Qualityze Inc attends ISO 9001 and Audits World Conference, gains valuable insights on quality management and auditing!
Tampa, FL USA, 23rd March 2023: Qualityze is pleased to announce our recent participation in the ISO 9001 and Audits World Conference. The event took place on March 13-14, 2023 and brought together professionals around the globe to discuss quality management and auditing. The ISO 9001 and Audits World Conference is a premier event in […]
Nonconformance Management : How to Turn Costly, Defective Products into Value-Adding Products
There’s nothing better for a business than the virtuous cycle of building high-quality products that people keep coming back to – providing repeat and referral business.
But what happens when that product has a nonconformance and is sold in the market? That virtuous cycle can become a downward spiral. Not only does the company’s brand, reputation and customer satisfaction get negatively impacted, the company may also face heavy penalties from the FDA and other regulatory agencies. Furthermore, a nonconformance can lead to consumer harm or even patient death.
All of this can be avoided or minimized by enabling good management practices with the right nonconformance management software. Our team of experts – who developed the first generation of enterprise quality management systems over 20 years ago – have leveraged that experience to create a modern software platform that helps companies manage all types of products and process nonconformances.
Scroll down to find out more about how Qualityze helps companies implement a flexible, scalable, next generation nonconformance management solution to ensure product quality, safety, and compliance.
As regulatory standards and guidelines become more stringent, paper-based systems are no longer effective ways to develop and maintain nonconformance management processes and workflows. Our Qualityze Nonconformance Management system offers a better alternative. It is a cloud-based, compliance-driven tool that helps mitigate quality, safety, and operational risks while allowing an organization to support a culture of continuous improvement. With this solution, companies can minimize nonconformance costs, including rework and recall costs, FDA warning letters, and regulatory fines by providing easy-to-use tools to:
With Qualityze Nonconformance Management Software, you can standardize the process to:
- Identify and Document the Issue
- Evaluate and Review the Issue
- Segregate the Nonconforming Material
- Disposition of the Nonconforming Material
- Investigate the Nonconforming Material for CAPA
Nonconformance Management Overview
Ensuring a product’s quality, reliability, and safety requires conformance with the internal and external specifications. Qualityze Non-Conformance Software solution enables organizations to identify non-conforming materials, assess the risk threshold, upload reference documents, and initiate the necessary actions to contain/dispose of the materials thoroughly. Also, it helps you track events originating from an internal source, caused by suppliers, or identified by customers. Using a non-conformance management solution in all instances will allow you to handle any non-conformance event in a dynamic and compliant way. With Qualityze Nonconformance Management, you can effectively and efficiently perform:
- NC Follow-up
- Digital Signature Validation
- Record Tracking with Audit Trail
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 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 Tracking Software 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 Is Nonconformance Management Important?
When a regulatory agency like the FDA or ISO audits your organization (and they will), your management and employees must demonstrate you have taken the requisite measures to identify, investigate and resolve each non-conformance. Sound nonconformance management principles and practices guide efforts while also encouraging organizations to:
- Learn from their mistakes.
- Extend their product lifecycles
- Increase market share
- Deliver quality products to customers
How does Qualityze Help Prevent or Minimize Non-Conformances?
Qualityze flexible, configurable, and scalable workflows allow for real-time visibility of your critical processes and their performance so you can rapidly identify and resolve quality issues.
With Qualityze Nonconformance Management, you can:
- Record Quality Issues with Details for Risk Assessment
- Minimize the Nonconformance Cycle Time
- Ensure Effective Resolution
- Integrate Nonconformances with CAPA and Other Quality Processes
- Integrate with Existing Business Systems
- Drive Smarter Decision-Making Process
- Control Nonconformance Records and Data
Record Quality Issues with Detail for Risk Assessment
Qualityze Nonconformance Management comes with user-friendly forms that enable you to capture all the information related to the quality issue, which may have been identified through an audit, a customer complaint, or an internal quality check. Form fields typically include a Defect Statement and Code, the Occurrence Date, the Reported Date / Reported By, the Location, the Products and Lot/Batch number and Quantity, and the NC Owner. The standardized forms allow you to add additional fields and the configurable workflows allow you to capture critical details consistently and efficiently.
Regardless of the source of the quality issue, Qualityze Nonconformance Management allows you to create workflows based on the risks associated with the problem. This risk-based approach helps you prioritize and make better business decisions to manage nonconformance and non-compliance effectively – whether for products, processes, systems, suppliers, or 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. Our automated email approvals, alerts and notifications, reports and dashboards, and other built-in capabilities make the nonconformance process faster, smarter and less burdensome.
Qualityze Nonconformance Management allows users to collaborate in real-time with all involved parties to plan the workflow, understand the need for CAPA, and make other critical decisions. You can instantly access all of the details related to a nonconformance record along with the objective evidence through quick and secure search options. You can also use a unique reference number to track NC records in seconds or minutes, even if that NC was created years ago.
Ensure Effective Resolution
Qualityze Nonconformance Management enables you to review the impact of quality issues by assessing their risk thresholds as a trigger to escalate to a CAPA. If the threshold is not reached, the nonconformance will continue on to subsequent steps such as 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.
Additionally, you can store nonconformance records and their resolution in order to meet regulatory compliance requirements and to demonstrate best practices during internal and external audits. The ability to systematically track NCs and follow risk-based workflows, reflects the organization’s culture of quality.
Integrate Nonconformances with CAPA and Other Quality Processes
It’s easy to access all investigation details, calibration records, and maintenance records associated with nonconformance records using Qualityze Nonconformance Management. We have developed a set of smarter quality solutions to help you succeed in quality management using a closed-loop system. Rather than trying to manage disconnected silos of NCs and CAPAs, 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 in a centralized database that your quality teams can access anytime from anywhere across the globe, significantly reducing the decentralization issues and long cycle time.
Integrate with Existing Business Systems
Qualityze Nonconformance Management can seamlessly integrate with all of your existing business systems and third-party applications such as CRM, ERP, LIMS, MES, and PLM. The ability to collect data from different sources and applications reduces manual labor, operational oversight 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 resolutions more efficiently.
Drive Smarter Decision-Making Process
Qualityze Nonconformance Management provides advanced reporting tools to users which help them to analyze data trends based on relevant criteria. This improves the quality and speed of business decisions. Our nonconformance solution also offers personalized dashboards to track all the tasks and activities at a glance. The improved visibility of NC records helps you understand the associated risks and implement the Risk-Based, Corrective, Correction, or Preventive action plans. Finally, we provide 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 in a secure, centralized cloud platform. For added security you can enable role-based security controls, password authentication, or track the audit trail to trace every activity performed on your organization’s quality data. Additionally, you can maintain compliance with regulatory standards, including but not limited to FDA 21 CFR Part 11 and EU Annex 11through our digital records and electronic signature features.
Qualityze Nonconformance Management Software – Reducing Quality Risks and Costs
Qualityze Nonconformance Management works for every industry – 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 regulatory standards.
Qualityze Nonconformance Management Solution comes with a(n):
- Centralized Nonconformance Database
- Audit Trail
- Configurable Workflow and Fields
- Personalized Dashboards
- Task Scheduler
- E-Signature Validation
- Seamless Integration
- Chatter Platform
Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Record, Resolve, and Track Quality Issues
A compliant Nonconformance Management System is a must-have in quality management. It helps organizations identify and manage the inconsistencies that can lead to product and process quality issues. Furthermore, a compliant NC system helps to ensure conformance with important, industry-specific regulatory requirements.
The Qualityze EQMS Suite helps enterprises align their quality processes with their business objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled benefits in managing today’s most difficult quality challenges. We empower you to optimize your quality processes by giving you the control and confidence to better manage deviations, so you can focus on growing the business.
Qualityze prepares you to succeed with a next-generation approach for managing quality and compliance risks, thereby fostering continuous process improvement, higher customer satisfaction, and market share growth.
Experience Qualityze Difference to Optimize Quality
Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference 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.
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 Nonconformance software for quality management 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.
Find the latest updates on