Root Cause Analysis (RCA).

Objective: To lay down a procedure for investigation of any discrepancy incidents, complaints, etc) using Root Cause Analysis (RCA).

 Scope: This procedure is applicable for investigation and RCA of (but not limited to):

·         Incidents

·         Market Complaints

·         Out of Trend (OOT)

Which are related to the quality of product and or system observed at ---------------------------

Responsibility: Officer / above of QA: Co-ordination with the investigation team.

Investigation Team: Investigation and Root Cause Analysis of the observed discrepancy. Head QA / Designee: Team Formation, Approval of Investigation Report.

Accountability: Head QA / Designee shall be accountable for the implementation of this SOP.

Procedure:

Whenever a discrepancy occurs, that shall be routed through the respective SOP For example if any incident occurs, then it shall be routed through SOP "Handling of Incident (QA-GN-005)".

After initiation of respective form as per the discrepancy, if the need for thorough the investigation is identified, then the investigation shall be initiated as per the procedure is given below:

Head QA / Designee will formulate a cross-functional investigation team (SMEs of the departments)

The investigation team shall start the investigation using the root cause analysis process.

The Root Cause Analysis Process has the following identifiable steps:

Define the Problem:

Ø  What wrong happened?

Ø  What are the specific symptoms?

 Collect Data:

Ø  What proof we have that the problem exists?

Ø  How long has the problem existed?

Ø  What is the impact of the problem?

Ø  We need to analyze a situation fully before we can move on to look at factors that contributed to the problem. To maximize the effectiveness of RCA, get together everyone - experts and front line staff - who understands the situation. People who are most familiar with the problem can help lead us to a better understanding of the issues.

Identify Possible Causal Factors:

Ø  What sequence of events leads to the problem?

Ø  What conditions allow the problem to occur?

Ø  What other problems surround the occurrence of the central problem?

Ø  During this stage, identify as many causal factors as possible. Following tools can be used to help identify causal factors (but not limited to):

A. Events and Causal Factor Charting

B. Change Analysis

C. Barrier Analysis

D. Ishikawa diagrams

E. 5 Why Method

F. Pareto Analysis

G. Storytelling

H. Fault Tree Analysis

I. Failure Modes and Effect Analysis

Note: Refer Annexure No. QAGNO32/A02 for investigation tools details,

Identify the Root Cause(s):

Why does the causal factor exist?

What is / are the probable reason(s) of the occurred problem?

Impact Assessment of the discrepancy:

What is the impact of the discrepancy?

Is there any impact on the product's safety, efficacy, identity, purity & strength?

Recommend and Implement Solutions:

What can you do prevent the problem from happening again?

How will the solution be implemented?

Who will be responsible for it?

What are the risks of implementing the solution?

Finally based on the recommendations, came out of the investigation, CAPA shall be proposed

The investigation report shall be prepared as per the template (as per Format No. QAGNO32/F01).

The proposed CAPA in the investigation shall be implemented and tracked through the current version of SOP on "Corrective and Preventive Action", numbered "QAGN-024".