Tuesday, 21 September 2021 14.00 - 15.30 h
Due to the pandemic-related travel restrictions, supervising authorities are currently mostly carrying out so-called distant assessments. However, most inspectorates also carry out partial on-site inspections, sometimes even unannounced.
The PIC/S has now developed a "Covid-19 Risk Assessment for National Routine On-Site Inspections". This risk assessment is based on a FMEA (Failure Mode and Effects Analysis) and should be carried out during the planning phase of the inspection together with the company to be inspected.
Topics to be discussed and assessed include:
If an unannounced inspection has to take place, an "individual bespoke risk assessment" should be carried out; the assessment suggested in the document should then not be used.