Pre-Requisite Programs

(PRP)
and
Critical Control Points (CCP)
STANDARD MALAYSIA CERTIFICATION BODY FORUM
19 June 2012
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Presentation Guide
Introduction
Pre-Requisite Program PRP
PRPs & oPRPs
Critical Control Point (CCP) & Its
Determination
Summary
2
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Introduction
FOOD SAFETY
PLAN
PRP/support
programs
(GMP, SOP,
SSOP, etc.)
+
HACCP
+
Effective training
=
3
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HACCP
= Hazard Analysis & Critical Control Point
A system that identifies, evaluates &
emphasize controls of hazards which are
significant for food safety
Other hazards are controlled under
GHP/GMP (PRP)
Identifies specific hazards & preventive
measures for their control
Consists of seven principles
4
FOOD SAFETY MANAGEMENT SYSTEM
PRP (GMP/GHP)
Design & facilities
Control of operation
Maintenance & sanitation
Personal hygiene
Transportation
Product information &
consumer awareness
Training
HACCP PRINCIPLES
1.Conduct hazard analysis
2.Determine Critical Control Points
(CCP)
3.Establish critical limit(s)
4.Establish monitoring system
5.Establish corrective actions
6.Establish verification procedures
7.Establish documentation &
records
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Malaysian standards
MS 1480:2007 Food safety according to HACCP
MS 1514: 2009 Good Manufacturing Practices (GMP)
Equivalent: Codex Food Hygiene Basic Text, Rev. 2003
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References:
Others:
o ISO 22000: 2005 Food Safety Mgt Systems
Requirements for any organization in the food chain
o USFDA cGMP Regulations & specific HACCP regulations
o EU legislations on Hygiene of Foodstuff, and specifics
for different food products
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PRE-REQUISITE PROGRAMS
(PRP)
7
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PRE-REQUISITES TO HACCP
Establishment is legal - food premises must
be registered
Operate according to relevant by-laws
Products comply with appropriate regulatory
requirements such as:
Food Act 1983: Food Regulations 1985;
Food Hygiene 2009; etc.
mandatory codes of hygienic practice
Products comply with:
customer/importer requirements
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Prerequisites to HACCP (PRP)
Practices and conditions needed
prior to and during
the implementation of HACCP
and which are essential for food safety
as described in the Codex
General Principles of Food Hygiene
and other Codes of Practice
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PRPs provide foundation for effective
HACCP Implementation
Developed, documented and implemented
before implementing HACCP
Required to control factors that may or may not
be directly related to the manufacturing controls,
but support the HACCP Plans
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Required conditions can be achieved through:
Good Manufacturing Practices (GMP) / Good
Hygienic Practices (GHP)
Sanitation Standard Operating Procedures
(SSOP)
PRP
Coverage depends on :
regulatory requirement
size of business
types of product
11
PRP and operational PRPs
PRP
Basic food safety
conditions and activities
that are necessary to
maintain a hygienic
environment throughout
the food chain suitable for
the production, handling
and provision of safe end
products and safe food for
human consumption
Operational PRP
Measures identified by the
hazard analysis as
essential in order to
control the likelihood of
introducing food safety
hazards and/or
contamination or
proliferation of food safety
hazards in the product(s)
or in the processing
environment
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Ref: ISO 22000: 2005
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SSOP USFDA REGULATIONS
Safety of water
contact with food, food contact surfaces, or used as ice
Condition & cleanliness of food contact surfaces
including utensils, gloves, and outer garments
Prevention of cross contamination
from insanitary objects to food / food contact surfaces
from raw product to cooked product
Maintenance of sanitary facilities hand washing, hand
sanitizing, and toilet
Protection of food from adulteration
Proper labeling, storage and use of toxic compound
Control of employee health condition
Exclusion of pests from the food plant
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CLEANING AND SANITATION
An effective cleaning and sanitation program is
important to minimize food contamination
Need to consider (SSOP):
what to clean
how to clean
when to clean, and
who will clean
Need to have appropriate equipment cleaning
and sanitizing facilities
Cleaning of cleaning facilities/implements shall be
documented & implemented
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PERSONNEL HYGIENE
what active records are needed
which needs to be filled in every
shift, every day, etc.
Hygiene and health requirements
Communicable diseases & Injuries
Attire and conduct of workers
Policy on visitors
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CHEMICAL CONTROL
Documented procedures in place to ensure segregation,
storage and proper use and control of non-food chemicals
in the plant. Includes cleaning chemicals, fumigants, baits,
etc. Chemical safety data sheets available
Chemicals should be:
correctly labeled including containers for mixing
stored in designated and well ventilated area, hazardous
chemicals under lock
protected from cross-contamination with food or food
contact surfaces or packaging material
dispensed and handled by trained and authorized staff with
procedures for receiving & issuing in place > records
16
PEST CONTROL
PRP
Pests include birds,
rodents, cockroaches,
flies and other insects
Effective and continuous
pest control program in
place
prevent entry of pests
elimination of breeding
grounds of pests
if using chemicals, get
expert advice
oPRP
In-house monitoring
activities
What
How
Who
Frequency
CA
External service provider
monitoring activities
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WASTE MANAGEMENT
Solid and liquid waste disposal
SSOP
Schedule of waste disposal from processing
area and from plant
Drains to have proper flow & traps for solids
Proper covering of waste disposal containers,
including those in the processing area
Cleaning of waste containers &
Central waste collection bins away from
processing area
Discharge must comply with DOE requirements
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SPECIFICATIONS
Written specifications for raw (including origin) and
packaging materials and finished products
Based on regulations, standards, scientific references or
own experiments
Ensure raw materials meet companys requirements
Prevent / reduce hazards in raw materials
Prevent unsuitable raw materials being used in production
Ensure uniform products
Contribute to HACCP implementation, e.g. reduce cost of
analysis, etc.
Meet regulatory requirements
Meet customers requirements
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RECALL AND TRACEABILITY
Documentation of recall procedure and
traceability system in place to ensure complete
and rapid recall of affected lot
Do a mock recall to evaluate effectiveness
Able to trace up & down
X
CUSTOMER COMPLAINTS
Documented procedure for customer complaints
(including auditing)
Records of complaints and actions taken. Use as
feed back
Returned products isolated & appropriate action
taken (destroyed, reworked or reprocessed)
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Maintenance of PRP
Maintenance is essential to ensure continuous
control of favourable operational conditions
The premises & equipment should be kept in
good state of repair
Sanitation control should be monitored for their
suitability & verified for effectiveness
Good record keeping to provide evidence on
continuous adherence to sanitation control
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GENERAL REQUIREMENTS
All PRPs should be:
- Documented (including plant lay-out for materials,
equipment, workers amenities, footbaths, bait stations)
- Monitored and records/checklists kept
- Corrective actions taken and documented
- Records and CA verified
- PRPs maintained & verified where applicable, e.g. hygiene
& sanitation, raw materials, clean rooms
- Use results to update and improve PRPs if necessary
- Reviewed before implementing HACCP Plan, to verify if all
requirements have been met, and if all the necessary
controls and documentation are in place
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CRITICAL CONTROL POINT
&
ITS DETERMINATION
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Critical Control Point
A step in the food chain where activities are
carried out, or conditions prevail which can
have an influence on the safety of the
product, and where control can be
exercised over one or more factors to
prevent or eliminate a food safety hazard
or reduce it to an acceptable level
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Critical Control Point (CCP)
HACCP Principle 2
CCPs are points, procedures or operational
steps in the process that can be controlled to
prevent or eliminate the hazard, or minimize the
likelihood of its occurrence
CCPs are determined through thorough
knowledge & expert judgment of team
members (& specialist advisor) in Principle 1
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PRINCIPLE 1
Conduct a hazard analysis
Prepare a list of steps of the plants
processes
Identify where significant hazards could
occur
Also identifies all possible hazards
Describe the control/preventive measures
At all identified steps
Controlled under HACCP or PRP
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Hazard Analysis - definition
The process of collecting and evaluating
information on hazards
and conditions leading to their presence
to decide which are
significant for food safety
and should be addressed
in the HACCP plan
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Hazard Analysis
A thorough hazard analysis is the key to preparing an
effective HACCP plan
When conducting a hazard analysis, safety concerns
must be differentiated from quality concerns
Hazard analysis & identification of associated control
measures accomplish three objectives:
Those hazards and associated control measures are
identified
The analysis may identify needed modifications to a process
or product so that product safety is further assured or
improved
The analysis provides a basis for determining CCPs in
Principle 2
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hazard analysis involves two stages:
hazard identification & hazard evaluation
1. Hazard identification
Consider all potentially significant hazards
Assess likelihood of occurrence of the hazards
2. Hazard evaluation assess severity of the
hazard
Use flow diagram that has been verified
identify preventive measures for their
control
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reasonably likely to
occur
likely to result in an
unacceptable risk to
consumers
significant hazards =
likelihood x severity
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hazards that are reasonably likely to
occur
Decision is based on:
Experience
Illness data
Scientific reports
Other information (e.g., Hazards and Control
Guide)
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Hazard-Analysis Worksheet
Set up the hazard-analysis worksheet
Identify the potential species-related
hazards
Identify the potential process-related
hazards
Complete the hazard-analysis
worksheet
Understand the potential hazard
Determine if the potential hazard is
significant
Identify the critical control points
(Identify the oPRPs)
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HAZARD ANALYSIS WORKSHEET (MS 1480)
1 2 3 4 5 6
Process
Step
Potential
hazard
State
whether
B, C or P
Rational for
inclusion or
exclusion as
a hazard
Is this a
significant
hazard?
(Yes / No)
What
preventive
measure
or control
can be
applied to
prevent
this
significant
hazard?
Is this
step a
critical
control
point?
(Yes /
No)
CCP 1
B =
C =
P =
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Control Measures
Actions and activities that can be used to
prevent or eliminate a food safety hazard
or reduce it to an acceptable level
Control measures must be validated for
effectiveness
Column 5 on Hazard-Analysis Worksheet
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Hazard Analysis Worksheet
1 2 3 4 5 6
Process Step
Potential
hazard
1
State whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or
control can be
applied to
prevent this
significant
hazard?
Is this
step a
CCP?
5
(Yes/No)
Biological
In / Ex: justify
Chemical
In / Ex: justify
Physical
In / Ex: justify
Example
1. Receiving of
semi-process
raw soya sauce
2
B: Pathogens:
S aureus
In: Likely to occur
based on
historical data
Yes Control water
activity below (a
w
)
0.75; salt content
above 20%.
No
3
C: 3 MCPD (3-
chloro-1,2-
propanediol)
Ex: Strict
control of
suppliers under
Approved
Supplier
Program
(Leave
Blank)
Testing every 6
months to ensure
compliance. PRP #5
Chemical Analysis
Records
4
P: None (Leave Blank) (Leave
Blank)
(Leave Blank)
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PRP or CCP?
How to know if the hazard
is to be controlled under
PRP or HACCP
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Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
Process
Step
Potential
hazard
1
State
whether
B, C or P
Rational for
inclusion or
exclusion as
a hazard
Is this a
significa
nt
hazard?
(Yes /
No)
What
preventive
measure or
control can be
applied to
prevent this
significant
hazard?
Is this
step a
CCP?
5
(Yes
/No)
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1
Identify potential food safety hazards introduced, controlled or
enhanced at this step. Do not carry the hazard through subsequent
steps
5
Column 6 will be answered yes only if the step in column 1 is a
critical control point. The control measure is applied at that step
37
Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
Process
Step
Potential
hazard
1
State
whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes /
No)
What preventive
measure or
control can be
applied to
prevent this
significant
hazard?
Is this
step a
CCP?
5
(Yes
/No)
Example
1.
Receiving
of semi-
process
raw soya
sauce
2
B:
Pathogen:
S aureus
In: Likely to
occur based
on historical
data
Yes
Control water
activity
below (a
w
)
0.75; salt
content
above 20%.
No
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2
If the group identifies a potential hazard in column 2, and is Inclusion,
justification is required in column 3. This justification normally includes
the scientific, regulatory, or historical reasons for the decision. A control
measure is required in column 5. The group then determines whether
the hazard is significant using the hazard matrix (Y/N in column 4)
38
Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
Process Step
Potential
hazard
1
State whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or
control can be
applied to
prevent this
significant
hazard?
Is this
step a
CCP?
5
(Yes/No)
Example
1.
Receiving
of semi-
process
raw soya
sauce
3
C: 3
MCPD (3-
chloro-
1,2-
propanedi
ol)
Ex: Strict
control of
suppliers
under
Approved
Supplier
Program
(Leave
Blank)
Testing every
6 months to
ensure
compliance.
PRP #5
Chemical
Analysis
Records
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3
If the group identifies a potential hazard in column 2, & is Exclusion,
justification is required in column 3. This justification normally includes
PRP or procedures that manage the hazard to ensure that this step is
not necessary to be controlled under HACCP. A control measure is
required in column 5. Column 4 will be left blank
39
Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
Process Step
Potential
hazard
1
State whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or
control can be
applied to
prevent this
significant
hazard?
Is this
step a
CCP?
5
(Yes/No)
Example
1.
Receiving
of semi-
process
raw soya
sauce
4
P: None
(Leave
Blank)
(Leave
Blank)
(Leave
Blank)
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4
If the group does not identify a potential hazard in column 2, then
columns 3, 4 and 5 will be blank
40
More examples safety alone is not sufficient
1 2 3 4 5 6
Process Step
Potential
hazard
1
State
whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or control
can be applied to
prevent this
significant hazard?
Is this step
a CCP?
5
(Yes/No)
1. Pasturi-
zation (soy
sauce)
B: 1. S
aureus
Inc. Known to
occur due to x
contn from fd
handler
No
- Testing of fd
handlers every 3
months to
ensure not a
carrier, oPRP #7.
- Fd handlers
hygiene in place.
SOP 1
*
No/Yes
2. A.
oryzae
Exc. Quality
issue
(Inc.)*
-
(Yes)*
Ensure time-T
o
met
3. Film
yeast
Exc. Quality
issue
(Inc)*
-
(Yes)*
Ensure time-T
o
met
C: Nil
P: Nil
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* No technically correct, but need Yes to control spoilage, so its CCP
41
More examples
1 2 3 4 5 6
Process Step
Potential
hazard
1
State whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or control
can be applied to
prevent this
significant hazard?
Is this step
a CCP?
5
(Yes/No)
2. Pasturi-
zation
(milk)
B:
Salmonella
Brucella, S.
aureus
Inc.
Known to
occur in
milk
Yes
Ensure time-T
o
to destroy
pathogens met
(>65
o
C,
>15min)
Yes
C: Nil
P: Nil
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More examples
1 2 3 4 5 6
Process
Step
Potential
hazard
1
State
whether
B, C or P
Rational for
inclusion or
exclusion as a
hazard
Is this a
significant
hazard?
(Yes / No)
What preventive
measure or
control can be
applied to prevent
this significant
hazard?
Is this
step a
CCP?
5
(Yes
/No)
3. Washing
of hands
(bakery/
catering/
restaurant)
B: E coli, S.
aureus,
Salmonella
Inc:
Happen -
ned before.
Likely to
occur from
fd handlers
hands
Yes
1. Ensure fd
handlers wash
& sanitize
hands every h
2. Fd handlers
undergo
medical check
every 6 month
to isolate
carriers
Yes
C: free
chlorine
Exc: Residue
validated for
SOP
- Ensure correct
amount used,
strict adheren-
ce to SOP
P: Nil - - -
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1 2 3 4 5 6
INGREDIENT/
PROCESSING
STEP
IDENTIFY
POTENTIAL B,
C & P
HAZARDS
ASSOCIATED
WITH THIS
PRODUCT &
PROCESS
ARE ANY
POTENTIAL
FOOD
SAFETY
HAZARDS
SIGNIFICANT
AT THIS
STEP?
(YES/NO)
JUSTIFY
YOUR
DECISION
FOR
COLUMN
3
WHAT
PREVENTIVE
MEASURE(S)
CAN BE
APPLIED FOR
THE
SIGNIFICANT
HAZARDS?
IS THIS
STEP A
CRITICAL
CONTROL
POINT?
(YES / NO)
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FIRM NAME: PRODUCT DESCRIPTION:
FIRM ADDRESS: METHOD OF DISTRIBUTION AND STORAGE:
INTENDED USE AND CONSUMER:
HAZARD ANALYSIS WORKSHEET (US)
44
Relationship between a
significant hazard and a CCP
CCPs are steps in the process where
HACCP control activities will occur
For every significant hazard identified
during the hazard analysis (principle 1)
there must be one or more CCPs where
the hazard is controlled
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DETERMINING CCP
CCP - step where control can be applied & is
essential to prevent, eliminate or reduce a
food safety hazard to acceptable levels
CCPs can be determined through the Use of
the CCP Decision Tree
Caution - CCP must be correctly identified
too many CCPs will dilute effort
too few could result in unsafe food
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use of a CCP decision tree
Application of the CCP decision tree
can be useful in determining if a
particular step is a CCP for a previously
identified hazard
It is merely a tool and not a mandatory
element of HACCP
A CCP decision tree is not a substitute
for expert knowledge
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CCP
Q1. Are there preventive measure(s)
for the identified hazard?
NO
Is control at this step necessary
for product safety?
NO Not a CCP STOP
Modify process step, Process
or product?
YES
YES
Q2. Is step specifically designed to
eliminate or reduce likely occurrence
of a hazard to an acceptable level?
YES
NO
Q3. Could contamination occur at unaccept.
levels or increase to unaccept. levels?
NO Not a CCP STOP
YES
Q4. Will a subsequent step eliminate or
reduce hazard to an acceptable level?
NO
CCP Decision Tree (MS/Codex)
Questions to be answered for each potential hazard for each step
YES
CCP DECISION TREE (US)
Q1. DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK AND
SEVERITY TO WARRENT ITS CONTROL?
YES NO NOT A CCP
Q2. DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?
YES NO
Q3 NO
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IS
CONTROL
AT THIS
STEP
NECESSARY
FOR
SAFETY?
MODIFY THIS
STEP, PROCESS
OR PRODUCT
YES
NOT A CCP STOP*
49
CCP DECISION TREE
Q3. IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE
OR REDUCE THE RISK OF THE HAZARD TO CONSUMERS?
YES
CCP
NO NOT A CCP
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STOP*
This decision tree is derived from one that was developed by the National
Advisory Committee on Microbiological Criteria for Foods, USA
50
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HAZARD
A biological, chemical or
physical
agent in, or condition of,
food
with the potential
to cause an adverse health
effect
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HACCP is not a stand alone system
depends on management commitment
depends on a solid foundation of PRPs: GMP/
GHP; SSOPs & relevant codes of practice
HACCP does not replace nor diminish PRP
attention must be focused on basic hygienic
practices before embarking on HACCP
The effectiveness of PRP has to be assessed
during the development & implementation of the
HACCP Plan
SUMMARY
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Pre-requisite Programs
PRPs must be developed, documented and
implemented
They have to be effectively monitored and
controlled, including proper record keeping,
validation and verification
They are required to control factors that may or
may not be directly related to the processing
controls, but support the HACCP Plan
53
Principle 1 identifies hazards associated with
food production at all stages from raw materials
to point of consumption
The first most important step, wrong hazard analysis
results in faulty HACCP plan
Identifies steps to be controlled as CCPs or oPRPs
Significant hazard = likelihood x severity
Identify control measures for hazard elimination/
reduction/ prevention in the HACCP Plan
CCP HACCP Principle 2 determined
from hazard analysis in Principle 1
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