Investigation tools for root cause analysis

In Pharmaceutical Industries generally following investigation tools are used by investigator-

Different Investigation tools:
A-5W and 1-How:

Ask five “W” and one “H” as mentioned below,
1) What?? 
2) Where?? 
3) When? ?
4) Who?? 
5) Why?? 
6) How?? 
Observe the problem first hand, personally (not to rely on the report of other).

Talk to those at the sharp end (counselling).
Explore the contributing visible and invisible factors.
Analyze each factor and conclude probability.

2- Brain storming
This is one of the best Technique i.e. “Brainstorming” may be used to identify the root cause of the problem. The details of Brainstorming are mentioned below-
Brainstorming: One of the creative problem solving method that allows the people to come-up with suggestion / ideas that could solve the problem or help to identify the root cause of the problem.
A meeting with Cross Functional team may be called to brain storm on problem / situation.
Relevant people shall ask to think and share their views / suggest ideas to overcome the problem.
All views and suggestions shall analyse to identify the cause of problem.

3-Third technique “Six-M Framework” (Ishikava diagram) using Fish bone diagram may be used to
identify the root cause of the problem The steps to use “Six M framework” are given below.
Pictorial presentation of fish bone diagram of Root cause analysis includes,
Head of Fish: Problem of Effect
Bones of the Fish: “Six –M” i.e. Major Causes: Man, Machine/Equipment, Material, Method/Process,
Measurement and Environment/Define your problem from the following source:

• Internal: OOS Reports, Self Inspection, Deviations, Trend analysis. 

Root Cause Analysis team should involve those who are most familiar with the processes and systems and include participation of the Department Head, Quality Assurance.
Label each “bone of the fish” The major categories typically utilized are: Man, Machine/Equipment, Material, Method/Process, Measurement and Environment/Mother Nature. The team should identify probable causes, these could be Man,Machine/Equipment, Material,
Method/Process, Measurement and Environment/Mother Nature.Analyze the information and identify the actual or hypothesis. Analysis of data must be objective and logical.