Presentation on theme: "CONFIDENTIAL Lavonne Kucera Corporate Director Quality Assurance Product Recalls: A- Z."— Presentation transcript:
CONFIDENTIAL Lavonne Kucera Corporate Director Quality Assurance Product Recalls: A- Z
Recalls A-Z Raw Alfalfa Sprouts Linked to Salmonella Contamination Raw Alfalfa Sprouts Linked to Salmonella Contamination Sat, 25 Apr 2009 23:00:00 -0500 The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination
Recalls A-Z FDA Alerts Consumers to Recall of Certain Pistachios FDA Alerts Consumers to Recall of Certain Pistachios Sun, 29 Mar 2009 23:00:00 -0500 The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif.
Recalls A-Z March 16, 2009 - Texas Star Nut & Food Company Announces Voluntary Recall of Raw Peanuts Due to Potential Health RiskTexas Star Nut & Food Company Announces Voluntary Recall of Raw Peanuts Due to Potential Health Risk March 16, 2009 - Grower's Outlet Recalls Honey Roasted Peanuts Because of Possible Health RiskGrower's Outlet Recalls Honey Roasted Peanuts Because of Possible Health Risk March 16, 2009 - Ultimate Nut and Candy Co. Recalls, Sugar Free & Low Carb Peanut Butter Cups, Peanut Butter Crisp (a chocolate bark), and Peanut Butter Jars Because Of Possible Health RisksUltimate Nut and Candy Co. Recalls, Sugar Free & Low Carb Peanut Butter Cups, Peanut Butter Crisp (a chocolate bark), and Peanut Butter Jars Because Of Possible Health Risks March 14, 2009 - Jay Robb Enterprises Inc. Voluntarily Recalls Peanut Butter JayBarsJay Robb Enterprises Inc. Voluntarily Recalls Peanut Butter JayBars March 13, 2009 - Kerry, Inc. Expands Voluntary Recall of Peanut Products Following Expanded FDA Investigation of Peanut Corporation of AmericaKerry, Inc. Expands Voluntary Recall of Peanut Products Following Expanded FDA Investigation of Peanut Corporation of America March 13, 2009 - Weaver Popcorn Company Issues a Nationwide Precautionary Voluntary Recall of 12 oz. (340g) Trail's End® Chocolatey Peanut ClustersWeaver Popcorn Company Issues a Nationwide Precautionary Voluntary Recall of 12 oz. (340g) Trail's End® Chocolatey Peanut Clusters March 13, 2009 - Asia Cash and Carry Recalls Crown Farms Brand "Gulsha" Fish Because of Possible Health RiskAsia Cash and Carry Recalls Crown Farms Brand "Gulsha" Fish Because of Possible Health Risk
Recalls A-Z Statistics: 73 million people a year become ill from food 350,000 are hospitalized 5,000 deaths Less than 10% of food borne illness is reported
Recalls A-Z When is a Recall required? –When a product is misbranded or misrepresented Health definitions such as light or lite, low fat, etc Weights are not as declared –When a product is adulterated: Foreign material Chemical contamination Microbiological contamination Package labeling does not follow Food Code Ingredients decks are incorrect Undeclared allergens
Recalls A-Z Allergens: Unlabeled Peanut Allergen LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen Unlabeled Peanut Allergen LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen Mon, 04 May 2009 23:00:00 -0500 LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen
Food Allergens What is a food allergy? A food allergy is an immune system response to a food that the body mistakenly believes is harmful. What is a food allergen? A food allergen is a food product that triggers an allergic response in the body.
Food Allergens The Big 8 –Eight most common allergenic foods –Account for 90 percent of food allergic reactions –Include: Milk Eggs Peanuts Tree nuts (almonds, walnuts, pecans) Wheat Soybeans Fish (bass, flounder, cod) Crustacean shellfish (crab, lobster, shrimp)
Food Allergens Statistics: In the U.S., more than 4 million people have food allergies Each year, food allergies are believed to cause: –30,000 emergency room visits –2,000 hospitalizations –150 deaths
Recalls A-Z FDA –over 600 recalls to date in 2009 –Approximately 4 recalls every day USDA –33 recalls to date in 2009 –12 closed with over #100,000 product identified –21 cases remain active
Recalls A-Z Who Requests a Recall? What is it the difference between a Recall and a Voluntary Recall? Who is responsible for carrying out a Food Recall? What is the difference between a –Recall –Market Withdrawal –Stock or Inventory Recovery Public Notice – who puts them out How to close a Recall?
Recalls A-Z Regulated product –USDA: meat, poultry and eggs –FDA: all other food including seafood, water, and non-food related Protect the consumer –Remove items that may cause temporary or irreversible health consequences Protect the Brand –Suppliers –Manufacture
Recalls A-Z 1 st celebrity falls victim to Swine Flu….
Recalls begin in one of two ways: Company discovers a problem with product –Company production records, routine testing, etc. –Customer Complaint process Regulatory Agency (FDA, USDA) –Routine destination or origin testing –Conducted by Federal Agency, military, State or local health departments
Terminology Recall/Voluntary Recall Removal of product that has left the firms control, distributed in interstate commerce and there is reason to believe the product is adulterated or misbranded within the meaning of the Federal Food Code. Recall does not include a market withdrawal or stock recovery
Terminology Market Withdrawal Firms voluntary removal of distributed product that exhibits a minor company quality issue or regulatory program infraction that would not cause the product to be adulterated or misbranded. Defect would not be subject to FDA regulatory action i.e.: product does not meet company quality standards due to discoloration
Terminology Stock or Inventory Recovery Removal or correction of product that has not been marketed or has left the direct control of the firm Product has not been marketed, or sold to a secondary party Must be located on the premises owned by the producing firm or under its control All product can be accounted for and has not been released for sale or use
Classifications FDA/USDA (FSIS) Classifications: –Class I : Reasonable probability that use or exposure would cause serious adverse health consequences or death i.e.: product contaminated with glass –Class II: Use may cause temporary or medically reversible adverse health consequences i.e.: presence of undeclared allergens –Class III: Use is not likely to cause adverse health consequences i.e.: presence of an undeclared, generally recognized as safe substance i.e.: product not meeting specification, such as weight
Depth of Recall Wholesale level –Product has been distributed to a warehouse of distribution center and it is not under the control of the manufacture Retail Level –Product is at retailers, but has not been sold to consumers HRI Level –Product is at hotels, restaurants or other institutional customers Consumer Level –Product has been sold to consumers, some product may remain under control of the retailer.
Recalls Who Requests a Recall? –Regulatory Agency (FDA, USDA) –Military, local and State Health Departments via Regulatory Agency –Supplier of ingredients –Manufacturer of finished goods
Recalls What is the difference between a Recall and a Voluntary Recall? –Recall: initiated by regulatory agency when the manufacturer does not initiate the removal of adulterated product. FDA has the power to institute a seizure of food via court order that it believes is adulterated or misbranded USDA inspectors can withdraw from inspected facilities, effectively banning product from interstate commerce Order manufacturing to stop until compliance with Code of Federal Regulations is met Detention and seizure of product in commerce Initiates a recall letter and media notification –Voluntary Recall: initiated by the manufacturer
Recalls Who is responsible for carrying out a Food Recall? –Manufacturer of the adulterated finished product –Supplier of ingredients –Distributor –Warehouses –Retail Stores –Regulatory Agencies (Federal, State, Health, etc.) –Media –Consumers
Recalls Focus on Manufactures or Suppliers Responsibilities..
Manufacture Responsibilities Key Recall Steps: –Determine the extent of the affect product by lot, quantity, customers, states, etc. via production and distribution records –Initiate the voluntary recall with the Federal Agency –Notify consumer, further processing agents, distributors, warehouses –Track action of all that handle product –Assure proper destruction of affected product
Manufacture Responsibilities Key Recall Steps continued: –Conduct Effectiveness Checks –Handle Media inquiries –Handle consumer concerns and questions –Conduct daily update meetings with Recall team –Determine root cause and implement corrective action –Clear production to produce safe, wholesome product to fill pipeline –Maintain accurate records of actions taken and request closure of recall
Manufacture Recall Responsibilities In Depth Look: –Determine the extent of the affect product by lot, quantity, customers, states, etc. via production and distribution records –Determine root cause and implement corrective action –Clear production to produce safe, wholesome product to fill pipeline –Maintain accurate records of actions taken and request closure of recall
Manufacture Responsibilities Validation of product name and loting to production records Lot tracking of inbound ingredients –Quantities received vs. shipped from manufacture –Dates received with quantities Production Records –Date(s) when ingredient utilized –Names of finished product(s) that are affected –How much was produced –What are the affected lots –Product remaining in inventory or warehouse –Quantity in process (WIP), R&D, etc –Rework –Waste calculations –Quantity in carry over –Other items that were run same day or same equipment – clean to clean
Manufacture Responsibilities Shipment records –Dates finished goods received into inventory –Inventory reconciliation records –Quantities shipped vs inventory in freezer/refrigerated warehouse, distribution centers –Damaged goods, samples, employee purchased, etc –PO or Customer shipment lists –Items in transit Quarantine inventory at facilities, warehouses, distribution centers –Remove and physically HOLD –Deplete any electronic inventory system
Manufacture Responsibilities Determine root cause of adulterated or misbranded product –HACCP Review –Validate and implement corrective action Swabbing records, additional swabs to find source Engineering for PM, equipment disassembly/reassembly Sanitation for records, personnel and on demand cleaning Floor personnel for common links –Resources Food Safety extension Regulatory Agents Clear production to manufacture –COAs on in-bound ingredients –Elevated Environmental Swabbing –HOLD & test –Finished goods testing
Manufacture Responsibilities Maintain accurate records of action –Potential causes –Actions taken –Conclusions Work with regulatory agency on daily basis –In plant program and record review –Facility swabbing and monitoring Establish Recall communications…
Communications Distribution channels –Warehouses –On-line customers –Retail stores Public Notice –Voluntary Recall: Initiating firm issues the press release with approval of USDA/FDA –All Class I recalls must have a press release –Regulatory agency sends to Associated Press –Recalling firm can send directly to affected states for inclusion –Posted on FDAs website: www.fda.govwww.fda.gov –FDA weekly publication entitled Enforcement Reports –USDA (FSIS) posts on Recall Notification report
Communications Clear and concise is key –Why the product is being recalled (may be contaminated with...) –Brand Names product can be recognized as –Name of the product as found on package –Name of company recalling product –Loting of the product being recalled (use by, sell by, etc) –Risks involved in consuming products; symptoms and people that are at risk –Directions on what to do with product Return to store Hold for pick up for central destruction –Certificate of Destruction at landfill, notify Regulatory Agency Properly destroy adulterated product –Deface package and destroy contents –Consumer contact information –Media contact information, name and number
Closing a Recall Effectiveness Checks –Recalling firms means of evaluating how effective the recall process was in notifying direct customers of the recall and assuring it was read, understood and followed. Verifies recall reached the appropriate level in the distribution chain If not effective, a second communication notice should be sent Effectiveness checks are: –Conducted by the initiating firm –Validated by Regulatory Agency Methods –Consignee lists –Set of questions to verify notice was received and followed –Can be conducted via mail, telephone, personal visit or via returned electronic methods such as e-mail or fax
Closing Recalls Initiating firm requests close from governing agency Written closure to include: –Name of firm requesting closure –Information regarding recalled product (name, package info, etc.) –Why product was originally recalled –Amount of product recovered –Where product was recovered from by type of business; Warehouse Distributors Stores Consumers –How product was destroyed, include letter of destruction if necessary –Action taken to assure process deviation that caused recall has been corrected –Method and percent effectiveness checks –When firm believes all product was out of the market –Any reports of customer illness
Closing Recall Governing agency; –Conduct Effectiveness checks –Visit processing site to assure corrections have occurred –Issue closure if recall actions taken have been satisfactory
Recall Learnings Communication is critical –Receiver needs to understand action required –Distributors through retail stores must have solid practices in place so product does not end up back in out-bound inventory Retail and Consumers do not always heed… –Communication for following required steps Stores may be busy Personnel understanding of need to act –Loting information with size and manufacture codes Complicated – pull it all
Recall Learnings Understand the risk associated with ingredients Manage suppliers to control potential risks you are only as good as your suppliers Watch carry over and rework process…
Recall Learnings Third party audits do serve a purpose, but understand they are usually announced, paid for, snap shot in time inspections. Read the fine print! Distribution chain has emergency information for key contacts
Recalls A-Z Recalls are Common –In 2009, approx 4 per day Have a solid recall program in place, people understand their roles and practice for preparedness –Practice, practice, practice –Emergency contacts –Model letters and notices prepared in advance
Recalls A-Z Work together to remove adulterated product