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The legal imperative

The legal imperative. Louise Manning, PhD. Legal imperative. Legislation Due diligence defence Validation Monitoring Verification The role of the audit. Food Safety Act 1990. Main responsibilities:

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The legal imperative

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  1. The legal imperative Louise Manning, PhD

  2. Legal imperative Legislation Due diligence defence Validation Monitoring Verification The role of the audit

  3. Food Safety Act 1990 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.

  4. Due Diligence defence “took all reasonable precautions and exercised all due diligence” 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.

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

  6. Due diligence for retailers

  7. What constitute reasonable precautions? prevention Control • Assurance • Detection

  8. SQA – Supplier Quality Assurance SPC – Statistical Process Control GMP – Good Manufacturing Practice Food safety within a quality management programme (Mortimore, 2001)

  9. Is HACCP a zero risk system?

  10. How do we minimise risk? Validation Monitoring Verification

  11. Validation: What is it? 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.

  12. When do you validate (revalidate) your product or food process? 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

  13. Monitoring and Verification 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).

  14. A glass item audit – control measure, monitoring or verification?

  15. Verification includes: 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 .

  16. Key mechanism for verification is the audit • System audit • Compliance audit • Investigative audit • Internal • External • Third party (intrinsic)

  17. Effective auditing and due diligence 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)

  18. To have a due diligence defence audit evidence must be: • Valid, • Authentic, • Current; and • Sufficient. • Auditors must also be able to demonstrate their food safety knowledge and their technical competence and their skills

  19. The role of auditing • 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

  20. Legal imperative (recap) Legislation Due diligence defence Validation Monitoring Verification The role of the audit

  21. Thank you Louise Manning PhD, MIFST, NSc, PGCHE Email l.manning@btinternet.com

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