Some professionals in the Pharmaceutical industry may already be familiar with some elements of the Root Cause Analysis (RCA) problem solving method.
After all, investigating the cause of a quality failure or some other production problem is an activity that all pharmaceutical companies must do, some with greater frequency than others. As a result, firms, governments, and regulators are strongly encouraging the sector to employ effective RCA methods as a way to substantially improve quality, safety and reliability.
Sologic are an established provider of Root Cause Analysis skills to the pharmaceutical industry. We work with some of the largest organisations 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
- Creating a competitive edge for winning new business
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 pharmaceutical companies.
Our evidence based method enables pharmaceutical companies and professionals to uncover the genuine systemic and non-systemic causes of failure and understand where they can focus their continual improvement efforts.
I would recommend this course to anyone who deals with deviations or Corrective Actions and Preventive Actions (CAPAs).
Quality Assurance Officer