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TQCSI Auditor Training
“ISO 22000 - OPRPs vs HACCP”
TQCSI Auditor Training
References
• ISO 22000:2005 Standard
• ISO 22004:2005 Guidance on application
• ISO 22003:2013 Auditor requirements
• WI 41 FSMS.
TQCSI Auditor Training
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.
TQCSI Auditor Training
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.
TQCSI Auditor Training
ISO 22000
• food safety policy
• food safety objectives.
TQCSI Auditor Training
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.
TQCSI Auditor Training
ISO 22000
• Food Safety Team Leader responsibilities
• Company to communicate internally to Food Safety Team.
TQCSI Auditor Training
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).
TQCSI Auditor Training
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.
TQCSI Auditor Training
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).
TQCSI Auditor Training
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)
STEP INPUT HAZARD CAUSE Risk (High or Low)
Am
ount
pe
rmit
ted
in f
inal
pr
oduc
t ?
Is e
limin
atio
n /r
educ
tion
for
sa
fe f
ood
requ
ired
? Y
/N
Is c
ontr
ol o
f ha
zard
fo
r ac
cept
able
leve
ls
need
ed ?
Y/N
Control(s) measures
Controls include OPRP
or CCP
Y/N
Severity Likelihood
Overall
Storage Dry Goods Microbiological, Chemical, Physical, Quality
Infestation of product
Ineffective pest control, poor housekeeping
4 B 14 Nil N N PRP –pest control program in place.
PRP- Cleaning program.
N
Cooking Meat, vegetables, handling, cookers
Microbiological, Chemical, Physical, Quality
micro
Insufficient cooking of product.
2 C 8 As per FP specification
Y Y Cooking temperatures and times established & monitored.
PRP- Training
Y (OPRP/CCP)
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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;
TQCSI Auditor Training
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
Status CCP/OPRP & reason
Validation of CCP Limits
a b c d e f g
Goods receival/ Temperature
inspections for goods received.
yes Yes-on receival
Yes-last control
Not likely high Y N CCP-control specific, monitoring in real time, last step for control.
FSANZ
Goods receival/ Product
inspection
yes Yes-on receival
Would be
checked at
further steps
possible low Y N OPRP- would be detected further down process
N/A
Cooking/Cooking Time/Temp &
monitoring
yes yes Last control
possible high Y N CCP- last step, significance of failure
FSANZ
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Product Realisation (Section 7)
• a HACCP plan is required to describe CCPs and their controls.
TQCSI Auditor Training
Product Realisation (Section 7)
• an OPRP Plan is required for OPRPs and controls
• critical limits are not required for OPRPs (generally specifications).
TQCSI Auditor Training
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.
TQCSI Auditor Training
Product Realisation (Section 7)
Verification Planning:
• other procedures implemented and effective
• verification results to be recorded & communicated to the FST.
JLB - Lead Auditor Course - Module FS - # 42
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.
Typical ISO 22000 Documentation
JLB - Lead Auditor Course - Module FS - # 43
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.
ISO 22000 + HACCP Certification
JLB - Lead Auditor Course - Module FS - # 44
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.
ISO 22000 + HACCP Auditing
JLB - Lead Auditor Course - Module FS - # 45
• audit using ISO 22000 methodology & requirements will meet HACCP requirements
• audit using HACCP methodology WILL NOT meet ISO 22000 requirements.
ISO 22000 vs HACCP Auditing
TQCSI Auditor Training
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.
TQCSI Auditor Training
TQCSI
Thank you!