Audits and CAPA #

Objective and access #

In Parameters → Audit log → Program & CAPA, the assurance teams plan an annual program, missions and their findings. Operations follows audit and administration roles.

Program and mission #

Create the program, then a mission with scope, team, main auditor, dates and declaration of independence. Finalize the report after collecting evidence.

Findings and CAPA #

A finding is an observation, opportunity, minor or major non-compliance. It bears responsibility, deadline and proof. CAPA documents root cause, correction, corrective and preventive action.

Review and closure #

A person separate from the manager judges the effectiveness. An ineffective decision reopens the action; closing is only permitted after the mandatory information has been provided.

Roadmap #

<span class="badge-status planned">Planned</span> Explicit bidirectional links between non-conformities and action plans have not yet been delivered.

Prerequisites and responsibilities #

Create the perimeters and users before the program. The owner controls the annual coverage; the main auditor leads the mission; members collect evidence; the person responsible for the report processes the discrepancy. The effectiveness review must be carried out by a person other than the manager.

Annual program #

Start in draft, identify the areas to audit then have the program approved before activation. Archiving preserves missions and findings.

Create a mission #

1. Open the relevant program.
2. Set title and scope.
3. Select Primary Auditor and Team in the tenant.
4. Enter start and end dates.
5. Document the Declaration of Independence.
6. Change from Scheduled to In Progress at startup.
7. Add findings and evidence references.
8. Fill in the reference of the final report before completion.

The statuses are Planned, In Progress, Report Review, Completed, or Canceled. A canceled mission must retain its justification in the audit file.

Qualify a finding #

The report contains title, factual description, evidence, responsible and due date. Avoid accusatory formulations: describe the criterion, observed situation and deviation.

CAPA workflow #

1. Analysis: identify the root cause, not just the symptom.
2. Correction: immediately treat the observed effect.
3. Corrective action: prevent recurrence.
4. Preventive action: reduce a similar risk when relevant.
5. Evidence: demonstrate implementation and results.
6. Effectiveness review: an independent person concludes.
7. Closing: only if the required information is complete.

The statuses cover Open, Analysis, Action in progress, Effectiveness review, Closed and Rejected. An ineffective review puts the finding back into the processing flow.

Dashboard and filtersUse the dashboard to track missions by status, open findings, deadlines and pending reviews. Filter by program, period, scope, type, status or manager when available. #

Pre-closing checks #

• referenced final report;
• accessible evidence;
• documented root cause;
• separate correction and corrective action;
• deadline met or justified delay;
• effectiveness validator different from the manager;
• conclusion of explicit effectiveness.

Common errors #

A person absent from the selector may be inactive or out of possession. A rejected close typically indicates a missing CAPA field or role separation. Do not turn an observation into non-compliance just to force action.

Example #

A review reveals that provider accounts are not deactivated at the end of contracts. The fix disables the identified accounts; the root cause shows the absence of HR/Purchasing notification; corrective action automates reporting and an independent review verifies three subsequent departures.

Linked corrective actions #

An audit finding may link to several action plans, and one action may address several findings. The bidirectional relationship is organization-scoped. The finding retains its CAPA workflow while actions carry execution and evidence.