SIMPLIFYING THE DEVELOPMENT OF

HACCP PLAN MEETING FOOD SAFETY

REGULATORY REQUIREMENTS

Alberto R. Cariso, Jr.

President, Philippine Association of Food
Technologists, Inc (PAFT) and
Assistant Director
Food Development Center
National Food Authority

 1. Responsibility for Food Safety

2. Simplifying the Development of Food Safety

Plan Based on HACCP

(With an Illustrative Example of Developing a
HACCP Plan for the Manufacturing of Fruit Juice)
3. The Twelve (12) Steps in Developing HACCP
Plan Based on Seven (7) HACCP Principles as
Prescribed by the Codex Alimentarius
Commission (CAC)
4. Examples of Prerequisite Programs

 Food borne illness is a significant burden

About 48 million (1 in 6 Americans) get sick each year
128,000 are hospitalized
3,000 die
Immune-compromised individuals more susceptible
Infants and children, pregnant women, older individuals,

those on chemotherapy

Food borne illness is not just a stomach acheit can cause

life-long chronic disease

Arthritis, kidney failure

Source: USFDA, 2010

 Responsibility for food safety rests first and

foremost with the food industry -- those who

grow, process and market food.

Government doesnt make food and

government cant make it safe.

We (both public and private sectors) all have

crucial roles to play on food safety and we need

to work together to be successful.
- Michael R. Taylor (2014)
Deputy Commissioner for Foods and
Veterinary Medicine
U.S. Food and Drug Administration

(With an Illustrative Example of

Developing a HACCP Plan for the
Manufacturing of Fruit Juice)

 The Codex Alimentarius Commission

(CAC) defines HACCP as

a system which identifies, evaluates,
and controls hazards which are
significant for food safety.

Food Safety Plan Based on HACCP

POTENTIAL HAZARDS
SOURCES OF
HAZARDS

Biological

Chemical

Physical

Incoming Materials
Process Steps

PREVENTIVE/
CONTROL
MEASURES
Prerequisite Programs
Example: GMP, SSOP

Significant Hazard
HACCP

SAFE FOOD

Form 1. Product Description

HACCP Generic Model:

Product Description

Form 1

Source: Canadian Food Inspection Agency:

HACCP Generic Model

1. Product name(s)
2. Important Product Characteristics
(aw, pH, Salt, Preservatives, )
3. How it is to be used
4. Packaging
5. Shelf life
6. Where it will be sold
7. Labeling instructions
8. Special Distribution Control
Date:___________

Approved by:______________

HACCP Generic Model: Aseptic Fruit Juice

Product Description

Form 1

Source: Canadian Food Inspection Agency:

HACCP Generic Model

1. Product name(s)

Apple Juice from Concentrate

2. Important Product Characteristics

(aw, pH, Salt, Preservatives, )

aw = 0.97
pH = 3.6 4.5
No preservatives
Vitamin C added

3. How it is to be used

Ready-to-drink

4. Packaging

Hermetically sealed tetra-brick multi-laminated board

(plastic, foil, paper)

5. Shelf life

10 months at room temperature (less than or equal to 20oC)

6. Where it will be sold

Through retail, hotel, restaurant, institution to the general

population, which would include vulnerable groups, such as
infants, elderly, infirm & immunocompromised

7. Labeling instructions

Refrigerate after opening

None required for safety

8. Special Distribution Control

Shipping/storage temperature range between 5oC and 20oC

Proper storage control

Date:___________

Approved by:______________

Form 2. LIST OF PRODUCT INGREDIENTS AND INCOMING MATERIAL

PRODUCT NAME:
Main Ingredient

Additives/
Processing Aids

Packaging Material

LIST OF PRODUCT INGREDIENTS AND INCOMING MATERIAL

Form 2

PRODUCT NAME: Aseptic Fruit Juice

Main Ingredient
1. Apple concentrate
2. Water

8. Air

Additives/
Processing Aids
3. Apple Aroma
4. Ascorbic Acid
5. Hydrogen peroxide

Packaging Material
6.Packaging Material
Roll
7. Shrink Wrap

FORM 3. PROCESS FLOW DIAGRAM

PRODUCT NAME(S):

PROCESS FLOW DIAGRAM

Form 3

Process Flow Diagram

Aseptic Fruit Juice
1. Apple Juice
Concentrate
Receiving

5. Water
Intaking

2. Apple Juice
Concentrate
Transferring
3. Apple Juice
Concentrate Storing

6. Softening

Form 3

7. Apple Aroma
Receiving

10. Ascorbic Acid

Receiving

23. Hydrogen
Peroxide Receiving

8. Apple Aroma
Storing

11. Ascorbic Acid

Storing

24. Hydrogen
Peroxide Storing

9. Apple Aroma
Adding

12. Ascorbic Acid

Adding

25. Hydrogen
Peroxide Bathing

20. Packaging
Material Roll
Receiving
21. Packaging
Material Roll
Storing
22. Unrolling

4. Blending/Mixing
13. Filtering
14. Metering

17. Air Filtering

15. Heat Treating

18. Air Sterilizing

16. Holding (Aseptic)

28. Shrink Wrap

Receiving

19. Forming/Filling/
Sealing
26. Filled Package
Inspecting

29. Shrink Wrap

Storing

27. Wrapping
30. Storing

Source: Canadian Food Inspection Agency:

31. Shipping

HACCP Generic Model

FORM 4. PLANT SCHEMATIC

PRODUCT NAME(S):

PLANT SCHEMATIC

Form 4

FORM 4. PLANT SCHEMATIC

PRODUCT NAME(S)

PLANT SCHEMATIC

Form 4
Source: FAO, 2003

How to Develop a HACCP Plan?

There are 12 steps prescribed by Codex

Based on the application of seven principles

The Seven HACCP Principles

(Source: Codex, 2003)

1. Conduct a hazard analysis

2. Determine the Critical Control Points (CCP)
3. Establish Critical Limits (CL)
4. Establish a system to monitor the CCP
5. Establish a corrective action to be taken when
monitoring indicates that a particular CCP is not
under control
6. Establish procedure for verification to confirm that
the CCP system is working effectively
7. Establish documentation concerning all procedures
and records appropriate to these principles and
their application

Twelve (12) Steps in

Developing a HACCP Plan
(Source: Codex, 2003)

1.
2.
3.
4.
5.

Assemble the HACCP Team.

Describe the product.
Identify intended use and consumer.
Develop process flow diagram.
On-site confirmation of process flow diagram.

Developing a HACCP Plan (contd)

6. Conduct hazards analysis and determine
control measures for each hazard.
7. Determine CCPs
8. Establish critical limits
9. Establish monitoring procedures for each CCP
10. Establish corrective actions
11. Establish verification procedures
12. Establish documentation and record keeping

HAZARDS INDENTIFICATION
FORM #5
PRODUCT NAME(S):
LIST ALL BIOLOGICAL HAZARDS RELATED TO INGREDIENTS,
INCOMING MATERIAL, PROCESSING, PRODUCT FLOW, ETC..
IDENTIFIED BIOLOGICAL HAZARDS

CONTROLLED AT

Form 5A

Biological Hazards and Controls

Product Name: Aseptic Fruit Juice
List all Biological Hazards related to Ingredients, Incoming Material, Processing, Product Flow, etc.
Identified Biological Hazards
(Pathogens, Parasites, Viruses...)

Controlled at

Incoming Materials
Apple Juice Concentrate
- None

Not Applicable

Apple Juice Concentrate

- Could contain patulin

CCP-1BC

Apple Aroma
- None

Not Applicable

Ascorbic Acid
- None

Not Applicable

Water
- Water not meeting the drinking water criteria established by
Health Canada

Prerequisite programs (Premises/Water Quality)

Packaging Material
- Could be contaminated with pathogens as a result of damaged
packaging material rolls

Prerequisite programs (Personnel/Training)

Air
- None

Not Applicable

Process Steps
#1 Receiving
- Reception of apple juice concentrate from non--contract suppliers without
valid specifications could result in product contaminated with patulin

CCP-1BC

#1 Apple Aroma/Ascorbic Acid Receiving

- Pathogen contamination could occur if drums/packages are damaged

Prerequisite programs (Personnel/Training)

#1 Packaging Material Receiving

- Could introduce pathogens through damaged rolls of packaging material during
receiving

Prerequisite programs
(Personnel/Training)

#3 Apple Juice Concentrate Transferring

- Pathogen contamination could occur from pipes or from pumping concentrate from
tanker into open barrels
#3 Apple Juice Concentrate Storing
- Temperature abuse could lead to the growth of pathogens
#4 Ascorbic Acid Storing
- Could become contaminated with pathogens if not adequately protected during
storage

Prerequisite programs (Sanitation, Personnel)

Prerequisite programs (Equipment, Personnel)

Prerequisite programs (Premises, Personnel)

#4 Apple Aroma Storing

- Temperature abuse could lead to the growth of pathogens

Prerequisite programs (Equipment, Personnel)

#5 Packaging Material Storing

- Could become contaminated with pathogens if not adequately protected during
storage

Prerequisite programs (Premises,

Personnel)

#6 Water Softening
- Could be contaminated with pathogens from unclean equipment

Prerequisite programs (Sanitation)

#7 Blending/Mixing
- Inadequate cleaning could result in pathogen contamination from the
equipment
#8 Apple Aroma/Ascorbic Acid Adding
- Improper handling practices could introduce pathogens to blending tank

Prerequisite programs (Sanitation)

Prerequisite programs (Personnel)

#9 Filtering
- Poor handling or inadequate cleaning could result in pathogens contamination of
the product

Prerequisite programs (Sanitation)

#10 Metering
- Poor handling or inadequate cleaning could result in pathogens contamination of
the product

Prerequisite programs (Sanitation)

#11 Air Filtering

- Dirty or inefficient filters could result in contaminated air

Prerequisite programs (Sanitation)

#12 Heat Treating

- None

Not applicable

#13 Air Sterilizing

- None

Not applicable

#15 Holding (Aseptic)

- An interruption of aseptic conditions could lead to the introduction of pathogens

Prerequisite programs (Equipment, Personnel)

#16 Hydrogen Peroxide Bathing

- None

Not applicable

#17 Forming/Filling/Sealing
- None

Not applicable

#18 Filled Package Inspecting

- None

Not applicable

Date: ______________________

Approved by: ________________________

Source: Canadian Food Inspection Agency:

HACCP Generic Model

HAZARDS INDENTIFICATION
FORM #6
PRODUCT NAME(S):
LIST ALL CHEMICAL HAZARDS RELATED TO INGREDIENTS, INCOMING
MATERIAL, PROCESSING, PRODUCT FLOW, ETC.
IDENTIFIED CHEMICAL HAZARDS

CONTROLLED AT

Form 6A
Chemical Hazards and Controls
Product Name: Aseptic Fruit Juice
List all Chemical Hazards related to Ingredients, Incoming Material, Processing, Product Flow, etc.

Identified Chemical Hazards

Controlled at

Incoming Materials
Apple Juice Concentrate
- Could contain pesticide residues

CCP-1BC

Water
- Could be contaminated with heavy metals and chemical residues

Prerequisite programs
(Premises)

Packaging Material
- Could be contaminated with harmful chemical residues, which could leach into
the product
Hydrogen Peroxide
- If not food grade could contain unknown impurities

CCP-1BC

CCP-1BC

Source: Canadian Food Inspection Agency:

HACCP Generic Model

Process Steps
#1 Receiving
- Reception of ingredients and materials from non--contract suppliers without valid
specifications could result in product contaminated with harmful chemical residues (pesticides
etc.)
#3 Apple Juice Concentrate Transferring
- Pipes or barrels could contain cleaning chemical residues

#3 Apple Juice Concentrate Storing

- Concentrate could become contaminated with cleaning chemicals if not properly stored

#7 Blending/Mixing
- Product could become contaminated from cleaning chemical residues

#9 Filtering
- Product could become contaminated from cleaning chemical residues

#10 Metering
- Product could become contaminated from cleaning chemical residues

CCP-1BC

Prerequisite programs
(Sanitation)

Prerequisite programs
(Sanitation)

Prerequisite programs
(Sanitation)

Prerequisite programs
(Sanitation)

Prerequisite programs
(Sanitation)

#11 Air Filtering

- Compressed air could be contaminated with oil

Prerequisite programs
(Equipment)

#12 Heat Treating

- Product could become contaminated from cleaning chemical residues because of improper
rinsing

#15 Holding (Aseptic)

- Product could become contaminated with cleaning chemical residues

Prerequisite programs
(Sanitation)

#16 Hydrogen Peroxide Bathing

- Product could become contaminated with residues

Prerequisite programs
(Equipment)

#17 Forming/Filling/Sealing
- Product could become contaminated with hydrogen peroxide on packaging material

Date: ______________________

Prerequisite programs
(Sanitation)

Prerequisite programs
(Sanitation)

Approved by: ________________________

Source: Canadian Food Inspection Agency:

HACCP Generic Model

HAZARDS INDENTIFICATION
FORM #7
PRODUCT NAME(S):
LIST ALL PHYSICAL HAZARDS RELATED TO INGREDIENTS, INCOMING
MATERIAL, PROCESSING, PRODUCT FLOW, ETC.
IDENTIFIED PHYSICAL HAZARDS

CONTROLLED AT

Identified Physical Hazards

Controlled at

Incoming Materials
Apple Juice Concentrate
- None

Not Applicable

Apple Aroma
- None

Not Applicable

Ascorbic Acid
- None

Not Applicable

Packaging Material
- None

Not Applicable

Source: Canadian Food Inspection Agency:

HACCP Generic Model

Process Steps
#1 Apple Aroma/Ascorbic Acid Receiving
- Hazardous extraneous material contamination could occur if drums/packages are damaged
during handling

#3 Apple Juice Concentrate Transferring

- Hazardous extraneous material i.e.. metal, plastic and glass fragments and wood
slivers from pipes or from environment could contaminate concentrate when
pumping from tanker to open barrels

Prerequisite program (Personnel)

Prerequisite program (Personnel)

#3 Apple Juice Concentrate Storing

- Concentrate could become contaminated with hazardous extraneous material if not
adequately protected during storage

Prerequisite programs (Transport &

Storage, Personnel)

#4 Apple Aroma/Ascorbic Acid Storing

- Ingredients could become contaminated with hazardous extraneous material if not
adequately protected during storage

Prerequisite programs (Transport &

Storage, Personnel)

#8 Apple Aroma/Ascorbic Acid Adding

- Reconstituted juice could become contaminated with hazardous extraneous material during
addition to blending/mixing tank

Prerequisite program (Personnel)

Source: Canadian Food Inspection Agency:

HACCP Generic Model

Form 10. HACCP Plan Form

1.
CCP

2.
Hazards

3.
Critical
Limits

Monitoring

4.
What

5.
How

6.
Frequency

8.
Corrective
Actions

7.
Who

9.
Verification

10.
Recordkeeping

Form 10
HACCP Plan Form
Product Name: Aseptic Fruit Juice
1.

CCP

2. Hazards

3. Critical
Limits

Monitoring
4.
What

1. Apple Juice
Concentrate
Receiving

Reception of
apple juice
concentrate
from noncontract
suppliers
without valid
specification
s could
result in
product
contaminate
d with
patulin
and/or
excessive
level of
pesticide
residues

Must meet
Food &
Drugs Act
and
Regulations
Suppliers
must be
listed with
valid
contract
specification
s

Suppliers
name and
address

5.
How

6.
Frequency

Receiver
checks
suppliers'
names and
addresses
against list of
approved
suppliers
with valid
contact
specification
s

Every arrival

7.
Who
Receiver

8.
Corrective
Actions
Receiver
rejects lot,
notifies
management
and records
deviation

9.
Verification

10. Recordkeeping

QC does
periodic
analysis of
ingredients
for patulin
and for
pesticide
residues

Supplier lists
contractual
agreements
lot receipt,
reject/
deviation
report

Source: Canadian Food Inspection Agency:

HACCP Generic Model

Form 10
HACCP Plan Form
Product Name: Aseptic Fruit Juice
1.

CCP

2. Hazards

3. Critical
Limits

Monitoring
4.
What

20.
Packaging
Material Roll
Receiving

Reception of
packaging
materials
from noncontract
suppliers
without valid
specification
s could
result in
product
contaminate
d with
hazardous
chemical
residues

Must meet
Food &
Drugs Act
and
Regulations
Suppliers
must be
listed with
valid
contract
specification
s

Suppliers
name and
address

5.
How

6.
Frequency

Receiver
checks
suppliers'
names and
addresses
against list of
approved
suppliers
with valid
contact
specification
s

Every arrival

7.
Who
Receiver

8.
Corrective
Actions
Receiver
rejects lot,
notifies
management and
records
deviation

9.
Verification

10. Recordkeeping

QC checks
with Health
Canada re
approval of
packaging
material

Supplier lists
contractual
agreements
lot receipt,
reject/
deviation
report

Source: Canadian Food Inspection Agency:

HACCP Generic Model

Form 10
HACCP Plan Form
Product Name: Aseptic Fruit Juice
1.

CCP

2. Hazards

3. Critical
Limits

Monitoring
4.
What

23.
Hydrogen
Peroxide
Receiving

Reception of
hydrogen
peroxide
from noncontract
suppliers
without valid
specification
s could
result in
product
contaminate
d with
hazardous
chemical
residues

Must meet
Food &
Drugs Act
and
Regulations
Suppliers
must be
listed with
valid
contract
specification
s

Suppliers
name and
address

5.
How

6.
Frequency

Receiver
checks
suppliers'
names and
addresses
against list of
approved
suppliers
with valid
contact
specification
s

Every arrival

7.
Who
Receiver

8.
Corrective
Actions
Receiver
rejects lot,
notifies
management and
records
deviation

9.
Verification

10. Recordkeeping

QC checks to
ensure
hydrogen
peroxide is
labeled food
grade and is
listed on the
Agriculture
& Agri-Food
Canada list
of non-food
chemicals
and
materials

Supplier lists
contractual
agreements
lot receipt,
reject/
deviation
report

Source: Canadian Food Inspection Agency:

HACCP Generic Model

HACCP Generic Model: Aseptic Fruit Juice

Example Only
Receiving
Date

Receiver
Name

Product
Code

Approved
supplier
(Contractual
specification
in file)

Apple Juice
Concentrate. Visual
Inspection (Odor, color
absence of foreign
material). No damaged
cartons. Approved

Hydrogen Peroxide.
Visual Inspection.
Approved

Packaging
Material.
Visual
Inspection.
Approved

Action /
Comments

Initials

Source: Canadian Food Inspection Agency:

HACCP Generic Model

4.1 Good Manufacturing Practices (GMP)

4.2 Sanitation Standard Operating Procedures (SSOP)
4.3 Risk-Based Preventive Controls
4.4 Other Examples

Good Manufacturing Practices (GMP)

(Source: USFDA, 2014)

General requirements to bring out the safe and

sanitary handling of foods. It includes
requirements for the following:
- Personnel
- Plants and grounds
- Sanitary operations
- Sanitary facilities and controls
- Equipment and utensils
- Processes and controls
- Warehousing and distribution

Sanitation Standard Operating Procedures

(SSOP)
(Source: USFDA, 2014)

SSOP addresses eight key areas:

1. Safety of water used
2. Condition and cleanliness of food-contact
surfaces
3. Prevention of cross-contamination
4. Maintenance of hand-washing,
hand-sanitizing and toilet facilities

SSOP (contd)
5. Protection of food, packaging materials
and food contact surfaces from
adulterants
6. Labeling, storage and use of toxic
compounds
7. Control of employee health condition
8. Exclusion of pests from food plant

Sanitation Standard Operating Procedures(SSOPs) are an

integral part of the food Hazard Analysis Critical Control
Point (HACCP) implementation
1. Processors should have and implement a written SSOP plan;
2. Processors shall monitor the sanitary conditions and practices;
3. Processors shall correct insanitary conditions and practices in a
timely manner; and
4. Processors shall maintain sanitation control records.
Source: USFDA, 2014

Daily Sanitation Report for Small Juice Processing Firms

(For use with a written SSOP)
Company:_________________________ Product: ___________________
Address: ____________________________________________________
Product:
Date:
Time:
Pre-op Post-op
1) Safety of water
2) Surfaces
____________
____________
____________

Pre-op Post-op Pre-op Post-op

Product:
Date:
Time:
Pre-op Post-op Pre-op Postop
3) CrossContamination
4) Employee
Hygiene
5) Adulteration
6) Toxic
Compounds
7) Employee
Health

Pre-op Postop

Product:
Date:
Time:
Pre-op Post-op

Pre-op Post-op Pre-op Post-op

8) Pest Control
Operators Initial
Corrective Action
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
Reviewed by:

Date:

 Sanitation
Training for supervisors and employees
Environmental controls and

monitoring
Food allergen controls
Recall contingency plan
Good Manufacturing Practices (GMPs)
Supplier verification activities

Source: USFDA, 2015

General Quality Systems;

Monitoring Programs; GMP
Use of Approved Suppliers
Rework Practices
Formulation (e.g., excess restricted
ingredient addition)
Post Cook Recontamination
Product Sequencing
Extraneous Detection / Removal
Programs
Brine Programs (treatment & testing)

Recalls
Hold & Release
Recall Procedures
Traceability / Code Dating
Specifications
Raw Materials
Formulas
Manufacturing Procedures
Finished Product

Packaging
Labeling

Premises
Building Structure & Utility Systems
Outside Property
Water Quality Program
(treatment & testing)

Sanitation
Pest Control
Equipment Cleaning
Housekeeping
Period Cleaning

Receiving / Storage
Raw Material Management
Receiving / Storage Distribution
Certificate of Analysis (COA)
Letters of Guarantee
Hold & Release
Truck / Carrier Inspection
Label Review for Accuracy (e.g., keep
refrigerated, cooking instructions)

Personnel Training Program

Employee Hygiene
Employee Practices

Equipment Performance & Maintenance

Preventative Maintenance
Equipment Calibration
Compressed Air Filtration
Equipment Design

Source:
William H. Sveum, Ph.D.
Kraft Foods 09/2002S

Food Safety Plan Based on HACCP

POTENTIAL HAZARDS
SOURCES OF
HAZARDS

Biological

Chemical

Physical

Incoming Materials
Process Steps

PREVENTIVE/
CONTROL
MEASURES
Prerequisite Programs
Example: GMP, SSOP

Significant Hazard
HACCP

SAFE FOOD

CLEAN
PERSONNEL

CLEAN
PLANT
SAFE
CLEAN
FRESH

CLEAN
EQUIPMENT

CLEAN
METHODS

FOOD

We will achieve the best food safety results if we

define in workable, science-based standards the
approaches to managing food safety systems that we
know are effective in preventing food safety problems
AND if we achieve high rates of compliance with those
standards .
If we are successful, we will have accomplished our
goals of protecting food safety, strengthening public
confidence, and facilitating trade in safe food.
- Michael R. Taylor (2014)
Deputy Commissioner for Foods and
Veterinary Medicine
U.S. Food and Drug Administration

FORM 8. CCP DETERMINATION

Form 8

CCP DETERMINATION
Process
Step/
Incoming
Material

Category and
Identified Hazard
Determine if fully
controlled by
prerequisite
program(s).
*If yes=indicate
Prerequisite Prog.
and proceed to next
identified hazard.
*If no=proceed to
Question 1 (Q1)

Q1. Could a control

measure(s) be used by
the operator at any
process step?
*If no=not CCP +
identification on how
this hazard will be
controlled before and
after the process +
proceed to the next
identified hazards.
*If yes=description +
next question

Q2. Is it likely that

contamination will be
identified hazard could
occur in excess of the
acceptable level or
could increase to an
unacceptable level?
*If no=not
CCP=proceed to the
next identified hazard
*If yes=next question

Q3. Is this process

step specifically
designed to
eliminate/reduce the
likely occurrence of
the identified hazard
to an acceptable
level?
*If no=not a CCP
*If yes=CCP + go to
last column

Q4. Will a subsequent

step eliminate the
identified hazard or
reduce likely
occurrence to an
acceptable level?
*If no=CCP + go to last
column
*If yes=not a CCP +
identify subsequent
step + proceed to the
next identified hazard

CCP Number
*Proceed to the
next identified
hazard

FORM 9. HAZARDS NOT CONTROLLED BY OPERATOR

PRODUCT NAME(S):
HAZARDS

HAZARDS NOT CONTROLLED BY OPERATOR

Indicate the way the hazard could be addressed
(cooking instructions, public education,
use before date,...)

Form 9