A staggering 83% of manufacturers are at severe or very high risk of not being able to demonstrate compliance or due diligence for the now active European RoHS (Restriction of Hazardous Substance) regulations based on their documentation management capabilities.
That is the top finding of a survey among hundreds of manufacturers by on-demand PLM (product lifecycle management) service provider Arena Solutions. Its RoHS Readiness Survey assesses risk based on 16 key capabilities around tracking, documenting and reporting.
While its study found most respondents had implemented an RoHS transition plan, 69% did not have a centralised management system accessible to employees and suppliers – critical to ensuring any company can produce complete and accurate reports when required to do so, and to facilitating ‘design for compliance’.
Which is not good news. The EU isn’t being very flexible with RoHS: already Apple and Palm, for example, two companies respected for their manufacturing approaches, have felt its teeth – with products like the Treo 650 Smartphone being disallowed in Europe.
Current regulations require a complete compliance record – from certificates of compliance to supplier audit reports and component risk evaluation procedures – to demonstrate due diligence. They also require that the record is kept for four years after a product has been launched. A spreadsheet is not deemed adequate.
“The EU is not just looking for a list of parts and materials,” insists Eric Larkin, CTO and co-founder of Arena Solutions. “Companies need to have built compliance into their business systems, and be able to show record keeping and the process controls involved all they way from design, through procurement, materials handling, receiving and inspection.”
Arena’s research also found that 60% of companies are not confident they can track all parts and materials in their products: they don’t have complete associated compliance records and can’t verify compliance independently. Further, 73% don’t have sufficient controls and documentation around change management, compliance verification of incoming parts, and closed-loop processes for non-conforming materials.
Just as worrying, 63% of manufacturers say that their current systems to track compliance will not scale for multiple regulations, and that compliance for history revisions is not well kept.
“Converting products to become RoHS compliant by the July 1st deadline was only half the battle,” says Larkin. “Manufacturers need to be prepared to report and ‘live’ with compliance – meaning they need to have a robust compliance management solution in place that allows them to track, document and report compliance as well as demonstrate due diligence when required.”
He claims that PLM is essential to making the change, and unsurprisingly suggests that Arena’s hosted offering presents one of the lowest cost, lowest risk ways of getting what they need.
“They need something that’s quick to start up, carries a low risk of adoption and then scales up as they need it to. And they also need a solution that’s being developed as the requirements change… We have users that started in 2001, long before RoHS become a significant challenge. They are now using the latest version of Arena with 46 upgrades. 100% of our customers can take full advantage of our updated software.”
Certainly Arena’s customers fare far better than the rest. Jerry Jacobus, director of quality and manufacturing engineering at networking systems maker SilverStorm Technologies, says: “Arena PLM enables SilverStorm and our global supply chain to share – in real time – a single version of the product record, which massively simplifies our product design and manufacturing collaboration, and ensures accountability when designing for compliance. We can properly track, document, and report on RoHS compliance, and are confident we will be well prepared for the next wave of regulations.”
Says Larkin: “PLM is not the be all and end all – companies need good manufacturing and business processes too. But the core value of PLM is its ability to track compliance information and to document that due diligence has occurred. In the eyes of the regulators, if it’s not documented it didn’t happen. And if there’s a reporting problem, the relevant agency can stop a shipment.”