In simple terms, a NonConformance refers to the occurrence of a problem that needs to be immediately addressed. The issue/problem is reported as a nonconformance only when a product(s) does not match the specifications or requirements set by the companies’ quality standards.
Qualityze Nonconformance Management software (QNC) is designed to complement your existing nonconformance process streamline your organization tasks in:
- Identify the Issue
- Document/Report the Issue
- Evaluate/Review the Issue
- Segregate the NonConforming Material
- Disposition of the NonConforming Material
- Investigate the NonConforming Material for CAPA
Qualityze Nonconformance Management Software system is enabled with powerful analytics and reporting capabilities that enable you to access critical defect information to make informed quality decisions.
Identify and Document the Issue
A nonconformance issue arises when a product does not meet the specifications or requirements as required by your compliance targets/goals. Such issues need to be identified, documented, and resolved on an immediate basis, based on compliance and quality standard targets.
With Qualityze Nonconformance Management system, you can address such issues with a simple initiation and product information gathering step. The initiation step allows you to capture key information about the product such as:
- Defect Statement and Code
- Occurrence Date
- Reported Date
- Reported By
- Products and Lot/Batch number and Quantity
- NC Owner and others
Additionally, you can customize the new fields based on your business structure to capture the requisite information. Once you have completed the record creation, you will get a unique system generated reference number to track the remaining processes.
Evaluate and Review the Issue
Once the issue has been identified and recorded, the next step calls for the evaluation and review of the issue to determine the investigation progress regarding the nonconforming material(s).
Exactly what do the Qualityze nonconformance resolution steps allow you to do? This step gives the NC owner the option to utilize a Risk Assessment for a thorough review and identification of the next steps in the process. If you find that the issue reported is not a valid nonconformance after evaluation and review, you can simply close the record stating the reason. However, you could continue with the NC process by creating a new CAPA or link it to an existing CAPA issue that has been previously identified as a valid nonconformance.
We understand that every nonconformance requires a different level of investigation depending upon the material-type, component(s) and product(s) involved along with the complexity, suspected or confirmed impact on the product’s performance or intended use.
The Qualityze Nonconformance Management system software comes with a user-friendly, intuitive interface that allows you to select/de-select the tasks, define task owners and due dates which are necessary for each nonconformance record.
Segregate the NonConforming Material
The nonconforming material must be identified and segregated in a controlled (Containment) area to prevent being used inadvertently until the material review board (MRB) makes a final disposition.
With Qualityze EQMS software, you can identify and document the material under this product information step along with relevant details such as batch, lot or serial number, and the quantity associated with the nonconformance. Further, you can use the containment task to specify the actions taken for the segregation of the nonconforming material.
You can also integrate Qualityze Nonconformance management system with your existing ERP solution to signal placing a ‘Quality Hold’ on the lot, batch or serial numbers of the suspected materials for proper segregation and containment.
Disposition of the NonConforming Material
After the identification, tagging, and segregation of the non-conforming material in a controlled area, the MRB or authorized expert can make the final disposition call. A written rationale or justification for disposition decision needs to be documented with an electronic signature for the approving regulatory authorities.
In Qualityze nonconformance management and reporting software module, you can use the disposition task to document the final disposition and all its relevant information. It comes with a built-in mistake proofing technique that tracks and alerts you about the completion of the disposition activities. It also keeps you notified in the case, when the identified non-conforming material has not been completely dispositioned.
Investigate the NonConforming Material for CAPA
The investigation of a nonconformance is one of the most important steps of the quality management system. It must be reported and properly documented.
Qualityze NonConformance management and reporting system enables you to combine the Investigation and Implementation tasks together to allow the effective documentation of nonconforming material. In the Investigation task, you also need to document the root cause. Our NonConformance solution allows you to list multiple root causes and defects associated with the NonConformance. And finally, in the Implementation task you need to define the action plans to correct the root cause with corrective, preventative action plan.
Qualityze NonConformance Management Software for Multiple Industries
Qualityze NonConformance Management System works for many industries with the same effectiveness and efficiency. From nonconformance management software for life sciences to Complex or General Manufacturing, Automotive, Aerospace, Healthcare, biotechnology, Pharmaceuticals, Logistics, Medical Devices, Food and Beverage operations, ours is a solution that makes it easy for you to maintain high quality standards with:
Configurable Cloud-Based Platform
The Qualityze nonconformance management system is built on the world’s leading a cloud-based platform Salesforce.com. Allowing you to easily configure it to your individual requirements. It is a flexible and scalable solution that expands as you grow. If you are in automotive industry, you can simply opt nonconformance management software for automotive industry to manage your quality processes.
Adherence to Compliance Standards
For every industry, Qualityze follow the relevant standards requirements set by the regulatory committees such as Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc.
Qualityze nonconformance management and reporting software is built with an intuitive interface so that any user can operate it with utmost ease by simply entering the fields data correctly. The need for technical expertise is eliminated especially for industries like General Manufacturing. You can use the nonconformance management software system in Manufacturing with complete ease.
Why NonConformance is Important?
The recording of Nonconformances is an important step in keeping high quality standards while identifying opportunities for continuous improvement. It encourages any organization to:
- Learn from its mistakes.
- Extend their product lifecycles
- Boost market share
- Deliver quality products to customers
Verifying and Validating the Quality Standards for Businesses
Qualityze Nonconformance tracking and reporting software complies to the industry-specific standards including ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949 to ensure that only best practices are followed. Our solution is designed carefully to allow verification and validation of the problem identified through containment and disposition steps.
Our EQMS software solution supports multi-level and multi-site approval process so that every disposition activity is documented and verified to propose the appropriate action plan. You can track all the necessary details including the product code, issue, concerned department, number of products, and much more. Being on cloud you can maintain as much history of your quality data as your organization requires.
Do you want to improve your product quality and reduce its time to market? It’s time to get Qualityze NonConformance management software for your organization.
You are just a click away from experiencing the Qualityze difference, just click on the Request Demo button, or call us on 1-877-207-8616 and our customer success team will be right there for you.