This blog was co-authored by Kalypso's Marc Fowler, Veda Deshpande, and Benley Saint-Jean.
In the world of product development, a heavy emphasis has been placed on connecting the digital thread across R&D, manufacturing, and the supply chain. Quality management has often been pushed to the side, largely due to regulations and companies using disparate systems to track and manage their quality programs. Connecting the outputs from various quality issues and events has traditionally been difficult, as most product data is integrated into different business intelligence tools or exported to a data lake, producing poor reporting against the products. The primary reason for this is that quality issues and events are rarely tied to a bill of materials (BOM) structure, and/or to the individual part that makes up the finished goods.
Why is that? Quality management systems (QMS) don’t account for the concept of a BOM structure, although most systems will be capable of importing a list of finished good SKUs to associate quality processes like CAPAs, complaints, nonconformances, and audits. What about other systems outside the general QMS? Do these systems have the same SKUs? Where are the finished goods and parts managed?
The answer is within your global PLM system, where engineers and product designers execute change management, outline the full digital product definition, and manage product families and variations of the same parts and products. Integrating quality systems into PLM leads to a closed-loop quality management system which not only streamlines your multitude of processes to one central location, but also alleviates the burden imposed on quality management resources during quality events. Furthermore, it improves your organization’s control of processes and significantly lowers your cost of poor quality (COPQ) budget.
The benefits of a digital thread cannot be achieved without connecting all the quality issues and events across your enterprise to the digital parts managed within your PLM system. This is where a paradigm shift is happening for manufacturers that have invested in a digital product definition. Digital product quality (DPQ) provides a solution to take these issues across an enterprise and relate them to the parts and product definitions managed with PLM.
Below is the DPQ solution framework for connecting quality issue intake systems across an enterprise to the digital product definition managed within PLM. It provides a solution for collecting these issues for evaluation by quality product subject matter experts, to disposition them against a continuous improvement process (CIP) within PLM, or to an external system, creating full traceability across the digital thread.
Three core value drivers are pushing this paradigm shift towards the digital thread:
Initiating quality issues against a part or product creates a digital history of events that can be viewed by R&D, quality, and manufacturing. Issues can be evaluated, initiated, and linked to CIPs within PLM, or to external systems like QMS or manufacturing execution systems (MES). The digital product definition managed under enterprise change also has traceability and connectivity to the CIPs, leading to increased transparency throughout the change management process. With increased traceability against parts, products, and issues, quality teams can better determine where there are opportunities to leverage CIPs, not only for the current part, but also for each variation of it. With greater efficiencies and a reduction in redundant CAPAs, the process moves away from a documentation exercise and focuses on collaboration and continuous improvement, more closely aligning with the original intent of the ISO 9001 standard.
Many large enterprise organizations manufacture their products and parts across the globe, leading to poor visibility as it relates to products and their associated quality processes. By consolidating all quality issues or processes with respect to the digital part/product definition, stakeholders across the organization can gain better visibility into the parts/products of their expertise. Anyone who has access to the global PLM system can view product quality data in real-time, meaning that issues affecting one region can be easily seen by other regions to understand if a global change is required, or if the issues are isolated. Having this enhanced visibility leads to greater collaboration and improves the speed to market for next generation products.
Lastly, completing the digital thread by relating quality issues and processes to the digital product definition creates a foundation to drive predictive and prescriptive analytics. Applying machine learning to the digital part or finished good enables organizations to start interpreting what events are happening in each region, along with what events or outcomes can be expected. A company can then move to risk-based continuous improvement by evaluating the biggest risks to their products, patients, and brands, and taking proactive measures before they become mission critical issues across the enterprise. Change management can then be linked to a prediction model to initiate, escalate, and formulate the appropriate actions for the parts/products, reducing the product’s time to market and helping drive next generation products to market faster.
For more on how PTC and Kalypso can help your organization raise the standard on product quality, visit Digital Quality Management.
As a senior manager at Kalypso: A Rockwell Automation Company with a focus on life sciences, Marc helps develop meaningful relationships to understand business challenges, aligning technologies with processes to overcome those challenges.