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ISO Nonconformance and cost of conformance

Ensuring Quality Across Departments & Locations

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ISO Nonconformance and cost of conformance

What is ComplianceQuest’s Nonconformance Management Software?

Identifying and managing product and process Nonconformance 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. CQ’s Nonconformance Management Solution provides the required framework to capture, triage, investigate and disposition all nonconformances in a timely and effective manner.

ISO Nonconformance Management Features

Identification - CQ’s ISO Nonconformance Management Software

Identification

CQ’s ISO Nonconformance Management Software 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.

End to End Documentation by CQ’s ISO Nonconformance Management Software.

Documentation

Simple, easy-to-use Nonconformance user interface allows instances of Nonconformance from one or multiple sites. Critical information such as the product, process, lot/unit/batch, processes and location can all be documented.

Evaluation - ISO Nonconformance Management

Evaluation

CQ’s ISO Nonconformance Management software enables comprehensive triaging of all quality events and instances of Nonconformance 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.

Containment - ISO Nonconformance Management

Containment

When a quality event or a Nonconformance is determined to impact production, CQ’s QHSE 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.
Disposition - ISO Nonconformance Management

Disposition

CQ’s ISO Nonconformance Management Software enables users to propose different disposition types and hold virtual material review boards. CQ’s QHSE Platform makes possible the collaboration that may be required between employees from one or multiple sites and divisions to work on reducing a Nonconformance.

Root Cause Analysis - ISO Nonconformance Management

Root Cause Analysis

CQ’s ISO Nonconformance Management Software 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 Nonconformance record. Those Nonconformances that may be candidates for CAPA will then be submitted for CAPA evaluation.

CAPA Evaluation - ISO Nonconformance Management

CAPA Evaluation

CQ provides for every nonconformance 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.
Collaboration - ISO Nonconformance Management

Collaboration

Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up ownership of the tasks.

Anywhere, anytime and on any device. Complete access to the solution

Mobile Access

Access your QHSE 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.
Connect on Social Media Platforms

Social Like & Follow

Like and follow relevant records in the system. Choose to be notified via email, dashboard, and mobile to stay abreast of developments.
Reporting and Analytics - ComplianceQuest

Reporting And Analytics

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.

ISO Nonconformance Management Datasheet

Ensuring Quality Across Departments & Locations

ComplianceQuest’s ISO Nonconformance Management Software 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 Nonconformance and executing corrective/preventive actions.

 

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