REGTech Insights: “Warning Letters” show deficits in standard Q-processes

It is quite astonishing: The dreaded “warning letters” (so-called 483s) of the FDA do not only flutter into the house when Compliance deficits in special areas are detected; they rather uncover primarily deficiencies in standard Q-processes. This diagnosis can be made when looking based on FDA data in for medical devices in 2017 and 2018 [1]. Of a total of 699 warning letters, 354 concerned CAPA processes or CAPA documentation (86), complaints (229), procurement and supplier management (142), non-conformities (119) and processes for quality audits (78). The findings in the area of training are also interesting; more on this later.


Symbolische Darstellung einer FDA WarnungIt is therefore not primarily the regulatory requirements for product development processes that cause difficulties; and it is not so much the widely discussed complexity of the Medical Device Regulation (MDR) that causes companies to fail in the audit. Companies are certainly struggling with these requirements – and it can be a tough battle for many companies, especially smaller ones. However, the figures mentioned refer to something much more fundamental, namely weak points in the standard processes – CAPA, deviations, complaints, document management and control, etc. – of a quality management system oriented towards regulatory compliance.

Now, the FDA’s statistics do not provide detailed information about the causes behind the figures. A look at current practice, however, suggests the following assumption: Many complaints are very likely the result of a lack of digitization of Q-processes. Without digitization, there is no automation by means of workflows, no continuous and complete documentation of activities and events in the quality management system, no adequate integration and consistency of Q-processes across different technical areas. Paper-based and manually controlled processes are associated with a higher risk of errors and lead to incomplete data in the audit. In this respect, a plea for technically integrated, digital management systems can also be derived from the FDA figures.


Furthermore, the situation in the area of training is of interest. A total of 48 warning letters concern inadequacies in the determination of training needs (“Procedures for training and identifying training needs have not been [adequately] established”); 17 complain about inadequate documentation of training activities (“Personnel training is not documented”); there are also 10 for the deployment of insufficiently qualified personnel. Processes and documentation of activities are therefore the main weak points here. One could, however, also take the results as an opportunity to reflect on the traditional training organization as a whole: Is the common verification that a document has been “read and understood” still enough? Must the focus not be more on determining learning success, i.e. on qualitative aspects? Is it enough to “train documents”, i.e. to focus strongly on documents of an instructive character and on conveying their content? From the perspective of these questions, this would mean: The focus on the topics “learning” and “training” should be broadened to include informal learning processes and non-formalized content. And it would have to expand beyond the focus on documents. Learning or training situations would then be triggered by various quality-relevant events – complaints, deviations, non-conformities, etc. – in the company, and employee competencies would be continuously checked, expanded and documented. “Learning” and “training” would thus become cross-sectional topics for all areas of quality management. In that case, there is really no way around digital solutions.


Read also: How digitization will change document management in regulated industries? The white paper “Status quo and Trends in the Management of Standard Operating Procedures” (in German) publishes the results of an industry survey on digital transformation in quality and compliance management. The whitepaper can be ordered here free of charge.