The ISO STANDARD 22000Food Safety Management Systems

Requirements for organizations throughout the food chain

By Claus Heggum (Danish Dairy Board)

Targeted users of ISO 22000

National legislationbased uponCodexHACCP Guidelines

ISO 22000

Willing, but not (yet) capable

Not willing, not capable

Willing & capable

Scope: All types of organizations within the food chains(advanced/less advanced, with/without CCPs)

Key characteristics� Clarifies existing terms that are often

confused� Systematic decision making � Transparent control system� Food chain approach� Combines recognized key food safety

elements:¾ System management (ISO 9000 approach)¾ Interactive communication (internally, externally)¾ Prerequisite programs (=basic hygiene, GHP, etc)¾ HACCP based hazard control

� Further development of the HACCP concept

Terms that are often confused� Risk & Hazard

Risk = probability of getting ill by ingesting a certain hazard & the severity of that illness

Hazard = agent causing the illness

� Risk analysis & Hazard analysisRisk analysis = governmental taskHazard analysis = industry task

� Monitoring - Verification - Validation• During operation• Documenting that

the control measure functions as intended

• After operation• Documenting that

• monitoring works• degree of intended

control has been delivered

• Prior to operation• Documenting that

the control measure is capable of delivering the needed effects

Key characteristics� Clarifies existing terms that are often

confused� Systematic decision making � Transparent control system� Food chain approach� Combines recognized key food safety

elements:¾ System management (ISO 9000 approach)¾ Interactive communication (internally, externally)¾ Prerequisite programs (=basic hygiene, GHP, etc)¾ HACCP based hazard control

� Further development of the HACCP concept

Principle of equivalence

One extreme: Developing countries- no/minimal control of animal health- ”normal” or additional control during manufacturing- often, additional control at consumption level

Opposite extreme: Raw milk cheese:- Max. control of animal health and hygiene at farm

level- Increased control during/after manufacture, using

hurdle technology- minimal control at consumption level

Solution:Outcome

focus & food chain

management

Primary producer Manufacturer Distributor Consumer

A ”milk product chain”

Control measures

Key characteristics� Clarifies existing terms that are often

confused� Systematic decision making � Transparent control system� Food chain approach� Combines recognized key food safety

elements:¾ System management (ISO 9000 approach)¾ Interactive communication (internally, externally)¾ Prerequisite programs (=basic hygiene, GHP, etc)¾ HACCP based hazard control

� Further development of the HACCP concept

Hazard analysis based design

Available control measuresAvailable control measures

Planning of the control system

Prerequisite programs (PRPs)

Updating

Acceptable practise

Verification

HACCP planOperational PRPs

Verification

System Verifikation

Available knowledge & data

Data & information

Hazard analysis

Validation

The 3 ”legs”

Control measures controlled by Prerequisite Programs (PRPs)

Controlmeasures

controlledby the

HACCP plan

Control measures controlled by Operational PRPs (OPRPs)

The hazard analysis

Hazards to be controlled and the needed degree of

control

Hazard identification

Hazards assessment

Determination of acceptable levels in end products

Combinations of control measures

Validation the capability of meeting acceptable levels in end products

Selection of control measures

Assessment of control measures

Combination that controls the hazards to

the needed degreeCategorization of control measures

O-PRPs HACCP plan

How to control the control measures

Factors determining the categorization� Effect on hazards relative to

applied intensity

� Feasibility for monitoring in time to withhold affected end products

� Ranking of the hazard, e.g:

� Location relative to other control measures (stress, synergy)

� Likelihood of operational failure

�Variation in operational function

The HACCP Plan ?

Operational PRPs

Severe ??? ??? ??? CCP

Moderate OPRP ??? ??? ???

Mild OPRP OPRP ??? ???

Likelihood of occurrence Seldom Occasional Frequent Always

Afverse health effect

Stringency in controlling the control measure

Updating of control measure combinations-

Exisitng Operational PRPs

Existing HACCP Plan

Hazard analysis Modified Operational PRPs

New HACCP plan

Superfluous control measures

Internal communication, e.g.Results of system

verification and review Changed likelihood of hazard occurrence

Product changes

Process changes

External communication

Changes in controls applied beyond the

organization´s system

Changed acceptable hazard(s) level(s)

New requests for specific control

measure(s) (authorities/customers)

New knowledge

Main differences to the current approach

Current approach:• Starting point: Flow diagram

• What can go wrong (events)?

• Focus on determinining the CCPs

• Limited documentation of hazard analysis

• Tends to result in static control system

• Semi-quantitative approach (zero-tolerance/ALARA)

ISO 22000 approach:• Starting point: Outputyinput

• Controls needed & not needed?

• Focus on determining the control measure combination

• Full documentation of hazard analysis

• Encourages dynamic control systems

• Enables a quantitative approach (FSO/PO approach)

Example – Danbo cheese Which hazards need be controlled?

Hazard identification:

39 pathogenic microorganisms

Hazard assessment:

18 pathogens ruled out due to:• Effect of control at steps prior to reception at dairy

plant (feed sector, milk production, imports, ingredients)

• PRPs in place at the dairy plant

Remaining 17 hazards to be controlled by OPRPs + the HACCP plan

Degree of required controlExample: Listeria monocytogenes:

Acceptable level:• Official target/criteria: < 100 cfu/g (at intake/end of shelf life)

Sources:• Endemic in environment

• Staff: 1-10% healthy carriers

• Milking environment: Prevalence 33% (Saana et al, 1996)

• Healthy cows: Prevalence up to 4% (several authors)

• Bulk milk tankers: up to 21% (several authors)

• Mastitis milk: 2000-20.000 cfu/ml (Hahn, 1996)

Estimated content: 100 cfu/ml in all raw milk

Degree of control required: No net increase

Cheese manufacturing

Development of L. monocytogenes during manufacture of Danbo-type of cheese

-10,0

-9,0

-8,0

-7,0

-6,0

-5,0

-4,0

-3,0

0 5 10 15 20 25Processing time(hours)

log

cfu/

g

A: No prior storage of cheese milk C: Prior storage of cheese milk for 6 hrs

+5-6 logs

Control measures availableProcessing:• Temperature (storage & transportation steps)• Time (storage & transportation steps)• Heat treatment• Microfiltration• Heat treatment of caraway seeds added after heat treatment

Control of contamination:• Cleaning (equipment, environment)• Staff

Intrinsic factors of end product:- pH & water activity (salt, moisture)- Preservatives (nitrates, sorbates, natamycin- Lactate & Lactic acid bacteria (antagonism)

Development of L. monocytogenes during ripening of Danbo-type cheese

-10,0-9,0-8,0-7,0-6,0-5,0-4,0-3,0

0 20 40 60 80Ripening time (dage)

log

cfu/

g

A: Surface - no prior storage of cheese milkC: Surface - Prior storage of cheese milk for 6 hrs.A: Interior - No prior storage of cheese milkC: Indre - Prior storage of cheese milk for 6 hrs.

Cheese ripening

y5-7 logs

Processing:• Temperature (storage & transportation steps)• Time (storage & transportation steps)• Heat treatment• Microfiltration• Heat treatment of caraway seeds added after heat treatment

Control of contamination:• Cleaning (equipment, environment)• Staff

Intrinsic factors of end product:- pH & water activity (salt, moisture)- Preservatives (nitrates, sorbates, natamycin- Lactate & Lactic acid bacteria (antagonism)

Selection of control measures

Given by other

priorities

Kept out of environment

•Temperature & time:

• transportation of raw milk

• storage of raw milk

• storage of cheese milk

•Heat treatment

•Scalding of caraway seeds

•Staff hygiene

Categorization of control measures

OPRPs

HACCP plan (2 CCPs)

PRPs + safety margin

Weighing of alternatives:

Heat treatments: 11 log red. (Pasteurization)2,5 log red. (68qC, 15 sec)5 log red. (69qC, 15 sec / 72qC, 5 sec)

Level in raw milk: min. <1/ltr (= <10-3 cfu/g)

max. 20.000/ltr (=104,3 cfu/g)

Microfiltration: 2-3 log red.

0,1 log (4 hrs., < 10 qC) - 1 log increase (10 hrs., 20 qC)No increase (immediate use) - 1 log increase (36 hrs., 9 qC)No storgae (� lag phase during first processing steps) - 1 log increase (36 hrs., 9 qC)

Collection:

Storage raw milk:

Storage cheese milk:

Thank you!