Nonconformance and CAPA
Record, contain, investigate, correct and independently verify a nonconformance. The screen preserves the source record and routes any required physical action back to its owning authority.
Screen orientation
Quality roles can see and act only within their tenant/site/classification scope. Triage, action ownership and effectiveness verification maintain required separation of duties.
The register lists current NCRs. Opening a record reveals its lifecycle: triage, containment, investigation, action plan, response, independent effectiveness verification and closure.
Field reference
The entries below describe the current screen controls and read-only values. They do not relax server-side validation, site scope, classification handling or required independence in a governed decision.
| Field or value | Control | Required or shown when | How to use or read it | Result |
|---|---|---|---|---|
| NCR title / Nonconformance description | Text and long text | Required to open an NCR. | Name the issue precisely and describe observed nonconformance; do not assert root cause before investigation. | Creates the controlled quality case. |
| Site / Classification | Select | Required. | Select the affected authoritative site and handling classification. These control downstream visibility and eligible sources. | Scopes the case and its related evidence. |
| Affected object / Affected reference | Select/text | Required for the recorded scope. | Identify the exact source record, item, supplier or configuration context without copying it into a parallel record. | Anchors the NCR to its authoritative source. |
| Confirmed severity / Recurrence risk | Select | Required during governed triage. | Select the independently assessed level based on the documented finding, not a desired closure outcome. | Controls the review and response context. |
| Containment action / Containment due | Long text and date | Required when triage requires containment. | State the immediate control and due date. Use the owning Inventory/Manufacturing/Quality route for the actual transaction. | Retains containment intent without silently moving stock. |
| Root cause / Root-cause method | Long text | Required before the corrective-action decision where applicable. | Record evidence-based cause and method; distinguish contributing factors from the verified root cause. | Provides attributable investigation evidence. |
| Action owner / Due date / Objective verification criteria | Select, date and long text | Required for a corrective action. | Assign an eligible accountable owner, due date and measurable effectiveness expectation. | Creates an attributable action that requires response and independent verification. |
| Residual risk / Closure summary | Select and long text | Required to close when all prerequisites are final. | State the post-action risk and closure rationale. Closure cannot erase retained historical NCR evidence. | Records the final Quality lifecycle decision. |
Actions and effects
When to use: After the reported source and scope are understood.
What it does: Records the Quality decision and routes required execution to the authoritative module.
When to use: When evidence supports a corrective path.
What it does: Creates attributable investigation and action evidence without changing the source transaction.
When to use: By the required independent Quality role after responses are complete.
What it does: Records the outcome and residual risk; does not release stock or close unrelated source records.
Lists and states
- NCR register: status, severity, site, affected reference and due dates identify work needing attention.
- Action history: author, owner, response and verification distinguish an action plan from an independently proven result.
Authority boundary
Quality governs the quality decision. It does not silently change stock, repair material, issue an engineering change, pay a supplier or send external communication outside a dedicated flow.