IST NONCONFORMANC MANAGEMENT SOFTWARE
Nonconformance Management Software: A Strategic Approach to Manage Defects and Deviations for Continuous Improvement
Companies face the challenge of balancing customer needs with compliance requirements. This often leads to quality issues that may be identified during an audit, management review, internal quality control, or customer complaint. This can impact quality objectives and brand reputation. Therefore, we should streamline key processes to efficiently manage all types of products and process deviations. At this point, implementing flexible, scalable, next-generation nonconformance management software becomes critical to ensure product quality, safety and compliance.
With IST Nonconformance Management Software, you can standardize the process
- 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
To ensure the quality, reliability and safety of a product, it must conform to internal and external specifications. The IST Non-Conformance Software solution enables companies to identify non-compliant materials, assess the risk threshold, upload reference documents, and take the necessary actions to carefully contain/dispose of the materials. It also helps you track events that originate from an internal source, are caused by suppliers, or are identified by customers. Using an all-case nonconformance management solution allows you to handle any nonconformance event in a dynamic and compliant manner. With IST Nonconformance Management, you can work effectively and efficiently:
- Review
- Containment
- Disposition
- Investigation
- Implementation
- NC Follow-up
- Digital Signature Validation
- Record Tracking with Audit Trail
Identify and Document the Issue
A nonconformance issue occurs when a product does not meet the specifications or requirements demanded by your compliance objectives. Such problems must be identified, documented, and resolved immediately, based on your compliance targets and quality standards.
With the IST Nonconformance Management System, you can address such issues with a simple step of initiating and collecting product information. The initiation step allows you to capture important information about the product, such as:
- Defect Statement and Code
- Products & Lot/Batch number & Quantity
- Occurrence Date
- Reported Date
- Reported By
- Location
- NC Owner & others
Evaluate and Review the Issue
Once the problem has been identified and recorded, the next step is to evaluate and review the problem to determine the investigation progress on the non-compliant material(s). What exactly can you do with the IST Software steps to resolve nonconformances? This step gives the NC owner the opportunity to use a risk assessment for a thorough review and identification of next steps in the process. If, after the assessment and review, you determine that the reported issue is not a valid nonconformance, you can simply close the record, stating the reason. However, you can continue with the NC process by creating a new CAPA or linking it to an existing CAPA issue that was previously identified as a valid nonconformance. We recognize that each nonconformance requires a different level of investigation depending on the type of material, component(s), and product(s) involved, as well as the complexity, suspected or confirmed impact on the product’s performance or intended use. IST Nonconformance Management software has a user-friendly, intuitive interface that allows you to select or deselect the tasks, task owners, and due dates required for each defect record.
Segregate the Nonconforming Material
The defective material must be identified and segregated in a controlled area (containment) so that it cannot be used inadvertently until the Materials Review Board (MRB) makes a final decision. With IST EQMS software, you can identify and document the material as part of this product information step, along with relevant details such as lot, batch or serial number and quantity associated with the deviation. In addition, you can use the containment task to determine the actions to be taken to discard the nonconforming material. You can also integrate the IST Nonconformance Management System with your existing ERP solution to signal that the lot, batch, or serial numbers of suspect materials are quality locked for proper segregation and containment.
Disposition of the Nonconforming Material
The defective material must be identified and segregated in a controlled area (containment) so that it cannot be used inadvertently until the Materials Review Board (MRB) makes a final decision. With IST EQMS software, you can identify and document the material as part of this product information step, along with relevant details such as lot, batch or serial number and quantity associated with the deviation. In addition, you can use the containment task to determine the actions to be taken to discard the nonconforming material. You can also integrate the IST Nonconformance Management System with your existing ERP solution to signal that the lot, batch, or serial numbers of suspect materials are quality locked for proper segregation and containment.
Investigate the Nonconforming Material for CAPA
Investigating a nonconformity is one of the most important steps in the quality management system. It must be reported and properly documented. IST With the Nonconformity Management and Reporting System, you can combine the tasks of investigation and implementation to effectively document nonconforming material. When investigating, you must also document the root cause. With our defect tracking software solution, you can list multiple root causes and defects associated with the nonconformance. Finally, in the implementation task, you need to define the action plans to address the root cause with a plan for corrective and preventive actions.
Why Nonconformance Management Is Important?
Managing nonconformances is an essential step in maintaining quality standards and identifying opportunities for continuous improvement. It encourages every organization to:
- Learn from its mistakes.
- Extend their product lifecycles
- Increase market share
- Deliver quality products to customers
How does IST Nonconformance Management Software Help Businesses?
Track your critical processes and their performance regularly to identify quality issues and resolve them quickly with Qualityze’s 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
IST Nonconformance Management has user-friendly forms that allow you to capture all the information you need about a quality issue identified during an audit, customer complaint, or internal quality review. This typically includes a defect explanation and defect code, date of occurrence, report date, report creator, location, products and lot/batch number and quantity, NC owner, and more. The standardized forms and configurable workflows allow you to capture important details consistently and efficiently. Regardless of the root cause of quality issues, Qualityze Nonconformance Management lets you create workflows based on the risks associated with the issue. The risk-based approach helps you make better business decisions to effectively manage nonconformance and noncompliance, whether for products, processes, systems, suppliers, and audits.
Configurable Cloud-Based Platform
Adherence to Compliance Standards
User-Friendly Interface
The IST non-conformance management system is built on the world’s leading cloud-based platform, Salesforce.com. This means you can easily customise it to meet your unique needs. It’s a flexible and scalable solution that grows as you grow. If you are in the automotive industry, you can easily choose automotive defect management software to manage your quality processes.
For each industry, IST follows the relevant standard requirements of 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.
IST nonconformance management and reporting software is equipped with an intuitive user interface so that any user can operate it with the utmost ease, simply by entering the field data correctly. Especially in industries such as general manufacturing, technical expertise is no longer required. You can use the software system for managing defects in manufacturing with absolute ease.