Writing Incident and Deviation Investigation Reports

Course description:

Writing an investigation report is sometimes viewed as a “penalty” when something doesn’t go as planned or when an unwanted – or unforeseen – event occurs. From a quality perspective, these reports have the potential to contribute to product and process understanding and help prevent recurrences from occurring in the future.

This course is aimed at those who write, review, and approve incident and deviation investigation reports for laboratory, operations, and other GMP areas. The course identifies what national authorities and quality auditors are looking for in reports and provides a structured approach for doing investigations, identifying Corrective Actions and Preventive Actions (CAPAs), and writing sections of reports that are defendable, yet clear and concise.

The course includes activities where participants evaluate investigation reports and identify ways to improve them. The final activity is for participants to write an investigation report based on different case studies.

Course outline

• Identify four different audiences of investigation reports and what they are expecting to see in an investigation report.
• Identify the different sections of an investigation report and what each section should include.
• Discuss how investigation reports can contribute to product and process understanding throughout the lifecycle of a drug.
• Describe and utilize tools that can be used to determine “root causes” of an incident.
• Discuss options of what can be done when a definitive root cause cannot be identified.
• Discuss how “human error” is not, in itself, a useful root cause.
• Given an investigation report with deficiencies, identify ways to improve that report.
• Given a case, determine the alignment of the root cause(s) and the specific immediate actions, corrective actions and preventive actions to be taken.
• Given a case, write a self-contained summary for case.
• Given a case, write an investigation report.
• Given an investigation report, review it and provide suggestions for improvement.

Learning objectives

Provide participants a model for a well-written investigation report and enhance their skills at writing and reviewing such reports.

Who should attend

Operations, laboratory, technical, and quality personnel who write, review, approve, or contribute to incident, deviation, OOS or CAPA investigation reports.