1-5. PROCEDURES MANUAL (SOP)
a. Procedure Contents.
(1) Must include computer entry directions, as well as incorporating the
directions supplied by the manufacturers of the reagents and equipment in use. If the
manufacturer's guidance is not followed, data that support deviations from that guidance
must be on file. Licensed facilities must obtain approval from the FDA prior to
implementing changes from manufacturer's instructions.
(2) Procedural details (reagent volumes, times and temperatures of incubation,
etc.) in the written SOP must match exactly the details in the processing records.
(3) Relevant product labels.
(4) Examples of forms used to record test results and interpretations.
(5) Procedures for the review, maintenance, and disposition of records.
(6) Written or pictorial description of how to read, score, and record all test
results and interpretations, when applicable.
(7) Directions for managing possible problems and criteria for consulting a
b. Validation of Procedure Process. Before implementation, procedures should
be tested for completeness, accuracy, conformance to regulations, and potential impact
on other systems and should be reviewed and approved by the QA unit.
c. Document Control. There must be a master copy of each procedure and an
index of all current procedures in addition to distributed working copies of each
procedure. The number of procedures in circulation should be controlled to ensure that
none are overlooked when changes are implemented. A procedure should include the
date it was first written and dates of implementation and revision.
d. Review and Revision. AABB Standards requires a review of each procedure
yearly. When manufacturer's instructions or regulations change, the SOP should be
examined for conformance with requirements. When procedures are added to or
replaced in the manual, the new instructions must be marked with the effective date.
Regulatory agencies require a system to document that the laboratory director has
approved SOPs and that all personnel are aware of and will comply with changes in the
e. Archive. Electronic media (magnetic tapes, optical disks or on-line computer
data storage) are widely used for archiving documents. Pages removed from the SOP