Other Laboratory Operations
Food and Drug Administration
- 3.2.1 General
- 3.2.2 Analyst Worksheets
- 3.2.3 Instrument-Generated Reports and Charts
- 3.2.4 Photographs, X-Rays, Videotapes, and Compact Disks (CDs)
- 3.2.5 Field Accomplishments and Compliance Tracking System (FACTS)
- 3.2.6 Notebooks
The laboratory analyst records all descriptive information pertaining to the sample, its handling in the laboratory, and analytical findings and observations on worksheets (e.g. FD-431, FD-431a), and in the web application, such as FACTS or LIMS. General directions and considerations for completing these forms or electronic records include the following:
- Handwritten worksheets are started with the receipt of the sample by the analyst. Blocks 1 through 9, and description of the container, labeling, codes, and product in Block 10 (FD-431), can be completed at this time.
- All raw data and observations are recorded directly on the worksheets or entered into a computerized worksheet or web application (see 22.214.171.124 ) as it is acquired. When handwriting worksheets, the writing will be in permanent black ink, and must be legible, neat, and of an adequate size so that it can be easily read and photocopied.
- Do not write in the left margin on the front of the worksheet page and the right margin on the back. Any information placed in these areas can be obscured or lost when the worksheets are assembled.
- Do not erase, overwrite, or use correction fluid or tape to correct errors. For all errors, draw a single line through an incorrect entry, write the correct entry nearby, date and initial. The correction should be written clearly, not obscuring any other data, and in a manner that would cause the data to be misinterpreted. Also, annotate the reason for the change, if it is not obvious.
- Use only common abbreviations. The United States Pharmacopeia, General Notices, and the Official Methods of Analysis of AOAC INTERNATIONAL, Definition of Terms and Explanatory Notes, contain recognized scientific abbreviations. Clearly, explain any abbreviations that are unusual or would not reasonably be expected to be known by anyone reviewing the worksheet (e.g. define them the first time they are used).
- All measurements are made using metric terms (e.g. cm, gm). When applicable for comparison to label declarations, or the accepted convention for reporting the value, the final results can be converted to the English system (e.g. oz, lb).
- A new FD-431 is started whenever a check or additional analysis is performed. Flag this new worksheet per 3.3.2 of this document. These worksheets are completed following the instructions in part 3.3.2 with the following exceptions:
- Blocks 8 and 9 need not be repeated, and can be left blank, or have the statement "see original analysis".
- Under Block 10 for all items that remain the same, such as the description of the container, labeling, codes, and product, enter the statement "see original analysis".
A variety of supplemental worksheets and related forms have been developed to support internal laboratory sample data recording and handling.
126.96.36.199 Basic Worksheets
The analyst worksheet (FD-431) with its general continuation sheet (FD-431a) comprise the basic worksheets. Part 3.3.2 provides step-by-step instructions for preparing these worksheets. Computer templates of the FD-431 and FD-431a preserve the general format of the printed forms. Local management reviews and approves such templates before use. Once worksheets are signed, the document becomes the final analytical package. LIMS generates a PDF file for transmission which contains similar information as required and presented in the handwritten analyst worksheet.
188.8.131.52 Specialized Worksheets and Continuation Sheets
See ORA Laboratory Manual Volume IV for worksheets related to program samples.
184.108.40.206 Electronically Entered Raw Data
Analysts may use various computer, electronic worksheets, or web application in lieu of the printed forms or computerized templates for entry of raw data and observations following the usual procedures for preparing the basic worksheets. All data and observations are recorded directly on these templates, either electronically or in writing on a hard-copy printed form. When data and observations are recorded electronically, laboratories take additional measures to protect its integrity. This may include the following:
- The entering analyst should carefully review all such entries before closing an entry session (e.g. saving and closing the file containing the entries).
- Once raw data is entered electronically and the filed closed, changes to effect corrections to entries are now traceable (e.g. by initialed-and-dated strikeouts and additions).
- The files containing raw data entries are identified in order to link them to the sample. The files are protected (e.g. locked cells, password) from inadvertent change or loss until the worksheet is printed to hard-copy in final form and signed or electronically generated by the web application.
- Once printed and signed, the hard-copy document or LIMS generated PDF file becomes the official worksheet. If corrections are necessary, they are made in accordance with 3.2.1 d. and not replaced by printing a corrected file.
When instrument-generated reports are included in an analytical package, the report should provide all information needed to interpret its graphic, tabular or computational output, including: absorbencies, peak areas, retention times, wavelength maxima. This should appear on each sheet of a report.
If the instrument report does not provide this information, the analyst enters it, initials and dates the entries. He or she may use prepared stamps, when available, for recording this information. The web application may also contain this information from the instrument-generated data. The analytical package has available spectra or chromatograms that show the peak shapes, baseline noise, and other characteristics used in the generation of results.
In situations where an instrument produces a large number of spectra (e.g. GC/MS and FTIR/MS) and it is not practical to annotate them all, then only annotate those used to form analytical conclusions.
The analytical package may include photographs, x-rays, videotapes, and compact disks to illustrate labeling, to assist in describing the product, or to show an analytical finding. Because the size of an object may not be evident from the photograph or photocopy, it is important to include a ruler along with the object in the picture. When providing a photocopy with an enlargement or reduction, indicate the percent enlargement or reduction on the photocopy or mounting sheet. Photographs, x-rays, videotapes, and compact disks should include sample identification, date, and initials, where applicable.
3.2.5 Field Accomplishments and Compliance Tracking System (FACTS) and Laboratory Information Management System (LIMS)
Laboratory analysts enter analytical findings and observations following the analysis, and supervisors will enter their conclusions and sample classification codes following reviews in accordance with the FACTS or LIMS Manual. Laboratory personnel will make every effort possible to ensure that they accurately enter the sample information, analytical findings, and conclusions entered into FACTS or LIMS are accurate, and that errors are corrected as quickly as possible.
Analysts electing to do so, may keep bound notebooks to record non-sample specific data and observations. Sample-specific data and observations are recorded on the worksheets. The notebook is not to contain data, observations, and results applicable to identified samples. Keep in mind that sample background and other supporting information that may be contained in a notebook can be used as evidence in litigation.
220.127.116.11 Typical Uses of Notebooks
When an analyst elects to keep a notebook, it is bound and the pages are hand-numbered or preprinted with numbers. Examples of the data that may be recorded in a notebook include the following:
- calibration of weights, glassware and equipment;
- preparation and standardization of solutions and reagents;
18.104.22.168 Maintaining the Notebook
General instructions for entering data are discussed in part 3.2.1 d.