PTI - international

• Identify the purpose of the report
• Outline the system/process for writing reports
• Highlight components of good technical reports

VII. Avoid Common Barriers to Success

• Identify tips for resolving conflicts
• Audit the investigation/deviation systems
• Review and trend the corrective and preventive actions

Exercise: Role-Play Conflict Situations Related to Investigation

VII. Compile the Details of the Incident

• Describe methods of data collection
• Use tools to gather facts and determine potential root causes

Exercise: Practice Collecting Information on Sample Deviation and Investigation Incidents
Discussion: Helpful Interview Techniques and Approaches to Fact Finding

IX. Write the Introduction and Purpose of the Report

• Write appropriately for your audience (inspector/auditor, non-scientific reader)
• Convey the facts of the incident
• Document fact-based conclusion and proposed corrective actions

Exercise: Write the Introduction of Sample Incidents

X. Capture the Investigation Process

• Clarify the approach to the investigation/deviation
• Determine what to include and what not to include in the text
• Incorporate relevant attachments
• Assess whether or not other systems are affected by the failure

Exercise: Write a Concise and Complete Description of the Investigation of the Incident

XI. Convey the Conclusion and Corrective Actions

• Examine the steps necessary to ensure closure of the report
• Outline the steps of a CAPA system
• Obtain timely approval of the investigation report

Exercise: Write the Conclusion of the Incident