Connecting the Dots: How Digital Product Traceability Can Determine the Root Cause of Issues




Imagine that you are employed by a medical device manufacturer that produces, among other medical devices, pacemakers. A shortage of a part from your preferred vendor forces you to switch to a vendor that your organization has only used in a different product. You’ve never had any problems with this other vendor so there is no hesitation in using them to complete the latest batch of pacemakers.

A few years later, a small percentage of pacemakers in the field begin malfunctioning. The question is: Will you be able to immediately identify if the pacemakers with the parts from the alternative vendor is responsible or will you need to pull all devices from the market until you can determine the root cause – hurting your company’s reputation and causing thousands of dollars in damages in the process? 

If you have been paying attention to PTC’s Digital Engineering Journey of Transformation, then your organization is probably already investing in some sort of a Digital Product Definition – which is considered to be a digital representation of the product that acts as a single source of truth for all artifacts – to better understand your products, the processes followed to design and assemble them, and the systems used to manage and archive this data. Having all of your product data from various enterprise systems consolidated into one definition will make it much easier for your team to be able to begin Digital Product Traceability. 

Digital Product Traceability is the ability to track all information about a product throughout its lifecycle: from initial requirement to product design, manufacturing and finally in the field. By maintaining this digital thread of information, stakeholders are able to look back at a product’s history when determining the origin of issues that arise later in the lifecycle. Conversely, they are able to look forward to determine what sort of impact a modification will have on the product – meaning in the example above, when the suggestion was first made to use the other vendor, downstream teams such as manufacturing would have been alerted and will have the opportunity to review the other vendor part characteristics – realizing that they did not adequately meet requirements and would have abandoned attempts to use it. 

With Digital Product Traceability, a single connected solution provides traceability among system models, requirements, CAD and product data. Change management is used to update information as it goes through the lifecycle, and outcomes from Corrective and Preventive Action (CAPA) root-cause analyses are used to identify intent behind design changes and requirements. 

The benefits of traceability are critical to the business’s success. Key among them is that of risk management: Digital Product Traceability ensures compliance with industry standards – especially important for industries such as the medical device industry – as well as reduces program risk by improving product specification quality and test management and increases IP protection. Other benefits include reduced costs due to non-compliance and Cost of Poor Quality (CoPQ). Finally, traceability encourages revenue growth by improving next-generation designs with visibility into field product performance and with efficient impact analysis for requirement changes. 

Being able to trace product information back through manufacturing and into design is vital to transforming the way your organization engineers in the era of Internet of Things (IoT) technology. PTC’s Journeys of Transformation playbook outlines how organizations can compete and succeed in the IoT era by taking three simple steps. Implementing Digital Product Traceability is a key part of the second step: advancing your organization’s activities and technologies to deliver new value for smart, connected products. You can read more about the overall Digital Engineering Journey here

For an overview of the Digital Engineering Journey, visit PTC.com

Author’s Note: A special thank you to Francois Lamy for his contribution to this blog post. Francois Lamy is the VP of PLM Solutions Management at PTC. He is responsible for driving PLM solutions strategy and roadmap, leading the PLM segment solution and product management team. Since joining PTC in 1998, Francois has held several product and people management positions in both MCAD and PLM organizations. He has a Bachelor of Sciences in mathematics and an MS degree in Mechanical Engineering from “Arts & Metiers”, France.