Methodologies: Potent Roadblocks for Smart Concepts in Drug Discovery
Tools and methodologies as such may be useful but neither is their universal application (“if you have a hammer, every problem looks like a nail”) nor their over-extensive use (10 level FMEA).
The first gatekeepers towards smart concepts like value adding quality systems in drug discovery are frequently tools associated with the topic. FMEA, SWIFT, FMECA, FTA, Cause-and-Effect Diagrams, HAACP, HAZOP, Ishikawa-Diagrams – select any from the lot. Regardless of your choice, be ready for a deep dive into the methodologies powers and limitations. And prepare for lengthy discussions about the details of application.
Tools and methodologies as such may be useful but neither is their universal application (“if you have a hammer, every problem looks like a nail”) nor their over-extensive use (10 level FMEA). Most important, methodology obsession dangerously diverts the attention of a team, channelling attention from the quality initiatives objectives to an operational side track.
Methodologies can easily send any performance initiative into the dangerous waters of methodology application for methodologies sake, taking teams and motivation with it at the same time. Once team members have spent some frustrating days with a methodology, generating in a complicated process results that gut feeling would have predicted right from the beginning, the initiative has lost serious drive.
Of course, methodologies can be helpful, provided they are applied for the sake of objectives and not for the sake of the methodology. As a rule of thump – the simpler the application of the methodology, the better the chance that it is focused on objectives.
Risk analysis for example is a useful concept in science and should be considered in drug discovery as well. FMEA is a well established methodology for risk analysis but not necessarily the right hammer for the problematic nails of discovery. Simpler alternatives like a science based discussion between experienced experts may generate better results, faster and with less impact on resources. And once a minimum amount of structure is applied to the discussion and the results are informally documented, it has all the benefits of a “real” risk analysis.
Frequently discovery units shy away from the gatekeepers, stating that tools and methodologies are too complex, too resource demanding, not matching discovery needs and so on. These statements are correct but misleading since they confuse concept and methodology. Complex SOP systems are a GMP tool and probably not applicable for discovery. However, the concept that written procedures guarantee precise and reproducible activities is certainly applicable.
As part of a risk hedging initiative at a Biotech Company, a risk analysis of routine operations was performed. Following an intensive methodology training, risks were identified and analysed, using a 10 level FMEA. The immediate consequence were lengthy and pointless discussions whether the severity of a risk is a “6” or a “7” or rather more a “6.5”. Application of a simplified FMEA, using a 3 level scale (low, high, unknown) structured the discussions significantly and paved the way to the question that really matters – how to control and manage unacceptable risks.