Audit programmes and findings
Approve an audit programme and versioned plan, record independent fieldwork and findings, then verify responses and close only after linked NCR/CAPA closure.
Screen orientation
quality_audit:read is constrained by site and clearance. Programme authoring, planning, approval, execution, report review, correction, verification and closure use quality_audit:programme, :plan, :approve, :execute, :review, :correct, :verify and :close. The named Internal Auditor alone executes the assigned audit; the assigned Quality Engineer process owner responds. QA decisions exclude conflicting authors/auditors/owners, even if a button is visible. The read-only Auditor role is distinct from Internal Auditor.
Six summary cards show programme/plan review, fieldwork/report, finding-response and closure work. New programme opens an inline editor. Programme cards contain their audit plans, nested accepted-report findings and version-history sections. Stage-specific forms appear below the register; Plan audit opens its editor inside the active programme.
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 |
|---|---|---|---|---|
| Site / Title / Classification | Select, text and select | Site and classification required at programme creation; programme and plan titles at least 10 characters. | Choose the scoped programme site and handling classification. Audits inherit programme context. The replacement-programme editor retains the existing site and classification rather than offering these controls again. | Creates the governed programme identity and access scope. |
| Frequency / Period start / Period end | Select and two dates | Required; end cannot precede start. | Choose ANNUAL, SEMI_ANNUAL, QUARTERLY, RISK_TRIGGERED or ONE_OFF. Frequency records the programme cadence; it does not automatically create audits. The replacement editor retains frequency. | Defines the approved window within which audit plans must fit. |
| Objectives / Scope / Risk basis | Three multiline text controls | Each required; at least 20 characters each. | State the programme objectives, boundaries and risk-based selection rationale separately. | Freezes the justification for the programme version. |
| Criteria (one per line) / Criteria | Multiline text | 1–50 criteria required for programme and plan, unique ignoring case. | Enter controlled references one per line; comma-separated entries are also split. Replacement programmes label this Criteria. References are not a substitute for stored evidence. | Retains the criteria against which fieldwork is planned. |
| Programme evidence / Replacement programme evidence | Controlled evidence select | Required for each initial or replacement programme version. | Select one CLEAN immutable version from an active same-site document within programme classification. | Pins the programme basis; replacement is offered only after rejection. |
| Submission note | Multiline text | Required; at least 20 characters; the current version's author submits it. | Explain why the programme or audit plan is ready for independent QA review. | Sends a draft programme to PROGRAMME_REVIEW or a draft audit plan to PLAN_REVIEW. |
| Decision / Independent decision note / Decision evidence | Select, multiline text and controlled evidence select | Required at programme/plan decision or report review; note at least 20 characters. | APPROVE/REJECT programme or plan; ACCEPT/REJECT report. Use CLEAN same-site evidence. Programme approval excludes its author; plan approval also excludes the programme-version author, plan author, lead auditor and process owner. | Records the independent decision without overwriting the submitted version. |
| Audit type / Planned start / Planned end | Select and two dates | Required under the current approved ACTIVE programme. | Choose QMS_PROCESS, PRODUCT, PROJECT, SUPPLIER or COMPLIANCE. The ordered start/end dates must remain within the approved programme period. | Defines the audit scope type and planned window. |
| Lead Internal Auditor / Audited process owner | Two selects | Required; author, lead auditor and process owner must be three different users. | Select an active, scoped and cleared INTERNAL_AUDITOR and QUALITY_ENGINEER. The server validates eligibility even when names appear in the dropdowns. | Assigns independent fieldwork and response ownership. |
| scope Summary / objectives / sampling Plan | Three multiline text controls | Each required in the audit-plan editor; at least 20 characters each. | These are the current generated labels. Define audit boundaries, objectives and the sample selection/depth; they are distinct from the programme-wide Scope and Objectives. | Freezes the plan's inspection approach and sampling rationale. |
| Audit-plan evidence | Controlled evidence select | Required for initial and replacement audit plans. | Select the exact CLEAN same-site plan evidence within audit classification. | Pins the immutable plan version to its approved programme context. |
| Started on / Opening meeting summary / Fieldwork-start evidence | Date, multiline text and controlled evidence select | Required at READY; date cannot be future, summary at least 20 characters. | The assigned lead auditor records the actual opening meeting and CLEAN same-site evidence. | Moves the audit to FIELDWORK; it does not create findings automatically. |
| Completed on / Audit summary / Sampled records | Date and two multiline text controls | Required for the report; date cannot be future and both texts at least 20 characters. | The assigned lead auditor describes completed work and exact sampled-record references. | Retains the basis of the new immutable report version. |
| Conclusion | Select | CONFORMING or NONCONFORMING required. | NONCONFORMING requires at least one major/minor finding. CONFORMING may contain observations or opportunities, or no findings; changing to CONFORMING converts existing major/minor rows to observations and clears their due dates. | Controls the submitted finding set and the report's declared conclusion. |
| Number / Type / Requirement reference / Response due | Repeatable text, select, text and date | Up to 100 findings; unique numbers ignoring case; due date required for MAJOR_NONCONFORMITY or MINOR_NONCONFORMITY. | Classify each finding as major/minor nonconformity, OBSERVATION or OPPORTUNITY. Add Finding or Remove before submission. In this UI, observations/opportunities can accompany a nonconforming report that also contains a major/minor finding. | Separates response-bearing nonconformities from recorded observations/opportunities. |
| Finding statement / Objective evidence | Two multiline text controls per finding | Each required; at least 20 characters each. | State the requirement gap and the observed evidence separately. A finding is not automatically an NCR. | Freezes the finding content in its report version. |
| Immutable report evidence | Controlled evidence select | Required for report submission. | Select CLEAN same-site report evidence; the current report remains pending until independently reviewed. | Sends the audit to REPORT_REVIEW. |
| Linked NCR/CAPA | Select | Required for a response to an open nonconformity finding in the current accepted report. | The assigned process owner selects an existing same-site NCR within audit classification. It need not yet be closed at response capture; independent NCR/CAPA closure is required before audit closure. | Links the response to the corrective-action system without creating or closing an NCR. |
| root Cause / correction / corrective Action / completion Summary / effectiveness Criteria | Five multiline text controls | Each required for a response; at least 20 characters each. | These are the current generated labels. Record the cause, immediate correction, recurrence action, completed work and criteria for testing effectiveness. Completed on also applies to the response and cannot be future. | Stores an immutable process-owner response version, not independent verification. |
| Finding-response evidence | Controlled evidence select | Required for response submission. | Select the CLEAN same-site evidence of completed correction/action. | Moves the finding to RESPONSE_SUBMITTED for independent verification. |
| Residual risk / Verification method / Observed result / Independent verification evidence | Select, two multiline text controls and controlled evidence select | Required with an EFFECTIVE or REJECT Decision; texts at least 20 characters. | Use actual verification results and CLEAN same-site evidence. EFFECTIVE cannot retain UNACCEPTABLE risk; ACCEPTABLE or MONITOR is allowed. The verifier must be independent of the plan author, auditor, process owner and response submitter. | EFFECTIVE verifies the finding; REJECT reopens it for a new immutable response. |
| Closure summary / Independent closure evidence | Multiline text and controlled evidence select | Required at CLOSURE_PENDING; summary at least 20 characters. | Check every current nonconformity finding has an effective verified response and a closed linked NCR/CAPA, then select CLEAN same-site closure evidence. | Records independent audit closure only after the separate corrective-action prerequisites pass. |
| Follow-up audit required / Follow-up due date | Checkbox and conditional date | Date required when the checkbox is selected. | Record the follow-up requirement and deadline. This form retains the requirement; it does not create or schedule a new audit automatically. | Keeps follow-up context on the closed audit. |
Actions and effects
When to use: An author creates and submits a complete risk-based programme; independent QA reviews it.
What it does: Approval sets ACTIVE and enables Plan audit. Rejection retains the version and enables an immutable replacement, not an edit to an approved programme.
When to use: Under the current approved programme, with independent assigned auditor/owner and dates inside its period.
What it does: An approved plan becomes READY. A rejected plan must be replaced and resubmitted; version history remains intact.
When to use: Assigned lead auditor starts and reports, then independent QA reviews.
What it does: Review rejection returns to FIELDWORK for a new report. Acceptance routes nonconformities to RESPONSE_PENDING; without nonconformities it routes to CLOSURE_PENDING, not directly CLOSED.
When to use: Assigned process owner responds to each current nonconformity; independent QA verifies.
What it does: Rejection permits a new response version. All current nonconformities must be verified before the audit reaches CLOSURE_PENDING.
When to use: Independent QA acts at CLOSURE_PENDING after all linked corrective-action prerequisites pass.
What it does: Closure requires both effective finding responses and closed linked NCR/CAPA records. It does not close those NCRs or automatically create a follow-up audit.
Lists and states
- Audit programme register: programme number, version, period, frequency, classification and author identify the approved scope. Nested audit cards show audit number/status, plan/report versions, audit type, assigned auditor and process owner.
- Findings are displayed for the current ACCEPTED report. Major/minor findings carry response and verification work; observations/opportunities are recorded without the same response requirement. Response lines show immutable version, status and linked NCR status.
- Programme history and plan/report history appear when multiple versions exist. Retained versions and decisions are not editable records; a green review badge is not proof of completed NCR/CAPA closure.
Authority boundary
Audit assurance never moves or releases stock, changes supplier approval or product configuration, automatically closes an NCR or sends an external message. CLOSURE_PENDING is not permission to bypass unresolved linked NCR/CAPA control, and frequency/follow-up fields do not automatically schedule audits.