Regulatory bodies like the FDA and MHRA are adapting guidelines to accommodate the evolving AI landscape, stressing the importance of innovative compliance approaches alongside traditional software regulations, including audit trails, electronic records, and signatures.
A good QMS will control nonconformities by acting as a defense line, catching discrepancies and abnormalities in products before they ever reach the customer.
Manufacturers thrive in a competitive market by prioritizing customer needs: price, quality, and delivery. However, long-term success hinges on quality, which ensures products perform as expected from manufacturing through to post-sale. While price is influenced by costs and market dynamics, and delivery by productivity, quality is key to building trust and customer loyalty.
The hype around "big data" has mainly aimed at niche market sales without delivering expected benefits. Similarly, the business world's obsession with Lean Six Sigma has shown minimal returns on investment. In contrast, over the last 25 years, I've leveraged small Excel files to significantly cut costs and increase profits, often by millions of dollars, through a reliable sequence I discovered.
Statistical Process Control (SPC) is evolving to not just detect defects, but also to predict and prevent issues. Modern factories use more sensors and collect more data, allowing SPC to analyze real-time patterns and forecast potential issues.
In today's tech-driven world, companies use software to collect data, but the analysis can be flawed. Charts with only specification limits, arbitrarily chosen warning and action limits, and misused Process Behavior Charts contribute to misinterpretation.
A recent report by the National Academies of Sciences, Engineering, and Medicine highlights data quality as a significant concern for the reliability of digital twins.
The Digital Twin Consortium (DTC) Composability Framework provides a transformative approach to digital twin system development, focusing on interoperability, security, trustworthiness, scalability, and design reuse to align with businesses’ objectives and evolving needs.
Front-office operations offer strategic opportunities for continuous improvement. Automating tasks can maximize effectiveness, free up senior employees, and lead to significant improvements in productivity and profitability.
Quality starts with requirements. Conformance to requirements is important, but not enough. The quality of the requirements is equally critical. An effective quality management system ensures that requirements are not only present and up to date, but also adequate for creating quality.