How do I manage all these NCRs?
A non-conformance reporting system is a system designed to identify, capture, and segregate non-conforming outputs. Additionally, the system design provides an organization the ability to determine the cause of the output non-conformance and develop a plan to eliminate (if possible) the non-conformance from recurrence. This paper deals with non-conformances that occur during the manufacturing process before output delivery to a customer.
The organization should perform these tasks in a designated order that enables an organization to identify and recognize non-conforming outputs during the manufacturing process or quality inspections or final inspections before delivery.
When a non-conforming output (referred to as NC) is observed, the NC output should be immediately segregated from conforming production and placed in an area designated for NC product. After segregation, the organization should attempt to determine the reason or cause for the non-conformance and develop and implement a plan to eliminate the NC output from happening again. A well-developed and viable non-conformance reporting system will allow the organization to have a firm grasp of NC outputs and provide assurance that the system enables the organization to capture the lion’s share of NC outputs before reaching any customer.
The chore of causal determination is best served by performing a root cause analysis on the NC product to determine the actual cause and create a plan to eliminate its recurrence.
A vital tool and a requirement of ISO 9001:2015 is trending analysis or looking for like occurrences in NC outputs. This process allows the organization to track similar or similar circumstances and create a robust plan to eliminate the events from happening in the future. In a large manufacturing setting, many instances of NC outputs can occur daily, if not hourly, and attempting to determine the cause on potentially hundreds of NC outputs can be daunting. Automated software that can track hundreds of permutations of NC outputs can significantly enhance a non-conformance reporting system by adding confidence in outcomes and speed that individuals cannot achieve.
Using proven determination methods such as 5 whys and fishbone diagrams can significantly aid the organization in cause determination and assist in developing a plan of attack to eliminate the NC output recurrence. I will discuss these methods in further detail in a later paper on non-conformance reporting.