In today's globalized markets, the competition is fierce, while customer expectations are greater than ever. Supply chains are becoming increasingly complex, and regulations around the quality of products and services are becoming more stringent. Organizations are thus under increasing pressure to demonstrate their commitment to quality based on the implementation of effective quality management systems, good corporate governance practices, sound environmental policies, and a robust safety culture. As a result, companies are seeking to deploy Integrated Quality Management Solutions that can bring all business units under a single program, replace segmented decision making, and lead to successful synergizing of the supply chain.Download a Solution Brief
Many organizations have deployed quality management industry standards, methodologies and guidelines such as ISO, IEEE, SAE, DMAIC, cGMP, Six Sigma, 8D and others to reduce costs, shorten manufacturing cycle times, and improve overall product and process quality. Homegrown systems, stand-alone applications, and even manual paper-based systems are often used to support these processes. However, such point-solutions lack a broad enterprise reach, and thereby fail to address systemic quality problems, or provide top-level visibility into quality management processes.
As a result, many companies are seeking to deploy Integratedt Quality Management Solutions that can bring all business units under a single program, replace segmented decision making, and lead to successful synergizing of the supply chain.
As market boundaries dissolve, organizations around the world are rapidly expanding their reach. Not only are they catering to customers across geographies, but they are also sourcing raw materials from different countries, and outsourcing processes such as manufacturing and assembling to a global ecosystem of suppliers.
While this approach has several benefits, it also throws up a number of critical challenges. The cost of quality, for instance, increases with a complex global supply chain. Managing quality itself becomes difficult across a proliferation of products and varying customer requirements. In addition, trying to juggle compliance with local and global quality regulations and guidelines can be a risky endeavor. Every country/region has its own regulations that organizations with global operations, supply base and markets need to ensure compliance with. Non-compliance can result not only in fines and severe penalties, but also in delays in customer shipments, and a loss of brand equity.
Traditional systems are typically implemented at the plant or departmental level, and are designed to track product and process quality data. However, they fail to address enterprise quality concerns or even exceptions. As a result, issues slip through the cracks, leaving organizations at the risk of non-compliance and its consequent penalties.
To avoid such risks, organizations are implementing integrated quality management systems that break down business/ functional silos, and enable a centralized approach to managing quality and compliance across all enterprise stakeholders - including internal staff, global suppliers, and customers.
Benefits of Integrated Quality Management
Integrated Quality Management
An organization typically has three major quality processes - supplier quality processes, internal quality processes, and customer quality processes. These processes may be required to comply with quality frameworks or guidelines such as ISO 9000, CMMI, or 21CFR Part11.
Historically, these quality processes have been managed in silos. However, best practices call for supplier quality, internal quality, and customer quality to be managed using a single, underlying quality management system. Such a system enables streamlined and closed-loop quality processes with automated workflows and notifications to help ensure that nothing slips through the cracks.
A single quality management system is also useful in effectively resolving customer quality related complaints which may require the organization to work closely with one or more internal manufacturing sites and even certain suppliers to address the root cause of the complaint. With a single integrated system, it becomes easier and more efficient to track and manage the customer quality process, ensure that issues have been resolved, and communicate responses back to the customer.
A single system also makes it easy to aggregate quality-related metrics from downstream sites for effective reporting. In addition, it provides the organization a 360-degree view of quality-related risks.
MetricStream Integrated Quality Management Solution
MetricStream offers a comprehensive and integrated software solution for managing quality programs within an organization, and strengthening compliance with regulations and standards. The solution streamlines quality processes across organizations, suppliers, and customers, eliminating redundancies and improving operational efficiencies.
Its integrated and centralized approach to quality management enables organizations to create a transparent environment for proactively identifying, tracking, and resolving quality issues. It also breaks down organizational silos, enabling departments and business units to collaborate on investigating quality issues, and arriving at a solution that can then be deployed across organizational units.
Embedded best practices support compliance with standards and regulations such as ISO 9000, Six Sigma, ISO /TS 16949, ISO /TS 29001, ISO 22000, ISO /IEC 20000, AS9100, QS-9000, TL 9000, FDA 21CFR Part 11, Quality System Regulation, and ISO 13485:2003.
By providing a complete, top-level view of the impact of quality programs on performance, the solution facilitates better strategic decision-making. It also enables more efficient planning of quality programs and allocation of resources.
Being a scalable enterprise system, the solution helps standardize and harmonize multiple quality management methods and processes across the organization. It also helps align quality systems and processes with operational and business processes, thus promoting a more business focused approach to quality audits and compliance. Audit results from across suppliers and internal units are consolidated in a single database for top management to easily identify trends and areas of concern.
The solution also has built-in checks and balances which prevent users from making inadvertent mistakes, and thereby enabling and the organization moves in direction of greater overall accuracy in quality management.
MetricStream Solution Highlights:
Supplier Quality Management
The nature of an organization's relationship with its suppliers has dramatically changed. Global outsourcing and co-development is on the rise as organizations strive to focus on their core competencies. With more suppliers being added to the supply chain, there is an increasing need for organizations to put in place an advanced system that can increase visibility into supplier quality, improve accountability, and reduce the cost of poor quality.
MetricStream quality management solution provides a centralized supplier quality management framework with real-time views of each supplier’s performance, quality, and compliance. The solution streamlines the complete supplier governance process - right from onboarding and approval audits, to quality inspections and audits, to corrective actions and chargebacks. In addition, its integrated Web-based capabilities support seamless collaboration and information sharing with suppliers.
- Automatically aggregates supplier data from various sources such as self-assessments and surveys, to provide a consolidated and quantifiable risk profile of each supplier
- Helps monitor supplier performance through advanced and configurable scorecards
- Facilitates risk-based supplier audits, thereby enabling optimal utilization of resources
- Supports the identification, evaluation, segregation, and disposition of non-conforming material
- Tracks supplier non-conformance issues in real time
- Provides powerful capabilities to capture problem data from anywhere across the enterprise, conduct failure analyses to investigate the root cause of the problem, and manage interim containment action items, as well as long term corrective action
- Facilitates a collaborative and proactive approach to supplier corrective action management
- Automates cumbersome processes such as notifying suppliers of corrective action requests, and alerting them if deadlines are missed
- Enables efficient management of supplier chargebacks - right from aggregating the costs of an incident, to collaboratively resolving the disputed recovery amounts
MetricStream Solution Highlights:
Internal Quality Management
Organizations strive to differentiate themselves on the basis of the quality of their goods and services. However, the growing mix of complex products and global expansion of business operations require a new approach to internal quality management - one that unifies processes, and provides complete visibility into these processes across the global enterprise.
MetricStream’s quality management solution is enabling leading organizations to replace their point solutions and paper-based systems with an integrated framework that streamlines and automates internal quality management processes. The solution helps ensure closed-loop quality management by closely tracking events as they move from one stage to the next. Graphical executive dashboards with drill-down capabilities provide real-time quality statistics, analytics, and trending information, enabling data-driven decision-making.
- Offers innovative capabilities for efficiently planning, scheduling, and conducting internal quality audits
- Automatically routes quality issues through a systematic process of investigation and root cause analysis. Supports industry standard methodologies like 8D, 5 Why, DMAIC etc.
- Enables quality risk assessments and analysis
- Accelerates the recording and routing of non-conforming material for review and disposition
- Enables cross-functional teams to collaborate closely on the development and implementation of CAPAs
- Streamlines document control for SOPs (Standard Operating Procedures), batch records, regulatory filings, quality reports, and other documents
- Supports training process by maintaining course offerings for easy review, helping schedule classes, managing feedback, and archiving training records
- Enables automated and work-flow driven scheduling for routine equipment calibrations
- Imports internal quality metrics from various organizational systems to provide an aggregated quality score which can be leveraged to identify areas of improvement
MetricStream Solution Highlights:
Customer Quality Management
Visionary organizations are realizing that handling and resolving product or service quality issues reported by customers in a consistent, efficient, and predictable manner is critical to customer loyalty and repeat business. Being systematic in customer complaints management is also important as it helps generate ideas for product enhancements and new products. Moreover, regulations from organizations such as the FDA, and quality standards such as ISO 9000, require well-defined guidelines for recording, responding to, and resolving customer complaints.
The MetricStream solution enables a structured, efficient, and streamlined approach to customer complaints management. Any complaints or issues reported by customers are captured in detail from across sources such as phone calls and emails, and recorded in measurable and specific terms. These details are automatically routed to the appropriate personnel for investigation and root cause analysis. All customer issues and complaints can be tracked and quantified in real time. This enables top management to quickly identify and resolve areas of concern, thereby reducing the cost of poor quality.
- Enables teams to collaborate closely on the development and implementation of CAPAs, assigns follow-up actions, and enables effective tracking of complaint cases from initiation to closure
- Provides complete visibility into the customer complaints lifecycle as well as individual case status tracking
- Allows complaints data to be viewed by a variety of parameters such as status, category, priority, and action type
- Facilitates systematic review and approval workflows for product changes
- Standardizes the process of initiating and communicating product changes to all affected customers as well as internal groups
- Automates report creation, thus minimizing the manual effort involved
- Supports generation of reports in customer mandated formats and files
- Integrate quality management across processes, people, and technology in a single system for greater transparency and collaboration
- Streamline end-to-end quality management workflows, thus minimizing redundancies and duplicate actions
- Simplify and strengthen compliance with quality related regulations and standards such as IEEE, ISO 9001:2000, CMMI and Six-Sigma
- Reduce the risk of poor quality, and enhance the achievement of company objectives
- Establish clearly defined roles and responsibilities for integrated quality management, thereby ensuring accountability
- Automate various quality management processes, thus minimizing manual effort and documentation
- Enable a risk-based approach to quality management, making it easier and more effective to prioritize key issues and areas of concern
- Ensure quick adoption of the MetricStream solution through intuitive and easy-to-use capabilities