PHIS 

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FSA Documentation 

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• Use appropriate FSA tools in PHIS

• If Word version needed, obtain from Advanced EIAO

SharePoint site to ensure current version

• Do not keep notes outside tools as they may be evidence

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Noncompliance 

Noncompliance 

Noncompliance 

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• Noncompliance observed during the FSA will always be

documented in the FSA report.

• Additionally, noncompliance will be documented in either

an NR or it may be included in an enforcement letter

(NOIE or NOS).

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• Example:

• EIAO determines the establishment failed to identify a step in the

flow chart.

• This is regulatory noncompliance, but it may not pose an

immediate health risk.

• It would be prudent to complete the assessment process to

determine how the matter should be addressed (NR or part of an

enforcement letter if other noncompliance exists).

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• If additional noncompliance is observed during the FSA

and an NOIE is warranted: 

• The NOIE documents noncompliance findings supporting the

proposed action. 

• Other noncompliances that are not in support of the NOIE would

be documented on NRs.

• All enforcement letters and NRs are presented to the

establishment at the exit meeting.

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Noncompliance 

Noncompliance 

Noncompliance 

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• If no enforcement is warranted, any noncompliance would

documented on NRs.

• Work with the FLS and IPP to assure NRs are presented at

the exit meeting.

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• FSIS must first stop the practice and take a RCA

immediately if an establishment is: 

• shipping or producing adulterated product,

• operating without a HACCP plan

• treating animals inhumanely

• engaging in any other type of noncompliance that supports

taking action under the Rules of Practice

• A NR should be issued to the plant ASAP

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• For immediate enforcement, correlate with the IPP, the

FLS, and the District Office.

• If a suspension without notice is warranted, the NR can

serve as a basis to support the action .

• The Food Safety Assessment can be completed later

during the enforcement process.

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Noncompliance 

Noncompliance 

Noncompliance 

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• Anytime noncompliance is observed, it is important to

bring it to the establishment’s attention and discuss it as

soon as possible.

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• Whenever noncompliance is discussed with the

establishment:

• Document what was discussed, including when the discussion

took place and who was present.

• The written summary can be part of the FSA or a separate

memorandum for the record.

• It is important in the administrative record to support that

noncompliance was brought to the establishment’s attention in

a timely manner.

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• When notified of noncompliance that is not part of an

enforcement action:

• The establishment may take action to bring themselves back

into compliance

• An NR will still be documented and presented at the exit meeting

• This is why it is important to document that the

establishment was notified, in the FSA or in an MOI.

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Noncompliance 

Noncompliance 

Follow-up 

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• NRs are fundamental “building blocks” to effective

enforcement.

• They assure establishments have been provided the

opportunity to correct situations before enforcement

becomes necessary.

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• EIAO should reiterate with inspection team importance of

documenting noncompliance, associating NRs, and building a case

• Being able to show history of multiple, recurring

noncompliances is an important factor to support issuing a NOIE

• When suspending the assignment of inspectors without

notice, documentation must exist to support action is

warranted.

• Work with FLS to determine whether noncompliances

require a follow-up

• Document need for follow-up in General Tool

• Contact the FLS within 30 days of the exit meeting to

determine status of the NR

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