TQCSI Auditor Training “ISO 22000 - OPRPs vs HACCP”

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.

Objective

• be aware of differences between ISO 22000 and HACCP

• not to describe how

• describe what is required.

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.

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.

ISO 22000 at a glance

• Standard approach & common elements with ISO 9001

• terminology

• HACCP (GMP, CCP, CP)

• ISO 22000 (PRP, CCP, OPRP)

• no exclusions.

ISO 22000

• food safety policy

• food safety objectives.

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.

ISO 22000

• input & output requirements for FST meeting

• FSTM – MRM - FSTM.

ISO 22000

• Food Safety Team Leader responsibilities

• Company to communicate internally to Food Safety Team.

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.

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).

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.

ISO 22000

• pre-requisite programs (PRPs)

• control measures OPRPs & CCPs

• hazard analysis methodology/documents & records.

• 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.

• 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.

• 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.

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.

• 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.

Codex Decision Tree identifies CCPs only - this is not to be used for classification of control measures for ISO 22000.

• for each hazard type, at each step, two questions must be considered and recorded

- referenced in Decision Tree (also documented in 7.4.3).

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?

Record results:

• if answer is Y (some or all controls are OPRPs or CCPs).

Selection of Control Measures:

• select appropriate combination of control measures.

Validation of control measures:

• the control measures selected need to be validated to ensure the acceptable level of the hazard is achieved.

STEP INPUT HAZARD CAUSE Risk (High or Low)

Control(s) measures

Controls include OPRP

or CCP

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.

Cooking Meat, vegetables, handling, cookers

Microbiological, Chemical, Physical, Quality

Insufficient cooking of product.

2 C 8 As per FP specification

Y Y Cooking temperatures and times established & monitored.

PRP- Training

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).

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.

• 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).

• OPRP or CCP –??

• categorisation of controls by assessment of

items listed 7.4.4 a-g.

• 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).

• OPRP vs CCP categorisation examples provided in ISO 22004 Guidelines.

AGAIN - the CODEX Decision Tree is not to be used!!

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;

• 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).

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.

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

Cooking/Cooking Time/Temp &

monitoring

yes yes Last control

possible high Y N CCP- last step, significance of failure

• a HACCP plan is required to describe CCPs and their controls.

• an OPRP Plan is required for OPRPs and controls

• critical limits are not required for OPRPs (generally specifications).

• both OPRP and CCP monitoring records require evidence of review by designated person, with knowledge and authority to initiate corrective action.

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.

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

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

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

• 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

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.

Thank you!

TQCSI Auditor Training “ISO 22000 - OPRPs vs HACCP”

Documents

22000 ISO 22000&— HACCP&ISO ISO 22000ne ISO 22000 Auth …order.nissyoku.co.jp/book/iso22000/contents.pdf · 2020. 9. 15. · 22000 ISO 22000&— HACCP&ISO ISO 22000ne ISO 22000

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