The 5 "W"s of Quality Agreements

Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.

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Things Change - Plan On It

People often bemoan the requirements relating to monitoring and measuring. The general consensus is that it's a good idea to track error and defects, but to monitor that which appears to be running smoothly is a waste of precious resources. Within these tough economic times, that argument can't help but sway managers, unless a compelling counterbalance is offered. Time and again, quality professionals stake their justifications in "ISO says so" rather than in objective indicators.

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