Root cause analysis is a comprehensive and systematic approach used to explore the relationship between the cause and effect of a problem to figure out what negative events are occurring.
How organizations manage non-conformance once they faced defining the effectiveness of their management systems. Implementing effective corrective action based on root cause analysis is crucial for creating better products compliance, gaining competitive advantage and higher customer satisfaction.
Whether an organization is operating in the Europe market, Asia or in USA, the regulations are quite clear once faced non-conformance, it is crucial to do a thorough investigation which is possible through root cause analysis to find out the problems and to identify key points of failure, finally to determine solutions to address those problems and key points issues.
Management system professionals apply one of the seven basic quality tools called Ishikawa diagrams (fishbone diagrams, cause-and-effect diagrams) to track down the reasons for imperfections, variations, defects, or failures during root cause analysis.
Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa and now famously used by project managers, quality and food safety system experts to identify many possible causes for an effect, non-conformance or problem. An effective and successful root cause analysis involves five major steps to explore the cause and effect of the underlying problem.
1. Define the problem statement
Define a statement of the problem which organization is facing and collect data such as potential impact, actual impact, the focal points etc. and necessary to understand the current situation.
2. Identify the factors that caused the problem
Assemble a team of people directly involved in the execution of the procedure to find out specific problems. Work as a facilitator to keep the team focused on problems with effective countermeasures through fishbone diagram using 6 M techniques or 5 ways diagram.
3. Identify the root cause
Identify at least one root cause, discuss with your teammates, and agree on the countermeasures to prevent a recurrence of the problem
4. Decide the corrective measures
Decide to follow corrective actions carefully to mitigate the initial problem to prevent its recurrence.
The team may need to modify the countermeasures or replace them altogether. It is best to use 5 ways to ensure that you have determined the exact root cause.
5. Review and Evaluate
At the end review and evaluate the effectiveness of the corrective action and if necessary, make amendments for the purpose of improvement
Root cause analysis is a simple and effective tool for discovering the root cause of a problem. It can be used in troubleshooting, problem-solving and overall quality improvements initiatives. It is an ongoing process in which you find out the root cause of a problem and identify countermeasures that will prevent its recurrence.
Written By Sagar Mahmood Khan (Head of QA Compliance Center MCC Global Quality Assurance Management, METRO AG, Germany)