STANDARD MALAYSIA CERTIFICATION BODY FORUM

19 June 2012

Pre-Requisite Programs
(PRP)
and
Critical Control Points (CCP)

Zahara Merican
 Presentation Guide

Introduction

Pre-Requisite Program PRP

PRPs & oPRPs

Critical Control Point (CCP) & Its
Determination

Summary

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 Introduction
PRP/support
programs
(GMP, SOP,
FOOD SAFETY SSOP, etc.)

PLAN = +
HACCP
+
Effective training

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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
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 FOOD SAFETY MANAGEMENT SYSTEM

PRP (GMP/GHP) HACCP PRINCIPLES

Design & facilities 1.Conduct hazard analysis
Control of operation 2.Determine Critical Control Points
Maintenance & sanitation (CCP)
Personal hygiene 3.Establish critical limit(s)
Transportation 4.Establish monitoring system
Product information & 5.Establish corrective actions
consumer awareness
6.Establish verification procedures
Training
7.Establish documentation &
records
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 References:

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

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)

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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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 PRP
Required conditions can be achieved through:
Good Manufacturing Practices (GMP) / Good
Hygienic Practices (GHP)
Sanitation Standard Operating Procedures
(SSOP)
Coverage depends on :
 regulatory requirement
 size of business
 types of product

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 PRP and operational PRPs
PRP Operational PRP
Basic food safety Measures identified by the
conditions and activities hazard analysis as
that are necessary to essential in order to
maintain a hygienic control the likelihood of
environment throughout introducing food safety
the food chain suitable for hazards and/or
the production, handling contamination or
and provision of safe end proliferation of food safety
products and safe food for hazards in the product(s)
human consumption or in the processing
environment

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
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 PEST CONTROL
PRP oPRP
Pests include birds,
In-house monitoring
rodents, cockroaches,
activities
flies and other insects
What
Effective and continuous How
pest control program in Who
place Frequency

prevent entry of pests CA

elimination of breeding
External service provider
grounds of pests
monitoring activities

if using chemicals, get
expert advice

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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

CUSTOMER COMPLAINTS
Documented procedure for customer complaints
(including auditing)
Records of complaints and actions taken. Use as
feed back
X
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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significant hazards =
likelihood x severity

reasonably likely to likely to result in an

occur unacceptable risk to
consumers

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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
What
preventive Is this
Potential measure step a
Process Rational for Is this a or control
hazard critical
Step inclusion or significant can be
State control
exclusion as hazard? applied to
whether prevent point?
a hazard (Yes / No) this
B, C or P (Yes /
significant
hazard? No)

B=
CCP 1 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
Is this
What preventive step a
measure or CCP?5
Potential Rational for Is this a
control can be (Yes/No)
Process Step hazard1 inclusion or significant
applied to
State whether exclusion as a hazard?
prevent this
B, C or P hazard (Yes / No)
significant
hazard?

Biological In / Ex: justify

Chemical In / Ex: justify
Physical In / Ex: justify
Example 2B:Pathogens: Yes Control water
In: Likely to occur
1. Receiving of S aureus based on activity below (aw) No
semi-process historical data 0.75; salt content
raw soya sauce above 20%.
3C: 3 MCPD (3- (Leave Testing every 6
Ex: Strict
chloro-1,2- control of Blank) months to ensure
propanediol) compliance. PRP #5
suppliers under
Chemical Analysis
Approved Records
Supplier
Program
4P: None (Leave Blank) (Leave (Leave Blank)
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

What
Is this a preventive
Potential significa measure or Is this
Rational for
Process hazard1 nt control can be step a
inclusion or
Step State hazard? applied to CCP?5
exclusion as prevent this
whether (Yes / (Yes
a hazard significant
B, C or P No) /No)
hazard?

1Identify potential food safety hazards introduced, controlled or

enhanced at this step. Do not carry the hazard through subsequent
steps
5Column 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

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 Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
What preventive
Is this a measure or
Potential Is this
Rational for significant control can be
Process hazard1 step a
inclusion or hazard? applied to
Step State prevent this CCP?5
exclusion as a (Yes /
whether significant (Yes
hazard No)
B, C or P hazard? /No)

Example 2B: Control water

In: Likely to
1. Pathogen: occur based Yes activity No
Receiving S aureus on historical below (aw)
of semi- data 0.75; salt
process content
raw soya above 20%.
sauce
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)
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 Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
What preventive
Is this
measure or
Potential Rational for Is this a step a
control can be
Process Step hazard1 inclusion or significant CCP?5
applied to
State whether exclusion as a hazard? (Yes/No)
prevent this
B, C or P hazard (Yes / No)
significant
hazard?

Example 3C: 3 Ex: Strict (Leave Testing every

1. MCPD (3- control of Blank) 6 months to
Receiving chloro- suppliers ensure
of semi- 1,2- under compliance.
process propanedi Approved PRP #5
raw soya ol) Supplier Chemical
sauce Program Analysis
Records
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
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 Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
What preventive
measure or Is this
Potential Rational for Is this a step a
control can be
Process Step hazard1 inclusion or significant CCP?5
applied to
State whether exclusion as a hazard? (Yes/No)
prevent this
B, C or P hazard (Yes / No)
significant
hazard?
Example
1. 4P: (Leave (Leave (Leave
None
Receiving Blank) Blank) Blank)
of semi-
process
raw soya
sauce

4Ifthe group does not identify a potential hazard in column 2, then

columns 3, 4 and 5 will be blank

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 More examples safety alone is not sufficient
1 2 3 4 5 6
Potential What preventive
Rational for Is this a Is this step
hazard1 measure or control
Process Step inclusion or significant a CCP?5
State can be applied to
exclusion as a hazard? (Yes/No)
whether prevent this
hazard (Yes / No)
B, C or P significant hazard?
1. Pasturi- B: 1. S Inc. Known to - Testing of fd
zation (soy aureus occur due to x handlers every 3
No
sauce) contn from fd months to
handler ensure not a
carrier, oPRP #7.
- Fd handlers *
hygiene in place. No/Yes
SOP 1
2. A. Exc. Quality - Ensure time-To
oryzae issue met
(Inc.)* (Yes)*
3. Film Exc. Quality - Ensure time-To
yeast issue met
(Inc)* (Yes)*
C: Nil
P: Nil
* No technically correct, but need Yes to control spoilage, so its CCP
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 More examples

1 2 3 4 5 6
What preventive
Potential Rational for Is this a Is this step
measure or control
Process Step hazard1 inclusion or significant a CCP?5
can be applied to
State whether exclusion as a hazard? (Yes/No)
prevent this
B, C or P hazard (Yes / No)
significant hazard?

2. Pasturi- B: Inc. Ensure time-To

zation Salmonella Known to to destroy Yes
(milk) Brucella, S. occur in
Yes pathogens met
aureus milk (>65oC,
>15min)
C: Nil

P: Nil

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 More examples
1 2 3 4 5 6
What preventive
Potential Is this a measure or Is this
Rational for
Process hazard1 significant control can be step a
inclusion or
Step State hazard? applied to prevent CCP?5
exclusion as a this significant
whether (Yes / No) (Yes
hazard hazard?
B, C or P /No)

3. Washing B: E coli, S. Inc: 1. Ensure fd

of hands aureus, Happen - Yes handlers wash
Salmonella & sanitize
(bakery/ ned before.
hands every h
catering/ Likely to 2. Fd handlers
restaurant) occur from undergo
fd handlers medical check Yes
hands every 6 month
to isolate
carriers
C: free Exc: Residue - Ensure correct
chlorine validated for amount used,
SOP strict adheren-
ce to SOP
P: Nil - - -

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 HAZARD ANALYSIS WORKSHEET (US)
FIRM NAME: PRODUCT DESCRIPTION:
FIRM ADDRESS: METHOD OF DISTRIBUTION AND STORAGE:
INTENDED USE AND CONSUMER:
1 2 3 4 5 6

ARE ANY WHAT

IDENTIFY POTENTIAL PREVENTIVE
JUSTIFY
POTENTIAL B, FOOD MEASURE(S) IS THIS
YOUR
C&P SAFETY CAN BE STEP A
INGREDIENT/ DECISION
HAZARDS HAZARDS APPLIED FOR CRITICAL
PROCESSING FOR
ASSOCIATED SIGNIFICANT THE CONTROL
STEP COLUMN
WITH THIS AT THIS SIGNIFICANT POINT?
3
PRODUCT & STEP? HAZARDS? (YES / NO)
PROCESS (YES/NO)

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 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 Decision Tree (MS/Codex)
Questions to be answered for each potential hazard for each step

Q1. Are there preventive measure(s) Modify process step, Process

for the identified hazard? or product?
YES
YES NO Is control at this step necessary
for product safety?
Q2. Is step specifically designed to
eliminate or reduce likely occurrence NO Not a CCP STOP
of a hazard to an acceptable level?
YES
NO
Q3. Could contamination occur at unaccept.
levels or increase to unaccept. levels?

YES NO Not a CCP STOP

YES
Q4. Will a subsequent step eliminate or
reduce hazard to an acceptable level? NO
CCP
 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?

MODIFY THIS
YES NO STEP, PROCESS
OR PRODUCT

IS
CONTROL
AT THIS
STEP YES
NECESSARY
FOR
SAFETY?

Q3 NO NOT A CCP STOP*

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 CCP DECISION TREE
Q3. IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE
OR REDUCE THE RISK OF THE HAZARD TO CONSUMERS?

YES NO NOT A CCP STOP*

CCP

This decision tree is derived from one that was developed by the National
Advisory Committee on Microbiological Criteria for Foods, USA

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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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 SUMMARY
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
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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

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 CCP HACCP Principle 2 determined
from hazard analysis in Principle 1

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

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