Quality Management and Compliance
The Hygienic Laboratory has two Quality Assurance (QA) officers: Marcia Valbracht and Jeff Wasson. They develop, conduct and lead continuous quality improvement processes to improve the efficiency and effectiveness of operations and services. This includes applying process improvement concepts to quality management systems, collecting and analyzing data, and assuring compliance, training, education, leadership and supervision.
The QA officers are independent of all analytical activities, and provide assistance, guidance and interpretation of Quality Control (QC) requirements. The officers perform internal reviews, evaluations and formal audits of sections within the Hygienic Laboratory on a regular, rotating basis. This assures that the Hygienic Laboratory is in compliance with management system activities required by various accrediting agencies.
A key activity during fiscal year 2013 was assisting with an ISO/IEC 17025:2005 (International Organization for Standardization/International Electrochemical Commission) accreditation grant from the Food and Drug Administration. The ISO/IEC is a comprehensive standard with a high degree of specificity for laboratories that produce testing and calibration results. The QA officers wrote the training plan, training model and quality management plan for the Hygienic Laboratory's implementation of the standard.
Another major undertaking has been the implementation of a new document control software system for more than a thousand procedures and policies that are tracked and managed throughout the year.
The QA officers are responsible for reviewing and contributing to several internal standard operating procedures (SOPs). They also prepare application materials, assure compliance standards are being addressed, and complete compliance corrective action documents for multiple accrediting and regulatory agencies. These include the American Industrial Hygiene Association, National Environmental Laboratory Program, state of Iowa Lab Accreditation Program and Clinical Laboratory Improvement Amendments accreditation.