Internal Audit

The Internal Audit module allows you to plan, execute, and track internal audits within your organization. You can create audit templates with predefined checklists, schedule audits, assign auditors and auditees, record checklist observations, document findings, and submit completed audits for approval.

Overview

The Internal Audit section has two tabs:

• Audits — Lists all audit instances with their current status, and allows you to create, execute, and manage audits
• Audit Templates (admin only) — Create and manage reusable audit checklist templates

Audit Types

Audit Statuses

Finding Types

During an audit, findings can be categorized as:

Audit Templates

Audit templates define reusable checklists that can be used when creating new audits. Templates save time and ensure consistency across audits.

Creating an Audit Template

1. Navigate to QMS → Internal Audit → Audit Templates tab
2. Click the Create Template button
3. Fill in the template details:
   • Template Name (required) — e.g., "ISO 13485 Clause 4 Audit"
   • Audit Type — Internal or External
   • Department — The department this template is designed for
   • Description — Describe the scope of this audit template
4. Add checklist items:
   • Each item represents a question or checkpoint the auditor must evaluate
   • Add as many items as needed for a thorough audit
5. Click Save to create the template

Managing Templates

• Edit — Update template details and checklist items
• Delete — Remove a template (does not affect audits already created from it)
• Search — Use the search bar to find templates by name

Creating a New Audit

1. Navigate to QMS → Internal Audit → Audits tab
2. Click the Schedule Audit button
3. Fill in the audit details:
   • Template (optional) — Select an audit template to auto-fill the title, type, department, and checklist
   • Title (required) — Name of the audit (auto-filled from template if selected)
   • Description — Describe the audit scope and objectives
   • Audit Type (required) — Internal or External
   • Department — The department being audited
   • Scope — Define the scope of the audit
   • Scheduled Date — When the audit is planned to take place
   • Lead Auditor — Select the lead auditor from your team
   • Auditors — Select one or more auditors
   • Auditees — Select the personnel being audited
4. Click Schedule Audit to create the audit

The audit will be created with status "Scheduled" (or "Draft" if no date is set).

Conducting an Audit

Step 1: Start the Audit

1. Navigate to QMS → Internal Audit
2. Find the scheduled audit and click View
3. Click the Start Audit button to begin
4. The audit status changes to "In Progress"

Step 2: Fill in the Checklist

1. On the audit detail page, you will see the checklist items from the template
2. For each checklist item, record your observation:
   • Yes — The requirement is met
   • No — The requirement is not met
   • Not Applicable — The item does not apply to this audit
   • Observations / Comments — Add detailed notes for each item
3. Click Save to save your checklist progress (you can save and return later)

Step 3: Record Findings

If you identify any issues during the audit, record them as findings:

1. Click the Add Finding button on the audit detail page
2. Fill in the finding details:
   • Finding Type — Major Non-Conformity, Minor Non-Conformity, Observation, or Opportunity for Improvement
   • Description — Detailed description of the finding
   • Clause/Reference — The ISO clause or SOP reference related to the finding
   • Root Cause — Analysis of why the non-conformity occurred
3. Click Save to record the finding

Findings can also be linked to CAPAs for follow-up corrective actions.

Step 4: Complete the Audit

1. After filling in all checklist items and recording findings, click the Complete Audit button
2. Enter:
   • Summary — A summary of the audit results
   • Conclusions — Overall audit conclusions
3. Click Complete to finalize the audit
4. The audit status changes to "Completed"

Submitting for Approval

After completing an audit, you can submit the audit report for approval:

1. On the completed audit detail page, click the Submit for Approval button
2. Select the Approval Workflow to use (workflows of entity type "Audit")
3. Optionally add comments
4. Click Submit
5. The audit status changes to "Pending Approval"

Approvers in the selected workflow will see the audit in their Pending Approvals and can approve or reject it.

If e-signatures are enabled for your company, approvers will need to enter their password when approving or rejecting.

Creating a CAPA from an Audit Finding

If an audit finding requires corrective or preventive action:

1. Navigate to the audit detail page
2. Find the finding in the Findings section
3. Click the Create CAPA button next to the finding
4. You will be redirected to the CAPA creation page with the finding details pre-filled
5. Complete and submit the CAPA

This links the CAPA to the original audit finding for traceability.

Filtering and Searching Audits

On the Audits list page, you can filter by:

• Search — Search by audit title, number, or department
• Status — Filter by audit status (Draft, Scheduled, In Progress, etc.)
• Type — Filter by Internal or External

Best Practices

• Use templates for recurring audits — Create templates for your standard audit checklists (e.g., ISO 13485 clause-by-clause) to ensure consistency
• Assign qualified auditors — Ensure auditors are trained (use the Training module to verify)
• Document findings thoroughly — Include specific references to clauses, evidence, and root causes
• Create CAPAs for non-conformities — All major and minor non-conformities should have corresponding CAPAs
• Submit for approval promptly — Complete and submit audit reports within a reasonable timeframe after the audit

Next Steps

• Set up Roles and Approval Workflows for audit report approvals
• Learn how to create CAPAs from audit findings
• Use Training to ensure auditors are properly trained