Effective root cause investigation for Life Science

Ways to conduct better investigations and corrective actions

Problems like deviations and failures are a fact of life but individuals and organizations that understand what happened and why are in a much stronger position to establish corrective actions to reduce the likelihood that the event happening again.

Course description

This two-day workshop examines a defined, logical process that can be applied to investigations that are performed in the drug, biotech, and medical device industries. Tools like data collection sheets, checklists, and interview worksheets, based on some of the best practices in the pharma industry and beyond, and provided and used. A variety of problem solving, interviewing, and data collection techniques will also be examined.

“Human error” will be discussed along with ways to more fully understand what really caused or contributed to the incident and how those factors can be effectively addressed.

Participants will also have the opportunity to see the importance of a team approach when doing an investigation. Teams will review and critique an investigation report and discuss risk-based alternatives when a definitive root cause cannot be determined.

Course outline

• Why investigate?
• Definitions and models
• 14 steps to better investigations
• Conducting the investigation: tools to help identify the causes and contributors
• Interviewing skills
• Working with subject matter experts
• What if you can’t find the root cause?
• Putting it together: creating an investigation plan
• Assessing and managing risks related to investigations
• Corrections and corrective actions (and preventive actions)
• Writing it up: key elements in a report
• “Writing comes easier when you have something to say”
• Your investigation system: what will you take back and do differently?
• Summary/wrap-up

Course objectives

Develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.

• Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs, and investigation reports.
• Differentiate between six different accident/incident models and how they can be applied during an investigation.
• Differentiate between root cause, contributing cause, and proximal cause.
• Discuss why human error is not a valid root cause.
• Given an incident, develop an investigation plan.
• Discuss the relationship between root, contributing, and proximal causes to corrections and corrective actions.
• Discuss a model that can be used to illustrate multiple layers of control and mitigation.
• Using a guideline, evaluate an interview.
• Identify four different audiences of investigation reports and what each is expecting to see in an investigation report.
• Discuss options of what can be done when a definitive root cause cannot be identified.
• Given an investigation report with deficiencies, identify ways to improve the report.

Who should attend

Those who conduct, review, or approve investigations in development, quality assurance, laboratories, operations, technical services, and maintenance/engineering.