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GMP, SSOP, HACCP Seminar

SHERRY SALAZAR
Sr. Product Specialist
Food Safety
I. Definition
II. Need for Food Safety
III. Food Safety Tools
a. GAP and GHP
b. GMP
c. sSOP
d. HACCP
 What is Food Safety?

Refers to the assurance that food will not cause harm

to the consumer when it is prepared or eaten
according to its intended use
- Food Safety Act, RA 10611
The Need for Food Safety
FIRST: Brand Protection

• Severe breaches in food safety can cause the

collapse of a brand or an entire company.
 SECOND: Socio-economic
Implications

People suffer from diseases

Worldwide, food borne diseases take

heavy toll on human life.

Millions of jobs were lost.

 FOOD SAFETY TOOLS
ENSURING FOOD SAFETY FROM FARM TO FORK
 Farm to Fork Approach

Producers Processors Distributors Consumer

Monitoring by Verification
 Hygiene and
Sanitation

• Good hygiene and

sanitation is the
framework of a good food
processing facility
Good Agricultural Practices
(GAP)

Addresses environmental,
economic, and social
sustainability for on-farm
practices

Results to safe and quality food

 Good Hygienic
Practices (GHP)

All practices regarding the conditions and

measures necessary to ensure food
safety at ALL stages of the food chain
 Good Manufacturing Practices
(GMP)

Ensures that products are consistently manufactured

to quality standards appropriate for the intended use
Hazard Analysis and
Critical Control Points
(HACCP)

Identifies, evaluates, and

controls hazards which are
significant for food safety in
the food supply chain
 TOTAL QUALITY
MANAGEMENT
SYSTEM

HACCP

GAP GHP

GMP
 Food Safety Regulatory System

Combination of regulations, food safety standards, and other

activities responsible for the control of food safety risks in the
food supply chain.
Regulatory Level Setting

Monitoring

Inspection
Testing
Data Collection
What Do We Have to Test
For?
Pathogens
E. coli, Salmonella, Listeria, parasites, etc.

Toxins
Mycotoxins, Histamine, Neurotoxins, etc.

Other substances
– Allergens
– Additives
– Heavy Metals, etc.
 Philippine Food Standards
• FDA Circular No. 2013-10
List of Microbiological Standard for Processed Food

• Summary of Current Food Standards

Minimum Requirement for Analysis of Finished Product
GOOD MANUFACTURING
PRACTICES (GMP)
Describe the methods, equipment, facilities, and
controls for producing processed food.

The minimum sanitary and processing requirements

for producing safe and wholesome food
Food produced under unsanitary condition is deemed
adulterated and unfit for human consumption

•USFDA
 Assessment Criteria
• Plant Premises
• Equipment
• Personnel Training and Hygiene
• Sanitation and Pest Control
• Recall System
• Records
• Cleaning Procedures (sSOP)
 Plant Premises
GMP

Design should minimize contamination by allowing

effective maintenance, cleaning, and disinfection
LOCATION

Away from polluted areas,

areas subject to
flooding, pest
infestations and
presence of wastes
BUILDING INTERIOR
• Separation of activities that can cause contamination
• Sufficient space for operations
• Excludes pests
• Walls, doors and partitions with smooth surface
• Floors with adequate drainage and area for waste disposal facilities
• Adequate lighting and ventilation
SANITARY FACILITIES
• Washrooms
• Hand Washing Notices
• Toilet
• Equipment cleaning and sanitizing
facilities
WATER SUPPLY
• Analyze for potability

• Maintain a record for all analysis done pertaining to

chemical and microbiological safety.
 Equipment
GMP

• Food contact surfaces – NON – TOXIC MATERIALS

• Design and installation

• Should be properly maintained and calibrated
 Personnel Training and Hygiene
GMP

TRAINING
- All personnel must have proper training on specific
operation, hygiene, and safety.

HYGIENE
- people with illness that is likely to be transmitted in
food should not be allowed inside the processing area.
- suitable clothing and covering
• Jaundice
• Diarrhea
• Vomitting
• Fever
• Sore throat with fever
• Visible infected skin
lesions (boils, cuts, etc)
• Discharges from the ear,
eye or nose
Areas
Frequently
Missed
 Sanitation and Pest Control
GMP

• Protocols
• Programs
• Records
 Recall System
GMP

• Procedure
• Product Code Identification
• Recall Capability
• Distribution Records
 Records
GMP

• For all records to be kept

legible, permanent and accurate
signed and dated by the person responsible
 Sanitation SOP
GMP

Written procedures that an

establishment develops and
implements to prevent direct
contamination or adulteration of
product
Pre-operational
•Description of equipment
disassembly and reassembly after
cleaning
•Use of acceptable chemicals
•Cleaning techniques

Operational
• Equipment and utensil cleaning/
sanitizing/ disinfecting during production
• Procedures for employee hygiene
• Product handling in raw and in cooked
product areas
 Key Factors
Safety of water and ice
Potability, source, supply, handling and storage

Condition and cleanliness of food contact

surfaces
Chopping boards, employees garments etc.

Prevention of cross contamination

Separation of raw and cooked areas etc.
Key Factors
Maintenance of hand washing and toilet
facilities
Condition, location, adequacy

Protection of food and food contact surfaces from

adulteration
Lighting, ventilation, unsanitary water

Proper labeling, storage and use of toxic

compounds
 Key Factors

Employee health conditions

Fit to work, no communicable disease

Exclusion of pests and animals from the

plant
Rodents, Insects and animals
 HAZARD ANALYSIS AND
CRITICAL CONTROL
POINTS

•Originally developed for the safety of NASA

astronaut’s foods
•Pro-active and never fixed

•Recognized by regulatory bodies and widely adopted around

the world
• Can be incorporated in other QA systems such as the ISO 9000
series
Hazard

An agent in, or condition of, feed or food with the

potential to cause an adverse health effect.
 HACCP Principles
1. Conduct a hazard analysis
 Identify hazards and risks associated with them
 Physical, Biological, Chemical
 Describe possible control measures

2. Determine Critical Control Points (CCP)

 Essential controllable step to prevent/eliminate hazard
 Decision Tree
 HACCP Principles
3. Establish critical limits
 Each control measure must have a critical limit

4. Establish a monitoring system

 Scheduled monitoring of a CCP

5. Establish a corrective action for CCPs with

deviation
 HACCP Principles

6. Establish procedures for verification of the

effectiveness of the HACCP Plan
 Audit and random sampling

7. Establish documentation system for all records

 Developing a HACCP Plan

Task 1 – Establish a HACCP Team

• Interdisciplinary team to fully understand the commodity
system and all likely hazards and CCPs
1. Team Leader
2. Commodity specialist
3. Production
4. Engineering
5. Other Specialists
• Microbiologist, Mycotoxicologist, Chemist, QC Manager, Process
Engineer, etc.
6. Technical Secretary
 Developing a HACCP Plan

Task 2- Describe the Product

• Full product description
• Customer/Client Specification
• Includes information relevant to product safety
o Nutritional and analytical characteristics
o Details of any medications included and associated withdrawal period

• Packaging, storage, and transportation requirements

•Can be amended when any relevant changes take place.

 Developing a HACCP Plan

Task 3- Identify the Product’s Intended Use

• Usually presented with product description
• Important to identify the relevant hazards
Discrimination between the different demographic groups
• Normal Consumers
• Susceptible Group: Infants, Elderly,
Immunocompromised
• Human Food vs. Animal Feed
 Developing a HACCP Plan

Task 4 – Draw up the Commodity Flow Diagram

Requires the expertise of the Commodity Specialist
– Commodity systems differ in detail in different parts of the world

Secondary Processing Facility

Needs a detailed process flow
General flows should only be used as a guide
 Developing a HACCP Plan

Task 5 – On site Confirmation of Flow Diagram

• On-site comparison of CFD and actual process
“Walking the Line”
Inclusion of missed details in the CFD

• Should be repeated as much as possible to ensure that all

relevant information will be collected
Actual problems
Deviations

•Consultation with people from related fields or industry

 Developing a HACCP Plan

Task 6 – Identify the Hazards

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Chemical Hazards
 Developing a HACCP Plan

Task 6 – Identify the Hazards

Hazard Analysis
• Conducted to understand the relative health risk to man
or animal posted by the hazard by means of available
scientific information

• High-risk hazard will move on to be identified as a CCP

 Developing a HACCP Plan

Task 6 – Identify the Hazards

Control Measure
Activity that can control the level of the identified hazard
into an acceptable level

GAP, GMP, and GHP

Conditions in determining control measures
• Can the hazards be eliminated?
• Can the hazards be removed by engineering design
• Can the hazards be managed by automated process
control system?
• Can the hazard be managed by personnel action?
 Developing a HACCP Plan
Task 7 – Determine the CCPs
• Hazard-containing Steps
– Control Point
• Hazard can be controlled/eliminated at latter stage
– Critical Control Point (CCP)
• Step where an identified hazard can be adequately controlled and is best
controlled at this step

• Decision Tree
– Useful in identifying CCPs
– Every step in the CFD is evaluated to determine
 Developing a HACCP Plan
Task 8 – Establish Critical Limits for Each CCP
• Critical Limits
– Must be specified and validated for each CCP
– Maximum and/or minimum value to which a hazard must
be controlled
– Basis
• Legislative requirements
• Experience or scientific research

• Must be documented in the HACCP Plan

Worksheet
 Developing a HACCP Plan
Task 9 – Establish a Monitoring Procedure
• Monitoring
– Mechanism for confirmation that critical limits are being
met
– Method must be sensitive and fast

• Time, Temperature, & Moisture content

Most common measurements taken
 Developing a HACCP Plan
Task 10 – Establish Corrective Action
• Should take into account should take into account the worst
case scenario
• Assessment of hazards
• Risk and severity
• Final use of the product

• CCP monitors should be familiar with and is trained in

how to effect a corrective action
 Developing a HACCP Plan
Task 10 – Establish Corrective Action
• Corrective Action
– Ensure that CCP has been brought back under control
– Pre-emptive and Preventive

• Alarm system
Installed whenever possible to indicate that critical limit
is being approached
 Developing a HACCP Plan
Task 11 – Verify HACCP Plan
• Established plan, CCPs, and critical limits must be
validated
• Once established, it must be verified and reviewed at
regular intervals
• Microbiological and other chemical tests can be used to
confirm that the plan is effective
– Audit (Internal and External)
– Random sampling and testing
– Observing operations at CCPs
– Complaints monitoring
 Developing a HACCP Plan
Task 12- Keep Record
• Essential part of HACCP
• Conformity
• Traceability

•Records
All processes and procedures linked to GMP, GHP, CCP
monitoring, deviations, and corrective actions

•Manual or Digital
 Form 1. Product Description
FORM 1
PRODUCT DESCRIPTION

PROCESS/PRODUCT TYPE NAME

1. PRODUCT NAME(S)

2. IMPORTANT PDT. CHARACTERISTICS

3. HOW IT IS TO BE USED

4. PACKAGING

5. SHELF LIFE

6. WHERE IT WILL BE SOLD

7. LABELLING INSTRUCTIONS

8. SPECIAL DISTRIBUTION CONTROL

 Form 2. List of Product Ingredients and
Incoming Materials
FORM 2

LIST OF PRODUCT INGREDIENTS AND INCOMING MATERIAL

PRODUCT NAME:
 Form 3. Process Flow Diagram
FORM 3

PROCESS FLOW DIAGRAM

PRODUCT NAME (S):

 Form 4. Plant Schematic
FORM 4

PLANT SCHEMATIC

PRODUCT NAME (S):

Form 5. Hazards Identification (Biological)
FORM 5

HAZARD IDENTIFICATION

PRODUCT NAME (S):

LIST ALL BIOLOGICAL HAZARDS RELATED TO ING., INCOMING

MATERIAL, PROCESSING, PRODUCT FLOW, ETC.

IDENTIFIED BIOLOGICAL HAZARDS CONTROLLED AT

(Bacteria, Parasites, Viruses)

Incoming Materials:

Process Steps:
 Biological Hazards
• Vegetative cells (eg. E.coli, Salmonella, Vibrio)
• Spores (eg. Bacillus cereus, Clostridium)
• Parasites (eg. Toxoplasma gondii)
• Viruses (eg. Hepatitis A virus)
• Biological toxins (eg. Staphylococcus aureus)
• Seafood toxins (eg. Scombroid)
Form 6. Hazards Identification (Chemical)
FORM 6

HAZARD IDENTIFICATION

PRODUCT NAME (S):

LIST ALL CHEMICAL HAZARDS RELATED TO ING., INCOMING

MATERIAL, PROCESSING, PRODUCT FLOW, ETC.

IDENTIFIED CHEMICAL HAZARDS CONTROLLED AT

Allergens, Histamine, Pesticide residue

Incoming Materials:

Process Steps:
 Chemical Hazards
• Biogenic amines, toxins (eg. Histamine)
• Natural chemicals, fungal and mushroom
toxins (eg. Lead, Mercury)
• Allergens and intolerance (eg. Peanut, milk,
egg, soy, chili)
• Residues (eg. Pesticides)
• Other natural toxins (eg. honey intoxication)
Form7. Hazards Identification (Physical)
FORM 7

HAZARD IDENTIFICATION

PRODUCT NAME (S):

LIST ALL PHYSICAL HAZARDS RELATED TO ING., INCOMING

MATERIAL, PROCESSING, PRODUCT FLOW, ETC.

IDENTIFIED PHYSICAL HAZARDS CONTROLLED AT

Glass, Wood, Stones, Plastic wrap

Incoming Materials:

Process Steps:
 Physical Hazards
• Hard foreign objects (eg. Glass, wood, stones,
metal, bones)
• Functional hazards (eg. Packaging defects,
particle size deviation)
• Choking hazards (eg. Pieces of food, plastic
wrap)
• Thermal hazards (eg. food so hot that it burns
tissue)
  QUIZ 
1. Food Safety Act – RA ______
2. Name one pathogen commonly tested for in food products.
3 – 6. State correct order of Farm to Fork Approach.
A. Producers
B. Consumer
C. Distributors
D. Processors
7. Give one frequently missed area during hand washing.
8. GMP stands for __________________________.
9. “s” in sSOP stands for __________________________.
10. True of False: Jewelry can be worn inside the production area.
  ANSWERS 
1. Food Safety Act – RA 10611
2. E. coli, Listeria, Salmonella, parasites
3 - 6. ADCB
A. Producers
D. Processors
C. Distributors
B. Consumer
7. Thumb, fingertips, nail, in between fingers, palm lines
8. Good Manufacturing Practices
9. Sanitation
10. FALSE