Quiz 10 Frequently missed Q's

Question 1

Validation activities are required for all Process Preventive Controls (PCs) in a Food Safety Plan, and documentation for Initial Validation studies or ongoing validation activities must be overseen by or reviewed by and accepted as appropriate for the process by a trained / designated PCQI (Preventive Controls Qualified Individual).

Answer 1

True

Question 2

For each Process PC in a Food Safety Plan, there must be specified parameters or values (critical limits) associated with the control, that indicate if the Process is “in control” or “not in control” and these critical limits need to be expressed as a single-point criterion or ‘less than or equal to’ or ‘greater than or equal to’ a value, but NOT as a range of values.

Answer 2

True

Question 3

The FDA requires identification of Process Preventive Controls for things that you identify during your Hazard Analysis that would be serious hazards likely to occur that are only able to be controlled by SOMEONE ELSE IN YOUR SUPPLY CHAIN, before the product comes into your facility.

Answer 3

False: Process preventive controls need to be controlled by you

Question 4

A new requirement by the FDA under the PCHF rule is that you are now required to perform a “root cause analysis” before finalizing the documentation of “corrective actions” any time a food product fails to meet a specified critical limit for a Process PC or HACCP CCP.

Answer 4

True:

Question 5

If you designate a metal detector as a Process PC in your Food Safety Plan, you must define the hazard being controlled as “hard or sharp metal fragment” rather than the more general definition of “hard or sharp foreign material large enough to cause injury to a consumer if swallowed”.

Answer 5

False: designate metal detector only is your trying to find metal