Lean Regulation
The views expressed are those of the author and do not necessarily reflect the views of ASPA as an organization.
By Kate McGovern
September 16, 2020
Lean process improvement principles and techniques were developed in manufacturing to maximize value to the customer while eliminating waste. In adapting Lean for the public sector, it is useful to understand a dynamic tension in many governmental processes. Public administrators have a dual responsibility, delivering prompt services while assuring compliance. Lean can be used to improve services without sacrificing standards.
Identifying Customers and Stakeholders
Public sector customers include applicants for building permits, drivers’ licenses, veteran’s benefits and much more. They are people seeking to borrow a library book or report an emergency. Each of us is a customer when we use public services. Government also serves the public at large, enforcing regulations for clean air and water, for safe buildings, bridges, food, pharmaceuticals and much more. We are all stakeholders in the health and safety of our society.
Regulatory Processes
An optimal regulatory process is fair, transparent and efficient. It protects the public without placing undue burden. A sub-optimal process is laden with unreasonable hurdles and delays, commonly known as red tape. Lean techniques can improve the quality and efficiency of such processes.
Assessing the Value of Regulation
Few of us think about health inspections when we eat at a restaurant. We assume that the food is safe. Restaurant owners and the public can agree that regulation has value. Responsible restaurant owners appreciate a level playing field, so they will not be undercut by shoddy operations. However, their appreciation may wane under a cumbersome regulatory process.
The inspection process could be “leaned” using a structured improvement event known as a kaizen. The project team would include staff who work in all sections of the process, as well as a restaurant owner (customer of the process) and a public member (stakeholder in the outcome).
The team would examine the process to understand the purpose of each step and how it serves the public good. Drilling down, they may identify unwarranted impediments such as requirements for notarized documents or redundant reports. Then, the team would redesign the process to grant prompt approval to qualified applicants while assuring the public is protected. As I discussed in a previous column, the team might need administrative or legislative approval for certain reforms. Although change is not always easy, fully implemented Lean initiatives can make regulatory processes more efficient, transparent and customer friendly.
Leaning the COVID 19 Crisis Response
The stakes have never been higher for a regulatory agency than the challenges currently facing the U.S. Food and Drug Administration (FDA). The FDA Commissioner is permitted to grant Emergency Use Authorizations (EUAs) for, “Unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions…when there are no adequate, approved and available alternatives.”
It makes sense to have a fast lane for exigent circumstances when the benefits of a methodical regulatory process are offset by urgent need. No one wants “red tape” to stand in the way of life saving medicines or vaccines, nor do we want our loved ones to be harmed by unsafe treatments.
Since the start of the pandemic, the FDA has come under criticism for being too restrictive on the approval of diagnostic tests, too lenient with antibody tests and hydroxychloroquine and equivocating with convalescent plasma. Political motives are suspected. Public confidence is eroded.
While it is beyond the scope of this article to assess the current state of the EUA process, I suggest that Lean tools be applied to assess the regulatory framework. The purpose is to vet the process itself, not the outcomes. Consider the use of a kaizen rapid improvement event:
- Prepare a charter, identify a Lean facilitator, and schedule a kaizen event (typically five days).
- Convene a team. As with any Lean project, the core team is comprised of the staff who do the work in the process (in this case, the FDA professionals). Outside medical practitioners and academics (subject matter experts who can bring a fresh perspective), medical product providers (the customers applying for approval) and members of the public (stakeholders in the outcome) should also be on the team.
- Develop a common understanding of the criteria for issuing EUAs.
- Map the current state of the process, determining the value of each step. Recommend process redesign that would enhance efficiency, quality, integrity, objectivity and transparency.
- Implement the changes and share the information with the public.
Summary
Applying the kaizen technique to public regulatory processes can find the Goldilocks amount of regulation: not too little, not too much. It can maximize public protection while minimizing red tape. A lean regulatory process can require transparent decisionmaking based on objective criteria. Such a process could earn back public confidence during this historic emergency.
Author: Kate McGovern, MPA, Ph.D. is a Lean trainer who conducts programs and facilitates kaizens for states, municipalities and nonprofits. In addition to her Lean work as a state employee and a consultant for Daniel Penn Associates, Kate teaches at College Unbound. She is the author of A Public Sector Journey to Lean: Fighting Muda in Times of Muri. [email protected]
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Lean Regulation
The views expressed are those of the author and do not necessarily reflect the views of ASPA as an organization.
By Kate McGovern
September 16, 2020
Lean process improvement principles and techniques were developed in manufacturing to maximize value to the customer while eliminating waste. In adapting Lean for the public sector, it is useful to understand a dynamic tension in many governmental processes. Public administrators have a dual responsibility, delivering prompt services while assuring compliance. Lean can be used to improve services without sacrificing standards.
Identifying Customers and Stakeholders
Public sector customers include applicants for building permits, drivers’ licenses, veteran’s benefits and much more. They are people seeking to borrow a library book or report an emergency. Each of us is a customer when we use public services. Government also serves the public at large, enforcing regulations for clean air and water, for safe buildings, bridges, food, pharmaceuticals and much more. We are all stakeholders in the health and safety of our society.
Regulatory Processes
An optimal regulatory process is fair, transparent and efficient. It protects the public without placing undue burden. A sub-optimal process is laden with unreasonable hurdles and delays, commonly known as red tape. Lean techniques can improve the quality and efficiency of such processes.
Assessing the Value of Regulation
Few of us think about health inspections when we eat at a restaurant. We assume that the food is safe. Restaurant owners and the public can agree that regulation has value. Responsible restaurant owners appreciate a level playing field, so they will not be undercut by shoddy operations. However, their appreciation may wane under a cumbersome regulatory process.
The inspection process could be “leaned” using a structured improvement event known as a kaizen. The project team would include staff who work in all sections of the process, as well as a restaurant owner (customer of the process) and a public member (stakeholder in the outcome).
The team would examine the process to understand the purpose of each step and how it serves the public good. Drilling down, they may identify unwarranted impediments such as requirements for notarized documents or redundant reports. Then, the team would redesign the process to grant prompt approval to qualified applicants while assuring the public is protected. As I discussed in a previous column, the team might need administrative or legislative approval for certain reforms. Although change is not always easy, fully implemented Lean initiatives can make regulatory processes more efficient, transparent and customer friendly.
Leaning the COVID 19 Crisis Response
The stakes have never been higher for a regulatory agency than the challenges currently facing the U.S. Food and Drug Administration (FDA). The FDA Commissioner is permitted to grant Emergency Use Authorizations (EUAs) for, “Unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions…when there are no adequate, approved and available alternatives.”
It makes sense to have a fast lane for exigent circumstances when the benefits of a methodical regulatory process are offset by urgent need. No one wants “red tape” to stand in the way of life saving medicines or vaccines, nor do we want our loved ones to be harmed by unsafe treatments.
Since the start of the pandemic, the FDA has come under criticism for being too restrictive on the approval of diagnostic tests, too lenient with antibody tests and hydroxychloroquine and equivocating with convalescent plasma. Political motives are suspected. Public confidence is eroded.
While it is beyond the scope of this article to assess the current state of the EUA process, I suggest that Lean tools be applied to assess the regulatory framework. The purpose is to vet the process itself, not the outcomes. Consider the use of a kaizen rapid improvement event:
Summary
Applying the kaizen technique to public regulatory processes can find the Goldilocks amount of regulation: not too little, not too much. It can maximize public protection while minimizing red tape. A lean regulatory process can require transparent decisionmaking based on objective criteria. Such a process could earn back public confidence during this historic emergency.
Author: Kate McGovern, MPA, Ph.D. is a Lean trainer who conducts programs and facilitates kaizens for states, municipalities and nonprofits. In addition to her Lean work as a state employee and a consultant for Daniel Penn Associates, Kate teaches at College Unbound. She is the author of A Public Sector Journey to Lean: Fighting Muda in Times of Muri. [email protected]
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