All regulated life science companies have a requirement to provide a process for systematically performing investigations in any channel of the organization. This is true especially when it comes to unplanned deviations such as customer complaints, product non-conformances, material problems, OOS’s, design challenges, and many other “channels”.
This process will be described in terms of notice of event (NOE) escalation, and the importance that risk-gating and review of data/information is utilized in critical thinking processes (CTS). We will introduce the (5) CTS processes and how they compliment each other in effective resolution during the investigation of deviations. The context of this discussion will be in support of the CAPA process and citations for poor investigations.
- Deviation Investigation process
- Context of CAPA with this process
- The connection of the deviation spectrum to risk, data analysis and process resolution which includes change control
- Brief descriptions of the (5) CTS models and their interaction
- FDA citations that bear out the failures with such investigations
- Tools/resources used to support such processes
- Senior Management
- Middle Management
- Quality Departments
- Regulatory Affairs Departments
- R&D Departments
- Operations Departments
- Production Departments
- Manufacturing Departments
- Engineering Departments
- Marketing Departments
FDB2391
