-->

Mar 6, 2014

The Bright Future of Quality and Compliance

By Craig Gygi, Executive Vice President, Operations, MasterControl Inc. 

 Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?
Only three decades ago, all business computing capability resided in the hands of programming and IT specialists. If you needed any computational or data power to perform your business function, you were referred to the computer department. They queued your request and later dispensed the results—a report or an analysis. The methods and tools of their craft remained mysterious to most. Yet their expertise in the arcane enabled the critical functions of business.
But inevitably the professional specialty of computing, and its clientele, matured: the monolithic hardware-software providers started to have to compete with system integrators who offered tailored, commodity-based solutions; the personal computer began to distribute some computing power—formerly contained only in mainframes—to individuals; graphical user interfaces replaced the command prompt and blinking cursor; and application software began to bridge the gulf between the non-expert user and the mysterious computer infrastructure.

This was a tumultuous—and exciting—time. The computing old guard dug in, touting their established architectures and approaches as the only viable way to continue. They’d been successful, hadn’t they? But the business world had moved on. The potential of every professional accessing the computing power and information they needed was liberating and enabling. It unlocked level upon level of effectiveness and efficiency improvement. And in short order, the DECs and Wangs and IBMs faded or adapted under the maturing requirements of business. The classic “1984″ Super Bowl ad from Apple Computer became an icon of this wonderful transformation.



Looking back at how the computer industry matured gives a glimpse of the path ahead for quality and compliance. Rather than continuing to keep all computing expertise within an expert “caste,” businesses began to train their key employees to utilize these emerging computing options. Later, entire staffs gained basic computer capabilities. Throughout all this, the adoption of the personal computer and the development of application software allowed non-experts to do more and more of what before only the experts could do. Interestingly, the specialized experts never disappeared. Instead they were freed to advance projects that tapped their technical potential.
The field of quality and compliance is now heading into similar turbulence and transformations. Still, some quality and compliance traditionalists seem largely unable to escape their scripted role: they warn that variation from the traditional formats or conventions will dilute its effect; the same old wine is poured into new bottles.
But like with what happened with the computer industry, disruption and turbulence will give way to the enduring future of the quality and compliance field—a future where compliance is used to increase the quality and the availability of life-improving and life-saving products, where compliance is a true accelerator of business.


Craig Gygi is a recognized quality industry leader and veteran of continuous improvement. He is a Master Black Belt, a bestselling Lean Six Sigma author, and a master practitioner, teacher, deployer, and developer-integrator of the methods of Lean, Six Sigma, Design for Six Sigma (DFSS), and Business Process Management (BPM). Gygi is responsible for MasterControl’s product development, quality assurance, technical support, information technology, services and product management functions.
Gygi served as the principle consultant and managing director at CKGygi LLC, a firm he founded that specializes in assisting organizations implement Lean and Six Sigma methods, establish and measure critical metrics for key business processes and provide advanced analytical and quality engineering expertise for engineering, design, production and back-office projects and programs. He also served as director of aerospace quality and operational excellence at ES3 and as director of operational excellence at Fiji Water. He was the founder, president and director of software development for TolStack, Inc. With more than 18 years’ experience applying and leading continuous improvement, Gygi is a recognized leader in the quality industry. Gygi received both a Bachelor of Science degree and a Master of Science degree in Mechanical Engineering from BYU. He may be reached at cgygi@mastercontrol.com.







Watch Videos

 Using MasterControl for FDA Compliance (3:53)
 Passing Audits and Inspections with MasterControl (3:08)
 Saving Time with MasterControl (3:29)



Free Downloads

Product Data Sheet: MasterControl Clinical Suite™

Q&A: FDA Medical Device Investigator Offers Insights on Inspection


Related Links