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U.S. Department of Health and Human Services

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Volume IV - 1.5 Additional Records

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-01
VERSION NO.: 1.4

Section 1 - Laboratory Orientation

EFFECTIVE DATE: 10/01/2003REVISED: 05/02/14

 1.5.1 Notebook

Notebooks may be kept to record data and observations that are not related to samples. During training, tabulations of assignments and reports on completed work or training sessions notebooks may be useful.

The notebook is the analyst's record of observations made during work in the laboratory. It is subject to the limitations outlined under Notebooks (see ORA Lab Manual, Volume II). Data generated during a sample analysis and related to a sample is to be recorded only on the analytical worksheet or its attachments, never on scrap paper or in the notebook. Comments on methods used may be recorded in the notebook but without reference to a sample number. Information on difficulties encountered with methods and how they were overcome should be an integral part of the analyst's training records.

 1.5.2 Training Progress Report 

To better evaluate the analyst's progress during training, the supervisor expects one or more reports, including:

  1. A periodic tabulation of completed analyses and other assignments (see Form 1A). This tabulation is mandatory through the basic training period.
  2. An oral or written response on each exercise, analysis or training section, covering the points outlined below. (see Form 1B)
    1. Analysis
      • Principles of the analysis (chemical equations, metabolic process, filth isolation techniques, etc.). 
      • Weakness or pitfalls in the procedure used.
      • Specificity of the method: what (ion, microbe, insect part, etc.) was identified and measured. Was the procedure direct or indirect?
      • What other sample constituents could give the same result using this method?
      • What conditions of the sample or the environment could cause higher or lower than true results?
      • What controls were run concurrently with the sample?
      • What other methods or procedures could be used? List their advantages and disadvantages.
      • (optional) Further questions that could be discussed include: Give an example calculation of the results using significant figures and units; List the % error introduced by the instrument, dilutions, and measurements; What concentration range and matrix the procedure was designed for; How the accuracy and precision were determined; What role the analyst's technique played in the accuracy and precision; and What precautions were used for safety, waste disposal and contamination.
    2. Program (for sample analyses)
      • Under which compliance program should the sample have been collected? Summarize the background of that program.
      • Was Part IV of the compliance program followed? Does the program prescribe that methods to be used?
      • Was the FACTS or LIMS data entered correctly?
    3. Legal Aspects
      • What is FDA's legal interest in the product? Under what part of the Act (or other law) does FDA have jurisdiction? Do the records or the Collection Report (C/R) indicate or prove interstate movement of the product?
      • How is the consumer protected by our analysis of this product? Approximately how much (estimate) did this protection cost?
      • If the sample was violative, how might a defense attorney attack our analysis or handling of the sample? How can this be avoided or countered?