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An EQMS offers insight into quality processes and work flows, streamlines supplier audits, helps manage design changes and can even trigger warnings early on in the manufacturing process should something seem wrong. By leveraging an EQMS to tie various internal departments and suppliers together, OEMs can achieve greater traceability and accountability. An EQMS can also help log and analyze data through predictive analytics and leading indicators, turning issues or mistakes into valuable lessons learned.

Supplier Quality Warning Signs Having structured, automated workflows and quality processes throughout your supply chain can help ensure that medical devices meet not only written, but internal quality standards. This is especially important in today’s increasingly regulated global business landscape. With new regulations being imposed by government bodies frequently, medical device manufacturers are under extreme pressure to ensure quality is maintained.

Mistakes unfortunately do happen. Should it become apparent that quality standards are not being met, either internally or by a supplier, a corrective and preventative action (CAPA) or a supplier correction action request (SCAR) should be established and addressed. Being aware of the common warning signs that may trigger the need for remediation helps ensure issues are addressed quickly. The warning signs include:

Non-conforming materials. For example, should an audit reveal that a supplier is using a conflict mineral (tungsten, tin, tantalum, and/or gold mined from war-torn areas such as the Democratic Republic of Congo) to produce a specific device component, that supplier – and, in turn, the OEM – is not in compliance with the Dodd-Frank Act. Changes that have not been approved. Change control is crucial for all manufacturers, but doubly so for makers of medical devices. Should a supplier decide it’s more cost effective to use latex instead of neoprene, a supplement to the medical devices UDI must be filed. Changes that have been made without informing pertinent members/departments of a supply chain. A lack of transparency between internal departments and external suppliers means a lack of control over quality, which increases the chance of an uncaught error and potential recall. Incomplete incoming materials. There are some instances where incomplete materials – such as integrated chipswithout heat-sink mounting – can pose an issue to the final medical device. Excessive field failures as a result of a supplier component. Should some suppliers use an outdated assembly process or materials, too many of the non-conforming products could make it to market, resulting in greater-than-forecasted field failures and product returns.

An EQMS helps streamline the warning sign/trigger process by developing a repeatable, compliant, and closed-loop CAPA and SCAR process that logs and manages quality issues originating from any source. Having same-system access with all of your suppliers helps for the quicker assignment and completion of CAPAs and SCARs, ensuring quality is maintained without slowing down the manufacturing process.

Prevent – Don’t React – To Quality Issues From 2007 to 2012, the total number or FDA warning letters increased by 104 percent. Specifically for the medical device industry, FDA-issued warning letters doubled from 2007 to 2012.

Rather than waiting for a warning letter from the FDA – or worse, a device recall – medical device manufacturers should take a proactive approach to preventing, rather than reacting to quality issues. If a medical device company is spending too much time and resources on corrective actions, this is a leading indicator that they are in reactionary mode instead of taking preventative measures to invest in the proper resources, tools and processes necessary to maintain quality.

An EQMS can be used to help prevent said issues: for example – streamlining employee training programs. The automated tracking and management of employee training helps ensure relevant activities are scheduled and tracked through to completion. An EQMS provides a seamless environment to ensure compliance with government and industry regulations while maintaining a standard of excellence in controlling the training initiative. Centralized, comprehensive training records that are managed via an EQMS provide proof of compliance and maintain an accurate reflection of training needs.

While we have seen a slight trend in final assembly re-shoring recently, we shouldn’t expect global supply chains to shut down over night. There are many advantages to working with contracted partners and suppliers around the world, including decreased costs and the ability to join forces with the best and brightest our planet has to offer. By adopting an EQMS to help streamline and manage various initiatives, medical device manufacturers help ensure quality is backed and managed throughout a medical devices’ entire lifecycle, no matter which site the devices were manufactured – that’s not just good, it’s great.