Do you often feel confused with the usage of terms Nonconformance and Noncompliance? If yes, you are not alone.
Since both the terms are used interchangeably, the confusion is the common outcome. In this post, we will understand the differences between the two, which may initially seem trivial to you. But once you will get to know how these processes work for attaining the goal of product quality, there won’t be a room for confusions anymore.
Let’s quickly have a look through the basic definitions for Nonconformance and Noncompliance before diving deep into the details
It generally refers to a product/material that doesn’t conform to the specifications defined/customer requirements. It could be a deviation in a process, design, documentation, or procedure that may deteriorate the product quality.
It can be broadly classified as Major and Minor Nonconformance
It refers to the situation where one of the components of QMS or entire QMS breakdowns or the quality processes fails to address the key requirements specified by a regulatory authority such as ISO 9001. Auditors consider such nonconformities as a part of a system failure or its inability to ensure process and product control.
It refers to the situation that indicates a failure in conforming to the specified requirements, which may not affect the functionality of the quality management system. It may be a single incident that may have minimal or no risk for the customers. It could be some abrupt change, which is not documented or unapproved purchase order, etc.
It generally refers to the situation wherein a product/material fails to meet the requirements specified by the regulatory authorities. It could be a deviation in a process, design, documentation, or procedure that may deteriorate the product quality. For example, setting up the exceptions for accepting an individual into a program.
Both nonconformance and noncompliance should be managed effectively to ensure minimum quality issues, regardless of the industry and company-size.
Internal audits are performed to keep a check on compliance – with ISO, FDA, and other industry-specific standards as well as the quality management system. Every industry shall regularly, keeping in consideration the predefined schedules and procedures, perform the internal audits for their processes and activities to ensure that all their operations are in line with the requirements of the quality management system and the International standards.
An internal audit activity shall address all the components of the management system including the test and improvement activities.
In addition to the internal audits, you can rely on following mentioned sources to get information regarding a non-conformance record:
To have a better understanding of nonconformance and noncompliance, we can have a quick look through the definitions of compliance and conformance.
It is commonly referred to as following the instructions – you need to do only what you are told to do. This is the most simplistic definition. However, when we talk about the quality industry and quality management functions, the definition of compliance gets complex. It has some key traits including legality/standards/requirements specified as the most fundamental one through which the legal implementations are carried out. The second key trait of compliance also gets reflected through the first key trait that legalities/standards applied are the requirements that are specified externally to the person(s) or organization.
The complexity arises with the recognition of the authoritative person who can implement such legal expectations or external requirements that includes a wide range of entities and environments.
It is referred to as doing something in a recognized way – you need to follow the guidelines for attaining product quality so that it serves the intended purpose. It has wide implications throughout the different facets of life; not being limited to work life. The act of going against the specified guidelines results in a non-conformance. The main objective of keeping the quality systems and their application conforming is to ensure improved products and processes that a company may have established to deliver consistent results, products, or services.
The standards of conformance may change for different locations and situations based on the acceptable things for that particular marketplace. But in any industry, having all the operations in place and implementing the best practices are required to meet conformity.
Managing nonconformance and noncompliance is important for every organization in terms of achieving business goals in terms of product quality, which requires different functions in place including:
All these activities should be structured in a way that both the non-conformances and non-compliances can be managed easily. However, these critical activities need proper documentation, approval, and time-mannered processes that you cannot accomplish manually.
To ensure completion of the review, audit, and complaints management process, you need to implement a next-generation enterprise quality management software like Qualityze EQMS. It enables you to establish a closed-loop quality system in your organization to mitigate quality and operational risks while enabling you to meet the compliance and regulatory standards.
From the management of critical documentation like SOPs, work instructions, etc. to creating audit checklists using the pre-defined templates, Qualityze is a one-stop-solution for all your quality management needs. This cloud-driven suite comprises of different products such as Nonconformance Management Solution, CAPA Management Solution, Document Management Solution, Audit Management Solution, Supplier Quality Management Solution, Training Management Solution, and Customer Complaints Management Solution.
You can leverage all the advantages of being on a cloud platform like flexibility, scalability, and security with Qualityze since it’s built on the world’s most secure and powerful platform. The features that will help you ensure compliance and conformance are Electronic Signature for validation and verification process, Outlook Email Approval, Audit Trails, etc.
Nonconformance and noncompliance may differ at the fundamental level, but they need to be managed effectively to ensure the quality of products and services delivered to the customer. The effective management implies proper documentation for analysis and evidence-based decision making, planning and scheduling of audits, keeping a regular check on execution of audit activities, and communicating with the customers to ensure satisfaction. All these activities are vulnerable to errors, delays, and other risks in manual execution.
Make sure you have implemented the right quality management system in your organization to manage all the critical functions with minimal vulnerabilities while creating a culture of continuous improvements to strive with industry best-practices.
Author
Qualityze Editorial is the unified voice of Qualityze, sharing expert insights on quality excellence, regulatory compliance, and enterprise digitalization. Backed by deep industry expertise, our content empowers life sciences and regulated organizations to navigate complex regulations, optimize quality systems, and achieve operational excellence.
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