Some professionals in the Life Sciences/Pharmaceutical industry may already be familiar with the elements of the Sologic Root Cause Analysis (RCA) problem solving method.
In an environment of strict regulation and compliance, the risk of off-spec or mislabeled products must be managed closely. As a result, the pharmaceutical sector must employ effective RCA methods as a way to identify and eliminate the causes of these problems so that reliable product quality and safety is assured.
Sologic is an established provider of Root Cause Analysis skills to the Life Sciences industry. We work with some of the largest organizations in the industry, both in Europe and the US. As a result, our training courses, methods and software apps are tailored to the specific needs of the sector.
So, what exactly is a truly effective RCA and what does it deliver? At its core, RCA is a process for identifying the causes of problems or events in order to prevent them from recurring. It is based on the idea that effective management requires more than putting out fires for problems that develop but finding a way to prevent them. RCA can also be employed as a means of identifying best practice, supporting continual improvement and rewarding evidence-based decision making.
The methodology provides pharmaceutical professionals with:
- Insight into underlying causes of problems and successes in clinical trials
- Solutions with immediate and lasting impact
- A unified method to overcome silos and increased complexity in systems
- Compliance with the expectations and guidelines of regulators and regions
- Reducing complaints and building a better reputation and experience for customers
- Opportunities to improve weakness or failures through testing
- Automated reports for improved transparency and compliance
This all becomes increasingly vital with regulators around the world often citing insufficient or poorly executed root cause analysis programs as major compliance weaknesses in the Life Science industry.