In a simple language, a nonconformance means that a problem has occurred and it needs to be addressed. It happens when something does not meet the specification or requirements in some way.
Qualityze Nonconformance Management software (QNC) solution complements your established nonconformance process and enables your organization by helping to,
- Identify the problem
- Document the problem
- Evaluate/Review the problem
- Segregate non conforming material
- Dispose non conforming material
- Investigate non conforming material on need of further corrective actions
Qualityze’s Nonconformance management software has powerful analytics and reporting capability that provides you a real-time visibility of critical information of the nonconformance system to help you make an informed quality decision.
Identify and Document the problem
A nonconformance occurs when something does not meet the specifications or requirements. When it occurs you should be able to identify, document and resolve it quickly and in a compliant manner.
With Qualityze’s Nonconformance management system, this can be achieved by completing the Initiation and Product Information steps. Within the Initiation step, you can capture key information such as,
- Defect Statement and Code
- Occurrence Date
- Reported Date
- Reported By
- Products and Lot/Batch number and Quantity
- NC Owner and others
Besides this information, you have an option to create additional custom fields to capture information that your business needs. Once the record is saved, a unique number will be assigned by the system for you to keep track of the nonconformance record.
Evaluate and Review the problem
Once the problem is identified and documented, the next step in the process is to quickly evaluate and review the problem to determine the extent of investigation of the nonconforming material(s).
In the Resolution step of the Qualityze nonconformance management software module, you as the NC owner, have an option to utilize Risk Assessment section to further review and determine the next steps in the process. If after the evaluation and review, you determine that it is not a valid nonconformance, you have an option to close the record with a reason. Or if you feel that further action is necessary, you have an option to either continue with the NC process, create a new CAPA or link to an existing CAPA.
We understand that not every nonconformance requires same level of investigation. The extent of the investigation depends on the particular material, component or product involved, the complexity and the suspected or confirmed impact of nonconformance on product performance or use.
The flexibility of the Qualityze nonconformance management system module allows you to choose and select/de-select the task, define the task owner and the task due date that is necessary for each nonconformance record.
Segregate nonconforming material
The nonconforming material must be identified and segregated in a controlled area to prevent being used inadvertently until the material review board (MRB) makes the final disposition.
In Qualityze, the Product Information step is used to identify and document the material, batch/lot number, and quantity associated with the nonconformance. Additionally, you can use the Containment task to document the actions taken to segregate the nonconforming material.
To further segregate and contain the material, Qualityze can integrate with your ERP solutions to put a ‘Quality Hold’ on lot/batch number of the suspected materials.
Dispose nonconforming material
Once the nonconforming material is identified, tagged and segregated in a controlled area, the MRB or authorized management person makes the final decision on disposition. A written rationale or justification for disposition decision needs to be documented and signature of those approving the disposition.
In Qualityze, you use the Disposition task to document the final disposition and related information. The built-in mistake proofing technique automatically tracks and alerts & prevents you from completing the disposition activities if all the identified material have not been dispositioned completely.
Investigate nonconforming material for further corrective actions
The investigation of a nonconformance is an important part of the quality management system. The nonconforming material must be investigated when appropriate and the investigation must be documented.
In Qualityze, you can use the combination of Investigation and Implementation task to document the investigation of a nonconforming material. Investigation task is where you document the root cause of the nonconformance. The flexibility of the system allows you to document multiple root causes and defect associated. Whereas, in the Implementation task you document the actions such as correction, corrective, preventative and risk based as appropriate.