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](https://qlogix.ai/app/investigations) ## The investigation procedure Root cause investigation - Person 1. Create from the write-up Type, write-up, SOPs and records attached - AI drafts 2. Draft the analysis Problem, containment, 5 Whys, fishbone, CAPA - Person 3. Test each hypothesis Result, evidence, statistics, outcome - Person 4. Disposition each cause Root cause, contributing or ruled out - Person 5. Conclude IS / IS NOT check, verification, confidence - Person 6. Decide the CAPA plan Accept or reject each action - E-signature 7. Review and approve - 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 - 1Step 1 : Open [Investigations](https://qlogix.ai/app/investigations) and choose New investigation (or Start the root cause investigation from a complaint). - 2Step 2 : Choose Investigation of: Deviation (numbered in the DEV series), OOS or OOT result, Complaint, Audit or inspection finding, or Other (INV series). - 3Step 3 : Add your reference, the area or process and a title (optional; the AI suggests one). - 4Step 4 : Paste the Deviation write-up (20 to 12,000 characters), with personal identifiers removed. - 5Step 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). - 6Step 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 A withdrawn document stays on the record with the reason; redraft the analysis to use new or withdrawn documents.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 Step What it holds What you do 1 Problem Problem statement and IS / IS NOT for what, where, when, extent Correct it; fill in every "To confirm" 2 Containment Actions taken or suggested, product and patient impact, other batches, regulatory assessment, classification Confirm what was done; set the classification 3 5 Whys Chains from the likeliest causes, each step Evidence or Assumption Verify assumptions; add whys or chains 4 Fishbone Causes in the six categories, each a hypothesis with a test plan Test each one and disposition it 5 Root cause Statement, category, confidence, rationale Set the confidence 6 Conclusion Robustness checks, verdict, next steps, AI review Answer the IS / IS NOT and verification checks 7 CAPA Corrections, corrective and preventive actions with owners, timing and effectiveness checks Accept 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. - 1Step 1 : Run the test, then enter Result found (what it showed, with the numbers) and Evidence (report, record, data set or document ID). - 2Step 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. - 3Step 3 : Set Outcome of the test: Supported, Refuted or Inconclusive (with a reason). - 4Step 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. Verdict Meaning Supports confidence Robust Every check met Confirmed Adequate Root cause supported by its test with evidence; no core check failed Confirmed Weak A root cause is named but not yet well supported Probable Not established No root cause supported by a test Not 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](https://qlogix.ai/docs/records-and-signatures)). After approval, Open a CAPA record from this investigation carries the problem statement, root cause, classification and accepted actions into a [CAPA](https://qlogix.ai/docs/capa); Raise a change control from this investigation starts a [change control](https://qlogix.ai/docs/change-control). --- Source: https://qlogix.ai/docs/investigations QLogix · contact@qlogix.ai · +17146639012