Type
Technical Guide
Topic
Inspection in regulated production
Published
Dec 3, 2025
Access
Read online
Define the defects, with samples
List every defect class you need to detect and provide physical samples. A requirement such as "detect all cosmetic defects" cannot be tested.
Build a challenge set
Agree a set of known-defective and known-good samples, with the number per class. Acceptance is then measurable: for example, ≥ 98.0 % detection per class and a maximum false-reject rate on good product.
Separate requirements from solutions
The specification should state what must be detected, at what rate and with what records — not which camera to use. That leaves room for a feasibility study.
Records and data integrity
State which records are required (batch reports, images of rejects, audit trail) and who may change settings. These requirements drive the software design.
Responsibilities
Be explicit about who does what: the integrator provides specifications, tested equipment and test documentation; the manufacturer performs qualification and release according to its own quality system.
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Solutions
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Industries
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