Author Archives: greg

#41 – IMPLEMENTING A SYSTEMS APPROACH TO PHARMACEUTICAL QUALITY SYSTEMS – CHRISTINE PARK

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In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing.  While the FDA hasn’t changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations. Continue reading →

#41 – MOVING FROM INDIVIDUAL CONTRIBUTOR TO LEADER – ELIZABETH LIONS

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Elizabeth Lions PixEvery woman looks forward to the day that she gets the promotion, wears the new suit and takes on a leadership position.

She is told for years in her career that when she finally makes this quantum leap, she will have ‘arrived’.  Oddly enough, corporate America rarely supports nor trains their leaders, but instead promotes with a sink or swim attitude.

Most leaders – male and female – statistically learn on the job.  Only 10% go through a formal leadership training program.  Women however are flocking to leadership courses, seminars and books in droves, seeking information to crack the code.  Women are seeking knowledge and authentic power. Continue reading →

#41 – CYBER SECURITY IS NOW JOB #1 – NIST CYBER SECURITY FRAMEWORK – GREG HUTCHINS

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Thirty years ago Ford Motor Company had a tag line in all its advertising:

Quality is Job #1!

Great tagline.  Now we believe that everyone’s new tagline is:

Cyber Security is Job #1!

Greg Hutchins pixThe US National Institute of Standards and Technology (NIST) has just finalized its much expected cyber security risk management framework.

President Obama directed NIST to develop a risk management   framework to secure infrastructure vital to the US and for that matter’s any country’s critical infrastructure such as banking, electrical power grid, water, and transportation. Continue reading →

The Process Approach of ISO 9001 by T. Dan Nelson

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Two enormous challenges confront the quality management community–and these challenges affect quality consultants, organizational management and quality auditors. There is an urgent need to abolish a mindset pervading the community for decades, one that has reduced quality to its current confused state. Conversely, it is necessary to promote a new mindset that will bring glory to quality management, Deming and Shewhart, and ISO 9001.

“Until those in the quality community unequivocally accept and promote the process approach the value of ISO 9001 will continue to evade organizations hoping to find value in their ISO 9001-certified quality management systems. For those customer-focused quality professionals who understand and promote the process approach, the future is bright. Although the process approach isn’t new, it’s the future of quality management.”