louise manning, phd. legislation due diligence defence validation monitoring verification the...
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Louise Manning, PhD
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Legislation Due diligence defence Validation Monitoring Verification The role of the audit
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Main responsibilities:
Ensure you do not treat a food in any way which means it would be damaging to the health of people eating it;
Ensure food sold is of the nature, substance or quality which consumers would expect;
Ensure that the food is labelled, advertised and presented in a way that is not false or misleading.
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Legal defence designed to balance the protection of the consumer against the right of food businesses not to be convicted of an offence they have taken all reasonable care to avoid committing.
“took all reasonable precautions and exercised all due
diligence”
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Defence of due diligence also applies to offences under the General Food Regulations 2004 and the Food Hygiene Regulations 2006.
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Own label Branded product
Offence was someone else’s fault (not under retailer's control) or resulted from their relying on information supplied by that person;
Yes Yes
they had no reason to suspect that they were committing an offence; and
Yes Yes
they made reasonable checks on the food or reasonably relied on checks made by the supplier;
Yes NoNot required
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PREVENTION CONTROL
Assurance Detection
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Quality Management System
Total Food Safety
HACCPHACCP StudyHACCP PlanHACCP Team
Training and AwarenessCommitment
Pre-requisite ProgrammesHygiene SQAGMP SPCComplaints Management SanitationCrisis/Incident/Recall Pest ControlPreventative Maintenance
Food safety within a quality management programme (Mortimore, 2001)
SQA – Supplier Quality AssuranceSPC – Statistical Process ControlGMP – Good Manufacturing Practice
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Validation
Monitoring
Verification
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Validation is the activities undertaken to demonstrate that the scientific and technical content of the food safety (HACCP) plan is designed to be and continues to be effective in minimising food safety risk.
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Product development Product and process changes Routinely to identify “shift” or
variability which will impact on the effectiveness of control measures
System failure New scientific or regulatory
information
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Monitoring is the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control
Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan
(CAC, 2003).
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Review of the FSMS, PRP, HACCP plan and associated records;
Review of deviations and product dispositions; and
Confirming that CCPs are kept under control and that critical limits have not been exceeded .
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System audit
Compliance audit
Investigative audit
Internal
External
Third party (intrinsic)
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Objective evidence i.e. qualitative or quantitative information, records or statements of fact pertaining to the safety of a product or process or to the existence and implementation of a FSMS element, which is based on observation, measurement or test and which can be verified
(adapted from ISO 10011:1 1990)
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Valid,
Authentic,
Current; and
Sufficient.
Auditors must also be able to demonstrate their food safety knowledge and their technical competence and their skills
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Obtain objective evidence that the FSMS and HACCP plan and PRP are appropriate, implemented and effective through the collation of data, observation and test.
Systematic analysis of process, product and organisational performance in meeting food safety objectives
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Legislation Due diligence defence Validation Monitoring Verification The role of the audit