Medical Device Recalls – Paperless Forms to Capture and Trace Data

In the last few weeks, we've heard three separate companies tell us about their problems with recalls of medical devices.  FDA regulations require that manufacturing companies archive test data for a certain period for each medical device serial number. That's an entirely prudent regulation, however some of the test data for some of the manufacturing and testing processes is done on paper.  When there's a recall (such as this recent recall) the ability to quickly view that data is non-existent if the source is stuck in a file cabinet in Archives. We, and those…continue reading →

TQM, SPC and Six Sigma

If you have been in management or involved with large companies for any length of time, you have probably heard the terms TQM, SPC and Six Sigma. From a high level, these terms are virtually identical, so one typical question is what are the differences between them and why should you care… In this blog, we will try to answer both questions in a concise way. TQM = Total Quality Management. This is a high level philosophy that focus on how to continuously improve the quality of your company’s products and services. TQM…continue reading →

Paperless Forms 2.0 – Digitizing your Test Data

  Real-Time SPC on Test Data Web Based Forms for Test Data Collection Advance Reporting Capabilities Dashboard views of SPC Trends from anywhere in the World Recall and Return events on Medical Device and Aerospace products can have serious outcomes where the FDA, your customers or other authorities quickly want to understand and root cause failures. These events have caused the industry to create rules around Compliance and Traceability on the Test Data. In many manufacturing environments today, much of the Test Data is still recorded in Paper based processes. Paper based Test Data potentially means inaccurate…continue reading →

Capturing Key Performance Indicators at a Glance

Key Performance Indicators (KPIs) are now an everyday requirement of large organizations. The problem today is that organizations are swimming in product quality test data and to understand their KPIs is a daunting task. Only now, are we seeing companies leverage their massive amounts of available Test Data through visualization software, mining tools and dashboards. Dashboards allow the users to view the information they need to make an effective decision and to take appropriate action. Through active dashboards, businesses can implement an action plan and assign ownership for each KPI, should that KPI…continue reading →

Compliance & Traceability: Problems happen…be prepared for them

Web Based Analytics to quickly root cause issues  Full Traceability of all Test Data on Products  FDA, Aerospace and other Test Data Compliance  Recall and Return events on Medical Device, Aerospace, and other Electronic products can have serious outcomes where the FDA, your customers, or other authorities quickly want to understand and root cause failures of those products. Whether the investigation is done via “paper” or through manual manipulation of spreadsheets with Test Data, the process can be prone to error, tedious and slow. In today’s fast pace environment and customer’s expectations of quick…continue reading →