the legal imperative

Louise Manning, PhD

Legislation Due diligence defence Validation Monitoring Verification The role of the audit

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.

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”

Defence of due diligence also applies to offences under the General Food Regulations 2004 and the Food Hygiene Regulations 2006.

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

PREVENTION CONTROL

Assurance Detection

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

Validation

Monitoring

Verification

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.

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

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).

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 .

System audit

Compliance audit

Investigative audit

Internal

External

Third party (intrinsic)

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)

Valid,

Authentic,

Current; and

Sufficient.

Auditors must also be able to demonstrate their food safety knowledge and their technical competence and their skills

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

Legislation Due diligence defence Validation Monitoring Verification The role of the audit

Louise Manning PhD, MIFST, NSc, PGCHE

Email l.manning@btinternet.com