Noncompliance

Question 1

What is a noncompliance?

Answer 1

• An establishment’s failure to meet a regulatory requirement
• Serves as FSIS official documentation of plant’s failure to meet regulations
• This is a legal document –> need good documentation practices

Question 2

What should an IPP do when a non-compliance is noted?

Answer 2

• Notify establishment management
• Document noncompliance on NR (NR FSIS Form 5400-4) in PHIS and present this to plant management
• Verify plant takes appropriate actions to bring itself into compliance

Question 3

How many noncompliance records can be completed per inspection task?

Answer 3

• Only one, although you can site multiple noncompliance in one NR
• Can be used to support additional enforcement action

Question 4

What is an open Noncompliance in PHIS? Finalized?

Answer 4

• Open: A noncompliance has been documented in PHIS

- Finalized: noncompliance is ready to deliver to establishment management

Question 5

What is an open Noncompliance Record (NR) in PHIS? Completed?

Answer 5

• Open: An NR has been created in PHIS
• Completed: All mandatory regulations have been verified. Establishment has brought itself into compliance with regulations for each noncompliance/ NR

Question 6

What are the 6 W’s used for writing NRs?

Answer 6

• While: identify scheduled inspection task and provide brief summary of regulations used
• When: when was NC discovered (date, time, operation status), when it began , when has it happened before
• What: what is the NC and exact conditions (adulterant, environment, etc)
• Where: Specific room/ location at establishment
• Who: Must be reported to establishment management
• Why: why is there an NC? What regulations were not met?

Question 7

When should NR’s be associated?

Answer 7

• When there is a developing trend of the same cause
• The trend may cause the establishment’s failure to implement its proposed preventative measures
• Notify establishment of ineffective further planned actions
• Provide documentation to further support enforcement actions

Question 8

What procedures should be followed for association NR?

Answer 8

• Document the previous NR and date plus the specific further planned action that were not effective or not implemented
• Record the reason in the Inspection Notes section