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


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Presentation GuideIntroduction

Pre-Requisite Program PRP

PRPs & oPRPs

Critical Control Point (CCP) & ItsDetermination

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 aresignificant for food safety

Other hazards are controlled underGHP/GMP (PRP)

Identifies specific hazards & preventive

measures for their control

Consists of seven principles4


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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 specificsfor different food products

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PRE-REQUISITE PROGRAMS(PRP)

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PRE-REQUISITES TO HACCP

Establishment is legal - food premises mustbe registered

Operate according to relevant by-lawsProducts 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 safetyas described in the Codex

General Principles of Food Hygiene

and other Codes of Practice

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Required conditions can be achieved through:

Good Manufacturing Practices (GMP) / GoodHygienic Practices (GHP)

Sanitation Standard Operating Procedures

(SSOP)

PRP

Coverage depends on : regulatory requirement

size of business types of product

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PRP and operational PRPs PRPBasic food safety

conditions and activitiesthat are necessary tomaintain a hygienicenvironment throughout

the food chain suitable forthe production, handlingand provision of safe endproducts and safe food for

human consumption

Operational PRPMeasures identified by the

hazard analysis asessential in order tocontrol the likelihood ofintroducing food safety

hazards and/orcontamination orproliferation of food safetyhazards in the product(s)

or in the processingenvironment

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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, handsanitizing, 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 isimportant 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 bedocumented & 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 chemicalsin 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, hazardouschemicals 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

Pests include birds,

rodents, cockroaches,flies and other insects

Effective and continuouspest control program in

place prevent entry of pests

elimination of breedinggrounds of pests

if using chemicals, getexpert 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) andpackaging 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 andtraceability system in place to ensure completeand rapid recall of affected lot

Do a mock recall to evaluate effectiveness Able to trace up & down

XCUSTOMER 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 theirsuitability & verified for effectiveness

Good record keeping to provide evidence oncontinuous 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 necessarycontrols 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 beexercised overone or more factors to

prevent or eliminate a food safety hazardor 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 toprevent or eliminate the hazard, or minimize thelikelihood of its occurrence

CCPs are determined through thoroughknowledge & 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 hazardsand conditions leading to their presence

to decide which are

significant for food safetyand should be addressed

in the HACCP plan

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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 thehazard

Use flow diagram that has been verified

identify preventive measures for theircontrol

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hazards that are reasonably likely tooccur

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-relatedhazards

Identify the potential process-relatedhazards

Complete the hazard-analysis

worksheet

Understand the potential hazard

Determine if the potential hazard is

significant

Identify the critical control points

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HAZARD ANALYSIS WORKSHEET (MS 1480)

1 2 3 4 5 6

Process

Step

Potential

hazardState

whether

B, C or P

Rational for

inclusion or

exclusion as

a hazard

Is this a

significant

hazard?

(Yes / No)

Whatpreventivemeasureor controlcan beapplied topreventthissignificanthazard?

Is this

step a

criticalcontrol

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 hazardor reduce it to an acceptable level

Control measures must be validated foreffectiveness

Column 5 on Hazard-Analysis Worksheet

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Hazard Analysis Worksheet1 2 3 4 5 6

Process StepPotentialhazard1

State whetherB, C or P

Rational forinclusion or

exclusion as ahazard

Is this asignificant

hazard?(Yes / No)

What preventivemeasure or

control can beapplied to

prevent thissignificant

hazard?

Is thisstep aCCP?5

(Yes/No)

Biological In / Ex: justify

Chemical In / Ex: justify

Physical In / Ex: justify

Example

1. Receiving ofsemi-processraw soya sauce

2B: Pathogens:

S aureus

In: Likely to occur

based onhistorical data

Yes Control water

activity below (aw)0.75; salt contentabove 20%.

No

3C: 3 MCPD (3-chloro-1,2-propanediol)

Ex: Strictcontrol ofsuppliers underApprovedSupplierProgram

(LeaveBlank)

Testing every 6months to ensurecompliance. PRP #5Chemical Analysis

Records

4P: None (Leave Blank) (LeaveBlank)

(Leave Blank)

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PRP or CCP?

How to know if the hazardis to be controlled under

PRP or HACCP

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Hazard Analysis Worksheet - Explanation

1 2 3 4 5 6

ProcessStep

Potential

hazard1

State

whether

B, C or P

Rational forinclusion orexclusion as

a hazard

Is this asignifica

nthazard?(Yes /

No)

Whatpreventivemeasure or



hazard?

Is this

step aCCP?5

(Yes/No)

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1 Identify potential food safety hazards introduced, controlled orenhanced at this step. Do not carry the hazard through subsequent

steps5Column 6 will be answered yes only if the step in column 1 is acritical control point. The control measure is applied at that step

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H d A l i W k h E l i


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Hazard Analysis Worksheet - Explanation1 2 3 4 5 6

ProcessStep

Potentialhazard1

State

whether

B, C or P




hazard?(Yes /

No)




hazard?

Is thisstep aCCP?5

(Yes/No)

Example

1.Receivingof semi-

processraw soyasauce

2B:Pathogen:S aureus

In: Likely tooccur basedon historicaldata

YesControl wateractivitybelow (aw)0.75; salt

contentabove 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 includesthe scientific, regulatory, or historical reasons for the decision. A controlmeasure is required in column 5. The group then determines whetherthe hazard is significant using the hazard matrix (Y/N in column 4)

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H d A l i W k h t E l ti


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Hazard Analysis Worksheet - Explanation

1 2 3 4 5 6






hazard?(Yes / No)




hazard?

Is thisstep aCCP?5

(Yes/No)

Example

1.Receivingof semi-

processraw soyasauce

3C: 3MCPD (3-chloro-1,2-

propanediol)

Ex: Strictcontrol ofsuppliersunder

ApprovedSupplierProgram

(LeaveBlank)

Testing every6 months toensurecompliance.

PRP #5ChemicalAnalysisRecords

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If the group identifies a potential hazard in column 2, & is Exclusion,justification is required in column 3. This justification normally includesPRP or procedures that manage the hazard to ensure that this step isnot necessary to be controlled under HACCP. A control measure isrequired in column 5. Column 4 will be left blank

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More examples safety alone is not sufficient


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More examples safety alone is not sufficient

1 2 3 4 5 6

Process Step

Potentialhazard1

StatewhetherB, C or P




hazard?(Yes / No)

What preventivemeasure or controlcan be applied to

prevent thissignificant hazard?

Is this stepa CCP?5

(Yes/No)

1. Pasturi-zation (soysauce)

B: 1. Saureus

Inc. Known tooccur due to xcontn from fdhandler

No

- Testing of fdhandlers every 3months toensure not acarrier, oPRP #7.- Fd handlershygiene in place.

SOP 1

*No/Yes

2. A.oryzae

Exc. Qualityissue(Inc.)*

-(Yes)*

Ensure time-To

met

3. Filmyeast

Exc. Qualityissue

(Inc)*

-(Yes)*

Ensure time-To

met

C: Nil

P: Nil

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

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More examples


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More examples

1 2 3 4 5 6






hazard?(Yes / No)

What preventivemeasure or controlcan be applied to

prevent thissignificant hazard?

Is this stepa CCP?5

(Yes/No)

2. Pasturi-zation(milk)

B:SalmonellaBrucella, S.aureus

Inc.Known tooccur inmilk

YesEnsure time-T

o

to destroypathogens met(>65oC,>15min)

Yes

C: Nil

P: Nil

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More examples


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More examples1 2 3 4 5 6

ProcessStep

Potentialhazard1

State

whether

B, C or P




hazard?(Yes / No)


control can beapplied to prevent

this significanthazard?

Is thisstep aCCP?5

(Yes/No)

3. Washingof hands

(bakery/catering/restaurant)

B: E coli, S.aureus,Salmonella

Inc:Happen -ned before.Likely tooccur from

fd handlershands

Yes

1. Ensure fdhandlers wash& sanitizehands every h2. Fd handlersundergo

medical checkevery 6 monthto isolatecarriers

Yes

C: freechlorine

Exc: Residuevalidated for

SOP

- Ensure correctamount used,

strict adheren-ce to SOP

P: Nil - - -

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HAZARD ANALYSIS WORKSHEET (US)


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1 2 3 4 5 6

INGREDIENT/PROCESSINGSTEP

IDENTIFYPOTENTIAL B,C & PHAZARDS

ASSOCIATEDWITH THISPRODUCT &PROCESS

ARE ANYPOTENTIALFOODSAFETYHAZARDS

SIGNIFICANTAT THISSTEP?(YES/NO)

JUSTIFYYOURDECISIONFORCOLUMN3

WHATPREVENTIVEMEASURE(S)CAN BEAPPLIED FOR

THESIGNIFICANTHAZARDS?

IS THISSTEP A

CRITICAL

CONTROLPOINT?

(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)

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DETERMINING CCP

CCP - step where control can be applied & isessential to prevent, eliminate or reduce afood safety hazard to acceptable levels

CCPs can be determined through the Use ofthe 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 aparticular step is a CCP for a previouslyidentified hazard

It is merely a tool and not a mandatoryelement of HACCP

A CCP decision tree is not a substitutefor expert knowledge

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CCP Decision Tree (MS/Codex)


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CCP

Q1. Are there preventive measure(s)

for the identified hazard?

NOIs 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?

YESNO

Q3. Could contamination occur at unaccept.

levels or increase to unaccept. levels?

NO Not a CCP STOPYES

Q4. Will a subsequent step eliminate or

reduce hazard to an acceptable level?

NO

Questions to be answered for each potential hazard for each step

YES

CCP DECISION TREE (US)


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CCP DECISION TREE (US)

Q1. DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK ANDSEVERITY 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 THISSTEP, PROCESS

OR PRODUCT

YES

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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

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

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HAZARD

A biological, chemical orphysicalagent in, or condition of,

foodwith the potentialto cause an adverse health

effect

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SUMMARY


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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 hygienicpractices before embarking on HACCP

The effectiveness of PRP has to be assessedduring the development & implementation of theHACCP Plan

SUMMARY

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CCP HACCP Principle 2 determined


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Principle 1 identifies hazards associated withfood 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

CC CC c p e dete edfrom hazard analysis in Principle 1

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

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