GMPs & HACCP

Quick links:

GMPs
7 Principles of HACCP
HACCP Video
 HACCP
Hazard Analysis and
Critical Control Points

References:
Procedures to Implement the Hazard
Analysis Critical Control Point System, IAMFES
(International Association of Milk, Food and Environmental Sanitarians, Inc.)

OMAFRA Ontario Ministry of Agriculture, Food and Rural Affairs

http://www.omafra.gov.on.ca/english/food/foodsafety/processors/advantageprocesssing.htm
 Foodborne diseases
• Considerable morbidity and occasional
mortality can be associated with
spoiled/unsafe food consumption
• The principles for controlling most diseases,
particularly those caused by unsafe foods are
well known by Public Health Authorities
– i.e. Inspections are carried out routinely to
prevent/control the incidence of foodborne
diseases
 Inspections
• However! It is important to note that often
times inspections are found:
– To NOT be frequent enough
– To NOT be thorough enough to provide and
acceptable degree of food safety
– To NOT be conducted at times when high risk
foods or critical processes are being done
 Also important to note:
• Microbiological testing is limited statistically to
a limited number of test samples
• Tests may take a few days (performed within
36 hours, but results may require additional
wait/incubation time)
• THEREFORE, food may have already been
shipped to the provider or even eaten by the
consumer
 HACCP
• HACCP (Hazard Analysis and Critical Control
Points) is a systematic approach to food safety
– In the 1960s, food processors and the US
aerospace program collaborated to come up with
a program to try to standardize food microbiology
+ quality control + risk assessment
– Since then, there have been ongoing changes
occurring to the way HACCP is applied in the food
industry
• Currently, OMAFRA (Ontario Ministry of Agriculture,
Food and Rural Affairs) has broken down the
certification process for food processors into 3
progressive levels
– Together, the system is called “ADVANTAGE”

Level 1: Good Manufacturing Practices (GMP)

Level 2: Hazard Analysis Critical Control Points (HACCP)

Level 3: Hazard Analysis Critical Control Points Plus

(HACCP Plus)
 Level 1: Advantage Good Manufacturing
Practices (GMP)
• GMPs control hazard related to people and the processing
environment
• These practices are the basis of any effective food safety
program
• The Advantage GMP program covers hazards associated with:

 Personnel practices  Pest control

 Shipping, receiving,  Recall
handling, and storage  Water safety
 Sanitation  Processing environment
 Equipment
 Level 2: Advantage Hazard Analysis
Critical Control Points (HACCP)
• Advantage HACCP gives you the tools you
need to detect and control hazards specific to
your process and the products
• This program is based on the seven principles
of HACCP
• It includes the Advantage GMP components
as well as eight forms to support a HACCP
plan
 7 Core Principles of HACCP
Click on the red to take you to the appropriate slide!

1. Conduct a Hazard Analysis

2. Determine the Critical Control Points
3. Establish Critical Limits
4. Establish Monitoring Procedures
5. Establish Corrective Actions
6. Establish Verification Procedures
7. Establish Record-keeping and
Documentation procedures
 1. Conduct a Hazard Analysis
• Identify the hazards that might affect a particular
product in a specific processing facility
– Performed by lab people or consultants
– Takes time (follow-up audits usually are quicker)
– HACCP designers need a thorough understanding of Food
Microbiology, Food technology, and often Toxicology
• Collecting and evaluating information on the hazards
and the conditions leading to their presence
• Deciding which hazards are SIGNFICIANT to food
safety
– All operations must address these hazards via HACCP
plan(s)
 Hazard Definition
• Hazard: Unacceptable contamination of a biological,
chemical, or physical nature
– Survival and/or multiplication of microorganisms of concern to
safety (or spoilage)
– Unacceptable production of foods, with toxins or any other
undesirable products of microbial metabolism
• Biological Hazard: Infectious or toxigenic bacteria, viruses,
moulds, parasites, mushrooms, fish, etc.
• Chemical Hazards: Pesticides, cleaning compounds,
antibiotics, heavy metals, additives (i.e. sulfites, MSG, etc.)
• Physical Hazards: Metal fragments, glass, wood splinters,
stones, etc.
– May cut mouth, break teeth, choke, perforate gut, etc.
 Hazard Analysis continued
• Hazards vary between establishments even if
they produce the same food because:
– Source of ingredients may differ
– Formulations
– Processing equipment & methods
– Duration of processing and storage
– Experience, knowledge, attitude of personnel
– Distribution practices
 As part of Hazard Analysis…
• It is important to be able to assess each identified
potential hazard’s severity and risks
• Severity: magnitude of hazard/degree of
consequences
– 3 classifications:
I. Li= Life threatening illness
II. Si= Severe or chronic illness
III. Mi= Mild or moderate illness
• IMPORTANT TO NOTE: TIME AND PLACE MAY REQUIRE
MOVEMENT OF SOME OF THESE FROM ONE CLASSIFCATION
TO ANOTHER
– i.e. Usually a HIGHER DOSE means shorter incubation time for
bacteria and a more severe outcome
 Eg. Li
• Clostridium botulinum
• Salmonella typhi
• Listeria monocytogenes
– fetuses, infants, immunocompromised
• Vibrio cholerae
• Vibrio vulnificus
– Halophile, food poison/sepsis/sores
• paralytic or amnesic shellfish
poisonings
 Eg. Si
• Brucella • Vibrio
• Campylobacter parahaemolyticus
• pathogenic • Yersinia
E.coli enterocolitica
• Salmonella • Hep A virus
• Shigella • mycotoxins
• Strep type A • Ciguatera toxin
• tetramines
 Eg. Mi
• Bacillus • L. monocytogenes
• C. perfringens – in healthy adults
• S. aureus • histamine like
• Norwalk-like substances
viruses • heavy metals
• most parasites
• diarrhetic shellfish
poisoning
• Risk: An estimate of the probability of occurance of a
hazard
– Or sequential occurrence of several hazards

DEGREE OF RISK
– High H
– Moderate M
– Low L
– Negligible N
– May Vary V

• Microbiological hazards: Highest risk to the greatest

number of people
• Physical hazards: Usually limited; risk to individuals
2. Establish Critical Control Points
• “an operation” (or practice, procedures,
process, or location) at which a preventive or
control measure can/should be exercised in
order to eliminate, prevent, or minimize a
hazard or several hazards
 Critical Control Point classification
• CCP1: Hazards are eliminated / prevented
• CCP2: minimized, reduced delayed
• CCPe: Eliminated
– retorting, pasteurizing steps
• CCPp: Prevented
– freezing step ... hazard may return if thawed
• CCPr: Reduced (minimized, delayed)
– NOT eliminated or even prevented
– eg. handling food with sanitized utensils, rather
than your hands, or putting perishable foods in
the fridge
 Ordinary Control Points
• There are also ordinary control points where
preventative/control steps are taken
– Mandated by GMPs, regulations, product
reputation, company policies, etc.
 A Process
Diagram for
Frozen
tortellini
.. Handler contam

Surfaces

Raw ingredients
 ..
Handler
contam

Surfaces
CCP’s

Raw
ingredients
 3. Establish Critical Limits
• Critical Limits must be specified for each CCP
– Specified criteria or characteristics

• Physical: time, temperature, etc.

• Chemical: amount of salt, acetic acid, etc.
• Biological: sensorial, microbiological
 4. Establish Monitoring Procedures

• Check that process at each CCP meets the

criteria
• Observing: handling/cleaning practices
• Measuring:
• Time
• Temperature • Detergent or disinfectant
• pH, acidity concentration
• Aw • Container conditions
(seams, vacuum, etc.)
 Monitoring
• Collecting and testing samples
• Keeping records
– To confirm monitoring
• Increasingly important especially with FISO iniatives
– Food International Organization for Standardization
 CONTROL MEASURES
• Preventive measures selected or designed
to take care of the CCP (eliminate or
prevent/reduce)
• Criteria can differ with certain processes
and measurements
• Variability is inherent
• Have realistic tolerances / limits
Food category Control
Hazard
Operation measures
Cheese: Contamination by -Ensure starter
Addition of starter S.aureus is not contam’d
culture

Ageing Survival of -Store several

bacterial months
pathogens

Storing Survival of Bact -Store: cold / dry

-erial pathogens conditions
Growth: Molds -Intact package
Growth: psych- -Restrict storage
pathogens duration
Food category
Hazard Control measures
Operation
Coconut: Contam by Store : - dry conditions
Harvesting and molds that -prevent animal contam
storing of nuts produce
mycotoxins

washing Contam by -use potable water

Enteric
bacteria

Grinding / Contam by -clean / disinfect equip.

shredding hands and -separate raw & processed
equipment product
-applies for ALL steps after
pasteurization
 5. Establish Corrective Actions
• are clearly specified
• In advance of trouble
• there are prompt
actions when criteria
are not met:
– a flow diversion valve
– an extended cooking
time
 6. Establish Verification Procedures

• supplemental tests
• review of monitoring records
• tells you when part of HACCP system need
modification
 7. Record Keeping and Documentation
There are 8 forms that make up a good HACCP plan
• Form 1 is the Product Description, which identifies all
products being produced.
• Form 2 is the Ingredients & Incoming Materials,
which identifies all ingredients and incoming
materials, including packaging materials and
processing aids that come in contact with the product
or are used in processing the product.
• Form 3 is the Process Flow Diagram, which will be
created separately; examples are in the HACCP
Advantage Guidebook.
• Form 4 is the Plant Schematic, which will be created
separately; examples are in the HACCP Advantage
Guidebook.
• Form 5 is the Hazard Description and Critical Control
Point Determination.
– This version of Form 5 is a new format which utilizes the
decision tree and it is saved as a "form".
– Simply type your plan name and types of hazards in the
white boxes then click on the boxes beside the "yes/no"
answers. You will need a new page for each hazard.
• Form 6 is the Flow Diagram with Critical Control
Points, you will add the CCPs determined from form
5 onto the flow diagram made in form 3.
• Form 7 is the Uncontrolled Hazards, which are
determined by using form 5.
• Form 8 is the HACCP Matrix, documenting the
critical limits, monitoring, verification and records
for each CCP. (A summary of the HACCP plan)
 Level 3: Advantage Hazard Analysis Critical
Control Points Plus (HACCP Plus)
• This program includes the prior two levels,
PLUS:
– Tools to trace food safety form source (ex. Farm)
to table
– Extra security measures
• With this program in place, you will fully
document all traceability and security
measures
– Essential step in protecting consumers and your
operations in case of a food safety crisis
 Application of HACCP
• Currently, HACCP is applied to:
– All types of food operations!
• Growing and harvesting crops
• Raising livestock and Poultry
• Catching and holding fish
• Transporting, storing, processing, marketing and
preparing food
• HACCP is implemented by Industry, and
verified by food control agencies (ex. CFIA)
• HACCP essentially simplifies food safety by
allowing Industry professionals to focus on a
FEW critical operations and give MEANINGFUL
ways to control and monitor them
• Managers are responsible for understanding
and implementing new information
continually, BUT it really is the workers who
are responsible for actually running/having a
“working knowledge and practice” of HACCP