What is non-conformity? How to manage it?

If you are a leader, QHSE manager or supervisor, non-conformity management is inevitably part of your tasks. However, you’re constantly looking for the best way to streamline their treatment process.

Non-conformity indicates that something has gone wrong with a process or a product and that the result does not match the initial requirements.

Note that in a highly competitive market, customer satisfaction is crucial. In fact, implementing a non-conformity management system must be a real priority to ensure continuous improvement.

non conformity

Quality management: How to deal with non-conformities?

Companies must implement a methodology to deal with non-conformities based on five steps. This aims to permanently remove them from the map and turn them into opportunities for improvement. Here are the steps to follow:

Detecting non-conformity

Every stakeholder of the organization can detect non-conformity. By stakeholders, we mean:

Customers
Suppliers
External auditors
Internal staff
Public administration staff

This is done either during internal and external audits, quality control, customer complaints or complaint analysis. In this context, non-conformity must be identified as quickly as possible.

In this first phase of the process, it is important to properly describe the non-conformity and to provide information such as:

The document indicating what should have been done but wasn’t
Proof of non-conformity
The date and the person that detected non-conformity,

Immediate correction of non-conformity

Once non-conformity is defined, it must be addressed and corrected. This helps to remove the non-conformity situation that caused it in the short term.

Bu the work does not stop there. Since it is not a one-time problem, it can recur repeatedly. It is therefore essential to eliminate the root cause.

Corrective actions and preventive actions (or CAPA) are designed to improve the organization’s processes and protocols by eliminating non-conformities.

The CAPA has a series of phases that must be carried out efficiently. Every action taken is recorded for continuous quality improvement. However, the correct execution of CAPAs must comply with the guidelines of the ISO 9001 standard.

Whenever non-compliance occurs, it is important to react quickly in two stages:

Problem control: to reduce risks. This can be done by alerting the customer, isolating a product or immediately revising a process.
Immediate corrective action: this involves planning the necessary steps to bring the product or process back into compliance.

Detection and analysis of the root cause of non-conformity

The third phase is important to prevent future reproduction of non-conformity. There are various useful methods to identify the root cause such as the 5 why analysis and problem solving tool.

Corrective action plan to eliminate the root cause

Once you are aware of the root cause of non-conformity, you need to determine one or more corrective actions. You also need to define who will be responsible for carrying them out and when they will be implemented.

Checking the effectiveness of corrective actions

The last phase of your quality management service is one the most important phases. It helps to know whether the corrective and preventive actions taken have been effective or not. As soon as a situation similar to the one that produced non-conformity arises, you must check that the deviation no longer occurs.

Quality approach: Tips to prevent non-conformity

Here are some tips to follow in order to reduce the risk of non-conformity and ensure quality service:

Adherence to Standard Operating Procedures

Operators must follow the production processes defined by the company. This ensures that operations run smoothly. SOP (Standard Operating Procedures) must be drawn up and made available to each staff member at the workplace. In addition, each employee must report any changes to these procedures. In fact, unauthorized change of documents can cause non-conformity and undermine quality objectives.

Adequate training

Operators must train their employees using procedures that conform to ISO 9001 standard. This is important to prevent errors that could lead to non-conformity. In fact, small details like incorrect calibration can hinder production.

Product testing

One practical method of ensuring compliance with ISO 9001 standard is to constantly test your products. This is a good practice for quality assurance and control. Product testing prevents non-compliant products from being delivered and sold to customers.

Constant use of an ISO 9001 audit checklist

An audit report form or checklist helps operators remember and complete each instruction, process and necessary steps.

Using tools for the management and traceability of non-conformities

There are several tools available to ensure quality. However, you can choose tools that fit the specifications and requirements of your field:

The size of your organization,
Its activities,
Its processes
Its objectives,
Its direct environment,

In addition to the non-conformity form, you can also opt for other media to manage and anticipate anomalies.

For example, the FMECA method (Failure modes, Effects and Criticality Analysis) is a preventive analysis tool. It can be applied to a process, equipment or product. Its mission is to identify and deal with the causes and origins of malfunctions and defects before they occur.

Make an appointment

How can we define non-conformity?

To define non-conformity, we can say that it is an unforeseen event that occurs during the manufacturing process and affects the final quality of the product.

In other words, non-conformity or (NC) is a failure in a process, service or product that is not compliant with the standards and regulations set by the sector concerned (pharmaceutical, agrifood, biotechnology…).

You should know that non-conformities have a negative impact on the reputation, costs and efficiency of companies.

As a result, your company must set up specific controls during the various phases of production, up to transport. This is in order to make sure that all the procedures in place comply with health and safety, quality, hygiene and environmental protection standards. There are two types of non-conformities that can be distinguished during an ISO certification audit:

Major non-conformity

It is a non-conformity that rarely occurs. Besides, it is easily detected and has no direct impact on customers.

Minor non-conformity

This is a recurring non-conformity. It is therefore difficult to discern. In addition, this type of non-conformity has a negative impact on customers if it is not addressed and corrected.

Note that the difference between these two types of non-conformity lies in the number of corrective measures to be carried out. This helps bring your organization back into compliance. However, regardless of the type of non-conformity, it is essential to address it immediately.

To determine whether non-conformity is minor or major, you should consider:

Its frequency
Its detection
Its impact

ISO 9001 standard: non-conformity management

As mentioned previously, non-conformities can be minor or major. However, classification is broader. The management of these various events can be linked to any of the existing ISO standard. Note that ISO 9001 is one of the most common standards.

ISO 9001: 2015 is a world-renowned quality management technique. In fact, it is implemented by many industrial companies to constantly improve their processes and consolidate the quality of their production. The aim is to become more competitive and more efficient while increasing customer’s satisfaction by implementing corrective and preventive actions.

In ISO 9001 management system, the most common non-conformities are generally due to:

Non-compliance with technical requirements of products (materials, characteristics, operation…
Non-compliance with processes (quantity errors, delays in delivery, misuse of equipment, human failure due to lack of training…

Non-conformities: the negative impact on an industrial company

Non-conformities can quickly become a real nightmare for industrial companies that are unable to manage them. Their impact on the final quality of products leads to other negative impacts such as: lack of efficiency, productivity and company reputation.

However, early detection of non-conformity should be seen as an opportunity for improvement.

Here are the different steps to follow to deal with non-conformities so that every company would be able to investigate the origin of the problem, find a solution and prevent this from happening again.