Learn about nonconformity, examples, ways to prevent, and procedure.
Non-conformance or nonconformity is the failure to meet specified requirements. Nonconformity can occur on both the process and the product. Consequently, nonconforming procedures such as not utilizing the management system correctly or not following the standard operating procedures can lead to nonconforming products.
Non-conformance is typically categorized into two different types—minor non-conformance and major-non-conformance. What is the difference between these two?
This is considered to be minor failures that would unlikely lead to major consequences. Most minor non-conformances are isolated cases and are easier to solve . Examples of minor nonconformity for processes are instances such as:
This is a significant failure to meet quality requirements and major standards such as ISO 9001 . Major non-conformance mistakes adversely affect production processes and products which can be costly to the company. Examples of major nonconformity are incidents such as:
Here’s an example of an ISO 9001 checklist that can help ensure the facility’s processes and Quality Management System (QMS) are in compliance with the ISO standard.
The simple answer is to fix the mistake and ensure that processes and products are in compliance with the ISO 9001:2015 standard. The FDA recommends corrective and preventive action (CAPA) for severe non-conformance that negatively affects design and manufacturing. It is not required to document the non-conformance procedure, however, nonconformities and the corrective action that was conducted have to be recorded along with other related information according to the ISO 9001 standard.
Additionally, Code of Federal Regulations (CFR) 820.90(b) highly suggests that nonconforming products should either be scrapped, returned to the supplier, revert back to previous versions if the product was an upgrade, or use as if the product’s safety and effectiveness haven’t been affected.
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Lessen the possibility of nonconformity with the following tips:
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Policies and procedures set out the rules and guidelines that your workers should follow to secure workplace efficiency, as well as guarantee everyone’s health and safety. The best way to engrain these guidelines into your workers is by putting together robust training on ensuring conformance with set standards, policies, and procedures.
By reinforcing your policies and procedures through training, workers will be better equipped with the knowledge and skills needed to identify potential hazards. With this training, they’ll be able to take the appropriate measures to prevent accidents and process issues from ever occurring. This can lead to a mindset shift, where your policies and procedures become a natural part of their work habits, creating a safer work environment for everyone.
Creating effective training is quick and easy – as long as you have the right tool in hand. For that, try SafetyCulture (formerly iAuditor)’s Training. Create and deploy training courses and programs to your employees to ensure they follow best practices and help achieve conformance in the workplace.
You can also make training courses accessible to your team using their preferred devices. With Training’s offline access, they can brush up on SOPs even without an internet connection.
The non-conformance process flow includes 5 steps:
Personnel should be ready to take corrective action after completing these steps.
Non-Conformance Process Flow | SafetyCulture
Utilize a non-conformance report form to document necessary details regarding nonconforming processes and products. This report helps quality managers gather data that is required for ISO 9001 such as the description of the non-conformance situation, corrective action, and signature of the personnel. In the event that the non conformity case is difficult to describe, staff can take photos and upload them to the form. This enables accurate recollection of the non-conformance issue.
Non-Conformance Digital PDF Report Sample | SafetyCulture
Eliminate manual tasks and streamline your operations.
It is important for a company to keep documents organized especially for processes that majorly impact day-to-day operations. Nonconformity cases need to be documented to meet standards such as ISO 9001:2015. SafetyCulture is the leading quality management tool used for conducting inspections and filing reports. Other key QMS features include:
Here are two examples of nonconformity-related templates for minor and major non-conformance situations:
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SafetyCulture Content TeamThe SafetyCulture content team is dedicated to providing high-quality, easy-to-understand information to help readers understand complex topics and improve workplace safety and quality. Our team of writers have extensive experience at producing articles for different fields such as safety, quality, health, and compliance.
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