Lessons Learned and Change Management

One of the hallmarks of a quality culture is learning from our past experiences, to eliminate repeat mistakes and to reproduce success. The more times you do an activity, the more you learn, and the better you get (within limits for simple activities).  Knowledge management is an enabler of quality systems, in part, to focus on learning and thus accelerate learning across the organization as a whole, and not just one person or a team.

This is where the” lessons learned” process comes in.  There are a lot of definitions of lessons learned out there, but the definition I keep returning to is that a lessons learned is a change in personal or organizational behavior as a result from learning from experience. Ideally, this is a permanent, institutionalized change, and this is often where our quality systems can really drive continuous improvement.

Lessons learned is activity to lessons identified to updated processes
Lessons Learned

Part of Knowledge Management

The lessons learned process is an application of knowledge management.

Lessons identified is generate, assess, and share.

Updated processes (and documents) is contextualize, apply and update.

Lessons Learned in the Context of Knowledge Management

Identify Lessons Learned

Identifying lessons needs to be done regularly, the closer to actual change management and control activities the better. The formality of this exercise depends on the scale of the change. There are basically a few major forms:

  • After action reviews: held daily (or other regular cycle) for high intensity learning. Tends to be very focused on questions of the day.
  • Retrospective: Held at specific periods (for example project gates or change control status changes. Tends to have a specific focus on a single project.
  • Consistency discussions: Held periodically among a community of practice, such as quality reviewers or multiple site process owners. This form looks holistically at all changes over a period of time (weekly, monthly, quarterly). Very effective when linked to a set of leading and lagging indicators.
  • Incident and events: Deviations happen. Make sure you learn the lessons and implement solutions.

The chosen formality should be based on the level of change. A healthy organization will be utilizing all of these.

Level of ChangeForm of Lesson Learned
TransactionalConsistency discussion
After action (when things go wrong)
OrganizationalRetrospective
After action (weekly, daily as needed)
TransformationalRetrospective
After action (daily)

Successful lessons learned:

  • Are based on solid performance data: Based on facts and the analysis of facts.
  • Look at positive and negative experiences.
  • Refer back to the change management process, objectives of the change, and other success criteria
  • Separate experience from opinion as much as possible. A lesson arises from actual experience and is an objective reflection on the results.
  • Generate distinct lessons from which others can learn and take action. A good action avoids generalities.

In practice there are a lot of similarities between the techniques to facilitate a good lessons learned and a root cause analysis. Start with a good core of questions, starting with the what:

  • What were some of the key issues?
  • What were the success factors?
  • What worked well?
  • What did not work well?
  • What were the challenges and pitfalls?
  • What would you approach differently if you ever did this again?

From these what questions, we can continue to narrow in on the learnings by asking why and how questions. Ask open questions, and utilize all the techniques of root cause analysis here.

Then once you are at (or close) to a defined issue for the learning (a root cause), ask a future-tense question to make it actionable, such as:

  • What would your advice be for someone doing this in the future?
  • What would you do next time?

Press for specifics. if it is not actionable it is not really a learning.

Update the Process

Learning implies memory, and an organization’s memories usually require procedures, job aids and other tools to be updated and created. In short, lessons should evolve your process. This is often the responsibility of the change management process owner. You need to make sure the lesson actually takes hold.

Differences between effectiveness reviews and lesson’s learned

There are three things to answer in every change

  1. Was the change effective – did it meet the intended purposes
  2. Did the change have any unexpected effects
  3. What can we learn from this change for the next change?

Effectiveness reviews are 1 and 2 (based on a risk based approach) while lessons learned is 3. Lessons learned contributes to the health of the system and drives continuous improvements in the how we make changes.

Citations

  • Lesson learned management model for solving incidents. (2017). 2017 12th Iberian Conference on Information Systems and Technologies (CISTI), Information Systems and Technologies (CISTI), 2017 12th Iberian Conference On, 1.
  • Fowlin, J. j & Cennamo, K. (2017). Approaching Knowledge Management Through the Lens of the Knowledge Life Cycle: a Case Study Investigation. TechTrends: Linking Research & Practice to Improve Learning61(1), 55–64. 
  • Michell, V., & McKenzie, J. (2017). Lessons learned: Structuring knowledge codification and abstraction to provide meaningful information for learning. VINE: The Journal of Information & Knowledge Management Systems47(3), 411–428.
  • Milton, N. J. (2010). The Lessons Learned Handbook : Practical Approaches to Learning From Experience. Burlington: Chandos Publishing.
  • Paul R. Carlile. (2004). Transferring, Translating, and Transforming: An Integrative Framework for Managing Knowledge across Boundaries. Organization Science, (5), 555.
  • Secchi, P. (Ed.) (1999). Proceedings of Alerts and Lessons Learned: An Effective way to prevent failures and problems. Technical Report WPP-167. Noordwijk, The Netherlands: ESTEC

Quality and Ethics are Inseparable

There is a strong correlation between quality and ethics. Leadership’s demonstration of their philosophy and practice of ethical behavior impacts the whole organization in education, government or commercial enterprises

Dennis Sergent, The Ethics of Quality. The W. Edwards Deming Institute Blog

Quality is a management methodology, a set of ethics and a grab-bag of technical skills and tools (many of which are not unique to quality).  Dennis Sergent does a good job riffing off of Deming’s Code of Professional Conduct, and in light of my recent post “Being a Quality Leader” I wanted to briefly talk about how leadership is perhaps the most effective lever in producing an ethical organization.

There are three major parts of ethical leadership:

  1. Conscientiousness
  2. Moral identity
  3. Cognitive moral development, meaning how sophisticated one’s thinking is about ethical issues

Ethics and Quality are hand-in-hand. You cannot create a quality product if you do not have an ethical framework. I often think this is a part of Deming’s message that has been lost.

Being a Quality Leader

Domain Knowledge

Having recently said farewell to a leader in our quality organization, I have been reflecting on quality leaders and what makes one great. As I often do, I look to standards, in this case the American Society of Quality (ASQ).

The Certified Manager of Quality/Organizational Excellence (CMQ/OE)leads and champions process improvement initiatives—that can have regional or global focus—in various service and industrial settings. A CMQ/OE facilitates and leads team efforts to establish and monitor customer/supplier relations,supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement.

American Society of Quality

The ASQ’s Certified Manager of Quality/Operation Excellence (CMQ/OE) body of knowledge‘s first section is on leadership. 

To be honest, the current body of knowledge (bok) is a hodge-podge collection of stuff that is sort of related but often misses a real thematic underpinning. The bok (and the exam) could use a healthy dose of structure when laying out the principles of roles and responsibilities, change management, leadership techniques and empowerment.

There are fundamental skills to being a leader:

  • Shape a vision that is exciting and challenging for your team (or division/unit/organization).
  • Translate that vision into a clear strategy about what actions to take, and what not to do.
  • Recruit, develop, and reward a team of great people to carry out the strategy.
  • Focus on measurable results.
  • Foster innovation and learning to sustain your team (or organization) and grow new leaders.
  • Lead yourself — know yourself, improve yourself, and manage the appropriate balance in your own life.

In order to do these things a leader needs to demonstrate skills in communication, critical thinking, problem solving, and skills motivating and leading teams (and self).

The best leaders know a lot about the domain in which they are leading, and part of what makes them successful in a management role is technical competence. A Quality leader needs to know quality as a domain AND the domain of the industry they are within.

Three domains necessary for a quality leader

In my industry it is just not enough to know quality (for now we’ll define that as the ASQ BoK) nor is it enough to know pharmaceuticals (with regulatory being a subdomain). It is not enough just to have leadership skills. It is critical to be able to operate in all three areas. 

To excel as a leader in practice, you also need a lot of expertise in a particular domain. 

As an example, take the skill of thinking critically in order to find the essence of a situation. To do that well, you must have specific, technical expertise. The critical information an engineer needs to design a purification system is different from the knowledge used to understand drug safety, and both of those differ in important ways from what is needed to negotiate a good business deal.

When you begin to look at any of the core skills that leaders have, it quickly becomes clear that domain-specific expertise is bound up in all of them. And the domains of expertise required may also be fairly specific. Even business is not really a single domain. Leadership in pharmaceuticals, transportation, and internet (for example) all require a lot of specific knowledge.

Similarly, with only leadership and technical, you are going to fumble. Quality brings a set of practices necessary for success. A domain filled with analytical and decision making capabilities that cross-over with leadership (critical thinking and problem-solving) but are deepened with that perspective. 

There are also other smaller domains, or flavors of domains. If I was building this model out more seriously I would have an interesting cluster of Health and Safety with Quality (the wider bucket of compliance even). I’m simplifying for this post.

Development of knowledge

To go a step further. These three domains are critical for any quality professional. What changes is the development of wisdom and the widening of scope. This is why tenure is important. People need to be able to settle down and develop the skills they need to be successful in all three domains. 

Good quality leaders recognize all this and look to build their organizations to reflect the growth of technical, quality and leadership domain. 

When things go seriously bad

An owner and four former employees of a now-shuttered Framingham compounding pharmacy were convicted Thursday of federal charges related to a 2012 meningitis outbreak that’s killed more than 100 people who took tainted drugs made at the facility, authorities said.

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

To say that the crimes of the  New England Compounding Center have changed the very regulations for compounding pharmacy in this country is no overstatement. For those of us in other  regulated industries, and for those in quality in other fields, this is an important case to reflect on.

According to prosecutors, pharmacists “knowingly made and sold numerous drugs” in an unsafe manner. “The unsafe manner included, among other things, the pharmacists’ failure to properly sterilize NECC’s drugs, failure to properly test NECC’s drugs for sterility, and failure to wait for test results before sending the drugs to customers. They also approved the use of expired drug ingredients, and the mislabeling of those drugs in order to deceive customers.”

Travis Anderson “5 people convicted of federal charges in Framingham compounding pharmacy case” Boston Globe (2018)

It is important to reflect that we in Quality, that everyone in our industries, has a commitment to the health and well-being of our customers that is nothing less than a moral imperative. That the imperative question for us and our organizations is always “Have I done enough to ensure the best quality and safety.”

There have now been 11 employees or executives of the drug compounding company convicted of ignoring safety precautions and forging documents to allow contaminated drugs to be manufactured and shipped.

Shira Schoenberg “Former compounding center employees convicted in deadly meningitis outbreak ” Boston Business Journal (2018)

Mylan Warning Letter

Mylan’s West Virginia plant received a Warning Letter this month and US FDA Commission Scott Gottlieb tweeted on it, and Mylan recently issued a press release.

I’ve made a few posts on their 483:

Mylan’s issues really need to be viewed as a lens of current regulatory body thinking and not as an issue of a company behind the times. In short, this could be you and if your company is not pouring through these and evaluating your own systems you should be.

The Warning Letter has a few trends we see in this sort of document:

  1. Requiring an independent review. If your system is broke than the agency doesn’t trust you to say its okay. Get an independent consultant.
  2. Lack of quality unit authority. One of the best things my site head of quality ever said (and if he is reading this, take this as a serious compliment) was to a group of high school interns when he said the quality unit is the only part of the Pharma manufacturing organization with duties required by law. That we have a legal duty to our companies and to the patients.
  3. Go to the ICH guidance documents
  4. This is happening at more than one site. Clean it up corporate wide.

The last one is worth further thought:

These repeated failures at multiple sites demonstrate that Mylan’s management oversight and control over the manufacture of drugs is inadequate.Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products you manufacture, consistently conform to FDA requirements.

It is a critical part of your inspection program to be evaluating issues at each and every one of your sites for all your sites. The CAPA program needs to have the ability to assess CAPAs for similar root cause at all sites, that’s part of the preventive, and without it you are truly not addressing all the potential risks in your organization.

In past decades Mylan was a golden-child of cGMPs, and a lot of thought has gone into why the massive backslide. Cases like this, and Toyota, really reaffirm how a quality culture is something that must be constantly maintained and grown, and how easy it is to go backwards.