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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.

  • 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
TypeDescription
Non-ConformityA failure to meet a specified requirement
Non-ComplianceA failure to comply with regulatory requirements
ObservationA noted condition that could lead to a non-conformity
Positive FindingA noteworthy good practice observed during the audit

Each finding is assigned a severity level that determines its visual priority:

SeverityIndicatorDescription
CriticalRed badgeImmediate risk to product quality, patient safety, or regulatory compliance
MajorOrange badgeSignificant deviation that requires prompt corrective action
MinorBlue badgeA lesser deviation that should be addressed but poses limited immediate risk
ObservationGray badgeAn area for potential improvement, not a formal non-conformity

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.

  1. Open the audit detail page and navigate to the Findings tab
  2. Click Create Finding
  3. Fill in the finding form:
FieldRequiredDescription
TitleYesBrief summary of the finding
DescriptionYesDetailed explanation of what was observed
CategoryYesClassification of the finding
SeverityYesCritical, Major, Minor, or Observation
Finding TypeYesNon-Conformity, Non-Compliance, Observation, or Positive Finding
ISO ClassificationNoReference to specific ISO clause or standard
LocationNoPhysical location where the finding was identified
Process AreaNoThe process or department involved
Standard ReferenceNoSpecific standard or regulatory reference
EvidenceNoDescription of the objective evidence collected
Root CauseNoInitial root cause analysis
Contributing FactorsNoFactors that contributed to the finding
Immediate ActionsNoAny immediate containment actions taken
Corrective Action RequiredNoWhether a formal corrective action is needed (checkbox)
Proposed Corrective ActionNoSuggested corrective action
Responsible PersonNoPerson assigned to address the finding
Target Completion DateNoDeadline for resolution
Evidence AttachmentsNoSupporting documents, photos, or files
  1. Click Submit to save the finding

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

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

Click on a finding to open its detail page with three tabs:

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

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

Displays all evidence attachments linked to the finding, with download capabilities.

When a finding is in Open status and has no active dispute:

  1. Open the finding detail page
  2. Click Accept Finding
  3. Confirm the action in the dialog
StatusDescription
OpenFinding has been recorded and is awaiting review
In ProgressCorrective actions are being implemented
ResolvedCorrective actions are complete, pending verification
ClosedFinding is fully resolved and verified
ActionRequired Role
View findingsAny user with audit access
Create findingsAdmin, QA Team, Lead Auditor
Edit findingsAdmin, QA Team, Lead Auditor
Accept findingsAny authorized user (when finding is open with no dispute)
Dispute findingsAuditees (when finding is open with no prior dispute)