21st Anniversary

I don’t write much about personal stuff on my blog, but today is my 21st anniversary, so I think it’s appropriate.

I think any good relationship is an exercise in continuous improvement. There are mistakes made, people grow in different ways, things change, and let’s be honest we grow a lot in understanding of the other person. I think that understanding never ever ends.

When you start a relationship, you don’t really know the other person. It is only through time and experiences do you get to know them. And maybe you don’t always like what you get to know. And in my relationship with Jess that’s been the case. And again being honest, it has really been on both sides (maybe a little more towards me).

For me, it has really become a joy in discovering new levels, new details, and new depths to my partner. I love what it means to be in a relationship with a person who is continually growing and continually has new things, and new depths to discover.

So happy Anniversary Jess. I Love you.

Enforcement Actions Take Too Long

There is a strong case to be made that enforcement actions take way too long with the FDA, and as a result our drug and food supply are less safe than they should be.

Take the consent decree from last week with Morton Grove Pharmaceuticals Inc. The Warning Letter was from March 2017 from an Inspection that ended in February 2016. So from inspection to consent decree, it took over five-and-a-half years. No matter where you sit on the regulatory action landscape, I hope you see a problem with that timing.

Thinking of Swiss Cheese: Reason’s Theory of Active and Latent Failures

The Theory of Active and Latent Failures was proposed by James Reason in his book, Human Error. Reason stated accidents within most complex systems, such as health care, are caused by a breakdown or absence of safety barriers across four levels within a system. These levels can best be described as Unsafe Acts, Preconditions for Unsafe Acts, Supervisory Factors, and Organizational Influences. Reason used the term “active failures” to describe factors at the Unsafe Acts level, whereas “latent failures” was used to describe unsafe conditions higher up in the system.

This is represented as the Swiss Cheese model, and has become very popular in root cause analysis and risk management circles and widely applied beyond the safety world.

Swiss Cheese Model

In the Swiss Cheese model, the holes in the cheese depict the failure or absence of barriers within a system. Such occurrences represent failures that threaten the overall integrity of the system. If such failures never occurred within a system (i.e., if the system were perfect), then there would not be any holes in the cheese. We would have a nice Engelberg cheddar.

Not every hole that exists in a system will lead to an error. Sometimes holes may be inconsequential. Other times, holes in the cheese may be detected and corrected before something bad happens. This process of detecting and correcting errors occurs all the time.

The holes in the cheese are dynamic, not static. They open and close over time due to many factors, allowing the system to function appropriately without catastrophe. This is what human factors engineers call “resilience.” A resilient system is one that can adapt and adjust to changes or disturbances.

Holes in the cheese open and close at different rates. The rate at which holes pop up or disappear is determined by the type of failure the hole represents.

  1. Holes that occur at the Unsafe Acts level, and even some at the Preconditions level, represent active failures. Active failures usually occur during the activity of work and are directly linked to the bad outcome. Active failures change during the process of performing, opening, and closing over time as people make errors, catch their errors, and correct them.
  2. Latent failures occur higher up in the system, above the Unsafe Acts level — the Organizational, Supervisory, and Preconditions levels. These failures are referred to as “latent” because when they occur or open, they often go undetected. They can lie “dormant” or “latent” in the system for an extended period of time before they are recognized. Unlike active failures, latent failures do not close or disappear quickly.

Most events (harms) are associated with multiple active and latent failures. Unlike the typical Swiss Cheese diagram above, which shows an arrow flying through one hole at each level of the system, there can be a variety of failures at each level that interact to produce an event. In other words, there can be several failures at the Organizational, Supervisory, Preconditions, and Unsafe Acts levels that all lead to harm. The number of holes in the cheese associated with events are more frequent at the Unsafe Acts and Preconditions levels, but (usually) become fewer as one progresses upward through the Supervisory and Organizational levels.

Given the frequency and dynamic nature of activities, there are more opportunities for holes to open up at the Unsafe and Preconditions levels on a frequent basis and there are often more holes identified at these levels during root cause investigation and risk assessments.

The way the holes in the cheese interact across levels is important:

  • One-to-many mapping of causal factors is when a hole at a higher level (e.g., Preconditions) may result in several holes at a lower level (e.g. Unsafe acts)
  • Many-to-one mapping of causal factors when multiple holes at the higher level (e.g. preconditions) might interact to produce a single hole at the lower level (e.g. Unsafe Acts)

By understand the Swiss Cheese model, and Reason’s wider work in Active and Latent Failures, we can strengthen our approach to problem-solving.

Plus cheese is cool.

Swiss Cheese on a cheese board with knife

Call a Band-Aid a Band-Aid: Corrections and Problem-Solving

A common mistake made in problem-solving, especially within the deviation process, is not giving enough foresight to band-aids. As I discussed in the post “Treating All Investigations the Same” it is important to be able to determine what problems need deep root-cause analysis and which ones should be more catch and release.

For catch and release you usually correct, document, and close. In these cases the problem is inherently small enough and the experience suggesting a possible course of action – the correction – sound enough, that you can proceed without root cause analysis and a solution. If those problems persist, and experience and intuition-drive solutions prove ineffective, then we might decide to engage in structured problem-solving for a more effective solution and outcome.

In the post “When troubleshooting causes trouble” I discussed that lays out the 4Cs: Concern, Cause, Countermeasure, Check Results. It is during the Countermeasure step that we determine what immediate or temporary countermeasures can be taken to reduce or eliminate the problem? Where we apply correction and immediate action.

It helps to agree on what a correction is, especially as it relates to corrective actions. Folks often get confused here. A Correction addresses the problem, it does not get to addressing the cause.

Fixing a tire, rebooting a computer, doing the dishes. These are all corrections.

As I discussed in “Design Problem Solving into the Process” good process design involves thinking of as many problems that could occur, identifying the ways to notice these problems, and having clear escalation paths. For low-risk issues, that is often just fix, record, move on. I talk a lot more about this in the post “Managing Events Systematically.”

A good problem-solving system is built to help people decide when to apply these band-aids, and when to engage in more structured problem-solving. This reliance on situational awareness is key to build into the organization.

Design Problem Solving into the Process

Good processes and systems have ways designed into them to identify when a problem occurs, and ensure it gets the right rigor of problem-solving. A model like Art Smalley’s can be helpful here.

Each and every process should go through the following steps:

  1. Define those problems that should be escalated and those that should not. Everyone working in a process should have the same definition of what is a problem. Often times we end up with a hierarchy of issues that are solved within the process – Level 1 – and those processes that go to a root cause process (deviation/CAPA) – level 2.
  2. Identify the ways to notice a problem. Make the work as visual as possible so it is easier to detect the problem.
  3. Define the escalation method. There should be one clear way to surface a problem. There are many ways to create a signal, but it should be simple, timely, and very clear.

These three elements make up the request for help.

The next two steps make up the response to that request.

  1. Who is the right person to respond? Supervisor? Area management? Process Owner? Quality?
  2. How does the individual respond, and most importantly when? This should be standardized so the other end of that help chain is not wondering whether, when, and in what form that help is going to arrive.

In order for this to work, it is important to identify clear ownership of the problem. There always must be one person clearly accountable, even if only responsible for bits, so they can push the problem forward.

It is easy for problem-solving to stall. So make sure progress is transparent. Knowing what is being worked on, and what is not, is critical.

Prioritization is key. Not every problem needs solving so have a mechanism to ensure the right problems are being solved in the process.

Problem solving within a process