Medical Device Metalworking and Manufacturing Streamlined


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InfinityQS International, Inc., is featuring its ProFicient Enterprise Quality Hub. Powered by a centralized Statistical Process Control (SPC) analytical engine, ProFicient manufacturing quality software leverages manufacturing intelligence and is designed to help global manufacturers improve product quality, decrease costs and maintain compliance.

Proactive Quality Control

When integrated with measurement tools like CMMs, gauges and scales, InfinityQS ProFicient is designed for proactive quality efforts to reduce defects and identify recall possibilities before they occur. "Companies creating metal tubing for spinal implants must ensure that these tubes have a certain diameter. As data is collected and something is determined to be out of spec, ProFicient alerts the operator with a pop-up window or an email, prompting corrective action. By analyzing the same data collected on the plant floor, engineers, quality professionals and executives gain the manufacturing intelligence needed to make adjustments to their processes and machinery to improve product quality and overall equipment effectiveness," said a company spokesperson.

Acceptance Sampling

InfinityQS ProFicient allows manufacturers to employ electronic acceptance sampling techniques in their metalworking processes. According to the company, using ProFicient's SPC and acceptance sampling techniques manufacturers can reduce inspection frequency and still maintain the highest level of quality.

Scrap and Yield Monitoring

There is a high volume of scrap in medical device manufacturing, especially with the many metalworking phases the materials go through to achieve the right dimensions and finish. "Although manufacturers note scrap and yield numbers, many do not track these numbers over an extended period of time and do not understand why the numbers are so high. InfinityQS ProFicient monitors scrap and can trace it back to its root cause. Adjusting processes based on this analysis can decrease the amount of waste, cut costs and raise profits," said the spokesperson.

Paperless Processes

InfinityQS ProFicient automates data collection, inputting information into a single, centralized repository. With ProFicient's database, manufacturers can create definitive traceability for every product and component. Extending automation to incoming inspection with device integration saves both time and personnel hours.

Compliance & Validation

"The medical device industry is especially unique due to its stringent safety regulations on both products and technology. Complying with laws, like the Federal Drug Administration's (FDA) 21 CFR Part 11 and Part 820, is challenging and can cause delays in production. Utilizing InfinityQS ProFicient, manufacturers can access the data needed to satisfy reporting requirements. Additionally, InfinityQS provides validation assistance for its software, which further expedites the deployment process," said the spokesperson.

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