Unlocking Synergy: The Power of Integrating QMS and PLM Software

Product Life Cycle Management (PLM) is a strategic approach and set of practices aimed at managing all aspects of a product's life cycle, from conception and development to retirement or disposal. It includes managing the product’s journey through ideation, design, production, sales, service, and obsolescence. It acts as a centralized repository for product specifications, engineering specifications, supplier details, CAD drawings and files, bills of material, quality KPIs, plans for performance testing, and a whole range of product-related data/documentation.

It also acts as a single source of truth as it pulls up data from a variety of systems such as Enterprise Resource Planning (ERP), Supply Chain Management (SCM), and Manufacturing Execution Systems (MES). And one such important source is data residing in the Quality Management System (QMS).

QMS helps manufacturers improve quality performance with streamlined audits and inspections, complaint handling, nonconformance management, quality training, risk management, supplier quality processes, etc. Data from the quality management system can provide valuable insights to improve product specs, and enhance the product development process, minimizing product risk, and the number of complaints. The specifications can be revised, if needed, based on data.

It can help with the better management of QMS processes and enhance regulatory compliance. In today’s world where speed and accuracy matter, QMS can provide a cohesive view of the product development history, allowing manufacturers to deliver world-class products, on time and within budget.

Siloed QMS and PLM Processes - A Bottleneck

Although QMS and PLM have a natural synergy and enable manufacturers to continuously improve and manage their products better, the fact that they are managed by separate teams hinders an integrated approach. Using paper-based QMS processes or legacy systems can further create data silos that prevent businesses from leveraging the data available in the systems to improve their efficiency, productivity, and quality. As increasing competition puts pressure to bring products to market quickly, failure to meet standards pushes businesses back. In highly regulated industries, like say medical devices, this can also lead to receiving warning letters from the FDA (Food and Drug Administration) and product recalls.

When QMS and PLM are not integrated, it results in poor communication between the systems and disjointed business processes. It increases the risk of failure of design processes due to a lack of feedback from QMS. Limited visibility into the product development process can impede quality assurance and lead to quality errors.

Relying on spreadsheets, paper documents, and e-mails poses a challenge in version control, affecting the effectiveness, efficiency, and productivity of the teams. Collaboration in a globalized environment, change management, communication, risk management, and supplier management are other areas where the lack of integration can affect the development and delivery processes.

Integration for Automation of PLM and QMS Processes

Integrating QMS with PLM Quality Management facilitates a unified, comprehensive view of the product development process. This helps to improve collaboration, with automated workflows, data and analytics capabilities, and access to improved communication channels.

Some of the benefits include:

End-to-end Quality Management: The quality function becomes integral to the product development life cycle, right from the time of design to even providing service and support. It helps with proactive quality to eliminate non-conformance, which lowers the development cost and reduces scrapping and wastage.

Creating a Culture of Quality: Regulatory bodies require businesses to integrate quality at every step of the way. Integrating PLM Quality Management enables businesses to do just that and create a culture of quality. It also results in improved employee engagement, productivity, safety, and customer satisfaction.

Improved Risk Management: Regulations also require a risk-based approach to quality management. Integrating the two functions provides businesses with the data needed to identify and rank risks for implementing mitigative measures.

Document Management and Version Control Across Both Product and Quality Processes: The product design and development process is iterative. Version control and document management can become challenging in a paper-based or legacy system, leading to errors slipping into the system. This results in scrapping, wastage, delays, and additional costs. Automated QMS and PLM systems that are integrated minimize the risk of errors by providing all stakeholders with access to a centralized document and product history.

Root Cause Analysis and CAPA: Identifying the root causes of any issues, and implementing corrective and preventive action are crucial to continually improve the development and management processes. Integrating the two functions enables the development teams to identify issues and take timely action to minimize errors and prevent recurrence. This also improves compliance with the required standards and regulations.

Change Management: Another critical area for quality management is change management. Integrating PLM with QMS helps bring change under control and evolve products quickly to speed up time to market while meeting the quality needs.

Improved Collaboration and Communication: A single platform for PLM Quality Management and QMS facilitates better collaboration and communication from within the system. Alerts and notifications whenever a change is made, reviews, and approvals are simplified and accelerated, reducing errors and confusion.

Integrated QMS and PLM from ComplianceQuest

ComplianceQuest QMS and PLM are unified on the Salesforce platform, enabling businesses to leverage the cloud-based solution to improve visibility and traceability. The features of the integrated product include:

• Audit
• Inspection
• Document
• Risk
• Change
• Supplier
• Complaints
• Equipment
• Training
• CAPA
• Nonconformance
• Management Review
• Design Controls
• Product Inspection

The features are modular, making them scalable and cost-effective. Being aligned with the ISO family of standards, they help with compliance as well.

To know more, request a demo here:
https://www.compliancequest.com/product-lifecycle-management-plm/