Controlled: Haccp Study Revision: 0 September 2010

CONTROLLED
HACCP STUDY
REVISION: 0
SEPTEMBER 2010
DOC NO: MASTER MANUAL
BLANK HACCP STUDY - MASTER DOCUMENT Approved by the Managing Member 01 / 09 / 2010 Page 1 of 45 Rev : 0
INDEX OF CONTENT Pg
HACCP STUDY - AMENDMENT RECORD SHEET 3
KEY TERMS 4-6
HACCP OVERVIEW 7
SPECIALIZED PROCESSES & PROCEDURES 8-9

REQUIRING A HACCP PLAN
~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~ 9
Task 1: ASSEMBLY OF OUR HACCP TEAM. 10-12
Task 2: DESCRIPTION OF OUR SERVICES. 13
Task 3: IDENTIFYING THE INTENDED USE OF OUR SERVICES. 14
Task 4: CONSTRUCT OF A SERVICE FLOW DIAGRAM. 15-17
Task 5: ON-SITE CONFORMATION OF THE FLOW DIAGRAM. 18
Task 6: LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURES

TO CONTROL THE HAZARD. 19-26
(Principle 1)
Task 7: DETERMINING CRITICAL CONTROL POINT (CCPS) 26-27

(DECISION TREE).
(Principle 2)
Task 8: ESTABLISHING CRITICAL LIMITS FOR EACH CCP. 28

(Principle 3)
Task 9: EST. A MONITORING SYSTEM FOR EACH CCP. 28-29

(Principle 4)
Task 10: ESTABLISHING CORRECTIVE ACTION PLANS. 30

(Principle 5)
Task 11: EST. VALIDATION, VERIFICATION & REVIEW 30-43

PROCEDURES.
(Principle 6)
Task 12: EST. RECORD KEEPING & DOCUMENTATION. 43-44

(Principle 7)
“ A complete HACCP system is the result of implementing the HACCP principles in an

operation that has a solid foundation of comprehensive, prerequisite programs in place. A
HACCP system includes the HACCP plan and all prerequisite programs ”
HACCP MANUAL - AMENDMENT RECORD SHEET
This MASTER HACCP STUDY is approved and issued by the BLANK,

MANAGING DIRECTOR. ALL amendments to this Manual shall be approved
by the BLANK MD prior to issue.
This original (MASTER) will be held in the office of the BLANK MD. When a
change to this MASTER HACCP Study is incorporated, the details below are
required to be completed.
A new CONTROLLED Version ( or the changed ‘ pages thereof ’ shall then

be retained by the BLANK MD – nb: the ‘old’ version/s is/are required to be
filed within the BLANK CONTROLLED DOCUMENTS – REVISION FILE.
Authorise Brief Revision Signature of Date

d by Description of No Authorisation
amendments
COPYRIGHT: THIS HACCP STUDY IS THE PROPERTY OF BLANK AND MAY NOT - IN ANY FORM
WHATSOEVER - BE REPRODUCED, COPIED OR TRANSMITTED WITHOUT PRIOR WRITTEN
PERMISSION FROM THE BLANK MANAGING DIRECTOR !!
Key Terms
~ aw
A measure of the free moisture in a food, is the quotient of the water vapor
pressure of the substance divided by the vapor pressure of pure water at the
same temperature
~ Control Point
Any point in a specific food system at which loss of control does not lead to an
unacceptable health risk.
~ Critical Control Point
A point or procedure in a specific food system where loss of control may result
in an unacceptable health risk.
~ Critical Limit
The maximum or minimum value to which a physical, biological, or chemical

parameter must be controlled at a critical control point to minimize risk that the
identified food safety hazard may occur.
~ Deviation
Failure to meet a required critical limit for a critical control point.
~ Good Retail Practices (GRPs)
Preventive measures that include practices and procedures to effectively

control the introduction of pathogens, chemicals, and physical objects into
food, that are prerequisites to instituting a HACCP or Risk Control Plan and
are not addressed by the Food Code interventions or risk factors.
~ HACCP
An acronym for Hazard Analysis Critical Control Point
~ Hazard Analysis Critical Control Point (HACCP)
A prevention-based food safety system that identifies and monitors specific

food safety hazards that can adversely affect the safety of food products.
~ HACCP Plan
A written document that delineates the formal procedures for following the
Hazard Analysis Critical Control Point principles developed by the National
Advisory Committee for the Microbiological Criteria for Foods.
~ HACCP System
The result of implementing the HACCP principles in an operation that has
foundational comprehensive, prerequisite programs in place. A HACCP
system includes the HACCP plan and all prerequisite programs.
~ Hazard
A biological, chemical, or physical property that may cause an unacceptable

consumer health risk.
~ Hazard Analysis
The process of collecting and evaluating information about hazards associated

with the food under consideration to decide which are significant and must be
addressed in the HACCP plan.
~ Monitoring
A planned sequence of observations or measurements of critical limits

designed to produce an accurate record and intended to ensure that the
critical limit maintains product safety. Continuous monitoring means an
interrupted record of data.
~ pH
The symbol for the negative logarithm of the hydrogen ion concentration,
which is a measure of the degree of acidity or alkalinity of a solution.
~ Potentially Hazardous Food l
A food that is natural or synthetic and that requires temperature control

because it is in a form capable of supporting the rapid and progressive growth
of infectious or toxigenic micro organisms; the growth and toxin production of
Clostridium botulinum, or in raw shell eggs, the growth of Salmonella
~ Enteritidis
Prerequisites for HACCP
Practices and conditions needed prior to and during the implementation of

HACCP and which are essential for food safety, as described in Codex
Alimentarius Commission’s Principles of Food Hygiene and other Codes of
~ Practice
Preventive Measure
An action to exclude, destroy, eliminate, or reduce a hazard and prevent
recontamination through effective means.
~ Risk
The likelihood that an adverse health effect will occur within a population as a
result of a hazard in a food.
~ Risk Factor
One of the factors identified by the Centres for Disease Control and
Prevention (CDC) as a contributor to the foodborne outbreaks that have been
investigated and confirmed. The factors are unsafe sources, inadequate
cooking, improper holding, contaminated equipment and poor personal
hygiene.
~ Severity
The seriousness of the effect(s) of a hazard.
~ Standard Operating Procedure (SOP)
A detailed set of instructions, steps or procedures that control the operational

conditions within a food establishment allowing for environmental conditions
that are favourable to the production of safe food. These written procedures
are often equivalent to prerequisite programs of HACCP. The extent to which
operators employ various SOPs will determine which critical control points
need to be controlled.
~ Validation
Validation is that element of verification focused on collecting and evaluating

scientific and technical information to determine if the HACCP plan, when
properly implemented, will effectively control the hazards.
~ Verification
Verification means those activities other than monitoring, that determine the
validity of the HACCP plan and that the system is operating according to the
plan.
HACCP Overview
Simply stated, Hazard Analysis Critical Control Point (HACCP) is a logical
and thorough process control system designed to identify and control hazards.
HACCP focuses on prevention and control of food safety problems at highly
specific (and controllable) points in the process chain. Implementing a well-
designed HACCP program provides food manufacturers and food handlers a
high level of control over product safety.
HACCP has been around since the 1960’s, when the Pillsbury Company
introduced it in the production of foods for the space program. The application
of HACCP is based on sound technical and scientific principles that assure
food safety. Recently, numerous meat and poultry operations have been
mandated to utilize HACCP to address concerns with food safety.
HACCP plans should be specific for each operation. Committed personnel

involved in the processing operation should conduct the design and
implementation of a HACCP plan.
Although many of the larger food establishments and chains have the expertise
available to develop and implement HACCP systems, some of the smaller
establishments may require assistance from university extension programs,
industry associations, consultants, and government for development of their
plans.
SPECIALIZED PROCESSES & PROCEDURES REQUIRING A HACCP PLAN
Use of food additives or adding components such as vinegar as a method of
food preservation or to render a food so that it is not potentially hazardous Use
of unpasteurized whole shell eggs in highly susceptible population (HSP)
operations to prepare food in quantities other than single service portions
Reduced oxygen packaging (ROP) with barriers;
1. Custom processing animals;

2. Molluscan shellfish tanks;
3. Smoking for preservation;
4. Curing;
5. Time as a public health control;
6. Preventing contamination from hands.
Processes requiring a variance from the State and a formal HACCP plan:
• Smoking food as a method of preservation but not if smoking only for

flavor enhancement (using smoking solely for preservation is rarely, if
ever, done);
• Curing foods such as hams, sausages, etc.;
• Using food additives or adding components such as vinegar as a method

of food preservation or to render a food so that it is not potentially
hazardous);
• Reduced Oxygen Packaging (where C.Bot is a concern and only one

barrier exists);
• Using more than one container of shellfish at a time (co-mingling);
• Serving or offering for sale raw or lightly cooked animal foods in a ready-
to- eat form (raw eggs, raw marinated fish, raw molluscan shell fish, steak
tartar, lightly cooked fish, soft cooked eggs, undercooked meat other than
“whole muscle intact beef) and not wanting to use a consumer advisory;
• Molluscan shellfish display tanks that are used to store/display shellfish

that are offered for human consumption;
• Brewing alcoholic beverages;
• Preparing, serving or transporting food by another method that is

determined by the HEALTH DEPARTMENT to require a variance or
HACCP plan.
Processes requiring a variance from the State but no HACCP plan:
• Custom processing of animals or fish for personal use in a licensed food

Establishment
• Any other requests that vary from the rules of the code where it is
determined that a variance is sufficient without a HACCP Plan
Processes requiring a formal HACCP plan and not a variance from the
State:
• Pooling of eggs in a food establishment that serves a highly susceptible

population (retirement home, nursing home, hospital, day car, etc.);
• Reduced oxygen packaging (where C.bot is a concern and more than one
barrier exists) Processes requiring only a written procedure and/or
approval by the Health Department;
• Using time only as a public health control for potentially hazardous food;
• Use of a two compartment sink for some limited processes
~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~
Task 1: ASSEMBLY OF OUR HACCP TEAM
8.2.1 General
Management shall ensure the establishing of criteria for the selection of team
members to assist with the study, establishing, implementation, maintenance
and continual improvement of the HACCP system. Every team member shall
accept, in writing, his assignment and commitment to the HACCP team.
8.2.2 The team shall consist of a
a) Team leader
The team leader shall be trained in the requirements as set out in this
standard.
NOTE: The management representative and the team leader may be the
same person.
b) Team members
The team shall be multi-disciplined and members shall be drawn from each
part of the organization likely to be affected, for example from production,
purchasing, finance, technical, engineering, quality and distribution. The
HACCP team shall consist of personnel with specific knowledge of and
expertise with regard to the service, the food handling process and food safety
hazard categories. Where appropriate, team members with knowledge in the
following areas should be considered for inclusion in the team:
1) food science;
2) microbiology;
3) quality control;
4) engineering;
5) industrial chemistry;
6) work studying;
7) risk assessment;
8) production;
9) marketing or sales;
10) distribution; and
11) food service management.
8.2.3 The HACCP team shall establish documentation defining the

scope of the HACCP study and the team’s activities. The team’s
activities should include establishing the following:
a) the rules and guidelines for team meetings;

b) the criteria used for decision making processes;
c) the methodology to be used by the team to determine

hazards and CCPs;
d) the methodology for reporting on the status of the HACCP system; and
e) the methodology for the establishment for procedural requirements or

integration with other relevant management system procedures.
8.2.4 Where the necessary skills or knowledge are not available within
the food handling organization, the service of a consultant may be
used on condition that the consultant acts only as an expert
advisor to the team.
Introduction:
There are twelve tasks required to develop a HACCP plan and these are
designed to ensure that the seven principles are applied correctly. Principle 1,
which is to conduct a hazard analysis, requires that the first five tasks have all
been addressed in a logical and honest manner so that all real hazards
associated with the commodity have been identified.
Establish a HACCP Team
To fully understand the commodity system and be able to identify all likely
hazards and CCPs, it is important that the HACCP team is made up of people
from a wide range of disciplines. The team should include:
A team leader to convene the group and to direct the work of the team ensuring
that the concept is properly applied. This person must be familiar with the
technique, be a good listener and allow all participants to contribute.
A specialist with a detailed knowledge of the commodity system is required.

This specialist will have a major role in the production of the commodity flow
diagrams.
Several specialists, each with an understanding of particular hazards and

associated risks, e.g. a microbiologist, a chemist, a mycotoxicologist, a
toxicologist, a QC manager, a process engineer.
People, such as packaging specialists, raw material buyers, distribution staff or

production staff, farmers, brokers, who are involved with the process, and have
working knowledge of it, may be brought into the team temporarily in order to
provide relevant expertise.
The team's progress and results of the analysis should be recorded by a

technical secretary.
If any changes are made to composition or operational procedures, it will be
necessary to re-assess the HACCP plan in the light of the changes.
The first activity of the HACCP team is to identify the scope of the study. For
example, will the whole commodity system be covered, or only selected
components? This will make the task more manageable and specialists can be
added to the team as and when they are required.
Our HACCP TEAM

i.e. Who
Task 2: DESCRIPTION OF OUR SERVICES
A complete description of the service shall be given in terms of type and

composition (allergens, microbiological, chemical and physical properties),
relevant legislation, handling, processing, presentation or packaging, storage
and distribution condition and the shelf life under prescribed conditions.
Describe the Product / Service
To start a hazard analysis, a full description of the product, including customer

specification, should be prepared.. This should include information relevant to
safety, e.g. mycotoxin regulation/target level, composition, physical/chemical
properties of the raw materials and the final product, the amount of water
available for microbial growth (aw), the amount of acid or alkali in the product
(pH). Also information regarding how the product is to be packaged, stored
and transported should also be considered together with facts regarding its'
shelf life and recommended storage temperatures. Where appropriate, labelling
information and an example of the label should be included. This information
will help the HACCP team to identify 'real' hazards associated with the
process.
Activity Description
Facility: Site:
Project Activity:
Coordinator:
Site
Manager:
Address:
Phone:
SERVICES DESCRIPTION
i.e. What; Where & When
Task 3: IDENTIFYING THE INTENDED USE OF OUR SERVICES
The intended use and possible abuse of the service by consumers, consumer
groups or customers shall be described. Attention shall be focused on the
likely uses and abuses of the service after it has left the control of the food
handling organization. Factors such as the vulnerability of the consumer, and
instructions for use shall be taken into account.
Identify the product's / Services intended use
How the product is intended to be used is an important consideration.

Information on whether the product will be consumed directly, or be cooked, or
be further processed, will all have a bearing on the hazard analysis, see task
6). The nature of the target group for the product may also be relevant,
particularly if it includes susceptible groups such as infants, the elderly, and
the malnourished. The likelihood of misuse of a product should also be
considered, such as the use of pet food as a human food, either by accident or
design. This information can be recorded on the same form as the product
description,
INTENDED USE OF OUR SERVICE

i.e. Why
Stage 4: CONSTRUCTION OF OUR SERVICE FLOW DIAGRAM
8.5.1 The HACCP team shall prepare a detailed floe diagram for the
specified food services or process categories relevant to the
defined scope of the HACCP study.
8.5.2 The following should be considered when preparing the flow

diagram:
a) the selection of raw material;
b) processing activities;
d) processing delays;
e) packaging and storage;
f) distribution, retail and customer handling of the service;
g) any outsourced processes; and
h) removal of intermediary services, by-services and waste.
8.5.3 A floor plan relevant to the areas falling within the defined scope of
the HACCP study shall be prepared. The following should be
considered during the preparation of the floor plan as relevant
technical data for an effective evaluation of the service flow:
a) layout and design features of equipment;
b) service flow of liquids, powders, raw and cooked foods;
c) routes of personnel and their personal hygiene practices;
d) service recycle or rework loops;
e) routes of potential cross-contamination through movement of materials

(ingredients, returns, water, packaging materials, etc);
f) segregation of high risk areas from low risk areas where a risk of
cross-contamination exists;
g) storage and distribution conditions of the different materials used in the

food handling process;
h) packaging materials used; and
I) factory hygiene, cleaning and disinfection procedures.
Draw up the Commodity Flow Diagram (CFD)
The first function of the team is to draw up a detailed commodity flow diagram
(CFD) of the commodity system, or that part of it which is relevant. The
expertise of the commodity specialist is important at this stage. Commodity
systems will differ in detail in different parts of the world, and even within one
country there may be a number of variants. Secondary processing will need to
be detailed for each facility, using generic flows only as a guide.
BLANK FOOD SERVICES – COMMODITY FLOW DIAGRAM

i.e. How
NOTE: For your information only –
two EXAMPLES of FOOD SERVICES’ FLOW DIAGRAMS
1.
Receiv
Refrigerated
2.
Storage
Stage 5: ON-SITE CONFIRMATION OF THE COMMODITY FLOW
DIAGRAM
The HACCP team shall confirm the accuracy of the flow diagram and the floor
plan on site during all stages and hours of operation, so as to ensure that the
flow diagram, floor plan and technical data as described in 8.5.3 gives an
accurate representation of the operation. The flow diagram shall be amended
to take into account any deviation from the original diagram.
Records shall be kept.
On site confirmation of flow diagram
Upon completion of the CFD, members of the team should visit the commodity
system (e.g. farm, store or manufacturing area) to compare the information
present on the CFD with what actually happens in practice. This is known as
"walking the line", a step by step practice to check that all information
regarding materials, practices, controls etc. have been taken into consideration
by the team during the preparation of the CFD. Information such as time of
harvest, drying procedures, storage conditions, the marketing chain, socio-
economic factors, grading systems and any incentive for improved quality or
safety, and processing systems, should be collected and included in the CFD as
appropriate. The site for which the HACCP plan is being designed should be
visited as many times as possible to ensure that all relevant information has
been collected.
Stage 6: LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURES
TO CONTROL THE HAZARD.
(Principle 1)
8.7.1 The HACCP team shall use the confirmed flow diagram, including
all the technical data, as a guide to identify all the potential food
safety hazards (inherent and introduced) that might reasonably be
expected to occur at each step of the food handling process.
Relevant legislation related to the food safety hazards and their
control shall be considered. The hazards shall be considered in the
light of the significance, likelihood and severity of such a hazard in
terms of the safety of the consumer.
8.7.2 Control measures for each identified food safety hazard shall be
established in order to control such a hazard. More than one
hazard and control measure might be applicable to one step in the
process, and more than one control measure might be necessary
to control a particular hazard.
8.7.3 Records shall be kept.
Identify and analyse hazard(s)
Effective hazard identification and hazard analysis are the keys to a successful
HACCP Plan. All real or potential hazards that may occur in each ingredient
and at each stage of the commodity system should be considered. Food safety
hazards for HACCP programmes have been classified into three types of
hazards:
Biological: typically foodborne bacterial pathogens such as Salmonella,

Listeria and E. coli, also viruses, algae, parasites and fungi.
Chemical: There are three principle types of chemical toxins found in foods:
naturally occurring chemicals, e.g. cyanides in some root crops, and allergenic
compounds in peanuts; toxins produced by micro-organisms, e.g. mycotoxins,
and algal toxins; and chemicals added to the commodity by man to control an
identified problem, e.g fungicides or insecticides.
Physical: contaminants such as broken glass, metal fragments, insects or

stones.
The probability that a hazard will occur is called a risk. The risk may take a
value from zero to one depending on the degree of certainty that the hazard will
be absent or that it will be present. After hazard identification, a hazard
analysis must be conducted to understand the relative health risk to man or
animal posed by the hazard. It is a way of organizing and analyzing the
available scientific information on the nature and size of the health risk
associated with the hazard. The risk may have to be assessed subjectively and
simply classified as low, medium, or high. Only those hazards considered by
the HACCP team to present an unacceptable risk of being present are taken
forward to Stage 7, Principle 2.
Once a food safety hazard has been identified, then appropriate control
measures should be considered. These are any action or activity that can be
used to control the identified hazard, such that it is prevented, eliminated, or
reduced to an acceptable level. The control measure may also include training
of personnel for a particular operation, covered by Good Manufacturing
Processes ( GMP).
IDENTIFICATION OF BLANK’s HAZARDS
To identify all biological, chemical, physical and allergen hazards associated

with the purchasing, delivering, storing, usage and sale of BLANK’s services.
Biological Hazards
The following biological hazards were covered by the terms of reference of our
HACCP study:
1. Yeast & Moulds,

2. Coliforms,
3. E. coli,
4. Listeria,
5. Salmonella,
6. Enterobacteriaceae,
7. Aerobic Mesophile,
8. Salmonella spp.
Chemical Hazards
The following chemical hazards were covered by the terms of reference of our
HACCP study:
1. Cleaning residues,
2. Printing inks, lacquers from packaging,
3. Chemical contaminants and residues in raw materials.
Physical Hazards
The following physical hazards were covered by the terms of reference of our
HACCP study:
1. Metal,
2. Glass,
3. Hair,
4. Wooden splinters,
5. Dust / dirt particles,
6. Plastic,
7. Insects.
Allergen Hazards
All the following common allergens were considered as part of our HACCP
study.
1. Milk,
2. Egg,
3. Nuts,
4. Soya,
5. Gluten,
6. Crustaceans,
7. Fish,
8. Peanuts,
9. Celery,
10. Mustard,
11. Sesame Seeds,
12. Sulphites,
13. Lupin,
14. Molluscs, and products thereof.
CHEMICALS USED IN FOOD PROCESSING

Point of use Type of chemical
Growing crops Pesticides, herbicides, defoliants
Raising livestock Growth hormones, antibiotics
Production Food additives, processing aids
Plant Lubricants, paints, solvents
maintenance
Plant sanitation Cleaners, sanitizing agents, pesticides
SOME FOOD-BORNE BIOLOGICAL HAZARDS

Bacteria Parasites Seafood toxins
Aeromonas Anisakis spp. Ciguatera fish poisoning
hydrophila
Bacillus cereus Ascaris lumbricoides Gempylotoxin
Brucella spp. Cyclospora Tetrodotoxin
cayetanensis
Campylobacter Cryptosporidium Scombrotoxin
jejuni parvum ( histamine )
Clostridium Diphyllobothrium spp. Paralytic, neurotoxic and
botulinum
Clostridium Entamoeba histolytica Diarrhetic shellfish poisoning
perfringens
Listeria Giardia lamblia
monocytogenes
Pathogenic Taenia spp.
Escherichia coli
Plesiomonas Viruses
shigelloides
Salmonella spp. Hepatitis A virus
Shigella spp Mycotoxigenic moulds Polioviruses
Staphylococcus Aspergillus spp. Norwalk virus group
aureus
Streptococcus Fusarium spp.
pyogenes
Vibrio cholera Penicillium spp.
V.
parahaemolyticu
s
V. vulnificus
Yersinia
enterocolitica
EXAMPLES OF PHYSICAL HAZARDS & THEIR SOURCES

Physical Source
hazard
Metal Bolts, nuts, screws, screens / sieves, steel wool
Glass Light bulbs, watch crystals, thermometers, etc.
Wood splinters Pallets, equipment bracing, overhead structure
Insects Environment , electrocution traps, incoming ingredients
Hair Meat ingredients, employees, clothing, rodents
Mould Poor sanitation, inadequate cleaning of equipment
Rodents / Inadequate rodent controls, incoming ingredients
droppings
Dirt, rocks Raw materials, poor employee practices
Paint flakes Equipment, overhead structure
Band-aid Poor employee practices
Pen caps Poor employee practices
Carcass ID tags Slaughterhouse
Hypodermic Veterinarian
needles
Bullets / shot / Animals shot while in fields
BBs
Feathers Poor sanitation, inadequate pest ( bird ) controls
Gasket material Inadequate preventive maintenance of equipment
Grease Poor equipment maintenance programme
NB: Please refer to the generic Hazard Analysis Questionnaire ( under CHECKLISTS ) – this
checklist is for PER PRODUCT USED!!
INFO can also be obtained from the products’ MSDS ( MATERIAL SAFETY DATA
SHEET ) AND / OR The Products’ Ingredients Listing!!
EXAMPLE 1 OF HACCP DECISION TREE
Q1. Does this step involve a
hazard of sufficient likelihood
of occurrence and severity to
warrant its control?
Yes No Not a CCP
Q2. Does a control measure for the hazard Modify step,

exist at this step? process or product
No
Yes
Is control at this step
Yes
necessary for safety?
No Not a CCP
Q3. Is control at this step necessary

to prevent, eliminate, or reduce the
risk of hazard to consumers
Yes No Not a CCP
This is a critical control point
EXAMPLE 2 OF HACCP DECISION TREE
Q1. Do control measure(s) exist
Modify step, process or
for the identified hazard?
product
Yes No
Is control at this step necessary

Yes
for safety?
Q2. Does this step eliminate or reduce

the likely occurrence of a hazard
to an acceptable level?
Yes
No
Q3. Could contamination with identified

hazard(s) occur in excess of
acceptable level(s) or could these
increase to unacceptable level(s)?
Yes No Not a CCP
Q4. Will a subsequent step, prior to

consuming the food, eliminate the
identified hazard(s) or reduce the
likely occurrence to an acceptable
level?
No This is a critical control point
Yes Not a CCP
IDENTIFICATION OF BLANK’s HAZARDS
Biological Hazards
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Chemical Hazards
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Physical Hazards
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Allergen Hazards
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Stage 7: DETERMINING CRITICAL CONTROL POINT (CCPS) (DECISION

TREE)
(Principle 2)
The HACCP team shall determine whether a particular step in the food
handling process is a CCP.
The method by which a CCP is determined shall be recorder.
NOTE The decision tree in annex B can be as a guideline.
INTRODUCTION:
A Critical Control Point (CCP) is a step at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to an acceptable
level.
If a hazard has been identified at a step where control is necessary for safety, and no
control measure exists at that step, or any other, then the product or process should
be modified at that step, or at any earlier or later stage, to include a control measure.
Determine the Critical Control Points (CCPs)

Each step in the commodity flow diagram, within the scope of the HACCP
study, should be taken in turn and the relevance of each identified hazard
should be considered. It is also important to remember the stated scope of the
HACCP analysis at this stage. The team must determine whether the hazard
can occur at this step, and if so whether control measures exist. If the hazard
can be controlled adequately, and is not best controlled at another step, and is
essential for food safety, then this step is a CCP for the specified hazard. A
decision tree can be used to determine CCPs. However, the HACCP team's
judgement, expertise and knowledge of the process are the major factors in
establishing CCPs.
If a step is identified where a food safety hazard exists, but no adequate control
measures can be put in place either at this step or subsequently, then the
product is unsafe for human consumption. Production should cease until
control measures are available and a CCP can be introduced.
The proper identification of Critical Control Points (CCPs) is crucial to the
ultimate effectiveness of a HACCP plan. The plan must specify where each
identified hazard will be controlled.
Hazards that cannot be controlled by the operator must be identified on the
HACCP plan. The plan must indicate how these hazards will be addressed
outside the establishment (i.e. purchasing pre-frozen fish, where the supplier is
responsible for the freezing requirements as specified by regulation).
Note: The evaluation for completeness of the written CCPs will ensure that all
relevant information dealing with critical limits, monitoring, corrective actions,
verification procedures and record keeping is specified for each identified
hazard.
DETERMINING CRITICAL CONTROL POINTS

( C C P S ) (HACCP principle 2)
The determination of a CCP in the HACCP system shall be facilitated using a

decision tree – as is shown in the following diagram :
HACCP concept element Application step & principle
Define the food and the processes

involved in production.
Application steps 1-5
Break down the process into steps.
Determine possible hazards associated

with each step and probability of hazard HACCP principle 1
persistence in end product if no affective
preventive measures are implemented.
Application step 6
Specify control measures.
Consequently, determine critical control HACCP principles 2 and 3

points ( CCPs ).
Establish critical limits. Application steps 7-8
Monitor CCPs to ensure proper

implementation of control measures. HACCP principles 4 and 5
Take corrective action when parameter
monitoring indicates failure of control Application steps 9-10
measure.
System to be reviewed, confirmed and

audited. HACCP principles 6 and 7
Records must be generated for the
system to be documented.
Application steps 11-12
Stage 8: ESTABLISHING CRITICAL LIMITS FOR EACH CCP.
(Principle 3)
The HACCP team shall establish specific and measurable critical limits
appropriate for each CCP. Critical limits that can be measured quickly and
easily shall be used. Measurements can include sensory examination, mass
measurements, temperature measurements, time, moisture level, PH value
and chemical analysis.
Records shall be kept.
Establish critical limits for each CCP
Critical limits must be specified and validated for each CCP. Criteria often
used include measurements of temperature, time, moisture level, pH, water
activity, and sensory parameters such as visual appearance. In the case of
mycotoxins for example, they may include the moisture content or the
temperature of the commodity. All critical limits, and the associated
permissible tolerances, must be documented in the HACCP Plan Worksheet,
and included as specifications in operating procedures and work instructions.
i.e Critical limits have to be established for all critical components associated
with each hazard that is controlled by a CCP.
Critical Limits must meet or exceed relevant regulatory and program

requirements. Some establishments set critical limits to exceed regulatory
requirements. This is acceptable, but the establishment should be made aware
that if these limits are the ones written into the HACCP plan, the inspection will
be conducted against these more stringent limits.
Critical limits normally include measurements such as temperature, time,

moisture level, pH, aw, available chlorine, and sensory attributes. When
applicable, compare the critical limits found the establishment HACCP plan to
those considered standard industry practice.
For Critical Limits without regulatory or program requirements, the company

must validate that the critical limits in its plant specific HACCP plan are
appropriate. This could include product sampling and laboratory analysis and
should be relevant to the hazard being addressed.
Stage 9: ESTABLISHING A MONITORING SYSTEM FOR EACH CCP.

(Principle 4)
The HACCP team shall establish a monitoring system to ensure that control of
the CCP is effective.
The control measures established as part of the monitoring system shall be

such that they can confirm that all CCPs are under control.
The following shall be addressed in establishing the monitoring system:
a) Responsible person or equipment. Responsibilities and authorities for the

monitoring of a specific CCP shall be identified. This person or equipment
shall have the knowledge or compatibility to ensure effective monitoring of
the CCP. A person shall be given the responsibility and authority to take
the necessary corrective action when the specified critical limit of the CCP
is exceeded. A responsible person other than the person doing the
monitoring shall verify records associated with the monitoring of a CCP.
Equipment used for the monitoring of a CCP shall be calibrated.
b) Frequency of monitoring. The frequency of monitoring shall be specified.

The frequency shall be adequate to ensure the control of the CCP.
c) Monitoring methodology. A detailed description shall be given to indicate

precisely haw the monitoring shall be done.
Records shall be kept to prove effectiveness of the monitoring system.
NOTE: Microbiological testing is seldom effective for the routine monitoring

of CCPs owing to the fact that it can be time consuming and that
there are problems related to the detection of contaminants.
Establish a monitoring procedure
Monitoring is a scheduled observation or measurement of a CCP and its limits.

The purpose of monitoring is two-fold: to assess whether a CCP is under
control and to generate data that will be used to produce an accurate record
for future verification. Monitoring procedures should be accurate and done at
appropriately established frequency.
Monitoring can be carried out by observation or by measurement, on samples

taken in accordance with a statistically based sampling plan. Monitoring by
visual observation is basic but gives rapid results, and can therefore be acted
upon quickly. The most common measurements taken are time, temperature and
moisture content.
Visual observations are usually based upon a predetermined inspection

checklist, which usually involves observing temperatures, or cleanliness of
equipment. Chemical testing may include measuring pH or acidity, or sanitizer
levels Sensory monitoring involves examining raw materials for "off" doors,
presence of moulds, or other defects.
Microbiological testing has a limited but important role due to the time delay
involved for results. While it is not possible to use microbial data to stop a
process on the spot or to bring a CCP under control, microbial testing is used
to set/maintain acceptance standards on raw materials and ingredients in
hazard analysis. Microbial data may also be used in HACCP verification (see
Principle 7).
Stage 10: ESTABLISHING CORRECTIVE ACTION PLANS.

(Principle 5)
The HACCP team shall establish corrective action plan for each CCP when
monitoring of the critical limits indicates deviation from the limits. The
responsibilities for and manner of disposal of the unsafe service shall be
clearly identified.
Records shall be kept of all corrective action.
Establish corrective action
If monitoring indicates that critical limits are not being met, thus
demonstrating that the process is out of control, corrective action must be
taken immediately. The corrective action should take into account the worst
case scenario, but must also be based on the assessment of hazards, risk and
severity, and on the final use of the product. Operatives responsible for
monitoring CCPs should be familiar with and have received comprehensive
training in how to effect a corrective action.
Corrective actions must ensure that the CCP has been brought back under
control. They must also include appropriate disposition of any affected
commodity or product. Whenever possible an alarm system should be
introduced which will activate when monitoring indicates that the critical limit
is being approached. Corrective action can then be applied to pre-empt a
deviation and prevent the need for any product disposition.
Ref: Please refer to the BLANK CORRECTIVE ACTION PROCEDURE –

(HACCP MASTER MANUAL)
Stage 11: ESTABLISHING VALIDATION, VERIFICATION AND REVIEW

PROCEDURES.
(Principle 6)
8.12.1 Validation
8.12.1.1 Validation activities shall include actions to confirm that
a) the established critical limits for CCPs are capable of achieving the
intended control of the food safety hazards for which they are designated,
and
b) the control measures are effective and capable of ensuring control of the
identified food safety hazards to be able to obtain end services that meet
the defined levels of acceptance.
8.12.1.2 If validation results show that one or more of the above elements
cannot be confirmed, the relevant elements shall be modified and
reassessed.
Verify the HACCP plan
Once the HACCP plan has been drawn up, and all of the CCPs have been
validated, then the complete plan must be verified. Once the HACCP plan is in
routine operation, it must be verified and reviewed at regular intervals. This
should be a task of the person charged with the responsibility for that
particular component of the commodity system The appropriateness of CCPs
and control measures can thus be determined, and the extent and effectiveness
of monitoring can be verified. Microbiological and/or alternative chemical
tests can be used to confirm that the plan is in control and the product is
meeting customer specifications. A formal internal auditing plan of the system
will also demonstrate an ongoing commitment to keep the HACCP plan up to
date, as well as representing an essential verification activity.
Ways in which the system can be verified include:
1. collecting samples for analysis by a method different from the

monitoring
procedure
2. asking questions of staff, especially CCP monitors
3. observing operations at CCPs
4. formal audit by independent person
It is important to remember that the HACCP system is set up for a particular

formulation of product handled and processed in a given way.
Key Terms
Validation
Validation is that element of verification focused on collecting and
evaluating scientific and technical information to determine if the HACCP
plan, when properly implemented, will effectively control the hazards.
Verification
Verification means those activities other than monitoring, that determine
the validity of the HACCP plan and that the system is operating according
to the plan.
INTRODUCTION:
Validation is the process of making sure that a HACCP plan, as designed, is effective
in controlling hazards that may result in illness or injury. The validation process
primarily involves reviewing a plan to ensure that:
1) all of the necessary components of the written plan have been included, and that
2) the information and protocols are effective in preventing, eliminating or

significantly reducing the hazards, if properly implemented.
Industry has the primary responsibility for validating their HACCP plans to
ensure that all components have been included in the plan and that it can
effectively control the identified hazards as designed. The regulatory authority is
responsible for reviewing and validating mandated plans prior to implementation
and approval.
The Validation Process
Before validating the HACCP plan(s), the regulator should review the
compliance history of the food establisment to ensure all HACCP prerequisites
have been addressed (SOPs, GRPs).
When validating a plan, the reviewer is using the principles of HACCP to verify
that items, including but not limited to the following, have been properly
identified:
1. Product or process (flow chart)

2. Hazards
3. Selection of CCPs
4. Critical limits, monitoring procedures, corrective actions
and verification
procedures for each CCP selected
5. Verification (validation) procedures to ensure that the
plan is updated and
validated as needed by the HACCP plan administrator
6. Recordkeeping procedures and forms
7. Employee training
In some cases it may be necessary to request additional information such as

product formulation, physical facility layout, standard operating procedures
and scientific documentation or laboratory data for performance standards.
WRITTEN HACCP PLAN REVIEW
The regulatory review of the written HACCP plan should be carried out by the
regulator to verify that each HACCP plan is complete. The model HACCP Plan
Review Application, which is to be completed and signed by the operator, can
be used by the regulatory authority to facilitate the validation process.
In order for a documented HACCP plan to be considered complete, it must be

dated and signed by the designated person in charge or HACCP coordinator.
It must also meet all regulatory requirements and include all required
components of a HACCP plan.
When any section of the written plan is found to be incomplete, the

deficiencies should be described in the "Comments" section of the HACCP
Plan Review Application. Reasons for noted deficiencies (i.e. regulations,
laboratory results, scientific data, etc.) should also be included. When all the
items on the HACCP plan have been evaluated, the overall assessment of the
written plan is complete.
If the HACCP plan documentation package is found to require further

information or modification, the components, which are not acceptable, should
be returned to the establishment with a cover letter explaining the deficiencies.
The establishment is responsible for correcting all deficiencies and

resubmitting the amended HACCP Plan to the regulator for follow-up review.
When the regulator is satisfied that all deficiencies have been corrected, or
that the initial plan is acceptable, and the operator has informed the regulatory
authority of the implementation date, the HACCP plan validation process is
complete.
Below is an example of an APPROVAL OF A HACCP PLAN – FLOW CHART for
the process of both validation and on-going verification of the Plan:
NB: Regulatory Approval = Validation + Verification
ELEMENTS OF THE HACCP PLAN VALIDATION PROCESS
A. Product Description
1. All individual products are identified by brand name and/or common name
in the HACCP plan. (Like products are grouped in an acceptable manner.)
2. Characteristics of the product(s) which are important to ensure its safety

are listed e.g., pH and aw. The characteristics must be similar for all
products covered by the HACCP plan(s).
These characteristics are critical in controlling any common food safety

concerns. Products with different characteristics cannot be grouped. For
example, reduced oxygen packaged foods cannot be grouped under the
same HACCP plan as sushi because the product characteristics are
different.
3. Description of how the product is to be used, eg., raw, ready to eat, ready
to cook, etc.
4. Packaging material and packaging conditions used for the product(s) are
identified.
5. Anticipated shelf life of the product(s) listed under normal marketing

conditions at given temperatures.
If the determined shelf life of the product exceeds industry practices,

laboratory data or scientific studies, the establishment must provide
sufficient background data to support the safety of the chosen shelf life. In
this case, any reference documents must be made available at the time of
review.
6. Safe handling and usage information pertinent to the product is indicated,

e.g., “keep refrigerated,” best “use by” date, etc.
7. If applicable, the HACCP plan includes a description of any special

controls required during shipping and storage, i.e. temperature
requirements.
8. Labelling information for each product is available. The sample label is

found to be consistent with: "Product Name", "Intended Use", "Safe
Labelling Instructions" and "Special Distribution Control" on the HACCP
plan.
10. When applicable, recipes are available upon request to determine if the
formulation/method of preparation is consistent with those submitted with
the HACCP plan.
11. When applicable, a floor plan, showing the layout of the preparation area.
12. When applicable, a brief description of the lot identification system.
B. Incoming Materials
1. All ingredients, incoming materials and processing aids coming in contact

with the product(s) or used in the preparation of the product(s) are listed.
2. Hazard analysis is one of the most important steps in developing a

HACCP plan. A wrong or faulty hazard analysis will significantly
jeopardize the effectiveness of the HACCP plan.
The establishment should evaluate hazards of significance and

preventative measures needed for each food product and process. All
hazards associated with incoming materials and ingredients should be
specifically identified as biological, chemical, or physical in the HACCP
plan. The hazards must at least include those that are commonly
associated with a specific product.
It may be necessary to use a variety of sources to gather information.

Some of those sources could include scientific literature, regulations and
other regulatory guidelines, laboratory records, and product
specifications.
C. Validation of New/Modified HACCP Plans
Where an establishment has added a new process, requiring an additional

HACCP plan, or modification of the existing one, the HACCP plan will require
a full validation review.
The new/modified HACCP plan must be submitted to the responsible regulator

in a timely manner.
As in the case of the initial validation process, the new/modified HACCP plan
must be in operation prior to the verification audit.
8.12.2 Verification
8.12.2.1 The HACCP team shall establish a system for the verification of all
HACCP procedures and records. Verification and auditing
methods, procedures and tests, including random sampling and
analysis, shall be used, as appropriate, to determine the
effectiveness of the HACCP system.
8.12.2.2 Regular internal audits shall be scheduled and conducted to

ensure that the HACCP system conforms to the planned
arrangements and the CCP monitoring system and that the
corrective action plans are affective. All processes relevant to the
HACCP system shall be audited.
8.12.2.3 The audit criteria, scope, frequency and methods that form part of
the audit programme shall be defined and documented. Selection
of auditors and conduct of audits shall be such that objectivity and
impartially are ensured during the audit process.
Records shall be kept of validations and verifications.
8.12.3 HACCP plan review
8.12.3.1 The HACCP team shall establish a procedure for the review of the
HACCP plan. This procedure shall include events that will
automatically trigger a HACCP plan review (internal and external
factors should be considered). The HACCP plan shall be updated
after such a review. The review may lead to a reduction in/or the
addition of CCPs, or the inclusion of additional critical limits in
order to improve the HACCP plan.
8.12.3.2 The following potential events can influence food safety and shall
automatically trigger a HACCP plan review:
a) any report from the marketplace that indicates a health or spoilage risk
associated with the service (customer and consumer complaints);
b) an anticipated change in customer and consumer use;
c) a change in raw materials or service formulation;
d) a change in food handling process activities;
e) a change in food handling organization layout and environment;
f) any modification to food handling equipment;
g) a change in the cleaning and disinfection programme;
h) a change in the packaging, storage and distribution system;
i) changes to staff levels and responsibilities;
j) changes to staff levels and responsibilities;
k) results of validation and verification activities; and
l) any changes pertaining to PRPs.
8.12.3.3 Records of HACCP plan reviews shall be kept, and the results
shall be discussed at management reviews.
INTRODUCTION:
A working HACCP system is dynamic and flexible, and allows for change. It should
have provisions for verification of its effectiveness.
Verification is a process designed to:
� Review the HACCP plan

� Establish whether the CCPs and CLs are being adequately controlled and
monitored
� Determine if the procedures for product deviations and record keeping are being
followed correctly
Verification involves actual observation of procedures and a thorough review of

records. The verification team should be clearly identified and empowered. On-going
verification should be on a well-defined and established frequency, i.e. once per shift,
daily, weekly, etc. However, a comprehensive HACCP system verification should be
conducted at least annually or whenever there is a change in the HACCP system. If
the results of that comprehensive verification identify deficiencies, the HACCP plan
must be modified, as necessary, to ensure the HACCP plan is controlling the hazards.
The Verification Process
1. Verification procedures exist for each CCP.
2. Verification procedures must be complete (Who, What, When and How).
This may include review of operations & records, and analytical testing.
3. Verification procedures ensure that the CCP is valid and effective (i.e.
critical limits, monitoring procedures, and corrective action procedures are
appropriate to ensure food safety).
Examples of on-going verification activities include:
 Calibration of monitoring equipment

 Direct observations of monitoring activities and corrective actions
 Record Review
Record Keeping
The following should be identified in the written HACCP plan:
• Corrective actions
• Records (including name and location)
• Verification
The requirement to record events at CCPs on a regular basis ensures that

preventive monitoring is occurring in a systematic way. Unusual occurrences
must be corrected and recorded immediately with notation of the corrective
action taken.
The level of sophistication of the record keeping necessary for the food
establishment is dependent on the complexity of the food preparation
operation.
For example: a sous-vidé process or cook-chill operation for a large institution

would require more record keeping than a limited menu cook-serve operation.
The simplest effective record keeping system that lends itself well to
integration within the existing operation is best.
Plan Review and Revalidation
The operator is required to review the HACCP plan on a yearly basis to verify
that it is effective over time. Whenever significant changes are made in any of
the following areas, they must be incorporated into the HACCP plan the
HACCP plan must be revalidated.
 Products added
 Formulations changed
 Processes or packaging added or changed
 Menu items added
 Suppliers, customers, equipment, or facilities changed
 Regulatory requirements changed
 Introduction of new technologies that may impact food safety
Review procedures must be written and include:
a. What is reviewed
b. The specified frequency for the review
c. Person responsible for the review
d. Person responsible for making necessary changes to the HACCP plan
Records must be kept to show that reviews are performed as written and to
identify changes made to the HACCP plan. These records must include:
a. A description of the changes

b. Where the changes are located in the HACCP system
c. The date changes took place
d. Person responsible for verifying and, if necessary, validating the changes
ADDITIONAL INFORMATION :
Revalidation of the HACCP plan includes a documented on-site review and

verification of all flow diagrams and CCPs in the HACCP plan.
a. On-going field verification of the HACCP plan is conducted by the

regulatory authority. Verification is necessary to ensure that the validated
HACCP plan reflects current establishment conditions and that it is
functioning effectively.
b. The written HACCP plan must be validated and accepted as complete

before the field verification inspection takes place.
c. The model HACCP Field Verification Report Form can be used by the
regulatory agency, in conjunction with the inspection report form, to
facilitate the verification process. The form can be easily completed by the
regulator while validating the plan.
d. In addition, the HACCP plan must be in operation prior to the verification

inspection. In some cases, the regulatory authority may feel it necessary
to conduct a pre-operational inspection to verify physical facilities and
equipment requirements.
Such verification activities may include:
1. Review of the HACCP plan;
2. Record review;
3. Review of corrective actions and their resolution;
4. Review of critical limits to ensure adequacy for controlling hazards;
5. Direct observation or measurement at a CCP;
6. Sample collection and analysis to determine the product meets all

safety
standards;
7. On-site observations of activities carried out by the responsible

employees;
8. Review of modifications of the HACCP plan.
Verification of the validated HACCP plan will be made for each CCP. This
assessment is made after record review and on-site observations have been
completed. The HACCP plan should not be accepted as final until the field
inspector is confident that all requirements of the validated HACCP plan have
been fulfilled. Failure to comply with the approved procedures must be
documented on an inspection report form.
When any section of the validated HACCP plan does not comply with findings
noted during the field inspection, the deficiencies should be noted on the
HACCP Field Verification Report Form as well as on the inspection report form
cover sheet. Deficiencies should also be described on the narrative section of
the food establishment inspection report form, which serves as an order for
correction (i.e. regulations, laboratory results, scientific data, etc.)
An emergency suspension of operations may need to be considered by the

regulatory authority if significant non-compliance with monitoring of critical
control points is noted.
When the regulator is satisfied that all deficiencies have been corrected, or
that the components of the validated plan match findings noted during the field
inspection, the HACCP plan approval process is complete. The HACCP Field
Verification Report Form should be dated and signed by the reviewer for the
record.
An inspection frequency should then be established.
Elements of the HACCP Plan Verification Procedures
1. Record Keeping Procedures
The first step in the verification process is to review the records.
This is usually done in the office. The approved HACCP Plan and associated
records must be on file at the food establishment and available for review.
Records must be kept to show that CCPs are properly controlled. The
establishment’s HACCP plan must specify which records are in place for
monitoring, corrective action, and verification procedures for each CCP.
Records documenting the monitoring of CCPs and their critical limits could
include the recording of actual times, temperatures, or other quantifiable
values, as described in the establishment’s HACCP plan; the calibration of
monitoring instruments; corrective actions, including all actions taken in
response to a deviation; verification procedures and results; and product
code(s), product name or identity. Each of these records shall include the date
the record was made.
Monitoring records should be retained at the establishment for a minimum of

one year or, for the extent of the shelf life of the product, if it exceeds one
year, and are available upon request.
Generally, the following are examples of documents that can be included in
the total HACCP system:
A. List of the HACCP team members and assigned responsibilities;
B. Description of the product and its intended use ;
1. Ingredients
Supplier certification and letters of guarantee documenting
compliance with establishment and regulatory requirements.
2. Preparation
Records from all monitored CCPs.
3. Packaging
Records indicating compliance with specifications of packaging
materials and sealing specifications.
4. Finished product
a. Sufficient data and records to establish the efficacy of
barriers in maintaining product safety.
b. Sufficient data and records establishing the safe shelf-life of
the product; if age of product can affect safety.
c. Documentation of the adequacy of the HACCP procedures
from an authority knowledgeable of the hazards involved
and necessary controls.
5. Storage and distribution

a. Temperature records.
b. Records showing no product shipped after shelf life date on
temperature-sensitive products.
c. Flow chart indicating CCPs
d. Hazards associated with each CCP and preventive
measures
e. Critical limits and preventive measures
f. Monitoring records
All monitoring activities are recorded and signed by the
person doing the monitoring on a timely basis. They are up-
to-date and complete for each CCP.
Records show that the monitoring procedures are carried
out as described in the validated HACCP plan and that they
are effective.
g. Corrective action plans for deviations from critical limits.
Validation records and modification to the HACCP plan
indicating approved revisions and changes in ingredients,
formulations, preparation, packaging, and distribution
control, as needed.
All deviations and the resulting corrective actions are
recorded and initialled by the responsible person on a timely
basis. They are up-to-date and complete for each CCP.
Records show that the corrective action procedures are
carried out as described in the validated HACCP plan and
that they are effective.
h. Verification procedures
All verification activities are recorded and signed by the
responsible person on a timely basis. They are up-to-date
and complete for each CCP. Records show that the
verification procedures are carried out as described in the
validated HACCP plan and that they are effective.
i. Employee training
Records indicating that food employees responsible for
implementation of the HACCP plan understand the hazards,
controls, and procedures. These records should indicate the
training courses completed by each employee.
2. Flow Chart and Facility Layout Diagram
On-site verification is performed to confirm that the flow chart is accurate

in relation to hazard identification and conforms to all aspects of the
validated HACCP plan. The facility layout diagram must also be accurate
and complete in relation to hazards associated with cross-contamination
from product flow and employee traffic patterns.
3. Recipes/Formulations/Method of Preparation
Assessment is made for completeness of the product description and to

ensure that the establishment is following its written procedure. When
possible, this review should take place while the product is being
prepared.
Obtain the recipe/formulation/method of preparation that corresponds to

the validated HACCP plan.
If a deviation is found, stop and ask the company to review all its
formulation/methods of preparation for this HACCP plan.
4. Incoming Materials
Compare actual ingredients and incoming materials to the establishment's

HACCP plan. This will include raw materials, product ingredients,
processing aids, and packaging materials.
5. Labels
Randomly select one or more labels covered by the HACCP plan. Inspect
the label(s) to ensure it matches the written product description.
If a deviation is found, select at least one more label. If an additional
deviation is found, stop and ask the company to review all its labels for
this HACCP plan.
6. Monitoring Procedures
Monitoring procedures must be defined for each critical limit at each CCP
to make sure the CCP is under control. Individuals are interviewed and
should be able to demonstrate that they have an understanding of the
critical limits, reason & importance of the monitoring of this CCP and how
to perform the related monitoring procedures, including record keeping.
Monitoring procedures are to be ongoing at all times during processing

and must be done in a location that accurately reflects the critical limit. In
some cases, the frequency of monitoring reflects regulatory requirements
(e.g., visual examination of packaging for proper vacuum seal).
Results of monitoring procedures must be readily available and give

information on a timely basis allowing a decision to be made on the
acceptability of the product and conformance to the validated HACCP
plan.
Please refer to the BLANK INTERNAL HACCP CONTROL AUDIT

QUESTIONNAIRE
Stage 12: ESTABLISHING RECORD KEEPING AND DOCUMENTATION.

(Principle 7)
8.13.1 Document control
The HACCP team shall ensure that a procedure for document control is
established. The document control procedure shall address at least the
following:
a) Approval of documents for adequacy before being issued;
b) review and update of documents as necessary and re-approval of these

documents;
c) identification of changes to documents and the current revision status;
d) ensure that the current versions of applicable documents are available at

points of use;
e) ensure that documents are legible and readily identifiable;
f) ensure that documents of external origin are identified and their

distribution controlled; and
g) prevention of the unintended use of obsolete documents and application

of suitable identification to them if retained for any purpose.
A method of control for identification of the latest versions of all documents

shall be established.
8.13.2 Records control
The HACCP team shall ensure the establishment of a procedure for the
control of records. The procedure shall address the identification, collection,
storage, protection, retrieval, retention times and disposal of such records.
Records shall be legible, easily retrievable and accessible and shall provide
evidence of conformance to the requirements of the HACCP system.
Keep record
Record keeping is an essential part of the HACCP process. It demonstrates that

the correct procedures have been followed from the start to the end of the
process, offering product traceability. It provides a record of compliance with
the critical limits set, and can be used to identify problem areas.
Records that should be kept include: all processes and procedures linked to
GMP monitoring, deviations, and corrective actions.
Documents should also include those that recorded the original HACCP study,
e.g. hazard identification and selection of critical limits, but the bulk of the
documentation will be records concerned with the monitoring of CCPs and
corrective actions taken. Record keeping can be carried out in a number of
ways, ranging from simple check-lists, to records and control charts. Manual
and computer records are equally acceptable, but a documentation method
should be designed that is appropriate for the size and nature of the enterprise.
Please refer to the Documentation Control and Records Control Procedures

( HACCP MASTER MANUAL )
~ end ~

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CONTROLLED

HACCP STUDY - AMENDMENT RECORD SHEET 3

KEY TERMS 4-6

SPECIALIZED PROCESSES & PROCEDURES 8-9

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~ 9

Task 1: ASSEMBLY OF OUR HACCP TEAM. 10-12

Task 2: DESCRIPTION OF OUR SERVICES. 13

Task 3: IDENTIFYING THE INTENDED USE OF OUR SERVICES. 14

Task 4: CONSTRUCT OF A SERVICE FLOW DIAGRAM. 15-17

Task 5: ON-SITE CONFORMATION OF THE FLOW DIAGRAM. 18

Task 6: LISTING OF OUR FOOD SAFETY HAZARDS AND MEASURES

Task 7: DETERMINING CRITICAL CONTROL POINT (CCPS) 26-27

Task 8: ESTABLISHING CRITICAL LIMITS FOR EACH CCP. 28

Task 9: EST. A MONITORING SYSTEM FOR EACH CCP. 28-29

Task 10: ESTABLISHING CORRECTIVE ACTION PLANS. 30

Task 11: EST. VALIDATION, VERIFICATION & REVIEW 30-43

Task 12: EST. RECORD KEEPING & DOCUMENTATION. 43-44

“ A complete HACCP system is the result of implementing the HACCP principles in an

This MASTER HACCP STUDY is approved and issued by the BLANK,

A new CONTROLLED Version ( or the changed ‘ pages thereof ’ shall then

Authorise Brief Revision Signature of Date

~ Critical Control Point

The maximum or minimum value to which a physical, biological, or chemical

Failure to meet a required critical limit for a critical control point.

~ Good Retail Practices (GRPs)

Preventive measures that include practices and procedures to effectively

An acronym for Hazard Analysis Critical Control Point

~ Hazard Analysis Critical Control Point (HACCP)

A prevention-based food safety system that identifies and monitors specific

A biological, chemical, or physical property that may cause an unacceptable

The process of collecting and evaluating information about hazards associated

A planned sequence of observations or measurements of critical limits

~ Potentially Hazardous Food l

A food that is natural or synthetic and that requires temperature control

Prerequisites for HACCP

Practices and conditions needed prior to and during the implementation of

The seriousness of the effect(s) of a hazard.

~ Standard Operating Procedure (SOP)

A detailed set of instructions, steps or procedures that control the operational

Validation is that element of verification focused on collecting and evaluating

HACCP plans should be specific for each operation. Committed personnel

SPECIALIZED PROCESSES & PROCEDURES REQUIRING A HACCP PLAN

1. Custom processing animals;

• Smoking food as a method of preservation but not if smoking only for

• Curing foods such as hams, sausages, etc.;

• Using food additives or adding components such as vinegar as a method

• Reduced Oxygen Packaging (where C.Bot is a concern and only one

• Using more than one container of shellfish at a time (co-mingling);

• Molluscan shellfish display tanks that are used to store/display shellfish

• Brewing alcoholic beverages;

• Preparing, serving or transporting food by another method that is

Processes requiring a variance from the State but no HACCP plan:

• Custom processing of animals or fish for personal use in a licensed food

• Pooling of eggs in a food establishment that serves a highly susceptible

• Use of a two compartment sink for some limited processes

~ A HACCP STUDY - PROCESS FLOW DIAGRAM ~

Task 1: ASSEMBLY OF OUR HACCP TEAM

8.2.2 The team shall consist of a

10) distribution; and

11) food service management.

8.2.3 The HACCP team shall establish documentation defining the

a) the rules and guidelines for team meetings;