Food Investigation Response Manual
8.0 Verification

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Scope

The purpose of the verification process is to assess the effectiveness of the recall measures taken by the recalling firm and other associated firms (i.e. distributors and retailers).

8.1 Roles and Responsibilities

8.1.1 Industry

The recalling firm not only has the responsibility for conducting the recall but also for ensuring that its actions have been effective in removing the product from the marketplace. To ensure the effective removal of the products, the recalling firm needs to advise its accounts to remove the product from sale and/or to further notify their accounts down the distribution chain as appropriate to the recall depth.

Note: The procedures outlined in this section are designed only for the Canadian Food Inspection Agency's (CFIA) verification activities. The time standards and sample sizes identified in the procedures do not directly apply to the verification activities conducted by a recalling firm; therefore, it is the responsibility of the recalling firm to apply appropriate procedures.

8.1.2 Canadian Food Inspection Agency

8.1.2.1 Office of Food Safety and Recall (OFSR)

Throughout the verification process, the OFSR may provide advice to the Area field staff involved in the verification activities.

8.1.2.2 Area Recall Coordinator (ARC) / Regional Recall Coordinator (RRC)

The Area Recall Coordinator is responsible for providing guidance and support on the verification process. The ARC is also responsible for receiving requests for verification activities from other Areas and ensuring that they are acted upon in a timely manner.

8.1.2.3 Lead Investigator

The Lead Investigator is responsible for gathering the information necessary to initiate the recall verification activities from the recalling firm and in consultation with the Supervisor and/or Inspection Manager, is responsible for planning, coordinating, reporting and closing the CFIA recall verification process.

8.1.2.4 Area Field Staff

CFIA Area field staff verify whether consignees to whom a product has been sold have been notified of the recall and whether the implicated product has been removed from sale and properly segregated pending disposition.

8.1.3 Provincial/Territorial/Municipal Governments

Where agreements are in place with other government departments or agencies to assist with verification activities, the ARC will forward to the appropriate department the necessary information. The ARC will also forward to the appropriate CFIA office the results of the verifications conducted by an external partner. Please refer to appendices 6A, 6B, 6C and 6D for example documents that may be used for preparing and recording such requests.

8.2 Verification Process

The CFIA works with the recalling firm on the strategy developed by the firm to recall products from sale and verifies the effectiveness of the recalling firm in completing and assessing its own recall. Using a statistical sampling plan, the CFIA identifies a sample of consignees to verify the recall's effectiveness. If the CFIA determines that the recalling firm has not been successful in conducting an effective recall, it will take appropriate actions to ensure the safety and well-being of the consumer.

The following describes the procedures which are applied by the CFIA to verify the effectiveness of food recalls. Additional procedures such as 100% checks may also be applied as considered necessary, for example, in case of a food borne illness outbreak or distribution targeted to institutions such as day care centres or retirement homes. Further deviations with the established procedures may also occur in exceptional circumstances. With the agreement of his/her Supervisor and/or Inspection Manager and in consultation with the ARC and the OFSR, the Lead Investigator may modify the approach proposed in this section provided that the CFIA has sufficient confidence and evidence that the recalled product has been taken off the market.

Notes:

  1. An example of the latter situation is when the recalling firm or distributor conducts effectiveness checks immediately following the start of the recall and the checks are deemed satisfactory by the CFIA. With the approval of his/her Supervisor and/or Inspection Manager, the ARC and the OFSR, the Lead Investigator may modify the current approach by reducing the number of establishments to be verified. Such a practice would apply only to single-circuit distributions where the success of an effective recall is not dependent upon another distributor.
  2. For Class III recalls, two approaches for verifications are available:
    • The primary approach is to verify removal or correction of a recalled product by the recalling firm by obtaining (via E-mail, fax or visit) necessary documents such as a recall notice and other company documents which show the removal/correction of a recalled product. This verification should be completed within a suitable time (Table 1). Since products under Class III are "not likely to cause any adverse health consequences," this approach is considered acceptable and should be used to verify the removal or correction of recalled products for Class III recalls.
    • The secondary approach is to employ the procedure outlined in the following sections. The secondary approach is for recalls where the primary approach is considered less effective or efficient. This approach should be used only in exceptional circumstances and only in consultation with the Supervisor/Manager/ARC/OFSR.

8.2.1 The Lead Investigator will:

For a Class I and Class II recall:

  1. Immediately request a detailed list of consignees from the recalling firm. The list of consignees should contain sufficient details to allow the CFIA inspectors to understand the distribution patterns and make contacts without further delay;

    Note: It is anticipated that the majority of recalling firms would immediately start the recall activities and provide a list of accounts to the CFIA for the verifications process. However, in some cases of a Class I recall or a recall with a public announcement, where a recalling or an associated firm is slow to respond, the CFIA may use previously available lists to initiate a verification process.

  2. The list should have sufficient details including:
    • Names, addresses including postal codes and phone numbers of all consignees who are notified by the recalling firm;
    • Separation of consignees within the list by geographical regions (as applicable); and
    • Separation by consignee within the list type - hospitals, chains, independents etc. , (as applicable). See Suggested Procedure for Obtaining List(s) of Consignees for the recommended procedures.

    Notes: Preferably the list should have the names of all consignees who received the recalled product. However, the list often includes the names of all of the recalling firm's consignees, some of which may not have received the recalled product.

    Preferably the list of all retail consignees should be available. However, often the list includes both retailers and distributors consignees and in some cases some further manufacturers.

    The Lead Investigator should at the time of the initial request determine the types of consignees included in the list. If the list contains further distributors or manufacturers, appropriate CFIA offices should be immediately notified, so that distributors can be contacted to obtain a detailed list of retailers. If there are further manufacturers in the original list, separate recall food safety investigations would be initiated.

  3. In consultation with the Supervisor and/or Inspection Manager and appropriate CFIA offices, determine the best estimate of the number of consignees, sampling interval and the random starting point sample for verification (refer to section 8.2.3 for details), while the recalling firm is compiling the list;
  4. Prepare a plan, including the sampling interval and the random starting point, the recommended time frames for completion, the related IMS number and any other details which may help conduct the verification activities more effectively. The plan will then be forwarded to the ARCs in those areas where products have been distributed. Attached to the plan will be copies of the lists, product/carton labels, recalling firm's notice of recall, and copies of corrected labels and the public warning (if applicable);
  5. Ensure that the recalling firm and appropriate associated firm(s) including distributor, chain store head office or a store are notified and that the corrective action is initiated, when informed of a deviation; and
  6. Review the results of the recalling firm's recall activities; this activity is most effective when conducted on-site and is likely to include a review of documentation such as confirmed recall notices, receipts of returned product, telephone call reports and email confirmations.

For a Class III recall in consultation with Supervisor/Manager and as needed with ARC/OFSR initiate the most efficient/effective approach (see note 2, section 8.2).

8.2.2 The Inspectors Assigned the Verification Activities Will:

  1. Ensure receipt of the recalling firm's distribution list as well as the distribution list from other distributors involved;

  2. Assist the Lead Investigator, while the distribution list is being compiled, in determining the best estimate of the number of consignees and the provinces where the product has been distributed (refer to section 8.2.3 for details);

  3. Ensure that copies of the recalling firm's Notice of Recall, and as applicable, copies of the public warning and labels are on hand when conducting verification activities; these documents can then be referenced and/or left with consignees if required;

  4. Bring the issue to the attention of the recalling firm, where there is suspicion that the distribution list is not accurate or complete (i.e. a generic list of chain stores is missing a few known stores); and where necessary, evidence will be gathered and a list will be prepared, identifying other potential retailers and/or distributors who may carry the recalled products, but are not included on the distribution list.

  5. Select the consignees, after receiving the actual copy of a distribution list, and identify the type of check to be conducted for the selected consignees, for verification (see section 8.2.3) and inform the appropriate ARC (or the CFIA office as per area protocol) to conduct the checks;

  6. Conduct checks to determine if the consignees have received a Notice of Recall from their supplier and have taken the prescribed action. Conduct checks by on-site visits or phone according to the provisions in notes below;

    Notes:

    1. Telephone checks should be done according to the method listed in the Recommended Telephone Verification Procedure. On-site visit checks should be done according to the method listed in the Recommended On-site Verification Procedure.

    2. For checks, Chain Stores are defined as two or more retail outlets under a common system. These would include company owned stores as well as franchised stores. These include outlets such as gas stations, hardware stores etc. where food items are sold. Independent Stores are defined as all non-chain outlets where food items are sold.

    3. For chain stores, checks by telephone and by visits are considered equally effective.

    4. At independent stores conduct 75% checks by on-site visits and 25% by phone.

    5. For independent stores, checks by visit are more effective than the checks by telephone. Therefore, using telephone checks in lieu of on-site visits for independent stores is considered acceptable only in exceptional circumstances and only after consultation with ARC.

  7. Request immediate compliance with the instructions if the recalled product is being held for sale or used against directions provided in the Notice of Recall;
  8. Immediately advise the Lead Investigator and any other inspector responsible of the deviations encountered and assist the Lead Investigator and/or ARC in contacting the appropriate recalling firm to notify the observed deviation and take necessary corrective action; and
  9. Enter the data electronically in the Issues Management System (IMS) and include a summary of the verification results in the Task / Activity log before closing the assignment.

8.2.3 Determining the Consignees to be Contacted (the Sample):

The consignees to be contacted will be determined by the Lead Investigator and the appropriate Regional Inspectors. The verification process uses a statistical approach that incorporates a systematic sampling method. The verification activities should be timely and should include sufficient numbers of checks at appropriate consignees.

The Lead Investigator will:

  1. Determine the actual or the best estimate of the number of consignees, (e.g. 1200);

    Notes:

    • The Lead Investigator should attempt to obtain the entire distribution list within the appropriate time lines (see Table 1). If such a list is available in time, the actual number of consignees is determined from that list.
    • In order to ensure timely response, the CFIA cannot wait for the entire list to be available before the checks are initiated; therefore, at the very beginning, the Lead Investigator should, in discussion with the recalling firm and as needed (if there are distributors on the list) through other CFIA offices, determine the best estimate of the number of actual retailers (who received the recalled product or who will be notified of the recall). Example: If the recalling firm has 50 retailers and 5 distributors and the 5 distributors in turn have 400, 200, 300, 100 and 150 retailers, the best estimate of the number of consignees on the list is 1200 retailers. The effectiveness check is done from the list of 1200 names.
    • The best estimate is not the "customer" list of a recalling firm. It is rather the estimate of retailers which would have received the recalled product or would receive the recall notification from the recalling firm. The best estimate can be determined via phone/E-mail without obtaining actual copies of the lists; however, care must be taken that the estimate would not significantly differ from the actual list(s) (See the Suggested Procedure for Obtaining List(s) of Consignees).
    • The Lead Investigator should use the actual number or the best estimate and Tables 2 and 3, 4, 5 or 6 to determine the sufficient numbers of checks.
  2. Determine if the distribution is a multi-channel or a single channel distribution. For example, where distribution is by one source/location or only within a chain system, it can be classified as a single channel distribution, (i.e. distribution to1200 stores including a few distributors and various chain and independent stores, would be multi-channel, while distribution to 1200 stores all within one chain store or from one distribution point would be a single channel);

  3. Determine the appropriate sampling rate, using Table 2. For example, for a Class I recall and the list of 1200 consignees in a multi-channel distribution, the appropriate table is table 3 and the sampling rate is 160. On the other hand for a Class I recall and the list of 1200 consignees in a single distribution system, the appropriate table is table 4 and the sampling rate is 87;

  4. Determine a sampling interval by dividing the total number of actual or estimated consignees (example 1200) by the minimum sample size (160 for the multi-channel list and 87 for the single channel list). In this example, sampling intervals would be 7 (1200/160 = 7.50 rounded to the lower whole number) or 13 (1200/87 = 13.79 rounded to the lower whole number);

  5. Randomly select a number between 1 and the sampling interval to determine the starting point. For example, say 3 for a sampling interval of 7 or 2 for a sampling interval of 13;

  6. Provide the sampling interval and the random starting point along with any available lists to the applicable area(s); and

  7. Provide the ARC with the number of verification requests to be expected.

    The inspectors assigned the verification activities after receiving the actual copy of the distribution list will:

  8. Select the consignees for verification, using the predetermined sampling interval and the random starting point;

    Notes:

    • Put the distribution list in any order, count from the top until you reach the starting point 3rd name on the list in the example. Select 3rd name, then go down the list and select every 7th as an example to 10th, 17th and further (according to the predetermined sampling interval) until the list is exhausted. From any grouping (such as all stores in Ontario or BC; or a group of all hospital accounts) within the list which has fewer consignees than the predetermined sampling interval, at least one name should be randomly chosen.
    • If there are groupings of consignees which sell to susceptible populations likely to be affected by the recalled product (such as a list of day care centers, hospital cafeterias, retirement homes, etc. ), they must be included and checked at higher frequency on case-by-case basis.
  9. separate selected consignees into chain and independent stores. Provide appropriate office(s) details (names, phone numbers, addresses and the type checks) of the consignees to complete the checks according to section 7.2.1; and
  10. Continue with all the assigned checks even though, regionally, a recall may appear ineffective.

8.2.4 Verification Result Summaries

The Lead Investigator will prepare and enter in the IMS the summary of recall activities. The focus of the summary should be to:

  • Determine how many consignees still have the product(s) on sale;
  • Identify reasons for continued sale;
  • Identify other deficiencies;
  • Assign an overall effectiveness rating to the recalling firm's recall activities; and
  • Summarize corrective actions.

The summary should include a description of the corrective actions taken to correct each identified deficiency (i.e. the product removed and segregated in shipping area, re- notification was issued for all convenience stores including names of affected distributors, as applicable, etc.).

The IMS should be updated with the summary and complete the item Satisfactory under Action Taken.

8.3 Time Frames for Initiating and Reporting on Verification Activities

Recall verification activities are to be considered a high priority by receiving Areas, Regions or Districts. Table 1 describes the recommended time frames for the initiation of verification activities and for the submission of results of these activities. It is recognized that each recall is accompanied by its own risk management strategy; therefore, specific circumstances may affect the time frames presented in this table. It is the responsibility of the receiving Area to notify the Lead Investigator of circumstances which may delay the verification and/or reporting activities.

The time standards presented in Table 1 are for the CFIA's verification activities. It should not be misunderstood that for a Class I recall a recalling firm has 3 days to initiate and 10 days to complete a recall. Recall activities by firms should be immediate upon deciding a recall or receiving notification of a recall. During this time, the Lead Investigator will also have an oversight function to assess whether the recall activities have in fact been initiated by the recalling firm.

Table 1 - Recommended time frames for initiating and reporting verification activities within the CFIA
Recall classification Following the initiation of a recall, the verification activities must begin within a period of: Following their initiation, verification activities must be completed within a period of:
Class I 3 days Table Note 1 10 days
Class II 5 days 12 days
Class III 10 days 17 days

Table Notes

Table note 1

Working days: working days may include Saturday and Sunday, depending upon the risk associated with a recalled product.

Return to table note 1 referrer

Verification results should be submitted to the Lead Investigator via fastest possible means E-mail, fax, phone or IMS as soon as possible.

8.4 Concluding the Verification Activities

The objectives of verification activities are to evaluate:

  • The overall effectiveness of the recall;
  • The recalling firm's process; and
  • The actions taken by the consignees when advised of the recall.

8.4.1 Deviations

Deviations are those occurrences where unfavorable results are encountered. Two types of deviations may be encountered:

  1. Product deviations are defined as those occurrences where the affected product remains available to the consumer.
  2. Process deviations are related to the overall recall strategy or process and may include:
    • The Notice of Recall was not received by all consignees within the established time frames;
    • Effectiveness checks were not properly conducted;
    • Problems encountered were not adequately addressed; and
    • A break-down in the notification process by a secondary distributor.

The Lead Investigator must be advised immediately when deviations are encountered so that the recalling firm and/or appropriate consignee can be informed.

Also, the Lead Investigator must determine if the deviations follow a pattern or trend, thus allowing for a focused and appropriate application of corrective measures. During the evaluation of the deficiencies and associated reasons, it is important to distinguish between isolated reasons (i.e. the product was removed in a store but was re-shelved by mistake) and widespread systemic reasons (i.e. breakdown in the notification process or delay caused by the schedule of sales personnel).

The Lead Investigator, in consultation with the Supervisor and/or Inspection Manager, will assess if the verification process has been found to be effective and will communicate their decision via E-mail/IMS, etc.

Note: Depending upon the actual sampling calculations, the final sample count would likely differ (generally be higher) from the count listed in the tables, therefore, caution should be used in the interpretation of the critical numbers. The recall activities should be classified as effective or ineffective, after considering both the number and the nature of the deviations.

8.4.2 Determining the Overall Effectiveness of the Recall

Was the recall process effective in removing the product from sale?

For a recall to be deemed effective, the number of consignees checked that are found to have the product available to the public must be equal to or less than the critical number in the sampling plan.

Where a product has been removed from sale but process deviations are identified (i.e. the consignee did not receive the Notice of Recall but became aware of the recall by the media), the Lead Investigator must still be advised as soon as possible.

8.4.3 Determining the Overall Effectiveness of the Recalling Firm's Process

Was the recalling firm's strategy implemented properly and effectively?

Where the process deviations are encountered, it may be concluded that the recalling firm did not properly carry out its recall process or that the firm's recalling strategy may be inappropriate. The CFIA will take the appropriate measures and provide needed guidance to ensure the recalling firm addresses the deviations.

8.4.4 Determining if the Appropriate Actions were Taken by the Consignees when Advised of the Recall

Did the distributors / consignees take the appropriate product action when advised of the recall?

Deviations will be recorded where it is found that the consignees (retailers, wholesalers, etc. ) along the distribution chain were properly advised of the recall but did not take the appropriate actions. The CFIA will take the appropriate measures to ensure the product is removed from sale. In such instances, inspectors may seek advice, guidance and assistance from an investigation specialist within the Enforcement and Investigation Services.

Where it is found that the consignees (distributor or other resaler) along the distribution chain were properly advised of the recall but did not properly carry out the recall to the next level of distribution as requested by the recalling firm, the CFIA will take appropriate measures to ensure that the recall is properly carried out by the affected consignee.

Examples/Scenarios of Effective and Ineffective Recalls:

Note: Only the Lead Investigator assigns this (effective or ineffective) classification. Inspectors conducting checks would need to continue with all the assigned checks even though, regionally, a recall may appear ineffective.

Using the example of 1200 consignees on a list for a Class I recall, with verification done at 160 randomly selected consignees where critical number is seven.

  1. All consignees checked have received the Notice of Recall from the recalling firm and have removed the product from sale.

    Action: None, recall is effective.

  2. Eight consignees (1 more than critical number) checked are found to have deviations. Four have not received the recall notice and still offering the product for sale; four have received the notice but have not taken the requested product action. Therefore, the product remains available to the consumer at 8 locations, exceeding the critical number.

    Action: Recall is deemed ineffective (a total of eight consignees still have the product available). Product action will be taken and a recall may need to be repeated, in the appropriate area/region. Measures will be applied against those consignees who received the information but did not take appropriate action.

  3. Ten consignees checked are found to have deviations. Seven are found to have process deviations and 3 have product deviations.

    Action: Overall recall would appear effective as the product deviations are less than the critical number; however, the recalling firm may have an inappropriate recalling strategy. The recall may be ineffective if the reason(s) for the deviations was systemic or effective if the reason(s) was isolated. The CFIA will take the appropriate measures to ensure the recalling firm and/or consignees address the deviations and will provide the guidance as required.

    Product action will be taken and a recall may need to be repeated, in the appropriate area/region. Measures will be applied against those consignees who received the information but did not take appropriate action.

8.4.5 Ineffective Recall

If at any time during the verification of the recall, the CFIA determines that the recall effort is ineffective, the OFSR should be notified. The CFIA will assess the root cause of the failure and determine which actions are appropriate to the situation. The CFIA will discuss the situation with the responsible firm to determine what action the responsible firm intends to take to improve its recall effort, such as issuing additional recall communications, etc.

A letter should be written by the Lead Investigator detailing the reasons why the recall has been found to be ineffective. The Lead Investigator should request a written response from the responsible firm confirming the actions that will be taken to address the situation.

If, after having been formally notified by the CFIA of the ineffectiveness of their recall, the responsible firm is unwilling or incapable of extending or modifying its recall, the Inspection Manager/Supervisor/ARC will forward the recommended actions to be taken by the CFIA, to the OFSR. Risk management options to be considered may include public warnings issued by the CFIA, product seizures or other appropriate legal and/or compliance actions.

Table 2: Selection of Appropriate Sampling Table for Recall Effectiveness Verifications
Recall Distribution Class I Class II Class III
Multi-channel Table 3 at prescribed rate Table 4 at prescribed rate Table 5 at prescribed rate
Single channel Table 4 at prescribed rate Table 5 at prescribed rate Table 6 at prescribed rate
Table 3. Class I Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 10000 200 9
5000 - 9999 195 9
3500 - 4999 190 9
2600 - 3499 180 8
2000 - 2599 175 8
1600 - 1999 170 8
1150 - 1599 160 7
1000 - 1149 155 7
850 - 999 150 7
750 - 849 145 6
650 - 749 135 6
550 - 649 130 6
500 - 549 120 5
400 - 499 115 5
350 - 399 110 4
290 - 349 95 4
255 - 289 85 3
230 - 254 80 3
175 - 229 75 3
150 - 174 65 2
125 - 149 60 2
100 - 124 50 1
90-99 45 1
75-89 35 1
65-74 30 0
< 65 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 4. Class I Single Channel, Class II Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 5000 110 5
3000 - 5000 105 5
2000 - 2999 100 4
1600 - 1999 95 4
1250 - 1599 90 4
1000 - 1249 87 4
850 - 999 84 3
750 - 849 80 3
650 - 749 77 3
550 - 649 74 3
500 - 549 70 3
400 - 499 69 3
350 - 399 65 2
300 - 349 61 2
250 - 299 58 2
225 - 249 55 2
200 - 224 52 2
175 - 199 50 2
150 - 174 45 1
125 - 149 40 1
115 - 124 35 1
100 - 114 32 1
80-99 30 1
< 80 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 5. Class II Single Channel, Class III Multi-Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 2000 70 3
1000 - 2000 65 3
750 - 999 55 2
600 - 749 50 2
400 - 599 45 1
350 - 399 40 1
325 - 349 35 1
100 - 324 30 1
< 100 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Table 6. Class III Single Channel Selection of Consignees for Recall Effectiveness Verifications
Consignees Select Critical #s
> 2000 50 2
1500 - 2000 45 2
1000 - 1499 40 1
750 - 999 35 1
500 - 749 30 1
400 - 499 28 1
300 - 399 26 1
< 300 25 or 100% 0

Note: Irrespective of the classification of the recall, corrective actions are taken, even if only one consignee is found to be selling the product. There is no tolerance for a consignee selling a recalled product.

Suggested Procedure for Obtaining List(s) of Consignees

Steps:

  • Prepare by reading the recalling firm file to understand its clients and distribution system.
  • Have reference documents ready, i.e., news release, Memorandum to the Minister (MTM), Recall Authorization, the label, etc.
  • First try by phone and if no or limited cooperation, visit the recalling firm. Identify yourself and ask to speak with the owner/manager/supervisor/person in charge. Ensure that the person you are speaking with has the authority to respond to product recall activities and/or was involved in recall activities.
  • Explain the general purpose of requesting distribution lists and clarify the role of the CFIA (the recalling firm is responsible for removing recalled product off the shelf, the CFIA only does the monitoring). Inform the recalling firm how the recall effectiveness would be verified - not all accounts checked, only random checks are done etc.

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please describe how your product is distributed including - how orders are taken?" "How does the product flow from your location to the stores?" "Is product sold to retail stores only by the case or the case is broken?"
  • "How far is your product distributed?" "Clarify the geographical distribution by provinces?" "Do you export the affected product?" If yes. "To which countries?"
  • "Do you directly sell to retailers?" "Do you sell to cash and carry outlets?" "Do you wholesale to distributors?" Do any recalling firms buy a recalled product to make its own products? If there are distributors/manufacturers involved, immediately request lists of those accounts.
  • "Was this product sold to day care centers, hospital cafeterias, school cafeterias, retirement homes, kids camps or other institutional accounts?" "Was the product sold or otherwise provided to food banks?"
  • "Do or can you know which of your customers received this product?" If yes. "How would you be preparing the list of your accounts for this product?" "How do you track your batches when selling?" If no. "Would you be contacting ALL your clients and how?" "How would you be narrowing the list for notification?"
  • "How quickly you can get the list of your accounts to us?" Determine if an actual list can be obtained within time lines (Table 1).
  • "Approximately how many retailers sell the recalled product?" "How did you determine this number?"

Outcome:

At the end of the request and discussion regarding distribution and accounts, you should know:

  1. If the recalling firm is capable of providing a detailed list (names, phone numbers etc.) within the time lines;
  2. the estimated number of consignees who are selling or could have received the recalled product;
  3. Area/regions where the product was distributed;
  4. If the product was distributed to locations frequented by susceptible population;
  5. If there are any distributors/manufacturers who bought the product, their names and contacts; and
  6. You would have made a request to obtain a detailed list including - names, addresses and phone numbers, with consignees grouped by geographical location/provinces and/or types (see section 8.2.1).

Recommended Telephone Verification Procedure

Steps:

  • Have reference documents ready, i.e., news release, Memorandum to the Minister (MTM), Recall Authorization, the label, etc. Have a blank effectiveness form ready for use.
  • Print from the IMS, to ensure the use of the latest version.
  • Identify yourself and ask to speak with the owner/manager/supervisor/person in charge.
  • Ensure that the person you are speaking with has the authority to respond to product recall notifications and/or was involved in recall activities.
  • Explain the general purpose of your call - "A product recall has been initiated; the CFIA is conducting verification activities to determine the effectiveness of the recalling firm's recall efforts. Your store (recalling firm) was included in the distribution list provided to us by the recalling firm."

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please tell me about the recall notice?" Let the person describe the situation and follow-up with specific questions, e.g. "Are you aware of a product recall conducted by recalling firm x of product y?" "When, how and whom did you become aware of this recall?" - If notified by fax or letter, ask if a copy can be faxed or read to you. Verify the date of receipt. If by telephone, "who called you?" Information on the notice of recall should be reviewed for accuracy of information on product, risk and clarity (i.e., no promotional information etc.).
  • "What happened at the store once the notice was received?" Again let the person describe the activities and follow-up with the specific questions, e.g., "What quantity of the product was on your store shelves when the notice was received from the recalling firm?" "What action was taken with this product?" "What quantity of the product was in your storage area or stockroom?" "What action was taken with this stored product?" Physically verify the disposition of the product.
  • "What happens to the product which is removed?" Once again let the person describe the activities and follow-up with specific questions, e.g., "While the product is segregated, until final disposal, how will you ensure that the product is not mistakenly returned to the store shelf?"
  • "What happens after the recall work is done?" Do you and how will you inform your head office/Manager/Owner once the product has been removed/disposed?
  • "Other than retail sales to individual consumers, do you further distribute this product (act as a wholesaler...)? If so, have you taken any measures to relay the recall information to your clients? When, how and by who was this done?" If the client was notified by fax or letter - "Could a copy be faxed to me or read over the telephone?" "The CFIA will need to follow up with these accounts as well, when could we receive a copy of your distribution list?"

Outcome:

At the end of the check make sure you have answers to all questions on the form and if there was a problem - cause is known and that the corrective action has been taken/initiated.

Recommended On-Site Verification Procedure

Steps:

  • Bring copies of the news release (if applicable) or other reference documents, and copies of News Release can be left with the store/consignee if requested. Have a blank effectiveness form ready for use. Print the effectiveness form from the IMS, to ensure the use of the latest version.
  • Before approaching a representative, the inspector should see if the recalled product is on the shelf.
  • Identify yourself and ask to speak with the owner/manager/supervisor/person in charge. Ensure that the person you are speaking with has the authority to respond to product recall notifications and/or was involved in recall activities.
  • Explain the general purpose of your visit- "A product recall has been initiated; the CFIA is conducting verification activities to determine the effectiveness of the recalling firm's recall efforts. Your store (recalling firm) was included in the distribution list provided to us by the recalling firm."

Questions to consider:

Prepare your questions ensuring they are such that they avoid leading the respondent to answering what they think we want to hear.

  • "Please tell me about the recall notice?" Let the person describe the situation and follow-up with specific questions, e.g.,"Are you aware of a product recall conducted by recalling firm x of product y?" "When, how and from whom did you become aware of this recall?" - If notified by fax or letter, ask to review the copy. Verify the date of receipt. If by telephone, "who called you?" Information on the notice of recall should be reviewed for accuracy of information on product, risk and clarity (i.e., no promotional information etc.).
  • "What happened at the store once the notice was received?" Again let the person describe the activities and follow-up with the specific questions, e.g., "What quantity of the product was on your store shelves when the notice was received from the recalling firm?" "What action was taken with this product?"
  • "What quantity of the product was in your storage area or stockroom?" "What action was taken with this stored product?" Physically verify the disposition of the product.
  • "What happens to the product which is removed?" Once again let the person describe the activities and follow-up with specific questions, e.g., What measures are taken to ensure the affected product is not mistakenly returned to store shelves?
  • "What happens after the recall work is done?" Do and how you inform your head office/Manager/Owner once the product has been removed/disposed?
  • "Other than retail sales to individual consumers, do you further distribute this product (act as a wholesaler...)?" If so, have you taken any measures to relay the recall information to your clients? When, how and by who was this done? If the client was notified by fax or letter, ask to see a copy. "The CFIA will need to follow up with these accounts as well, when could we receive a copy of your distribution list?"

Outcome:

At the end of the check make sure you have answers to all questions on the form and if there was a problem - cause is known and that the corrective action has been taken/initiated.

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