“You are into a business of manufacturing glass studs of size 50 mm. But an inspection revealed that a particular lot of the studs measures 45 mm.”

“A product you recently delivered to a customer didn’t match their specification, and was of a different color. More so, it was delivered to a wrong address initially. You came to know this when a customer complaint was received in this regard.”

“Crucial details such as temperature information, and the supervisor’s signature, are missing from your batch records.”

“A reduction of quality at your plant floor has been experienced due to a certain manufacturing procedure.”

What do you make of these statements?

These are all examples of nonconformance, or nonconformity, which essentially means that something has went wrong somewhere; either in a product, a service, a process, material from a supplier, or in the management system itself. It basically is an activity or a process which doesn’t fulfil its intended purpose.

A nonconformance in quality management generally occurs when something some way does not meet the specifications or requirements that could be defined either by a customer, or a regulatory body, or by an organization. It is ubiquitous, can happen anywhere, and at any time in a business, and is usually identified externally by customers, or auditors, and internally by testers or staff from other departments.

Any nonconformity or nonconformance in quality management can result in bad customer experiences, rework, product recall, and may even impact the organizations in terms of cost, reputation, productivity, and efficiency. It is important for the businesses to identify and address them in a timely manner through corrective actions and preventive actions (CAPA).

Non-Conformance In Terms of ISO

The international standard that highlights the requirements for a quality management system (QMS), ISO 9001 ensures that a business organization consistently offers quality products and operates appropriately under its regulatory measures. And if it doesn’t operate up to the set standards, it’s called non-conformance.

ISO 9001 defines nonconformance in quality management as the failure to meet one or more of the existing requirements. When an organization goes outside the regulatory boundaries, it must control and fix the problem before continuing business. Failure to do so may lead to the company’s downfall, as these standards mean everyone needs to play by the same rules.

Satisfying their customer base is one of the biggest objectives of organizations, and the ISO 9001 standards have been put in place to ensure that this objective is met, along with the other objectives such as quality and safety for the employees as well as the customers, high employee morale, etc. If not for these standards, the organizations wouldn’t be held responsible for their business practices and actions.

Nonconformance Management System- The Secret to Efficiently Managing Non-conformances

No wonder, managing the nonconformances is of great significance for business organizations; especially the ones that put great value on quality of their products, services, and processes. For all such organizations, nonconformance management is a very handy quality tool which can quickly determine systemic issues within the business.

Nonconformance management is fundamentally the process whereby the business organizations manage nonconformances in a way that they are promptly identified, properly documented, thoroughly investigated, and appropriately segregated and dispositioned on the basis of applicable regulations and standards.

And for effective as well as efficient nonconformance management, organizations rely on a nonconformance management software. The investment made in a nonconformance management system is a massive decision, and can potentially make or break an organization. That’s why the businesses need to invest in the right software, which can offer a number of benefits.

Here’s What a Functioning Nonconformance Management System Can Offer

Nonconformance in quality management requires a robust tool that provides features and support to identify and manage product conformance. The features mentioned here include the steps required to recognize and resolve the nonconformance issues from all sources, including identification, remedial action, root cause determination, CAPA, etc.

A functioning nonconformance management system allows users to:

• Identify and register any nonconforming materials, and keep a track of them.
• Set processes, due dates, escalations, and even notifications to ensure the materials are managed quickly and in a timely way.
• Link deviations to any nonconformance records, and initiate corrective actions.
• Create a history of risk within a product, process, supplier, or production line.
• Close the loop on nonconformances by initiating change management, so that improvements can be made organization-wide, and risk of recurrence could be mitigated.

Investing in the right nonconformance management system has immense benefits for the businesses. Check out the benefits of an effective, and functioning nonconformance management software:

• It helps businesses streamline their conformance processes
• It allows businesses Identify any materials that don’t conform, and also the areas that require action
• It helps avoid the risks of escalated nonconformance costs, including the internal/external failure costs, regulatory fines, etc., and also in terms of reputation and resources
• It improves quality processes by facilitating efficient use of resources
• It allows businesses to easily see where their procedures aren’t working as planned, thus giving them an opportunity to address this and improve the effectiveness of their system
• It provides the businesses with an opportunity to drive continual improvement by consistently addressing their nonconformity.
• It brings down the quality costs substantially
• It facilitates stronger collaboration and a better risk response

To sum up

Nonconformances, as we mentioned above, are ubiquitous. In addition, they are inevitable, and can adversely affect the businesses in more ways than one. It is essential for businesses to identify and address them in the most effective as well as timely manner. For the same, they turn to a nonconformance management software.

A functioning nonconformance management system could be a standalone solution, or a part of a QMS software. Regardless of how it comes into the system, it should address risks and allow the internal/external stakeholders to browse reminders, conformance notifications, and the escalated issues related to quality.

It makes sense for businesses to invest in a fit-for-purpose nonconformance management system that delivers these benefits. If your existing system is not good enough, it would be prudent to explore other options such as QualityPro, a best-in-class QMS with a potent nonconformance management functionality, to quickly see these benefits. Write to us for more information, or to schedule a demo.