The impact of a company's equipment maintenance strategy on its competitiveness

The contribution of regulatory agencies to the continuous improvement of the equipment maintenance processes management Pharmaceutical companies have followed the internal development process that regulatory agencies like US FDA, EMA or ANVISA, for example, have passed through on the last years. If, some time ago, their auditors were focusing more on product quality itself when auditing production sites, nowadays they want to see the quality mindset embedded in other areas of support like maintenance, logistics or human resources. Also, their professionals currently have a skills set broader than they used to have in terms of out-of-the-pharmaceutical-box knowledge. It means that many of them know what to look for when auditing, for example, the quality of a maintenance plan, the skills matrix of a technician or even the root cause analysis of an equipment breakdown. In this aspect, it is reasonable to say that the audits of these regulatory agencies are currently much more constructive because they focus not on finding issues, but on how the issues are systematically treated in order to avoid reoccurrence. Then, when auditing maintenance departments, it’s not a surprise that they want to see how the maintenance processes are managed, what established flows for normal activities are in place and what treatment is given when deviations on these flows occur. This ‘push’ is highly contributing to the development of a quality mindset inside maintenance departments and forcing pharmaceutical companies to see maintenance not only as the needed evil, but also as a strong contributor to make sure that the products will have the minimum quality standards. The challenge is to deliver the activities needed by the maintenance processes in a way that the overall production costs will not be ‘overloaded’ by the quality needs.