Other Laboratory Operations
Food and Drug Administration
- 3.5.1 Assembling the Analytical Package
- 3.5.2 Reviewing the Analytical Package
- 3.5.3 Approving the Analytical Package and Reporting
Once the analysis is complete, records related to the sample are assembled for review as follows:
- Worksheets & Continuation Sheets (FD-431 and 431a)
- (Optional) Other Documents
The analyst having primary responsibility for the sample assembles these documents.
The composition of the analytical package varies depending upon how the sample is handled or treated by the laboratory. Different classifications of the sample may result in a package lacking one or more of the records. Examples of this include samples that are classified as Class 5 which are ones collected for analytical purposes but not examined or held for further action, and perishables that have arrived at the laboratory decomposed and can not be analyzed. In this case, there will be no worksheets or analytical package; the sample will be closed in FACTS or LIMS.
Worksheets, Continuation Sheets, and Attachments - Worksheets, continuation sheets, and attachments are assembled in a manner that effectively organizes and displays the analyst’s findings.
Page Numbering and Identification - Worksheets and continuation sheets compose the main sections of the analytical package and are numbered in consecutive order using a format showing the total number of pages (e.g. 1 of 6, 2 of 6. . .6 of 6.)
Attachments - Additional analytical records (e.g. instrument or computer generated charts and data sheets, photographs, negatives, developed x-rays, videotapes, photocopies) accumulated during the analytical phase of the sample examination attached as needed to support laboratory findings and conclusions.
- Each page of each attachment will be directly identified with the FACTS sample number, unique LIMS number (if available), and unique attachment number or letter, date, and initials of the analyst.
- The first page of each attachment is also titled, and attachments with multiple pages are numbered (e.g. 1 of 4, 2 of 4. . . 4 of 4).
- If the attachment is less than the size of a page or of awkward shape, the item may be mounted securely on heavy mounting paper. If mounting paper is used, it is also identified with the sample number, date, and the analyst's initials.
- The number of attachments included with the analytical package is listed as Attachments A to ZZ" or Attachments 1 to 99" in the bottom of block ten or in the bottom margin of the first page worksheet (FD-431).
- In situations where an instrument produces a large number of spectra (e.g. GC/MS and FTIR/MS) and it is not practical to attach them all to the package only those used to form analytical conclusions need be attached.
- Labels and Labeling - Labels and labeling are separate from attachments and should not be identified as such in the analytical package. The number and types of labels and labeling included with a package are identified in Block 9 of the basic worksheet.
After assembling the analytical package, the package is forwarded for review.
Worksheet Check -A second qualified analyst or supervisor will review the package prior to it being forwarded to the responsible Branch level reviewing official. This reviewer inspects the package for accuracy and completeness, and if any errors or omissions are discovered, returns it to the analyst for correction. Once this reviewer determines the worksheets and supporting documentation are satisfactory, they will sign and date in Block 13 on the first page of the worksheet. If not performed by the supervisor, the package is forwarded to the responsible branch or section level supervisor for further review and classification.
Supervisor Review - Following the worksheet check, the responsible branch or section level supervisor reviews it for accuracy and completeness. If any errors or omissions are discovered, it will be returned to initial reviewer or the analyst for correction. Once the reviewing supervisor determines that the worksheets and supporting documentation are satisfactory, he or she completes Block 13 (if it is not already completed as a result of an analyst review), and enters their conclusions, related program assignment, and sample classification codes into FACTS or LIMS application.
Follow-Up Actions - If the data compiled by the analyst is insufficient or inadequate to determine the sample’s compliance status, the responsible supervisor will contact the client (e.g. compliance officer, investigator, Center) to discuss and identify additional actions to resolve this situation.
Sample classifications are defined in part 3.8 Definitions.
Approval of Class 1, 2, 4, and 5 Samples - Analytical packages for non-actionable samples will be approved by the responsible branch or section supervisor. To indicate approval, the branch or section level supervisor will set the sample status in FACTS or LIMS to Completed".
Approval of Class 3 Samples - Analytical packages for actionable samples are approved by the laboratory director or designee. The responsible section or branch level supervisor will enter their recommended conclusions, related program assignment, and sample classification codes into the FACTS or LIMS application when they find the package to be satisfactory. This supervisor will then set the status in FACTS or LIMS to “Ready for the Laboratory Director’s Review” or equivalent status in LIMS and forward the package to the director or designee. The laboratory director or designee reviews both the analytical package and recommended conclusions in FACTS or LIMS. If the director or designee is not satisfied with the package, it or the FACTS or LIMS summary is returned to the responsible branch or section level supervisor for corrections, changes, or additional testing. If the director or designee finds the analytical package and FACTS or LIMS input satisfactory, they will indicate their approval by setting the sample status in FACTS or LIMS to “Completed”.
See Laboratory Manual Volume II Section 2, ORA.LAB 5.10 Reporting Laboratory Data. This procedure defines the process for reporting analytical findings.
Report Microbiological results in sample summary as indicated below:
- Salmonella – No Salmonella spp. was detected in two composities analyzed.
- Salmonella – Salmonella sp. was detected in one of two composities analyzed.
- EHEC – No Enterohaemorrhagic Escherichia coli (EHEC) or STEC was detected in ten subs analyzed individualoly.
- Listeria – No Listeria spp. was detected in two composites analyzed.
- Listeria monocytogenes was detected in one of two composites analyzed.
- Shigella – No Shigella spp. was detected in two composities analyzed.
NOTE: In the applied method section for Salmonella, Listeria, and Shigella testing, record “not speciated” under the Spcs Code.
Report Chemical results as indicated below:
- Results less than the Limit of Detection (LOD) or Method Detection Limit (MDL) – report as less than LOD or MDL and include the detection limit concentration.
- Results between the LOD or MDL and the Limit of Quantitation (LOQ) – report the concentration and include the detection limit and quantitation limit concentration
- Results above the LOQ, report the sample concentration
Reporting presumptive positive results or Can’t Rule Out (CRO) – when initial testing or screening indicate the possibility that the analyte or organism in question is present. Additional analysis is required to confirm the presence, absence or concentration.