For Pharmaceuticals and Biotechnology

Why the "Band-Aids" Keep Falling Off
by Vivian Bringslimark, President HPIS Consulting, Inc.



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When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Without a lot of fuss, we resolve a messy situation and expect the cut to heal in a few days. Having a box of these adhesive strips on hand allows us to reach for them again and again. The danger in applying a Band-Aid so automatically is that we fail to stop and inspect just how deep the wound really is. Maybe it will just heal on its own, we hope. So why are we surprised when the bleeding starts again after the Band-Aid is removed?

Root cause fixes can be applied a lot like Band-Aids; a quick solution to stop the bleeding and hope the problem solves itself. When the problem returns again or worsens, we realize that our quick fix might have backfired into something more. Peter Senge, author of "The Fifth Discipline Fieldbook," describes this as "Fixes that Backfire." His model depicts a two-cycle process. The cycle begins at the onset of a problem and we quick-fix (put on a Band-Aid) the problem. Solving the problem quickly allows us to get back to the task at hand. Unfortunately, the original problem wasn't solved; but the symptom went away temporarily so we fool ourselves into thinking it's solved. Over time, however, the cycle repeats itself with intensity and becomes a bigger problem than at first glance.

What's the Alternative?

We have to refrain from looking at the symptoms only and work at surfacing the underlying causes. Only then can we begin to apply corrective and preventive actions. Symptoms are easier to see and feel and can easily be confused for the real problem. Begin first by identifying the discrepancy and refrain from rushing to solve it.

A discrepancy means that there is a difference between what was expected and the result. It becomes a deficiency, nonconformity, anomaly, etc. when someone has evaluated the result as unacceptable. In most case, this means departure from the SOP, policy, or CFR regulations. And so begins the root cause analysis quest to find "the why" did it happen. Typically, the analysis begins with a focus on the event and the elements of the "story." We ask the five universal problem-solving questions: who, what, where, when and how. But we need to abstain from asking why at this point and continue uncovering possible causes.

How to Move Away from Events-Only Focus

Ask more questions that:
  • Suggest a pattern; a reoccurring theme?
  • Enable information sharing - "what makes you say that?"
  • Drive a deeper understanding - "what else might be causing this behavior?
  • Delve into unintended consequences - "what would happen if we left it alone?"

The results will provide answers that form the basis of possible causes; not just the first one that comes to mind. Upon a closer look, these answers can be grouped into three levels.

Three Levels of Interaction Influencing Performance


1st Level - Individual Performer: Here we explore the assignment of the task and ask about the effectiveness of the training and whether or not the person(s) were qualified to do the task. If not careful, root cause analysis teams can get stuck here, especially if facts reveal that the person(s) involved were not trained properly. The easy fix is to "Train 'Em." Caution! Recall the "fixes that backfire" model because the easiest way out will often lead back in!

2nd Level - Task/Process: The investigation needs to review the design of the procedures, materials, and facilities to identify weaknesses that can occur up to and including the point of discovery.

3rd Level - Systems: This involves an analysis of how the procedures, policies, initiatives, etc. are being followed and whether Management Review is being conducted properly. This includes the feedback loops and systems performance results. By reviewing the situation from all three levels, your search for the true root cause takes on a deeper focus; one that will be more effective in stopping "the fixes that backfire."

The best corrective actions are the ones that map back to the root cause. By grouping typical performance gaps into clusters, you can do the same with corrective actions. The American Society for Training and Development offers a six-box model for improving performance gaps. Why not use these same categories to draw upon for corrective actions? For example, when there is a lack of confidence to use the skills, provide practice, feedback and mentoring. If the root cause points to task interference and other obstacles, provide corrective actions that improve physical resources and/or processes.

Effectiveness Checks - Did We Solve the Problem for Good?

Certain industries require that the effectiveness check (EC) is developed at the same time as the corrective action (CA). This is a proactive activity that forces the team to be realistic about the corrective action and to plan in advance for how they are going to realistically measure success. Using a performance improvement approach includes gathering a sufficient amount of data that represents the actual performance expectation and include the expected acceptance criteria that represents the actual task. In other words, match the EC to performance expectation and the results will indicate whether the CA was successful.

The Ultimate Success: Management Review and Active Engagement

Senior leaders need to do their part to ensure prevention of reoccurrence as well. The following actions need to be taken:
  • Ensure that procedures are the most effective, reliable and efficient that they can be.
  • Ensure procedures are being followed.
  • Make certain that system performance problems are resolved in a timely manner.
  • Commit to process changes being managed effectively.

So, the next time a problem presents itself, rather than fumbling for the box of Quick-Fix solutions, try moving beyond the event to look at the performer, the task and the systems contributing to the problem to find the true root cause the first time and apply a six-box solution instead.

Vivian Bringslimark has more than 20 years of experience as a field practitioner within the Life Sciences community, serving in various professional and management positions as well as consulting internally and externally on diverse assignments. She currently serves as president of HPIS Consulting Inc., partnering with clients to analyze true root causes of human performance gaps and implementing appropriate solutions that align with stated business outcomes to bring about more long-term and predictable performance, resulting in yearly goal achievement and operational excellence. She worked previously for Parexel Consulting and is frequently sought as a guest speaker for training conferences. Reach Vivian at (203)-270-6519 or vbringslimark@hpisconsutling.com. Visit her website at www.hpisconsulting.com.

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FDA Link

ORA Laboratory Manual, Corrective Action Procedure ORA-LAB 411
http://www.fda.gov/ora/science_ref/lm/Volume_2_ISO_17025_ORA_Laboratory_Procedures/Section_1_-_Management_Requirements(Templates)/ORA-LAB.4.11.html

Additional Article

Bringslimark, Vivian. "Management Engagement: The Key to Quality Systems", BioProcess, April, 2008. http://www.bioprocessintl.com/default.asp?page=article_display&docid=40120082&display=full