Remote Audits from the Perspective of Notified Bodies
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We have already reported on the experiences of notified bodies regarding remote audits in the past. Recently, the results of a survey addressed to notified bodies on remote audits have been published. Out of 52 requested notified bodies, 46 had participated in the survey with a total of more than 33,000 audit days.
In the vast majority of cases, the audits were deemed "generally successful." Only 10% of the cases resulted in a "generally unsuccessful". Interestingly, the audit results of remote audits are 87% comparable to on-site audits in terms of the number of deficiencies. In 11% of the cases even fewer deficiencies were found, in 2% of the cases more, compared to on-site audits. However, "remote audits" require more time than on-site audits. 5-33% more time needed is indicated.
What have been the experiences of "remote audits"?
Positive experiences have been:
Reduced travel time and travel costs
A tight focus
It is easier to take notes
Very effective for non-physical processes (e.g. software) and pure QMS aspects
Verification of the quality of reports is more accurate compared to on-site audits
Remote audits are more successful with established customers
And what negative experiences were there?
Problems with large time differences
Problems with internet connections
A video does not allow the same opportunity to look around as being on site yourself
In general, less spontaneity (e.g., further reactions to defects) during the audit
One question still deals with the issue: which requirements of the Medical Devices/IVD Regulation cannot be fully audited in a remote audit? The answers are:
Infrastructure (ISO 13485 - § 6.3)
Working environment and control of contamination (ISO 13485 - § 6.4)
Production and service provision (ISO 13485 - § 7.5)
Control of monitoring and measuring equipment (ISO 13485 - § 7.6)
Control of non-conforming products (ISO 13485 - § 8.3)
Requirements of the Medical Devices Regulation to be audited on site (10.1, 10.9(g), 10.9(k), 10.9 (m))
Manufacturing processes of a physical nature
Market surveillance issues with an in-depth look into the production process
Medical Devices Regulation Annex VII, 4.5.2.b
Medical Devices Regulation Annex IX, point 2.3, 3.3 - but the Commission announcement C/2021/119 is valid