SECTION K - QUALITY ASSURANCE
K1.000 QUALITY ASSURANCE PROGRAM
All tissue banks shall have a QA Program.
K1.100 Basic Elements
QA programs shall include, at a minimum, the following elements:
(relevant part only)
7) Maintenance of specific documentation including, but not limited to:
a) Master copy of current SOPMs;
b) For those authorized to perform or review tasks, records of names, signatures, initials or identification codes and inclusive dates of employment shall be maintained (e.g., by Human Resources, Quality Assurance, or by department);
c) Reports and conclusions of process Validation and Equipment Qualification Studies;
d) Records of supply and reagent acceptance or rejection;
e) Archived documents; and
f) Master lists of preprinted labels.
Publication date: February 10, 2009 (AATB Bulletin No. 09-08)
Effective date: May 11, 2009 (in 90 days)