– The designated Compliance Liaison or Incident Response Manager is responsible for preparing and transmitting all reports to external agencies using secure, documented communication channels. • Follow-Up and Feedback: – External agencies may request additional information or conduct their own investigations. All correspondence and feedback are documented and integrated into the internal Incident Report for future reference and process improvement.
f. Investigation Procedures
Proper investigation of reported incidents is essential to identifying root causes, addressing immediate issues, and preventing recurrence. The investigation procedures are designed to be thorough, impartial, and well ‑ documented.
1. Initiation of the Investigation • Immediate Response:
– Upon receiving an incident report, the direct supervisor and Incident Response Team initiate an immediate review. For serious incidents, an emergency investigation is launched within minutes. – A preliminary incident review meeting is scheduled with all involved personnel present as soon as it is safe and feasible. • Case Assignment: – A designated investigator (typically a member of the Quality Assurance or Compliance team) is assigned to the case based on their expertise and the nature of the incident. • Data Collection: – The investigator collects all relevant documentation, including the completed Incident Report Form, witness statements, photographs/videos (if available), and any electronic logs from monitoring systems. – The investigator interviews involved parties, including the person who reported the incident and any witnesses, ensuring that all perspectives are considered.
2. Conducting the Investigation • Root Cause Analysis (RCA):
– The investigation process employs RCA methodologies such as the “5 Whys” or Fishbone Diagram to determine underlying causes rather than assigning blame. – Focus areas include process deviations, communication breakdowns, environmental hazards, and potential training deficiencies. • Collaborative Review:
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