Sanitation Standard Operating Procedures (SSoP) Reference Guide
Fs■ Sanitation Standard Operating Procedures(SSoP) ega DAY ONE MANAGEMENT PROJECT on Managoment Program Human Resource Development Division Raom460· South Building 2700E. Bypass, Suite 3000 ashington. DC 20250 Coliege Staton, TX 77845 2027203697 Us. BOatman d ApraM.E0ddh地nm凡
Table of contents Table of Contents NOTE: The blocks" listed below and illustrated in the flow diagram on Block 15 FSiS continues official control action the preceding pag Each block discussion ad FSIS inspector at tha ocess. When applicable, sections Block 16 lIC contacts Area office in cases of from the regulatory quoted and/or other regulatory Block 17 lC and Co review plant situation Block 1 Start Block 2 Plant develops Sanitation SOP Block 19 llC provides documentation to IMP Block 3 tion soP does not meet regulatory Block 20 IMP and FOD prepare and provide Block 4 Plant complies NOTE: The following appendices are provided as additional Block 5 FSIS removes suspension Block 6 FSIS per Guidelines for Developing a SOP spendⅸA Block 7 Fsis determines if deficiencies exist Model of a soP for Sanitation Appendix B Block 8 FSIS classifies deficiencies using the Block 9 FSiS cial control action Selection and Verification of Establishment Appendix E Block 10 Plant defines and implements peace Appendix F Block 11 Fsis determines if plant actions Block 12 FSIS advises plant of consequences failure to implement effective Block 13 FSiS determines if there are repeated ted failures Block 14 FSiS removes official control action if failure is not 36
BLOCK 1-Start BLOCK 1. Start daily basis in individual establishments, but at a relatively large public PREAMBLE ost because it encouraged establishments to shift accountability for Plant Responsibilities inspectors have taken responsibility for slaughter establishment before it begins daily processing. In extreme The proposed requirements for Sanitation SOPs were the result of cases, inspectors have led daily bucket brigades"of slaughter many years of observations by FSIS of establishment sanitation and leanup. In these circumstances, FSIs has, in effect, taken me meat and poultry establishments was documented in the"1,000 sponsibility for establishment sanitation conditions Plant Review, "conducted by FSIS between September 1993 and Although ority of meat and poultry adequate sanitary conditions, some establishments have deficiencies noted. More than 60 percent of all deficiencies documented sanitation problems that can be resolved only through more clearl by the review involved establishment sanitation. The distribution of ning establishment wever. uniform in ibility and accountability for the daily percent of the sanitation deficiencies. Data collected through FSIS's clear that responsibility for identifying and conducting procedures needed to maintain sanitary conditions rests with the establishment, not Based Inspection System similarty documents that on is the most frequent deficiency noted by inspection personnel Finally, the Sanitation SOPs requirements of this final rule are set out Through analysis of this information, Fsis determined that the hese provisions are formatted differe Ifference between establishments with consistently sanitary conditions and those with chronic sanitation deficiencies is often that the better organize, and recodify the meat and poultry regulations. This performing establishments have effective qua lity control and sanitation regulatory reform project is well underway, and will, among other things programs, including written Sanitation SOP's, while the marginal eliminate unneeded regulations by combining, to the extent possible, the currently separate meat and poultry regulation ors Substantial evidence exists that insanitary facilities or equipment, poor improper personal hygiene, and similar insanitary contaminated with microorganisms, including pathogens. While commenters expressed concem that during inspection inspectors would some indiidual establishments still have difficulty getting their facilities soiety on record reviews instead of actually observing establishment and equipment ready to start operations each day and keeping conditions. Other commenters expressed concerns that Sanitation SOPs would merely provide FSIS s with more latitude to make nditions sanitary during establishment operations. FSIS affirms that intrusive and arbitrary decisions. FSIS strongly disagrees with this and a fundamental requirement of the inspection laws that the Agency inspection personnel, Industrys responsibility for producing safe meat and poultry and FSis responsibility for regulatory oversight are st, FSIS has enforced the sanitation requirements primar through a combination of prescriptive sanitation regulations, detailed Santation SOPs are the establishment s commitment to fsis that the guidance materials, and direct, hands-on involvement by inspectors in nsistently provide a sanitary FSIS inspectors will not be tasked with directing an establishment's day-to-day pre-operational and operational sanitation procedures in sanitation procedures, inspected establishments. This system achieved sanitation goals on a Sanitation SOPs. They will, however, verify that the Sanitation SOP's
BLOCK sTart BLOCK1· Start hat a rejected item, compartment or room is not related to other re being implemented and that they are effective in preventing direct withheld in rooms, depar produced. However, inspection would be processes or products production of contaminated or adulterated products where the Oversight of Sanitation SOP's will become an increasingly important establishment can not show FSIS that they have isolated the cause of the contamination or adulteration and have taken appropriate action to will occur less frequenty Periodic inspection tasks will include verifying event further co similar ve that Sanitation SOP's meet the regulation's requirements, are being he occurence of a sanitation problem that is effectively abated. These conditions. FSIS inspectors oversight will include review of the Sanitation SOPs and required records, direct observation of the if an establishment fails to identify and correct insanitary condtions. If ementation and monitoring of the Sanitation SOPs, and visual the establishment takes proper corrective action, they argued, t should observation of sanitary conditions in the production areas of the ewed as evidence that the Sanitation SOP's is being adequatel ented. FSIS agrees. Establishments that identify and correct sanitary conditions in a timely manner and make proper disposition of SIS expects that establishments will rely less on inspectors to direct any affected product will be considered to be in compliance with the them in maintaining sanitary conditions as establishments rely more on adherence to their own Sanitation SOPs, The max of inspector tasks that comprise sanitation inspection also will change. As establishments Although FSIS fully expects that the clarification of establishme adopt and successfully implement Sanitation SOPs, and consistently animation responsibilities will lead to better and more consistent suning that basic sanitation requirements are being met. Conversely. comply with the requirements in this final rule for Sanitation SOPs will SOPs and consistently achieve good sanitation, FSIs inspectors will be subject to appropriate compliance and regulatory action that be obliged to intensify ther focus on actual establishment conditions and when necessary, include suspension or withdrawal of inspection itiate appropriate enforcement actions. Ensuring establishments Further, as noted in the proposal, anyone who intentionally falsifies berate under sanitary conditions should be made easier for ins well as establishments, focus their attention on those aspects of ACTIONS establishment sanitation that pose the most risk of causing product BLOCK 1 latively low probability of is sanita Preparation is essential for success. Before performing any task for thereby consistenty preventing, or as appropriate, correcting, conditions at cause direct product contamination or adulteration. Some egulatory enforcement of Sanitation SOPs, FSIS inspection personnel will be ommenters were concerned about the effect on orcing the Sanitation SOPs requirements, reject one piece of equipment, utensiL, room or know the regulatory requirements for Sanitation SOPs impartment as insanitary. As previously stated, inspectors will take prompt action in cases where there is a finding of insanitation or have the equipment, supplies, and references needed to perform and document inspection findings and likelihood of product contamination or adulteration. The type and intensity of this response will vary. For example, establishme have access to pertinent plant records or documentation
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
