Leaving Quality Behind – Again No

Posted on September 28, 2006 by John Hunter

Is PAT Leaving Quality Behind? [the broken link was removed]

The intent of PAT was to advocate a more scientific and methodical approach to product development, scale-up and production. The impact of PAT will be felt in all sectors of the organization, and if applied correctly, will increase granularity in the quality and quantity of data being created throughout the product development lifecycle.

Ok, so in what way is that leaving quality behind? Does this add something to design of experiments, to PDSA, to control charts, to continuous improvement, to quality function deployment…

The Improvement Handbook will help people learn what quality improvement is about today (and was about in 1990).

Related: Management Improvement History and Health Care – Quality and Innovation – Management Improvement History – Management Advice Failures – SPC: History and Understanding

The recent emphasis on continuous improvement, operational excellence and Process Analytical Technology (PAT) within the pharmaceutical and biotech industries has driven us to evaluate the basic tenets of our approach to quality. Historically, the ability to ensure that a drug will meet its intended form, fit and function has been achieved through the combined application of quality infrastructure (SOP’s, policies, specifications), qualification or validation (commissioning, IQ, OQ, PQ process Validation) and Testing (in-process and final release)

Sounds more like catching up to what quality is suppose to be about? There is a big difference between needing to improve on previous attempts to adopt management improvement methods and needing to find new methods. Most of what is needed it to actually apply the good ideas that have been around for decades. And yes, sure try and find some new great ideas but where the focus should really be is on the hard work of execution not looking for some magic pill to solve the difficult task of managing well.

Also see: Fast Cycle Change in Knowledge-Based Organizations by Ian Hau and Ford Calhoun ( a great report on process improvement in a situation many see as outside the scope of process management)

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