Quality Management

Key Benefits

  • Improve customer relations and focus
  • Reduce the cost of lost time, recalls and litigation due to quality incidents
  • Significantly reduce the on-going cost and improve overall efficiencies of quality management system implementation and maintenance
  • Increase the consistency and comparability of quality performance across sites, business units or your entire corporation
  • Provide instant dashboard visibility of enterprise-wide quality compliance
  • Reduce the cost and effort involved with management system certification
  • Improve corporate brand reputation and recognition
  • Provide processes for continuous quality improvement and business performance

A Quality Management System is a common sense, well documented system that ensures consistency and improvement of working practices, including the products and services produced. It provides a framework for continuously improving quality.

Entropy® Software has a Quality Management module which can be used on its own or integrated with other Entropy Software modules like Environmental or Health & Safety to provide a fully integrated, certifiable and enterprise-wide management system solution.

Entropy Software allows users to add and integrate any number of risk disciplines into their management process to provide a complete framework for managing risk across an organization. It is designed to manage data effectively and efficiently to improve performance management, corporate reporting, and information and document management.

The Quality Management module is provided complete with all five key workflows of Entropy Software.

Key features of the Quality Management module include:

  • Document Control
    Document control tool helps increase the efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation making access to the information easy irrespective of geographic location. It integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., to provide a track-able process for continuous quality improvement.

  • Corrective and Preventive Action System
    The corrective and preventive Action tool interconnects different quality subsystems and tracks incidents that can escalate into a corrective action. A CAPA tool can be launched from any other part of the system (e.g., nonconformance), automatically entering relevant data and creating references and creating audit trails necessary to show compliance to auditors and regulators.

  • Change Control
    The change control tool provides capability to associate and track change requests for a specific product or product batch. It offers capability to incorporate priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change implies great impact on the product and is likely to require regulatory filing. Customizable reports provide real-time status of the entire quality system.

  • Training Management
    In FDA and ISO environments, companies are required to implement and document employee training to make sure that their personnel know how to perform their duties within company and industry guidelines. Adequate and continuous personnel training is deemed essential in manufacturing safe, reliable, and high-quality products. As a result, training control is critical to FDA and ISO compliance. The training tool automates assignment and monitoring of training tasks and tracking employee competency to meet manufacturing and regulatory requirements. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

  • Nonconformance Management
    The Nonconformance tool is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming equipment inventory, components, parts, and finished products. The nonconformance tool effectively connects all responsible personnel for timely disposition of a nonconformance. The tool offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or connect it to the CAPA process for automatic escalation when the situation warrants.

  • Audit Management
    The Audit tool automates, streamlines, and effectively manages the audit process. It provides capability to schedule, plan, execute and complete audits. The tool helps track audit information and audit findings. It automates scheduling of all recurring audit-related activities and provides analytics and reporting capability, so managers get a real-time view of the audit process.

  • Reporting
    In any industry involved in Quality Management, FDA Compliance Management, or Environmental Health & Safety, decision makers need to control and manage their business, without going through extensive reports to analyze the data to support those decisions. The reporting tool provides  Instant access to reports and allows managers and executives to concentrate on analysis and decision-making rather than system maintenance and data validation. Any QMS systems needs to provide the ability to quality events as a starting point for containment, corrective action, and preventive action. Examples of such as non-conformances, action plans to fix non-conformities, deviations from requirements, variances in manufacturing compared to requirements / demands and Customer Complaints. Other issues and observations such as irregularities in supplier products quality, manufactured batch of products, and others which may occur that do not fit any of these categories with the consequence of either being ignored or fed into a quality tracking system irrespective of suitability. These lead to quality – related information being lost or lack of visibility into the actual problem. The reporting tool provides detailed site reports for all tools, extensive category and query filter options, email reminders for overdue and pending tasks, Organization-wide roll-up reporting

  • Equipment Inventory
    The equipment inventory tool is designed to manage the configuration of equipments, systems and instruments as electronic records. The system allows companies to improve the reliability of their quality information, increasing the level of compliance while reducing the time spent daily to ensure that GxP or ISO requirements are met. The tool allows organizations to track all equipment, track historical maintenance and calibration records, and can provide reminders for inspection and calibration reviews.

  • Management Review
    Management Review is the vital cog for creating value from a QMS. In addition to fulfilling the standard requirements of ISO 9000 group of quality standards, the management review tool can be used as evidence of top management’s commitment to the QMS. The Management review tool helps schedule management reviews, document agendas, attendance and minutes. The tool also automatically creates actions plans and tasks as outcomes of the management review.

  • Products and Services
    The Products and Services tool plays a vital role in the management of product development through its components, subcomponents. The tool allows organizations to track product realization planning, managing the product lifecycle, tracks and control all data that is related to a particular product. By tracking and controlling all data that is related a particular product organizations can seamlessly track control of production and service provision, and are can track purchasing information for the components, suppliers, verification of purchased product and effectiveness of processes.

  • Legislative and Other Requirements
    The Legislative and Regulatory Requirements application assists organizations in identifying, accessing, and evaluating laws, regulations, Track customer-specific product requirements and internal organizational requirements that apply to the manufacturing aspects of its activities, products, and services. Identifying these regulations helps to evaluate their potential impacts on the company and its products, activities and services. The application helps with the creation of summaries of legislations, permits and codes of practices that need to be strictly followed. Tracks associated records necessary to show compliance with regulatory authorities over manufacturing processes and activities. Allows creation of reminders for reporting requirements so that improve compliance, save on penalties and maintain brand image.

  • Action Plans
    A Corrective & Preventative Action tracking software system is the core part of any quality management system. It is also a regulatory requirement that both FDA and ISO auditors consider critical to show compliance to quality management standards. When implemented properly, a Corrective Action software system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance. The Action Plans software allows organizations to create actions plans, allocate responsibility, tracks request that routes through review, determine root cause and helps defining task dependencies and miles stones. The software also provides the capability to allow reminders to be generated for completion dates, escalation through management structure on incomplete actions and providing an effective mechanism for tracking the source and costs of problems.

These and more provide senior managers and directors with all the tools necessary to identify, assess and manage quality risks and responsibilities across your business.

Entropy Software's Quality Management module supports the process of implementing and maintaining a management system certifiable to ISO 9001.

If you would like to learn more about how Entropy Software can help your business, please let us know your contact details.