Iso 22000 Standard

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) National legislation based upon Codex HACCP Guidelines ISO 22000
Willing & capable Willing, but not (yet) capable
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 = governmental task Hazard analysis = industry task
Risk analysis & Hazard analysis
Monitoring - Verification
During operation Documenting that the control measure functions as intended
Validation
Prior to operation Documenting that the control measure is capable of delivering the needed effects
After operation Documenting that monitoring works degree of intended control has been delivered
Key characteristics
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 - often, additional control at consumption level
Solution:
Outcome focus & food chain management
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
Key characteristics
Planning of the control system

Available control measures
Acceptable practise Available knowledge & data
Hazard analysis based design

Hazard analysis Validation Data & information
Prerequisite programs (PRPs)
Operational PRPs Verification
HACCP plan
Updating
Verification
System Verifikation
The 3 legs
Control measures controlled by Prerequisite Programs (PRPs)
Control measures controlled by Operational PRPs (OPRPs)
Control measures controlled by the HACCP plan
The hazard analysis

Hazard identification Hazards assessment Determination of acceptable levels in end products Selection of control measures Assessment of control measures Combinations of control measures Combination that controls the hazards to the needed degree Validation the capability of meeting acceptable levels in end products Categorization of control measures
Hazards to be controlled and the needed degree of control
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:
Afverse health effect Moderate
Mild Severe ??? OPRP OPRP Seldom ??? ??? OPRP ??? ??? ??? CCP ??? ???
The HACCP Plan ?

Stringency in controlling the control measure
Likelihood of occurrence
Occasional Frequent Always
Location relative to other control measures (stress, synergy) Likelihood of operational failure Variation in operational function
Operational PRPs
Updating of control measure combinations

Internal communication, e.g.
Changed likelihood of hazard occurrence Process changes Product changes Results of system verification and review
-
New HACCP plan Existing HACCP Plan
Hazard analysis
Exisitng Operational PRPs
Modified Operational PRPs Superfluous control measures
New requests for specific control measure(s) (authorities/customers)
New knowledge
Changed acceptable hazard(s) level(s)
External communication
Changes in controls applied beyond the organizations system
Main differences to the current approach

Current approach: ISO 22000 approach:
Starting point: Flow diagram Starting point: Output input What can go wrong (events)? Controls needed & not needed? Focus on determinining the CCPs Limited documentation of hazard analysis Tends to result in static control system Semi-quantitative approach (zero-tolerance/ALARA) 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
Example: Listeria monocytogenes: Acceptable level:
Degree of required control
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 -7,0 -8,0 -9,0
+5-6 logs
-10,0
10 15 Processing time(hours)
20
25
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 -5,0 -6,0 -7,0 -8,0 -9,0 -10,0
0 20
log cfu/g
5-7 logs
Ripening time (dage)
40
60
80
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)

Staff
Kept out of environment Given by other priorities
Intrinsic factors of end product:

- pH & water activity (salt, moisture) - Preservatives (nitrates, sorbates, natamycin - Lactate & Lactic acid bacteria (antagonism)
Categorization of control measures

Temperature & time:
transportation of raw milk storage of raw milk storage of cheese milk OPRPs
Heat treatment Scalding of caraway seeds Staff hygiene

HACCP plan (2 CCPs)
PRPs + safety margin
Weighing of alternatives:
Level in raw milk: Heat treatments: min. <1/ltr (= <10-3 cfu/g) max. 20.000/ltr (=104,3 cfu/g) 11 log red. (Pasteurization) 2,5 log red. (68 C, 15 sec) 5 log red. (69 C, 15 sec / 72 C, 5 sec) Microfiltration: Collection: Storage raw milk: 2-3 log red. 0,1 log (4 hrs., < 10 C) - 1 log increase (10 hrs., 20 C) 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)
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Iso 22000 Standard

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The ISO STANDARD 22000

Targeted users of ISO 22000

Not willing, not capable

Further development of the HACCP concept

Terms that are often confused

Risk analysis & Hazard analysis

Further development of the HACCP concept

One extreme: Developing countries

Opposite extreme: Raw milk cheese:

Further development of the HACCP concept

Planning of the control system

Hazard analysis based design

Prerequisite programs (PRPs)

Operational PRPs Verification

Control measures controlled by Prerequisite Programs (PRPs)

Control measures controlled by Operational PRPs (OPRPs)

Control measures controlled by the HACCP plan

The hazard analysis

Hazards to be controlled and the needed degree of control

How to control the control measures

Factors determining the categorization

The HACCP Plan ?

Occasional Frequent Always

Updating of control measure combinations

New HACCP plan Existing HACCP Plan

Modified Operational PRPs Superfluous control measures

New requests for specific control measure(s) (authorities/customers)

Changed acceptable hazard(s) level(s)

Changes in controls applied beyond the organizations system

Main differences to the current approach

Example Danbo cheese

Example: Listeria monocytogenes: Acceptable level:

Degree of required control

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

Estimated content: 100 cfu/ml in all raw milk

Degree of control required: No net increase

-5,0 -6,0 -7,0 -8,0 -9,0

A: No prior storage of cheese milk

C: Prior storage of cheese milk for 6 hrs

Control measures available

Control of contamination: Cleaning (equipment, environment)

Intrinsic factors of end product:

Ripening time (dage)

Selection of control measures

Control of contamination: Cleaning (equipment, environment)

Kept out of environment Given by other priorities

Intrinsic factors of end product:

Categorization of control measures

Heat treatment Scalding of caraway seeds Staff hygiene

PRPs + safety margin

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