From recurring nonconformances to root-cause hypotheses, accountable actions, and effectiveness decisions, CAPA Investigator gives quality teams one disciplined operating structure.
The clearest improvement is not more text. It is a single decision structure connecting root cause, ownership, completion criteria, and verification.
Every capability shown here comes from the existing cases: decide when to initiate, separate root cause from evidence, connect actions to verification, and surface management priorities.
Build a layered cause chain while clearly marking every missing input as “To be verified.”
Map containment, correction, corrective action, and prevention to owners, completion criteria, and verification.
Summarize open, closed, and overdue CAPAs, then identify the item that needs management attention.
The workflow begins with observed facts and ends with human quality approval. The Skill structures the work; it does not replace compliance judgment.
Provide what happened, frequency, scope, and the evidence already available.
Separate observed facts, causal hypotheses, and materials that still need verification.
Tie each measure to the root cause with an owner, due date, acceptance criteria, and verification method.
Check records, tests, and recurrence, then route the conclusion to the CAPA Owner and QA.
Built for everyday situations where teams need a shared view of evidence gaps, accountable actions, or management risk.
It does not make regulatory decisions for you. It makes the relationship between the issue, evidence, actions, and risk easier to inspect.
Each example uses the same Skill for a different decision: establish causes, design actions, or set management priority. Select a screenshot to inspect the full result.
Initiates CAPA after three recurrences and builds a process-control hypothesis chain without inventing evidence.
Turns a system control gap and missing QA review into five accountable actions and measurable effectiveness criteria.
Calculates a 50% open-item overdue rate and elevates the 130-day item for immediate review.
The output advances investigation and quality review. It does not automatically certify a root cause, declare effectiveness, or close a CAPA.
Missing inputs remain explicitly marked for verification; hypotheses are not presented as facts.
Causes, actions, and effectiveness criteria remain connected and reviewable.
The CAPA Owner and QA retain authority for effectiveness and closure decisions.
English and Chinese examples use their corresponding prompts and runtime results.
Give investigators, process owners, and management one shared structure for facts, actions, and decisions.
Structure investigations, review evidence, and approve effectiveness conclusions.
Coordinate causes, actions, deadlines, and cross-functional delivery.
Implement system or procedure changes and provide verification evidence.
Identify overdue, aging, and escalation priorities across the CAPA portfolio.
Provide the issue, frequency, scope, and available evidence. CAPA Investigator helps turn them into a reviewable cause chain, action plan, or status summary.
View the workflow →