Pharmaceutical Industry: Compliance Continuous Improvement
Regulatory, Compliance & Quality
A major generic pharmaceutical company
A high frequency of non-conformance events on the shop floor and in the laboratory led to client concerns about the effectiveness of the investigation process and the corrective and preventative (CAPA) action system. They also felt that the shop floor operators and laboratory analysts were not recognizing and avoiding potential non-conformance events. The client also thought that the current metrics were ineffective in identifying trends and preventive actions needed to avoid non-conformance events.
Tunnell took a two-step approach.
- Interviewed department managers and process stakeholders
- Reviewed procedures, processes, and existing investigations against industry best practices and compliance guidelines
Developed a focused Day In the Life Of (DILO) methodology using subject matter experts in manufacturing and the QC laboratory to work one-on-one with operators and front-line supervisors. Using Socratic interactions and constructive feedback about activities, these experts mentored and coached the staff. Working from a standardized methodology, these mentors also identified areas of potential non-compliance events and recommended steps to reduce the possibility of their occurrence.
- Gaps in the investigation process that hindered adequate investigation closure and reduced the effectiveness of the implemented CAPAs were identified.
- A client team of Quality, IT, and Manufacturing representatives revised the process and software system with facilitation by Tunnell. This enabled the client to:
- Understand the roles of system owners and quality in the investigation and CAPA process
- Identify high-risk non-conformance areas using investigation metrics and the CAPA process
- Conduct faster, more detailed investigations
- Change procedures, processes and equipment to reduce possibility of non-conformance
- The mentoring and coaching activities produced immediate modifications to operator/analyst behaviors and reduced deviations.