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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 2.4 Quality Assurance

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-02
VERSION NO.: 1.7

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03
REVISED:
08-25-14

A.  Objective

To present quality assurance and quality control concepts that ensure analytical results and written or electronic worksheets are of the highest quality.

B.  Assignment

  1. Read the following:

Laboratory Quality Management Plan and International Standard ISO/IEC 17025:2005(E) Sections 5.4, 5.5, 5.6, and 5.9.
ORA Lab Manual Volume II, Section 2 and laboratory’s corresponding SOPs.
ORA Lab Manual Volume III, Section 3, Records of Results – Analyst’s Worksheet
ORA-Lab.001 SOP Microbiological Controls for Sample Analysis

  1. Trainer will discuss with trainee the various techniques used such as positive, negative and system controls, environmental sampling, media growth promotion testing, correct media volume, pH and formulation, equipment controls, etc. Trainer should review forms used to report oral and written QA evaluations of worksheets.

C.  Questions

  1. What culture controls are used for an Escherichia coli enumeration analysis?  For a Staphylococcus aureus analysis?
  1. What does RODAC mean?
  1. Why are temperatures recorded for incubators, water baths etc.?
  1. Why are worksheets reviewed and signed by an analyst who has not worked on the sample?

Why are validated methods used?