are intended to be used and
who are the intended consumers of your products.
Let's look at intended use first.

For most raw seafood products it is generally

assumed that consumers will cook the product
before it is eaten. There are, however, some
important exceptions. Bivalve molluscan shellfish
like clams and oysters are likely to be eaten raw.
Some species of fish or shellfish are also eaten raw
in sushi or sashimi dishes. Other types of fish and
shellfish are processed to produce products that
may not be cooked by the consumer before they
are eaten. Some examples are cooked shrimp,
smoked fish, pickled or marinated dishes such as
ceviche, surimi, fish salads, crabmeat or heat-and-
serve seafood entrees. For these products bacterial
or viral pathogens are likely to be a health risk
because they will not be thoroughly cooked by the
consumer before they are eaten. In contrast, these
pathogens are not likely to be a health risk in raw
shrimp or raw fish if they will be thoroughly
cooked by the consumer before they are eaten.

Identifying the intended use of your products in

this Preliminary Step will help you to conduct
your Hazard Analysis in Module 5. The Species List
Worksheet provides space in the last column to
indicate whether each of your products will be
eaten raw or cooked.
 Seafood HACCP Alliance Training Course 3-18

Identify the Intended Consumers

of Your Product
The next part of this Preliminary Step also asks
you to identify who are the consumers of your
products. The purpose of this step is to identify
which products might be sold to consumers at
higher risk from food borne illness.

Most firms who sell their products to retail

stores or restaurants would identify the
intended consumers of their products as the
general public. For most healthy people in the
general population, the risks associated with
most foodborne illness are not likely to be life
threatening. However, some groups of people
are much more likely to experience complications
from a food borne illness that could be life
threatening.

Processors who sell seafood products to firms

that serve special higher risk populations may
need to add additional controls for some food
safety hazards. Examples of firms or
organizations that serve higher risk groups include
hospitals, clinics, nursing homes, elderly feeding
centers, day-care centers, schools, etc. that serve
the elderly, young children, or people with acute or
chronic illnesses that make them more susceptible
to complications of food borne illness.

Congratulations! You've now completed the third

Preliminary Step.
 Seafood HACCP Alliance Training Course 3-19

Develop and Verify Your Process

Flow Diagram
The 4th Preliminary Step asks you to develop and
verify your Process Flow Diagram. A process flow
diagram can be developed in simple block or
symbol form that shows all of the steps required to
process and distribute your food product. This
Preliminary Step provides an important visual tool
that the HACCP team will use to develop your
HACCP plan. It is important to include all the steps
within the facility's control, including receiving and
storage steps for all raw materials. Another step
that is often overlooked, is the rework step. The
flow diagram should be clear and complete enough
so that people unfamiliar with the process can
quickly comprehend how your products move
through your operation. An example of a simple
process flow diagram for a fish filleting operation is
shown to the left.
 Seafood HACCP Alliance Training Course 3-20

Verify the Process Flow Diagram

The accuracy of the flow diagram is critical to conduct your hazard analysis.
Because of this, your process flow diagram needs to be verified. The HACCP team
should walk through the facility and follow products through the operation to be
sure that the process flow diagram lists each processing step. Any required
changes in the flow diagram should be made at this point. The walk-through
allows each team member to gain an overall picture of how the product is made.
It may be helpful to invite additional plant personnel to review the diagram
during the walk-through.

So go ahead and make a flow diagram of one or more of your processes. Of

course you'll have to wait until you're off-line to verify it.

You've now completed the fourth Preliminary Step.

 Seafood HACCP Alliance Training Course 3-21

Management Commitment
The 5th and last Preliminary Step is designed to ensure that the individual or
team developing the HACCP plan understands the HACCP concept and how they
should develop their plan. At this point the team should also obtain any
commitments necessary from management or owners to ensure that the plan will
be fully implemented.

For a HACCP plan to work, it is extremely important to have the support of top
company officials such as the owner, director and chief executive officer. Without
it, HACCP will not become a company priority or be effectively implemented.
Experience has shown that unless there is a "buy in" from everyone, it just won't
work. This is one reason why FDA's Seafood HACCP regulation requires that a
high level company official sign the HACCP plan and that it has been accepted for
implementation.
 Seafood HACCP Alliance Training Course 3-22

HACCP Training
Education and training are important elements in developing and implementing an
adequate HACCP program. Employees who will be responsible for the HACCP
program must be adequately trained in its principles. A requirement of FDA's
Seafood HACCP regulation is that a trained individual performs specific HACCP
functions including: developing the HACCP plan, reassessing and modifying the
HACCP plan in accordance with corrective action and verification requirements,
and performing record reviews specified in the regulation. This "trained" individual
is someone who has attended a course like this one, or who has acquired on the
job experience that is equivalent to the information in a standardized training
curriculum such as this.

Individuals who complete this Internet training course and a one day Segment
Two practical training session or who attend a live three-day Seafood Alliance or
equivalent training course meet the training requirement of the FDA regulation.
 Seafood HACCP Alliance Training Course 3-23

Check Your Knowledge

Now you need to return to Module 3 via the Internet.

Click through the text pages until you get to the Check Your
Knowledge page (page 3-23). Submit your answers before
moving on to Module 4.

Good Luck!