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.

Swan Valley Medical, Inc.

Swan Valley Medical (SVM) designs, manufactures, and distributes patented, single-use, urology instruments, and accessories to manage the symptoms of urinary retention or incontinence. SVM’s T-SPeC® is proven to be the only clinically safe placement procedure on the market and is clinically proven to reduce catheter-associated urinary tract infection (CAUTI) rates by up to 86.6%.

Business Challenges

Regulated by the FDA and certified to ISO 13485:2016, SVM is required to maintain a system and detailed records to support its operations and exceptional quality standards. With design and manufacturing operations based in Denver, CO, and suppliers across the U.S. and Taiwan, the challenge was—how to improve product information management synchronization across a globally dispersed supply chain and organize evidence of compliance to avoid costly penalties.

Like many medical device companies, SVM faced the challenges of ineffective, manual, paper-based quality control procedures. This raised compliance risks since documents and crucial records were difficult to locate. Paper-based information was often prone to being misplaced, damaged, or unintentionally thrown away.

QMS Solution

To ensure operational efficiencies among global teams (internal/external) including engineers, operations, quality teams, supply chain partners, and contract manufacturers, SVM implemented a cloud-native QMS solution. The new QMS helps eliminate multiple siloed systems for document control while centralizing information for a single source of product and quality records. Additionally, all product and quality information can be linked for easy retrieval.

BENEFITS OF AN EXCEPTIONAL QMS

With a single cloud system for product and quality processes, SVM’s QMS:

• Streamlined audit processes
• Minimized paperwork mistakes
• Reduced resources required to manage compliance
• Eliminated delays and time-consuming administrative work
• Improved visibility and traceability
• Accelerated change review cycles
• Reduced audit risk

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.

Accuryn Medical

Using the latest advances in artificial intelligence and sensors, Accuryn 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, Accuryn 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. Accuryn 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

Accuryn’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 Accuryn 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 Accuryn’s 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.