Nonconformance Management : A Strategic Approach to Manage Defects and Deviations for Continuous Improvement
Businesses face challenges to maintain a balance between customer demands and compliance requirements. It often results in quality issues that may be identified during an audit, management review, internal quality check, or customer complaint. It can impact quality objectives and brand reputation. So, we should streamline the key processes to manage all types of products and process nonconformances efficiently. That’s where it becomes crucial to implement a flexible, scalable, next generation nonconformance management solution to ensure product quality, safety, and compliance.
Qualityze Nonconformance Management help establish a closed-loop workflow to address nonconformities, allowing you to document, evaluate, segregate, disposition, and investigate. It streamlines all the quality processes to manage defects and deviations, reduce cycle time, foster continuous improvements while meeting product quality specifications. Furthermore, it helps reduce operational costs by minimizing product rework and recalls.
With Qualityze Nonconformance Management Software, you can standardize the process to:
- Identify the Quality Issues
- Document/Report the Issue
- Evaluate/Review the Issue
- Segregate the Nonconforming Material
- Dispose of Nonconforming Material
- Investigate the Nonconforming Material for CAPA
Nonconformance Management Overview
A nonconformance occurs when something does not meet the specifications or requirements. When it occurs you should be able to identify and document the problem quickly and clearly. 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.
- Follow-up an NC
- Digital Signature
- Audit Trail
- Notification & Alerts
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
- Products & Lot/Batch number & Quantity
- Occurrence Date
- Reported Date
- Reported By
- NC Owner & others
Additionally, you can configure 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).
Precisely 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.
Why Nonconformance Management Is Important?
Nonconformances management is an essential 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
- Increase market share
- Deliver quality products to customers
How does Qualityze Nonconformance Management Help Businesses?
Track down your critical processes and their performance regularly to spot quality issues and resolve them quickly with Qualityze flexible, configurable, and scalable workflows.
With Qualityze Nonconformance Management, you can
- Record Quality Issues with Details for Risk Assessment
- Minimize the Nonconformance Cycle Time
- Controlled Nonconformance Records & Data
- Integrate Nonconformances with CAPA & Other Quality Processes
- Integrate with Existing Business Systems
- Drive Smarter Decision-Making Process
- Ensure Effective Resolution
Record Quality Issues with Details for Risk Assessment
Qualityze Nonconformance Management comes with user-friendly forms that enable you to capture all the information related to the quality issue identified through an audit, customer complaint, or internal quality check. It typically includes a Defect Statement and Code, Occurrence Date, Reported Date, Reported By, Location, Products and Lot/Batch number and Quantity, NC Owner, and much more. The standardized forms and configurable workflows allow you to capture critical details consistently and efficiently.
Regardless of the source of quality issues, Qualityze Nonconformance Management allows you to create workflows based on risks associated with the problem. The risk-based approach helps make better business decisions to manage Nonconformance and non-compliance effectively, be it for product, process, systems, suppliers, and audits.
Minimize the Nonconformance Cycle Time
With Qualityze Nonconformance Management, you can quickly identify the source of Nonconformance and take immediate action, including containment, disposition, or investigation. The automated email approval, alerts and notifications, reports and dashboards, and other built-in capabilities make the nonconformance process faster and smarter.
Qualityze Nonconformance Management allows users to collaborate in real-time with all involved parties to plan the workflow, understand the need for CAPA, and take other critical decisions. You can instantly fetch details about a nonconformance record along with objective evidence through secure search options. You can also use a unique reference number to track NC records in minutes, even if created years ago.
Ensure Effective Resolution
Qualityze Nonconformance Management enables you to review the impact of quality issues by assessing their risk threshold to escalate to a CAPA or continue the Nonconformance to contain, track, and dispose of nonconforming materials or products. The investigation step allows you to identify the root causes and ensure effective resolution by implementing your Risk-Based, Corrective, Correction, or Preventive action plans.
You can further store the nonconformance records and their resolution to meet regulatory compliance requirements and to demonstrate best practices during internal and external audits. The output reflects the organization’s culture of quality.
Integrate Nonconformances with CAPA and Other Quality Processes
It’s easy to access all the investigation details, calibration records, and maintenance records associated with nonconformance records using Qualityze Nonconformance Management. We have a set of smarter quality solutions to help you succeed in quality management, creating a closed-loop system. You can initiate a CAPA directly for a Nonconformance that requires a detailed investigation.
Qualityze Nonconformance Management allows you to capture all the relevant information and store it on a centralized database that your quality teams can access from anywhere across the globe, significantly reducing the decentralization issues and cycle time.
Integrate with Existing Business Systems
Qualityze Nonconformance Management can seamlessly integrate with all the exiting business systems and third-party applications such as CRM, ERP, LIMS, MES, and PLM, that your teams are already using in quality management workflows. The ability to collect data from different sources and applications reduces the operational oversights and ensures safer data exchange between systems.
Integrating Nonconformance Management with existing systems allows you to collect all relevant information regarding quality issues and develop effective resolution activity. With Qualityze, you can create a closed-loop quality system to streamline all your defects and deviation management processes
Drive Smarter Decision-Making Process
Qualityze Nonconformance Management provides advanced reporting tools to users that help analyze data trends for the specified criteria and make smarter business decisions, accordingly. The solution also offers personalized dashboards to track all the tasks and activities.
The improved visibility of NC records helps you understand the associated risks and implement the Risk-Based, Corrective, Correction, or Preventive action plans. The solution supports standardized reporting structures to meet compliance with applicable regulatory standards.
Transform your QMS into a smart decision-making engine with Qualityze!
Controlled Nonconformance Records and Data
Qualityze Nonconformance Management enables you to establish a standardized closed-loop workflow, keeping all your quality data and records securely stored on a centralized cloud platform. For added security you can put role-based security controls, password authentication, or track the audit trail to trace every activity performed on quality data. Additionally, you can maintain compliance with regulatory standards, including but not limited to FDA 21 CFR Part 11 and EU Annex 11(e.g., digital records and electronic signatures).
Our solution allows you to create a consistent nonconformance reporting structure, assigning each record a unique reference number for increased traceability. Experience a compliance-friendly way to manage product and process nonconformances
Qualityze Nonconformance Management – Reducing Quality Risks and Costs
Qualityze Nonconformance Management works for every industry, including – Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Cannabis/Hemp/CBD, Nutraceuticals, Biologics/Biotech, Food and Beverages, Automotive, Aerospace, Defense and Logistics, to identify, document, and resolve quality problems while maintaining compliance with applicable federal and state regulatory standards.
Qualityze Nonconformance Management Solution comes with
- Centralized Nonconformance Database
- Audit Trail
- Configurable Workflow and Fields
- Personalized Dashboards
- Task Scheduler
- E-Signature Validation
- Seamless Integration
- Chatter, and more.
Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Record, Resolve, and Track Quality Issues
A compliant Nonconformance Management System is an inevitable part of quality management. It helps identify and manage the inconsistencies to improve product and process quality while ensuring conformance to the specified industry and pertinent regulatory requirements. Our solution helps establish a closed-loop workflow to keep track of quality issues, regardless of their source. The cycle time of a nonconformance management process depends on the details captured and quality processes. Qualityze Nonconformance Management is an integrated solution to streamline deviation management and ensure effective resolutions for quality problems and improving operational excellence. Also, the overall cycle times are reduced without impacting product quality, safety, and global compliance.
Qualityze EQMS Suite help enterprises to align their key processes with the business quality objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled cloud benefits to manage your quality challenges. We empower you to optimize your quality processes by giving you more control and confidence in managing deviations, allowing you to focus on your business growth opportunities
Qualityze prepares you to succeed with a next-generation approach to manage quality and compliance risks, fostering continuous process improvements, and growing market share with higher customer satisfaction.