Top Quality Management Metrics in Medical Devices Manufacturing

Summary:

This article is going to highlight the key quality management metrics that must be dedicatedly monitored and improved by the medical devices manufacturing industry.

Upholding and improving the quality of medical devices is perhaps most challenging for their manufacturers. While most of them choose to achieve the ISO 13485 medical devices quality standard, they also need to assure they are fulfilling certain quality aspects or parameters. Operational excellence along with quality devices or products will help manufacturers in the medical sector survive in the long run.

A quality management system (QMS) can ensure everything from taking care of the attributes of products for safety and customer satisfaction to ensuring improvements in processes of their production. That is why a medical device manufacturer needs a brilliant, practical, and operational QMS to address all key quality parameters as well as ensure continuous enhancement of their processes.

The following are the key metrics that every medical device manufacturer needs to keep an eye on with their quality management approach or QMS.

Product Compliance

It is imperative for a medical device manufacturer to get certified with international regulatory standard ISO 13485 for assuring their products’ safety and quality. This metric for product compliance is the first most crucial parameter that measures the percentage of devices manufactured which are absolutely compliant with ISO 13485 requirements. It means a manufacturer should try and ensure maximum of their products meet requirements issued by governmental or regulatory authorities. Apart from the ISO requirements which primarily focus on assuring quality, there are several other regulations including product labelling, packaging, transporting, storage and medical device reporting. A manufacturer should ensure a high percentage of product compliance for these regulations too.

Customer Complaints

The second crucial metric to determine quality performance of medical devices by a manufacturer is its rate of customer complaints. Monitor complaints received every day, the nature of the complaints as well as any overdue complaints. Requests from customers for product refunds or instances of recalls should be recorded too. The overall trend of complaints needs to be evaluated over time by the manufacturer to understand whether there is any reduction of complaints received which would indicate progress in the improvement of the quality of devices.

Medical Device Reporting

Automated MDR (Medical Device Reporting) is essential to track to determine the improvement in quality management. Most of the critical issues being reported are regarding product designing and development or uses. To measure MDR as a crucial parameter, a manufacturer needs to compare MDRs submitted at present with that of MDRs submitted earlier when there was no proper quality management. If it has decreased, then the manufacturing firm is getting more competent in ascertaining quality.

On-time Delivery

The on-time delivery metric helps in knowing whether devices are delivered to customers at the right time (within preferred delivery date and time). The metric is calculated by dividing orders delivered on time with total orders received by the manufacturers. This metric is crucial to understand the medical manufacturers’ quality excellence because it demonstrates their capability to deliver essential items to needed by customers on time. A higher number of on-time deliveries shows their competence in meeting market supply requirements due to efficient processes and streamlined distribution systems.

Audit Findings

Any business needs to go through audit processes periodically, at least once or twice a year when qualified officials will assess the QMS for any issues, inconsistency or noncompliance with regulations (ISO standards and other general legislative regulations). Auditing officials are either assigned from manufacturer’s in-house quality department or an external agency. Many leading performance indicators are also tracked during audits to see whether improvements have been made or not. Key audit findings that a medical manufacturer needs to focus on are high-risk noncompliance issues, QMS nonconformity with ISO 13485, re-occurring quality issues, and rate of closure of corrective actions.

Analysing these key findings after audits will help manufacturers to find out the effectiveness of their existing quality management procedures. Noticing any major variations in these parameters will indicate them to take appropriate actions to further enhance their quality performance.

Maintaining or improving these quality management metrics or parameters is an essential requirement for medical product manufacturers. A QMS enables them with real-time visibility of all these metrics and so they need to keep track and improve them consistently. Also, complying with ISO 13485 medical devices quality requirements is a core necessity of medical device companies to ensure their products’ safety and superiority. It becomes easier to comply when they all these key quality metrics are identified, and efforts are made to improve.