One of the foundations of a quality approach in a company is to set up systems capable of detecting possible quality defects. The analysis of these failures allows to find the causes and to imagine solutions; it is the management of non-compliance, it must be a source of progress. It is one of the criteria for obtaining ISO 9001 certification, a guarantee of quality.
– According to ISO standards:
– non-compliance = “non-satisfaction of a requirement”,
– Requirement = “a stated need or expectation, usually implied or mandatory”.
– Requirements result from laws and standards, directives from the hierarchy and, of course, the wishes of the customer.
It is obvious that in order to be taken into consideration, requirements must be listed and known by the actors at each level of responsibility in the company.
The QMS (Quality Management System) has a role to play in establishing the requirements and their respect.
– ISO stands for “International Organization for Standardization”, it is the organization that creates and publishes the international standards, the famous ISO standards. In particular, the ISO 9001 standard which defines the good practices for the organization and management of a company.
Several channels can reveal a non-compliance, including:
– The personnel themselves during their work.
– The procedures put in place as part of the quality control, which indicates that they are effective.
– Audits (internal or external, or audits performed by organizations that grant certification of conformity to the requirements of ISO 9001).
– The customer (complaints, claims, after-sales service, …).
For the company’s image, it is preferable that non-compliance is identified internally rather than externally.
The management of non-compliance starts with their collection, continues with their analysis and then the implementation of measures to correct them.
Each report will generate a non-compliance form which will include
– a detailed description of the problem :
– nature of the non-compliance
– department(s) or person(s) concerned
– stage of the process
– date, time
– in a second step :
– proposed solution
– and finally :
– implementation of the solution
– follow-up of the action
It is advisable to write these sheets in simple terms, without technical terms, so that they can be used easily.
Some non-compliance will find a simple solution with an immediate action, for example a package not received will be reshipped.
But it is important to look for the root cause of the malfunction.
There are many methods that can be used to facilitate the search for the causes, and we will take a few examples of questions.
– The “5 Whys” method:
This method consists of a succession of simple questions that allow us to trace the original cause.
For example, for the package not received:
– Why was the package not received?
Because the package was not shipped
– Why was the package not shipped ?
Because it was not on the shipping list
– Why wasn’t it on the shipping list?
Because the clerk did not know the procedure
– Why didn’t the clerk know the procedure?
Because he was a substitute and was not properly informed
In this case, the solution is obvious: you just have to plan a training in case of replacement, define it, specify who will do it, check that it is understood and applied.
– The ” 7 W” questions (What, Who, Where, When, How, How much, Why) can be combined with the ” 5 Whys ” in order to go around the problem to be analyzed.
– Combine the “5 Whys” with the 5 M’s (M for Manpower, Machines, Method, Material, Measurement), or even the 6M’s if Management is added. It is also called “Ishikawa” or “Cause and Effect Diagram” and proposes to classify the causes of the problems.