Our last post discussed “Lesson #1: Think like a coach instead of a cop.” This post discusses: “Lesson 2: Spend more time on fire prevention and less time on firefighting … Getting it right up front can prevent you from spending time churning on resolving issues.”

Quality—like fire prevention—is everyone’s responsibility. What happens when only firefighters (or Quality departments) are responsible? They run all over looking for fires, always on alert and in a constant state of crisis. An alternative is to educate people and offer well thought-out education programs (e.g., Fire Prevention Week or reminders about battery replacement in smoke and carbon monoxide detectors) to proactively engage and sensitize people about such dangers and how to avoid them.

At its essence, your Quality system has similar goals (i.e., avoiding danger in a proactive manner) and can succeed through a thorough, thoughtful structure, which includes robust training that supports and engages all employees.

Building a strong quality system includes Good Documentation Practices, Inspection Readiness, Risk Assessment and Training. While quality system structures are complex, designing a robust, thoughtful structure boils down to four questions:

1. Are we “Inspection Ready?”
   Do we know where the gaps are? And are we working to close them? If we know the gaps, can we talk smartly about them and address them with inspectors (i.e., that we have a plan and are in control) in order to demonstrate transparency, accountability?
2. Do we know our risks?
   Do we know which are high, medium or low risks? Have we discussed/prioritized them and put appropriate plans in place?
3. Do we have a robust training program with curriculums and tools to measure comprehension?
   This is one of the most critical steps in taking a “fire prevention” approach and also where Quality can incorporate a couple of recommended steps (i.e., “Think like a teacher rather than a dictator” – our next post will take a more in-depth look at this suggestion).In my experience, a majority of non-compliances stem from poorly structured training programs coupled with a dictatorial approach to maintain compliance with said poorly structured program. I can’t stress enough the return on the investment you will receive by taking the time to thoughtfully construct a robust training program and work together with folks to implement it. I take the approach that “I need to get you trained” rather than saying to people “You need to get trained.” We must do this together; it is a shared responsibility.As an example of the criticality of a well-structured training program and its impact on internal/external compliance, I point to a recent NYT article about Theranos CEO Elizabeth Holmes, who was barred from running a blood-testing lab for two years. The article notes that “federal inspectors found deficiencies in the Newark laboratory that could lead to inaccurate results, including inadequately trained employees and samples stored at the wrong temperature (Also a training issue IMO).” Here is an interesting NPR infographic that gives an overview of the company’s entire rise and fall.
4.  Are we documenting items appropriately (both internally and externally)?
   Do you have systems in place to properly instruct folks in implementing good documentation practices so that decisions, experiments, investigations and processes can be replicated, tracked and understood years later?

By proactively and thoughtfully constructing fundamental building blocks of your Quality systems, you will reap the reward of not expending time and effort needlessly with putting out fires later. Quality must be a strategic corporate initiative involving everyone and built off a solid foundation. It can have a devastating effect on an organization when overlooked or disregarded.

It is important to work together and make Quality a part of everyone’s charter. Challenge your employees to “think like an auditor or an inspector.” Just as with many hands, many eyes can make light work as well.

“Alone we can do so little; together we can do so much.”
– Helen Keller

Up Next:
Lesson 3: Think like a teacher rather than a dictator