Form · FRM-09
Root Cause Analysis Worksheet
Five-whys and cause-and-effect (fishbone) worksheet supporting corrective action.
Purpose
Supports structured root cause analysis for corrective action using the five-whys technique and a cause-and-effect (fishbone) analysis across six categories, so that actions address underlying causes rather than symptoms or individuals.
What it covers
- 1. Problem statement
- 2. Five-whys
- 3. Cause-and-effect analysis
- 4. Conclusion
- Authorisation
How to complete it
- 1.Involve the people who did the work; the purpose is learning, not blame.
- 2.State the problem precisely (what, where, when, how detected, how big).
- 3.Five-whys: ask 'why did this happen?' repeatedly; stop only when the answer is a process or system condition the Laboratory can change. Branch where there is more than one cause.
- 4.Fishbone: list contributing factors under each category, then mark the ones supported by evidence.
- 5.Record the root cause(s) selected, the evidence supporting them, and the actions proposed, and transfer to FRM-08.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
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