What is Non-Conformance?
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.
What are Examples of Nonconformity?
Non-conformance is typically categorized into two different typesminor non-conformance and major-non-conformance. What is the difference between these two?
Minor Non-conformance
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:
- unauthorized change in documentation
- missegregation of non-conforming products
- improper machine calibration
- incorrect sequence of minor processes
- non-critical defects of product packaging
Major Non-conformance
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:
- frequent unauthorized changes
- shipping out of untested products
- missing critical documentation
- working in unsafe environmental conditions
- personnel who failed to take corrective action on a root cause of an issue
Heres an example of an ISO 9001 checklist that can help ensure the facilitys processes and Quality Management System (QMS) are in compliance with the ISO standard.
How do you Handle Nonconformities?
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 products safety and effectiveness havent been affected.
Report Non-Conformance with SafetyCulture
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. SafetyCultureis the leading quality management tool used for conducting inspections and filing reports. Other key QMS features include:
- Customizable non-conformance report forms
- Scheduling for product testing
- Adding detailed instructions for the personnel
- Ability to upload media files such as images
- Determine the corrective actions that need to be implemented to fix the nonconforming issue
- Name and signature of the person filling out the report
- Data Analytics to view overall quality management performance, asset management insights, and corrective actions that needs to be fulfilled and also observe for recurring non-conformance issues
SafetyCulture Content Team
