Title: Section 55-2.11 - Quality assurance officer: qualifications and responsibilities

55-2.11 Quality assurance officer: qualifications and responsibilities.

(a) Each environmental laboratory shall appoint a quality assurance officer (however named), who shall exercise oversight of the laboratory’s quality system. The individual so appointed shall have documented training, and/or experience in quality assurance and quality control procedures; be knowledgeable in the required quality system; and possess a general knowledge of analytical methods for which he or she performs data review.

(b) The quality assurance officer (and/or his or her designees) shall:

(1) serve as the focal point for the environmental laboratory’s quality assurance and quality control, and be responsible for monitoring and/or review of quality control data;

(2) evaluate data objectively and perform independent assessments without outside (e.g., managerial) influence;

(3) arrange for or conduct annual internal audits of the laboratory’s entire technical operation; and

(4) notify laboratory management of any deficiencies in the quality system and monitor required corrective actions.

(c) The quality assurance officer shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources, as well as to the technical director(s). The quality assurance officer shall fulfill his or her functions independently from laboratory operations for which he or she maintains quality assurance oversight; provided, however, for laboratories with limited staffing, the quality assurance officer may also be a technical director.