Tag Archives: ISO 9001:2015

The U.S. Constitution is a Quality System

In 2008, I defined a quality system as:

your organization’s blueprint: it identifies your business model and processes, provides details about how your people will work together to get things done, and establishes specifications for performance — so you can tell if you’re on track… or not.

https://qualityandinnovation.com/2008/10/18/quality-system/

By this definition, the U.S. Constitution is a quality system — just like ISO 9001, or any system developed using the Baldrige Criteria, or a system for strategy execution based on Hoshin planning and other lean principles. The Constitution defines the blueprint for how power will be distributed (among the three branches of government, and between the country and the states), provides details about how the branches will work together and what principles they will abide by, and establishes clear standards for performance right up front:

We the People of the United States, in Order to form a more perfect Union, establish Justice, insure domestic Tranquility, provide for the common defence, promote the general Welfare, and secure the Blessings of Liberty to ourselves and our Posterity, do ordain and establish this Constitution for the United States of America.

https://constitutionus.com/

(The preamble is the Constitution’s quality policy.)

But even though I’ve been working with (and researching) quality systems since the late 90s, I didn’t see the connection until yesterday, when I read some excerpts from the Don McGahn case. McGahn, who was subpoenaed by the House of Representatives to testify in the Trump impeachment hearings, was instructed by the White House to disobey the order. He asked a court to decide whether or not he should be made to appear. Federal District Court Judge Ketanji Brown Jackson, in a 120-page response, called on the characteristics of the Constitution that make it a quality system to make the determination:

…when a committee of Congress seeks testimony and records by issuing a valid subpoena in the context of a duly authorized investigation, it has the Constitution’s blessing, and ultimately, it is acting not in its own interest, but for the benefit of the People of the United States. If there is fraud or abuse or waste or corruption in the federal government, it is the constitutional duty of Congress to find the facts and, as necessary, take corrective action.

Committee on the Judiciary, U.S. House of Representatives vs. Donald F. McGahn II – Civ. No. 19-cv-2379 (KBJ) – Filed 11/25/2019

This pattern should be really familiar to anyone who’s worked with ISO 9001 or similar quality systems! After your company’s processes and procedures are put in place, and your performance standards are defined (for products as well as processes), you implement a monitoring system to catch any nonconformance that might arise. Then, after root cause analysis, you implement a corrective action to improve the impacted process.

In the U.S., those nonconformances are fraud or abuse or waste or corruption or even injustice that one person (or entity) experiences at the hands of another. You can take up the issue with the courts, which will (in many cases) interpret the laws, implement countermeasures, and potentially lead to larger-scale corrective actions, like new laws.

How can you tell if the quality system defined by the Constitution is working? Evaluate it against the performance standards. Is justice taking place? Is there domestic tranquility, adequate defense, and general welfare? If not, then the structure of the quality system (e.g. the Amendments) should change to better enable the desired outcomes.

Although the system is imperfect, it does — by design — support continuous improvement that incorporates the Voice of the Customer (VoC). This is done through Congressional representation, carefully selected juries of peers, and NGOs that research and advance specific interests.

So the next time you’re wondering whether your ISO 9001 system adds value, ask yourself… does the U.S. Constitution add value? I think you’ll conclude that both can provide a necessary foundation.


The link between quality and structures in the U.S. government was also noted by Tim J. Clark in this 2008 article from the Indianapolis Star, entitled “People working together can make a more perfect union.” He notes that ‘The aim of the American system of government is to enable “We the People” to work together to make progress – not toward a “perfect” union, which would be impossible – but rather toward a “more perfect” union’ and explains how this aligns with Deming’s philosophy.

How the Baldrige Process Can Enrich Any Management System

Another wave of reviewing applications for the Malcolm Baldrige National Quality Award (MBNQA) is complete, and I am exhausted — and completely fulfilled and enriched!

That’s the way this process works. As a National Examiner, you will be frustrated, you may cry, and you may think your team of examiners will never come to consensus on the right words to say to the applicant! But because there is a structured process and a discipline, it always happens, and everyone learns.

I’ve been working with the Baldrige Excellence Framework (BEF) for almost 20 years. In the beginning, I used it as a template. Need to develop a Workforce Management Plan that’s solid, and integrates well with leadership, governance, and operations? There’s a framework for that (Criterion 5). Need to beef up your strategic planning process so you do the right thing and get it done right? There’s a framework for that (Criterion 2).

Need to develop Standard Work in any area of your organization, and don’t know where to start (or, want to make sure you covered all the bases)? There’s a framework for that.

Every year, 300 National Examiners are competitively selected from industry experts and senior leaders who care about performance and improvement, and want to share their expertise with others. The stakes are high… after all, this is the only award of its kind sponsored by the highest levels of government!

Once you become a National Examiner (my first year was 2009), you get to look at the Criteria Questions through a completely different lens. You start to see the rich layers of its structure. You begin to appreciate that this guidebook was carefully and iteratively crafted over three decades, drawing from the experiences of executives and senior leaders across a wide swath of industries, faced with both common and unique challenges.

The benefits to companies that are assessed for the award are clear and actionable, but helping others helps examiners, too. Yes, we put in a lot of volunteer hours on evenings and weekends (56 total, for me, this year) — but I got to go deep with one more organization. I got to see how they think of themselves, how they designed their organization to meet their strategic goals, how they act on that design. Our team of examiners got to discuss the strengths we noticed individually, the gaps that concerned us, and we worked together to come to consensus on the most useful and actionable recommendations for the applicant so they can advance to the next stage of quality maturity.

One of the things I learned this year was how well Baldrige complements other frameworks like ISO 9001 and lean. You may have a solid process in place for managing operations, leading continuous improvement events, and sustaining the improvements. You may have a robust strategic planning process, with clear connections between overall objectives and individual actions.

What Baldrige can add to this, even if you’re already a high performance organization, is:

  • tighten the gaps
  • call out places where standard work should be defined
  • identify new breakthrough opportunities for improvement
  • help everyone in your workforce see and understand the connections between people, processes, and technologies

The whitespace — those connections and seams — are where the greatest opportunities for improvement and innovation are hiding. The Criteria Questions in the Baldrige Excellence Framework (BEF) can help you illuminate them.

Make Strategic Alignment Actionable with Baldrige

It can be difficult to focus on strategy when your organization has to comply with standards and regulations. Tracking and auditing can be tedious! If you’re a medical device manufacturer, you may need to maintain ISO 13485 compliance to participate in the supply chain. At the same time, you’ve got to meet all the requirements of 21 CFR 820. You’ve also got to remember other regulations that govern production and postmarket. (To read more about the challenges, check out Wienholt’s 2016 post.) There’s a lot to keep track of!

But strategy is important. Alignment is even more important! And in my opinion, the easiest way to improve alignment and get “Big Q” quality is to use the Baldrige Excellence Framework. It was developed by the Baldrige Performance Excellence Program, and is administered by NIST.

In Is Good, Good Enough for You? Taking the Next Step After ISO 9001:2015, former Baldrige Program Executive Director Harry Hertz outlines similarities and differences between ISO 9001:2015 and Baldrige. After examining complements, Harry shows how Baldrige helps organizations grow beyond the conformance mindset:

I have not shared all the commonalities of or differences between ISO 9001:2015 and the Baldrige Excellence Framework. Instead, I have tried to show the organizational possibilities of building on conformity assessment to establish a holistic approach for achieving excellence in every dimension of organizational performance today, with a look to the strategic imperatives and opportunities for the future. Baldrige helps an organization take this journey with a focus on process (55% of the scoring rubric) and results (45% of the rubric), recognizing that great processes are only valuable if they yield the complete set of results that lead to organizational sustainability… I encourage organizations that have not gone beyond conformity to take the next step in securing your future.

Read More Here! –>

Risk-Based Thinking: In ISO 9001 and Beyond (Interview)

On August 31, Quality Digest interviewed me on Quality Digest Live in advance of the webinar on Risk-Based Thinking that we held (sponsored by Intelex) on September 6. You can see it here on YouTube (13:42)! I answer the questions:

  • Is risk-based thinking different than enterprise risk management (ERM) or operations risk management (ORM)?
  • Who is risk-based thinking for?
  • Are there good and bad risks? Is opportunity really the “flip side” of risk?
  • Can focusing on risk inhibit innovation?

I’ll also be capturing the information from the webinar in a series of reports later this month that will be available to everyone. Stay tuned!