Quality Score for Suppliers Scores a point: Quality & Compliance Insights Jan05

[Quality and Compliance]

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Jan 2005

How to give a Quality Score to your Supplier

A supplier quality score provides a real-time and objective analysis of the quality performance of a supplier. The score empowers an organization to manage its supply base more effectively by enabling it to.

		Identify continuous improvement and cost savings opportunities
		Promote and encourage improved communication on performance issues
		Provide objective data for use in supplier management and sourcing decisions
		Recognize and promote exceptional supplier performance in quality

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	Systems Validation for 21CFR Part 11 Compliance
	21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. FDA issued a very comprehensive guidance on systems validation in a document released in January 2002. This white paper uses that FDA guidance as an input to define an ?easy-to-implement? framework for systems validation. Finally the paper identifies a best practice which calls for IT organizations and software vendors to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance.
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	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 such as issue tracking, developing and implementing corrective actions and reporting on the key process improvement metrics. While meeting these requirements enables an organization to standardize and automate its approach to quality improvement, it does not bring to light the key quality related issues that the senior management worries about.
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	In the Fifth Annual Quality Spending Survey 2005, Quality magazine projects spending to nearly match pre-9/11 levels and to exceed pre-recession levels. Forecasted total spending on test, inspection and measurement equipment, quality software, and consulting, training and contract services is $2.98 billion - an 8% increase from 2004 spending of nearly $2.8 billion. Money earmarked for quality expenditures during 2005 vs. 2004 -
			Nearly 62%, or $1.84 billion, is forecast to be spent on test, measurement and inspection equipment during 2005 and represents nearly a 10% increase from 2004 spending levels.
			11.5% and 26.5% are projected to be spent on quality software and services, respectively. For quality software, the 2005 projected spending of $342.1 million is a 32% increase in spending from 2004.
			In consulting, training and contract services there is expected to be a slight dip of 2.5% in spending during 2005 vs. 2004. However, this area has seen significant spending increases during the past 2 years as manufacturers chose to outsource much of their quality needs rather than invest in the capital themselves.
	- Quality Spending Survey for 2005. Quality Magazine
	The Four Absolutes of Quality Management:
		1.	Quality has to be defined as conformance to requirements, not as goodness.
		2.	The system for causing quality is prevention, not appraisal.
		3.	The performance standard must be zero defects, not "that's close enough."
		4.	The measurement of quality is the process of nonconformance, not indexes.
	- Philip Crosby   Quality Without Tears: The Art of Hassle-Free Management, 1984

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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