Reducing Error, and Paper

As sophisticated as medical device manufacturing technology is these days, in-house labeling information systems at some locations may be lagging behind. One maker of orthopedic devices, for instance, relied solely on paper to document labeling changes, updates, and approvals, amounting to nearly 20,000 sq ft of filing cabinets of paper, reports Matt Warren, technical solutions engineer for VIA Information Tools (www.via-it.com). In such voluminous paper-based environments, updates can get overlooked, and accountability may be hard to trace.

VIA is helping this manufacturer gather that paper-based data and store them in VIA’s ValiPack software solution. The company can then build electronic Device History Records and even keep track of label compliance by batch, lot, and process.

Items, lot, quantity, operators, and other details can be tracked and documented electronically using ValiPack from VIA Information Tools. These data can be stored in the electronic Device History Record.

ValiPack is based on VIA’s Man-IT traceability software. “We have focused our efforts on developing the most reliable and adaptable enterprise-level MES software for discrete manufacturing,” says Chanie McDuffie, program manager for VIA. “Man-IT not only performs millions of MES transactions per day on a large variety of parts, but Man-IT also helps ensure that many life-saving devices are made in accordance with specifications. This is a role that our entire company takes to heart.”

Man-IT allows nonprogrammers to map the flow of manufacturing processes based on standard operational procedures, products, and resources. Users can implement the structured solution in a rapid, repetitive manner, while still making minor adjustments to the software along the way. According to VIA, this enables users to become self-sufficient.

McDuffie explains that VIA’s new product release of ValiPack focuses specifically on validating each packaged unit for label compliance. “This is a huge need for pharmaceutical and medical packaging.”

The company believes that mislabeled product is the result of misidentification of product at the point of packaging. So the company designed ValiPack to identify each product prior to labeling and to ensure that the proper labeling is in place both on the unit and the packaging. In a case study performed by VIA, the company documented an 84% reduction in total rejects when ValiPack is used at the point of packaging. It also noted lower sort and rework costs and a 36% reduction in customer complaints.

Manufacturers often struggle to standardize operations across multiple facilities with differing equipment and processes. So VIA built its Business Atoms platform to share preferred processes and best practices while allowing for site variability. Users do not have to rework packaging processes to accommodate the software, nor do they have to customize the software, the company reports.

In terms of integrating with a machine vision inspection system, McDuffie explains that “our data communication software communicates with instrumentation and controls of many types and allows for the analysis of simple pass/fail all the way up to complex variable analysis with a two-way communication with the instrumentation and controls. Through this interconnection of VIA’s Man-IT software to shop floor equipment, we can track lots, validate content, enforce specifications, properly label, and provide management with real time key performance indicators that are actionable.  Typically we work with the controls engineer to define the handshaking and variable definitions.”

VIA’s solutions includes the following functions:

• Track & Trace.
• Label Error Proof (LEP).
• Dashboard (VOD).
• Packout and Labeling.
• Quality Management.
• Error Proofing.
• JIT Sequencing.
• Inventory eKanBan.
• ILVS Sequencing.
• Electronic Signature (eSIGN).
• Electronic Device History Record (eDHR).
• CFR 21 part 11 & CFR 820.

“ValiPack can be used throughout medical device operations, from inventory through to end-of-line packaging and labeling,” says Warren. “Our system can keep track of all products and components. We have been helping the automotive industry do so for years, and we are now helping medical device companies.”

The company exhibited the system at MD&M West 2011 in February.