This is the second in a three-part series on KMC Systems' medical device quality assurance practices.
Automation in KMC Systems' robust quality assurance system makes it easier to manage product safety, risk management and design control activities of medical devices. The former, manual, paper-based system in place at KMC Systems 13 years prior, and centralized input and management structure have been replaced by a fully automated, interactive system with real-time computer-based communications and product updates across all departments in the company.
|Gail Wiegand, Director of Quality Assurance and Regulatory Compliance, explains KMC's custom medical device MES.|
Now, KMC's robust medical quality control system is available to all key employees assigned to a product line. Employees can now openly observe the history of all complaints, non-conformances and performance and testing failures across all product lines, and can search by term and keyword to see anything about the development, performance and testing of a particular product.
KMC’s manufacturing execution system (MES), customized through Lotus Notes, provides a platform for all key participants in product programs to share and analyze data, and participate in decision making that improves program efficiencies and product quality, and identifies improved medical device manufacturing solutions. Each database is created by KMC’s Application Specialist, and all employees who have access to the programs can provide real-time updates on each product. As a result, the manufacturing process is more efficient, provides valuable, timely data, and the process is streamlined across all levels of management.
The product team, which consists of the quality assurance engineer, team leader, buyer planner and other personnel, can see if there are labeling errors, early life failures or performance and testing issues. This timeliness of data can help redirect a program and save time and money in production. More importantly, it alerts the product team that changes may need to be made or more rigorous testing programs need to be implemented.
KMC’s quality assurance team indicates how radically different the process is to the prior manual system, and each day sees the benefits of having easily accessible product data. Since installing the system, they have continued to customize the applications, improving the user interface to accommodate their unique manufacturing process.
The MES manages all assembly and test processes, drives regular compliance, and controls who can access the data. The security controls are a major part of the system as access is structured by product and databases, and only those authorized to access particular product data will be granted approval.
The medical quality control system promotes collaboration between all departments and senior management. Employees can provide recommendations, file complaints and report on product behavior that is critical to the device performance and quality. The complaint file provides details on who did what, when it was done, what was sent to the customer for communications and the root cause of the problem. This data is then immediately shared with each medical product team.
Every medical product has its own system failure notes which are reviewed individually and in management review sessions. KMC Systems analyzes the MES data and uses that data to drive decisions. If an issue is found while testing a module, the team evaluates the test system to decide where to focus their efforts.
The team reviews each program with the management team monthly. The management team reviews all active medical device programs to hear up-to-date developments.
Gail Wiegand, Director of Quality Assurance and Regulatory Compliance, said, “We see the value in tough scrutiny from the standpoint of product quality, customer satisfaction, and timeliness of delivery and overall improved manufacturing efficiencies.” The teamwork between manufacturing, engineering and quality assurance brings confidence to the decision-making process and accelerates the overall medical device development process.
New benefits of the KMC quality assurance process are recognized every day and the MES’ power to improve product quality is visible inside and outside the company. In addition to speed and efficiency in the medical instrument production process, the system;
- Streamlines the decision-making process
- Tightens communications between departments
- Provides valuable information back to the customers in product behavior and performance results
- Captures all product documentation and product data for FDA regulatory compliance and customer audits
- Provides timely updates on product performance and testing issues as they happen
- Accelerates the product development process
- Manages risks, and operating and manufacturing costs
- Monitors and manages security access by product line and the flow of information
The MES also troubleshoots errors and product failures in the field. As a customer, you can call if you experience an issue with a component, and we can search our database for previous issues with that component. Before sending a corrective action, KMC can see if any other programs have used the same component to attack the issue immediately and provide valuable data back to the customer.
“Our proprietary software helps us meet our customer’s requirements for quality, delivery and a cost-effective solution,” Wiegand said. “It has been proven time and time again to be built and managed in compliance with the ISO 13485 standard and the FDA regulations. The amount of data captured in our Notes applications is incredible, and it is data that drives KMC to make decisions, initiate actions and establish quality objectives.”
Read more about KMC's medical device quality assurance system.
Next week’s blog, the final in the three-part series, is titled: “At the KMC quality helm - a glimpse at Gail Wiegand’s passion for excellence and people”