Umang Shah

Cause(s) are the conditions that create the failure mode or problem. Based on the identified causes, there could be one or more potential causes identified for the problem/failure mode. These potential causes can be identified by various techniques such as Cause and effect diagram (Ishikawa technique). Further these can be narrowed down by 5 Why's, VA/NVA analysis to get the most probable cause(s) responsible for the problem/failure mode. These probable causes are the root causes which can be rectified and controlled so as to avoid the problem reoccurrence. For eg. For a batch of tablets not passing the specifications of physical dimensions such as thickness at the Q.C. lab. The various causes could be 1. Men- Not operating the process at defined parameters in the batch records. 2. Machine- Some instrument malfunctioning 3. Methods- Using a wrong method for analysis 4. Material- a different grade of material/ different vendor used 5. Measure- different measurement technique 6. Miscellaneous- other factors such as mixture from other product or any environment deviations. Based on the current quality systems at manufacturing location, it was identified that men( human error) is the most probable cause for the occurrence of the problem. Now the team has to work upon how to correct the root cause and provide a corrective and preventive action so that the chances of occurrence of such type of root cause never happen again.