©SOPHIABENNET@2024/2025 Tuesday, August 20, 2024 10:21 AM
FDSCTE 5310 midterm 3 Practice
Questions and Answers (100% Pass)
definition and goals of product recall (4) - Answer✔️✔️-process of removing
an unsafe product from the marketplace, stop delivery and sale of the
product, inform regulatory agencies, timely removal of product
reasons to recall (11) - Answer✔️✔️-chemical contamination, in-house
sabotage, tampering, illness patterns from CDC, supplier notification,
foreign objects, company generated information, misbranding, scientific
reports, fraudulent consumer claims, communicable diseases
agencies that oversee recalls (8) - Answer✔️✔️-company, FDA, FSIS, CDC,
USDA, local and state health agencies, FBI, EPA
classification and criteria for recalls (3) - Answer✔️✔️-class 1 (serious
adverse health effects or death possible), class 2 (health hazard may exist
but chances are remote), class 3 (consumption of product not likely to cause
harm)
FDA recall initiation types (3) - Answer✔️✔️-voluntary, FDA request, FDA
mandate
aspects of recall plans (4) - Answer✔️✔️-complaint, traceability, record
keeping, testing
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, ©SOPHIABENNET@2024/2025 Tuesday, August 20, 2024 10:21 AM
difference between quality assurance and quality control (1) - Answer✔️✔️-
quality control focuses on product while quality assurance focuses on the
process
important quality systems (9) - Answer✔️✔️-ANSI, Malcolm Baldridge
National Quality Awards, HACCP (FSMA and HARPC), GMP, Lean
manufacturing, TQM, ISO 9000, Six Sigma, Codex alimentarius
acronym and mission of ANSI - Answer✔️✔️-American National Standards
Institute, promote and facilitate voluntary consensus standards and
conformity assessment systems
ANSI guidelines (7) - Answer✔️✔️-administration (quality policies,
objectives, responsibilities), design assurance, control of purchased
materials, production quality control, user contact and field performance,
corrective action, employee relations
mission of Malcolm Baldridge National Quality Award - Answer✔️✔️-
government-mandated award to reward companies for improving quality,
establish guidance for US companies by making detailed information
available on previous winners
criteria for malcolm baldridge award (7) - Answer✔️✔️-leadership, strategic
planning, customer and market focus, measurement/analysis/knowledge
management, human resource focus, process management,
business/organizational performance results
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