Larry Mager

What do you attribute your success to?

I attribute much of my success to hard work and a willingness to learn through hands-on experience. I believe true growth comes from taking initiative, embracing challenges, and learning from both my successes and mistakes along the way. I developed some content, for a book I am finishing, that I hope you can utilize in the "feature" content...

"He built what command-and-control leadership never has: a structured system for strategic management control, where data sharpens instinct rather than overriding it"

Larry Mager found his thoughts were being inspired by the book Seeing David in the Stone, as he was considering how best to lead a Quality Management organization, over as nine important subsystems of work that he was now accountable for. Michelangelo never claimed to have created David. He said he had simply removed everything that wasn't David. The figure of David was already there, sealed inside a block of marble, waiting for someone with the insight to see it and the discipline to let it emerge.

He'd had witnessed the spectrum between two kinds of leadership styles. Command-and-control leaders had authority, not clarity. They trusted gut instinct so completely they never checked it against reality. Analysis-paralysis leaders had the opposite problem. They drowned every decision in so much outdated data that their instinct was muted, and by the time they were finally ready to act, the answer was obvious to anyone, but the damage was already done. Larry realized that the leadership solution he sought lived somewhere in between.

Larry sought a system for strategic management control, where data sharpened instinct instead of overriding it. Not a system that told people what to think. A system that helps business leaders see clearly enough that the right call becomes obvious, the way a trained eye looks at raw stone and already sees where the figure begins. What he wanted was a way to remove the noise created by the minutiae of day-to-day operations, so what mattered to the business could finally be seen clearly. Larry didn’t realize it at the time, but what he sought was nothing more than to shape the very future of leadership and management control over business operations.

What follows is his journey to accomplish that objective.

Early within his professional career, while employed by a highly-regarded Fortune 500 company, Larry was able to supplement the theoretical knowledge he gained from his mechanical engineering degree, with the practical insight that was provided with a comprehensive “lean-sigma” program, offered to prepare the engineering workforce, in addition to being trained as a Malcomb Baldridge Award Examiner.

Armed with this important knowledge and combined with significant exposure to a wide array of manufacturing operations, an understanding of their manufacturing processes, and the associated technologies, Larry was ready to move forward with a Silicon Valley medical device manufacturer, when he was asked to develop and deliver a device to facilitate robotic minimally invasive cardiovascular bypass surgery. Larry was ultimately awarded as the primary patent holder designation for that device, in addition to a second patent he received for another device that facilitates open-chest, beating-heart surgery. Both of those products were successfully produced through the business operations infrastructure and ‘quality’ management system (QMS) that Larry built from scratch, which successfully passed the Food and Drug Administration’s (FDA) Quality System Requirements (QSR).

The turning point in Larry’s career came when Larry joined another Fortune 500 manufacturer, located in the mid-west, as the Director of Quality... And the leader of a Quality Management organization, with over nine individual subsystems of work, with approximately one hundred thirty people and nine managers.

Soon after joining, the FDA placed this multi-site manufacturing corporation, with approximately twenty-four manufacturing locations, into a corporate level consent decree. This provided Larry with an opportunity to participate in the creation of a single corporate wide QMS that could replace the individual QMS solutions that were deployed across the twenty-four manufacturing locations.

During this FDA driven activity, Larry met a former FDA official, Georgia Layloff, who was credited with the Management Control component of the Quality System Inspection Technique (QSIT). Georgia immediately recognized that the management control concepts that Larry spoke of went well beyond what she and her team had considered for QSIT. Georgia and Larry collaborated further, as friends, and she persuaded Larry to write his first book... The Management Control Quality Plan, later augmented with an updated publication entitled The Quality Journey.

In the decades that followed, Larry pursued opportunities to support companies in resolving their FDA remediation issues, with a desire to focus on establishing improved management control over the ‘quality’ of operations, not just operational compliance to regulatory requirements. He found this was often a losing proposition because business leaders wanted to focus upon the specific FDA investigation findings, the symptoms but not the root cause, just enough to satisfy the FDA and get back to business.

Under QSIT, the Management Controls subsystem was treated as more of a gateway or overview element rather than a subsystem requiring deep sampling. However, QSIT has since been retired. The QSIT era treated Management Controls as a light overview step, and the QMSR era treats management oversight as a core, deeply reviewed area, with previously shielded records like internal audits and management review reports now squarely in scope. That was a game changer! All of the collective insights that Larry had gathered during multiple FDA remediation programs could now be adopted to provide a new era for management control.

Larry now offers a strategic solution for management control, not simply in the form of a new book, but in the form of a comprehensive business operations solution (BOS) that he labeled as The Quantum ‘quality’ Management (QqM) solution. At a summary level, the QqM business operations system (BOS) strategically aligns the external market needs of the business with the internal capability and capacity to profitably satisfy that market need. This is accomplished by:

·     modernizing the operational work of the business, transforming it from a procedural-based system of standard work, into an ecosystem of process workflows that are supported by a detailed dossier of standard work, known as the Quality Management System (QMS).

·     energizing a skilled, trained and competent workforce to execute the process workflows, within appointed roles that they became qualified to execute. The Quality System (QS) consists of the people who execute the processes within the QMS. (people + process)

·     digitizing each process workflow to enable the capture, curation and analysis of operational data, for the provision of “insights” that can be utilized by business leaders, for managing emerging issues and to identify systemic operational constraint. Once established, a QS must be managed. The digitization phase uses AI-enabled technology to “power” the scale of analysis that is required for an extraordinary level of management control over the QS.  

·     optimizing the capability, capacity and costs associated with actually managing the systemic operational constraint of the operational system. This is Quality Management (QM).

What’s the best career advice you’ve ever received?

I was inspired by the book Seeing David in the Stone, as I was considering how best to lead a Quality Management organization, over as nine important subsystems of work that I was now accountable for. Michelangelo never claimed to have created David. He said he had simply removed everything that wasn't David. The figure of David was already there, sealed inside a block of marble, waiting for someone with the insight to see it and the discipline to let it emerge.

This ultimately led me to build what command-and-control leadership never has: a structured system for strategic management control, where data sharpens instinct rather than overriding it

What advice would you give to young men entering your industry?

Never quit learning. Never be afraid to ask questions, because asking is one of the most valuable ways to learn and grow. Stay curious, remain open to new ideas, and remember that there is always something new to discover—no matter how experienced you become.