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Retool quality control software workflows for better products, compliance

Extended supply chains demand new quality control software workflows that resolve quality issues at the onset of product development.

With manufacturers more dependent than ever on extended supply chains, many are turning to new collaborative technologies and workflows to mirror the same visibility and traceability for quality control software and compliance as they have inside the four walls of their organizations.

Whether it’s through high-tech systems or low-tech process change, the imperative is the same: Develop formal communication channels that support managing quality and compliance as a shared responsibility through every stage of the product lifecycle. “It really comes down to a matter of scale,” said Peter Blok, a senior partner with Pharm Team USA, a Princeton, N.J.-based consulting firm. “If you have four suppliers, phones, faxes and emails may be fine. If you have 4,000 suppliers, that tends to be more difficult, and you likely need an IT system to address that.”

Putting the systems in place to address quality management as a continuous process is one thing. But in this age of distributed supply chains, it’s especially critical to design quality control workflows that identify and resolve possible quality issues at the onset of the design cycle, before any materials are procured and well ahead of when components, assemblies or recipes are manufactured or mixed on the production floor.

One solution is supplier networks that allow for a transfer of virtual product information between partners well ahead of when the actual components ship, which provides visibility all along and avoids last-minute surprises. That’s not how it works in a traditional workflow, where manufacturing customers buy physical products from suppliers—assemblies, control systems, drivetrains, for example—and test for quality when the orders arrive.

If there’s a problem with a physical unit, production is halted and engineers spend weeks, maybe longer, collaborating on a design fix, creating a workflow that adds unnecessary downtime to the go-to-market schedule, according to Michael Grieves, professor of information systems at the University of Iowa. Grieves is also a consultant to NASA and author of the book Product Lifecycle Management: Driving the Next Generation of Lean Thinking.

Grieves advocates a new workflow, where manufacturers require suppliers to deliver a virtual product weeks ahead of taking delivery of the physical orders. Not only can the manufacturer identify  issues involving a single component—related to quality, or noncompliance with environmental regulations, for example—it can also see what the product looks like in the digital world and get a jump on production or compliance concerns that could pop up later.

“Companies have to start to rethink how they procure products, and they have to demand this information from suppliers in advance, before the product shows up,” Grieves explained. “If you have that information well in advance, you can make a determination of whether or not you are being sent a nonconforming product before you actually get it.”

Laying the PLM data foundation

Pathway Medical Technologies Inc., a medical device manufacturer based in Kirkland, Wash., hasn’t gone so far as to request a virtual product from its suppliers, but it has modified its processes to become more proactive. Specifically, the company is moving away from its existing supplier approval system to a more stringent supplier certification system that involves more communication and collaboration about quality management. The new approach gives Pathway greater confidence that its suppliers can consistently meet its standards, said Ken Perino, senior director of quality assurance and regulatory compliance.

As part of the new system, Pathway will perform a more rigorous assessment of suppliers’ capabilities and more continuous monitoring of results. The first stage of the workflow transformation is to create a supplier report card that will track and measure things like percentage of failure rates, specifications and raw materials. Currently, Pathway benchmarks suppliers manually, but the long-term vision is to automate the process through software that will integrate with the company’s core PLM data platform, which is the central repository for all product-, quality- and compliance-related data, Perino said.

“Without the PLM system, we’d be digging through files to build a history and we’d have to start over every time,” he explained. “We continually feed information into the PLM system, and it’s right at our fingertips when we need it.”

PLM also serves at the heart of the quality management system at Instron, a manufacturer of materials testing equipment based in Norwood, Mass. Initially, the company used its PLM system to manage such customer-facing quality processes as tracking complaints and warranty issues, according to Cam Bickel, the company’s manager of document control. The next step is to integrate the supplier database housed in the ERP system with the PLM platform so Instron can build supplier-quality profiles and use them to manage supplier certification and quality metrics.

“Over time, this will allow us to build up a history around suppliers so we can make the determination when we’re designing a new product whether to use an existing supplier or to move away from a supplier based on past performance,” Bickel said. Traditionally, Instron engineers and purchasing managers have worked in silos, which meant they often weren’t on the same page when it came to making supplier choices. “This new system [and workflow] will put everything out in the open, so everyone can see what they’re getting themselves into,” he said.

ABOUT THE AUTHOR
Beth Stackpole is a freelance writer who has been covering the intersection of technology and business for 25-plus years for a variety of trade and business publications and websites.

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