ENSURING QUALITY ACROSS DEPARTMENTS & LOCATIONS
Identifying and managing material & process non-conformance and eliminating its cause should be one of the central functions of an organization’s quality system. This is especially pertinent in the stringent FDA and ISO environments, where a non-conforming product, material, or component could lead to costly rework, or worse, a product recall. FDA’s Current Good Manufacturing Practice (CGMP) regulations and the most popular ISO standards (ISO 9001, ISO 13485, ISO 14001) all require proper disposition of non-conformance. Relying on stand-alone point solutions or paper-based processes to manage non-conformance is ineffective as they fail to address systemic quality problems and do not have broad enterprise reach and visibility.
IDENTIFICATION CQ’s Non-Conformance Management Solution enables organizations to streamline recording and management of all types of events from single or multiple sites in one centralized system. Quality events related to non-conforming products, acceptance activities, process monitoring, supplier part failures, audits, equipment monitoring, field service issues, recalls, and training can be identified.
Simple, easy-to-use non-conformance user interface allows instances of non-conformance from one or multiple sites. Critical information such as the product, process, lot/unit/batch, processes and location can all be documented.
CQ’s Non-Conformance Management enables comprehensive triaging of all quality events and instances of non-conformance that originate in one or multiple sites. It enables organizations to perform comprehensive risk assessment across multiple sites and dimensions. The results, when documented, can provide direction for the required resolution.
When a quality event or a non-conformance is determined to impact production, CQ’s EQMS platform enables organizations to document and enforce containment activities related to lots, units and batches. Enforcement of containment activities ensures that non-conforming material is controlled and prevented from improper usage.
CQ’s Non-Conformance Management enables users to propose different disposition types and hold virtual material review boards. CQ’s EQMS Platform makes possible the collaboration that may be required between employees from one or multiple sites and divisions to work on a non-conformance.
CQ’s Non-Conformance Management allows for collaboration among different employees from one or multiple sites to perform root cause analysis. Detailed documentation on the outcome of this analysis including the investigations performed can be documented for each non-conformance record. Those non-conformances that may be candidates for CAPA will then be submitted for CAPA evaluation.
CQ provides for every non-conformance or event to be systematically evaluated against the CAPA requirements of your organization, and if required, a CAPA can be generated. The CAPA results, including the investigations, corrective and preventive actions, effectiveness plans and verifications are all accessible from the CQ’s NCM solution.
Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up on the ownership of the tasks.
Access your EQMS solution on the go- anywhere, anytime and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts etc. ensures business continuity and improves efficiency, visibility and flexibility.
Utilize pre-developed best practices based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.
Ensuring Quality Across Departments & Locations
ComplianceQuest’s Non-Conformance Management Solution is a comprehensive and configurable solution that enables companies to establish and follow consistent procedures for material or processes that do not conform to desired specifications. The solution supports identification, evaluation, segregation and disposition of non-conforming material as well as investigation and tracking, possibly leading to a corrective action (CAPA). The powerful analytics and reporting capability with graphical dashboards give managers complete real-time visibility into the quality system and provide critical information for addressing non-conformance and executing corrective/preventive actions.
Non-Conformance Management Overview
Non-Conformance Management Screenshots