For years industry analysts and software developers have affirmed the value of tracking compliance as a product design data element, but there is nothing like a big international scandal to change the discussion. Volkswagen was recently caught cheating on emissions tests on diesel engines sold in the US, and has set aside €6.5 billion ($7.3 billion) to deal with the aftermath. International bank Credit Suisse thinks the damage will more likely cost VW €78 billion ($87 billion) over time, in the indirect form of lost sales from its damaged reputation as well as the direct form of fines, legal fees, and possible sales bans.
The idea behind tracking compliance is simple. In this day and age products must conform to rules set by governments as well as those set by international engineering associations. There are four basic elements of compliance:
- Materials must come from legal sources and conform to standards regarding toxicity and other safety issues;
- Products must meet safety performance standards in operation;
- Products must meet or exceed energy consumption and emissions standards;
- Products must have an end-of-life strategy for recycling and avoidance of toxicity.
Compliance issues vary wildly with the nature of the product. A maker of garbage cans faces a lower regulatory burden than the manufacturer of an insulin pump. Complex systems like automobiles and jet aircraft must meet or exceed thousands of compliance directives.
The largest manufacturers started to include compliance as part of their product data management years ago, but smaller businesses have for the most part not made compliance a PDM or PLM element. As the Volkswagen case points out, the cost of lackadaisical compliance monitoring can be expensive. If VW was using its PLM system to track compliance management, then somebody in the organization was feeding the system false data at some point, and a lack of transparency—possibly combined with intentionally overlooking the problem—led to the false reporting software being installed in millions of cars.
The Ponemon Institute (PI) did a study on compliance costs in 2011 that is more relevant today than ever. PI concluded any cost associated with tracking compliance was more than recouped when compared to the costs associated with non-compliance or sloppy record keeping. “If companies spent more on compliance in areas such as audits, enabling technologies, training, expert staffing and more, they would recoup those expenditures and possibly more through a reduction in non-compliance cost.”
Non-compliance costs impact businesses because employees must deal with the issues of non-compliance instead of their regular duties. PI found the average incident cost of non-compliance in a manufacturing business to be over $8 million dollars, broken into four categories:
- Business disruption (average cost $3.2 million)
- Productivity loss (average cost $2.4 million)
- Revenue loss (average cost $2.1 million)
- Fines, penalties and related costs (average cost $1.4 million)
The PI report does not take malfeasance into consideration, and we hope you have no need to either. With systems available today from companies like Synergis Software, there is no excuse for not having a right-sized system in place for guiding and guaranteeing compliance throughout the design and manufacturing workflow. Using the Ponemon Institute numbers as a guide, avoiding just one incident of non-compliance would more than pay for any investment in compliance management automation.
For Volkswagen, the cost of non-compliance is becoming obvious, but what about in your company? How do you track the various rules you must follow in designing and manufacturing your products? Is there an automated audit trail? Are all relevant records, design documents, and approvals easily retrievable? Are your compliance procedures transparent? Who makes sure regulations are consistently followed, and made an integral part of the design process? If you don’t have straightforward answers to these questions, and an automated digital solution in place to manage it, you need to take action.
Randall S. Newton is the principal analyst and managing director at Consilia Vektor, a consulting firm serving the engineering software industry. He has been directly involved in engineering software in a number of roles since 1985. More information is available at https://www.linkedin.com/in/randallnewton.