Machine Vision for Regulatory Compliance

The latest generation of machine vision technology offers significant benefits for applications outside the semiconductor industry— a primary past beneficiary of huge investments in the technology.

Machine vision has brought quantifiable benefits to end users by boosting productivity on the production line and ensuring product quality, safety and security. The landscape is changing as vision companies are now providing end-to-end solutions for the pharmaceutical, food and beverage, and automotive industries.

Today’s class of integrated vision systems is providing solutions that enable manufacturers to meet regulatory requirements. Commercially available vision solutions can satisfy both traceability and genealogy capabilities down to the component level, without the need for extensive engineering to integrate into packaging, final assembly and batching operations.

Machine vision technology drivers are shifting from ‘to stay competitive’ to ‘must have’ for many applications. However, users across many industries have not fully embraced this technology, due to unfamiliarity and unawareness of its expanding solutions capabilities. The need for regulatory compliance has created opportunities for the use of machine vision technology in areas far beyond typical productivity and quality improvement applications. Suppliers recognizing these opportunities are developing end-to-end vertical solutions that support many aspects of business and regulatory requirements.

Supporting pharma compliance

Machine vision satisfies two key requirements of the pharmaceutical industry: one, product quality, safety and security inspection in manufacturing, and two, product tracking. Both of these applications are driven by the global regulatory and enforcement policies that are raising the bar for due diligence toward 100 percent inspection. This will enable tracking of products ensuring product security and traceability from final packaging to delivery.

The industry also has strict regulatory requirements for control system and software validation, as well as for subsequent system changes and related procedures. Manufacturers are aware of the benefits of production line flexibility, but the unique requirements of the pharmaceutical industry pose additional challenges when considering flexibility. Pharmaceutical manufacturers must avoid the costly and lengthy revalidation process of software and control systems to comply with regulatory requirements for change management.

The selection of machine vision system architecture is critical when seeking to minimize revalidation of software and systems on a production line. For example, when an additional camera is added to enhance the process on a currently operating production line, software will generally need to be modified and revalidated. Using a distributed architecture with software capable of expanding and adapting to additional cameras reduces, and may eliminate the need for revalidation of the existing application software.

Machine vision systems are playing a critical role in enabling current and anticipated regulatory requirements in the food and beverage, and pharmaceutical industries. Similarly, industries such as aerospace and automotive also face heightened requirements for unit level traceability due to product liability, warranty costs, regulatory issues and cost avoidance. Manufacturers need to contain potential quality problems before and after the product ships and provide detailed product genealogy information to supply chain partners. Original equipment manufacturers (OEMs) also are beginning to require component and sub-component genealogy and traceability information from supply chain partners.

Integrated machine vision systems and production management software applications are the result of strategic alliances between machine vision companies and enterprise software companies or integrators/OEMs to provide tightly coupled system solutions for component level traceability and genealogy.

Users need to overcome internal obstacles created due to unfamiliarity with machine vision technology and look for vertical solutions to reap greater benefits. Users should also establish relationships with integrators who provide and support broad automation solution capabilities with machine vision technology. ARC believes that the regulatory and business bar for product safety and security has been raised, and recommends the deployment of modern closed-loop quality, safety and security inspection systems.

Himanshu Shah, hshah@arcweb.com, is part of the automation consulting team at ARC Advisory Group, Dedham, Mass.

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