STANDARD MALAYSIA CERTIFICATION BODY FORUM

19 June 2012

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

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Presentation Guide

Introduction

Pre-Requisite Program PRP

PRPs & oPRPs

Critical Control Point (CCP) & Its
Determination

Summary
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Introduction

FOOD SAFETY
PLAN

PRP/support
programs
(GMP, SOP,
SSOP, etc.)
+

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

Control of operation
Maintenance & sanitation
Personal hygiene
Transportation
Product information &
consumer awareness
Training

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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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

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

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

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,

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

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

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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significant hazards =
likelihood x severity
reasonably likely to
occur

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likely to result in an
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

Process
Step

Potential
hazard
State
whether
B, C or P

Rational for
inclusion or
exclusion as
a hazard

What
preventive
measure
Is this a
or control
significant can be
hazard? applied to
prevent
(Yes / No) this
significant
hazard?

Is this
step a
critical
control
point?
(Yes /
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

Process Step

Example
1. Receiving of
semi-process
raw soya sauce

Potential
hazard1
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?

Biological

In / Ex: justify

Chemical

In / Ex: justify

Physical

In / Ex: justify

2B:

Pathogens:
S aureus

In: Likely to occur

3C:

Ex: Strict
control of
suppliers under
Approved
Supplier
Program

(Leave
Blank)

Testing every 6
months to ensure
compliance. PRP #5
Chemical Analysis
Records

(Leave Blank)

(Leave
Blank)

(Leave Blank)

3 MCPD (3-

chloro-1,2propanediol)

4P:

None

Yes

based on
historical data

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Control water
activity below (aw)
0.75; salt content
above 20%.

6
Is this
step a
CCP?5
(Yes/No)

No

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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

Process
Step

Potential
hazard1
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)

Identify 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

Process
Step

Example
1.
Receiving
of semiprocess
raw soya
sauce

2
Potential
hazard1
State
whether
B, C or P
2B:

Is this a
significant
Rational for
hazard?
inclusion or
(Yes /
exclusion as a
No)
hazard

In: Likely to

Pathogen: occur based

S aureus
on historical
data

Yes

What preventive
measure or
control can be
applied to
prevent this
significant
hazard?

Is this
step a
CCP?5
(Yes
/No)

Control water
activity
below (aw)
0.75; salt
content
above 20%.

No

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

Process Step

Example
1.
Receiving
of semiprocess
raw soya
sauce

2
Potential
hazard1
State whether
B, C or P

3C:

3
MCPD (3chloro1,2propanedi
ol)

3
Rational for
inclusion or
exclusion as a
hazard

Ex: Strict
control of
suppliers
under
Approved
Supplier
Program

Is this a
significant
hazard?
(Yes / No)

What preventive
measure or
control can be
applied to
prevent this
significant
hazard?

(Leave
Blank)

6
Is this
step a
CCP?5
(Yes/No)

Testing every
6 months to
ensure
compliance.
PRP #5
Chemical
Analysis
Records

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

Process Step

Example
1.
Receiving
of semiprocess
raw soya
sauce

2
Potential
hazard1
State whether
B, C or P

4P:

None

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?

(Leave
Blank)

(Leave
Blank)

(Leave
Blank)

6
Is this
step a
CCP?5
(Yes/No)

4If

the 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
Process Step

1. Pasturization (soy
sauce)

Potential
hazard1
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)

B: 1. S
aureus

Inc. Known to
occur due to x
contn from fd
handler

2. A.
oryzae

Exc. Quality
issue
(Inc.)*
Exc. Quality
issue
(Inc)*

3. Film
yeast

No

(Yes)*
(Yes)*

- Testing of fd
handlers every 3
months to
ensure not a
carrier, oPRP #7.
*
- Fd handlers
hygiene in place. No/Yes
SOP 1
Ensure time-To
met
Ensure time-To
met

C: Nil
P: Nil

* No technically correct, but need Yes to control spoilage, so its CCP

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More examples
1
Process Step

Potential
hazard1
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- B:
zation
Salmonella
(milk)
Brucella, S.
aureus

Inc.
Known to
occur in
milk

Yes

Ensure time-To
to destroy
pathogens met
(>65oC,
>15min)

Yes

C: Nil
P: Nil

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More examples
1

Process
Step

2
Potential
hazard1
State
whether
B, C or P

3. Washing B: E coli, S.
aureus,
of hands
Salmonella
(bakery/
catering/
restaurant)

C: free
chlorine

P: Nil

Is this a
Rational for
significant
inclusion or
hazard?
exclusion as a
(Yes / No)
hazard

Inc:
Happen ned before.
Likely to
occur from
fd handlers
hands

Yes

Exc: Residue
validated for
SOP

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5
What preventive
measure or
control can be
applied to prevent
this significant
hazard?

1. Ensure fd
handlers wash
& sanitize
hands every h
2. Fd handlers
undergo
medical check
every 6 month
to isolate
carriers
Ensure correct
amount used,
strict adherence to SOP
-

6
Is this
step a
CCP?5
(Yes
/No)

Yes

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HAZARD ANALYSIS WORKSHEET (US)

FIRM NAME:

PRODUCT DESCRIPTION:

FIRM ADDRESS:

METHOD OF DISTRIBUTION AND STORAGE:

INTENDED USE AND CONSUMER:

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

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WHAT
PREVENTIVE
MEASURE(S)
CAN BE
APPLIED FOR
THE
SIGNIFICANT
HAZARDS?

IS THIS
STEP A
CRITICAL
CONTROL
POINT?
(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)
for the identified hazard?

Modify process step, Process

or product?

YES

YES

Is control at this step necessary

for product safety?

NO

Q2. Is step specifically designed to

eliminate or reduce likely occurrence
of a hazard to an acceptable level?

NO

Not a CCP

STOP

YES

NO
Q3. Could contamination occur at unaccept.
levels or increase to unaccept. levels?

YES

NO

Not a CCP

YES
Q4. Will a subsequent step eliminate or
reduce hazard to an acceptable level?

NO

STOP

CCP

CCP DECISION TREE (US)

Q1.

DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK AND

SEVERITY TO WARRENT ITS CONTROL?

YES

Q2.

NO

NOT A CCP

DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?

YES

NO
IS
CONTROL
AT THIS
STEP
NECESSARY
FOR
SAFETY?

Q3
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NO

MODIFY THIS
STEP, PROCESS
OR PRODUCT

YES

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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