Quality Systems & CAPA
CAPA stands for this process of correcting and preventing issues
What is Corrective and Preventive Action?
These audits are conducted by qualified individuals within your site
What are Internal Audits?
These three hazard types must be controlled in food safety
What are biological, chemical, and physical hazards?
These practices are considered prerequisites for food safety and include gowning, pest control, and truck inspections.
What are Good Manufacturing Practices (GMPs)?
Keeping these closed helps prevent pests and supports food defense
What are doors?
This determines why an issue occurred
What is root cause analysis?
This type of audit is typically unannounced and enforces US Food laws
What is an FDA Audit?
This type of hazard includes invisible organisms like E. coli, Salmonella, and Listeria that can cause illness or injury.
What are biological hazards?
These principles include Attributable, Legible, Contemporaneous, Original, and Accurate
What is ALCOA?
This program reduces biological, chemical, and physical hazards
What is the sanitation program?
These actions ensure the issue does not happen again
What are preventive actions?
A serious FDA audit outcome documented after inspection
What is a 483?
These are essential control steps where hazards must be eliminated or reduced
What are Critical Control Points (CCPs)?
Records must be written for this audience who may not know your plant
Who are external auditors/readers?
Employees should do this if they see pest activity
What is report sightings?
These records are used to document quality issues such as incorrect coding
What are Quality Records (QRs)?
A finding from an audit that is recorded as this in ABTRAQ
What is a Nonconformance (NC)?
Magnets, filters, and allergen handling procedures are examples of this type of control that significantly minimizes food safety hazards.
What are Preventive Controls (PCs)?
Data must be complete, consistent, enduring, and this
What is available?
Leaders must ensure tools are clean, undamaged, and this is used.
What is the correct cleaning method/tool?
This ensures batches can be tracked and identified correctly
What is product identification and traceability?
Name two consequences of failed external audits
What are recall, loss of certification, loss of trust, or licensing loss?
Two examples of CCPs
What are heat treatment and sterilization?
Following GDPs helps achieve this performance goal
What is Right First Time?
Name two sanitation responsibilities of an FLL
What are correct cleaning methods, tool checks, PPE, and documentation?