“Laws, like sausages, cease to inspire respect in proportion as we know how they are made”
–John Godfrey Saxe, circa 1869.
The same sentiment might also be applied to standards. A finished standard carries a certain “weight” due to the esteem of the issuing organization. However, standards are written by human beings, and can contain all our noble aspirations and petty behaviors.
For those who are curious about the back-story of how quality requirements and standards are developed, a recent article by James and Sten Westgard provides an interesting glimpse into a not-so-well-run process. Titled, “The Milan Manifesto: Are Quality Goals Evolving, Devolving, or Revolving?” this article introduces both the technical subjects of the debate and also the politics of science.
As a participant in standards committees, I understand that standards development is a bit like making sausage. However, the process described at Milan seems sloppier than most. Part of what sounds offensive to the American reader, may just be a reflection of a European way of doing things, with policies more likely to be imposed from the top down, rather than arrived at by the more democratic give and take of consensus – a holdover from the monarchy system of government perhaps.
Regardless of where you stand on the politics of this process, the technical summaries and insights Westgard provides are worth the read. If you enjoy this article, you can also find related pieces on the Westgard site, including a copy of the 1999 Stockholm agreement and a technical summary of the current 2014 Milan proposal.
Note: Access to some parts of the Westgard site may require that you register and sign in, and I think it worth the effort. I’ve registered, myself, some years ago and have been pleased to be able to access interesting articles and have received no bothersome spam.
George Rodrigues, Ph.D., is Senior Scientific Manager at Artel, the global leader in liquid delivery quality assurance. Rodrigues is responsible for developing and delivering communications and consulting programs designed to maximize laboratory quality and productivity through science-based management of liquid delivery. Rodrigues is Artel’s chief representative to key commercial clients, government regulatory bodies and industry organizations. His speaking and teaching engagements, along with his publications, build awareness of the challenges and solutions for laboratories in maintaining data integrity and confidence in their testing protocols. He plays a key role in developing the manufacturing and quality assurance processes for Artel products and organizes programs to assist pharmaceutical, biotechnology and clinical laboratories in improving their liquid delivery quality assurance and analytical process control. Rodrigues earned his BS in Chemical Engineering at the U.C. Berkeley, and a PhD in Chemical Engineering at the University of Wisconsin.