Audit Findings
Audit findings are the core output of any audit. The findings management system allows auditors to record non-conformities, observations, and other issues discovered during an audit, track their resolution, and maintain a complete evidence trail.
What You Can Do
Section titled “What You Can Do”- Create findings with detailed categorization and evidence
- Filter and search findings by status, severity, category, and type
- View finding details including description, evidence, root cause, and attachments
- Add comments to findings for discussion and clarification
- Dispute findings when auditees disagree with a finding
- Accept findings to automatically create linked CAPAs
Finding Types
Section titled “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
Section titled “Severity Levels”Each finding is assigned a severity level that determines its visual priority:
| Severity | Indicator | Description |
|---|---|---|
| Critical | Red badge | Immediate risk to product quality, patient safety, or regulatory compliance |
| Major | Orange badge | Significant deviation that requires 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 |
Categories
Section titled “Categories”Findings can be categorized to aid in trending and analysis. Categories include non-conformity types, process areas, and other classification schemes configured in the system.
Creating a Finding
Section titled “Creating a Finding”- Open the audit detail page and navigate to the Findings tab
- Click Create Finding
- Fill in the finding form:
Finding Form Fields
Section titled “Finding Form Fields”| Field | Required | Description |
|---|---|---|
| Title | Yes | Brief summary of the finding |
| Description | Yes | Detailed explanation of what was observed |
| Category | Yes | Classification of the finding |
| Severity | Yes | Critical, Major, Minor, or Observation |
| Finding Type | Yes | Non-Conformity, Non-Compliance, Observation, or Positive Finding |
| ISO Classification | No | Reference to specific ISO clause or standard |
| Location | No | Physical location where the finding was identified |
| Process Area | No | The process or department involved |
| Standard Reference | No | Specific standard or regulatory reference |
| Evidence | No | Description of the objective evidence collected |
| Root Cause | No | Initial root cause analysis |
| Contributing Factors | No | Factors that contributed to the finding |
| Immediate Actions | No | Any immediate containment actions taken |
| Corrective Action Required | No | Whether a formal corrective action is needed (checkbox) |
| Proposed Corrective Action | No | Suggested corrective action |
| Responsible Person | No | Person assigned to address the finding |
| Target Completion Date | No | Deadline for resolution |
| Evidence Attachments | No | Supporting documents, photos, or files |
- Click Submit to save the finding
Findings List
Section titled “Findings List”The findings list displays all findings for an audit in a card-based grid layout. Each finding card shows:
- Finding number and title
- Severity and status badges
- Dispute status (if applicable)
- Finding type badge
- Category and reporter name
- Location and process area (if provided)
- Target completion date
- Attachment and comment counts
Filtering Findings
Section titled “Filtering Findings”Use the filter panel above the findings grid to narrow results:
- Search by title, description, finding number, location, or process area
- Status filter: Open, In Progress, Resolved, Closed
- Severity filter: Critical, Major, Minor, Observation
- Category filter
- Finding Type filter: Non-Conformity, Non-Compliance, Observation, Positive Finding
Finding Detail Page
Section titled “Finding Detail Page”Click on a finding to open its detail page with three tabs:
Overview Tab
Section titled “Overview Tab”Displays the complete finding information in two columns:
- Finding Details — Description, category, severity, status, finding type, location, process area, evidence, and root cause
- Quick Info — Reporter name, reported date, responsible person, and target completion date
Comments Tab
Section titled “Comments Tab”A threaded comment system for discussion on the finding:
- Click Add Comment to post a new comment
- Comments display the author name, date, and type badge (Comment, Dispute, Response, or Status Update)
- Comments may include file attachments
- Edit and delete actions are available for authorized users
Attachments Tab
Section titled “Attachments Tab”Displays all evidence attachments linked to the finding, with download capabilities.
Accepting a Finding
Section titled “Accepting a Finding”When a finding is in Open status and has no active dispute:
- Open the finding detail page
- Click Accept Finding
- Confirm the action in the dialog
Finding Statuses
Section titled “Finding Statuses”| Status | Description |
|---|---|
| Open | Finding has been recorded and is awaiting review |
| In Progress | Corrective actions are being implemented |
| Resolved | Corrective actions are complete, pending verification |
| Closed | Finding is fully resolved and verified |
Permissions
Section titled “Permissions”| Action | Required Role |
|---|---|
| View findings | Any user with audit access |
| Create findings | Admin, QA Team, Lead Auditor |
| Edit findings | Admin, QA Team, Lead Auditor |
| Accept findings | Any authorized user (when finding is open with no dispute) |
| Dispute findings | Auditees (when finding is open with no prior dispute) |
Related Topics
Section titled “Related Topics”- Dispute Resolution — How to dispute and resolve findings
- Audit Reports — Include findings in audit reports