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TREAD Act Requirements for the Automotive Industry
'Early Warning Reporting' deadline for the TREAD Act - The impact cannot be underestimated for automotive manufacturers and suppliers. The TREAD Transportation Recall Enhancement Accountability Documentation Act was passed by the TSA National Highway Traffic Safety Administration in order to generate increased efficiency in data reporting and to create better...
ISO 9000 - An Integrated Approach
Developed to improve quality in the manufacturing industry, ISO 9000 has been successfully extended across the services industry and government. The quality management system standard is issued by the International Standards Organization ISO to ensure quality in products/services. The primary focus of ISO 9000 is on a proactive approach to...
Quality and Compliance Management Solutions for High Tech Manufacturers
In the old, pre-wired economy businesses moved more slowly, and quality assurance meant running a few tests on finished products before shipping. Quality initiatives for the supply chain tended to be focused internally with little emphasis on collaboration or customer satisfaction. Organizational ideology was cued towards a reactive, rather than...
ISO/TS-16949:2002 - Transition to a Global Automotive Industry Quality Management System
ISO/TS 16949:2002 is an ISO Technical Specification aligning existing automotive quality system requirements developed by IATF, JAMA and supported by ISO technical committee (ISO/TC 176). ISO/TS 16949 applies to all internal and external suppliers of products or production material, or services such as heat treatment, painting, plating, varnishing, galvanizing or...
Hi-Tech: Issues, Perspectives & a Powerful Enterprise Solution
The Hi-tech and Electronics sector is composed of a wide variety of businesses that include semiconductors, networking, cable, computer software/hardware/peripherals, component manufacturing and related industries. The hi-tech industry is the motor for economic growth worldwide, setting a scorching pace in developing, producing, and marketing its hi-tech quality products across the...
Automotive: Issues, Perspectives & a Powerful Enterprise Solution
With ISO/TS16949:2002 global quality standard set to replace QS 9000, the automotive industry is poised for change. While QS 9000 is based on requirements from the Big three automakers, ISO/TS16949:2002 not only combines ISO 9001:2000, but includes automotive requirements from national and international quality standards (QS 9000, VDA 6.1, EAQF...
Can't Get Budget Approval for Your Quality Management System?
Many quality directors have difficulty in getting capital budget approvals to acquire a badly needed Quality Management System QMS. The reason in most situations is that their justification approaches the system benefits from a bottom-up operational perspective - the new system will provide a mechanism to achieve key quality objectives...
Corrective Action (CAPA) Systems at Innovative Companies
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process. Regulatory compliance requires organizations to capture all corrective action issues and track their corrective action process to completion. About 30% to 50% of all...
What Is Your Company's Cost of Poor Quality (CoPQ) - Tools for Calculating and Reducing It
Experts have estimated that Cost of Poor Quality typically amounts to 5-30% of gross sales for manufacturing and service companies. Independent studies reveal that COPQ is costing companies millions of dollars each year and its reduction can transform marginally successful companies into profitable ones. Yet most executives believe that their...
Impact of Regulatory Compliance on Quality and Profits
Regulatory compliance by enterprises could result in a positive impact on quality of the product and services that they generate. This could imply that the results of compliance can be quantified into direct economic value for the complying enterprises. Although this is not a tested hypothesis no one would dispute...
Implementing a Well Designed Audit Program
The authors previously discussed best practices for incorporating audits into a operational framework in another paper. In this paper, the authors take the discussion further and pose the question, on how to most effectively implement audits in a global organization. To put the problem in context, this paper looks at...
Incorporating Audits in Your Operational Framework
While Many books and articles have been written about how to drive greater management and organizational output, only recently are managers being asked to think about how to incorporate "Audits" as a management tool within their organizations. First of all, contrary to the belief, audit is not a responsibility of...
Paper-Based Quality System Is More Costly Than You Think
Paper-based quality management systems are fairly common in mid-sized organizations. While such systems can successfully manage product and process quality, they significantly increase the risk of cGMP non-compliance at FDA-regulated organization. They also impede a manufacturer's ability to implement continuous improvement initiatives. Such paper-based systems also become a bottleneck for...
Incorporating Quality Into Management Style
Quality and compliance are not necessarily after thoughts, which are achieved through systems and software, rather it's a part of the management style of managers and leaders. In progressive companies, managers are not merely focused on enhancing organizational output and productivity, but are also aware of achieving greater degree of...
Raising Your Audit Score Through Effective Document Control
This paper discusses how one can most effectively raise the audit scores of an organization by building effective document control processes. Document control and document lifecycle management have become increasingly important foundation for building and implementing a good compliance and quality system. With the growth of online manuals, Standard Operating...
Reducing New Product Introduction (NPI) Time Using a Packaged Software Solution
In several industries, the total time taken to introduce a new product into the market can be the key difference between a blockbuster and a mediocre performing new product. New Product Introduction involves several collaborative processes including product design, product quality planning, identifying and qualifying vendors and plants for sourcing...
Role of Compliance and Quality in Managing Warranty Reserves and Costs
Over the last few years, Compliance and Quality initiatives have begun to play a critical role in managing warranty costs for large and mid-size manufacturers. Manufacturers are challenged to both enhance product quality and reduce warranty costs at the same time. American manufacturers reserve and spend well over $24 Billion...
Spreadsheet-Based Quality System Is More Costly Than You Think
Spreadsheet-based quality management systems are fairly common in mid-sized organizations. While such systems can successfully manage product and process quality, they significantly increase the risk of cGMP non-compliance at FDA-regulated organization. They also impede a manufacturer's ability to implement continuous improvement initiatives. Such systems also become a bottleneck for companies...
Supplier Quality Management in FDA-Regulated Industry
Supplier quality management has reached high levels of sophistication in general manufacturing industries like automobiles and computer hardware as input cost reduction and supply chain efficiency is a key profitability driver in these industries. Concepts like supplier scorecards, cost-of-poor-quality, charge-backs and cost-recovery, have matured to a great extent enabling manufacturers...
Here Comes TS 16949
The International Automotive Task Force IATF took on the challenge of developing a standard to harmonize three European catalogs-VDA 6.1 Germany, AVSQ Italy, EAQF France-and the North American QS-9000 standard. The result was the ISO/TS 16949:2002 standard. The Big Three automakers have put their support behind ISO/TS 16949:2002. QS-9000 is...
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