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TQCSI Auditor Training

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Presentation on theme: "TQCSI Auditor Training"— Presentation transcript:

1 TQCSI Auditor Training
“ISO OPRPs vs HACCP”

2 References ISO 22000:2005 Standard
ISO 22004:2005 Guidance on application ISO 22003:2013 Auditor requirements WI 41 FSMS. TQCSI Auditor Training

3 Objective be aware of differences between ISO 22000 and HACCP
not to describe how describe what is required. TQCSI Auditor Training

4 ISO what is it? ISO provides elements of a food safety management system used for internal application, certification or contractual purposes, customer and regulatory requirements. aligns with ISO HACCP Principles. TQCSI Auditor Training

5 Differences ISO vs ISO 9001 Product realisation differences – HACCP vs ISO (Section 7) auditors need to be aware of differences between HACCP & ISO TQCSI Auditor Training

6 ISO at a glance Standard approach & common elements with ISO 9001 terminology HACCP (GMP, CCP, CP) ISO (PRP, CCP, OPRP) no exclusions. TQCSI Auditor Training

7 ISO 22000 food safety policy food safety objectives.
TQCSI Auditor Training

8 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. TQCSI Auditor Training

9 ISO 22000 input & output requirements for FST meeting
FSTM – MRM - FSTM. TQCSI Auditor Training

10 ISO 22000 Food Safety Team Leader responsibilities
Company to communicate internally to Food Safety Team. TQCSI Auditor Training

11 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. TQCSI Auditor Training

12 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 (a-m). TQCSI Auditor Training

13 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. TQCSI Auditor Training

14 ISO 22000 pre-requisite programs (PRPs) control measures OPRPs & CCPs
hazard analysis methodology/documents & records. TQCSI Auditor Training

15 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. TQCSI Auditor Training

16 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. TQCSI Auditor Training

17 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. TQCSI Auditor Training

18 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

19 Product Realisation (Section 7)
for hazard analysis use ISO 22004: (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. TQCSI Auditor Training

20 Product Realisation (Section 7)
Codex Decision Tree identifies CCPs only - this is not to be used for classification of control measures for ISO TQCSI Auditor Training

21 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). TQCSI Auditor Training

22 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? TQCSI Auditor Training

23 Product Realisation (Section 7)
Record results: if answer is Y (some or all controls are OPRPs or CCPs). TQCSI Auditor Training

24 Product Realisation (Section 7)
Selection of Control Measures: select appropriate combination of control measures. TQCSI Auditor Training

25 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. TQCSI Auditor Training

26 Product Realisation (Section 7)
TQCSI Auditor Training

27 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 Decision Tree, including categorisation of elements (7.4.4 a-g). TQCSI Auditor Training

28 OPRPs –what are they ? there is no direct correlation between CPs under a HACCP Code & OPRPs in ISO the Decision Tree process must be used. TQCSI Auditor Training

29 CCPs control measures deemed necessary to control identified hazards to acceptable levels (and categorised as a CCP) identified through ISO Decision Tree & by the categorisation of elements (7.4.4 a-g). TQCSI Auditor Training

30 Product Realisation (Section 7)
OPRP or CCP –?? categorisation of controls by assessment of items listed a-g. TQCSI Auditor Training

31 Product Realisation (Section 7)
record of the assessment is required to demonstrate a-g considered to distinguish control as OPRP or CCP methodology must be documented in procedure (“logical approach”- up to client). TQCSI Auditor Training

32 Product Realisation (Section 7)
OPRP vs CCP categorisation examples provided in ISO Guidelines. TQCSI Auditor Training

33 Product Realisation (Section 7)
AGAIN - the CODEX Decision Tree is not to be used!! TQCSI Auditor Training

34 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

35 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). TQCSI Auditor Training

36 Product Realisation (Section 7)
TQCSI Auditor Training

37 Product Realisation (Section 7)
a HACCP plan is required to describe CCPs and their controls. TQCSI Auditor Training

38 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

39 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. TQCSI Auditor Training

40 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

41 Product Realisation (Section 7)
Verification Planning: other procedures implemented and effective verification results to be recorded & communicated to the FST. TQCSI Auditor Training

42 Typical ISO 22000 Documentation
ISO Information Worksheet ISO Flow Chart (*) ISO Hazard Worksheet ISO CCP/OPRP Worksheet ISO Decision Tree ISO HACCP/OPRP Table (*) Verification Schedule. JLB - Lead Auditor Course - Module FS - # 42

43 ISO 22000 + HACCP Certification
For clients certified to both Systems: ISO requirements override HACCP requirements ISO will also meet HACCP requirements ISO requirements must apply to all operations ISO methodology to be followed. JLB - Lead Auditor Course - Module FS - # 43

44 ISO 22000 + HACCP Auditing For clients certified to both Systems:
use of ISO decision tree only categorisation of all controls must meet ISO , Clause requirements expect to see use of ISO records only do not expect to see any CPs expect to have PRPs, OPRPs & CCPs. JLB - Lead Auditor Course - Module FS - # 44

45 ISO vs HACCP Auditing audit using ISO methodology & requirements will meet HACCP requirements audit using HACCP methodology WILL NOT meet ISO requirements. JLB - Lead Auditor Course - Module FS - # 45

46 ISO Audit Report Report to include requirements of ISO including: information about PRPs used by organisation hazard analysis methodology comments on the Food Safety Team other relevant issues. TQCSI Auditor Training

47 TQCSI Thank you! TQCSI Auditor Training


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