1. Medical Devices QMS
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  3. Audits
Feature · Audits

Audits

Plan internal or supplier quality audits and keep each finding assigned to an owner.

OverviewFindings by due date
Medical Devices QMS · Audits

Findings by due date

Audit findings

New
AuditRequirementFindingSeverityDue dateClosed at
ADT-76526RQR-842FND-913Observation03 Oct04 Oct
ADT-46149RQR-895FND-796Minor08 Oct11 Oct
ADT-63163RQR-518FND-157Major12 Oct13 Oct
ADT-99792RQR-324FND-921Observation13 Oct14 Oct
ADT-36891RQR-302FND-559Minor07 Oct08 Oct
6 of 6 records
RQR-842Audit findings · AF-18747
Observation
AuditADT-76526
FindingFND-913
Due date03 Oct
Closed at04 Oct
Example screen with sample data

What you can do

Keep the audit and each finding together

An audit records its number, scope, planned date, completion date, status and auditor. Findings sit beneath the audit. Each finding names a requirement, describes the finding, records severity and carries a due date, closed date and owner. The audit gives the team context; the finding gives the responsible person a concrete item to address.

This structure helps a quality manager review an audit without treating the whole audit as one undifferentiated issue. Several findings may arise from one scope, and they can have different owners and due dates. The audit’s reporting state and the individual finding dates answer different questions about progress.

How the work is organized

  • Plan. The scope, planned date and assigned auditor identify the review being performed.
  • Report. Findings attach to the audit and cite the requirement behind each observation.
  • Follow-up. Each finding carries severity, due date and owner so the team can work through the reported issues.

For a supplier quality audit, the Auditor records the scope and planned date. During the work, a finding against a named requirement is added with its severity and owner. Another finding can go to a different owner with a different due date. When the auditor reports the audit, both findings remain connected to the same audit number.

What to agree during setup

Decide how audit numbers and scope descriptions are used by the team. Assign auditors and finding owners from the people records. Agree when an audit moves from planned to in progress, reporting and closed. Determine how the owner demonstrates that a finding is resolved and who records its closed date. Keep the audit’s completion separate from the closure of individual findings.

Use one representative audit in the pilot, ideally with more than one requirement. The team should test assigning findings to different people and finding them again by audit. A due date should reflect a real follow-up commitment, not an automatic closure decision.

Check the handoff on an actual case

Start a planned audit, confirm the scope and assigned auditor, then record a finding with its requirement, severity, due date and owner. Add another finding to the same audit. Review the audit and finding list as the Quality Reviewer so the relationship and assignments are clear. When a finding is addressed, record its closed date and confirm the audit still contains the original requirement and description.

Finally, compare the audit status with the findings. The reporting state should tell the team about the audit’s stage; the finding list should show which work items need attention. This distinction makes the next review meeting more precise.

What your team sees

  • Audit work — Planned, in-progress and reporting audits with their scope and auditor.
  • Findings by due date — Requirement findings, owners, due dates and closed dates.

Follow the work through

What it keeps track of

Data model
Audits
Internal and supplier quality audits
Audit findings
Findings raised against audit requirements
People
Quality staff, inspectors and approvers

Who uses it

Permissions
Auditor
Plans the work and records findings.
Quality Reviewer
Examines the audit and follow-up.
Admin
Maintains access to the people who carry those decisions.

Set up Medical Devices QMS your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started