By Paul Thomas, Managing EditorYou cant improve or control what you cant measure, goes the familiar axiom. In a focused discussion at Septembers IFPAC Summit in Puerto Rico, discussion leader David Radspinner, Thermo Electrons PAT expert, offered two corollaries:
- Just because you can measure it doesnt mean you can control it.
- Just because you can measure it doesnt mean you should control it.
- assume users know exactly what they want;
- assume all requirements are of equal criticality;
- view success as determined only by the completion of documentation;
- neglect or downplay risk assessment.
- Replacing laborious methods with rapid off-line methods (e.g., HPLC replaced with NIR);
- Moving traditional testing at-line or on-line, without linking to quality control;
- Measuring everything you can with unconnected specifications.