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AgVetLink February 2005

Compliance confusion

It has become apparent that a number of companies are confusing audit programmes, reality checks and compliance investigations.

Audits

An audit is a planned examination of persons, places, products, systems and/or activities to confirm compliance with regulatory requirements. The ACVM Group has a comprehensive compliance programme that includes audits. At this point, however, the only official audits are for manufacturers.

‘Slice of life’ or reality check reviews

The ACVM Group’s compliance programme also includes ‘slice of life’ or reality check reviews. (When first implemented last year these were referred to as ‘audits’, and that added to the confusion.) These reviews provide information on control of use programmes and their performance. They also determine in broad terms where gaps in ACVM Group policy, standards and procedures might lead to a lower than desirable level of risk management under the Act, or where regulatory intervention is excessive. Reality checks might also indicate that a formal audit is warranted.

Reality checks are not necessarily undertaken as a result of reported non-compliance but priority is likely to be given on the basis of identified concerns or of existing information gaps. These reviews are carried out by the NZFSA Compliance and Investigation Group (CIG) on behalf of the ACVM Group. The output of such a review is a report with recommendations to the ACVM Group Director. Responses to the recommendations are incorporated into the ACVM Group’s work programme.

Investigation

An investigation is a process initiated by the ACVM Group after having received information of possible non-compliance. Every suspicion or allegation of non-compliance is investigated.

If there is a need to visit premises, this may involve an Inspector appointed under section 65 of the ACVM Act who could be a staff member of the CIG or of the ACVM Group. Information gained from these visits is then ‘pieced’ together to compile a file, and to enable the ACVM Group to take any appropriate action.

One area of investigation that takes a considerable amount of time concerns unapproved products, especially those that require registration. Because such products have not undergone ACVM Group evaluation for relevant risk areas, they have the potential to create problems for international trade, to cause unacceptable residues in food or to harm animals.

The compliance process is designed to ensure that responsibilities in the supply chain are met and that all of the products in the New Zealand marketplace satisfy the approved conditions of the ACVM Act and related legislation.