EAS, Document Control Manager at a leading Medtech manufacturing company was faced with the challenge of preparing for the update in the Regulation of Hazardous Substances as per the European Union’s guidelines. This required an audit and removal of all substances involved in production that did not meet the newly developed regulation.
The Document Control Manager prioritized the compliance process by undertaking the required steps to meet the new regulation. He recognized that the current operating procedure for overseeing production materials was managed by 2 Change Analysts. This team was not equipped to deal with the volume of substances that needed to be monitored in order to fulfil the compliance, and would be prone to human error. Therefore, EAS contacted Xavor to develop a systematic way to meet the new compliance standards by implementing checks within their Agile PLM infrastructure, which the Medtech manufacturers used to manage production processes.
Xavor’s team of PLM experts answered this by implementing a process extension that automated flagging any outdated substances and made sure that only those substances were allowed for production that met the new ROHS 3 compliance. The Document Control Manager was able to implement this automation and bring his organization up to date on the ROHS 3 standards, without disrupting operations or subjecting his team to undue pressure.
A med-device manufacturing company that specializes in manufacturing medical aesthetic products have employed Xavor’s Agile PLM support services for 6 years. To resolve the issues they might face while using Agile PLM in a time sensitive and effective manner, they look to Xavor’s team of PLM experts who apply their decade-long experience in managing and supporting clients’ PLM infrastructure.
They contacted Xavor for a solution to meet the compliance standards for Regulation of Hazardous Substances (ROHS). This case study elaborates how Xavor addressed the compliance requirement and deployed the innovative response to the unique problem.
The updated ROHS stipulations (ROHS 3) dictate that clearance of hazardous substances must be at par with new standards, updated from ROHS 2.
The client sought an efficient method to ensure that all equipment being used in their manufacturing had ROHS 3 clearance and wanted to meet compliance before ROHS 3 was implemented. For this reason, they needed to remove all items that only carried ROHS 2 clearance in favor of the updated ROHS 3 regulation.
The Medtech manufacturers had previously delegated compliance concerns to Change Analysts, who oversaw all incoming parts and ensured that they met the company’s standards. Due to the sheer volume of the incoming parts, human error was expected, and efficiency was low in tracking changes and implementing regulations.
The client contacted Xavor to suggest an alternative method within Agile PLM to overcome this hurdle.
Xavor’s PLM experts configured an innovative automation script to verify that all parts being used had ROHS 3 clearance. The automated action blocked the inclusion any parts with ROHS 2 clearance from being used in any process.
Combined, the automation served as a verifier of all inducted parts, and the process was free of human error. The med-device company was provided the code written in Script PX, which meant users were already familiar with the language used for this automation process. Further, instructions were given to customize the automation script to their suiting.
The initial problem was solved by Xavor’s PLM experts successfully through the application of their vast PLM knowledge and adding an innovative edge. The Medtech manufacturer’s team welcomed the additional benefit of being able to edit the scripts according to their preference and needs. They were able to meet the ROHS 3 compliance standards comfortably with the help of Xavor’s automation script.
“I reached out Xavor and asked if there was some way we could add some kind of automation to our path or to one of our pathways, so that if there was a training item on a on a change then it had to have a certain thing marked on its on its document record or else it couldn’t be released. Honestly, without me having to even clarify very much, pretty much the perfect automation was set up for us in our dev system.”
EAS, Document Control Manager
For the ROHS 3 regulation adaption, Xavor was able to come up with a long-term solution, in a short amount of time.
The client gained the following benefits from the process extension Xavor provided:
“We had an issue on our end where we had people who were challenged now that there’s a Third ROHS regulation requiring for the EU, requiring what chemicals can and can’t be shipped into the EU.”
EAS, Document Control Manager
This leading med-device manufacturing company sustained a reliable partner that provided customized solutions effectively. They benefitted from a bespoke solution that addressed their compliance needs and were able to streamline operations.
Xavor’s advanced knowledge of the Agile PLM infrastructure and vast experience of dealing with a variety of Agile PLM users enable it to provide customizations and process extensions to create a smooth and productive PLM experience. Our team of PLM experts analyzes the problems carefully and provides innovative, easy to implement solutions at a fast pace to sustain smooth operations for your Agile PLM.