Deviation Management - The way forward

In continuation of the Risk driven approach towards dealing with QMS concerns, today I shall be discussing about Deviation Management.  These are one of the areas of interest to the auditors. 

Deviation is a common phenomenon.  In fact Deviations provide us an opportunity to improve by reviewing & enhancing the Controls, if these are investigated in depth and taken with Serious & Holistic approach.  Handling any Deviations with a Global perspective only adds value.

Deviations cost the organizations, stunning losses in terms of productivity, compliance and finance.  In my opinion, average COST OF A DEVIATION should be calculated and shared with the group in the MANAGEMENT REVIEW MEETINGS, so as to make the group understand what the organization has lost due to A DEVIATION. 

Discussing below certain factors, if we consider, we will be able to make Deviation as a strong forte towards growth.

WHY SHOULD WE WAIT FOR A DEVIATION TO OCCUR

I always emphasize that we must understand the INHERENT RISK involved in whatever we do.  Monthly, quarterly, and annual QMS review meetings provide us a very good platform for review of any incidents. 

Historical data is a valuable treasure of information for diagnosis and is the best tool to proactively take care to mitigate the RISK in future.

If we expand the scope of the evaluation of a deviation, beyond its face value, it gives us a good insight not only to :

a.       Understand the number of deviations with similar pattern, (Frequency of deviations)

b.      Understand the derived Root cause analysis

c.       Decide a proper CAPA,

But also provides an opportunity to discuss if;

a.       A deviation happens repeatedly, why is it recurring.

b.      RCA, it requires further investigations

c.       RC was correctly identified, does it require to further strengthen CAPA.

d.      CAPA was correctly identified, then

e.       It was not implemented & monitored effectively to prevent recurrence.

A deviation means a gap in the system or function.  It should draw our immediate attention.   If not addressed timely, it may lead to more such incidents in future, leading to an uncontrolled chain reaction.

A PROACTIVE  RISK based Approach will help us in deriving a Correct RC as well as deriving strong CAPA. 

WHAT WILL HAPPEN IF DEVIATIONS ARE LEFT PENDING & WE PROCEED?

Sometimes, organizations may miss-out on addressing the Deviations ON-LINE.   

If a Deviation is not addressed “On-Line & On-Time”,  we miss the real time facts, which could help us in identifying the exact Root cause & other Risks, which resulted into the Deviations.  The outcome is;

a.       Incorrect Root cause

b.      Poor CAPA

c.       Invitation to recurrence of failures

The historical data collected with Off-line review of deviations, will not add much value for deciding corrective & preventive actions for future. 

MAN IS A SOFT TARGET (HUMAN ERROR)

Commonly said, if we review the Deviation history, and screen the Root Cause Analysis (RCA), then in most of the incidents we observe, ‘HUMAN error’, is the most commonly documented RCA.  The poor man is a SOFT TARGET, probably easy to address through Trainings.

But it leads us to a Big Question?

Looking at recurring human error, sends a BAD signal to the Management & the Auditor.   The doubts come on:

a.       Our people are not adequately trained to operate.  The organization is not Training driven and therefore invites risks resulting into Deviations.

b.      QMS is not strong enough, to in depth investigate a Deviation and find out a PRECISE Root cause hence, CAPA will not be good enough to address the underlying reasons. 

c.       The organization doesn’t have a proper monitoring system to ensure adequate implementation of CAPA and monitor its effectiveness. 

 In my opinion, “Important is to find a correct, underlying root cause and to transform it in terms of practically implementable Action Plan.” 

DEALING WITH THE SITUATION - NOT ABLE TO REACH A ROOT CAUSE

Though, No regulatory standard requires that all investigation should end with the identification of a ‘definitive’ root cause. Finding the true root cause is very important as it surfaces the fundamental reason that allowed the deviation to occur.   It is our accountability to arrive at a concrete and/or a most probable root cause based on available sufficient scientific data.  

Different tools are available for identification of RCA and can be used to identify the RC.  For example, ‘Ishikawa & 5 why analysis’, are very good tools to investigate an incident and arrive a RC.

Majority of the deviations are always linked to a concrete root cause, however, there may be a few situations where we may not reach a root cause at all. 

Few of the reasons for not able to reach the root cause might be;

a.       Not committing adequate time and resources for investigation.

b.      Not able to collect all the facts and relevant details

c.       People are not trained sufficiently to conduct an effective investigation

On the other hand, we might have put our best efforts, still we didn’t succeed to identify a root cause. It will lead to a situation, that a “definitive” root cause could not be established, regardless of availability of detailed investigation report and the investigation remained conclusion less.

It is not the conclusion.  Please follow the next blog to find, how should we conclude a Deviation investigation.