BLOCK5· FSIS Removes BLOCK 6. FSIS Performs Verification Tasks As stated earlier, re evaluation of a Sanitation SOP will be performed as PREAMBLE an"each occurrence(Eo)task generated through the Performance Based Inspection System(PBIS). In other woro In this final rule, FSIS is clarifying that it will verify that the Sanitation Sanitation SOPs will be evaluated by FSIS'as they occur. This type OPs are being implemented and maintained, and that they a of evaluation will not be unusual. Plants must routinely assess the effectiveness of their sanitation sop and make modifications as omplying with the requirement to develop, implement, and maintain lant facilities Sanitation SOPs, and to maintain daily records for them, but also tha the Sanitation SOP's are in fact working. Inspectors will review the DECISIONS animation SOPs, the daily records, the conduct of procedures After the plant complies with Sanitation SOP regulatory requirements and FSiS removes suspension, FSIS inspection personnel will proceed to The failure by an establishment to comply with the Sanitation SOPs regulations may initiate regulatory action. The full array of compliance includes process deficiency reports, tagging of equipme hdrawal of inspection, The nature of FSIS's response will depend on the circumstances. Minor omissions or errors in Sanitation SOP Following re-evauabon of a plant's'modified" Sanitation SOP, the FSIS spector will proceed l urate with the severity of the violation. For example, process deficiency reports might be issued to direct correctiv action. However, a pattern of violations of the Sanitation SOP's provisions would lead to additional responses, with persistent and BLOCK 6 if all the regulatory requirements have been met serous failures resuing in suspension or withdrawal of inspection fror the establishment. Suspensions and withdrawals would be made in accordance with applicable rules of practice for those proceedings BLOCK 3 if one or more regulatory requirements have not been FSIS determines that an establishments Sanitation SOPs fail to aduteration or that required records are not being kept, the Agen tag affected facilities and equipment and suspend inspection until the failure is remedied. Because the tagging of insanitary facilities ar quipment is based on current statutory aut provisions for tagging in the proposal are not retained in this final rule REFERENCES FSIS Directive 11, 100.3, Evaluating, Verify ovisions are distinguishable from actions taken as a consequence of Sanitation Standard Operating Procedure (E finding of product adulteration under the sanitation requirements th Regulatory Req findings are likely to be connected. A finding of deficient Sanitation SOPs or Sanitation SOP's records may prompt additional inspection adulteration has occurred. If it has, FSIS will take appropriate action prevent adulterated product from entering commerce and, where ecessary, seek recall of product that has already entered commerce 17
BLOCK 6. FSIS Performs Verification Tasks BLOCK 6.FSIS Performs Verification Tasks Process Verification sonne rform pre-operational records FSIS inspection personnel will perform pre-operational process verification Pbis tag and operational record verification PBIS venfication PBIS task and operational process verification PBIS a. Establishments are maintaining daily records which document Establishments are the effectiveness of the pre-operational activities of the 1. implementing the pre-operational activities of the SSOP 2. monitoring of the pre-operational activities of the SSOP. 2. the monitoring of the pre-operational activities of the SSOP 3. initiating corrective actions to prevent direct product initiation of corrective actions to prevent direct product contamination or adulteration. Corrective actions must nclude products that may be contaminated or adulterated ( restoration of sanitary conditions (n) prevention of recurrence of direct product revention of recurrence of direct product contamination or adulteration including appropriate ontamination or adulteration including appropriate re-evaluation or modification of the sso evaluation or modification of the sso b. Establishments are b. Establishments are maintaining daily records which document implementing operational activities of the SSOP 1. The effectiveness of operational activities of the SSOP; and 2. monitoring of operational activities of the sso 2. The monitoring of operational activities of the SSOP 3. initiating corrective actions to prevent direct product lamination or adulteration. Corrective actions must 3. Initiation of corrective prevent direct product include ontamination o adu orrective actions must procedures to products that may be contaminated or sure the cts that may be contar adulterated ( restoration of sanitary conditions (ui) prevention of recurrence of direct product contamination or adulteration including appropriate (ii) prevention of recurrence of direct re-evaluation or mod fication of the SSoP re-evaluation or modification of the sso Process verification involves observation and comparison of results to
BLOCK 6.FSIS Performs Verification Tasks BLOCK 6.FSIS Performs Verification Tasks which effectiveness of the operational activities of the Sanitation b. monitoring of the operatonal activities of the Sanitation SOP ACTIONS actions as needed during ope contamination or adulteration. NOTE BLOCK 6 must include: cts that may be contaminated or adul FSIS inspect orm both records and erification tasks to determine the effectiveness of a plant s Sanitation SOP. Verification asks for Sanitation SOPs will be generated through PBIS (3 evention of recurrence of direct product Records Verification mination or adulteration including appropriate evaluation or modification of the sanitation SOP is task es observation or"hands-on effectiveness of the pre-operabiona! activities of Sanitation SOP. hter performing the " hands-on b. monitoring of the pre-operational activities of the Sanitation 1. FSIs inspectors w erification PBis task to prevent direct product contamination or adulteration a. implementing the pre-operational activities of the Sanitation NOTE: Corrective actions must include e appropriate disposition of Sop. oring the pre-operational activities of the Sanitation initiating corrective actions as needed before operations to (3) must include or adulteration including (1) procedures to ensure appropriate dis products that may be contaminated or 2. FSIS inspectors will perform operational record verification to venty that a plant is maintaining daily records (2) restoration of santary conditions, and
BLOCK 6.FSIS Performs Verification Tasks BLOCK 7 FSIS Determines if Deficiencies Exist 2. FSIS inspectors will perform operational process verification PB/S task to verify that a plant is: BLOCK 7 a. implementing the operational activities of the Sanitation SOP Records Verification and ng the operational activities of the Sanitation SOP To determine if records deficiencies exist, FSIS inspection c. initiating corrective actions as needed during operations to Do the records document the effectiveness of the activities of the prevent direct product contamination or adulteration. NOTE Corrective actions must includ the records document monitoring the activities of the Sanitation to ensure appropriate disposition of products that may be Do the records document corrective actions taken to include all (2) restoration of sanitary conditions; and 3) prevention of recurrence of direct product Are the records requirements of the Sanitation SOP met? contamination or adulteration including appropriate re-evaluation or modification of the Sanitation SOP if the answer to any of these questions is"no, one or more deficiencies exist. Each deficiency is identified as the specific requirement which DECISIONS was not me pon completion of a records or process verification task, FSIS Process verification spectors will procee ocess or "hands-o BLOCK 7 to determine if deficiencies exist will be answered REFERENCES FSIS Directive 11, 100.3, Evaluating Verifying and Enforcing a tation Standard Operating Procedure(Verification of Compliance Is there evidence that the plant is monitoring activities of the Regulatory Requirements Sanitation SOP appropriately? Are corrective actions taken and documented as required? if the answer to any of these questions is"no", one or more deficiencies
BlOcK 7 FSiS Determines if Deficiencies Exist BLOCK 8-FSIS Uses the Deficiency Classification Guide exist. Each deficiency is identified as the specific requirement which RECORDS VERIFICATION was not met. NOTE: If the plant has identified a deficiency and is taking appropriate action, FSIS inspection personnel will nof identify the Pre-Op Sanitation and/or Operational Sanitation problem as a regulatory deficien us on whether the record requirements and plant inspection DECISIONS After evaluating the results of a records or process verification task. complete a daily record(s)may be presumptive evidence FSIS inspection personnel will that the plant is producing product that poses a health and safel k if one or more deficiencies exist PROCESS VERIFICATION Pre-Op Sanitation and/or Operational Sanitation STOPI if there are no deficiencies Focus of verification task is on equipment, facilities, and employee which cause direct product contamination or adulteration m s pe classified using the Classification Guide(DCG ACTIONS BLOCK 8 rsonnel eficiencies Records deficiencies /hen classifying record deficiencies, FSIS inspection personnel will vidence e plant is producing product that poses a food safety Consequently, further inquiries may be required to determine the ull extent of such failures