QA at IITRI - Uniting Policy and Customer Service

"Quality," said the pioneer quality expert W. Edwards Deming (1900-1993), "is everyone's responsibility." Very true, although for some, quality is even more - it's a vocation.

At IITRI, the Quality Assurance Unit (QAU), under the direction of Glenn B. Miller, M.S., C.Q.M. (Certified Quality Manager), is responsible for guaranteeing not only that the Life Sciences Group's studies, records and reports comply with Good Laboratory Practice (GLP) regulations, but also that customers' requirements for quality results are fully satisfied.

	"The function of the QAU is contributing to the successful completion of the study in the most efficient method possible while still fulfilling regulatory requirements." Glenn B. Miller, M.S., C.Q.M. Manager, Quality Assurance Unit

By the Book

GLP regulations, as promulgated in the Code of Federal Regulations, are the rules that govern the conduct of non-clinical laboratory studies in the U.S. These regulations, first enacted in the late 1970s and enforced by the Food and Drug Administration and the Environmental Protection Agency, ensure the quality, integrity and reliability of study data.

GLP regulations translate to routine study procedures at IITRI. "The responsibility for quality falls on each member of the Life Sciences Group in his or her day-to-day work," Miller says. "However, the QA Unit needs to be involved on a proactive basis at the very beginning of the process - when that study is first being put together, when the protocol is being developed."

Throughout the study, all study data, notebooks and files are audited by the QAU to ensure compliance to the protocol, standard operating procedures and GLP regulations. Final reports are audited to ensure that they accurately reflect the raw data and provide a description of the experimental methods, observations and results. At final review, the QAU prepares and signs a Quality Assurance Statement that is included with the final report.

"The function of the QAU is contributing to the successful completion of the study in the most efficient method possible while still fulfilling regulatory requirements," Miller says.

Best of Both Worlds

Quality assurance is an integral part of business operations at IITRI. "Quality assurance procedures are of course required from a regulatory standpoint, but from a business standpoint it just makes good sense to set up an independent organization to review processes and collected information - and to make sure the final output reflects the work that's being done," he says.

With more than 20 years of experience in both quality and operations, Miller notes that one of the keys to an organization's success is working within available resources while also reliably fulfilling the quality needs of its customers. As Deming once said: "Profit in business comes from repeat customers - customers that boast about your project or service and that bring friends with them."

"Our focus," adds Miller, "is on identifying customers' needs - and putting programs in place to satisfy those needs by adding value to the services we provide."

Meet IITRI's QA Team

• Glenn B. Miller, M.S., C.Q.M., Manager, Quality Assurance Unit, received his undergraduate degree from Lewis University in Romeoville, and his graduate degree in Environmental Management from Illinois Institute of Technology's Stuart School of Business. Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP).
  
• Marilyn Marlow, Senior QA Auditor, has 40 years of experience with IITRI and audits chronic, sub-chronic and acute studies.
  
• Elaine Brown, Senior QA Auditor, has been with IITRI since 1975. RQAP-GLP registered, she audits chronic, sub-chronic and acute studies.
  
• Lucy Touma-Youakim, Research QA Auditor, has a biology background, and is responsible for mouse lymphoma and a variety of other study types.
  
• Sibby Cantrell-Gordon, Research QA Auditor, has a background in biology and is responsible for auditing cytotoxicity studies.
  
• Bertram Perkins, Research QA Auditor, has a chemistry background and is responsible for auditing smoke chemistry studies.
  
• Jeffrey Thivel, Assistant QA Auditor, has a biology background and is responsible for auditing Ames assay (reverse mutation assay) studies.
  
• Madelaine Matthews, Archivist/SOP Coordinator, has an administrative and paralegal background and is responsible for maintaining IITRI's archives and updating its SOP library.