Validation, Verification and Improvement of the Food Safety Management System
ISO 8
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
HACCP Principle 6
• Establish procedures for verification that the HACCP system is working correctly.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Verification
• NACMCF Definition (USA)
– “Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.”
• Codex Definition
– “The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan.”
• ISO 22000
– “Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.”
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Validation
• NACMCF (USA)
– “That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.”
• Codex
– “Obtaining evidence that the elements of the HACCP plan are effective.”
• ISO 22000
– “Obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Validation vs. Verification
• Validation – asks whether the hazard analysis was complete and if the control measures are effective
• “Are you doing the right thing” • Verification – asks whether the HACCP system is being implemented according to the plan
• “Do what you say”
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
ISO 22000:2005 – Section 8 • Validation of control measure combinations
• Control of monitoring and measuring
• Food safety management system verification
– Internal audit
– Evaluation of individual verification results
– Analysis of results of verification activities
• Improvement
– Continual improvement
– Updating the food safety management system
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Validation of Control Measure Combinations – Section 8.2
• The organization will validate that the:
– Selected control measures are capable of controlling the food safety hazards.
– Control measures are effective and capable of ensuring control of the food safety hazards.
• If this can not be confirmed, modify and reassess.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Control of Monitoring and Measuring –
Section 8.3
• The organization shall provide evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Control of Monitoring and Measuring –
Section 8.3
• The measuring equipment and methods used shall be:
– calibrated or verified at specified intervals
– adjusted or re‐adjusted as necessary
– identified to enable the calibration status to be determined,
– safeguarded from adjustments that would invalidate the measurement results
– protected from damage and deterioration
• Records of calibration and verification activities must be maintained.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Internal Audit – Section 8.4.1
• Internal audits shall be conducted at planned intervals to determine whether the food safety management system
– conforms to the planned arrangements, to the food safety management system requirements established by the organization, and to the ISO 22000 requirements
– is effectively implemented and updated
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Verification Planning – Section 7.8
• Verification activities shall confirm that:
– PRPs are implemented
– The Hazard Analysis is continually updated
– Operational PRPs and HACCP Plan elements are implemented and effective
– Hazard levels in products are within acceptable limits
– Other procedures as required are implemented and effective
• Verification results are recorded and communicated to the food safety team.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Evaluation of Individual Verification Results – Section 8.4.2
• The food safety team must evaluate results of verification activities described in Section 7.8.
• If verification does not demonstrate conformity with the planned arrangements, the organization shall review:
– existing procedures and communication channels
– the conclusions of the hazard analysis, the established operational PRP(s) and the HACCP plan
– the PRP(s)
– the effectiveness of human resource management and training activities
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Analysis of Results of Verification Activities – Section 8.4.3
• The food safety team shall analyze the results of verification activities in order to:
– Confirm the overall performance of the system meets the requirements
– identify the need for updating or improving the food safety management system
– identify trends which indicate a higher incidence of potentially unsafe products
– plan the internal audit program
– provide evidence that corrections and corrective actions are effective
• Results of the analysis and the resulting activities must be recorded and reported to top management.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Continual Improvement – Section 8.5.1
• The organization must continually improve the effectiveness of the food safety management system through the use of –
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–
–
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–
–
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communication management review internal audit evaluation of individual verification results analysis of results of verification activities validation of control measure combinations corrective actions
food safety management system updating
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Updating the Food Safety Management System – Section 8.5.2
• Top management shall ensure that the food safety management system is continually updated.
• The food safety team shall evaluate the food safety management system at planned intervals. • The team shall review the
– hazard analysis
– established operational PRP(s)
– HACCP plan
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
Updating the Food Safety Management System – Section 8.5.2
• The evaluation and updating activities shall be based on
– External and internal communication
– Other input concerning the suitability, adequacy and effectiveness of the food safety management system
– Results of verification activities
– Management review.
• System updating activities shall be recorded and reported to top management.
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
QUESTIONS?
© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA
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