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AMC2 ARO.GEN.305(c) Oversight programme

ED Decision 2017/006/R

OVERSIGHT PLANNING CYCLE

(a) For each organisation certified by the competent authority all processes should be completely audited at periods not exceeding the applicable oversight planning cycle. The beginning of the first oversight planning cycle is normally determined by the date of issue of the first certificate. If the competent authority wishes to align the oversight planning cycle with the calendar year, it should shorten the first oversight planning cycle accordingly.

(b) The interval between two audits for a particular process should not exceed the interval of the applicable oversight planning cycle.

(c) Audits should include at least one on-site audit within each oversight planning cycle. For organisations exercising their regular activity at more than one site, the determination of the sites to be audited should consider the results of past oversight, the volume of activity at each site, as well as main risk areas identified.

(d) For organisations holding more than one certificate, the competent authority may define an integrated oversight schedule to include all applicable audit items. In order to avoid duplication of audits, credit may be granted for specific audit items already completed during the current oversight planning cycle, subject to four conditions:

(1) the specific audit item should be the same for all certificates under consideration;

(2) there should be satisfactory evidence on record that such specific audit items were carried out and that all corrective actions have been implemented to the satisfaction of the competent authority;

(3) the competent authority should be satisfied that there is no evidence that standards have deteriorated in respect of those specific audit items being granted a credit;

(4) the interval between two audits for the specific item being granted a credit should not exceed the applicable oversight planning cycle.