Meeting compliance mandates requires a good look at the shop floor

For companies in highly regulated industries, compliance is a monumental step in getting product to market, yet until recently, it has gone unaddressed by most automated systems. In fact, users often resort to manual workarounds for quality planning, compliance status reports, and other regulatory procedures.

New modules of product life-cycle management (PLM) systems are being introduced that help users gain visibility, enhance collaboration, and foster integration with plant-floor applications—eliminating those manual workarounds.

Historically, manufacturers in the automotive, aerospace & defense, high-tech, and electronics industries have been the predominant users of PLM systems. "The automotive sector, for example, has a great deal of rules and regulations governing product recalls," says Sath Rao, industry manager at the San Antonio, Texas-based office of Frost & Sullivan.

"Tires used in specific models may need to be recalled, for example," adds Rao, "so systems must be able to find customers who need to be informed of the recall. And managers want to determine if the problem can be traced back to a design flaw, or a manufacturing error."

Problems associated with human safety—such as the recent case of laptop computer batteries catching fire—require fast corrective and preventive actions. "Companies must know model numbers and be able to locate potentially dangerous products in the field," says Rao.

It is important for PLM systems to integrate with manufacturing execution systems and other supply chain applications since additional data may be necessary to make design and quality decisions.

"When faced with a defective product or a large number of customer complaints about a product, users need a view to the plant floor to trace the origin of the problem," says Rao. "They may find that an operator assembled the product the wrong way."

Or if the error is traced back to the supply level, companies may need to change suppliers. "Some procurement clauses penalize suppliers for field rejects or poor quality," continues Rao. "Companies may want to consider that fact for future supplier negotiation processes."

If companies don't have tight integration, they may lack perspective for how they are satisfying customer requirements, says Marc Lind, a VP for PLM systems vendor Aras. "Design teams must be careful—especially in medical, automotive, and aerospace—because failure mode is driven by characteristics such as warranty recalls and catastrophic failure."

Aras Innovator's new compliance module includes a library of characteristics as categorized by supplier. "For example, users working on a steering column may discover that if the neck is too thin, it can break and cause an accident," says Lind. "Therefore, when a design team performs a risk analysis on the next-generation product, they can see steering-column thickness is a critical characteristic."

Aras introduced its regulatory compliance module last year, which can be used in conjunction with any best-of-breed PLM solution.

"Our automotive customers requested it because they were doing manual workarounds and using file cabinets full of documents," says Lind. "There was no visibility or collaboration, which is necessary at the supplier level where it is mandated to ensure quality."

Compliance can be mandated by various sources, including industry, government, or customer.

"Say a supplier doesn't provide part number 516 for a manufacturer; that supplier likely won't get plans for a new product," says Lind.

Users can view compliance status in the system by customer, which displays everything a company is working on for a particular OEM, Lind adds. They also can see who hasn't submitted a report, ensuring a design team is on schedule for a product launch.