Last updated June 2006
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
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 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 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.
INITIATING A TRACEBACK INVESTIGATION
Initiation of a traceback investigation usually begins when 1) epidemiological evidence implicates a food product and 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 FDAs 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:
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 supervisors endorsement and the FOI statement, a timeline and the flow diagram(s). The following items should also be included for each firm you visited:
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 supervisors 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.
You, the investigator, are responsible for completing the following tasks:
TRACEBACK RESPONSIBILITIES
The EOC Coordinator is responsible for completing the following tasks:
CFSANs responsibilities are described in the CFSAN Emergency Response Procedures, July 25, 2000.
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 firms 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 FDAs 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 someones 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:
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 FDAs 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 firms 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
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:
Step 2. Fill in Receipt Dates.
Step 3. Review the pertinent information collected during the interviews and observations.
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.
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:
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:
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 at the firm.
Step 3. Review the pertinent information from interviews and observations
Step 4. Implicate shipments and suppliers.
Step 5. Contact EOC.
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.
Please see the DFI Guide to Produce Farm Investigations, available at http://www.fda.gov/ora/inspect_ref/igs/iglist.html for further guidance.
Emergency PAC Code | Title | Problem Area Flag (for sample collection & analysis) |
---|---|---|
03R175 | Cyclospora Emergency | MIC, PAR |
03R265 | E. Coli 0157:H7 (EHEC) Emergency | MIC |
03R225 | Enterotoxigenic E. coli (ETEC) Emergency | MIC |
03R266 | Listeria Emergency | MIC |
03R263 | Salmonella Emergency | MIC |
03R264 | Salmonella Enteritidis in Eggs Emergency | MIC |
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 NEC | PES, ELE, CDW |
07R279 | Biotoxin Emergency | BIO |
07R280 | Alflatoxin/Mycotoxin Emergency | BIO |
07R839 | Molecular and Natural Toxin Emergency - NEC | BIO |
09R839 | Food and Color Additive Emergency NEC | FAD, COL |
21R281 | Infant Formula Emergency | NIF, MIC, PES, ELE |
21R839 | Food Composition, Standards, Labeling & Economics Emergencies NEC | NUT, MIC, FAD, PES |
71R839 | Post Approval Animal Drugs, Feeds and Devices NEC | PES, ELE, MIC, MYC |
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
The timeline chart is an easy visual reference that provides information on the receipt dates 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
Information gathered from interviews and observations at the POS:
After completing the investigation at the POS, the investigator will want to fill in the timeline and analyze the POS information.
Distributor, XYZ Produce
Information gathered from interviews and observations at the Distributor:
Distributor, Zenith Fresh
Distributor Best Produce
Conclusions: 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.
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 Joes Steak House (POS) Daily inventory |
3 | 0 | 4 | 5 | 1 | 0 | 0 | 0 | 3 | 2 | 0 | |
From XYZ Produce |
0 | 5 | 0 | 4 | 0 | 4 | 2 | 5 | 0 | 4 | 0 | |
From Nations Foods |
2 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 | |
At XYZ Produce no inventory | ||||||||||||
From Zenith Fresh |
0 | 40 | 40 | 30 | 25 | 35 | 50 | 0 | 45 | 35 | 35 | |
From Best Produce |
0 | 0 | 10 | 5 | 5 | 10 | 5 | 55 | 10 | 10 | 5 | |
From Superior Vegetables |
50 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
At Zenith Fresh no inventory | ||||||||||||
From New Products |
450 | 500 | 0 | 0 | 0 | 0 | 250 | 300 | 200 | 300 | 0 | |
From Fresh-N-Fast Grower- State F |
0 | 0 | 550 | 450 | 400 | 500 | 200 | 300 | 300 | 200 | 450 | |
At Best Produce no inventory |
||||||||||||
From World Dist. Country X |
0 | 0 | 950 | 0 | 0 | 0 | 900 | 0 | 0 | 0 | 950 |
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.
The boxes and lines that are in bold lettering indicate the implicated products 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.
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. OR
Select the shape of the box for the diagram (the first two are probably the best choices).
They will look like this:
OR
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 too small. | This box has been widened 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
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
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:
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
TO BEGIN A NEW TIME LINE
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 1st column, 1st 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 distributors 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:
SUSPECT SHIPMENT IDENTIFICATION ON THE TIME LINE
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 |
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
Outgoing Deliveries to Customers and Incoming Deliveries from Suppliers
Shipping and Receiving Practices
Product Handling and Storage Practices