21 Process validation and regulation of vision inspections in regulated industries
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21.1 Process validation of inspection systems
21.1.1 IQ, OQ and PQ for vision systems
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21.1.2 Validating an inspection against its acceptance criteria
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21.1.3 Linking validation to the sampling and R&R methods of Chapter 18
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21.1.4 Software validation and computer-system validation (CSV/CSA)
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21.1.5 Validating learning-based inspections: special considerations
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21.2 The EU Artificial Intelligence Act
21.2.1 Scope, definitions and territorial reach
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21.2.2 Prohibited practices
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21.2.3 The high-risk category and Annex III
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21.2.4 Obligations for providers and deployers of high-risk AI
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21.2.5 Limited- and minimal-risk tiers
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21.2.6 Timelines, enforcement and penalties
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21.3 US regulation for AI and inspection
21.3.1 The FDA framework for AI/ML-enabled devices
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21.3.2 Predetermined change-control plans and the total-product-lifecycle approach
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21.3.3 21 CFR Part 11: electronic records and signatures
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21.3.4 NIST AI Risk Management Framework
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21.3.5 Comparison of EU and US approaches
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21.4 Medical-device and pharmaceutical inspection
21.4.1 MDR and IVDR requirements relevant to vision inspection
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21.4.2 FDA 21 CFR 820 / QSR and process validation expectations
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21.4.3 GMP and pharma visual-inspection requirements
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21.4.4 Validating automated visual inspection against manual inspection
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21.5 Other high-risk and safety-critical sectors
21.5.1 Aerospace inspection and qualification expectations
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21.5.2 Automotive quality and functional-safety context
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21.5.3 Common threads across regulated industries
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