Audit Findings

Audit findings document non-conformities, observations, and other issues discovered during an audit. This page covers how to create, filter, review, comment on, and accept findings.

Finding types

Type	Description
Non-Conformity	A failure to meet a specified requirement.
Non-Compliance	A failure to comply with regulatory requirements.
Observation	A noted condition that could lead to a non-conformity.
Positive Finding	A noteworthy good practice observed during the audit.

Severity levels

Severity	Indicator	Description
Critical	Red badge	Immediate risk to product quality, patient safety, or regulatory compliance.
Major	Orange badge	Significant deviation requiring prompt corrective action.
Minor	Blue badge	A lesser deviation that should be addressed but poses limited immediate risk.
Observation	Gray badge	An area for potential improvement, not a formal non-conformity.

Create a finding

1. On the left sidebar, select Audit.
2. Select the view (eye) icon on an audit row to open the audit detail page.
3. Select the Findings tab.
4. Select Create Finding.
5. Complete the finding form fields described below.
6. Select Submit.

Required fields

Field	Description
Title	Brief summary of the finding.
Description	Detailed explanation of what was observed.
Category	Classification of the finding.
Severity	Critical, Major, Minor, or Observation.
Finding Type	Non-Conformity, Non-Compliance, Observation, or Positive Finding.

Optional fields

Field	Description
ISO Classification	Reference to specific ISO clause or standard.
Location	Physical location where the finding was identified.
Process Area	The process or department involved.
Standard Reference	Specific standard or regulatory reference.
Evidence	Description of the objective evidence collected.
Root Cause	Initial root cause analysis.
Contributing Factors	Factors that contributed to the finding.
Immediate Actions	Any immediate containment actions taken.
Corrective Action Required	Whether a formal corrective action is needed (checkbox).
Proposed Corrective Action	Suggested corrective action.
Responsible Person	Person assigned to address the finding.
Target Completion Date	Deadline for resolution.
Department Affected	The department impacted by the finding.
Repeated Finding	Whether this finding has been raised in a previous audit (checkbox).
Related SOP	Reference to the related Standard Operating Procedure.
Notes	Additional notes or context for the finding.
Evidence Attachments	Supporting documents, photos, or files.

Tip

Attach evidence files directly to the finding during creation. This keeps all supporting documentation linked to the specific finding for easy retrieval during reviews and follow-up audits.

Filter findings

On the Findings tab, use the filter panel above the findings grid:

1. Enter text in the Search box to filter by title, description, finding number, location, or process area.
2. Select a Status filter: Open, In Progress, Verified, or Closed.
3. Select a Severity filter: Critical, Major, Minor, or Observation.
4. Select a Category filter.
5. Select a Finding Type filter: Non-Conformity, Non-Compliance, Observation, or Positive Finding.

View finding details

1. On the Findings tab, select a finding card.
2. The finding detail page opens with three tabs:
   • Overview — displays complete finding information including description, severity, status, evidence, and root cause.
   • Comments — threaded discussion on the finding.
   • Attachments — evidence files linked to the finding.

Add a comment to a finding

1. On the finding detail page, select the Comments tab.
2. Select Add Comment.
3. Enter the comment text.
4. Select Post.

Comments display the author name, date, and type badge (Comment, Dispute, Response, or Status Update).

Accept a finding

Accepting a finding creates a linked CAPA for tracking corrective and preventive actions.

1. Open a finding that is in Open status with no active dispute.
2. Select Accept Finding.
3. In the confirmation dialog, select Confirm.

Note

Accepting a finding automatically creates a CAPA linked to the finding. This ensures that accepted findings are tracked through to resolution.

Verify finding effectiveness

After a finding is Closed, a post-closure effectiveness check confirms that the corrective action actually worked. Verifying moves the finding to the terminal Verified status.

1. Open a finding that is in Closed status.
2. Select Verify Effectiveness.
3. Enter the effectiveness verification note (required — describe the evidence that the corrective action was effective; it is written to the audit trail).
4. Complete the electronic signature: select Get verification code, enter the 6-digit code emailed to you, then select Verify effectiveness.

The finding status changes to Verified, stamping who verified it and when. Verified is a terminal state.

Note

Verifying effectiveness is a 21 CFR Part 11 electronic signature. It requires the audit.update_findings permission — held by the Admin and QA Team roles by default, and grantable to custom roles — or audit.admin. The Verify Effectiveness button appears only for Closed findings.

Finding statuses

Status	Description
Open	Finding has been recorded and is awaiting review.
In Progress	Corrective actions are being implemented.
Closed	Finding is fully resolved and closed.
Verified	Post-closure effectiveness check has confirmed the corrective action worked (terminal).

Permissions

Action	Who can do it
View findings	Any user with access to the audit
Create findings	Users with the audit.create_findings permission (Admin and QA Team by default), the audit’s lead auditor and audit team members, and external auditors through their access link
Edit findings	Users with the audit.update_findings permission (Admin and QA Team by default), the finding’s reporter, or its responsible person
Accept findings	The finding’s responsible person, or a user with the audit.update_findings permission — when the finding is open with no active dispute
Dispute findings	The finding’s responsible person, or a user with the audit.update_findings permission — when the finding is open with no prior dispute
Verify effectiveness	Users with the audit.update_findings (or audit.admin) permission, when the finding is closed

These are permissions, not fixed role names: Admin and QA Team hold them by default, and a workspace-authored custom role can be granted them.

Practical example: recording a finding during a document control audit

Scenario: During the “Pre-Certification Document Control Audit Q1 2026” (AUD-2026-004), auditor Maria Lopez discovers that three obsolete SOPs are still accessible in the shared network drive without any “OBSOLETE” watermark, which violates ISO 13485:2016 clause 4.2.4.

1. Maria opens audit AUD-2026-004 and selects the Findings tab.

2. She selects Create Finding and fills in the form:

   Field	Value
   Title	Obsolete SOPs accessible without identification
   Description	Three obsolete SOPs (SOP-MFG-012 Rev 2, SOP-MFG-015 Rev 1, SOP-PKG-003 Rev 3) were found on the shared network drive (\\server\quality\sops) without any “OBSOLETE” watermark or other identification. Current employees confirmed they could access these documents without restriction. This creates a risk of unintended use of superseded procedures in production.
   Category	Nonconformity
   Severity	Major
   Finding Type	Non-Conformity
   ISO Classification	4.2.4
   Location	Document Control — Quality Department
   Process Area	Document Control
   Standard Reference	ISO 13485:2016 clause 4.2.4(c); SOP-QMS-003 Rev 5, section 6.4
   Evidence	Screenshots of network drive directory listing showing obsolete documents without identification. Interviews with two production operators confirming access.
   Root Cause	The EDMS retirement workflow does not automatically remove or watermark copies stored on shared network drives outside the EDMS.
   Corrective Action Required	Yes (checked)
   Proposed Corrective Action	1) Immediately remove or watermark the three identified obsolete SOPs. 2) Conduct a sweep of all shared drives for additional obsolete documents. 3) Update SOP-QMS-003 to include shared drive cleanup in the document retirement procedure.
   Responsible Person	Karen Wells (Document Control Manager)
   Target Completion Date	2026-04-15

3. Maria attaches the screenshots as evidence files.

4. She selects Submit. The finding is created as AUD-2026-004-F001 with Open status.

5. After the QA team reviews, they select Accept Finding, which automatically creates a linked CAPA to track the corrective actions through to completion and effectiveness verification.

Related topics

• Dispute resolution
• Audit reports