Digital Strategy

Does Quality Belong in PLM?

December 7, 2021

PLM and QMS are highly complementary. In this article, we’ll explore why combining the two can help companies deliver high-quality products, while improving patient outcomes.

What are the goals of PLM? To reduce time to market, improve product quality and effectively manage a product from cradle to grave.

What are the goals of QMS? To improve product quality, reduce risks, gain production efficiencies and garner customer loyalty.

Product quality is part of both PLM and QMS. As it turns out, these two initiatives are highly complementary but are often owned by different departments and managed as separate processes. In this article, we’ll explore the pluses and minuses of separating and combining the two functions

The Benefits of Separating PLM and QMS

If a company uses a traditional approach to QMS, where the focus is on ensuring that every time a process is performed, the same information, methods, skills and controls are applied, this function truly is a task unto itself.

Likewise, if different organizations own QMS and PLM, managing the two efforts separately can be more efficient technically.

The Costs of Separating PLM and QMS

When QMS and PLM are managed separately, the lack of integration can sometimes hinder a company’s ability to deliver timely, high-quality products.

  • Lack of transparency: Implementing a stand-alone QMS tool that isn’t built to work with the PLM processes from which quality issues arise means not having full visibility into how product quality looks in real-time across the organization.
  • Inefficiency and redundancy: When organizations run two concurrent work streams, the likely result is out-of-synch data, difficult traceability, a lot of duplicative effort and redundant functionality. 
  • More difficult to enforce quality standards: A siloed approach to product lifecycle management results in members of the R&D, innovation, marketing and regulatory teams not having on-demand access to quality requirements, making it harder to reference and enforce quality standards as product development progresses.
  • Harder to track history: The ability to generate a full history of complaints, deviations, non-conformance, and product changes is more difficult, making the impact on product quality over time, across products & suppliers harder to analyze.
  • Tougher to loop in supply chain partners: Few standalone QMS systems enable secure supply chain partner participation under customer-designed workflows, making it difficult to track and trend vendor quality issues.  
  • Collaboration challenges: Implementing a QMS system separately prevents you from being able to have full collaboration throughout the entire supply and value chain.
  • Data harmonization difficulties: Product data from the PLM system often needs to be imported into QMS system fields, which can require customized coding, resource-intensive integration or continual manual data collection.

The Benefits of Combining PLM and QMS

Leveraging PLM to support quality along with product innovation, product development and engineering processes gives you a single, consistent source of product data. It enables you to have a collaborative system that includes all players who need to be at the table.

  • Full transparency:  The combined solution enables you and everybody on your team to have a complete view of product quality and product lifecycle in real-time.
  • Efficiency: Quality management best practices can be applied seamlessly across the whole product lifecycle. 
  • Easier to enforce quality standards: PLM can capture quality data directly on product specifications with vendor questionnaires and auto-enforce quality limitations and restrictions on that data throughout the innovation and development process.
  • Easier to track history: You will be able to generate a full history of complaints, deviations, non-conformance, and product changes.
  • Easy to loop in supply chain partners: PLM systems more effectively  enable supply chain partner participation, making it easy to track vendor quality issues.  
  • Enables QMS to have a broader role:  Under the PLM umbrella, the quality team can be involved with a new idea from the very start, rather than focusing strictly on manufacturing repeatability and customer complaints. 
  • Good collaboration: Quality and safety parameters can be directly integrated into formula design with data templates and workflows, empowering the quality and R&D teams to collaborate and making quality management a shared initiative, rather than an ad-hoc process.
  • Good reporting: Quality groups can generate reports capturing ECR, ECO, CAPA, NCMR, DMR and DHF documentation in one place.

The Next Generation of QMS Software

The next generation of QMS software plays a central role in modern PLM software. Combining QMS and PLM enables the integration of customers, suppliers and vendors into a closed-loop process focused on quality. It is cloud-based and mobile-ready to take advantage of the scalability and collaborative benefits of the architecture and integrations with advanced CRM. The approach allows customers and suppliers to participate in product design by allowing for feedback cycles from concept to end-of-life. The integration of PLM with QMS ensures that you have a single source of product data and that you are able to incorporate QMS early and often in the new product development (NPD) process. 

QMS from Propel

Propel uniquely combines Salesforce CRM with PLM tools to deliver that next generation of cloud-based QMS software. Customer information like software, hardware and IoT installations, contract commitments, and privacy policies, can all affect product design and deployments. With Propel QMS software, teams can leverage this information to optimize for quality in the design, delivery and support of the product.

Propel QMS helps customers become compliant with 21 CFR Part 820, 21 CFR Part 11, ISO 13485 and EU MDR.

Take our product tour to learn more about Propel’s QMS offerings. 


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Author

Betty Kaufman

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