Investigation report generator
Build a structured investigation report: team and data reviewed, a guided 5-Why, a 6M fishbone drawn from your entries, an is / is-not table, root cause with category and status, impact on other batches, products and equipment, and a disposition recommendation. The tool flags gaps, such as a root cause that stops at human error, before you export.
Investigation report
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Scope and team
Why this matters
The level of effort, formality and documentation of the investigation should be proportionate to the level of risk.
Source: ICH Q10 Pharmaceutical Quality System (2008)5-Why
Why this matters
Ask "why" until you reach a cause that, if removed, would stop recurrence. Stopping at "operator error" usually means the investigation is not finished.
Good practice / example in-house approach — follow your SOP.Fishbone (6M)
Why this matters
A fishbone (Ishikawa) diagram groups possible causes under Man, Machine, Method, Material, Measurement and Environment so that no area is skipped. ICH Q9(R1) lists cause-and-effect diagrams among basic risk management facilitation methods.
Source: ICH Q9(R1) Quality Risk Management (2023)Is / Is not
Root cause and impact
Why this matters
Apply an appropriate level of root cause analysis. Where human error is suspected or identified as the cause, justify it, after making sure that process, procedural or system-based causes have not been overlooked.
Source: EU GMP Part I, Chapter 1, para 1.4(xiv) (EudraLex Vol. 4, revision 3, in operation 31 January 2013)Why this matters
Unexplained discrepancies and batch failures must be thoroughly investigated, the investigation must extend to other batches that may be associated, and a written record of the investigation, its conclusions and follow-up must be kept.
Source: 21 CFR 211.192 — Production record review (US FDA, current eCFR text)Disposition and conclusion
Why this matters
State a clear batch disposition recommendation (release, reject, rework/reprocess under procedure, or keep on hold pending data). The final decision belongs to the quality unit / authorised person under your SOP.
Good practice / example in-house approach — follow your SOP.Report text and export
Frequently asked questions
Which root-cause tools does it include?
A guided 5-Why that checks every why is answered and goes deep enough, a fishbone (6M: Man, Machine, Method, Material, Measurement, Environment) drawn from your entries, and an is / is-not table.
Why does it warn about human error?
Human error is rarely a root cause on its own. If the root cause points to human error without a deeper process, procedural or system cause, the tool asks for one, because retraining-only CAPA is a known weak spot.
Does it carry details from the deviation?
Yes. If you filled a deviation report in this browser, the deviation number and description are carried forward. You can edit them.
What is the difference between a probable and a confirmed root cause?
A confirmed root cause is supported by evidence, for example a test or data that reproduces or rules out the alternatives. A probable root cause is the most likely explanation when it cannot be proven; state the evidence and any added monitoring.
Who decides the batch disposition?
The investigation recommends a disposition with its basis. The final decision belongs to the quality unit or authorised person under your SOP.
Related guides on pharmaguideline.net
- Failure Investigation SOP and Report Template
- OOS Investigation Form Template (Free Printable)
- Deviation Management in Pharma: Complete Guide (GMP, CAPA)
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