Quality Risk Assessment and Management Strategies for Biopharmaceutical Companies
December 1, 2013
You’ve probably been hearing a lot about risk assessment in recent months. Indeed, some 15 times more articles have been printed referencing the concept over the past year relative to a 12-month period just three years ago. That truly represents a geometric progression. Unfortunately, very few authors have been able to disambiguate the different methods or provide insight into this time-tested, multiple-industry philosophy that at its core uses good science to make better decisions.
When we undertake the challenge to understand risk, we are simply trying to be honest with ourselves in accepting that there are always unforeseen (as well as foreseen) risks in every process and system. In analyzing flood risk — for which the human decision-making engine is probabilistically underprepared to function well — one field statistician observed, “For extremely rare events, correct uncertainty estimates may lead us to conclude that we know virtually nothing. This is not such a bad thing. If we really know nothing, we should say so!” (1).
PRODUCT FOCUS: BIOPHARMACEUTICALS
WHO SHOULD READ: EXECUTIVES, PROJECT MANAGERS, QUALITY AND REGULATORY AFFAIRS
KEYWORDS: RISK MANAGEMENT, FMEA, LOGIC, DECISION-MAKING, ISHIKAWA DIAGRAM, ANALYSIS
LEVEL: INTERMEDIATE