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Introduction
1.
Regulatory citations
2.
Regulatory requirements
3.
Definitions
4.
Writing guidelines
Deviation
Statement
1.
Components
2.
Questions for clarification
3.
Expected performance versus actual
practice or deviation
4.
Gap assessment
5.
Examples
6.
Activity: Writing clinic
Background
Information
1.
Related information
2.
Previous related investigations
3.
Other affected materials
4.
References
5.
Examples
6.
Activity: Writing clinic
Deviation
Investigations
1.
Investigation findings
2.
Chronology based reports
3.
Incident based reports
4.
Activity: Writing clinic
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Root
Cause Analysis
1.
Categories
2.
Assumptions made
3.
Questions answered
4.
Root cause options
5.
Root cause statement
6.
Activity: Writing clinic
Corrective
Actions
1.
Path forward
2.
Rationale
3.
Expected outcome and completion date
4.
Metrics
5.
Activity: Writing clinic
Preventive
Actions
1.
Path forward
2.
Rationale
3.
Expected outcome, and completion date
4.
Metrics
5.
Activity: Writing clinic
Executive
Summary
1.
Stating the root cause
2.
Summarize the important points of the
investigation supporting the root cause
3.
Stating corrective action
4.
Stating preventive action
5.
Activity: Writing clinic |
