One of the essential requirements to join PIC/S is that Competent Authorities must have the arrangements necessary to apply an inspection system comparable to that referred to in this Scheme and whose requirements and procedures could ensure the proper implementation of the Scheme and contribute to its effective operation. Being equivalent is not only required for accession but all the time and duly verified during reassessments. This is why compliance to the PIC Scheme is one of PIC/S’ most important and critical areas, which needs to be constantly monitored.
Compliance to the Scheme has been entrusted since 2014 to a specific Sub-Committee on Compliance (SCC), chaired by Ms Anne Hayes (Ireland / HPRA).
Assessment and Pre-Assessment
It usually takes between 3 and 6 years before PIC/S Membership is achieved through the PIC/S' Accession process, which can be preceded by a pre-accession process (for more details see "Accession"). During the assessment period, various changes and improvements recommended by the PIC/S Committee may have to be implemented; if necessary, follow-up assessment visits are undertaken by a PIC/S delegation to verify the suitability of corrective actions.
For many years, only Applicants were subject to assessment. Founding Members were, however, never assessed. In order to ensure that both new applicants and older members fulfil the same requirements, a Joint Reassessment Programme (JRP) was launched in 2000 under which existing PIC/S Members (Participating Authorities) are now also reassessed for equivalence on a regular basis.
Results of other assessments such as those under the EU Heads of Agencies’ Joint Audit Programme (JAP), the (pre-) MRA inspections, etc. can be accepted. The assessment results under the JAP are accepted on a mutual basis in order to avoid unnecessary duplications. Of course, the principle of mutual acceptance only applies between programmes using equivalent sets of tools (e.g. PIC/S JRP and EU JAP).
There is only one PIC/S tool for the assessment and reassessment of PIC/S Members (Audit Checklist). Auditors used under the PIC/S assessment / reassessment should be trained according to the JRP-JAP training module (for more details see "Training for Auditors").
For the complete mandate of the SCC, see box below.
The mandate of the SCC is to