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Insights: Quality Management


Internal auditing is a mechanism by which an organization examines a business process to evaluate its ability to comply with internal and external requirements...

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)...


Most enterprise software projects require its champion to build a business case to justify the capital spend. In building a business case...

Best Practices in CAPA
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...


Information technology has become a core enabler of business processes within the organizations today. As a result, companies are required to audit and validate their relevant IT systems to ensure that their business processes...

Cost of Poor Quality
Despite the availability of off-the-shelf compliance and quality applications in the market, many...

Impact of Regulatory Compliance on Quality and Profits
A manufacturing company had annual sales of $250 million. Its quality department calculated the total cost of repair, rework, scrap, service calls, warranty claims and write-offs from obsolete finished goods...

Implementing a well designed audit program
Regulatory compliance by enterprises could result in a positive impact on quality of the product and services that they generate...

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...

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...

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...

Raising your Audit Score through effective Document Control
In our August 2004 issue, we discussed best practices for implementing a well-designed audit program. In this issue, let us discuss how one can most effectively raise the audit scores of your organization...

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...


Six Sigma is a disciplined, data-driven approach to improving product and process quality.Ever since Jack Welch labeled Six Sigma as one of the most strategic initiatives undertaken by GE...

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...


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...

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...

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...