Why should laboratories appoint a full time Quality Manager?
By Polona K. Carson
In his interview for the March 2012 issue of Laboratory Manager, Dr. Michael Noble points out that there is a requirement in ISO 15189 (Medical Laboratories -Particular Requirements for Quality and Competence) for laboratory to appoint a Quality Manager. He emphasizes that this is a full time job. That it just won’t work when the role of Quality Manager is a part of an operational supervisor’s responsibilities.
Michael Noble is professor in the Department of Pathology and Laboratory Medicine at the University of British Columbia and Chair of the program Office for Laboratory Quality Management. According to Dr. Noble, the quality in medical laboratories is better than 25 years ago due to standardization, improved awareness, education, and predefined requirements and expectations for operating procedures. However, Dr. Noble emphasizes that a common challenge for laboratories is lack of commitment to quality, which results in “hopping around” several approaches to quality like ISO 9000, Six Sigma and Lean Six Sigma. This is probably also true for other testing laboratories.
Another standard that sets guidelines for harmonization of laboratory practices is ISO 17025: General requirements for the competence in testing and calibration laboratories. Similarly to ISO 15189 it also sets a requirement for laboratories to appoint a quality manager. In addition, both standards require (see clause 4.1.5. b in both) that laboratory management and personnel are “free from any undue internal and external commercial, financial or other pressure and influences that may adversely affect the quality of their work”.
How does this apply to Quality Manager position? To successfully implement, maintain and improve quality practices in the laboratory, it is essential for Quality Manager to be out of the operational chain of command. In addition, Quality Manager needs to have authorization to request re-work or stop work whenever there is a quality issue. Mixing of responsibilities for production and quality creates internal conflicts of interest that are detrimental to quality.
Another argument in favor of hiring a full time Quality Manager is that beside very good management, leadership and organizational skills this position also requires a sound knowledge of quantitative methods used in testing environment including some knowledge of statistics. Both standards have requirements for test methods validation, estimation of test result uncertainty and monitoring of method performance. To successfully implement these quality practices, it is imperative that Quality Manager understands available approaches and is able to make a good judgment on what does it take to implement them in the laboratory. In addition, Quality Manager needs to be able to choose and assign capable staff for quality related laboratory studies and provide them with adequate training or recognize a need for statistical consulting services. By working out of the chain of command for production, focusing on quality of testing activities and implementing valid statistical approaches to evaluate test methods and test results performance, Quality Manager can considerably contribute in creating a competitive advantage for the laboratory.