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| IKE Scenario 02-08 - Direct
Observation of Corrective Actions |
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IKE scenarios are a tool that FSIS inspection program personnel can use to better understand Agency policy. In addition, the IKE scenario result may be just one approach to address a specific situation and is not intended to be a definitive answer, indicating there may be multiple approaches.
Purpose:
This IKE provides guidance to inspection program personnel on how
to verify that establishments are properly conducting both
corrective actions and direct observation verification of
corrective actions when there is a deviation from a critical limit.
Situation: You are a consumer safety inspector
(CSI) assigned to a livestock slaughter operation. Today’s schedule
includes the 03J01 procedure. You are aware that the establishment
identified a deviation from its critical limit at the zero
tolerance CCP yesterday, so you decide to verify that the
corrective actions taken by the establishment meet the requirements
of the regulation 9 CFR 417.3(a). In addition, you decide to verify
the verification requirements of 9 CFR 417.4(a)(2) at all critical
control points (CCPs). You can verify these two regulatory
requirements as part of today’s scheduled 03J01 procedures using
either the recordkeeping or review and observation component.
You decide to perform the recordkeeping component of the 03J01
procedure to verify that both the verification and the corrective
action requirements were met. You request the corrective action
records for the previous day from the HACCP coordinator. You review
the corrective action record and see that the establishment
documented that it implemented corrective actions. Your review of
those corrective action indicates that the actions taken met the
requirements of 9 CFR 417.3(a). However, you do not see any record
entry that the actions the establishment took yesterday were
verified through direct observation. Before making a decision about
compliance you decide to seek additional information from
FSIS Directive 5000.1.
Discussion:
You review the directive and find the following information:
- since it cannot be predicted when a deviation from a
critical limit or an unforeseen hazard will occur, it would be
counterproductive to require that the establishment have
specific procedures and frequencies in its HACCP plan for
directly observing corrective actions
- it is necessary for an establishment to directly observe
corrective actions frequently enough to verify that these
actions are being performed in a manner that meets the
applicable regulatory requirements
- the establishment is to document these direct observations
in the same manner that it documents other verifications
Based on the discussion points above, what additional questions
could you seek answers to that would help you determine if
non-compliance with 9 CFR 417.4(a)(2)(ii) exists?
- Does the establishment have a history of deviations from
its critical limits?
- When a deviation occurs does the establishment implement
corrective actions as required by 9 CFR 417.3(a)?
- When was the last time any part of the corrective actions were
verified through direct observation?
You review the establishment’s records for corrective actions,
focusing on the frequency that the establishment conducts the
direct observation of corrective actions verification. You see that
once per month the establishment directly observes the performance
of all four parts of corrective actions listed in 9 CFR 417.3(a)
being implemented. Those corrective action requirements are:
- The cause of the deviation is identified and eliminated;
- The CCP will be under control after the corrective action is
taken;
- Measures to prevent recurrence are established; and
- No product that is injurious to health or otherwise adulterated
as a result of the deviation enters commerce.
Results of this verification activity are documented as required by
9 CFR 417.3(c) and 417.5(a)(3).
You meet with the HACCP Coordinator and ask what support the
establishment has for the frequency selected to directly observe
corrective actions. The HACCP Coordinator tells you that they have
historical documentation collected since the implementation of
HACCP in its operation that supports its frequency of once per
month. He tells you that initially the frequency was twice weekly
but as a result of their periodic analysis of their records, over
time, the frequency was decreased to once per month. The
establishment’s HACCP team has determined that, based on the
cumulative records, the current frequency shows that the
requirements of corrective actions have consistently been
implemented properly and successfully. You ask to review the
documents and confirm that they sufficiently support the frequency
at which the establishment conducts direct observation of the
corrective actions.
Resolution: You determine that there is regulatory
compliance with both 9 CFR 417.3(a) and 417.(4)(a)(2)(ii). You
record the 03J01 procedure as performed.
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Last Modified:
August 14, 2008 |
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