White Papers
Understanding, experience and technology for success

MetricStream QMS for Compliance and Quality Management

Do you want to:

  • Implement a closed-loop corrective action process to improve product or process quality?
  • Reduce the cost of poor quality within your operations or due to suppliers?
  • Achieve regulatory compliance with standards from organizations such as FDA, USDA etc. or comply with initiatives such as ISO9000 or TS16949?
  • Use KPIs to drive continuous improvement and the 8D process?
Organizations are successfully implementing enterprise-wide quality and compliance systems to gain visibility and control over key quality processes across their operations and to ensure compliance with government regulations, industry mandates, company policies and internal initiatives. Such systems allow organizations to achieve regulatory compliance with standards such as 21CFR Part 11, cGMP, OSHA or TREAD. They also allow organizations to comply with industry mandates such as TS16949 or QS9000:2002 or implement internal initiatives such as ISO9000 or six sigma.

Quality and compliance systems enable companies to identify, track, manage and correct issues and exceptions in key operational processes. If quality issues are not managed in a systematic, enterprise-wide manner, they result in line shutdowns, reduced employee productivity, higher internal costs, loss of key customers, and slower revenue recognition. Not achieving compliance with government regulations can lead to penalties, fines and plant shutdowns. Gaining enterprise-level visibility into key quality and compliance metrics is critical to managing risk and implementing continuous improvement practices throughout the organization.

MetricStream QMS, an industry leading Enterprise quality and compliance system from MetricStream, addresses these needs. Based on a scalable J2EE architecture, it is designed to function standalone, or easily integrate with ERP, CRM and other enterprise applications. MetricStream QMS is built for world-wide, mission-critical deployment and is typically implemented in a few weeks.

MetricStream QMS provides companies with tangible ROI...

  • Reduce Direct Labor Costs
    Improvement in efficiency of Quality Engineers (QEs), Aud itors and others
  • Reduce Material Costs
    Reduce raw material, manufacturing and scrap costs
  • Improve Line Utilization
    Prevent line downtime caused by poor material quality, non-conformance and other causes
  • Facilitate Continuous Improvement
    Enterprise-wide platform for all quality and compliance information provides full management review
  • Achieve Compliance with Government Regulations, Industry Mandates and Internal Initiatives
    Reduce risk and penalties associated with non-compliance

Closed Loop Control

MetricStream QMS Modules

AUDITS Manage all audits in the enterprise, including 3rd party audits, ISO audits etc. Create a central repository of all activities for regulatory and compliance business processes.
INSPECTION Collect, analyze and plot key inspection information through raw materials, work-in-process and finished goods
NON-CONFORMANCE Manage material and process non-conformance, internal corrective actions, preventive actions and root cause analysis, and integration to RMAs, customer complaints, audits and other regulatory processes. Tightly integrate into financial and business performance metrics.
CORRECTIVE/
PREVENTIVE ACTIONS
Integrate inspection and supplier corrective actions, with full collaboration to provide users a comprehensive view of cost of poor supplier quality, supplier responsiveness and performance.
DOCUMENTS Create a central repository and associated business processes for all documents, and seamlessly share with employees, customers, auditors, reviewers, managers and suppliers.
EQUIPMENT Manage all maintenance, calibration, repair, R&R, check in/check out and other activities associated with capital equipment. Manage kits, gages and other associated accessories.
TRAINING Manage employee certification, classes, training plans, gap analysis and authorization.

Sample Process Flow

MetricStream QMS - The Industry Leading Enterprise Quality Management System

  • Features full collaborative workflow capabilities, including flexible routing, escalation and workload assignment
  • Tightly integrated with KPIs for management visibility and control
  • Can be implemented as a stand-alone application suite, or can be integrated with existing ERP, CRM and MES application suites
  • J2EE-based scalable architecture is designed for worldwide, mission-critical deployment

Features

  • Integrated audit management, non-conformance tracking and closed-loop corrective action with change control and document management
  • 100% configurable to manage custom business processes through graphical process designer
  • Standalone mode, or Seamless Integration to legacy and other enterprise applications
  • Process flow engine drives problem resolution through the correct functional roles
  • Out-of-the-box best practice workflows for regulated and discrete manufacturing sectors
  • Best-practice metrics for supplier performance management & scorecards
  • Automatic Exception-based Diagnostics collect all necessary information to analyze exceptions
  • Automatic generation of possible alternatives for impact mitigation
  • Real-time, role-based dashboards for suppliers, customers and employees
  • Persistent, searchable repository of previous exceptions and resolutions
  • Fully validated 21 CFR Part 11 Compliant solutions for FDA regulated industries
  • Compliance with FDA, USDA, OSHA or NHTSA regulatory standards

MetricStream is a market leader in Enterprise-wide Quality and Compliance Management for global corporations. MetricStream solutions are used by leading corporations in diverse industries such as Automotive, Food, Pharmaceuticals, Manufacturing and Electronics to manage their quality processes, regulatory and industry-mandated compliance and corporate governance initiatives. MetricStream is headquartered in Palo Alto, California and can be reached at www.metricstream.com