ISO Standard 22000 Presentation

The ISO STANDARD 22000
Food Safety Management Systems

Requirements for organizations
throughout the food chain
By Claus Heggum (Danish Dairy Board)

Targeted users of ISO 22000
Scope: All types of organizations within the food chains

(advanced/less advanced, with/without CCPs)
ISO 22000
National
legislation Willing &
capable
based upon
Codex Willing, but not
HACCP (yet) capable
Guidelines
Not willing, not capable
Key characteristics
Clarifies existing terms that are often
confused
Systematic decision making
Transparent control system
Food chain approach
Combines recognized key food safety
elements:
System management (ISO 9000 approach)
Interactive communication (internally, externally)
Prerequisite programs (=basic hygiene, GHP, etc)
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 analysis

Risk analysis = governmental task
Hazard analysis = industry task
Monitoring - Verification - Validation

During operation After operation Prior to operation
Documenting that Documenting that Documenting that
the control monitoring works the control measure
measure is capable of
functions as degree of intended
control has been delivering the
intended needed effects
delivered
Key characteristics
confused
Food chain approach
elements:
Principle of equivalence
A milk product chain
Primary producer Manufacturer Distributor Consumer
Control measures
One extreme: Developing countries

- no/minimal control of animal health
- normal or additional control during manufacturing Solution:
- often, additional control at consumption level Outcome
focus & food
Opposite extreme: Raw milk cheese:
- Max. control of animal health and hygiene at farm
chain
level management
- Increased control during/after manufacture, using
hurdle technology
- minimal control at consumption level
Key characteristics
confused
Food chain approach
elements:
Planning of the control system
Available control measures
Acceptable practise Available knowledge & data
Hazard analysis based design
Hazard analysis
Data &
Validation information
Prerequisite Operational Updating

HACCP plan
programs (PRPs) PRPs
Verification Verification
System Verifikation
The 3 legs
Control
Control measures Control measures
measures
controlled by controlled by
controlled
Prerequisite Operational PRPs
by the
Programs (PRPs) (OPRPs)
HACCP plan
The hazard analysis
Hazard identification
Hazards assessment
Determination of acceptable levels in

end products
Hazards to be controlled
and the needed degree of
Selection of control measures control
Assessment of control measures
Combinations of control measures
Validation the capability of meeting

Combination that acceptable levels in end products
controls the hazards to
the needed degree
Categorization of control measures
How to control the
control measures
O-PRPs HACCP plan
Factors determining the categorization
Effect on hazards relative to
applied intensity
Feasibility for monitoring in time to
withhold affected end products The HACCP
Ranking of the hazard, e.g: Plan ?
Severe ??? ??? ??? CCP Stringency in

Afverse
health effect Moderate OPRP ??? ??? ??? controlling
Mild OPRP OPRP ??? ??? the control
Likelihood of occurrence Seldom Occasional Frequent Always measure
Location relative to other control Operational

measures (stress, synergy) PRPs
Likelihood of operational failure
Variation in operational function
Updating of control measure combinations
-
Internal communication, e.g.
Changed likelihood of Process Product Results of system
hazard occurrence changes changes verification and review
New HACCP plan

Existing HACCP Plan
Hazard analysis Modified
Operational PRPs
Exisitng Operational
PRPs
Superfluous
control measures
New requests for New Changed acceptable Changes in controls

specific control knowledge hazard(s) level(s) applied beyond the
measure(s) organizations system
(authorities/customers) External communication
Main differences to the current approach
Current approach: ISO 22000 approach:
Starting point: Flow diagram Starting point: Outputinput
What can go wrong (events)? Controls needed & not needed?
Focus on determinining the Focus on determining the
CCPs control measure combination
Limited documentation of Full documentation of hazard
hazard analysis analysis
Tends to result in static Encourages dynamic control
control system systems
Semi-quantitative approach Enables a quantitative approach
(zero-tolerance/ALARA) (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 control
Example: 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
-3,0
-4,0
lo g c f u /g
-5,0
-6,0
+5-6 logs
-7,0
-8,0
-9,0
-10,0
0 5 10 15 20 25
Processing time(hours)
A: No prior storage of cheese milk C: Prior storage of cheese milk for 6 hrs
Control measures available
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)
Cheese ripening
Development of L. monocytogenes during ripening
of Danbo-type cheese
-3,0
-4,0
log cfu/g
-5,0
-6,0
-7,0 5-7 logs
-8,0
-9,0
-10,0
0 20 40 60 80
Ripening time (dage)
A: Surface - no prior storage of cheese milk
C: Surface - Prior storage of cheese milk for 6 hrs.
A: Interior - No prior storage of cheese milk
C: Indre - Prior storage of cheese milk for 6 hrs.
Selection of control measures
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) Kept out of
Staff environment
Intrinsic factors of end product:

Given by
- pH & water activity (salt, moisture) other
- Preservatives (nitrates, sorbates, natamycin priorities
- Lactate & Lactic acid bacteria (antagonism)
Categorization of control measures
Temperature & time:
transportation of raw milk
storage of raw milk OPRPs
storage of cheese milk
Heat treatment
Scalding of caraway HACCP plan

(2 CCPs)
seeds
Staff hygiene PRPs + safety

margin
Weighing of alternatives:
Level in raw milk: min. <1/ltr (= <10-3 cfu/g)
max. 20.000/ltr (=104,3 cfu/g)
Heat treatments: 11 log red. (Pasteurization)
2,5 log red. (68C, 15 sec)
5 log red. (69C, 15 sec / 72C, 5 sec)
Microfiltration: 2-3 log red.
Collection: 0,1 log (4 hrs., < 10 C) - 1 log increase

(10 hrs., 20 C)
Storage raw milk: No increase (immediate use) - 1 log
increase (36 hrs., 9 C)
Storage cheese milk:No storgae ( lag phase during first
processing steps) - 1 log increase (36
hrs., 9 C)
Thank you!

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The ISO STANDARD 22000

Food Safety Management Systems

By Claus Heggum (Danish Dairy Board)

Scope: All types of organizations within the food chains

Risk analysis & Hazard analysis

Monitoring - Verification - Validation

Primary producer Manufacturer Distributor Consumer

One extreme: Developing countries

Hazard analysis based design

Prerequisite Operational Updating

Determination of acceptable levels in

Combinations of control measures

Validation the capability of meeting

Severe ??? ??? ??? CCP Stringency in

Location relative to other control Operational

New HACCP plan

New requests for New Changed acceptable Changes in controls

Estimated content: 100 cfu/ml in all raw milk

Degree of control required: No net increase

Development of L. monocytogenes during manufacture of

Intrinsic factors of end product:

Intrinsic factors of end product:

storage of raw milk OPRPs

storage of cheese milk

Scalding of caraway HACCP plan

Staff hygiene PRPs + safety

Collection: 0,1 log (4 hrs., < 10 C) - 1 log increase

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