If you are unable to understand the cause of a problem it is impossible to solve it
Naoto Kan
Now a days pharmaceutical and medical devices industries are getting more number of form-483 from USFDA, due to inadequate investigation of the problems and some time lead to voluntary action(import alert,warning letter) to the manufacturing sites.
“The significant violations included failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications”, the US FDA letter added.
“A structured approach or process of identifying root (that is, original) causes. Many techniques and statistical tools are available for analyzing the data to ultimately determine the root cause.”
Let me just tell you some examples before deep dive in the subject of the Root Cause analysis. If you are suffering from fever and you take a medicine to overcome fever, after having effect of drug in body for some hours its again raised the temperature of body, now its time to think for not only reducing fever but also identify root cause for the same which trigger for diagnosis of real cause so that fever can not happen again. Exactly same thing happen with root cause analysis. ie. it is one kind of diagnosis of your process to identify which factor is creating a fever in the process.
Root cause analysis is a collective term used to describe a wide range of
approaches, tools, and techniques used to uncover causes of problems.
Some of the approaches are geared more toward identifying the true
root causes than others; some are more general problem-solving techniques, while others simply offer support for the core activity of root cause analysis. Some tools are characterized by a structured approach, while others are more creative (and haphazard) in nature. The point is not to learn and apply all these tools, but rather to become acquainted with the root cause analysis toolbox and apply the appropriate technique or tool to address a specific problem.
These groups of tools contribute in their own way to the root cause analysis. Some are best applied sequentially; others can be applied at many different points in the analysis:
1. Problem understanding. Methods that help get to the bottom of
a problem. This phase focuses on understanding the nature of
the problem, and is a first step before starting the analysis. There are different tools are used to collect the information of understanding. Ex. Flowcharts, Critical incidents, Spider chart, Performance Matrix etc.
2. Problem cause brainstorming. Generic tools that can be applied at
different stages in the analysis. Brainstorming can help generate
ideas about possible causes. Since the analysis normally is carried
out in groups, methods that help you arrive at consensus solutions
are also useful. Ex. brainstorming, Brain writing, Is-is not matrix(Kepner Fourie), Nominal group technique, paired comparisons etc.
3. Problem cause data collection. These generic tools and techniques
are used to systematically and efficiently collect data related to a
problem and its probable cause. Ex. Sampling, surveys, Check sheets etc.
4. Problem cause data analysis. Tools used for making the most of
the data collected about the problem. When analyzing the same data
from different angles, different conclusions might emerge. Some
conclusions may not uncover the problem’s causes, so it is important
to have several data analyzing tools available. Ex. Histogram, Pareto chart, Scatter chart, Problem concentration diagram, Relationship diagram, Affinity diagram etc.
5. Root cause identification. The heart of root cause analysis. Root
cause analysis is not one single approach, and neither is this
group of tools. You can use these tools to more deeply analyze
the problem’s root cause(s). Ex. Cause and Efect diagram(Ishikawa diagram), Matrix diagram, Five whys, Fault tree analysis etc.
6. Root cause elimination. Devising solutions that will remove the root
cause and thus eliminate the problem. Ex. Six thinking hats, Theory of inventive problem solving(TRIZ), Systematic inventive thinking etc.
7. Solution implementation. Techniques and advice to aid the change
process of implementing the solution. Ex. Tree diagram, Force field analysis etc.
PROBLEM CAUSE DATA ANALYSIS TOOL SELECTION
Problem cause data analysis is about making the most of all the data collected about the problem. When analyzing the same set of data from different angles, many different conclusions may emerge. Some of these might uncover the problem’s causes, others not; thus it is important to have a number of data analysis tools available. The flow chart is below:
The Logistics of a Root Cause Analysis
As root cause analysis is a collection of many techniques, it is difficult to outline a more detailed procedure than the sequence. As an example, however, the following represents a typical design of a root cause analysis in an organization:
• A small team is formed to conduct the root cause analysis.
• Team members are selected from the business process/area of
the organization that experiences the problem, supplemented by
a line manager with decision authority to implement solutions, an
internal customer from the process with problems, and possibly a
quality improvement expert in the case where the other team
members have little experience with this kind of work.
• The analysis lasts about two months, relatively evenly distributed
between defining and understanding the problem, brainstorming
its possible causes, analyzing causes and effects, and devising a
solution to the problem.
• During this period, the team meets at least weekly, some times
two or three times a week. The meetings are always kept short, at
maximum two hours, and since they are meant to be creative in
nature, the agenda is quite loose.
• One person in the team is assigned the role of making sure the
analysis progresses, or tasks are assigned to various members
of the team.The person is known as facilitator and he plays very crucial role in moving and progress of RCA
• Once the solution has been designed and the decision to implement
has been taken, it can take anywhere from a day to several months
before the change is complete, depending on what is involved in the
implementation process.
In my next blog i will capture some tools related with RCA like Pareto, Kepner & Fourie.
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