Gaps and non-conformances exist in all management system. Businesses are continually managing non-conformance and improving the business process to reduce and eliminate non-conformances. All ISO Management system standards require the organisation to develop, implement and maintain and process to manage nonconformity and take appropriate corrective action.
So what is a non-conformance?
According to ISO 9001:2015 – Quality Management System, non-conformance occurs when something does not meet the specification or requirement of a process, system, internal policies & procedures, customer requirements and regulatory body. Non-conformance can be found in service, product, process, supplier, or in the management system.
In the event of nonconformity, the business shall take action to eliminate non-conformity and prevent its recurrence. To do this, the organisation to identify the root cause of the issue/problem/error/nonconformity.
In the alternative medical world, practitioners often say ‘Treat the cause, not the symptom’. However, in the business world, you need to both treat the symptom and the cause. When a nonconformance is identified, senior management should investigate the nonconformance and identify the underlying root cause. Identifying and treating the root cause eliminates the recurrence of the same nonconformance. It is a requirement of the standard to maintain documented information on the root-causes identified.
There are two different methodologies to identify potential root-cause few of them are listed below:
5 Why Methodology
5 Why is an iterative probing technique that used to explore the cause-and-effect of the nonconformance. This method poses a question ‘Why’ five times to each answer obtained to the previous question. The key steps to conduct root-cause analysis using this method are
- Write down the specific nonconformance (include description, facts and sufficient details to analyse the problem)
- Ask ‘Why’ the problem has occurred and write the response
- If the response did not provide sufficient information about the underlying cause, then ask ‘Why’ to the response given
- Continue this by asking up to 5 ‘Whys’ until the root-cause is identified. Note: in some cases, you will identify the root-cause sooner that asking 5 Whys.
5 Why technique is a powerful and simple root cause analysis tools that all businesses can implement as part of the nonconformance management system.
Example of root cause analysis using 5 Why method:
Problem: Customer compliant about food
- 1 Why: Because the food was uncooked
- 2 Why: Because the food was not cooked to required temperature
- 3 Why: The temperate scale showed the wrong information
- 4 Why: Because the scale was out of calibration
- 5 Why: No system in place to ensure calibration is maintained
Ishikawa diagram also called as fishbone diagram is another popular technique to identify the potential root cause of a non-conformance. This technique can also be combined with 5 Why Methodology.
Various causal factors are identified, examined, analyzed and probed to explain the defect (left side on the fish’s head). Using fishbone technique numerous root causes can be identified for a given problem or nonconformance. This technique can be used to manufacturing, production and service related businesses.