Inside Look at Four Companies With Exceptional Quality Management Systems
Three names you don’t see mentioned much nowadays regarding quality management are Walter A. Shewhart, the father of statistical quality control; Joseph Juran, founder of the Juran Trilogy (quality planning, quality control, and quality improvement); and W. Edwards Deming, the architect of the quality movement.
These three quality pioneers have significantly impacted how businesses and organizations approach quality in product development and manufacturing today, as well as in modern quality management methods. Although their approaches have some differences, they share a common goal of promoting continuous improvement and fostering a quality culture within organizations.
The high standards of maintaining quality
Companies in medical devices, aerospace and defense, electric vehicles (EV), and other industries that design and produce complex goods are meticulous when it comes to quality management. Quality processes need to be effective and streamlined due to strict regulations from the Food and Drug Administration (FDA), the International Standards Organization (ISO), and the International Aerospace Quality Group (IAQG). This includes risk assessment and decision-making procedures, as well as transparency to facilitate communication with suppliers, internal/external teams, and global contract manufacturers (CMs).
Many organizations and manufacturing companies rely on a quality management system (QMS) solution to adhere to quality regulations and automate their quality management processes. A QMS solution is a formalized business system for documenting policies, processes, responsibilities, and procedures to meet customer requirements and compliance with regulatory standards.
A QMS provides the necessary controls to manage your business effectively and efficiently. It allows you to identify problems early on, so corrective actions can be taken before it becomes too late.
A well-designed QMS helps companies:
- Improve their performance
- Achieve sustainable growth
- Improve productivity
- Reduce costs
- Increase efficiency
- Provide better service delivery
- Enhance their brand reputation
Here is an inside look at four companies that have redefined their approach to quality by implementing exceptional quality management systems that not only achieve compliance but place them as forerunners in their respective industries.
Kinsa Health
As an illness insights solutions company, Kinsa has built a comprehensive set of early warning and insights capabilities designed to provide individuals, schools, communities, businesses, and public health officials with real-time knowledge of spreading illness.
Business Challenges
Kinsa was tethered to manual processes. The company concluded they not only needed to modernize their quality management processes but also find a more efficient means to monitor the consumer complaint procedure—product defects must be tracked from each customer complaint through resolution. Therefore, a new solution would have to integrate with the Zendesk customer relationship management (CRM) system for support tickets and complaint management.
QMS Solution
After extensive research and a shared understanding that a medical device QMS needs to reflect the applicable requirements of a company’s processes to help ensure regulatory compliance, Kinsa chose a product-centric QMS.
BENEFITS OF AN EXCEPTIONAL QMS
With a single cloud system for product and quality processes, Kinsa’s QMS also provides:
- A flexible configuration that is secure, easily accessible, and enables integration with other business systems
- A systematic way for managing document control, product changes, and quality reporting
- Full training record management enabling teams to effectively track, train, and ensure compliance with policies and procedures
- The capability to maintain compliance with FDA/ISO requirements
- Integration with Zendesk CRM. Allows customer support to easily create a customer complaint record within the QMS.
Helping to predict better outcomes
The Pittsburgh health system Highmark Health recently teamed up with Kinsa and can now deploy Kinsa’s data analytics technology to predict operational trends and proactively identify potential barriers to managing an influx of care needs, such as staffing shortages or a lack of beds. As Kinsa continues to expand, the company can rely on its QMS to help customers and healthcare organizations meet demand while maintaining quality.
SIONYX
SIONYX is a silicon-based photonics company that develops and manufactures proprietary ultra low light CMOS image sensors and high-performance night vision camera systems. These sensors dramatically enhance the performance of light-sensing devices commonly used in commercial, industrial, medical, and defense-related applications.
Business Challenges
Being awarded a sizeable government contract, the company needed to step up and move away from manual processes. Their government customers required SIONYX to demonstrate that they had the proper handling of technical data, access control, full audit history, and a compliant setup between QMS and document control—a compliant platform architecture. All these prerequisites had to be accomplished within seven months.
QMS Solution
After contrasting and comparing systems, the company found a QMS solution that hit all the requirements including best practices on how to implement and the ability to keep pace with their schedule. After implementation, SIONYX was able to provide their defense customer with a road map of what they would be putting in place showing they were able to meet their customer’s requirements. The product-centric QMS has enabled the company to scale with the product lines. With product management, document control, and quality processes like corrective and preventive actions in place, the team has the foundation to expand both depth and breadth as needed.
BENEFITS OF AN EXCEPTIONAL QMS
SIONYX QMS has not only enabled them to meet compliance requirements but also helped to ensure quality product deliverables, as well as:
- Accelerate corrective and preventive action processes
- Provide transparent approved vendor list (AVL) management
- Deliver a secure native-based solution that scales with the company
- A compliant QMS that is aligned and works to support the company’s ISO 9000 efforts
Helping night vision marine cameras fly under the radar
After launching its Nightwave marine night vision camera, the company has introduced the SIONYX Nightwave ultra low-light marine navigational camera. It offers maritime professional agencies color digital night vision for surveillance and evidence-gathering, search and rescue, and covert operations. With their QMS in place and the ability to scale their product line and stay compliant, the company can deliver innovative quality products that help support the U.S. government defense and intelligence industry.
SomaLogic Inc.
SomaLogic is a global leader in proteomics. Powered by an industry-leading technology platform and one of the largest clinical proteomic databases in the world, the company’s goal is to revolutionize precision medicine to help address unmet medical needs.
Business Challenges
Relying on a content management system (CMS) to keep track of product and quality records proved futile, especially when it came to visibility and traceability across the full product record. The CMS made it harder to drive compliance and difficult to meet new product development (NPD) goals. SomaLogic needed a system they could embrace quickly without costly IT infrastructure or lengthy implementations.
QMS Solution
The company decided on a cloud-native QMS for its ease of adoption and scalability without needing expensive IT infrastructure, IT support, or a lengthy deployment period. With their new QMS, SomaLogic was able to conduct business immediately by linking all the product and quality information in a single platform. This product-centric approach to quality management reduces compliance risks while improving visibility, traceability, and control over the course of the entire product lifecycle. Bills of materials (BOMs), quality records, design files, and any changes or quality issues are all connected.
BENEFITS OF AN EXCEPTIONAL QMS
In addition to giving SomaLogic greater quality control, the QMS enables dispersed teams to stay connected and drive compliant quality processes, as well as provide:
- A traceable audit trail for all remote processes through electronic documentation, approvals, and signatures enabling the company to comply with FDA CFR Part 11, and similar regulations
- A convenient dashboard that offers automatic alerts plus rapid access to nonconformance reports (NCRs), corrective and preventative actions (CAPAs), and other outstanding issues
- The ability to develop timetables and plans for internal audits
- Control and traceability of product and quality information
Accelerating biomedical R&D in Southeast Asia
With goals to expand in Asia, SomaLogic currently has authorized sites in Japan, Singapore, and China. The objective is to bring the power of SomaLogic’s proteomics platform to the region to support advances in biomarker discovery and drug development. With their product-centric QMS, the company will be able to better inform product development processes and improve customer satisfaction.
Potrero Medical
Using the latest advances in artificial intelligence and sensors, Potrero Medical, Inc. is a personalized platform transforming patient care through precision fluid management and analytics. The company provides clinical decision support by furnishing precise data from the kidney.
Business Challenges
As a highly regulated medical device company, Potrero needed to ensure compliance with the ISO, FDA, and EU to achieve commercialization success. They were about ready to launch a new product. Using manual and paper-based processes for BOMs and engineering change orders (ECOs), the team determined the current processes would not scale or hold up to the scrutiny of an audit. It was decided that to meet current and future needs a QMS would be integral to the company’s business. Potrero chose a product-centric QMS over a typical document-centric system so they could manage BOMs and changes along with their quality processes.
QMS Solution
Potrero’s QMS has given the team confidence in its quality and compliance processes that couldn’t be realized using the old manual means. The company now has a solid, scalable platform to continue its growth and innovation in developing devices for the prevention of acute kidney injury and other critical diseases.
BENEFITS OF AN EXCEPTIONAL QMS
A product-centric QMS has helped Potrero to:
- Manage BOMs, engineering changes, and quality processes faster
- Achieve product commercialization and compliance goals
- Decrease complaint cycle time by 25%
- Improve component nonconformance by nearly 20%
- Improve training compliance from about 80% to greater than 98%
Extending their real-time assessment reach
Maclean Health recently signed an agreement to exclusively distribute Potrero’s Accuryn Monitoring System to the Veteran’s Association and Department of Defense medical centers across the U.S. and worldwide. The company’s QMS will be instrumental in maintaining product quality and helping patients with their AKI injuries.
The future of quality management lives on
It’s evident a quality management system should be an essential part of any business or organization aiming to thrive in an increasingly competitive, compliance-driven, and fast-changing business environment. As products and consumer needs grow in complexity, quality management will continue to play a crucial role in ensuring companies operate efficiently and effectively while meeting customer expectations. The three quality pioneers may be long gone, but their quality principles and approach to quality management will live on.
Arena helps overcome quality challenges
When it comes to trusting a single source of truth, Arena’s Cloud QMS solution can help you manage quality records such as change controls, CAPAs, DMR’s, DHFs, SOPs, and training records in context to the entire product record. Arena streamlines closed-loop quality management processes to reduce compliance and audit risks while enabling continuous improvement.
Learn how Arena’s QMS can help you achieve exceptional quality results.
Joseph Prock