These cookies are required for the website to function properly. They ensure security, enable basic features like page navigation, and store user session data. You cannot disable these cookies.
Feature · Audits
Example screen with sample data
Audits
Plan internal or supplier quality audits and keep each finding assigned to an owner.
OverviewFindings by due date×
Medical Devices QMS · Audits
New
Findings by due date
Audit findings
| Audit | Requirement | Finding | Severity | Due date | Closed at | |
|---|---|---|---|---|---|---|
| ADT-76526 | RQR-842 | FND-913 | Observation | 03 Oct | 04 Oct | |
| ADT-46149 | RQR-895 | FND-796 | Minor | 08 Oct | 11 Oct | |
| ADT-63163 | RQR-518 | FND-157 | Major | 12 Oct | 13 Oct | |
| ADT-99792 | RQR-324 | FND-921 | Observation | 13 Oct | 14 Oct | |
| ADT-36891 | RQR-302 | FND-559 | Minor | 07 Oct | 08 Oct |
6 of 6 records
RQR-842Audit findings · AF-18747
ObservationAuditADT-76526
FindingFND-913
Due date03 Oct
Closed at04 Oct
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
See audit follow-up and corrective action.
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.