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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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Product Realisation (Section 7)

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OPRPs what are they?


OPRPs are control measures deemed necessary
to control hazards to acceptable levels (that
havent 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)

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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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Thank you!

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