FISHBONE
Factors Affecting Approval Time in Drug Filing
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CASE ANALYSIS
Scenario
A pharmaceutical company is experiencing prolonged drug approval times and needs to identify root causes across people, processes, and systems.
Key decisions
- Selecting relevant categories covering all aspects of the filing process
- Prioritizing causes that directly impact timeline delays
- Structuring the diagram to maintain clarity with indented sub-causes
When to reuse this
This fishbone can be used in regulatory affairs improvement initiatives, root cause analysis meetings, and process optimization in drug development.
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