How to Identify Non-Conformance at Work

What are Examples of Nonconformity?

• 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 easier to solve. Examples of a minor nonconformity for processes are unauthorized change in documentation, missegregation of nonconforming products, and improper machine calibration. 
• Major Non-conformance – this is a significant failure to meet quality requirements and major standards such as ISO 9001. Major non-conformance are mistakes that adversely affect production processes and products which can be costly to the company. Examples of major nonconformity are frequent unauthorized changes, shipping out of untested products, personnel who failed to take corrective action on a root cause of an issue. 

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.

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 product’s safety and effectiveness hasn’t been affected.

Tips to Prevent Non-Conformance

Lessen the possibility of nonconformity with the following tips:

• Adhere to the standard operating procedure – Employees are expected to follow the production processes set by the company since most of these procedures incorporate controlled variables that are proven effective when producing quality products. This keeps operations running smoothly. SOPs should be written and made available to every staff member in the workplace. Employers should also remind employees to report any changes to these procedures even if it’s just part of the documentations since unauthorized change in documents can lead to nonconformity.
• Proper training – Employers have to train their employees with procedures that are in compliance with ISO 9001. This is necessary to prevent mistakes that could lead to non-conformance since minor details such as incorrect calibration can affect production.
• Test the products – A concrete method to ensure ISO 9001 compliance is to regularly test the products. This is a best practice for quality assurance and control. Product testing will prevent nonconforming products from being delivered and sold to customers.
• Consistently use an ISO 9001 Audit Checklist – An audit checklist or report form helps employees remember and complete every instruction, process, and necessary steps. 

Non-Conformance Procedure

The non-conformance process flow includes 5 steps:

1. Identification of the source or root cause of the failure.
2. Documentation of the non-conformance such as the material, problem, disposition, and signature of the person responsible. There should also be a documented standard operating procedure and work instructions.
3. Evaluation of the nonconformity and determine if an investigation is required. An investigation is not needed when a similar situation has already been investigated; however due to the recurrence, a corrective and preventive action (CAPA) procedure may be required (CFR 829.100).
4. Segregation of nonconforming products.
5. Disposition of nonconforming products (CFR 820.90(b)).

Personnel should be ready to take corrective action after completing these steps.

Non-Conformance Report Example

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 it to the form. This enables accurate recollection of the non-conformance issue.

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. SafetyCulture (formerly iAuditor) is 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 needs 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 and corrective actions that needs to be fulfilled and also observe for recurring non-conformance issues