Quality Management

Organizations must provide products that meet customer and regulatory requirements. You can accomplish this by putting systems into place that ensure conformity to these requirements and that support continuous improvement in customer satisfaction. Quality management initiatives can be internally driven or focused on certification initiatives such as ISO 9000 and ISO 9001:2000. OpenText provides solutions that facilitate quality management by enabling you to document processes, establish automated review and approval procedures, distribute standard operating procedures (SOPs) and link them to their respective processes; train employees on compliance; manage quality certificates, inspection reports, and master batch records; and manage your response to customer complaints and other quality-related incidents.

Business Goals

Maintain control over processes required to deliver quality
Provide quality and compliance training to employees
Manage documentation and training certifications to demonstrate compliance
Manage quality certificates, inspection reports and supplier non-conformance processes
Respond effectively to quality incidents and customer complaints

OpenText Quality Management solutions deliver this functionality with the following components:

Software
Livelink ECM - Accreditations Server, Content Lifecycle Management, Livelink ECM - Eloquent Media Server Archiving, , Document Management, , Extensions for SAP Solutions, Knowledge Management, Project Management

Supplemented by Business Content (e.g., predefined workflows) to give you a head-start in configuring workstreams and processes, Consulting Services, Training and Support tailored to meet your requirements.

Activities

Quality Management involves Audit Management, Batch Record Management, Complaint Management, Document Lifecycle Management, Employee Training & Accreditations, Quality Certificate Management, Quality Incident Management and Quality Inspection.

Audit Management

To pass a quality audit, you must demonstrate that you are managing documentation for quality policies, procedures, and reference materials required to support the process and record the test results. OpenText provides a quality management solution that makes it easy for you to demonstrate all this— with appropriate versioning and evidence approvals to make all documentation available for the auditor's perusal. OpenText solutions also provide learning management capabilities that facilitate employee training and certification programs and demonstrate compliance to the auditor.

Solution Adaptations: Archiving, , Document Management

Batch Record Management

If you need to trace the flow of raw materials into product lots or individual serial numbers, you must implement a system for creating and storing batch records. OpenText supports the storage and archiving of master batch records so that you can effectively manage the post production processes that support product quality. OpenText solutions integrate with your Enterprise Resource Planning (ERP) system, so that your staff has a single view across systems in order to quickly analyze batch problems when they arise.

Solution Adaptations: Archiving, , Document Management

Complaint Management

Your customer is the final judge of the quality of your product and it is essential that you manage the flow of information so that you can track customer complaints and track the source of quality issues. OpenText solutions integrate content across systems into a single view so that your staff can quickly locate the relevant information and retain all correspondence, including emails, that relate to the quality incident.

Solution Adaptations: , Document Management, Project Management

Document Lifecycle Management

Document Lifecycle Management requires compliance with policies, procedure, and regulations supported by controlled documentation. Organizations must implement systems that manage document authoring, modifying, approval and publishing processes so they can manage quality and demonstrate compliance during quality audits.

The OpenText solution is a complete Web-based solution that manages key documents such as standard operating procedures, quality assurance reports, regulatory submissions, and others throughout a controlled lifecycle.

Ensures consistency in the development of critical documentation
Controls the review process, ensuring revisions are correctly applied to documents
Manages the approval process with built-in workflow and security features
Automates processes to ensure that documents are released in accordance with your organizational policies and regulatory requirements

Solution Adaptations: Content Lifecycle Management

Employee Training & Accreditations

OpenText provides solutions for learning management and employee accreditation that maximize employee effectiveness and demonstrate appropriate training during quality audits.

Solution Adaptations: Livelink ECM - Accreditations Server, Livelink ECM - Eloquent Media Server

Quality Certificate Management

To track product quality and compliance, OpenText solutions manage quality certificates in a secure repository in the context of the supplier, product and batch lot. OpenText solutions integrate with your ERP system so that quality certificates are attached to the appropriate transactional data.

Solution Adaptations: Archiving, , Document Management, Extensions for SAP Solutions

Quality Incident Management

OpenText provides case management solutions that let you respond to incidents involving the quality of your products and services and the satisfaction of your customers.

Solution Adaptations: , Document Management, Extensions for SAP Solutions, Knowledge Management, Project Management

Quality Inspection

To ensure product quality, you must start with quality materials and implement processes to monitor the entire manufacturing process. OpenText solutions support your quality inspection process by enabling you to document non-conformance and manage the collaboration with external suppliers and internal staff to resolve problems. OpenText solutions integrate seamlessly with your ERP system, so that quality management can integrate the data with the documentation for the inspection and the correspondence leading towards resolution. OpenText solutions provide comprehensive workflow capabilities that enable you to manage the processes around all aspects of product quality.

Solution Adaptations: Archiving, , Document Management, Extensions for SAP Solutions