TQCSI Auditor Training
“ISO 22000 - OPRPs vs HACCP”
References
• ISO 22000:2005 Standard
• ISO 22004:2005 Guidance on application
• ISO 22003:2013 Auditor requirements
• WI 41 FSMS.
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Objective
• be aware of differences between ISO 22000
and HACCP
• not to describe how
• describe what is required.
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ISO 22000 - what is it?
• ISO 22000 provides elements of a food safety
management system
• used for internal application, certification or
contractual purposes, customer and regulatory
requirements.
• aligns with ISO 9001+ HACCP Principles.
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Differences
• ISO 22000 vs ISO 9001
• Product realisation differences – HACCP vs
ISO 22000 (Section 7)
• auditors need to be aware of differences
between HACCP & ISO 22000.
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ISO 22000 at a glance
• Standard approach & common elements with
ISO 9001
• terminology
• HACCP (GMP, CCP, CP)
• ISO 22000 (PRP, CCP, OPRP)
• no exclusions.
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ISO 22000
• food safety policy
• food safety objectives.
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ISO 22000
• FS Team responsibilities to plan to review
system (system updating)
• FS Team requirement to evaluate verification
results, verification activities, communication
& the food safety management system at
planned intervals.
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ISO 22000
• input & output requirements for FST meeting
• FSTM – MRM - FSTM.
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ISO 22000
• Food Safety Team Leader responsibilities
• Company to communicate internally to Food
Safety Team.
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ISO 22000
External communication:
• food chain communication
• suppliers, contractors, consumers, regulatory
and other organisations
• define responsibility/authority of personnel to
communicate externally regarding food safety
• records of communication.
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ISO 22000
Internal communication:
• arrangements to communicate internally to
personnel with impact on food safety
• Company to ensure Food Safety Team
informed of changes list 5.6.2 (a-m).
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ISO 22000
• emergency preparedness & response –
documented procedure and responsibilities
• a withdrawal exercise is required annually
(mock food recall)
• the withdrawal does not have to involve an
emergency response situation.
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ISO 22000
• pre-requisite programs (PRPs)
• control measures OPRPs & CCPs
• hazard analysis methodology/documents &
records.
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PRPs
• Company must identify applicable PRPs
• PRPs manage basic conditions & activities
• selected for maintaining hygienic
production/processing environment (eg programs pest control, calibration, PM, sanitation, suppliers)
• not selected for controlling hazards to
acceptable levels.
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PRPs
• PRPs applicable to products/processes should
be identified, established & implemented
• extensive compared to HACCP (air,
surrounding environment) - list 5.6.2
• procedure/instructions required to describe
how managed.
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PRPs
• include in verification schedule
• records required for evidence of verification
eg if calibration is identified as a PRP, it
should be in the verification schedule and a
record of the verification for calibration
available.
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Product Realisation (Section 7)
For each hazard in hazard analysis at each step:
• identify acceptable level of hazard in finished
product
• consider statutory, regulatory, customer
requirements, intended use
• result and justification recorded.
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Product Realisation (Section 7)
• for hazard analysis use ISO 22004:2005
(Figure 3 – Decision Tree)
• Decision Tree identifies when there are OPRPs
& CCPs and refers to process of categorisation
of control as an OPRP or CCP.
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Product Realisation (Section 7)
Codex Decision Tree identifies CCPs only - this
is not to be used for classification of control
measures for ISO 22000.
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Product Realisation (Section 7)
• for each hazard type, at each step, two
questions must be considered and recorded
- referenced in Decision Tree (also documented
in 7.4.3).
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Product Realisation (Section 7)
Food Safety Documentation:
Q1 - Is elimination or reduction of hazard
essential to the production of a safe food?
Q2 - Is control of the hazard needed for defined
acceptable levels to be met?
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Product Realisation (Section 7)
Record results:
• if answer is Y (some or all controls are OPRPs
or CCPs).
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Product Realisation (Section 7)
Selection of Control Measures:
• select appropriate combination of control
measures.
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Product Realisation (Section 7)
Validation of control measures:
• the control measures selected need to be
validated to ensure the acceptable level of the
hazard is achieved.
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Dry Goods
HAZARD
Microbiological
, Chemical,
Physical,
Quality
Infestation of
product
Cooking
Meat,
vegetables,
handling,
cookers
Microbiological
, Chemical,
Physical,
Quality
CAUSE
Ineffective
pest control,
poor
housekeeping
Risk (High or Low)
Severity
Likeli
hood
Overall
4
B
14
Nil
N
Is control of hazard
for acceptable levels
needed ? Y/N
Storage
INPUT
Is elimination
/reduction for
safe food
required? Y/N
STEP
Amount
permitted in final
product ?
Product Realisation (Section 7)
Control(s)
measures
N
PRP –pest
control program
in place.
Controls
include OPRP
or CCP
Y/N
N
PRP- Cleaning
program.
Insufficient
cooking of
product.
micro
2
C
8
As per FP
specification
Y
Y
Cooking
temperatures
and times
established &
monitored.
PRP- Training
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Y
(OPRP/CCP)
OPRPs –what are they?
• OPRPs are control measures deemed necessary
to control hazards to acceptable levels (that
haven’t been identified as CCPs)
• identified through ISO 22004 Decision Tree,
including categorisation of elements (7.4.4 a-g).
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OPRPs –what are they ?
• there is no direct correlation between CPs
under a HACCP Code & OPRPs in ISO
22000.
• the 22004 Decision Tree process must be used.
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CCPs
• control measures deemed necessary to control
identified hazards to acceptable levels (and
categorised as a CCP)
• identified through ISO 22004 Decision Tree &
by the categorisation of elements (7.4.4 a-g).
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Product Realisation (Section 7)
• OPRP or CCP –??
• categorisation of controls by assessment of
items listed 7.4.4 a-g.
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Product Realisation (Section 7)
• record of the assessment is required to
demonstrate 7.4.4 a-g considered to
distinguish control as OPRP or CCP
• methodology must be documented in
procedure (“logical approach”- up to client).
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Product Realisation (Section 7)
• OPRP vs CCP categorisation examples
provided in ISO 22004 Guidelines.
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Product Realisation (Section 7)
AGAIN - the CODEX Decision Tree is not
to be used!!
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Categorisation of controls (7.4.4)
• a) its effect on identified food safety hazards
relative to the strictness applied
• b) its feasibility for monitoring
• c) its place within the system relative to other
control measures
• d) the likelihood of failure in the functioning of
a control measure/processing variability;
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Product Realisation (Section 7)
• e) the severity of the consequence(s) in the case
of failure in its functioning
• f) whether the control measure is specifically
established and applied to eliminate or
significantly reduce the level of hazard(s)
• g) synergistic effects (ie interaction between
two or more measures results in combined).
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Product Realisation (Section 7)
STEP/ Control
Measure
Using 7.4.4 a-g
To identify controls as CCP or OPRP
a
Goods receival/
Temperature
inspections for
goods received.
Goods receival/
Product
inspection
Cooking/Cooking
Time/Temp &
monitoring
Status CCP/OPRP
& reason
b
c
d
e
f
g
yes
Yes-on Yes-last Not likely
receival control
high
Y
N
CCP-control
specific, monitoring in
real time, last step for
control.
yes
Yes-on
receival
Would possible
be
checked
at
further
steps
low
Y
N
OPRP- would be
detected further down
process
yes
yes
Last
control
high
Y
N
CCP- last step,
significance of failure
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possible
Validation of CCP Limits
FSANZ
N/A
FSANZ
Product Realisation (Section 7)
• a HACCP plan is required to describe CCPs
and their controls.
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Product Realisation (Section 7)
• an OPRP Plan is required for OPRPs and
controls
• critical limits are not required for OPRPs
(generally specifications).
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Product Realisation (Section 7)
• both OPRP and CCP monitoring records
require evidence of review by designated
person, with knowledge and authority to
initiate corrective action.
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Product Realisation (Section 7)
Verification Planning:
• documented verification plan for verification
activities
• activities to confirm PRP, OPRPs, CCPs
implemented and effective
• hazard analysis kept updated
• hazard levels within acceptable limits.
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Product Realisation (Section 7)
Verification Planning:
• other procedures implemented and effective
• verification results to be recorded &
communicated to the FST.
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Typical ISO 22000 Documentation
ISO 22000 Information Worksheet
ISO 22000 Flow Chart (*)
ISO 22000 Hazard Worksheet
ISO 22000 CCP/OPRP Worksheet
ISO 22000 Decision Tree
ISO 22000 HACCP/OPRP Table (*)
Verification Schedule.
JLB - Lead Auditor Course - Module FS - # 42
ISO 22000 + HACCP Certification
For clients certified to both Systems:
• ISO 22000 requirements override HACCP
requirements
• ISO 22000 will also meet HACCP requirements
• ISO 22000 requirements must apply to all
operations
• ISO 22000 methodology to be followed.
JLB - Lead Auditor Course - Module FS - # 43
ISO 22000 + HACCP Auditing
For clients certified to both Systems:
• use of ISO 22004 decision tree only
• categorisation of all controls must meet ISO
22000, Clause 7.4.4 requirements
• expect to see use of ISO 22000 records only
• do not expect to see any CPs
• expect to have PRPs, OPRPs & CCPs.
JLB - Lead Auditor Course - Module FS - # 44
ISO 22000 vs HACCP Auditing
• audit using ISO 22000 methodology &
requirements will meet HACCP requirements
• audit using HACCP methodology WILL
NOT meet ISO 22000 requirements.
JLB - Lead Auditor Course - Module FS - # 45
ISO 22000 Audit Report
Report to include requirements of ISO17021
including:
• information about PRPs used by organisation
• hazard analysis methodology
• comments on the Food Safety Team
• other relevant issues.
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