The answer is clear if we have some background about quality management, and we can build a quality management system (QMS). The definition of quality usually differs from the view of each stakeholder ( people with some stake or concern in the process). Figures 2 through 4 show that the added capability needed to build a more difficult product can come through different combinations of improving people, process, or both.
In today's globalized markets, the competition is fierce, while customer expectations are greater than ever. 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. 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. While this approach has several benefits, it also throws up a number of critical challenges. Traditional systems are typically implemented at the plant or departmental level, and are designed to track product and process quality data. An organization typically has three major quality processes - supplier quality processes, internal quality processes, and customer quality processes.
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.
A single system also makes it easy to aggregate quality-related metrics from downstream sites for effective reporting. MetricStream offers a comprehensive and integrated software solution for managing quality programs within an organization, and strengthening compliance with regulations and standards. Its integrated and centralized approach to quality management enables organizations to create a transparent environment for proactively identifying, tracking, and resolving quality issues. By providing a complete, top-level view of the impact of quality programs on performance, the solution facilitates better strategic decision-making. Being a scalable enterprise system, the solution helps standardize and harmonize multiple quality management methods and processes across the organization. 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 quality management solution provides a centralized supplier quality management framework with real-time views of each supplier’s performance, quality, and compliance. Organizations strive to differentiate themselves on the basis of the quality of their goods and services. 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. Automatically routes quality issues through a systematic process of investigation and root cause analysis.
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.


The MetricStream solution enables a structured, efficient, and streamlined approach to customer complaints management. While every company needs to be concerned about quality, nowhere is it more important than in pharmaceuticals, medical devices, biotechnologies, CROs and other highly regulated industries.
It’s a total solution for quality policy, quality assurance, quality controlling, quality improvement. We can refer to some starndard or guidlines to implement it: CMMi, ISO9000, TQM, six-sigma, lean.
Supply chains are becoming increasingly complex, and regulations around the quality of products and services are becoming more stringent.
Homegrown systems, stand-alone applications, and even manual paper-based systems are often used to support these processes. 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. These processes may be required to comply with quality frameworks or guidelines such as ISO 9000, CMMI, or 21CFR Part11.
However, best practices call for supplier quality, internal quality, and customer quality to be managed using a single, underlying quality management system. 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.
The solution streamlines quality processes across organizations, suppliers, and customers, eliminating redundancies and improving operational efficiencies. 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. Global outsourcing and co-development is on the rise as organizations strive to focus on their core competencies. The solution streamlines the complete supplier governance process - right from onboarding and approval audits, to quality inspections and audits, to corrective actions and chargebacks. 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.
The solution helps ensure closed-loop quality management by closely tracking events as they move from one stage to the next. Being systematic in customer complaints management is also important as it helps generate ideas for product enhancements and new products.
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 companies not only abide by strict internal quality management standards, but they must also comply with a myriad of rules mandated by regulatory agencies. While quality itself is evident in the product you produce, what defines it from a tracking and trending perspective can be subjective. It needs to build a working environment focusing on quality where people can feel proud to join in the processes to create higher quality products. So the answer for Who will help us increasing quality is all people in a company. 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.


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.
Managing quality itself becomes difficult across a proliferation of products and varying customer requirements. As a result, issues slip through the cracks, leaving organizations at the risk of non-compliance and its consequent penalties. Such a system enables streamlined and closed-loop quality processes with automated workflows and notifications to help ensure that nothing slips through the cracks.
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. In addition, its integrated Web-based capabilities support seamless collaboration and information sharing with suppliers. Graphical executive dashboards with drill-down capabilities provide real-time quality statistics, analytics, and trending information, enabling data-driven decision-making. 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. These details are automatically routed to the appropriate personnel for investigation and root cause analysis. By centralizing workflow management, consolidating tracking and streamlining regulatory reporting, companies are strategically positioned to identify and manage quality compliance issues across critical business processes.
Most would agree that at the core of every quality system – and every quality program – is Documentation and Documentation Management. FDA, the European Medicines Agency (EMEA) and regulatory bodies worldwide expect life science organizations to eliminate fragmented data silos and create a continuous, documented process for managing research, development, distribution and post-market events. 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. In addition, trying to juggle compliance with local and global quality regulations and guidelines can be a risky endeavor.
Implementing an integrated quality management system not only meets regulatory expectations, it also provides a structured framework that proactively monitors global compliance, reduces risk and lowers the total cost of quality.
Who and how to assure quality if members already tried their best but the product output is casehard to be judged ?
This enables top management to quickly identify and resolve areas of concern, thereby reducing the cost of poor quality. What companies choose to put in their quality management system is as varied as the number of vendors that provide the capabilities. Non-compliance can result not only in fines and severe penalties, but also in delays in customer shipments, and a loss of brand equity.



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