Quality events

Investigations, root cause and CAPA plan

Open an investigation from a deviation, OOS, complaint or audit finding; let the AI draft the problem statement, containment, 5 Whys, fishbone and CAPA plan from your write-up and documents; test each fishbone cause as a hypothesis; reach a robust conclusion and hand the CAPA to the QMS.

In the portal: /app/investigations

The investigation procedure

Root cause investigation
  1. Person

    1. Create from the write-up

    Type, write-up, SOPs and records attached

  2. AI drafts

    2. Draft the analysis

    Problem, containment, 5 Whys, fishbone, CAPA

  3. Person

    3. Test each hypothesis

    Result, evidence, statistics, outcome

  4. Person

    4. Disposition each cause

    Root cause, contributing or ruled out

  5. Person

    5. Conclude

    IS / IS NOT check, verification, confidence

  6. Person

    6. Decide the CAPA plan

    Accept or reject each action

  7. E-signature

    7. Review and approve

  8. Person

    8. Open the CAPA record

    Prefilled from the accepted actions

  • A test refutes a cause → it cannot be ruled in. A test supports it → it cannot be ruled out.
  • Every hypothesis refuted → revisit the problem statement and add causes.
  • Root cause confidence can be Confirmed only when the root cause's test supports it.

Open an investigation

  1. Step 1: Open Investigations and choose New investigation (or Start the root cause investigation from a complaint).
  2. Step 2: Choose Investigation of: Deviation (numbered in the DEV series), OOS or OOT result, Complaint, Audit or inspection finding, or Other (INV series).
  3. Step 3: Add your reference, the area or process and a title (optional; the AI suggests one).
  4. Step 4: Paste the Deviation write-up (20 to 12,000 characters), with personal identifiers removed.
  5. Step 5: Attach reference documents: SOP, batch record, lab record, equipment or maintenance log, training record, previous investigation, specification or other (PDF, Word, Excel, text, CSV or images; up to 20 MB each, 12 active documents).
  6. Step 6: Keep Draft the root cause analysis now ticked and choose Create and draft analysis.

Tip: Each document is fingerprinted (SHA-256) and given an ID (D1, D2…); the write-up is "W". Every quote in the analysis names its source. A withdrawn document stays on the record with the reason; redraft the analysis to use new or withdrawn documents.

The analysis, step by step

StepWhat it holdsWhat you do
1 ProblemProblem statement and IS / IS NOT for what, where, when, extentCorrect it; fill in every "To confirm"
2 ContainmentActions taken or suggested, product and patient impact, other batches, regulatory assessment, classificationConfirm what was done; set the classification
3 5 WhysChains from the likeliest causes, each step Evidence or AssumptionVerify assumptions; add whys or chains
4 FishboneCauses in the six categories, each a hypothesis with a test planTest each one and disposition it
5 Root causeStatement, category, confidence, rationaleSet the confidence
6 ConclusionRobustness checks, verdict, next steps, AI reviewAnswer the IS / IS NOT and verification checks
7 CAPACorrections, corrective and preventive actions with owners, timing and effectiveness checksAccept or reject each; add your own

Edits need a reason. Nothing is deleted: causes and actions are dispositioned, and you can add causes, actions, whys and chains. Redraft the analysis (with a reason) replaces the whole analysis, including edits; the earlier version stays in the audit trail.

Test each fishbone cause as a hypothesis

Each cause (C1, C2…) is a hypothesis: "If this is the cause, then…", with a test method (laboratory analysis, experiment or simulation, equipment inspection, statistical comparison of data, record review, process walk-through, interview or observation), what would support it and what would refute it.

  1. Step 1: Run the test, then enter Result found (what it showed, with the numbers) and Evidence (report, record, data set or document ID).
  2. Step 2: Optional: choose Test with data and run a statistical test (Welch, paired or one-sample t, Mann-Whitney, ANOVA, Fisher's exact or chi-square). The preview shows p-value, effect size and confidence interval; Save the test to the record recomputes it on the server.
  3. Step 3: Set Outcome of the test: Supported, Refuted or Inconclusive (with a reason).
  4. Step 4: Set the cause's Disposition: Root cause, Contributing or Ruled out (with a reason). It must agree with the outcome.

The fishbone marks each cause ✓ supported, ✗ refuted, ? inconclusive or ○ not tested, and the Hypothesis tests table lists them all.

Reach a robust conclusion

Step 6 judges the conclusion against eleven checks: problem defined, every hypothesis tested, root cause identified, supported by its test, tested objectively, alternatives excluded, 5 Whys on evidence, explains every IS and IS NOT, verified, a system cause rather than human error, and a corrective action with an effectiveness check.

VerdictMeaningSupports confidence
RobustEvery check metConfirmed
AdequateRoot cause supported by its test with evidence; no core check failedConfirmed
WeakA root cause is named but not yet well supportedProbable
Not establishedNo root cause supported by a testNot determined

Next steps list what to do, by priority (Now, Before closure, Follow-up): untested hypotheses with their plans, inconclusive tests to repeat, 5 Whys assumptions to verify, the IS / IS NOT check, verification, CAPA gaps and confidence changes. Review the conclusion asks the AI for a second opinion; it changes nothing.

Before review and signing

The panel Before submitting for review lists what remains. An investigation cannot be routed while any of these hold:

  • There is no analysis yet, or a fishbone cause is still open.
  • No cause is marked as the root cause, and the confidence is not "Not determined".
  • A CAPA action is neither accepted nor rejected, or the root cause statement is empty.
  • A cause ruled in or out has no hypothesis test result, or its disposition contradicts the result.
  • The root cause is Confirmed but its test does not support it, or the IS / IS NOT check is unanswered.

Then route it for review and approval (Records, review and signatures). After approval, Open a CAPA record from this investigation carries the problem statement, root cause, classification and accepted actions into a CAPA; Raise a change control from this investigation starts a change control.