Use test data to improve compliance and traceability

Harsh Wanigaratne- February 14, 2013

When something goes wrong in today’s marketplace of mission critical electronic devices and products, there can be serious repercussions. Consider these three cases:


July 2012: India suffered the largest electrical blackout in history, affecting an area encompassing about 670 million people, roughly 10 percent of the world’s population. Three of the country’s interconnected northern power grids collapsed for several hours, as blackouts extended almost 2,000 miles, from India’s eastern border with Myanmar to its western border with Pakistan. India’s government found itself on the defensive, as they could not definitively explain what had caused the grid failure or why it had happened on consecutive days.


June 2009: The France Airbus that crashed into the Atlantic Ocean was the highest death toll of any aviation accident involving that aircraft type.  The reason for the fatal crash was unknown, until finally the black box was located and recovered from the ocean floor in May 2011, nearly two years after the accident.  The final report was released that the accident resulted from a succession of events including electrical malfunctions that destabilized the flight path and led to a stall.

Of all medical devices, those related to cardiac devices have the biggest problems when it comes to recalls.   From a recent report issued by the US Government Accountability Office (GAO) in June 2011, the FDA “could take a more proactive approach to its oversight and dig into their plethora of data available on thousands of recalls, but presently are not effectively reviewing and analyzing the data in a systematic manner. More routine analyses of the data could help the FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”

 
Failures of products in these industries can cause serious human harm and disruption, making compliance and traceability very important. “Compliance” is the sense of rules that regulate the quality of the product that is delivered to the market and “traceability” allows failures to be investigated and preventive steps taken.

Compliance Trends
From 2000 to 2010, there have been a series of very disruptive economic, political, technical, and social shocks:   
•    In 2001 Enron went bankrupt in the largest scandal to date on accounting fraud.
•    In 2001 and 2008, there were a series of financial shocks that sent multiple economies around the world into recession.  
•    In 2001, the terrorist attack on the US caused years of wars in Iraq and Afghanistan
•    The internet company Facebook was founded in 2004 and in a short 8 years has over 900 million members, which makes equivalent to the 3rd largest country on the planet
•    In 2010, Google threatened to leave China over censorship issues. (Who would have thought an internet company would be shaping policy in China?)

With such a decade of rapid change, the natural inclinations of most governments are to impose regulations to ensure the situation does not get out of control. These regulations can solve some problems but can create costs around compliance to these regulations. With the backdrop of these world events, mission-critical industries are now getting caught up in a regulatory and compliance constriction.

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