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.

Copy of Copy of Copy of Copy of Copy of Copy of Hive (1)

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:

1

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

 

Fishbone Diagram

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.

2

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.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes:

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>