Technological Institute of the Philippines Chemical Engineering Department Joshua Peter E.

Cadoy 5th Year – BS Chemical Engineering CHEP582 Laws and Ethics for Chemical Engineers

Department of Trade and Industry (DTI)
Gregory L. Domingo, DTI Secretary Josephine C. Romero, DTI Assistant Secretary/Chief of Staff Armando Q. Mercado, Jr., Head Executive Assistant Letty C. Caoile, DTI Assistant to the Secretary Eduardo M. Ocol, DTI Assistant to the Secretary Nennette B. Pelagio, DTI Appointments Secretary Maria Lourdes A. Yaptinchay, E-Commerse Office Director Maria Crispina S. Reodica, E-Commerse Chief Abigail R. Zurita, Liaison Office for Legislative Affairs Officer‐in‐Charge Alfonso M. Valenzuela, Liaison Office for Legislative Affairs Information Officer Atty. Benjamin T. Subido, Office of Legal Affairs Director Atty. Rodolfo B. Gilbang, Office of Legal Affairs Chief, Administrative Adjudication & Investigation Division Atty. Marimel D. Porciuncula, Office of Legal Affairs Chief, Counseling & Litigation Division Maria Lourdes A. Yaptinchay, Office of Policy Research Director Thelma Dumpit‐Murillo, Public Relations Office Director IV Lydia R. Guevarra, Office of Special Concerns Director

Bureau of Food and Drugs (BFAD) / Food and Drugs Administration (FDA)
Kenneth Hartigan-Go, FDA Acting Director Dr. Oscar Gutierrez Jr., FDA food and drug regulation officer

Lourdes V. Internal Administration Group Deputy Commissioner Prudencio M. Lozada.. Suansing Jr. David J. Intelligence Group Deputy Commissioner Horacio P. Assessment & Operations Coordinating Group Deputy Commissioner Peter M. Undersecretary of Health Dr. Nemesio T. Teodoro J. Management Information System and Technology Group Deputy Commissioner Ericson A. Area Cluster Assistant Secretary for Visayas Assistant Secretary of Health Dr. Support to Service Delivery Technical Cluster II Assistant Secretary of Health Designate Dr.. Roland L. Jr. Post Entry Audit Group Assistant Commissioner Ma. Jr. Herbosa. Valera. Cortez. Caridad P. Bayugo. Elmer G. X-Ray Inspection Project Head Wilnora L. Manarang.. Area Cluster Assistant Secretary for Mindanao Assistant Secretary of Health Designate Dr. Support to Service Delivery Technical Cluster I Assistant Secretary of Health Designate . Punzalan. Biazon. Area Cluster Assistant Secretary for Northern and Central Luzon Undersecretary of Health Designate Dr. Reyes. Tañada. Health Policy Finance and Research Development Cluster Assistant Secretary of Health Dr. Alcovendaz. Manzano.Bureau of Customs Rozzano Rufino B. Secretary of Health Dr. Gako. Rosell-Ubial. Administration Technical Cluster Undersecretary of Health Dr. Lim. Mangaoang. Revenue Collection Monitoring Group Deputy Commissioner Danilo D. Madeleine R. Busuego. Commissioner of Customs Juan Lorenzo T. Enrique A. Enforcement Group Deputy Commissioner Ma. Cawile. Office for Special Concerns Assistant Secretary of Health Dr. Gerardo V. Area Cluster Undersecretary for Ncr And Southern Luzon Undersecretary of Health Dr. Enrique T. Interim Internal Control Division Chief Department of Health (DOH) Dr. Paulyn Jean B. Ona. Romulo A. Tayag.

the company may have a choice whether to repair or modify the product (no cost or reduced cost retrofit by customer or the company). motivate people to respond to the recall and take the action requested by the company. Depending on the seriousness of the situation. Recalls may be conducted on a firm's own initiative. Recalls are actions taken by a firm to remove a product from the market. Internal Finance Management Technical Cluster Assistant Secretary of Health Designate Dr. Lagahid. A company that undertakes a recall should develop a comprehensive plan that reaches throughout the entire distribution chain to consumers who have the product. refund the purchase price. the possibility still exists that dangerously defective products may reach the customers. Blesilda A. Kadil M. it must be removed from store shelves. by FDA request. but often recalled products can still be found on the second-hand market or in homes. leading to adverse verdicts in product liability litigations. Gutierrez. or initiate a total or partial recall (voluntary or mandatory). Director III (NCDPC-IDO). Support to Service Delivery Cluster III Assistant Secretary of Health Designate How to recall products in manufacturing company Despite a company's best efforts to design. Sinolinding. Department of Health . The company must design each communication to reach affected consumers. these defective products may pose a severe financial threat to the company and can have a very serious financial impact on the company forbears to come. the company can contest the notice of recall from a regulatory agency. In case of a mandatory recall. Nicolas B. Jaime Y. . Head Executive Assistant Dr. but attempting them without adequate planning can be much more costly. Unfavorable publicity may result in loss of sales and damage to the company's reputation. Lutero III. The very survival of a firm may depend on how well and how quickly it can respond to the first notice that a product recall may be necessary.Autonomous Region for Muslim Mindanao Secretary of Health Atty. or by FDA order under statutory authority. Unless appropriate action is taken promptly. Product recalls are certainly expensive. These products may cause accidents. manufacture and sell safe and reliable products.Ms. This should be done only after a thorough review of the situation and with appropriate legal counsel. If a product is recalled.

• Provision of publicity and damage control. plant or division level. distributors. • Coordination of internal activities/procedures for all personnel who may be involved in the recall. • Liaison (notification. • Notification of recall to the appropriate regulatory agency. Training and duties and responsibilities in the event of a recall should also be outlined. . Other elements of the recall plan should include: • Analysis of the seriousness of the reported safety hazards and recommended appropriate action. for example. and retailers about prearranged procedures and fees for essential services. The information should be included in a corrective action plan (“CAP”). The standby recall should also outline the coordination of the program. Administration and Coordination: The recall plan must have the endorsement of top management. and it should assign responsibility and authority for the decision to recall or fields modify a product to a specific executive officer of the company. coordination may rest with the product safety/liability coordinator at the corporate. if required. the staff works with the company to put together an effective plan for public notification and implementation of the recall. including collection. storage retrofit. • Notification of recall to the insurance company. • Monitoring and appropriate corrective actions.Once the staff and a company agree on a remedy to correct a product defect. cooperation. and assistance) with dealers. and press releases to the media. including the Communication Department to acquaint them with the plan and to draft needed announcements. wholesalers. and/or disposal of recalled items. to ensure that the situation is presented in a positive manner that will reduce negative perceptions. through letters and telegrams to all traceable customers.

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