Quick answer

A useful inspection criterion names the feature, method and acceptable result. It also links the result to an identified component or lot.

Scope of this guide: This guide explains how teams can make inspection language easier to use. The design owner must approve the actual limits, sampling plan and release decision for the component.

Illustrative textile component inspection under magnification

What exactly will the inspector check?

Replace broad words such as “inspect the component” with a named feature. Examples include textile position, seam route, loose thread, exposed support or surface damage.

Use a drawing view, photograph or approved sample when words alone may be unclear. State the lighting and magnification when they affect the result.

How will a dimension be measured?

Name the feature, measurement points, unit, tool and allowed range. State whether the component is relaxed, held in a fixture or placed in another defined condition.

Check that the tool can reach the feature and has suitable resolution. Record the method with the result so another reviewer can understand it.

How does the result support a decision?

Link the result to the sample or lot. Record the criterion, observed result, inspector and date. Show whether the item passed, needs review, can be reworked or was rejected.

ISO 13485 and the FDA QMSR provide quality-system context. They do not set the component-specific limits in this guide.

Sources: ISO — ISO 13485: quality management for medical devices · FDA — Quality Management System Regulation (QMSR)

Can each criterion answer these questions?

Test the wording with a trained person who did not write it. The same input should lead to the same decision.

  • Which named feature is being checked?
  • Which view, tool, lighting or magnification is required?
  • What result is allowed, including units and limits?
  • How is the sample or lot identified?
  • Who records and reviews the decision?

Source notes

Sources and further reading