©THEBRIGHT EXAM STUDY SOLUTIONS 8/19/2024 2:07 PM
FDSCTE 5310 mid3 Exam Questions
With Correct Answers.
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
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