BLOCK 1.Start BLOCK 2.Plant Develops Sanitation SOP PREAMBLE Once prepared, FSIS inspection personnel will proceed to All inspected establishments shall develop, implement, and maintain written Sanitation SoPs. The sanitation SOPs shall describe all BLOCK 2 if the task is evaluation of a Sanitation SOP procedures an establishment conducts daily to prevent direct ntamination or adulteration of product(s). FSis has clarified that Sanitation SOP's also shall specify the frequency with which ear BLOCK6 if the task is verification of a Sanitation SOP procedure in the Sanitation SOPs is to be conducted and identify the establishment employee(s)responsible for the implementation and maintenance of such procedure(s). While the employee responsible for implementation and maintenance of procedures in the Sanitation SOP's may be the employee who actually performs such activities, s/he instea may estabishment does not need to necessarily identify the employee (s )who will actualy perform the sanitation procedures. Also, an establishment's Sanitation SOPs may have more than one employee responsible for mentation and maintenance of sani example, one employee may be responsible for pre-operational ocedures and another may be responsible for operational procedures The rule provides such flexibility. Further, FSIS is clarifying in this final rule that establishments mu Sanitation SOPs, distinguishing them from sanitation activities to be FSIS in identifying which sanitation procedures are to be carried out ch day prior to start-up of operations siS is also requiring that Sanitation SOPs be signed and dated by the establishment, and that ment the Sanitation SoPs. This new langu grants establishments greater flexibility than did the proposed requirement that the establishment owner or operator be responsible specifies that Sanitation SOP's must be signed upon initiation and upon any modification. As in the proposal, the format and content of Sanitation SOPs are not
LOCK 2Plant Develops Sanitation SO BLOCK 2-Plant Develops Sanitation SOP specified in the final regulations. Because there are many types of inspected establishments that will achieve the required sanitary Following initial evaluation of the Sanitation SOP, FSIS inspection personnel will proceed to must analyze its own operations and identify possible sources of direct contamination that must be addressed in its sanitation SOPs CK 6 if all the regulatory requirements have been met ACTIONS BLOCK 3 if one or more regulatory requirements have not been Although there is no formal approval process for Sanitation SOPs, FSIS REFERENCES inspection personnel will perform an initial evaluation task to determine if the plant has met the following Sanitation SoP regulatory FSIS Directive 11, 100.3, Evaluating. Verifying, and Enforcing a requirements. Sanitation Standard Operating Procedure(Evaluation of Regulatory 1. The plant has a written Sanitation soP describing daily Regulation 416.11 procedures they will conduct before and during operations to Regulation 416.12 prevent direct product contamination or adulteration, The initation SoP also includes the frequency at which each authority on-site or a higher level official of the plant, Sanitation SOPs must be signed upon initiation or modification concede s must dress he cerating r od conitact sufaces. 4. The plant has identified individuals who will be responsible for 5. The plant has identified records they will maintain on a daily basis to document the implementation and monitoring of the Sanitation SOPs and any corrective actions taken
BLOCK 3. FSIS Suspends Operations BLOCK.FSIS Suspends Operations PREAMBLE ( PDR). The lC wil subsequenty notify the Inspection Operations Area Office(AO)of the action initiated Oversight of Sanitation SOP's will become an increasingly important c. If an estabishment fails to render immediate corrective action the pil l o u a l s rection a tPvir i ie the directing of sa intide activties hat a Compliance Officer(CO)assist that Sanitation SOPs meet the regulation's requirements, are beit with documentation of the alleged non-regulatory compliance. When necessary, a co will visit the establishment at the eariest will include review of the possible date to assist the llC. The AO wl subsequently notify Sanitation SOP's and required records, direct observation of the e circuit Supervisor(CS)of the action initiate plementation and monitoring of the Sanitation SOPs, and visual observation of sanitary conditions in the production areas of the d. The CO will initiate, develop and document an investigative case establishmen e. All documented findings will be handled by assigned inspectors and compliance officers in accordance with this Enforcement Actions When Compliance with Regulatory issuance FSIS inspection personnel may fnd that the establishment's SSOP's ACTIONS to include procedures to prevent direct contamination or adulteration of site or a higher level official of the establishment, and/or fail to identi BLOCK 3 required records. Such a finding alone supports the withholding of inspection to prevent use of the facilities and equipment in the production of products until the failure is remedied If initial evaluation by FSIS inspection personnel reveals that one or more Santation SOP regulatory requirements have not been met, FSIS a. If at any mplementation date FSIS will suspend operations. For example, the plants Sanitation SoP may meet the regulatory requirements for development or maintenance of a dulteration; or the SoP may not be signed appropriately: or required the following imt daily monitoring records may not be identifed. Any of these findings support the withholding of inspection to prevent of the faciliti 1. The inspector-in-Charge(lIC)will refuse to allow any meat and equipment for food production until d poultry products produced under the above conditions be abeled, marked, stamped, or tagged as "inspected and If a plant fails to meet the regulator ments for the developme or maintenance of a ion SOP FSiS will take action. The 2. The lC will attach a'US Retained" to all alleged adulterated meat or poultry products produced under such conditions or 1. Immediate steps will be taken to withhold inspection. The procedures Inspector-in-charge (lIC)will 3. The lIC will attach a"U.S. Rejected" tag to the applicable equipment, utensil, room or compartment nder the above conditions to be labeled, marked, stamped or tagged as inspected and passed" or inspected b. The lIC w immediately orally advise establishment management that the above steps have been taken and document the reasons for taking such action on FSIS Form 8820.2, Process Deficiency attach aU.S. Retained" tag to all alleged contaminated or
BLOCK 3. FSIS Suspends Operations BLOCK 3. FSIS Suspends Operations adulterated meat or poultry products; a c. attach aU.s. Rejected tag to the applicable equipment REFERENCES utensils, rooms, or areas FSIS Directive 11, 100.3, Evaluating, Verif Enforcing a 2. Immediate notification and documentation action will be taken Sanitation Standard Operating Procedure( Enforcement Actions when The Ic will Compliance with Regulatory Requirements Cannot be Verified) ement orally that the steps (a-c)in'l"above have been taken ocument the actions and the justifying rationale on FSIS Deficiency Record(PDR); and BLOCK 4. Plant Complies perations Area Office notified, if a plant fails to immediately correct the deficiency ACTIONS a, the ao will c officer( CO) BLOCK 4 regulatory non-compliance b, When necessary, the Co will visit the plant at the earliest No further action is required by FSIS in this block. The suspension until the plant complies with c. The AO will subsequently notify the Circuit Supervisor(CS) Sanitation SOP regulatory requirements of the action initiated d. The Co wi initiate and develop an investigative case file. All documented findings wll be handled by assigned inspectors As soon as the non-compliance is corrected, FSIS inspection personnel ind compliance officers in accordance with the MPl proceed to DECISIONS BLOCK 5 animation SoP regulatory requirement Go to blocK 4
BLOCK 6.FSIS Removes Suspension BLOCK 5.FSIS Removes Su PREAMBLE Modifications to SSOP's will be evaluated by inspection personnel as Each establishment is required to conduct pre-operational and specified in the SOP's, monitor the conduct of the procedures, and routinely evaluate the content and effectiveness ACTIONS of the SOP's and modify the SOP's accordingly. The Sanitation SOP's must be kept current. The establishment must evaluate and modify Sanitation SOP's as needed in light of changes to establishment facilities, personnel, or operations to ensu remain effective in BLOCK 5 eventing direct product contamination and As upon initial signed by the individual with overall authority on-site or a higher level official of plant is in compliance with Sanitation SOP regulaton nents, FSIS will remove the suspension and allow the plant to Establishment is allowed to resume operation. oTE: Any time the plant its Sanitation SOP after the he FSis inspector will perform an evaluation task to ascertain that the SoP as an“each a. The establishment has a written ssop desc FSIS actions will be the same as those used in the initial evaluation of operations and the frequency at which they will be conducted, to a Santation SOP. FSIS inspection personnel will determine if the plant prevent direct contamination or adulteration of product(s) has met the following Sanitation SOP regulatory requirements b, The SSOP is signed and dated by an offic The plant has a written Sanitation SoP describing daily n-site or a higher level official of the establishment. SSOP's procedures they will conduct before and during operations to must be signed upon initiation and any m Sanitation SoP also includes the frequency at which each c. The SSoP identifies procedures the establishment will conduct procedure wil‖ be done prior to the start of operations. These procedures at a minimum ust address the cleaning of food contact surfaces of facilities 2. The Sanitation SoP is signed and dated by authority on-site or a evel official of SOPs must be signed upon initiation or me 3. The Sanitation SOP identifies the procedures the plant will e, The establishment has identified records to be maintained that The plant has identified individuals who will lementing and maintaining daily sanitation activities his evaluation will be performed as an each occasion(EO) through the action System(PBIS). Establishments must ent fied records they will maintain on a daily basis routinely assess the effectiveness of SSOPs and adjust SSOP's in light of changes to establishment facilities, personnel, or operations SOPs and any corrective actions taken