Developing a Recall Plan

1. Developing a Recall Plan -Food Safety-

2. Every Processor Should Develop a recall plan Organization structure for product withdrawals quickly and effectively Development of a recall team Recommend changes in operation Assess a problem to determine if the problem is real Arrange for stock recovery or withdrawal Develop the recall plan Manage a recall Inform company employees and customers of corrective actions Coordinate with regulatory agencies Direct the recall activities Production Purchasing Marketing Quality assurance Legal Sales Distribution Consumer affairs and public relations Recommend changes in operation Assess a problem to determine if the problem is real Arrange for stock recovery or withdrawal Develop the recall plan Manage a recall Inform company employees and customers of corrective actions Coordinate with regulatory agencies Direct the recall activities Production Purchasing Marketing Quality assurance Legal Sales Distribution Consumer affairs and public relations

3. Recall Plan Organization Structure Identification of Information Needs Distribution Production Legal Counsel Public Relations Name and Phone for: President Recall Coordinator Distribution Production Accounting Legal Technical Sales and Marketing Other Distrubution Stop all in-transit shipment of questionable material, and arrange for return of product to collection points. Prepare inventory and distribution status of product showing where, when, to whom and quantity shipped Raw materials, ingredients and containers Operations, thermal processing records, HACCP records Changes in equipment or breakdowns Quality assurance or verification records Codes Shipping dates and product on hand Press coverage of recall Production Prepare a lot identification Halt production of product if related problem Investigate for cause of problem, check all records Clear product only as recommended by the Recall Coordinator. Do not destroy any product without observation by FDA/USDA of a health hazard is involved. Keep records of any destruction. Name and Phone for: President Recall Coordinator Distribution Production Accounting Legal Technical Sales and Marketing Other Distrubution Stop all in-transit shipment of questionable material, and arrange for return of product to collection points. Prepare inventory and distribution status of product showing where, when, to whom and quantity shipped Raw materials, ingredients and containers Operations, thermal processing records, HACCP records Changes in equipment or breakdowns Quality assurance or verification records Codes Shipping dates and product on hand Press coverage of recall Production Prepare a lot identification Halt production of product if related problem Investigate for cause of problem, check all records Clear product only as recommended by the Recall Coordinator. Do not destroy any product without observation by FDA/USDA of a health hazard is involved. Keep records of any destruction.

4. Recall Plan Technical Information Brokers Technical- Obtain lot identification and samples. Obtain product analysis to determine of pick-up or destruction is necessary Coordinate all actions through Recall Coordinator until problem is solved Consult with University Labs Consult with regulatory agencies, if a recall Brokers Assist in contact of customers Assist in product pick-up Technical- Obtain lot identification and samples. Obtain product analysis to determine of pick-up or destruction is necessary Coordinate all actions through Recall Coordinator until problem is solved Consult with University Labs Consult with regulatory agencies, if a recall Brokers Assist in contact of customers Assist in product pick-up

5. Steps to Take During a Recall Defining the Problem First � Hand Information and other Facts Effective Communication Physical Recovery of Product Include a method for verifying whether there is a problem or not. Any deviations in processing records Unusual occurrences in product preparation or handling The time period faulty product was produced Affected product codes Customers Public health significance First-hand facts best, but consider: Consumer complaints Newspaper or radio State or federal regulatory officials Distributors Sales Representatives Ingredient suppliers Container/packaging Trade Associations Company quality assurance and production records Clear, concise and accurate Who in the company will need to be notified Outside parties that should be notified Rapid communication, Fax, email, overnight mail Removal from distribution channels Must identify customers Plan for paying for the product or replacing with similar product Establish a method to count or weigh product Establish a warehouse to isolate the product in coordination with FDA or USDA Have a model press release or outline that can be used quickly Should contain Name of company Label name or names of affected product, codes and container sizes Area of distribution, naming each state Nature of problem Risk to consumers What consumers should do Statement the company is cooperating with regulatory officials Include a method for verifying whether there is a problem or not. Any deviations in processing records Unusual occurrences in product preparation or handling The time period faulty product was produced Affected product codes Customers Public health significance First-hand facts best, but consider: Consumer complaints Newspaper or radio State or federal regulatory officials Distributors Sales Representatives Ingredient suppliers Container/packaging Trade Associations Company quality assurance and production records Clear, concise and accurate Who in the company will need to be notified Outside parties that should be notified Rapid communication, Fax, email, overnight mail Removal from distribution channels Must identify customers Plan for paying for the product or replacing with similar product Establish a method to count or weigh product Establish a warehouse to isolate the product in coordination with FDA or USDA Have a model press release or outline that can be used quickly Should contain Name of company Label name or names of affected product, codes and container sizes Area of distribution, naming each state Nature of problem Risk to consumers What consumers should do Statement the company is cooperating with regulatory officials

6. Records Production and distribution records Case codes and package codes Limit the size of lots Private label distribution Product complaints

7. Recall Coordination Outline Institute a log showing date and time of events and actions taken. Correlate and evaluate known information on the extent and nature of the problem. Discontinue distribution of affected product codes. Notify (in order): company officials, trade associations, regulatory agency, and suppliers, as necessary. Decide whether to recall or to make further investigation

8. Recall Coordination Outline Determine area and level of distribution of product codes. Continue investigation of nature, extent, cause and remedy of problem. Re-examine recall decision, if necessary Notify and instruct company staff Determine disposition of recalled product.

9. Recall Coordination Outline Prepare and issue, with regulatory agency, recall requests. Include instructions. Prepare and issue news releases. Maintain records of progress. Report recall progress to company officials and regulatory agency. Complete effectiveness checks and final report.

10. If a Recall Should Happen!

11. Objectives of a Recall Contain the Problem Control the Information Correct the Problem Contain Identify all involved products, customers, states. Have supporting documentation/records Locate all affected products and customers Many times your customers may have sold to others. How do you track down the chain? Contact Within 24 hours � quicker if possible Draw a circle around the products Need cooperative distributors If not Further distribution Other customers Overblown portrayal of the problem Why? Accuracy, public health, product and company reputation How? Work with FDA/USDA, customers, state officials, consumers, press When? ASAP Issue your own press release Correct �New and Improved� Restore confidence Tell others what you have done Contain Identify all involved products, customers, states. Have supporting documentation/records Locate all affected products and customers Many times your customers may have sold to others. How do you track down the chain? Contact Within 24 hours � quicker if possible Draw a circle around the products Need cooperative distributors If not Further distribution Other customers Overblown portrayal of the problem Why? Accuracy, public health, product and company reputation How? Work with FDA/USDA, customers, state officials, consumers, press When? ASAP Issue your own press release Correct �New and Improved� Restore confidence Tell others what you have done

12. Points to Consider Companies are responsible and accountable for product recalls as all recalls are voluntary Tell your own story completely Fix your problems Be proud of the corrections and use it in marketing