iso 22000 standard copy
TRANSCRIPT
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!