Root cause analysis template pack
An investigation report, a 5 Whys worksheet and a fishbone diagram worksheet in Word, with worked examples from a GMP setting. Free to download, no email needed.
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Free to use and adapt in your organisation. No email address needed. Add your own document number and version, and approve the form under your document control before use.
- Word (.docx)
Root cause analysis report
Problem description, containment, team, timeline, analysis, root cause with evidence, impact, actions and approvals.
- Word (.docx)
5 Whys worksheet
One chain of why-questions with the evidence for each answer, and a worked example from a QC lab.
- Word (.docx)
Fishbone (Ishikawa) diagram
Printable diagram with six cause categories, a cause evaluation table and a worked example.
What this template is for
Root cause analysis explains why a deviation, complaint, audit finding or nonconformity happened, so the corrective action removes the cause instead of the symptom. ISO 9001, ISO 13485 and the GMP guidelines all expect the cause of a nonconformity to be determined before actions are chosen, and inspectors read the investigation to judge whether that happened.
The pack has three parts. The report records the investigation from problem statement to approved conclusion. The 5 Whys worksheet follows one chain of cause and effect. The fishbone worksheet helps a team list possible causes across six categories (people, method, equipment, material, measurement and environment) before testing each one against evidence.
Requirements it supports
How to fill it in
- 1
Describe the problem, not the cause
Write what happened, where, when, how it was detected and how much was affected, and compare it with the requirement. A problem statement that already names a cause steers the whole investigation.
- 2
Contain first
Record the immediate actions, such as quarantine, holds or stopping a line, with dates and record numbers. Containment protects product while you investigate; it is not the corrective action.
- 3
Collect data and build a timeline
Review batch or device records, logbooks, audit trails, training and calibration records, and talk to the people involved. A timeline with sources shows what changed and when.
- 4
Choose the tool that fits
Use the fishbone when several categories of cause are plausible, so the team considers each one. Use the 5 Whys for a single chain of cause and effect. Many investigations use both: the fishbone to list candidates, the 5 Whys to drill into the one the evidence supports.
- 5
Confirm the root cause with evidence
For every candidate cause, record how it was checked and the outcome. If the root cause cannot be confirmed, name the most probable cause and explain why the others were excluded.
- 6
Assess the impact and widen the scope
Check whether other batches, products, sites or systems share the same cause, and record the disposition decision for affected material.
- 7
Define actions and get approval
List corrective and preventive actions with owners and due dates, link them to CAPA records, and have QA approve the report.
Common mistakes inspectors flag
Human error as the root cause
"Operator error" or "did not follow the SOP" without asking why the error was possible is one of the most challenged conclusions. Inspectors expect the investigation to look at procedure clarity, training, equipment design and workload.
A conclusion without evidence
A root cause that is asserted rather than shown, with no data, records or tests referenced, does not demonstrate that the cause was found.
Scope limited to one batch
21 CFR 211.192 expects an investigation to extend to other batches and products that may be associated with the failure. Investigations that never ask the question are a recurring observation.
The same deviation, investigated again and again
Repeated deviations closed with the same conclusion and no trend review suggest the real cause was never found.
Investigations that stay open
Investigations past their due date without a documented extension, justification and interim risk assessment.
Do this in QFacts
A template works until the records pile up. QFacts keeps these records in one eQMS with workflows, electronic signatures and an audit trail. Try it for 14 days, no credit card needed.
- Record events with the impacted batches per product, and complaints with their source, recurrence check and impact level.
- QA assesses the impact of each event and closes it with a signed assessment.
- Escalate impactful events to an investigation that documents the root cause, and link CAPAs to it.
- Every step is kept in an audit trail that cannot be edited or deleted.
Frequently asked questions
What is the difference between a root cause and a contributing factor?
The root cause is the cause that, once removed, prevents the problem from recurring. Contributing factors made the problem more likely or worse but would not prevent it on their own. The report has separate fields for both, so actions can address each.
When should I use 5 Whys and when a fishbone diagram?
Use a fishbone diagram when you do not yet know where the cause lies and want the team to consider people, methods, equipment, materials, measurement and environment. Use 5 Whys to follow one cause down to the level where you can act on it. They work well together.
Do I always need to ask exactly five whys?
No. Stop when you reach a cause you can act on and that, once removed, prevents recurrence. That may take three questions or seven. Check each answer against evidence before asking the next why.
Can I use these templates in a GMP or ISO 13485 environment?
Yes, as a starting point. Add your document number and version, align the fields with your deviation and CAPA procedures, and approve the forms under your document control before use. A template does not make a process compliant on its own; your procedure and how it is followed do.
Are the templates free?
Yes. Download them without an email address and use them in your organisation. The newsletter sign-up on this page is optional.
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