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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 7Subtitle BChapter ISubchapter EPart 90 → Subpart D


Title 7: Agriculture
PART 90—INTRODUCTION


Subpart D—Quality Assurance


Contents
§90.101   General.
§90.102   Quality assurance review.
§90.103   Maintenance of quality control records.
§§90.104-90.200   [Reserved]

§90.101   General.

Laboratory service programs of laboratories certified and approved by the Science and Technology shall have quality assurance requirements that are generalized in this subpart.

[58 FR 42414, Aug. 9, 1993, as amended at 61 FR 51350, Oct. 2, 1996; 65 FR 64309, Oct. 26, 2000]

§90.102   Quality assurance review.

(a) Each laboratory performing tests and analysis under this subchapter will be subject to a quality assurance program evaluation at least annually, and more often if deemed necessary by the Deputy Administrator. Such evaluation will include:

(1) A review of the adequacy of quality control measures taken by the laboratory for the standardized method of analysis for a commodity and its related products;

(2) A review of the laboratory methodologies and procedures;

(3) A review of records for the calibration and maintenance of equipment;

(4) A review of records documenting sample handling;

(5) The evidence of quality control records;

(6) The evidence of correct reporting and determination of analytical data.

(b) A laboratory will receive a quality assurance report following the review. This evaluation will address any necessary improvements to the laboratory program(s) being examined.

[58 FR 42414, Aug. 9, 1993, as amended at 65 FR 64309, Oct. 26, 2000]

§90.103   Maintenance of quality control records.

Quality control records pertaining, but not limited to the following areas, shall be retained by the laboratory for at least the 3 most recent years:

(a) Prepared solution standardizations;

(b) Recovery studies by known analyte additions;

(c) The purity checks of reagents and test materials;

(d) Apparatus and equipment calibrations;

(e) The quality examination and testing of materials;

(f) The mandatory participation in proficiency check sample testing or collaborative studies;

(g) Daily critical parameter checks of equipment, such as temperature readings;

(h) The equivalency tests of new procedures with standard methodologies.

§§90.104-90.200   [Reserved]

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