Machine Vision Technology for Regulatory Compliance

Machine vision technology drivers are shifting from “to stay competitive” to ”must have” for many applications.

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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 in pharmaceutical, food and beverage, and automotive industries 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. This includes rapidly expanding and anticipated regulatory requirements and enforcement policy.

Machine vision satisfies two key requirements of the pharmaceutical industry: first, product quality, safety, and security inspection in manufacturing, and second, 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 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 further 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. Emerging standard networking technologies, such as Gigabit Ethernet (GigE), make change easier.

Similarly, industries such as aerospace and automotive also have heightened requirements for unit-level traceability due to product liability, warranty costs, regulatory issues and simply 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.

Machine vision systems are available with production management or manufacturing execution systems technology that provide end-to-end traceability solutions. 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.

Manufacturers are increasingly realizing that component identification leads to significant cost savings with such machine vision systems because they offer the right data management and reporting infrastructure, and also reduce the cost of compliance. Direct part marking is required in a growing number of industries in which serial numbers on parts must survive for the life of the part. Consequently, many machine vision systems play a key role as they begin to offer an easy-to-use software tool set.

Recommendations

Users need to overcome internal obstacles created due to unfamiliarity with machine vision technology and look for vertical solutions to reap greater benefits. They also should 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 Senior Analyst, Automation, with ARC Advisory Group Inc., in Dedham, Mass.
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