Quality management for multisite manufacturing

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In any enterprise plan, 'Quality' is central to the process, and in getting products out to market, a Hi-tech enterprise plan requires an effective global quality management system to manage the entire spectrum of activities towards final delivery. The ISO 9000 series are Quality System Standards recognized all over the world, and ensures that organizations have a sound quality system in place to meet their customer's highest manufacturing standards and to promote customer satisfaction. With ISO 9001:2000 set to replace ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, and organizations that are already ISO 9001 certified required to update their quality systems to meet the new ISO 9001:2000 requirements, its time to migrate to the next level in qualitative standards. The new standard being more specifically customer-oriented, expects organizations to communicate with its customers, and monitor customer satisfaction, thus helping reduce non-conformance issues that customers may have had in the past as well as forging better understanding between the customer and vendor in the future.

Quality Approach for Hi-Tech
In the old economy, businesses were relatively slow compared to the speed, connectivity, and interactivity of today's connected economy. Quality assurance meant running a couple of tests right before the product was shipped out. In the old economy 'quality initiatives' for the supply chain were purely focused internally with little emphasis on collaboration or customer satisfaction. The predominance of cost reduction compared to growth & profitability, organizational ideology created a reactive rather than a proactive or long-term approach to 'quality initiatives'.

In the new connected economy, 'Quality' is the watchdog that helps organizations set corporate objectives and financial goals, which translates into an effective well-planned process. Today with the high-speed world of the Internet, the most important factor in business success is 'time-to-market'. This has resulted in compressed product development cycles and immense pressure for organizations to get their products out to their customers, while leaving them little room for error. With this drastic change in quality assurance and testing, organizations that clearly define their 'Quality Approach' and adhere to the management principle of highest product quality combined with the best customer service are the ones that will capitalize on markets, competition and customers.

These organizations need to effectively channel and manage their 'Quality Approach' towards innovation, technical advances, and precision quality in R&D, while not only providing competitive price benefits for customers but also product enhancements and improved reliability. The implementation of a 'Quality Approach' provides organizations with an effective process system that helps optimize the design and development of new products by identifying and measuring progress, and one that allows modifications at specific intervals/all times. In addition, the 'Quality Approach' must start with qualified personnel who can be designated to establish responsibility and accountability for design and development activities, and provide adequate resources. The approach must allow for each department to communicate information in written form, which can then be reviewed periodically. It is also imperative that the testing and verification of the product at each design stage, ensures continued compliance with the design specifications.

This staged approach along with the establishment of 'quality circles', setting up of systemized quality procedures and continual improvement will guarantee an increase in customer satisfaction. Most importantly, quality is not about systems but about people, and to achieve any success with the 'Quality Approach' it must start with the people in that organization. It's the people in any organization who make quality a possibility, and only their dedication, consensus and constant involvement at all levels of the organization ensures 'total customer satisfaction'. Providing employees with the best tools helps optimize their skills in delivering the best. Following a process management 'Quality Approach', customer-focused organizations can internally enhance the design, development, production, testing and installation processes, and in accordance with the ISO regulations, set and maintain various control/test procedures at all stages of product design.

Requirements of the Quality Standard - ISO 9001: 2000
ISO Quality Standards require continual revisions to increase their effectiveness and satisfy the needs of users worldwide, and are therefore periodically revised as per ISO directives. The ISO 9001: 2000 revision focuses on the processes within the organization and applies to all types of organizations, irrespective of size or space, helping both product as well as service oriented organizations in achieving standards of quality that are recognized and respected all over the globe. ISO 9001:2000 replaces ISO 9001: 1994 while ISO 9002: 1994 and ISO 9003: 1994 quality standards have become obsolete. Organizations that are ISO 9001 certified will need to update their quality system in order to meet the new ISO 9001 2000 requirements, while ISO 9002 or ISO 9003 certified organizations will need to become ISO 9001:2000 certified.

The structure of ISO 9001:2000 was completely altered in comparison with ISO 9001: 1994 and ISO 9002:1994 with the name 'Quality System' changed to 'Quality Management System', while the scope was extended to include - applicable regulatory requirements, customer satisfaction, continual improvement and permissible exclusions. Customer satisfaction being the key objective of the ISO 9001: 2000 'Quality Management System' there is considerable emphasis on customer communication. To ensure focus on the customer its essential that organizations determine customer needs and expectations, be aware of customer requirements and consider these requirements in establishing objectives for improvement. The most important changes with regard to the terminology concern the use of the term "organization" instead of "supplier" and the use of the term "supplier" instead of "subcontractor". In order to tackle the wide range of organizations and activities that would avail the new standard, "permissible exclusions" to the requirements of ISO 9001:2000 was introduced.

The New Requirements of ISO 9001:2000 have five main clauses that replace the 20 clauses of the 1994 standard -

• Scope
• Normative Reference
• Terms and Definitions
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement, Analysis and Improvement

The 1994 version required conformance with 20 clauses and the lack of connection between the order in which they were listed and with the number of clauses, was proving problematic for most organizations. The quality manuals were rarely used since it never reflected the way most organizations conducted their business. With ISO 9001: 2000 organizations can look forward to developing a quality system that truly reflects the actual processes of their business enterprise, and not one that meets a set of clauses that may bear no relevance to it.

ISO 9001: 2000 considers continual improvement to be a planned process and one that must be demonstrated with the requirement to establish, communicate, monitor, and measure quality objectives further aiding the continual improvement process. 'Process' is an important and clearly emphasized part of the standard and ISO 9001:2000 Quality Management System is made up of at least 21 processes. In fact, the Quality Management System as a whole is a process and lays emphasis on understanding and meeting customer requirements, considering processes from the customer's perspective, evaluating processes in terms of performance and effectiveness and using objective measurements of process as the basis for continual improvement.

Transitioning to ISO 9001: 2000
By December 15, 2003 all organizations must register to the ISO 9001:2000 standard, and most experts recommend a quick transition, so that organizations can reap the benefits of early adoption. The transitioning will help organizations save time and resources by improving their quality systems and having to maintain only one quality system

There are many challenges that organizations will face as they attempt to develop and implement the ISO 9001:2000 quality management system. Primary among them are the following -

• Top management must have an expanded role and demonstrate leadership in directing and supporting the quality management system through a variety of methods from establishing and monitoring achievement of measurable quality objectives to communicating customer requirements to the work force. Top management must be involved during the development, as well as the implementation and maintenance of the quality management system.
• Organizations that seek ISO 9001: 2000 have a considerable task cut out for them in process documentation. Understanding and documenting its processes is going to be the most critical aspect. It’s important for organizations to realize the significance of a process approach and that it clearly applies to all activities that influence quality in their enterprise. Defining the process inputs, outputs, flows, measurement points and boundaries and understanding the aspects of each process to help identify which process parameters affect product conformity. Organizations need to establish the process parameters that can be monitored and measured to ensure conformity of product and suggest plans for actions to be taken when out-of-control signals are detected.
• Customer satisfaction is a critical area, where organizations must gather and analyze data that defines the customer's perception of how they are doing, and take appropriate improvement action. The information is to be communicated at all levels in the organization and analyzed, with inputs to the management for review.
• Its essential to have the full involvement of people at all levels in the organization, as it helps in forming effective decisions based on logical and intuitive analysis of data and information in achieving the right quality management system
• Improve the effectiveness of the quality management system by drawing on the quality policy along with the quality objectives, audit results and analysis of data with management review. Applying corrective and preventive action will go a long way toward driving continual improvement.

The benefits associated with the new certification are many - It has a logical structure and is easy to follow, consistent and profitable. The standard helps confer international recognition that is a crucial factor in global business. The new standard is far superior, mature and takes a realistic approach that enables organizations to gain actual returns in business and the potential of an increased market share. Increase in awareness of an employee's role in company functions and activities, which can lead to a considerable increase in output. ISO 9001 relies on a system of audits to provide assurance that the organization is meeting the requirements of the standard and includes an inspection of the documents and records that make up the organizations quality system. Most importantly it is an inspection of the way the people in the organization work and their knowledge about the operation of the quality management system. Although it is required that the organization carry out scheduled and planned internal audits of the quality management system, this in itself is not sufficient to obtain registration. Only a "third party registration agency" is accredited to issue a certificate attesting that an organization meets the requirements of the ISO 9001 standard.

The MetricStream Solution - Power Your Enterprise
Designed specifically for multi-site manufacturing in the hardware-manufacturing sector, contract manufacturing and assembly services which addresses key quality-related issues that enable Hi-Tech firms to achieve high growth

Hardware manufacturers face a dual challenge of shrinking product cycles and faster time-to-market requirements. Moreover, rapid globalization and increased service competitiveness has firmly put the focus on efficiency and quality improvement in products and processes. Hi-Tech firms that invested in enterprise software to manage inventory, financials and orders are gradually adopting solutions to reduce part defect rates and maintain supplier relationships.

MetricStream's enterprise-class quality management solutions (QMS) address key qualityrelated issues that would enable Hi-Tech firms to achieve high growth including -

Supplier Improvement - The ability to track supplier performance parameters including response times, inspection histories and preventive action reviews to facilitate Supplier Improvement initiatives and also help in price negotiations as a result of supplier's cost effectiveness

Metrics - The ability to measure costs of quality, measure parameters that relate to suppliers and provides visibility to all levels of management internally as well as to end customers and partners

Corrective and Preventive Action (CAPA) - Real-time reporting of problems combined with flexible workflows to ensure quick time to resolution

Non-conformance Management - Review of supplier materials, and in-process and finished goods to ensure conformance to specifications and standards

Audits and Inspections - Conducting internal audits or 3rd party supplier audits to ensure adherence to systems and identifying improvement opportunities. Product inspection helps in identifying and reducing the material defects and also enable trend analysis on inspection history to facilitate improvement measures aimed at improving overall finished or end product quality

MetricStream's seamlessly integrated suite of web-based products, facilitate enterprise- wide deployment and assist customers throughout all phases of installation and deployment.

Technical Details

• Fully web-based with an intuitive, easy-to-use user interface.
• J2EE and XML compliant, n-tier architecture
• Runs on Windows NT, Solaris and Linux
• Tightly integrates with Oracle Manufacturing, Financials, HR and other third party applications.

MetricStream’s quality and performance management solutions help Hi-Tech enterprises benefit significantly through the use of software solutions that enable regulatory compliance and increase operations efficiency. Through our enterprise-class quality management solutions (QMS) we can help power organizations by reducing administrative and operating costs, achieve business objectives, competitive advantage and increased market share. For more information on implementing solutions for your enterprise, please contact us at 1- 650-620-2955, or by email at info@metricstream.com.