Inspections

An inspection gives the team one place to identify the item under review, the type of inspection and the person assigned to it. The subject reference should match the operating record your team uses to find the material, lot or service case. The scheduled date puts planned work in order. The inspector begins a planned inspection, records requirement checks and submits the result for review. The reviewer makes the final disposition of the inspection.

This sequence matters when several checks apply to one subject. A pass on one requirement does not settle a failure on another. Each check keeps its own requirement, observation, result and evidence attachment. The parent inspection gives the reviewer the complete scope before a decision.

• Assignment. The inspection type, subject reference, scheduled date and assigned person explain what must be examined and who carries it.
• Evidence. Each linked check records the observed result against a named requirement and can hold an attachment.
• Disposition. The reviewer accepts eligible passing scope or rejects failed scope and raises a linked nonconformance for the failure.

A final inspection for a device lot can contain checks for packaging, labeling and the relevant work instruction. The inspector records the observation for each requirement. If labeling fails, the reviewer sees that failure next to passing checks and rejects the failed scope. The resulting nonconformance retains its link to the inspection.

Decide how subject references map to the manufacturing or service records your team already uses. Choose who creates planned work, who can record checks and who decides the review. Agree on which evidence belongs on a check and which belongs in a device history review or supplier certificate. These are distinct records linked to the operational inspection.

Use the inspection types consistently. Incoming covers received material, in process covers work during manufacture, Final covers completion review and Service covers service work. Agree what a reviewer needs to see before accepting an inspection, including how a failed or not-applicable check is explained. This gives both inspectors and reviewers the same rule for a pilot case.

Take one incoming component inspection from assignment to disposition. The Inspector checks the subject reference and records observations against the applicable requirements. Attach evidence to the checks that need it, then submit the inspection for review. The Quality Reviewer reads the checks in context and records the decision. If a check fails, follow the linked nonconformance from the rejected scope so the corrective action owner receives the same case that the reviewer decided.

Reopen the case as each role. The inspector should see the assigned work and submitted evidence; the reviewer should see the review queue and the reason for the decision. Confirm that the inspection number can be used to find the same record during follow-up.

• Inspection board — Inspections grouped by their current disposition and work state.
• Inspections awaiting review — Submitted cases ready for the Quality Reviewer to decide.
• Failed inspection checks — Requirement failures and evidence linked back to their inspections.

See inspection review and corrective action.