Following the recommendation of the European Commission (2013/473/EU), Notified Bodies, including TÜV SÜD Product Service GmbH, started this year to conduct unannounced audits (UAA) at Medical Device manufacturers that hold EC certificates. The measure, aimed at improving patient safety after several Medical Device scandals in the past, was subject of heated debates on both sides – certification bodies and manufacturers – in the run-up to its introduction. However, after only a few months the commotion died down.
TÜV SÜD has carried out roughly 150 unannounced audits since March 2014 and all were handled smoothly, professionally, and cooperatively by both parties, manufacturers and auditors.
Good preparation pays
Some manufacturers were clearly surprised to be among those selected in the early starting phase of unannounced audits. Nevertheless, all employees encountered on site were prepared for the unannounced audit. According to our auditors, the staff of Medical Device manufacturers were very cooperative and complied with the processes established for unannounced audits. Feedback from clients unanimously expressed that the unannounced audits were carried out in a highly professional and cooperative manner by very competent auditors.
Most companies audited since March 2014 had prepared for unannounced audits and had informed their employees of the requirements set forth in the Commission's recommendation. They had established processes that assist with the management and control of unannounced audits, and relevant staff had received training on this new type of audit.
These measures and the unannounced audit itself impact on the costs of the conformity assessment procedure. Given this, manufacturers should include these additional costs related to unannounced audits in their budgets.
Contracts and/or quality agreements concluded with critical subcontractors should have been adjusted by now to take unannounced audits into account. In addition, manufacturers should implement appropriate change management for the supplied materials/devices which should cover the following aspects:
Information in the event that the critical supplier changes material specifications or production methods
Current documentation in the supplier's and manufacturer's technical file
Change of production facility for a raw material or component
Information for audit planning
During the regular audit the audit team will request information about production periods, temporary periods of closure such as for maintenance, seasonal production, etc. TÜV SÜD Product Service will retain these data together with the audit documentation and make them available to the UAA team for the scheduling of the unannounced audit. For an unannounced audit to be successful, it is extremely important that these data are accurate and up to date. Otherwise implementation of the unannounced audit may prove impossible, causing additional costs for repeated audit scheduling and a new audit date.
Information about possible periods of closure at your suppliers is equally important. To ensure up-to-date, ongoing information of the Notified Body appropriate communication channels and responsibilities must be established and additional processes defined.