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- Medical Devices QMS
- Process
- Inspection review
Inspection review
An inspection decision starts with a clear subject reference and ends with a reviewer who can see the individual checks. The record supports incoming, in-process, final and service work. Keep the failed requirement visible beside the final decision.
Step by step
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Plan inspection Inspector
Inspector identifies the subject, inspection type, scheduled date and assigned person. The inspection starts as Planned.
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Begin work Inspector
Inspector starts the planned inspection and records the checks that apply to its scope.
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Capture evidence Inspector
Each check holds a requirement, observation, result and attachment where needed.
- Keeps each requirement result with the case
- Updates Inspection checks, Inspections
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Submit review Inspector
Inspector sends the inspection to Review after the checks are ready.
- Moves the case to Review
- Updates Inspections
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Decide disposition Quality Reviewer
Quality Reviewer accepts eligible passing scope or rejects failed scope.
- Records Accepted or Rejected
- Updates Inspections, Inspection checks
ApprovalA person approves before the work moves on. -
Open follow-up Quality Reviewer
For rejected scope, Quality Reviewer raises a nonconformance linked to the inspection.
- Links failed scope to an issue
- Updates Nonconformances, Inspections
Who does what
Roles and permissions- Inspector
- Records and submits the work.
- Quality Reviewer
- Decides disposition and raises the issue.
- Admin
- Manages access.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.