Do You Know How to do investigation of Human Error for finding the Root cause of deviations

 

In case of OOS/OOT/Deviation/Market complaint/Lab incidence and any other non-compliance, the investigation concludes Human error as a root cause, further investigation of Human error shall be carried out.

 

Upon identifying the root cause for above mentioned quality indicators, respective department shall request QA to issue the Human Error Analysis Tool (HEAT) (Annexure. I)

 

Human Error Analysis shall be conducted by respective Investigation Owner of the incident by interviewing the identified employee.

 

In case of multiple people to be investigated separate Annexure shall be used and comprehensive summary of this investigation shall be included in Investigation report of OOS/OOT/Deviation/Market complaint/Lab incidence (Whichever is applicable).

 

There are two types of Human error

1) Intentional:  Intentional human error is when an employee purposefully and knowingly takes an inappropriate action or response. This can be called intentional, misconduct or falsification. Behavioral gap comes under internal human error.

 

1a) Behavioral Gap: It's a function of the environment and the behavior repertory of individuals.

 

2) Un-intentional: Un-intentional human error can result from incorrect decision, an incorrect action or both, therefore human error is broken down into following sub-categories

2a) Learning Gap: Learning gap or knowledge gap is to assess whether employee has proper learning or knowledge to perform the task. Whether is not trained on the concerned topic or whether the employee handling task first time.

2b) Application Gap: Application gap as difference between knowledge acquired and related activity execution emphasizing person has knowledge but applied incorrectly.

 

2c) Attention Gap: A condition in which lack of attention or does not remember/Oversight/ Multitasking for task/performance/documentation even after having knowledge

 

2d) Decision Gap: Decision gap is observed when wrong decision taken in a given situation provided has knowledge about process and system.

 

2e) Procedure Gap: Procedure gap can occur due to inadequate/unclear procedures or due to incomplete procedures.

Based on this investigation conclusion shall be made and such conclusion shall also be reflected into the parent investigation (For OOS/OOT/Deviation/Market Complaint/Lab incidence).