Building a reputation as a high-quality medical device manufacturer or a contract manufacturer takes time, perseverance, and a great deal of effort. At the same time, in order to achieve the highest product quality and compliance criteria, medical device manufacturers must rely more than ever on their supply chains. In order to make medical devices, it is a must to check on the quality and compliance of suppliers.
Gesco Healthcare, being one of the top medical device manufacturing companies, bases our strategies for achieving compliance and quality objectives on key indicators obtained from our systems. The use of key performance indicators (KPI) provides the production data and intelligence required to make better shop floor decisions. These data are crucial in the manufacturing of medical devices as they allow factories to increase their scale, precision, and output.
Five Metrics for Quality Management
Building a reputation for world-class quality and compliance is essential for medical device manufacturers/ contract manufacturers to stay in business and grow. However, it’s a steep challenge. Here are five metrics we track at Gesco Healthcare to stay ahead of the competition and to manufacture the highest quality medical devices.
1. Customer Complaints
At any medical device manufacturing company, one of the most crucial data to be tracked is the turnaround times in addressing customer complaints. The speed with which complaints are processed should be increased for the sake of product quality. The number of open complaints, the average amount of time they spend open, and the number of complaints that are late are some of the metrics that should be monitored.
2. Non-conformance
In order to find patterns in recurrent nonconformance instances by type, metrics should include both the number and the percentage of nonconformance instances that were closed within sixty days. The quality management system (QMS) at the medical device manufacturing unit can be utilized to ensure that conditions that are outside of the specifications are automatically detected and communicated, hence providing visibility into what is occurring in real time. The non-conformance / corrective action (NC/CA) measure is one of the primary metrics that is typically utilized for the purpose of tracking this element of quality. During a quality audit, the auditors will look at how many cases are NC/CA and how many cases are closed.
3. Corrective and preventive action
Traditional manual and paper-based processes, such as approvals and escalations, can be streamlined with automated corrective and preventive action (CAPA) management. A software for a quality management system (QMS) makes it easier to identify root causes and communicate them to the company. This is a key part of making sure that processes keep getting better and that OEE stays as high as possible over time at the contract manufacturing company.
4. Internal and External Audits
Audits from both the external and the internal can be used to produce a wide variety of leading indicators. The number of severe noncompliances, the percentage of high-risk noncompliance cases, recurring issues, and the time it takes to close out corrective action requests are all examples of these. On-time completion rates for scheduled audits are also included by the contract manufacturer.
5. Strong Quality culture from top to bottom
The first step in providing senior executives with the data and manufacturing insight they require in order to make more informed decisions begins on the shop floor. Manufacturing managers employed at the medical device manufacturing unit are aided in reaching their operational and financial objectives by data and KPIs, that are collected at the machine level, combined into larger metrics and KPIs, and shown on dashboards.
When production management, product engineering, and senior management are all using the same key performance indicators (KPIs), signs of possible major problems can be detected and addressed more quickly. This close collaboration from the shop floor all the way up to the top floor offers improved insights into important areas such as yield rates, quality levels, scrap rates, production efficiency, and the cost of quality. By working together around shared KPIs, production delays can be avoided and the quality of the products can be made more consistent.
In addition, metrics and key performance indicators are crucial in the production of medical devices because they allow production centres to achieve unprecedented levels of scale, speed, and accuracy. The insights that can be derived from trending in each aspect of production are one of the most useful benefits that can be obtained from standardising on a single set of KPIs. The key performance indicators (KPIs) discussed in this article offer a starting point for manufacturers of medical devices who operate more than one production center. This enables them to compare relative production efficiency and quality levels at each location.
Implementation of KPI at Gesco:
The successful implementation of a quality management system should serve as the foundation of the manufacturing facility for medical devices. At Gesco Healthcare, our quality assurance specialists are involved in the product development process from the very first day. This is done to reduce risk and improve processes.
Our continual attention is focused on Overall Equipment Effectiveness, which helps to explain why one or all five metrics are not in compliance. This is because all of these factors are intricately connected to one another and, to some extent, rely on one another. We know that production assets that aren’t working right, aren’t in the right place, or have broken down can’t be expected to make goods that meet quality standards.
Once the tools for assessing OEE are in place, we utilize the technology to monitor other parameters. These metrics provide us with further insights into how to ensure that the quality of our products are exceptional, including perfect order performance, and the quality control.
