World Quality Week

Last week was World Quality Week, during which the CDx Quality Assurance team invites all employees to celebrate the Clinical Diagnostics culture of quality.

The first issue of Quality Time, the Quality Assurance newsletter, was recently released. The QA team defines "a culture of quality" as follows:

A Culture of Quality is an aligned approach to how Quality is embedded in our daily lives across LGC CDx, to enable the growth of our business in a safe and compliant manner.

Read the latest issue of Quality Time here!

At Technopath, IVDR certification has been received, ensuring that Technopath remains compliant as a manufacturer of in vitro diagnostic products. Successful ISO audits have been completed at almost all CDx sites, with the TCD audit pending for November. No non-conformances were issued during the Beckman Coulter customer audit in Massachusetts.

On the infrastructure side, the Document Control team in MA successfully completed a project to bring EtQ to API. The system went live in July. To further support continuity across the business, the QA team has been working to establish an Integrated Quality Policy across all sites. The policy affirms their commitment to deliver “Science for a Safer World” by:

• • • • • Providing high quality, safe, and effective products to achieve maximum customer satisfaction.
          
        • Maintaining effective Quality Management Systems and adhering to applicable regulatory requirements.
          
        • Establishing and monitoring meaningful Quality Objectives.
          
        • Encouraging employee empowerment, continuous improvement, innovation, and a Culture of Quality.

In August, a cross-functional TCD team held a Kaizen event with the goal of improving the design control process to ensure rapid time to market. They spent this time together mapping the current state and identifying roadblocks in the process. The team identified changes that would remove those roadblocks and bring products to market faster. Team members took ownership of the actions and are currently in the final stages of implementing the new Innovative Design Control Model.

This event was a testament to the value of the Kaizen tool and the team’s commitment to collaboration towards a common goal. Thanks to the whole Kaizen team and in particular to Catherine Laffan for leading the charge and the core team, Bill O’Brien, Catherine Kiely, and Linda Hennebry, for their support.