How Training Prevents the FDA From Freezing Your NPI Momentum

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Frozen NPI ProcessesThis facility is crude, but it should be adequate to freeze Skywalker for his journey to the Emperor.

―Darth Vader

Vader is of course referring to the class three carbon-freezing chamber located in Cloud City on Bespin. Darth Vader used the carbon-freezing chamber on Cloud City to encase smuggler Han Solo in carbonite. In turn, Solo was then given to Boba Fett to deliver to Jabba the Hutt for a bounty.

The carbon-freezing chamber (aka The Big Freeze) was developed and manufactured by Figg & Associates, a privately held business formed by Ecclessis Figg.

The carbon-freezing chamber was poised for commercial success as the freezing of sentient beings — as needs ranging from transportation to torture — was in high demand; however, the product’s continued quality failures with the gas freezing technology resulted in scrap, rework, brand damage and diminished consumer confidence that was hard to overcome.

For example, Han Solo — upon being released from encasement — suffered from serious hibernation sickness. Solo later sued and ended up settling out of court with the Dark Side; but because Solo was such a vaunted, high-profile hero of the Rebel Alliance, serious brand damage was beginning to mount.

Another blow to the manufacturers of the carbon-freezing chamber was that the Alderaanian Medical Association insisted that Figg put a warning sign on the chambers that inhaling carbon-freezing smoke was a health risk.

“Later I had to put on another warning label that ‘even the simplest of miscalculations as to exceeding one’s period of optimal-hibernated-freeze-time (OHFT) could lead to death,’” said Figg. “Geez, the FDA is making the freezing chamber sound as if it’s as dangerous as smoking cigarettes.”

So, why did this carbon-freezing chamber suffer from a quality failure so bad that “even a simple miscalculation could lead to death”? The answer: poor training management.

Companies must maintain training compliance in both federally regulated and standards-based environments subject to FDA, ISO, SOC, SOX and OSHA. Failure to comply can result in fines, lost revenue and even business closure. For many organizations, managing training records is a secondary focus but it must be done well to avoid compliance gaps.

Without training, audit stresses increase and costly non-compliance warnings or severe penalties — like the one’s Figg’s company received — worsen.

The problem with Figg’s manufacturing team was although they wanted to reduce compliance risk, their reliance on non-automated disparate product design systems made it difficult to do.

“The silo’d systems we were using prevented our regulatory and compliance managers access and traceability for regulated environments subject to FDA, ISO, OSHA, SOX, and SOC,” admits Figg. “Executives could not see which teams were trained on the latest policies, procedures, and work instructions. Lack of visibility into training processes created an unsafe, noncompliant environment that compounded our audit troubles.”

To avoid future compliance risks, Figg turned to Arena Training Management.

Arena Training Management is a cloud-based automated solution ensuring regulatory and corporate compliance, increased effectiveness for training programs, and streamlined training processes.

For Figg’s manufacturing group, Arena Training Management accomplished the following:

  • Simplified audit compliance with easy access and control of training plans, employee records, and training materials in a single system of record.
  • Placed training, document, change control, and quality processes into a centralized system improving visibility, traceability, and efficiency for all cross-functionally.
  • Provided proactive training compliance with automated notifications, scheduled retraining events, and increased training awareness via user-specific dashboards.
  • Simplified audits and paved the way for better outcomes.

Arena Training allowed Figg to create and manage their employee training while connected to the product record and quality processes in a single centralized secure system. This single solution improved visibility, traceability and efficiency ensuring Figg’s freezing chamber met increasingly stringent compliance standards, which resulted in renewed public confidence.

“Now these freeze chambers are selling like ice cream in summer because we have high quality ratings,” said Figg. “People are buying these chambers to freeze everyone, including enemies, back-stabbing co-workers, and bothersome in-laws. It’s a huge market and Arena helped us maximize our business results.”

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About the Author

John Papageorge
John Papageorge has worked at some of the biggest names in the high tech industry, launching products and programs for companies, such as Oracle, HP, Cisco, and Microsoft. John's passion ... Read More 

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