The advantages of PLM software are widely understood: improved product quality, lower development costs, valuable design data and a significant reduction in waste. However, one benefit that does not get as much attention is PLM's support of regulatory compliance. Here, Adam Bannaghan, technical director of product lifecycle management (PLM) provider, Design Rule, discusses the growing role of PLM in managing quality and compliance.
Nobody would dispute the necessity of regulatory compliance, but in the product development realm it certainly isn’t the most interesting topic. Regardless of its lack of glamour, failure to comply with industry regulations can render the more exciting advantages of PLM redundant.
From a product designer's perspective, compliance through PLM delivers notable strategic advantages. Achieving compliance in the initial design stage can save time and reduce engineering changes in the long run. What is more, this design-for-compliance approach sets the bar for quality product development, creating a unified standard to which the entire workforce can adhere. What is more, the support of a PLM platform significantly simplifies the compliance process, especially for businesses operating in sectors with fast-changing or complicated regulations.
For example, AS/EN 9100, is a series of quality management guidelines for the aerospace sector, which are globally recognised, but set to change later this year. December 2016 is the target date for companies to achieve these new standards - a fast transition for those managing compliance without the help of dedicated software.
Similarly, the defence industry has its own standards to follow. ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations) are notoriously strict exporting standards, delivering both civil and criminal penalties to companies that fail to comply.
"Fines for ITAR violations in recent years have ranged from several hundred thousand to $100 million," explained Kay Georgi, an import/export compliance attorney and partner at law firm Arent Fox LLP in Washington. "Wilful violations can be penalised by criminal fines, debarment, both of the export and government contracting varieties, and jail time for individuals."
PLM across sectors
The strict nature of all these regulations is not limited to aerospace and defence however. Electrical, food and beverage, pharmaceutical and consumer goods are also subject to different, but equally stern, compliance rules.
Despite varying requirements across industries, there are a number of PLM options that support compliance on an industry-specific basis. Dassault Systèmes ENOVIA platform, for example, allows businesses to input compliance definition directly into the program. This ensures that, depending on the industry, the product is able to meet the necessary standards. As an intelligent PLM platform, ENOVIA delivers full traceability of the product development process, from conception right through to manufacturing.
For those in charge of managing compliance, access to this data is incredibly valuable, for both auditing and providing evidence to regulatory panels. By acquiring industry-specific modules, businesses can rest assured that their compliance is being managed appropriately for their sector - avoiding nasty surprises or unsuccessful compliance.
For some industry sectors, failure to comply can cause momentous damage, beyond the obvious financial difficulties and time-to-market delays you might expect. For sensitive markets, like pharmaceutical or food and beverage, regulatory failure can wreak havoc on a brand’s reputation. What’s more, if the uncompliant product is subject to a recall, or the company is issued with a newsworthy penalty charge, the reputational damage can be irreparable.
PLM software is widely regarded as an effective tool to simplify product design. However, by providing a single source of truth for the entire development process, the potential of PLM surpasses this basic function. Using PLM for compliance equips manufacturers with complete data traceability, from the initial stages of design, right through to product launch. What’s more, industry-specific applications are dramatically simplifying the entire compliance process by guaranteeing businesses can meet particular regulations from the very outset.
Meeting regulatory standards is an undisputed obligation for product designers. However, as the strategic and product quality benefits of design-for-compliance become more apparent, it is likely that complying through PLM will become standard practice in the near future.