In this era of ever more stringent FDA oversight and regulations, the responsibility for vigilance falls on medical manufacturers and their manufacturing partners or customers. Those companies that support a “best practices” medical manufacturing environment often rely on a shop floor data collection (SFDC) system that embeds attributive data in each unit’s device history record (DHR). More recent advances allow for parametric, or performance, data to be captured as well, so that not only can the medical device’s progress through the manufacturing process be monitored, the device’s quality of performance at each stage can also be assessed. Access to this data facilitates timely decision- making, ensuring the highest quality medical product, and saving money due to reduced downtime, scrap and/or repair work.
Some manufacturers, such as Sanmina-SCI, an electronic manufacturing services (EMS) company, also make this valuable data instantly available to their partners via customized web-based applications. Medical manufacturers who utilize these advances in SFDC/DHR interfacing discover that they can:
• Initiate changes to design or materials at an earlier stage.
• Ready access to parametric data allows original equipment manufacturers (OEMs) and their partners to monitor device performance throughout production. This is especially useful for new product introduction (NPI). Pass/fail rates for each station can be evaluated in real time and, should a trend be discovered, the serial numbers of the affected units can be pinpointed at once. Manufacturers and their partners can work together to initiate timely changes to product design, materials, or process that lead to savings and preserve quality.
• Satisfy FDA inquiries more quickly via online access to data and reports.
Not every OEM has sufficient personnel available to monitor SFDC reports online; smaller companies let their manufacturing partners provide printed summaries. However, larger companies, which are subject to more FDA audits because of their very size, appreciate having instant access to the most complete product performance data. If a medical device is recalled from the field, for example, an OEM can immediately input the unit’s serial number and date code to determine the exact moment during the manufacturing process that the fault occurred. Of course any reputable manufacturing partner would concurrently be investigating the same issue, but the FDA’s emphasis on “best practices” medical manufacturing encourages all participants to be fully knowledgeable about every stage of the process.
Those OEMs who are considering online SFDC reporting but also concerned about protecting intellectual property should carefully review the security procedures set in place by their manufacturing partners. Sanmina-SCI, for example, erects a data firewall within its system that strictly limits what information can be viewed and by whom. Sensitive data cannot be accessed by anyone other than the owner of that data.
With daily increases in the amount of medical manufacturing occurring around the globe, and with the FDA stretching its oversight to include manufacturing done outside the US, it is vital for OEMs to have access to the most complete, real-time data, both attributive and parametric. Quality assurance agencies such as the FDA insist that medical components be manufactured under identically rigid guidelines no matter the location. To support their partners’ adherence to these guidelines, Sanmina-SCI, for one, uses a standardized SFDC/DHR interface system throughout its dozens of operations around the globe.
Utilizing online access to SFDC data, especially that containing parametric data, helps OEMs monitor the real-time performance of their medical devices — anywhere in the world — and assures them that their products are going to satisfy FDA manufacturing standards.
This technology was done by Sanmina-SCI, San Jose, CA. For more information, Click Here.