Elements of a Quality Assurance Program

Elements of a Quality Assurance Program
Each laboratory should develop and implement a written QA plan describing the QA
program and QC activities of the laboratory. The plan should address the following basic
common aspects:
a. Statement of objectives, describing the specific goals of the laboratory.
b. Sampling procedures, including selection of representative sites and specified holding
time and temperature conditions. If data may be subjected to litigation, use chain-of-custody
procedures.
c. Personnel policies, describing specific qualification and training requirements for
supervisors and analysts.
d. Equipment and instrument requirements, providing calibration procedures and frequency
and maintenance requirements.
e. Specifications for supplies, to ensure that reagents and supplies are of high quality and are
tested for acceptability.
f. Analytical methods, i.e., standardized methods established by a standards-setting
organization and validated. Ideally, these laboratory methods have documented precision, bias,
sensitivity, selectivity, and specificity.
g. Analytical quality control measures, including such analytical checks as duplicate
analyses, positive and negative controls, sterility checks, and verification tests.
h. Standard operating procedures (SOPs), i.e., written statement and documentation of all
routine laboratory operations.
i. Documentation requirements, concerning data acquisition, recordkeeping, traceability, and
accountability.
j. Assessment requirements:
1) Internal audits of the laboratory operations, performed by the QA officer and supervisor.
2) On-site evaluations by outside experts to ensure that the laboratory and its personnel are
following an acceptable QA program.
3) Performance evaluation studies, in which the QA officer works with the supervisor to
incorporate unknown challenge samples into routine analytical runs and laboratories are
encouraged to participate in state and national proficiency testing and accreditation programs.
The collaborative studies confirm the abilities of a laboratory to generate acceptable data
comparable to those of other laboratories and identify potential problems.
k. Corrective actions: When problems are identified by the staff, supervisor, and/or QA
coordinator, use standard stepwise procedures to determine the causes and correct them.
Nonconformances identified by external laboratory evaluation are corrected, recorded, and signedoff by the laboratory manager and QA officer.