7.23.2018

Quality Management Systems and Medical Device Manufacturers

Many manufacturers have established quality management systems in their organizations, but an impressive new book geared specifically to medical-device companies entitled Excellence Beyond Compliance: Establishing a Medical Device Quality System and authored by William I. White was published this past June.

This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. I recently spoke with William I. White and had a chance to ask him a few questions. Here are those questions with William's complete answers: 


What are the common obstacles medical device manufacturers face when developing a quality management system (QMS)?

It is an unfortunate truth that the QMS itself may provide obstacles between the employee who wants to do the right thing and the ultimate goal of effective compliance. Ironically, one of the most common sources of obstacles is excessive zeal in compliance. Sometimes this happens through a succession of audits.  Each audit may identify nonconformities.The nonconformities may lead to new procedures, but don’t always lead to revision or elimination of the old procedures, and then procedures are in place that may be inconsistent.  Some companies make it easier to create new procedures than to revise old procedures; this leads readily to a profusion of inconsistent requirements. In addition, a company finds itself with serious compliance problems and then brings in experts to ensure that it has procedures covering all aspects of compliance. In this situation, the primary motivation of the experts (understandably) is to ensure that compliance issues are fully addressed in the resulting procedures.  If the company is not a full partner in preparing these procedures and simply accepts blindly what the experts dictate, the result can be procedures so complex that they confuse employees more than they help them. In short, if not managed well, the complexity that is to some degree required by worldwide regulatory requirements can lead to confusion among employees who are struggling to do their best with an overpowering workload.


How can they overcome these problems?

The actions of people are ultimately what decide whether a quality system accomplishes its goals, and those actions depend upon documentation that is understandable and straightforward. People want to do the right thing, but if they have to struggle to figure out what they are supposed to do, they will lose patience and do whatever seems sensible (which may or may not correspond with the documentation). The most critical aspect is that employees must be able to determine readily those procedures that are applicable to their work. A well-planned documentation system can make this possible.

What do those who work for medical-device manufacturers think of William's perspective? How has your QMS been affected by compliance issues?  

6.25.2018

Lean System Management -- Can Structured Systems Unify and Align Quality Practices Throughout an Organization?

It has been argued that that the proven practices of performance excellence and quality cannot be sustained over the long term. A new book by Richard E. Mallory entitled Lean System Management for Leaders: A New Performance Management Toolset postulates that the reason for this failure is that there is no cohesive guidance on the management of groups of people working together toward specific goals. The author believes we currently have only a patchwork of two very specific knowledge areas -- one for process management and one for project management. I asked Richard a series of questions about how his book seeks to rectify this situation. I'm including those along with Richard's very interesting answers here:

Why do you believe that system management is new to management?
System management shows how to create and define a best practice ‘map’ for any or all management systems, and how to identify and define its influencing factors of success.  This allows manager to create an operational best practice map with measurable metrics and indicators of success.  Once that is done, the model itself provides a foundation of a perfect ‘learning organization’ that can review and improve on its practices over each performance cycle.  There is nothing in existing management practice that shows how to provide this kind of structure, evaluation, and learning for the management structure overall. 

Why do you call it a “fundamental” body of knowledge for all managers?
Much of current management literature is focused only on one-to-one interactions with individuals--“supervision“-- or generic group practices like “motivation”, “goal-setting”, “employee engagement”, or “encouraging the heart.”   Another approach puts its focus on generic organizational frameworks that provide a cookbook of advisory or prescriptive tactics under headings like “Baldrige”, “ISO”, or “The House of Lean."   It is a great omission of current management knowledge that there is firm structure for defining, analyzing, standardizing, or implementing best practices for the specific practice areas of individual managers – either for a program office or for specific management functions like governance, strategic planning, budgeting, quality control, and project management.

Isn’t systems management mentioned in a lot of management books?
Yes, many books use the plural word ‘systems’ with the same meaning as an organizational environment.  One business book says that “systems thinking is more of a concept than a tool,” and describes the system as ALL the factors that surround a process.  Another calls systems “a set of inter-related processes.”  Either definition will blind managers to the possibility of documenting and improving a SINGLE area of management practice with specific goals – the real definition of a system.  When systems are looked at one at a time, it is possible to define and map their primary activities and success factors, and this kind of documentation of systems redefines management. 

What is the difference between a process and a system?
A business process uses a specific set of sequential steps, each of which can be defined, to produce a specific output with a definable set of output requirements.  A process is often completed by a designated work team, and is designed to be done the same way with the same sequential steps time after time.  A system is more easily seen as a project, in that it produces a valuable output but will have a production cycle that may not be rigidly sequential, that is more changeable because of intervening factors in each cycle, and that may produce a number of outputs all of which cannot be defined in advance.  A system is less likely to follow a single predictable path and may have to obtain its result using personnel that are not a designated work team. 

Given all those differences, what makes you think that a system can be mapped?
All human knowledge is based on science, which itself is based on observation of repetitive cycles and learning about the factors that drive success in any given cycle.  If you start with the premise that each management system is cyclical and has quantifiable goals, then we can define and predict the principal activity groups (or milestones) that are necessary to achieve those goals. We can also then define the measurable attributes of success in each group.  Using cause and effect analysis, we can further break down the influencing factors (or “causes”) of success, and the metrics or indicators that can be seen when those practices are followed.  Even though the operational best practices of system are not sequential with specific assignable steps, the system map does provide a documented operational plan that can be evaluated and improved.
 
Can you explain the concepts of “native systems” and “design systems” that you refer to in your book?
Often times groups of people develop a habit, understanding, or “culture” about the way things are done around here, and this is the native system.  Like standing in line at the grocery store, people make things work based on assumptions of what is considered fair or right.  The same is true in larger organizations, so the way that we operate a program office, develop a budget, or decide on projects is often a combination of guess work and detective work.  The idea of design system is a deliberate decision of a leadership structure that for critical management outputs, there should be a focused effort to define how it will work best, to let everyone know about that operational plan, to evaluate its operation at the end of each cycle, and to innovate and improve based on learning.  This mirrors the practices recommended by the Framework for performance excellence of the National Quality Award that management systems should have a documented approach and deployment combined with periodic learning and innovation. 

The book title mentions Lean.  Does that mean if follows established process improvement methodology?
System management shows leaders how to achieve superior leadership results by applying a Lean DMAIC (Define, Measure, Analyze, Improve, and Control) structure to leadership systems and program office operations.  It shows leaders how to align and evaluate these systems using a Lean approach, and how to evaluate and score the maturity of management practices through the American Society for Quality System Management Standard (http://asq.org/gov).  It offers analytic skills to eliminate duplication and waste of executive and senior management time, and reduce the wait time and non-value add in dependent processes.

Explain how lean system management provides an agile framework for organizational change.
Lean system management presents a structured framework for defining and controlling organizations, along with a system maturity standard that allows regular measurement of the maturity and capability of defined management systems.  In this way it provides an agile framework for the organization-wide practice of quality (which we will refer to as “Performance Excellence”), and enables the use of a system maturity scorecard, showing the capability and maturity of quality management function throughout the organization.  It also allows and enables an organization-wide scorecard on the practice of quality at the process level, through use of the Process Management Standard (See Measuring Maturity, Quality Progress, Sept. 2016 --
http://asq.org/quality-progress/2016/09/process-capability/measuring-maturity.html).

What do you think of Richard's view of system management? Do you agree with his views on why performance excellence is currently not sustained by many organizations?

5.21.2018

What Is the "Toyota Template"?


Lean implementations, operational excellence initiatives, and even specifically, the Toyota Production System (TPS) are often misconstrued as simply a methodology focused on the formulaic implementation of tools. In a recent book entitled The Toyota Template: The Plan for Just-In-Time and Culture Change Beyond Lean Tools, the author -- Phil Ledbetter -- posits that the building of TPS, with the goal to eliminate waste, evolved as problems were encountered and solutions put in place and a wonderful byproduct of it was the growth of a problem-solving culture throughout Toyota that is unique in the business world. I spoke with Phil this month and asked him: “What is the Toyota template and how does it help sustain a Lean implementation?” Here is his response:

The Toyota template is about the relevance of the Toyota Production System to any type of business today. It succinctly identifies the key elements, places them in a logical, sequential or of implementation, and explains how each contributed to the formation of the Toyota culture. It's a blueprint for any business interested in a true lean transformation. The gold standard is Toyota and my book, The Toyota Template, demonstrates how businesses can use the "template" to arrive at a truly Lean, just-in-time production system.

Specifically, The Toyota Template explains the critically important elements of the Toyota Production System, analyzes the sequence of implementation as the system developed, and places these elements in a logical order of implementation based on the history and current knowledge. In addition, it addresses the effect of each element on the culture and some of the reasons for Lean implementation failures, including the problem with the value stream mapping.

Fujio Cho, Ohno protege' and former Chairman of Toyota Motor Corporation, has said, "Many good companies have respect for individuals, and practice kaizen and other TPS tools.... But what is important is having all the elements together as a system. It must be practiced every day in a very consistent manner, not in spurts." The Toyota Template shows exactly how to develop this system. 

What do you feel are the major hindrances to a successful and long-term Lean implementation? 

4.24.2018

Can Quality Standards Improve the Efficiency and Effectiveness of Government Operations?

Conventional wisdom says that government is not efficient and not effective – but, we are still unsure what works and what is broken in government, where to find some common sense, and where to start to fix it. So, with that in mind, I'm glad I had the chance to speak with Richard E. Mallory this month about his recently published book, Quality Standards for Highly Effective Government, Second Edition. I asked him a series of questions, and I'm including those along with Richard's very interesting answers here.

What are Quality Standards?
They are professional standards developed and endorsed by the American Society for Quality Government Division as international best practice standards for government. There are three standards that collectively apply to every area of government operations, and provide a framework for excellence. There is a standard for process management, system management (including project management), and for aligned leadership objectives. One or more of these standards align with the responsibility of every supervisor, manager, and executive in every government agency. Each provides a measurable standard, with uniform and objective criteria, that evaluate the design and application of best practice operational practices. The systematic use of quality standards provides the first-ever opportunity for an organizational scorecard, that measures the extent of quality practice in government. 


Why are these standards necessary for highly effective government?
The development of high-performing learning organizations depends on defining and testing a best practice operational structure that is specific to every one of its branches, divisions, and operating units. This can’t easily be done with existing frameworks, which depend on top-down application of uniform organizational practices, such as ISO 9001 or Baldrige. The application of Quality Standards is from the bottom to the top, and requires every supervisor and manager to develop a process map or a system map that defines the critical steps or milestones of value creation within that program area. It applies a cycle of learning that is based on a defined approach and deployment, combined with periodic evaluation and update or improvement. The development of indicators and measures of success cements the practices of learning and improvement. The application of system management at the executive level ensures organizational alignment.

Can’t we do the same thing with organization-wide deployment of Lean Six Sigma? 
No. The problem with most traditional Lean Six Sigma and DMAIC improvement efforts is that they are not sustainable over the long term, and require a continual “push” from leadership. Because their success requires each practitioner to dedicate current effort for longer-term gain, busy organizations often curtail these best practices to resolve short-term crises. If executive recognition ever wavers, or if leadership changes, the commitment to best practice operation also disappears. The use of Quality Standards changes this dynamic, by allowing executives to create a report on the existence and use of quality practices in their organization, so that executives are at last able to “see” where individual managers are maintaining best practice, and where efforts are lapsing. It will also allow organizations to create external reviews, and audit organizations to report on the continuing commitment to quality practices within every government organization. This reporting ensures that Lean and DMAIC practices are established, maintained, and sustained. No longer will the practice of quality be "invisible."

How do we know they work?
Quality Standards have been endorsed by the Government Division of the American Society for Quality as an international best practice standard for Government. A recent white paper of the National Academy of Public Administration on Strengthening Organizational Performance in Government has also endorsed the standards. The Process Management Standard is a part of the Process Management Handbook for the NASA Marshall Space Flight Center, and numerous government jurisdictions have found them to be a tool for organizational capacity reviews, both to evaluate current efforts and to offer further suggestions on the means and methods of improvement.

How can we get started?
This book provides the logic and approach behind the standards, and introduces each with its evaluation criteria, and the scoring plan. It is important and foundational, for those who will be using the standards, for those reviewing them, and for leadership who want to understand the benefits and the logic being followed. Each organization using the standards should plan to provide introductory training for all its managers and supervisors, to help them in identifying the key processes and systems that drive organizational results, and to help them define best operational practices for each. The effort should then transition to periodic review of each defined process and system, both to ensure the integrity of the approach, and to evaluate the next steps to its improvement.

What are the changes in the second edition book?
The second edition includes the newest revision to the system management standard, which applies to the work of executive managers, program office managers, and project managers. It completes the organizational framework by challenging those managers to define milestones of value creation relative to the work of their office, with the causes of success in each milestone. In addition, it allows the development of operational metrics and indicators. It is through the integrated definition of key processes and systems that an entire agile framework can be completed. The second edition looks ahead to the role of leadership in developing excellent performance through application of the Aligned Leadership Objectives Standard. 

Do any readers currently work in the public sector? What do you think of Richard's thoughts?  Have you adopted these quality standards in your organization?

3.22.2018

When 45 Business Gurus Share Their Most Important Insights

Last month, a very interesting book entitled The GuruBook: Insights from 45 Pioneering Entrepreneurs and Leaders on Business Strategy and Innovation, compiled by Jonathan Løw, was published. In it, 45 of the world’s leading entrepreneurs and leaders -- such as Salim Ismail (Singularity University), Naveen Jain (Moon Express), Jimmy Maymann (Huffington Post), Otto Scharmer (Theory U), and Blake Mycoskie (TOMS) -- plainly discuss their ideas about innovation, entrepreneurship, and authentic leadership.


I had the chance to speak with Jonathan Løw about this book, and one of the main questions I asked was: "What inspired you to compile the thoughts of these particular entrepreneurs, innovators, and leaders?" Here is his complete response:  

The GuruBook is first and foremost about listening. Although I have been a serial entrepreneur and have tried to start a number of businesses, have worked with innovation in both large and small organizations, and have been a leader in several organizations, I do not imagine in any way that I have all the answers in these exciting but also complex areas.



I believe that the ability to listen is one of the most important characteristics for future entrepreneurs, innovators, and leaders. This ability to listen, and the curiosity that is inherent in it, may be the factor that gives you an advantage over the competition. Consider, for example, the English mathematician and physicist Isaac Newton, who, like millions of others, saw an apple fall from a tree. The difference was that Newton asked "why."



As a result of my own curiosity and desire to listen more, it was obvious that I should invite the people who, in my eyes, have generated inspiring and pioneering ideas, organizations, and results, to share their thoughts and knowledge with the readers in The GuruBook.



This book’s gurus have been asked to talk/write about what they’re enthusiastic about. That means that you can look forward to becoming more knowledgeable about:



• How to start a business without an idea.



• Why some ideas succeed while others fail.



• How to demystify the task of scaling up a startup as an entrepreneur.



• How you can be enterprising, no matter what phase your organization is in.



• How to create an innovative culture.



• Why simple questions lead to the greatest innovations.



Why businesses and local authorities aren't startups, and what both can learn from each other.



• How to become authentic as a leader.



• Why authentic leadership is a strength.



• Why there’s an entrepreneur in every successful leader.



• Why the ability to listen is all-important whether you’re an entrepreneur or a leader.



The contents of The GuruBook have weight and value because the articles and/or interviews are with people who, for years, have perfected their ability to listen and have consistently become better at understanding their customers, partners, and colleagues.



Through thousands of meetings, sales calls, customer service responses, innovation processes, brainstorms, mail dialogues, LinkedIn discussions, and so on, they have listened and then acted on what they heard. These are the insights that The GuruBook contains.



I fundamentally believe the future belongs to the curious. The future belongs to the entrepreneurs, innovators, leaders, and passionate souls who are not only capable of “listening more intently” to the world about them, but who are capable of “ listening more intently” to the world about them but who also have the ability to act on the input they get.



A website for the book -- https://www.thegurubook.org/ -- includes a list of the gurus participating as well as some more background on the book.