Tim Wedel

A leading medical technology manufacturer commissioned an audit of an external logistics service provider after external reports of potential regulatory risks, particularly in relation to labelling processes, came to light. The logistics service provider assumes no regulatory responsibility in this context, meaning that the manufacturer remains fully responsible for compliance with regulatory requirements (e.g. ISO 13485, FDA requirements). There were organisational and documentation-related weaknesses that needed to be assessed at short notice.

The challenge was to gain a comprehensive overview of the process and compliance situation whilst under significant time pressure. Varying levels of maturity in the areas of labelling, risk assessment, document control, order management and the handling of instructions for use made a complete assessment difficult. In addition, the manufacturer needed to minimise regulatory risks, as deviations in the labelling process could have a direct impact on audit and regulatory requirements.

A manufacturing company based in Hamburg had an established ISO 9001 quality management system, the processes of which had become ‘well-established’ over the years and varied significantly from one department to another. Management had only limited insight into how the QMS was actually being implemented and wanted a comprehensive, reliable understanding of the system’s current maturity, efficiency and effectiveness, as well as its implementation across the various departments.

One challenge was the lack of consistent system transparency across departmental boundaries. Workflows that were, in some cases, unknown or interpreted differently, a lack of coordination between processes and responsibilities, and divergent implementation practices made it difficult to establish a consistent understanding of quality. At the same time, management wanted clear, transparent assessment criteria and recommendations for action.