Is your root cause investigation pointing in the right direction?

We have all been there.  A deviation occurs, we initiate the process of documenting it, start the investigation of the root cause while time passes and the pressure increases to close it and communicate the resulting corrective actions to the customer (internal or external). And  we end identifying the cause of the issue to a “human error”…

How many times have you looked into a deviation root cause and concluded that it is about a person not performing the task properly? How many times in the last year have you concluded that the corrective action will be a refresh of training?

You never did? Congratulations¡¡ you are entitled to the award of the year¡¡ However, if that is not the case, then I think you are with me. Sorry, not award coming our way, yet.

Seriously, refresh of training as corrective action is probably the most used wildcard.  As it is defining the root cause as a “human error”.  I would ask you Who is the human that originated the problem? The one that ultimately is at the end of the process performing a task that was the source of the deviation? Or the One that wrote the procedure, that one that as clearly room for improvement and could be streamlined to facilitate understanding and execution of the activity? The Human designing the records that need to be produced and kept, that are not self explanatory? The Human that provides the training on the activity? Too boring to keep attention and understood as a checking box task… The supervisor that did not follow up on the understanding and execution of the task? The human that did not reviewed the trends of KPI results previously obtained (if they exist) that were crying out loud that storm was coming? The human that did not rigorously evaluate the workload associated to the task/process/associate?…

I might continue, but I will let you fill in the dots.

With that simple conclusion “human error” we are stating that the process is perfect and cannot be improved.  How do you feel about that? Is the process that good? Did you care to ask the person behind the task how does she/he think the process could be improved?

One of the strongest principles of GxP is “keep the system under control”.  That obviously does not mean that mistakes, accidents or generally speaking “problems” do not occur (otherwise Quality events).  It means that we know them and strive to eliminate the source, pushing company Quality Management System (QMS) towards continuous improvement.  It means that we look back after some time and review if our decisions when dealing with those root causes were accurate or if we need to revisit our actions.  It means that associates are aware of the importance of knowing process weaknesses and acting upon them.  However, stating that human error is the source of our problem is as admitting that the process is not under control.  Why is that? Because there is really few we can do to avoid a true human error, and under that circumstances our process is as helpless as a little boat in a storm. We are not keeping it under control, external forces are pushing it up and down. Is that the image you have of your processes? I truly hope you do not.

One of the strongest principles of GxP is “keep the system under control”.  That obviously does not mean that mistakes, accidents or generally speaking “problems” do not occur (otherwise Quality events).  It means that we know them and strive to eliminate the source, pushing company Quality Management System (QMS) towards continuous improvement.  It means that we look back after some time and review if our decisions when dealing with those root causes were accurate or if we need to revisit our actions.  It means that associates are aware of the importance of knowing process weaknesses and acting upon them.

However, stating that human error is the source of our problem is as admitting that the process is not under control.  Why is that? Because there is really few we can do to avoid a true human error, and under that circumstances our process is as aimless as a ship in a storm. We are not keeping it under control, external forces are pushing it up and down. Is that the image you have of your processes? I truly hope you do not.

So, to make the long story short, next time you initiate a root cause investigation, please keep in mind which the objective must be.  Fulfil a deadline established by a procedure and have something written to check the box, whatever cost? Or improve the process?

Courtesy of Brian Kingston in Pixabay

Tough decision? Then revisit the procedure, and make sure that it is really aligned with risk management principles and continuous improvement based-thinking.

And, yes, still customer may not be immediately satisfied with the deadline. However she/he is likely to be more satisfied with the outcome, provided the process is being ultimately improved.

Do you want to hear more ideas to help you keep improving your QMS? Revisit our web page and subscribe to our news. Take care¡

Carmen Martínez