Page:NIOSH Manual of Analytical Methods - Chapter C.pdf/2

 aspects of quality control as they relate to industrial hygiene laboratory quality control.

It is not possible to design a quality assurance program to fit all laboratories since no two laboratories serve the exact same purpose or operate in exactly the same manner. Each laboratory must set its own operating procedures and quality control practices, and document them in a Quality Assurance Manual. This chapter, therefore, will not set forth concrete recommendations for implementing a quality assurance program, but rather will present aspects of laboratory quality assurance and quality control which should be addressed by each laboratory.

A successful quality assurance effort cannot be achieved through the efforts of only one individual. A laboratory’s quality assurance coordinator needs the assistance and cooperation of all laboratory personnel to be effective. To this end, it is necessary to discourage adversarial relationships between quality control personnel and bench chemists. Analysts must be trained and made aware of the purpose and value of quality assurance functions and, in turn, the quality assurance program must be designed so that its functions are based on sound goals directed toward improving the performance of both the individual analyst and the laboratory as a whole.

Frequently, analytical results are challenged months or years after the analysis is complete. In order to support the original data, an effective, complete, record-keeping system must be maintained. Another chemist must be able to reconstruct the exact treatment to which the samples were subjected solely from a laboratory’s records. Furthermore, if the appropriate quality control checks were performed with the analysis and documented, there can be no doubt regarding the results.

2. ORGANIZATION

A laboratory, just as any other organization, should have a clearly defined organizational structure. Responsibilities of each member of the laboratory staff should be in writing and understood by all. In this way, confusion regarding tasks which need to be performed can be avoided.

The specific organizational structure of the laboratory will vary, depending on the laboratory’s function. Two functions which relate to quality assurance should be assigned in every laboratory: the quality assurance coordinator and the sample clerk. The size and nature of the laboratory may preclude assignment of a full-time position to these functions; however, a laboratory member should be assigned these duties and it should be understood that they are to have top priority.

The quality assurance coordinator's functions will depend on the size and nature of the laboratory. This professional has overall responsibility for assuring that reported data meet established standards for precision and accuracy and that these results can be supported scientifically by the various quality control checks performed with the analysis. One of the major functions of this individual is to perform audits of the quality control system and to implement changes that eliminate recurring errors. Rh