Chapter 5 - Quality Assurance & Quality Control
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Quality Assurance Officer

The responsibility for ensuring all aspects of a Quality Assurance Program (QAP) are met within the organization, typically falls on the Quality Assurance Officer [QAO]. The QAO supervises and carries out the monitoring, recordkeeping, statistical techniques, and other functions required to maintain high quality data. This person may have these duties as a sole responsibility or may have other responsibilities within the company. The QA Officer should be involved in the daily activities of the company and interact at the lowest level of the company at which he or she can be effective and unbiased in objectively serving the needs of the organization. Even organizations consisting of one or two people need to designate the responsibilities of a QA Officer to someone involved in the day-to-day operations. In addition, an outside expert can be used to review statistical methods, procedures, training, or other QA issues.

The QA Officer assists in interpreting and developing the QAP for the company and provides technical support/review and approves QA products and procedures for the top manager. The QA Officer should, at a minimum, be responsible for:

  1. Developing and ensuring the implementation of a QAP, including procedures for chain-of-custody, statistical analyses, and data verification, among others, which will help the organization to meet the authorized standards of quality at minimum cost.
  2. Advising and assisting management in the installation, staffing, and supervision of a QA program.
  3. Monitoring QA/QC activities of the laboratory to determine conformance with authorized policies and procedures and with recognized industry practices.
  4. Making appropriate recommendations for correction and improvement of QA/QC activities, as necessary.
  5. Assisting in the development of specifications and acceptance criteria for purchased items and materials.
  6. Seeking out and evaluating new ideas and current developments in the field of QA, and recommending means for their application wherever advisable.
  7. Advising management in reviewing technology, methods, and equipment with respect to quality aspects.