FDSCTE 5310 mid3
acronym and overall mission for HACCP - Hazard Analysis Critical Control Points, systematic
approach to identify/assess risk and severity/control biological chemical and physical hazards associated
with a particular food production process or practice
classification and criteria for recalls (3) - 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)
definition and goals of product recall (4) - 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) - 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) - company, FDA, FSIS, CDC, USDA, local and state health agencies,
FBI, EPA
FDA recall initiation types (3) - voluntary, FDA request, FDA mandate
aspects of recall plans (4) - complaint, traceability, record keeping, testing
difference between quality assurance and quality control (1) - quality control focuses on product
while quality assurance focuses on the process
important quality systems (9) - 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 - American National Standards Institute, promote and facilitate
voluntary consensus standards and conformity assessment systems
ANSI guidelines (7) - 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 - 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) - leadership, strategic planning, customer and market
focus, measurement/analysis/knowledge management, human resource focus, process management,
business/organizational performance results
process of assessment for baldridge award (4) - 4 1/2 day site visit from examiners, work with
leadership to identify key strengths and opportunities, immediate feedback for organization, written
feedback report
acronym and overall mission for GMP - Good Manufacturing Practices, FDA-enforced regulation
that ensures every product is manufactured under conditions that make it suitable for human feed
general provisions in cGMP (3) - critical definitions, personnel, plant and grounds
important aspects of cGMP (4) - mandatory in USA for food production, every product needs to be
manufactured under conditions that make it suitable for human feed, detailed in CFR and enforced by
FDA, provides definitions and criteria to determine if a product: has been manufactured under
conditions that make it unfit for food; has been manufactured under unsanitary conditions; has been
rendered injurious to health
preliminary tasks for HACCP plan (5) - assemble HACCP team, describe food and its distribution,
describe intended use and consumers of food, develop flow diagram which describes process, verify flow
diagram
