Active Compliance Gets Easier With Bill Of Materials Management
Overconfidence in meeting regulatory compliance costs many companies real money—a 2013 study from ADP revealed that while 80 percent of midsized firms were confident in their compliance to government regulations, 30 percent of the same firms had tallied up an average of six penalties, for an average overall cost of $91,300. Smart companies don’t rely on their confidence when it comes to regulation—they manage their bill of materials (BOM) correctly to ensure their engineers aren’t wasting their time tracking down potential compliance issues, but rather doing what engineers do best: solving problems.
Today’s product lifecycle management (PLM) software offerings come with built-in compliance information—everything from declaring conflict minerals, to electrical waste, to the nuances of medical devices are covered within the compliance data, meaning there’s no need to burden existing staff with learning the nuances of these regulations, or trying to understand how they matter for your particular business. Let these companies do the hard work for you—by using a PLM system, you ensure the compliance dataset you’re working with is fully up-to-date with the latest from governments and regulatory bodies all over the globe.
With PLM systems and BOM management, information about compliance is automatic, immediate, and within view of key players. Every part in the BOM can be aligned with the necessary compliance data—if an engineer makes a change that breaks RoHS compliance, for example, that is automatically flagged within the PLM for immediate response, re-engineering, or other contingency planning. Again, leaving engineers to make changes and get the product where it needs to be.
All products need to comply to regulations, but some industries have particularly difficult needs that can be better met with PLM systems.
BOM management can assist manufacturers who deal with electronics or electrical equipment meet a number of stringent global standards. A European manufacturer developing an electronics product for global sale, for example, must comply with a handful of regulations levied by the European Union, such as like the Restriction of Hazardous Substances directive (RoHS), the Waste Electrical and Electronic Equipment Directive (WEEE), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), along with others in Japan and the U.S.
The PLM system will allow the company to dictate which revision of each regulation they must comply to, and will automatically mark potential issues, even if they’re the responsibility of a contract manufacturer or some other partner along the supply chain. Compliance tracking within the PLM ensures that potentially dangerous components of electronics are managed according to environmental regulation.
Medical devices to be sold in the U.S.need to match strict guidelines with the FDA, and at the core of compliance is the Device Master Record (DMR), which needs to contain every part, document, specification, production methods, QA procedures, and more. BOM management tools should offer functionality to create a DMR is not only centralized and automatically-updated, but also versioned by historical changes—key to FDA compliance is the Design History File (DHF), which captures a complete record of the product’s evolution. All products change between planning and manufacturing, but the FDA requires complete visibility of those changes, and BOM management can help make that easier than ever.
For a variety of different reasons, many manufacturers want to ensure that they not only achieve ISO 9001 standards for quality management, but maintain it—if they are a supplier for another company, for example, this certification might be a requirement for business. BOM management will allow for companies to control revisions and document changes in ways that will help them achieve the standards and fully integrate their quality management system (QMS) into the BOM and greater product development lifecycle. With quality concerns fully integrated into the PLM, quality engineers can better spend their time ensuring compliance rather than establishing systems to track every change, or backtrack on work that has already been accomplished.
BOM management will also simplify a variety of safety standards and certifications, which are often either required by business relationships or consumer demand. By giving engineers full access to the BOM, they can ensure that they are consistently applying their assessments of compliance with UL or CE certifications, for example. Because the PLM system maintains full historical information about a given product, it’s easier than ever to understand where, and how, a specific product changed from being compliant to non-compliant, and immediately put engineers on the task of returning it to a certification-ready state.
… and just about anything else
For many reasons, manufacturers will want to establish their own compliance standards, which can also be integrated into the PLM. Waterproofing, resistance to lock picking, won’t-break-when-run-over-by-a-Jeep testing—it can all be established and tracked as the product development lifecycle continues. BOM management tools will enable companies to establish themselves as active when it comes to compliance, responding to issues in real-time rather than waiting for negative results, or, worse, audits or punitive charges. Truly, there’s no set up standards too high—other than what your engineers can dream up.