GUIDE TO TRACEBACK OF FRESH FRUITS AND VEGETABLES IMPLICATED IN
EPIDEMIOLOGICAL INVESTIGATIONS

Note Since this guide published in April 2001, Emergency Operations has
become a separate office. The electronic copy of this document has been
modified to reflect that change (i.e. all references to DEIO have been
changed to EOC). No other changes have been made.\
7/06- Note a separate DFI Guide to Produce Farm Investigations has
recently published. This guide has been modified only to delete specific
instructions on produce farm investigations, and instead refer the
investigator to the Produce Farm Guide for further guidance.

######## TABLE OF CONTENTS

Introduction pg. 1

Traceback Procedures pg. 2

Initiating a Traceback Investigation pg. 2

Traceback Coordination pg. 2

Product Samples pg. 2

Use of FDA Reports and Forms pg. 2

Traceback Reports pg. 3

Requests for Information pg. 3

Traceback Responsibilities pg. 3

Methods and Analysis pg. 4

Point of Service Investigation pg. 4

Interviews pg. 5

Observations pg. 5

Record Collection pg. 5

Analysis of POS data pg. 6

Distributor Investigations pg. 6

Interviews pg. 7

Observations pg. 7

Record Collection pg. 8

Analysis of Distributor data pg. 8

Importer/Processor/Grower Investigations pg. 8

Farm/Source Investigations pg. 8

######## aTTACHMENTS

Attachment 1 -- PAC Codes

Attachment 2 -- Traceback Data Analysis Example

Attachment 3 -- Multi-State Flow Diagram Example

Attachment 4 -- Creating Electronic Documents

Attachment 5 -- Interview Questions

######## INTRODUCTION

A product investigation begins when a food is suspected or implicated in
a foodborne outbreak. Product investigations can include facility
inspections, food preparation reviews, sample collections, and
environmental, traceback, and source/farm investigations. A food can be
implicated or associated with foodborne outbreak through one or more of
the following methods: epidemiological or statistical, laboratory,
and/or a thorough food preparation review.

A traceback investigation is the method used to determine and document
the distribution and production chain, and the source(s) of a
[product]{.underline} that has been implicated in a foodborne illness
investigation. A traceback investigation involves good interviewing
techniques, a complete record review, and timely reporting to meet its
intended purpose. A subsequent source investigation may be conducted to
determine possible routes or points of contamination by inspecting
common distribution sites, processors, and/or growers identified in the
traceback investigation.

A traceback investigation may be conducted for several reasons: 1) to
identify the source and distribution of the implicated food and remove
the contaminated product from the marketplace, 2) to distinguish between
two or more implicated food products, and 3) to determine potential
routes and/or sources of contamination in order to prevent future
illnesses.

CDC or state/local health or regulatory agencies may conduct limited
tracebacks and/or traceforward investigations in order to strengthen an
epidemiological association by comparing the distribution of illnesses
and the distribution of the product. This is often referred to as an
"epi" traceback.

Fresh fruits and vegetables are extremely difficult to traceback because
they are perishable commodities and lot numbers and grower
identifications are not routinely used or recorded on shipping records.
If the distributor cannot identify specific shipments and their source,
the tools and interviewing techniques outlined in these instructions
will help identify possible shipment(s), suppliers, and the source(s)
involved in the outbreak. The procedures outlined in this guide are
[not]{.underline} to be used for tracebacks involving eggs.

Investigators working on multi-state foodborne outbreak investigations
will want to refer to the National Food Safety System manual,
*Multi-State Foodborne Outbreak Investigations: Guidelines for Improving
Coordination and Communications at <http://www.fda.gov/ora/fed_state> .*

This traceback guide is presented in three main sections: 1) Traceback
Procedures, 2) Methods and Analysis and 3) Farm/Source investigations.
It also includes examples of the analysis process and instructions for
creating electronic traceback documents.

**[Traceback procedures]{.underline}**

**INITIATING A TRACEBACK INVESTIGATION**

Initiation of a traceback investigation usually begins when 1)
epidemiological evidence implicates a food product **[and]{.underline}**
2) hazard analysis shows that other contributing factors were not to
blame (e.g., cross-contamination, ill food workers, other on-site
sources of infectious agent). Other factors that will be considered
prior to initiating a traceback investigation include disease severity,
the risk of ongoing exposure, the availability of shipping records,
reliable exposure data, the size and scope of the outbreak(s), and the
availability of resources to conduct the investigations.

FDA Emergency Operations Center (EOC) should be notified when a District
Office is aware of a foodborne outbreak or when a state/local agency
initiates a traceback investigation of a product that has the potential
to fall under FDA jurisdiction. The District Offices should refer all
requests for FDA to participate in or to conduct a traceback
investigation to EOC (301-443-1240). EOC will provide early alerts to
the District Offices and CFSAN when a traceback investigation has been
requested and/or may be assigned in the near future.

EOC may ask a District to obtain the following information from the
state/local agencies: a written epidemiologic summary, a hazard analysis
or environmental and inspection reports (including a food preparation
review), laboratory results, and copies of any invoices and distribution
information that have been collected. If CDC conducted or coordinated
the epidemiological investigation, EOC will request the information from
CDC.

The available data will be reviewed by EOC and CFSAN. At the request of
FDA, epidemiologists from other agencies, such as CDC, may also be asked
to review the epidemiological data. EOC will consult with CFSAN and
determine if a traceback is to be initiated. EOC will generate a
traceback assignment in FACTS. All inter-district traceback work
requests will be assigned in FACTS by EOC.

**TRACEBACK COORDINATION**

When a traceback investigation has been assigned to you, your District
should contact EOC. The EOC coordinator will then initiate a conference
call with you to discuss the assignment. Your District may wish to
include your supervisor or other designated person(s) on this initial
call. You will have frequent communication with the EOC coordinator
throughout the investigation. Upon completion of each traceback step,
you should contact the EOC coordinator to discuss the data analysis and
the next stage of the traceback. The District may choose to have other
individuals participate in these ongoing discussions, for training or
other reasons. After each firm visit, a copy of the records you
collected should be faxed to EOC. If there are a large number of
records, they can be sent by overnight mail.

There are several reasons why this communication and coordination with
EOC is a critical component of traceback investigations. The primary
reason is that most traceback investigations are in response to
multi-state foodborne outbreaks and therefore tracebacks are usually
occurring simultaneously in multiple Districts. The EOC coordinator will
be the main communication point, receiving and analyzing information
from multiple districts that will help to guide the investigations. This
central coordination will allow earlier notification to the District
Offices, provide the District management with greater flexibility in
assigning traceback work, provide training opportunities for
investigators, eliminate repetitive or unnecessary work, and improve
FDA's overall response time.

**PRODUCT SAMPLES**

If leftover food from the implicated meal(s) or product from an
implicated shipment is available, it should be collected. Contact EOC
for instructions on where to send the samples and what analysis to
request. Unless otherwise directed, product from later shipments should
not be collected.

**USE OF FDA REPORTS AND FORMS**

*FDA 463A* -- Affidavits are not required or encouraged to be used in a
traceback investigation. All pertinent information and discrepancies
that are noted during the investigation should be explained in the memo.
The following are examples when you ***may*** chose to use an affidavit
during a traceback investigation:

1)  to provide an explanation of inaccurate shipping records or written
    mistakes on records that cannot be verified or documented using
    other records but can be explained by an employee.

2)  to describe the personal knowledge or belief of an employee
    regarding the shipping and/or handling of the implicated product
    which is not supported by other documents or other interviews and
    would have a direct bearing on the analysis of the records.

*FDA 482, Notice of Inspection* - an FDA 482 should be issued to each
firm that is visited in the course of the traceback investigation.
*Memo* - if you conduct a food preparation review at the point of
service, this information can be reported in a memo*. FDA 483 List of
Observations, Establishment Inspection Report, and FMD 145
Post-inspection Letter* - if you conduct a domestic establishment
inspection as a result of a traceback investigation, the procedures
regarding these inspections and forms are outlined in the IOM and should
followed.

**TRACEBACK REPORTS**

You will be responsible for generating a report for the portion of the
traceback investigation that was assigned to you. The traceback report
should consist of a FACTS cover sheet with your supervisor's endorsement
and the FOI statement, a timeline and the flow diagram(s). The following
items should also be included for **each firm** you visited:

-   FDA 482

-   Invoices, inventory records, shipping/receiving records (including
    records and information obtained from other agencies).

-   A memo summarizing the information gathered from the observations
    and interviews at the firm, including explanations of the data
    analysis (i.e., how receipt dates were determined).

-   Affidavits (if used).

In addition to the flow diagram that you received from EOC at the
completion of their assignment, EOC will also send a final flow diagram
to you when the entire investigation is complete. If the traceback was
part of a multi-state outbreak, and more than one traceback was
initiated, there may be a third flow diagram that will be sent to you
that shows the results of all of the tracebacks. Your traceback report
should be maintained in your District Office and a copy should be sent
to EOC. The copy that is sent to EOC does not need to include a copy of
the records, as these have already been sent to EOC.

**REQUESTS FOR INFORMATION**

**FOI Requests**

You should include the following statement in your final traceback
report: "All FOI requests or other inquiries for release of foodborne
outbreak and traceback investigations should be referred to EOC
(HFC-160). " It is recommended that this statement be in bold lettering
at the bottom of the cover page and may be included as part of your
supervisor's endorsement. Some of the information collected in the
course of these investigations is non-public, commercial confidential
information.

**Release of Information to FDA Commissioned Officers**

Prior to releasing any foodborne outbreak and traceback documents to a
state or local official who is an FDA Commissioned Officer, you must
contact EOC. EOC will work with DFSR to verify the status of the
commission and the 20.88 Certification Commitment form to determine what
information can be released.

**TRACEBACK RESPONSIBILITIES**

######### You, the investigator, are responsible for completing the following tasks:

######### If requested, obtain the following information from the state/local agencies (if available) and provide a copy to EOC:

-   Epidemiological data

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-   Exposure dates

-   Exposure places

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-   Environmental inspection

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-   Food worker health

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-   Cross-contamination issues

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-   Preliminary traceback and distribution information

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-   Implicated product name and any available packaging, labeling

2\. Obtain the following from EOC:

-   Coordinator name and contact number(s)

-   Dates for record collection

-   FACTS Assignment Number

-   Traceback Event Code

-   Timeline

-   Flow Diagram

3.  Review the background information with EOC

> prior to visiting a firm.

4.  Conduct an investigation and record collection at

> each implicated firm, in the order it is assigned.

5.  Analyze the data. Fax (or overnight) a copy of

> the records to EOC after each firm is visited. Discuss analysis and
> next steps with EOC Coordinator before proceeding to the next
> implicated firm.

6.  Repeat Steps 4 and 5 until either a potential

> source (manufacturer, grower, producer, importer) is identified or an
> implicated firm is located out of your area of responsibility.

7\. Summarize each firm investigation in a memo.

8\. Send EOC a copy of the traceback report.

9.  Coordinate with state and/or local investigators. A courtesy call
    should be made to both the state health and state agriculture
    representative when a traceback is initiated in the state. DFSR and
    EOC can assist you with this notification.

10. Lead or participate in domestic and/or foreign source
    investigations, if requested.

The EOC Coordinator is responsible for completing the following tasks:

1.  Obtain a written summary of all available epidemiological,
    environmental and laboratory data from CDC (if available) or the
    District Office(s).

2.  Generate FACTS assignments and Traceback Event Codes.

3.  Obtain the shelf life of the product and any other product
    information.

4.  Set the parameters for the dates of the records collection.

5.  Initiate a conference call with investigator to discuss and share
    the background information on the outbreaks, the product, and the
    assignment.

6.  Maintain regular contact with the investigator.

7.  Review traceback records and data analysis.

8.  Conduct or assist with data analysis, as needed.

9.  Provide training to investigators, as needed.

10. Update and distribute the timeline and flow diagram to the
    investigators throughout investigation.

11. Issue Inter-District traceback assignments in FACTS.

12. Compile a final report for EOC that includes each investigator's
    report and the final timelines and flow diagrams.

13. Work with District management to identify investigators to lead and
    participate in domestic and foreign source investigations.
    Participate in domestic and foreign source investigations, as
    needed.

14. Communicate findings to the District Investigators and CFSAN.
    Provide a final flow diagram to all of the Districts that
    participated and CFSAN when the traceback(s) are complete. Using
    appropriate confidentiality agreements, release findings to other
    agencies (i.e., CDC, USDA, State agencies) when requested and
    approved by EOC management.

15. Complete FOI requests using guidelines pertaining to release of
    Commercial Confidential Information. EOC Management should review
    the documents prior to release of information.

CFSAN's responsibilities are described in the "CFSAN Emergency Response
Procedures", July 25, 2000. These procedures are available at
*[http://intranet.cfsan.fda.gov/ofp.]{.underline}*

**[Methods and analysis]{.underline}**

If an outbreak involves multiple points-of-service, each traceback will
be conducted and analyzed individually and then analyzed as part of the
overall traceback investigation. Appendix B provides an example of the
analysis process for a point-of-service outbreak. Appendix C illustrates
how multiple points-of-service tracebacks are analyzed.

**POINT-OF-SERVICE (POS) INVESTIGATION**

The goal of the point-of-service (POS) investigation is to determine and
understand the firm's ordering, receiving, stock rotation, inventory,
and preparation procedures and to obtain the appropriate records and
documentation. By understanding how the product is received, recorded,
rotated and prepared, you will be able to determine which shipments were
available and most likely consumed at the implicated meal.

It is also important to rule out on-site contamination as a contributing
factor especially when it is a single point-of-service outbreak. If the
local or state agencies have not conducted a food preparation review or
if it is not sufficient for FDA's needs, you are encouraged to contact
your Regional Retail Food Specialist, who may be able to assist with
that part of the investigation. Cross-contamination or on-site
contamination is less of a concern in multi-state or multiple
points-of-service outbreaks. In some situations, a food preparation
review may not be necessary.

In addition to the record collection and review, interviews and
observations are key parts of a traceback investigation. It is not
possible to do a thorough traceback investigation over the telephone.
You will need to conduct the interviews, make observations, and collect
records in person.

######### POS Interviews

If the POS is someone's home or a non-traditional place of business, the
exposure data and other product information will be collected and
verified by the state health agency and reviewed by FDA prior to the
initiation of the traceback. In these instances, the place the
consumer(s) purchased the food will be considered the point of service
(e.g., grocery store, caterer).

You should conduct interviews with more than one employee at multiple
levels of the organization (e.g., chef, kitchen manager, line cook) to
determine the following information:

-   Product Identifying Information- Include pertinent label information
    (collect copy if available), container type, size, color, grade, and
    lot codes, production or pull dates if available, and product
    origin. The firm may be using a different brand than what it was
    using at the time of the outbreak. Verify label, product information
    with invoices and shipping receipts for the time period in question.
    Only collect product label information for the product that was used
    during the outbreak exposure time period.

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-   Shipping and Receiving Practices - Determine the receiving dates and
    times for each shipment in the requested time period. Indicate how
    the dates on the shipping records reflect the date the product was
    received. Determine how supplier deliveries are documented or
    recorded. Determine the firm's suppliers during this time period,
    including any cash transactions. Determine or estimate the
    transportation time from the supplier to the point-of-service.

-   Handling and Storage Practices - Interview employees regarding
    receipt and preparation of the implicated product for the implicated
    meal, if this information hasn\'t already been provided by CDC,
    state, or local authorities.

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-   Stock rotation practices - Review the standard operating procedure
    at the firm. Determine how the product is unloaded and added to
    existing inventory. Determine if a first-in-first-out (FIFO)
    rotation policy is standard operating procedure and how closely it
    is adhered to.

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-   Daily (or otherwise) stock inventory - If an inventory record is
    available for this time period, understand how it is used, including
    its strengths and weaknesses, and determine what time of day the
    inventory is performed. Understand what each inventory number
    represents. Determine how partial cases or containers are accounted
    for, and how and if carry over is recorded.

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-   Ordering practices -- Determine how and when product is ordered.
    Determine average daily use.

######### POS Observations

You should observe and verify that the procedures described by employees
are reflected in their actual work. Whenever possible, have the
employees who regularly perform each of the tasks demonstrate their
procedure. You should be able to describe the flow of the product
through the firm. Walk through the receiving and shipping process and
follow a shipment of product physically through the firm and compare it
with the records (written and computerized). This information will be
critical for the analysis.

######### POS Record Collection

You should obtain a copy of all invoices, shipping and receiving
records, bills-of-lading, inventory records and any other records
regarding the implicated product that are available over the time period
requested.

You will want to review the records on site. There will often be many
dates and handwritten notes on the records. You should determine the
estimated date of receipt. The person who is responsible for receiving
the product should be able to assist in this. The shipping date, the
invoice date, and/or the order date may be the same as the receipt date
or they may be used to determine the receipt date. Do not make
assumptions regarding the dates on the records. Be sure to ask for an
explanation of all dates on the records.

Interview the employees and determine the date and time shipments are
received. Determine the transit time from the distributor shipping the
product to the POS. You will need to clearly document in the memo how
the receipt date was determined and how it relates to the dates on the
records. You should be able to read and understand all items on the
records. If the quantity printed on the record is difficult to read, it
may be calculated using the unit price and total price. This is the only
time that the price would be of interest. Some suppliers may be
reluctant to disclose pricing information. If the quantity is legible,
there is no reason why FDA needs the pricing information. If the
supplier prefers to redact the pricing information before releasing the
records that is acceptable and will not affect FDA's investigation. You
may encounter resistance when requesting records. You should take the
time to explain the reason for this investigation, including a summary
of the outbreak, the number of illnesses, and the importance of
identifying the source of the product. Be prepared to volunteer to go
through the firm's files to locate the records, assist clerical help in
doing so, make the copies (on-site or off-site), and go to other
locations where the records may be located.

######### 

######### If you are unable to obtain the records immediately, you should be persistent in obtaining them as quickly as possible. If you are not able to get the records in a timely manner (1-2 days), the EOC Coordinator should be notified immediately. Many states have laws that require these shipping records to be provided to the State health and regulatory authorities upon request. If the firm will not provide the requested records, you may ask for assistance from these agencies. 

[Analysis of Point-of Service Data]{.underline}

You will need to analyze the first level of data before continuing the
investigation at another firm. If you are being trained or would like
assistance with the analysis, you should contact your EOC Coordinator.
EOC will provide an electronic timeline for you to use in your analysis.
The data analysis will be described in this section and Appendix B
provides an example of the analysis process. You will need to follow
these steps in order to analyze the data.

Step 1. Use the timeline provided by EOC. The timeline should be labeled
with the following:

-   Title, Date, Event Code, Product

-   Dates of Record Collection

-   POS Firm name

######### Step 2. Fill in Receipt Dates. 

-   Add the names of the suppliers under the POS, one per line.

-   If an inventory list is available, place the quantity on the POS
    line corresponding to the appropriate date. You will need to note in
    the memo how and when inventory is taken.

######### Place the quantity of each shipment in the cell corresponding with the date it was received at the POS from the corresponding supplier. 

######### Step 3. Review the pertinent information collected during the interviews and observations. 

######### How the receipt date is determined

######### How inventory is handled

-   Delivery receiving times

-   Serving and preparation times

-   Stock rotation practices

Step 4. Implicate shipments and suppliers. Using the information from
the interviews and observations, determine which shipments received at
the point of service were available and could have been used in
preparing the implicated food item. This will tell you which firms
supplied those shipments.

######### Step 5. Contact EOC. 

######### Fax (301-827-3333) or overnight (5600 Fishers Lane Rm 12A55 Rockville, MD 20857) a copy of the invoices to EOC. 

######### Discuss the analysis with the EOC Coordinator. You will need to share the information you have added to the timeline. You may fax this or communicate the information by phone. 

######### If the implicated firm is in your district, you will continue the traceback at the implicated supplier (if it is assigned to you). EOC will add the firm to the FACTS assignment. 

-   EOC will provide an updated electronic copy of the timeline and flow
    diagram to you.

######### 

######### Do not write the traceback report until you have completed all of the implicated firms assigned to you. You may only have the point of service firm located in your district. If that is the case, then the report should be written at this time. However, if the implicated supplier(s) is/are in your District, the continuation of the traceback investigation should not be put on hold while a report for the point-of-service firm is written. When the traceback investigation is completed, the final flow diagram(s) will be sent by EOC to CFSAN and to each investigator who participated in the traceback. 

**DISTRIBUTOR INVESTIGATIONS**

The goal of the investigations at the implicated suppliers or
distributors is similar to the goal at the point of service. You will
not need to determine preparation procedures and serving times. You will
need to verify all previously collected shipping information from the
distributor to the point-of service and also collect new information on
all incoming receipts of product to this distributor from other
distributors, processors, importers or growers. Interviews, observations
and record collections should be done in person. You may or may not have
conducted the point-of-service investigation. It is important for you to
review the point-of-service analysis and shipping receipts prior to
beginning the investigation at a distributor.

There are several types of distributors and other firms that may be
encountered during the traceback investigation: distributors that supply
to the point of service, distributors that supply product to other
distributors, and brokers who may never physically handle the product,
only the paperwork. There may be transportation firms and cold storage
facilities whose paperwork may be available at a distributor. You will
not usually be asked to visit the transporter or storage facility, but
you should collect any of this related paperwork during your
investigations at the distributor.

You will be less likely to find inventory records that accurately
reflect the physical inventory at the distributor level. Many
distributors will use a computerized first-in-first-out inventory
system. It will not usually match exactly what is occurring on the
warehouse floor. You will need to take the time to understand how this
system works and if it can be used for analysis. Again, observation and
interviews will be critical. You should follow the instructions that
were provided for the POS investigation. Interview different employees,
observe their practices, and determine if the written procedures reflect
what is actually being done.

If the firm is able to link incoming and outgoing shipments, first
determine the accuracy of the system through observations and interviews
and then by "walking through the process" before using this information
in the analysis.

######### 

######### Distributor Interviews

You should conduct interviews with more than one employee at multiple
levels of the organization (e.g., floor manager, loading dock personnel,
shipping clerks, drivers, etc.) to determine the following information:

-   Product Identifying Information -- Verify that all information that
    is collected pertains to the implicated product. Check brand names,
    product descriptions, etc. The firm may be using a different brand
    or multiple brands than was shipped during the time frame under
    investigation. Verify label and product information with invoices
    and shipping receipts for the time period in question. Only collect
    records for the implicated product using label information provided
    by the point-of-service. The record collection dates for the
    distributor will cover the same time period that was assigned at the
    point-of-service.

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-   Shipping and Receiving Practices - Determine the receiving dates and
    times for each shipment in the requested time period. Indicate how
    the dates on the shipping records reflect the date the product was
    received. Determine how supplier deliveries are documented or
    recorded. Determine the firm's suppliers during this time period,
    including any cash transactions. Determine or estimate the
    transportation time from the supplier to the point-of-service.

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-   Stock rotation practices - Understand the standard operating
    procedure at the firm. Determine how the product is unloaded and
    added to existing inventory. Determine if a first-in-first-out
    (FIFO) rotation policy is standard operating procedure and how
    closely it is followed.

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-   Daily (or otherwise) stock inventory - If an inventory record is
    available for this time period, understand how it is used, including
    its strengths and weaknesses, and determine what time of day the
    inventory is performed. Understand what each inventory number
    represents. Determine how partial cases or containers are accounted
    for, and how and if carry over is recorded.

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-   Ordering practices -- Determine how and when product is ordered.
    Determine average daily use.

-   Product Handling and Storage Practices - Interview multiple
    organizational levels regarding receiving, repackaging, and/or
    handling of the implicated product prior to delivery to the
    point-of-service. Report on relevant unloading, storage, loading or
    other pertinent conditions. If the implicated product is repackaged,
    processed or handled in a way that could expose it to possible
    contamination, you should make a note of this and include it in the
    report memo. An inspection may be needed at a later date if this
    firm is determined to be a common point of distribution in the
    overall traceback. This cannot be determined until the traceback is
    fully completed. Unless otherwise instructed to do so, do not
    complete a GMP inspection at this time. In most cases, this is
    unnecessary and would cause a significant delay in the traceback
    investigation. If GMP violations are observed during the traceback
    investigation, notify District management immediately and then EOC.

######### Distributor Observations

You should observe and verify that the procedures described by employees
are reflected in their actual work. Whenever possible, have the
employees who perform each of the tasks demonstrate their procedure. You
should be able to describe the flow of the product through the firm.
Walk through the process and follow a shipment of product physically
through the firm and compare it with the written (and computerized)
records. This information will be critical for the analysis.

######### 

######### Distributor Record Collection

######### 

You will need to verify that the shipment information collected at the
point-of-service from this distributor is both accurate and complete.
This will involve looking at all outgoing shipments from this firm to
the point-of-service firm. You do not need to recopy these records. If a
previously unidentified shipment is found, you should copy that record.
You do not need to collect information on **outgoing** shipments from
this firm to firms other than the POS, unless directed to do so. You
will need to collect and review all receiving records for all
**incoming** shipments of the implicated product over the same time
period. Refer to the point-of-service investigation for additional
guidance on record collection and review.

######### Analysis of Distributor Data

You will need to analyze this data before proceeding to the next level
of distribution. If you are receiving training or would like assistance,
you should contact the EOC Coordinator. The analysis will be described
in this section. Appendix B includes an example for you to follow.

Step 1. Using the updated timeline provided by EOC, add the following
information:

-   Add the names of the suppliers under the distributor, one per line.

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-   If an inventory list is available, place the quantity on the
    distributor line corresponding to the appropriate date. You will
    need to note in the memo how and when inventory is taken.

Step 2. Fill in Receipt Dates. Place the quantity of each shipment in
the cell corresponding with the supplier and the date it was
[received]{.underline} at the firm.

Step 3. Review the pertinent information from interviews and
observations

-   How the receipt date is determined

-   How inventory is handled

-   Stock rotation practices

-   Time and dates product is received and shipped

Step 4. Implicate shipments and suppliers.

-   Using the information from the interviews and observations,
    determine which shipments received at this distributor were
    available and could have been used to fill the implicated shipments.

Step 6. Contact EOC.

######### Fax (or overnight) EOC a copy of the invoices. 

######### Discuss the analysis with the EOC Coordinator. You will need to share the information you have added to the timeline. You may fax this or communicate the information by phone. 

######### If the implicated firm is in your district, you will continue the traceback at the implicated supplier (if it is assigned to you). 

-   EOC will update and provide an electronic copy of the timeline and
    flow diagram to you.

######### 

######### Do not write the traceback report until all of the investigations of implicated firms assigned to you are completed. You may have more than one distribution firm located in your District. If additional implicated suppliers are in your District and assigned to you, the continuation of the traceback investigation should not be put on hold while a report is written. Once you have completed all the assigned firm visits, the report should be written and a copy sent to EOC. When the traceback investigation is completed, final flow diagram will be sent by EOC to CFSAN and to each investigator that participated in the traceback. 

**IMPORTER, PROCESSOR, AND GROWER INVESTIGATIONS**

If an implicated firm is an importer, you should conduct an
investigation in the same manner as a distributor investigation.
However, you will need to work with the importer to determine the
country of origin and the source of the product. There will be
additional records that will usually be available at the importer level
such as airway bills and customs entry documents. Collect all available
records related to the implicated shipments.

If a grower or processor is implicated, you should notify EOC. A visit
to the grower may not be necessary at this time. For multi-state
traceback investigations, the flow diagrams will be combined and
analyzed for common points of origin and distribution. After this final
analysis, a farm/source that was initially identified in one traceback
may no longer be implicated. See Appendix C for an example of a
multi-state traceback flow diagram that illustrates this point.

EOC and CFSAN will evaluate the traceback results along with the
epidemiological and laboratory findings and determine if an
inspection/investigation is needed at any of the implicated
distributors, packinghouses, or growers.

**[farm/source investigations]{.underline}**

Please see the DFI Guide to Produce Farm Investigations, available at
<http://www.fda.gov/ora/inspect_ref/igs/iglist.html> for further
guidance.

**Attachment 1:** **Program Assignment Codes for Emergency Responses**

+----------------+-------------------------------------+---------------+
| **Emergency**  | **Title**                           | **Problem     |
|                |                                     | Area Flag**   |
| **PAC Code**   |                                     |               |
|                |                                     | **(for sample |
|                |                                     | collection &  |
|                |                                     | analysis)**   |
+----------------+-------------------------------------+---------------+
| 03R175         | Cyclospora Emergency                | MIC, PAR      |
+----------------+-------------------------------------+---------------+
| 03R265         | E. Coli 0157:H7 (EHEC) Emergency    | MIC           |
+----------------+-------------------------------------+---------------+
| 03R225         | Enterotoxigenic E. coli (ETEC)      | MIC           |
|                | Emergency                           |               |
+----------------+-------------------------------------+---------------+
| 03R266         | Listeria Emergency                  | MIC           |
+----------------+-------------------------------------+---------------+
| 03R263         | Salmonella Emergency                | MIC           |
+----------------+-------------------------------------+---------------+
| 03R264         | Salmonella Enteritidis in Eggs      | MIC           |
|                | Emergency                           |               |
+----------------+-------------------------------------+---------------+
| 03R278         | Scombroid Emergency                 | MIC           |
+----------------+-------------------------------------+---------------+
| 03R224         | Shigella Emergency                  | MIC           |
+----------------+-------------------------------------+---------------+
| 03R236         | Sprouts Emergency                   | MIC           |
+----------------+-------------------------------------+---------------+
| 03R267         | Viral Emergency                     | MIC           |
+----------------+-------------------------------------+---------------+
| 03R277         | Vibrio Emergency                    | MIC           |
+----------------+-------------------------------------+---------------+
| 03R839         | Foodborne Emergency -- NEC          | MIC           |
+----------------+-------------------------------------+---------------+
| 04R839         | Pesticides and Chemical Contaminate | PES, ELE, CDW |
|                | -- NEC                              |               |
+----------------+-------------------------------------+---------------+
| 07R279         | Biotoxin Emergency                  | BIO           |
+----------------+-------------------------------------+---------------+
| 07R280         | Alflatoxin/Mycotoxin Emergency      | BIO           |
+----------------+-------------------------------------+---------------+
| 07R839         | Molecular and Natural Toxin         | BIO           |
|                | Emergency - NEC                     |               |
+----------------+-------------------------------------+---------------+
| 09R839         | Food and Color Additive Emergency   | FAD, COL      |
|                | -- NEC                              |               |
+----------------+-------------------------------------+---------------+
| 21R281         | Infant Formula Emergency            | NIF, MIC,     |
|                |                                     | PES, ELE      |
+----------------+-------------------------------------+---------------+
| 21R839         | Food Composition, Standards,        | NUT, MIC,     |
|                | Labeling & Economics Emergencies -- | FAD, PES      |
|                | NEC                                 |               |
+----------------+-------------------------------------+---------------+
| 71R839         | Post Approval Animal Drugs, Feeds   | PES, ELE,     |
|                | and Devices -- NEC                  | MIC, MYC      |
+----------------+-------------------------------------+---------------+

**Attachment 2: Traceback Data Analysis Example**

Data analysis is conducted with the use of a timeline and a flow
diagram. Investigators may choose to develop their own analytical tools.
EOC will continue to use the timeline and flow diagram for continuity
and sharing of data with other investigators and agencies. If an
investigator develops a new tool, they are encouraged to share this with
EOC.

[TIMELINE]{.underline}

The timeline chart is an easy visual reference that provides information
on the [receipt dates]{.underline} of deliveries made to each level of
distribution of the product implicated in the outbreak, and inventories
on any given date, if available. The timeline also illustrates
historical use patterns. Analyze data one distribution level at a time,
plotting one distributor per line. Use inventories, estimated turnover
rates, stock rotation and delivery times to identify suspect product
shipments and what distributors need to be visited to continue the
traceback. Only exclude shipment or distributor investigations if
analysis clearly shows they are not suspect shipments, and they are well
separated in time from any implicated outgoing shipments. It is key that
the investigator analyzes the data gathered from each distribution level
prior to planning data collection for the next level. Because the
timeline is expanded at each distribution level, it serves as a guide
for the decision making process for all subsequent levels.

#### DATA ANALYSIS 

The following instructions will use a hypothetical example to illustrate
how to use the timeline, flow diagram and information collected from
interviews. Use the completed timeline and flow diagram to follow along.
In the "DATE" row of the chart, insert the date of the event/purchase
under investigation into the right-most column. Fill in the dates in
each column beginning from the far right so that one shelf life (10
days) prior to the event/purchase date is covered.

[Point-of Service]{.underline}

Information gathered from interviews and observations at the POS:

-   The product was prepared for the 5/16 event on the morning of 5/15,
    prior to receipt of any shipments on 5/15.

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```
-   The POS had an inventory system. Inventory was taken early before
    any product arrived from suppliers, so the inventory does not
    reflect shipments received on the same day.

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```
-   The POS used a First-In-First-Out stock rotation which usually means
    the shipments overlap with only 2-3 shipments prior to the customer
    delivery date

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```
-   Certain shipments could be eliminated because the delivery times of
    product from suppliers to the point-of-service were after the
    suspect product was prepared.

After completing the investigation at the POS, the investigator will
want to fill in the timeline and analyze the POS information.

1.  Label the second row "At Joe's Steak House (the POS), Daily
    inventory." If an inventory is not available, indicate (no
    inventory). If the inventory was not done on a daily basis, only
    fill in the days for which there is inventory data available and
    leave the other days blank. Do not write zero if inventory was not
    taken. Zero means that there was not any product available on site
    (this includes partial cases, carry over, etc).

2.  The POS in this example was supplied by two distributors (XYZ
    Produce, Nations Foods) during the 10-day shelf life. On the next
    two lines fill in "From XYZ Produce" and "From Nations Food." Now
    add the number of shipping unit(s) (the product in this example is
    shipped in cases) [received]{.underline} on each day from each
    supplier. For example, at Joe's on 5/16 there was no shipment
    received from XYZ Produce. Two cases were received on 5/16 from
    Nations Foods. Remember from the data collection section that it is
    critical that the investigator clarifies the type of date gathered
    from the documents and adjusts it to best approximate the receipt
    date (and document this process). It is the date the product is
    received that is the determinant of whether product could, or could
    not, be utilized or delivered to the next level of distribution.

3.  Make sure that the amounts of product received are consistent with
    apparent usage and available inventory numbers (i. e., you can't
    sell more than you have). In this example, the POS inventory is
    taken each morning before business and before supplies are
    delivered. The inventory indicates that all product delivered on
    5/10, 5/11, and 5/12 was depleted before the next inventory was
    performed. This means that the 2 cases delivered from Nations Food
    on 5/10 were depleted prior to inventory being taken the morning of
    5/11. The 4 cases delivered on 5/11 from XYZ Produce were used at
    the POS before inventory was taken on 5/12, and the 2 cases arriving
    on 5/12 were depleted before inventory was taken on 5/13. Partial
    cases are recorded as 1 case or ½ case. Zero inventory means there
    was no product available. On 5/13 the inventory indicates that no
    product was available before the 5 cases were delivered from XYZ
    Produce. The inventory on 5/14 indicates that 3 cases from these 5
    were still in-house after business on 5/13 and 2 cases were in-house
    from XYZ Produce on 5/15 since no more product was delivered from
    Nations Foods. The shipment of 4 cases from XYZ Produce on 5/15
    would have arrived after the product was prepared for the event.
    Therefore, the likely shipment used to prepare the meal served at
    the event was the 5 cases on 5/13 from XYZ Produce. No suspect
    product from Nations Foods was in-house after 5/11 so, although
    product was delivered by this distributor during the shelf life of
    the product, there would be no need to visit the distributor for
    further information. Analysis at each level, as the data is
    collected, is thus a more efficient use of the investigators time
    than simply gathering data without subsequent analysis. In the event
    that there was no inventory, one would look at the historical usage
    and include the shipment on 5/12 and possibly on 5/11. Inventory
    records are very useful and help to eliminate shipments and
    suppliers. This reduces the number of implicated firms. Therefore if
    an inventory is available, it is a very important tool for the
    analysis. Lack of an inventory usually results in a few additional
    shipments and possibly suppliers being implicated.

[Distributor, XYZ Produce]{.underline}

Information gathered from interviews and observations at the
Distributor:

-   The Distributor, XYZ Produce, does not have an inventory system.

```{=html}
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```
-   The firm used a First-In-First-Out stock rotation which usually
    means the shipments overlap with only 2-3 shipments prior to the
    customer delivery date.

```{=html}
<!-- -->
```
-   Certain shipments could be eliminated because the delivery times of
    product from suppliers to the distributor were after early morning
    customer deliveries.

1.  Start a new row and label it "At XYZ Produce." There was no
    inventory available at XYZ Produce. Add the shipment data gathered
    from invoices and shipping records for each of the three XYZ Produce
    suppliers, one per row, being sure to approximate "receipt" dates.

2.  Although there is no inventory, it is clear from the product usage
    during this time that XYZ Produce would not have had any product
    from Superior Vegetables in-house at the time of the 5/13 delivery.
    This is based on a daily usage of approximately 48-50 cases per day
    and incoming deliveries approximately the same. Therefore, most
    product is probably turned over in 1-2 days. Product delivered to
    the POS on 5/13 (5 cases) would have had to be delivered to XYZ
    Produce on 5/12 or earlier since customer deliveries are made before
    any incoming shipments arrive. Since there is no inventory
    specifying that the product from 5/12 was the only product available
    for shipping on 5/13, the investigator would also implicate
    shipments from at least the previous day (5/11). There would be no
    way to differentiate between shipments from Zenith Fresh or Best
    Produce. Analysis indicates that the likely shipments contributing
    to the shipment of 5 cases to XYZ Produce were the four shipments in
    bold (2 on 5/11 and 2 on 5/12).

[Distributor, Zenith Fresh]{.underline}

1.  Start a new row and label it "At Zenith Fresh" indicating that
    shipment amounts entered for the rows below were determined to be
    in-house at Zenith Fresh during the shelf life of the product. Add
    the shipment data gathered from invoices and shipping records for
    each of the two Zenith Fresh suppliers, one per row, being sure to
    approximate "receipt" dates.

2.  Moving backwards at a diagonal through the timeline one can use
    judgment to ascertain which product shipments might have been
    implicated. The two shipments made from Zenith Fresh to XYZ were on
    5/11 and 5/12. Supplier deliveries on 5/12 or later would not have
    been in-house for delivery to XYZ Produce on 5/12 or earlier
    (deliveries to customers are loaded in the early morning before any
    supplier shipments are received). Therefore, no product from New
    Products (first shipment during shelf life was on 5/12) would have
    been implicated and no investigation is warranted at New Products.
    Average daily usage is approximately 450-500 cases so based on
    product usage the 5/12 shipment probably originated from the
    "Fresh-N-Fast" shipments on 5/11 and 5/10 (overlap always included
    if no specific inventory information is available). The 5/11
    shipment probably originated from the "Fresh-N-Fast" shipments on
    5/10 and 5/9. Therefore, the three Fresh-N-Fast shipments (5/9,
    5/10, 5/11) were likely to have contributed to the implicated
    shipments. Subsequent investigation determined that Fresh-N-Fast was
    the marketing entity for distributing product from an out-of-state
    domestically grown source farm.

[Distributor Best Produce]{.underline}

1.  As before, start a new row and label it "At Best Produce" indicating
    that shipment amounts entered for the rows below were determined to
    be in-house at Best Produce during the shelf life of the product.
    Add the shipment data gathered from invoices and shipping records
    for the Best Produce supplier, being sure to approximate "receipt"
    dates.

2.  The two shipments made from Best Produce to XYZ were on 5/11 and
    5/12 and average product usage was approximately 900-950 cases every
    4 days. The 5/12 shipment of 900 cases would not have arrived in
    time to be sent on to XYZ (deliveries to customers are loaded in the
    early morning before any supplier shipments are received) and usage
    of 250 cases/day makes it highly unlikely that product from the 5/4
    shipment was available. Therefore, the single World Product shipment
    on 5/8 was implicated in the investigation. Interviews at Best
    Produce indicated that they were direct importers of foreign produce
    from World Products in Country X.

[Conclusions:]{.underline} The outbreak associated with a 5/15 event at
the POS served product that traced back to three shipments of product
from Fresh-N-Fast (received 5/9, 5/10, 5/11) that were domestically
grown in state F and one shipment imported by Best Produce from World
Products in Country X.

**Example of a Completed Time Line**

**Receipt Date Event**

  --------------- ------ ------ --------- --------- --------- --------- -------- ------- ------ ------ ------
  DATE            5/06   5/07   5/08      5/09      5/10      5/11      5/12     5/13    5/14   5/15   5/16

  **At Joe's      3      0      4         5         1         0         0        0       3      2      0
  Steak House                                                                                          
  (POS)** Daily                                                                                        
  inventory                                                                                            

  From XYZ        0      5      0         4         0         4         2        **5**   0      4      0
  Produce                                                                                              

  From Nations    2      0      2         0         2         0         0        0       0      0      2
  Foods                                                                                                

  **At XYZ                                                                                             
  Produce** no                                                                                         
  inventory                                                                                            

  From Zenith     0      40     40        30        25        **35**    **50**   0       45     35     35
  Fresh                                                                                                

  From Best       0      0      10        5         5         **10**    **5**    55      10     10     5
  Produce                                                                                              

  From Superior   50     10     0         0         0         0         0        0       0      0      0
  Vegetables                                                                                           

  **At Zenith                                                                                          
  Fresh** no                                                                                           
  inventory                                                                                            

  From New        450    500    0         0         0         0         250      300     200    300    0
  Products                                                                                             

  From            0      0      550       **450**   **400**   **500**   200      300     300    200    450
  Fresh-N-Fast                                                                                         
  Grower- State F                                                                                      

  **At Best                                                                                            
  Produce** no                                                                                         
  inventory                                                                                            

  From World      0      0      **950**   0         0         0         900      0       0      0      950
  Dist. Country X                                                                                      
  --------------- ------ ------ --------- --------- --------- --------- -------- ------- ------ ------ ------

#  Example of a Traceback Investigation Flow Diagram

**Flow Diagram**

Most traceback investigations resemble a branching tree because of
multiple suppliers throughout the distribution chain. An easy way to
visualize the ongoing investigation and shipments of product is to draw
a flow diagram illustrating each level of the investigation as it
branches from the point of service to its original source(s). Prepare a
Flow Diagram illustrating distribution of the product up through the
distribution level currently under investigation. Include for each
implicated distributor: name, city, state, invoice number, receipt date,
quantity, lot numbers, and Freight/AWB numbers and dates. For
non-implicated distributors list only the distributor name. If there are
numerous shipments involved and the flow diagram would become too
complex, just list receipt date, quantity, and invoice number on the
flow diagram, and include other record information on a separate page.

**Attachment 3: Multi-state Flow Diagram Example**

The boxes and lines that are in **bold** lettering indicate the
implicated product's distribution pathway that links all of the
points-of-service outbreaks to the implicated grower. Tracebacks were
initiated at four points-of-service in response to a multi-state
outbreak of illnesses that were epidemiologically associated with a food
product under FDA jurisdiction. In the traceback that began at POS A,
Grower A and B were ultimately implicated. In the tracebacks initiated
at POS B and POS C, Growers B and D were both implicated. In the
traceback initiated at POS D, Growers B, C and D were implicated. None
of the distributors were identified a common supplier to all four
points-of-service. Therefore, none of them could have been the source of
the contamination. Although a total of four growers were implicated, the
only one in common to all of the four tracebacks is Grower B. The only
firm that will require an inspection by a team is Grower B.

# Attachment 4: Creating Electronic Traceback Documents

Open MS WORD. Select "File." Select "Open." Select "Save As."

Select Save In: Choose a file location (ex. the newly named "event
folder." )

Select File name: give the file a name (example: MI_09flow. doc)

From the top toolbar there should be an icon that has letters and shapes
on it. This is the "Drawing" toolbar (place the mouse over the icon the
word "Drawing" will appear). Select this icon. A new toolbar will appear
at the bottom of the screen.

# 

# TO CREATE BOXES

From this new "Drawing" toolbar, select "AutoShapes." From the pop-up
menu, Select "FlowChart." Select the shape of the box for the diagram
(the first two are probably the best choices). They will look like this:

Select the shape and the mouse pointer will become a " + ." Place this
" + " where you want the box by clicking once with the left mouse button
(it can be moved once it is placed).

# TO ADD TEXT TO THE DIAGRAM BOXES

To insert text into the box, place the mouse pointer on the edge of the
box and click the **Right** mouse button. A new menu will appear. Select
"Add text." Type inside the box. Put the name of the firm, the suspect
shipment date and quantity. You may choose to change the size of the
font before entering the data in the box from the top toolbar. You do
not want to use "Text Box" to insert the text. If you do, the text and
the box will not be attached and will not move together.

# TO CHANGE THE SIZE OF THE BOX

To increase the size of the box, select the box (left mouse click on the
box). Place the mouse pointer on one of the small squares outlining the
box. You should see a double pointed arrow when it is in position. The
end squares will increase the width, the top squares will increase the
length and the corner squares will do both. After you have chosen the
square, holding the left mouse button down, drag the square outward (or
inward) until it reaches the desired size. Release the mouse button.

This box is This box has been widened

too small. and lengthened.

# 

# 

# TO MOVE THE BOX

To move the box (and text) to a new position, select the box and place
the mouse pointer on an edge of the box until a double arrow appears.
Click (and hold) the left mouse button down and drag the box to the
desired position. Release the mouse button. You may edit any box anytime
by selecting it (left mouse click). To delete an unwanted box simply
select it and press delete.

# 

# 

#  

# ADDING ARROWS

To add arrows to the flow diagram, select the arrow icon from the
"Drawing" toolbar. Again you will see a " + " . Place this where you
want to begin the arrow. Click and hold the left mouse button and drag
to where you want the arrow point to end. Release the mouse button.

# MOVING AND CHANGING ARROWS

To move, shorten or change arrows, simply click on the arrow and a
square will appear at each end of the arrow. Using the left mouse
button, click and drag these squares to lengthen, shorten or redirect
either end of the arrow. To move the entire arrow, place the mouse
pointer in the center of the selected arrow and a crossed arrow will
appear. Again, left mouse click, hold and drag to new location.

To change the direction of an arrow, select the icon on the "drawing"
toolbar that has the 4 arrows lined up horizontally. From there select
the arrow direction or type that you want.

To delete an unwanted arrow, simply select it and press delete.

**[STANDARD ARROW USAGE]{.underline}**

Since these flow diagrams will be used to share information between
districts and with EOC a standard protocol should be followed. All
arrows should point in the direction of the traceback. For example, the
arrows should start at the point of service and go in the direction
towards the source. For a traceforward (if you are asked to do one),
direct the arrows from the source (or starting point of the
traceforward) towards the point of service.

**[HELPFUL HINTS]{.underline}**

Each of the levels of the Time Line and Flow Diagram should be
consistent with one another. The levels (i.e., to 5A, from 4A) are for
illustrative purposes. You will use the name of the Firm. If the diagram
does not fit on one page, you will need to indicate where the chart is
connected on the next page. (For inserting these instructions, you can
use the "text box" option on the "Drawing" toolbar).

Here is an example:

1^st^ page End of Right Margin 2^nd^ page

#  

# TO ADD A NEW PAGE 

Press Ctrl (hold) and END.

Select "Insert" from the top toolbar. Select "New Page." Be sure to
check the "Page Set Up" to see that it is still in Landscape format for
this new page.

# TO VIEW ENTIRE PAGE

This is helpful to see that all the levels are lined up and the arrows
are connected correctly. Select "View." Select "Zoom." Select "Whole
page." You will then see the document one page at a time. You may make
edits from this view. To change back to the previous page or to another
viewing size, Select "View" and choose the size you want.

**[TIME LINE]{.underline}**

**[TO BEGIN A NEW TIME LINE]{.underline}**

Open MS WORD.

Select "File." Select "Open." Select "Save As."

Select Save In: Choose a file location (example: the newly named "event
folder.")

Select File name: give the file a name (example: timeline. doc)

Select "Table" from the toolbar.

Select "Insert Table."

For number of columns: Choose Shelf Life plus 2 (1 column for event date
and 1 for labels).

For number of rows: Begin with 10 and add as needed (as investigation
proceeds).

Column width: Auto Format

Select "OK."

When the time line is complete, be sure to "save" and then it can be
submitted electronically via the e-mail system as an attachment.

#### TO FILL IN THE TIME LINE TABLE

Use the instruction forms provided in this document as to how a time
line is completed and analyzed. Remember to analyze at each level using
the time line and flow diagram and to consult with EOC before proceeding
to the next level. Place the cursor in the desired cell. Type "Date" in
the 1^st^ column, 1^st^ Row. Then fill in the dates (the furthest right
hand column will contain the event date). The second row will contain
the name of the POS and inventory (if kept) on each of the dates. The
third row begins the list of distributors who supplied to the POS during
the shelf life prior to the event. After these have been listed, the
next level will begin. It should start with "**at** Distributor (A)",
the name of the first supplier to the POS, and continue one row for each
of the supplier to Distributor (A). Label these "**from** Supplier C"
(using the name of the firm) for all suppliers to this first
distributor. Refer to other information on how to fill out and use a
time line.

#### 

#### TO ADD MORE ROWS TO THE TABLE 

When there are no more blank rows left in the table, you may need to add
more rows.

Place the cursor at the end of the number in the final cell. Press
"TAB." You will now have a new row.

#### TO CONTINUE A TABLE ON A NEW PAGE

If the table is too long for one page, choose a place to end the table.
Try not to split a distributor's list of suppliers between pages. Select
the final row in the table, by placing the cursor on the row. Select
"Table." Select "Select Row." After highlighting the final row for page
1, Select "Split Table." This will split the table. However on the new
page you will need to label the first row with the dates.

You may choose instead to Select "Insert." Select "Break." Select "New
page." On the new page repeat the above instructions for creating a new
table, including completely filling out the dates. If the table is too
wide (long shelf life), you will need to continue it on a new page,
beginning with the next date.

Example:

  ----------- ----------- ----------- ----------- ----------- -----------
  5/12        5/13                                5/14        5/15

                                                              

                                                              
  ----------- ----------- ----------- ----------- ----------- -----------

1^st^ page End of Right Margin 2^nd^ page

**[SUSPECT SHIPMENT IDENTIFICATION ON THE TIME LINE]{.underline}**

This table will be transmitted electronically, so you will need to be
able to indicate which shipments on the time line are suspect. To do
this, you may either put the shipment(s) in bold or shade in the cell
containing the shipment(s).

To indicate suspect shipment(s) by BOLD letters simply put the mouse
pointer to the left of the first number in the cell and click the left
mouse button (and hold) and drag across the numbers you want to be in
bold. They will be highlighted. Then from the lowest toolbar at the top
of the screen there will be a letter B. Select "B." The numbers you have
highlighted will now be **bold.**

  ------------------------------------------- ---------------------------
  Date                                        5/10

  Distributor A                               **5**

  Distributor B                               6
  ------------------------------------------- ---------------------------

### To indicate suspect shipments by SHADING the cell containing the shipment(s), simply highlight the entire cell by pointing the mouse pointer (move it until there is an arrow pointing in the cell) and click the left mouse button. This will highlight the entire cell. Select "Format" from the top toolbar. Select "Borders and Shading." Select "Shading" tab. From the Patterns/ Style menu you will see "CLEAR" as the selected choice, scroll down until you see 5% or 10% (grey). Select either of these two options. The 10% grey is shown below. 

  ------------------------------------------- ---------------------------
  Date                                        5/10

  Distributor A                               5

  Distributor B                               6
  ------------------------------------------- ---------------------------

**Attachment 5: Interview Questions**

In the July 1998 Traceback Guide, a questionnaire was completed and
included in the final reports. This questionnaire is no longer required.
However, many investigators have found these questions useful for
eliciting information, so they are included here as a reference.

**[POS Event Information]{.underline}**

Product Preparation Date/Time (a.m./p.m.):

Have there been any reports of illness to the POS?

Were any of your employees ill during the two weeks prior to the event?

#### Outgoing Deliveries to Customers and Incoming Deliveries from Suppliers

Can the source of implicated product delivered to customers be tracked
precisely by the use of a

lot numbering system?

How are **customer deliveries** documented or recorded?

Are the outgoing delivery records initialed or stamped with the delivery
date?

How are **supplier deliveries** documented or recorded?

Are the records of an incoming shipment initialed or stamped with the
receipt date?

If the records don't reflect receipt dates, explain how should the
recorded dates be adjusted to reflect receipt dates (for outgoing
shipping dates and incoming shipment receipts) ?

Were there any holidays or unusual occurrences that would have affected
delivery or receipt dates?

What are the transit times from each of the supplier(s) listed above to
the current establishment?

Are there any transfers of products within the company? How are these
handled and documented?

**[Shipping and Receiving Practices]{.underline}**

When and how does the firm order new stock?

Is there a standard stock "low point" after which the firm orders
additional product?

What happens if the firm does not have enough product to fill an order?

What are the firm's stock rotation practices?

Are the stocking practices generally followed at this establishment?
When might they be deviated from?

Is a stock inventory taken? How often and what time of the day is
inventory taken?

At what time does this establishment load its deliveries to customers?

If inventory is taken, is it taken before or after deliveries for the
day are loaded?

If inventory is taken, is it taken before or after shipments are
received?

Did the customer(s) pick up the order or was it delivered?

What are suppliers' general delivery times?

**[Product Handling and Storage Practices]{.underline}**

Does the firm have an SOP and documentation for rejected or returned
products?

Does the firm have an SOP for disposal of product too old to sell?

Is the product prepared, repackaged and/or handled prior to
distribution, service, or sale?

How is the customer product loaded?

Does the firm mix loads?

Is there an SOP for loading?

Does the firm have an SOP for truck cleaning or specifications for
acceptance of vehicles for loading?

Is it clear to the loaders which product should be loaded first?

What are the approximate shipping times to the firm(s) who received the
implicated product?

How is the incoming product handled upon receipt?

Do suppliers use any chemical or gas treatment on the product before
shipping?