Clause 8.5 – Production and Service Provision
AI-driven quality control systems, using machine vision and pattern recognition, now enable automated defect detection with far greater precision than human inspection. Integrating AI systems aligns with clause 8.5 by enhancing process control and reducing human error.
AI models can identify microscopic defects, perform real-time quality checks, and predict the likelihood of a defect based on production conditions. This predictive capability reduces scrap rates and improves overall product quality.
Compliance Consideration: AI systems must be validated and periodically reviewed to ensure reliability. Manufacturers must document AI decision criteria and inspection processes to demonstrate compliance during audits.
Clause 8.5.1 – Control of Production and Service Provision
Predictive maintenance, powered by machine learning, forecasts equipment failures before they occur. This ensures consistent equipment performance, reducing variability in product quality.
By using sensors to monitor equipment vibrations, temperatures, and operational patterns, predictive maintenance systems calculate when maintenance should be scheduled. This proactive approach minimizes downtime and prevents catastrophic failures.
Compliance Consideration: Predictive maintenance schedules, algorithms, and analysis results should be documented. This ensures audit trails are available, satisfying traceability requirements.
Clause 8.4 – Control of External Providers
AI-based supplier risk assessment tools assist in evaluating and monitoring supplier performance continuously. These tools assess factors like supplier delivery times, defect rates, and financial stability.
Compliance Consideration: Integrating AI evaluations into supplier audits ensures compliance while proactively identifying risks. Supplier selection and evaluation processes must be documented with AI-generated insights included.