Sections Included in this Document and Document History

1. Purpose
2. Scope
3. Responsibilities
4. Background
5. References
6. Procedure/(6. H. 1 added “or, if applicable” to 3rd sentence; 6. H. 2. added “DFS” to 1st paragraph and added second paragraph)
7. Definitions
8. Records/(Added Import Salmonella Template and Drug Survey Templates)
9. Supporting Documents
10. Attachments
11. Document History

1. Purpose

This procedure defines the process for reporting analytical findings and conclusions as prescribed by the agency.

2. Scope

This procedure applies to all Office of Regulatory Affairs (ORA) field laboratories and the release of information.

3. Responsibilities

1. Laboratory Director :
   • is responsible for ensuring the timeliness, accuracy and completeness of all analytical information reported by the laboratory; and
   • reviews violative worksheets prior to release by the laboratory.
2. Laboratory Supervisors:
   
   • are responsible for ensuring the timeliness, accuracy and completeness of all analytical information reported by the analyst; 
   • are responsible for ensuring that laboratory analysts comply with the data and information recording procedures; and
   • review analytical findings and supporting documentation generated by analysts, enter related conclusions, and sample classification codes into FACTS.
3. Analysts:
   
   • are responsible for capturing and recording accurate and complete analytical information on worksheets, continuation sheets, and other documents in accordance with the instructions of this procedure; and
   •  are to complete worksheets and enter analytical observations and findings into the FACTS computer in a timely manner.

4. Background

None

5. References

Food, Drug and Cosmetic Act, Section 704(d), Factory Inspection

ORA/Office of Regional Office/Division of Field Science.  (October 1, 1997). Field management directive No.  147, procedure for release of analytical results pursuant to section 704(d).

ORA/ORO/DFS.  (August 1 1996)  Field management directive No. 77, 
abbreviated analytical reporting.

Ottes, R.T. (1984, September).  Los Angeles district pesticide residue program (DHHS Memo).

6. Procedure

1. Introduction:
   
   The worksheets and applicable supporting records (e.g., labels, packaging, promotional materials, instrument charts, exhibits, memorandums, controls) referred to in this section are used to provide the written account of analytical findings that either support regulatory action or serve to classify the sample as non-actionable. This documentation is prepared so the history of the sample can be reconstructed with confidence, including details on which the analyst may respond to queries or challenges months or years later. They give an objective account of the sample handling and analysis efforts from the time of receipt to the time analysis and investigative efforts are concluded. There is no doubt about what was done, how it was done, who did it, and with what accuracy and precision the work was accomplished. The worksheet package presents a complete picture that can be understood by reviewers, even those not technically or scientifically trained, and not a part of the analyzing science unit.
2. Results:
   1. Analytical findings are presented on the basic worksheets, FDA form FD-431(Analyst Worksheet) and FD-431a (General Continuation Sheet) in a clear and concise manner to expedite interpretation of the results, especially by non-technical and non-scientific personnel. These forms and attachments make an analytical package. Whenever possible, the analytical data should be tabulated. Also, if subsamples with differing codes were individually examined, the results are clearly recorded for each code because regulatory action may be based on the results of a particular code exclusive of other codes. The following are some components of the analytical package.
      1. Analytical Worksheet
         
         The following information is included on the analytical worksheet:
         • Title (i.e. ANALYST WORKSHEET), Block 10 Summary of Analysis;
         • Name of laboratory (e.g. DEN-DO);
         • Unique identification of the worksheet on each page (i.e. sample number);
         • Identification of the method used;
         • Description of sample to include deviations, additions or exclusions from collector's report;
         • Date received;
         • Results;  and  NOTE: Results include the unit identification and reflect the correct number of significant figures indicated by the analytical method. If computer generated results are included in the final report, a statement on the report indicating the correct number of significant figures suffices when the number of figures presented by the computer exceeds the capability of the method. Statistical or other data reflecting accuracy and precision are included. Analytical results are compared with the label, labeling declarations, published tolerances and standards, regulatory action levels, manufacturer's specifications or other applicable criteria.  When requested, a statement of compliance or non-compliance with requirements or specifications are recorded. When discrepancies are found between analytical results and labeling statements or other criteria, these facts are set out clearly.
         • Analyst and reviewer signatures.
           
      2. Collection Report
         
         The report includes, but is not limited to the following information:
         
         • Name of sampling district;
         • Date of sampling;
         • Identification of the substance, material or product sampled;
         • Reason for collection;
         • Method of collection, how prepared; and
         • Analysis requested.
           
      3. General Continuation Sheets  
          
         These sheets contain the raw data, calculations, standard preparation, dilution schemes, quality control data, equipment used, reagents, media, test conditions, deviations, additions or exclusions from the test method, and other sample related information.
         
      4. Instrument generated reports and charts
      5. Photographs, labels
      6. Memoranda
         
   2. Field Accomplishments and Compliance Tracking System (FACTS)
       
      Analytical findings and observations are entered into FACTS by laboratory analysts. Supervisors enter conclusions and laboratory classification. The data is obtained by internal clients (FDA) through FACTS. Laboratory personnel are to make every effort possible to ensure the sample information, analytical findings and conclusions entered are correct and that any errors are corrected as quickly as possible.
      
3. The following information is found at the laboratory, but not necessarily provided in the  analytical packet or FACTS:
   
   • Address of the analyzing laboratory;
   • Address of the sampling district;
   • Statement to the effect that the results relate only to the item tested; and
   • Estimated uncertainty of measurement
     
4. Deviations and modifications
   
   Whenever there is a need to (a) deviate from or add to an official method, (b) use an entirely new method for a sample analysis or (c) modify test conditions such that it may effect the integrity of the analysis and interpretation of results, these deviations or new methods are comprehensively described by the analyst. Depending upon the magnitude of the deviation or change, this can be a relatively short entry on a continuation sheet (FD-431a) or as a separate memo. This memorandum describes the deviations and new methods employed and how the proper performance of the new or modified method was demonstrated in terms of accuracy, precision, specificity for the product being analyzed, and the estimated uncertainty of the measurements when this is needed for the validity or application of the examination. The validation techniques used will vary depending upon the situation.
   
5. Additional analysis
   
   Whenever a check or additional analysis is performed, a new FD-431 is started, however, blocks 8 and 9 need not be repeated on these second worksheets.  In addition, the description of the container, labeling, code in block 10 need not be repeated unless requested or instructed to do so.  For those items remaining the same, enter the statement See original analysis, and under the analysis category enter the subsample numbers retested whenever applicable. The information entered in block 7 is very complete in description to demonstrate continuity of sample handling.
   
6. Opinions and Interpretations
   
   The laboratory management interprets the analytical findings and assigns a sample classification in FACTS. Other opinions and interpretations by laboratory management may be included in the analytical package. These may be comprised of, but not limited to the following documents:
   • Opinion on the conformity of the results with regulatory requirements;
   • Recommendations on how to use the results; and
   • Guidance to be used for improvements, when needed and applicable.
     
7. Electronic Transmission of Results
   
   Results sent via facsimile contain a statement to the effect that the attached information is confidential. The statement may convey the  message that it is intended only for the  addressee or an employee or agent of the addressee, and would probably  note that any disclosure, dissemination, distribution or copying of this communication is strictly prohibited. The statement may further say that if you have received this fax, in error, please destroy the document and notify the sender of the error.
   
8. Reporting
   1. Reports issued to internal (within FDA) offices
      
      Reporting laboratory findings to compliance and other internal FDA offices is accomplished using the FACTS computer system found in each ORA laboratory   or, if applicable, via distribution of an analytical package to the home office responsible for the sample. Each laboratory maintains a record of package distributions.
      
   2. Abbreviated reporting
      
      Analytical findings and conclusions may also be reported using abbreviated procedures designed to minimize laboratory resources when such is authorized by the laboratory director , the Division of Field Science (DFS), and the applicable compliance program. The exact manner in which abbreviated reporting is accomplished is determined on a case by case basis.
      
      Abbreviated reporting has been authorized for Class I microbiology results for import samples and Drug Survey samples under the general surveillance program, 7356.008A. Abbreviated reporting templates and instructions are posted on the DFS website and are to be used for Import Salmonella and Drug Survey samples.
      
   3. Reports issued to agents responsible for any products tested by an ORA laboratory
      
      Section 704(d) of the Food, Drug and Cosmetic Act requires that the results of an analysis of a sample obtained during an inspection of an establishment where food is manufactured, processed or packaged be reported promptly to the owner, operator, packer or agent in charge. The Factory Food 704(d) Letter shall be mailed or faxed to the responsible firm within three (3) working days of approval of the Sample Summary Report.  The sample description includes the following:
      1. The nature of the sample, number and size of the units examined, and the code marks of the subdivisions examined.
      2. The results of analysis described in simple (lay) terms whenever possible, and restricted to addressing filth, decomposition or other factors causing the food to be unfit for food. Details should be given regarding any factors in the analysis that are significant in terms of the possible violation. A general summary should be provided on factors that are not significant.  
      3. Factory food letters shall not list the methods employed, conclusions drawn from the analysis, any details regarding the manner in which the sample was handled prior to the analysis, explanation of the type of examination made, or the results of examinations for factors other than filth, decomposition, or those causing the food to be unfit for food. These letters shall also not be mailed to other than the owner or manufacturer, processor or packer from whom the sample was collected.
         
   4. Reports issued in cooperation with industry and other Federal and State agencies
      
      Unsolicited requests for analytical results on any product may be sent to any firm, individual or cooperating agency that, in the judgement of the responsible region, has a legitimate interest in the results and when a useful purpose will be served.
      
      Specific guidance regarding when and how laboratory information is to be shared will be provided by the home office for the products involved on a case-by-case basis.
      
      On occasions where a laboratory enters into an interagency agreement with an external agency (i.e. State or local agency) to share analytical test results on the food, drug, cosmetic or medical device products being tested, this data is shared in compliance with the established agreement. As a minimum, this agreement includes terms and limitations designed to protect the privacy of the clients whose products have been tested.
      
9. Format of Reports
   
   The general format of the FD-431 consists of three parts:
   
   
   1. Heading which  includes these items: 
      • Product,
      • Sample number,
      • Seals,
      • Date received,
      • Received from,
      • District or lab,
      • Description of sample,
      • Net Contents, and 
      • Labeling.
   2. Body or Summary of Analysis which includes these subparts:
      • Container,
      • Labeling,
      • Code,
      • Product,
      • Analysis,
      • Method, and
      • Results.
   3. Closing which includes  vital information:
      • Reserve sample,
      • Signatures (worksheet check),
      • Date reviewed, and
      • Date reported
        
10. Issuing Modifications or Amendments to Reported Findings
    
    Material amendments to analytical results that have already been reported are made only in the form of a further document or data transfer. These reports are flagged Additional Analysis with the sample identification (unique package or sample number). These amendments are to clearly identify the sample or samples involved and describe the changes, additions and corrections being made and the rationale for why they are  needed.
    
    Transcription errors that do not affect the data, i.e. incorrect dates, are changed on the original analyst worksheet or if applicable, in FACTS.

7. Definitions

Original analysis - The initial examination conducted on a representative portion of the sample is an original analysis. 

Check analysis - An analysis performed by a second qualified analyst to confirm a finding that may be used by FDA or cooperating agencies in a
regulatory action is a check analysis. 

Additional analysis - Additional analyses performed on a sample to obtain information not provided by the original set of analyses or to verify originally
reported analytical results is an additional analysis.  Additional analysis may be performed on the original sample composite or extract, or an intact and unanalyzed unit of the sample.

Compliance sample - A compliance sample is collected on a selective basis as  the result of an inspection, complaint or other evidence that there may be a problem with the commodity.

Surveillance  sample - A surveillance sample is collected on an objective basis where there is no evidence or suspicion of a problem with the commodity.

Consumer Complaint Sample - A consumer complaint sample is collected from a consumer who is registering an official complaint (verbal or written) regarding the quality of a FDA regulated product.

Follow-up (sample) to consumer complaint -A follow-up sample is often denoted by FU to CC. A follow-up to a consumer complaint is a sample collected as a result of a complaint but not collected from the complainant.

Dealer holding sample - A dealer holding sample indicates that the dealer is holding the lot sampled. Normally, the dealer would like to be notified of the analytical results as soon as possible.

Split sample - A split sample indicates one portion of the sample is in the possession of one science unit and another portion has been sent to another science unit.

Sample classifications - Samples are assigned to different regulatory decision making classes (1-5) by laboratory supervisors based upon the results of the laboratory's examination.

Factory food samples - Factory food samples consist of raw materials, in-process, and finished products collected to demonstrate manufacturing conditions and are flagged as such on the FACTS collection report.

8. Records

FACTS data
Analytical package
Abbreviated packages
704(d) letters
Reports to industry
Modifications and amendments to reported findings
Import Salmonella Template
Drug Survey Template

9. Supporting Documents

Regulatory Procedures Manual (RPM)
FACTS Reference Guides

10. Attachments 

None

11. Document History

Approving Official's signature: _________________________________ Date: _____________