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Quality & Compliance-Paper based Quality systems-Costly, Non Compliant &

From: Quality and Compliance
Subject: Quality & Compliance-Paper based Quality systems-Costly, Non Compliant & more -Feb 2005
Date: Tue, 15 Feb 2005 08:24:26 -0600 (CST)

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Feb 2005
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 companies experiencing fast growth. This paper articulates various issues with paper-based quality management systems based on research with quality management executives at mid-sized companies.

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Role of a Quality Management System in Six Sigma Deployments  

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, it has seen its adoption increase dramatically across the world. Enterprise quality management systems play a key role in the Six Sigma deployments. This paper explains the role of such a system in the implementation of Six Sigma to improve the order-to-delivery process at a manufacturing site.

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Free webinar on "Managing Quality in an Outsourced Manufacturing Model" on
Wednesday, February 23, 2005 at 12:00 pm, PST.
How to build a Business Case for a Quality Management System  

Most enterprise software projects require its champion to build a business case to justify the capital spend. In building a business case, the champion needs to capture all tangible benefits that the company would obtain from implementing the software and then place a defensible monetary value on these benefits in terms of annual savings to the organization. The goal of the business case is to ensure that the project delivers value greater than the corporate hurdle rate for capital investments. This paper provides a proven step-by-step process to developing a business case for a Quality Management System (QMS) within an enterprise.

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"Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for. A product is not quality because it is hard to make and costs a lot of money, as manufacturers typically believe. This is incompetence. Customers pay only for what is of use to them and gives them value. Nothing else constitutes quality."

- Peter F. Drucker
"$688 Billion are spent in the US annually on regulatory compliance"
- Rochester Institute of Technology
Links to papers in the prior newsletter issues
Best Practices in CAPA Supplier Chargebacks & Cost Recovery
Workplace Safety Compliance IT Systems Validation for SOx and Regulatory Compliance
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