卫生标准操作程序(SSOP)及卫生标准操作介绍(SOP)(英文版)-III.ppt

Click to edit Master text styles,Second level,*,MPI Seminar for International Government Officials,Click to Add Title to Slide,*,Sanitation Standard Operating Procedures,SPS/SSOP,卫生标准操作程序,1,General Rules 416.11,Each official establishment shall,develop,implement,and maintain,written standard operating procedures,for sanitation(Sanitation SOPs)in,accordance with the requirements of,this part.,2,General Rules 416.11,Establishment must,develop and implement written procedures,maintain written procedures,make,SSOPs,available to FSIS on request,maintain daily records,3,Development 416.12(a),The Sanitation SOPs shall describe all,procedures an official establishment,will conduct daily,before and during,operations,sufficient to prevent direct,contamination or adulteration of product(s).,4,Development 416.12(b),The Sanitation SOPs shall be signed and dated by,the individual with overall authority on-site or a,higher level official of the establishment.This,signature shall signify that the establishment will,implement the Sanitation SOPs as specified and,will maintain the Sanitation SOPs in accordance,with the requirements of this part.The Sanitation,SOPs shall be signed and dated upon initially,implementing the Sanitation SOPs and upon any,modification to the Sanitation SOPs.,5,Development 416.12(c),Procedures in the Sanitation SOPs that are,to be conducted prior to operations shall,be identified as such,and shall address,at,a minimum,the cleaning of food contact,surfaces of facilities,equipment,and utensils.,6,Development 416.12(d),The Sanitation SOPs shall specify the,frequency with which each 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).,Frequency,7,Development 416.12,SSOPs,must,contain procedures to prevent direct contamination or adulteration of product,contain all the procedures the establishment will conduct daily,identify the procedures to be conducted prior to operations,8,Development 416.12,SSOPs,must,specify a frequency for each procedure,identify the responsible establishment employee,be signed and dated,9,Verification 416.12,You should,perform the 01A01 procedure,verify the basic requirements using FSIS Form 5000-2,perform the basic procedure when a new plant comes under inspection,understand the SSOP regulations,10,Verification 416.12,FSIS Form 5000-2,Sanitation SOPs Basic Compliance Checklist,Establishment Name,Establishment Number,Date the,SSOPs,implemented,If the SSOP meets the Basic requirements,there will be no checkmarks on the form,11,Verification 416.12,If,SSOPs,do not meet requirements of 416.12,write a Noncompliance Record(NR),contact the IIC or the District Office,the District Office will provide direction,12,Workshop I,Elements of Basic Requirements,13,FSIS responsibilities are outlined in FSIS Directive 5000.1,Revision 1.,Overview Go to Chapter I,Part XII of FSIS Directive 5000.1,Revision 1.,FSIS Responsibilities,14,Regulatory process includes,Inspection methods,Regulatory decision making,Noncompliance documentation,Enforcement actions,Regulatory Process for SSOP,FSIS Directive 5000.1,Rev.1,15,Inspection methods include the SSOP 01 and 02 procedures.,Gather Information,Review the SSOP and records,Ask questions,Assess the information,Determine if there is noncompliance,Regulatory Process for SSOP,16,FSIS Verification,To verify SSOP compliance perform,01B01/01B02 pre-op procedures,01C01/01C02 operational procedures,01B01/01C01 recordkeeping procedures,01B02/01C02 review and observation procedures,01 or 02,17,Inspection Methods:01&02 procedures,There is one part to the 01 SSOP procedure,Record Review,Review company records to verify that the regulatory requirements for sanitation are met,18,There are two parts of the 02 SSOP procedure,Review,Observation,The CSI should use both of these parts whenever possible in order to verify regulatory compliance,.,Inspection Methods:01&02 procedures,19,Example,Recordkeeping CSI reviews the establishment records to verify compliance,Review CSI conducts“hands on”procedure and compares the result with plant records to determine regulatory compliance,Observation CSI observes the plant employee perform the activity listed in the SSOP plan,Inspection Methods:01&02 procedures,20,01B01 Procedure,Verify all 4 requirements,implementation(monitoring),maintenance,corrective actions,recordkeeping,21,01B01 Procedure,When performing this procedure you,review the SSOP,review the daily pre-op documentation,verify authenticity of records,verify that monitoring is conducted daily,verify that when contaminated product or direct contact surfaces are found,corrective actions are documented,22,01B02 Procedure,Verify all 4 requirements,implementation(monitoring),maintenance,corrective actions,recordkeeping,23,01B02 Procedure,When performing this procedure you,review the SSOP,observe establishments pre-op monitoring,perform sanitation inspection,compare your findings with plant records,do both inspection and observation,if possible,24,01B02 Procedure,Before verifying pre-op sanitation,select an area or areas of the plant,have a flashlight,have a pen or pencil,have U.S.Rejected/U.S.Retained tags,have a notepad for findings,be trained in lockout/,tagout,25,01B02 Procedures,You should,verify the direct contact surfaces in the areas selected are clean,verify equipment sanitation after establishment monitoring,observe the establishment conducting its monitoring,26,01B02 Procedure,You should,verify that environment smells clean,verify that direct contact surfaces feel clean,verify that direct contact surfaces look clean,27,01B02 Procedure,Assess the information you have gathered by asking questions,Are the observed conditions creating an,insanitary,condition?,Are the observed conditions contaminating product?,28,01B02 Procedure,You should,verify that the environment is sanitary,take a regulatory control action when you observe direct contact surfaces or products that are contaminated,29,01B02 Procedure,You should not,remove the regulatory control actions until the establishment has proposed corrective actions,either verbally or in writing,that meets these requirements,30,Example,01B02 Procedure,31,01C01 Procedure,Verify all 4 requirements,implementation(monitoring),maintenance,corrective actions,recordkeeping,32,01C01 Procedure,When performing this procedure,Review the SSOP,Review the daily operational documentation,Verify record authenticity,Verify that monitoring is conducted daily,Verify that when contaminated product or direct contact surfaces are found,corrective actions are documented,33,01C02 Procedure,Verify all 4 requirements,implementation(monitoring),maintenance,corrective actions,recordkeeping,34,01C02 Procedure,When performing this procedure you,review the SSOP,observe establishments operational monitoring,perform sanitation inspection during operations,compare your findings with plant records,do both review and observation,if possible,35,Pop Quiz,What if you perform a review of either product or direct contact surfaces and you see direct contamination of the product/product contact surfaces and the company is doing nothing about itare you going to wait around and see what happens?,36,Pop Quiz,ANSWER:,NO,you will not wait Product contamination has occurred.,37,01C02 Procedure,Select area or areas and look for,equipment or facilities that are contaminating or adulterating product,employees that are contaminating or adulterating product because of poor employee or product handling practices,38,01C02 Procedure,Assess the information you have gathered by asking questions,Are the observed conditions creating an,insanitary,condition?,Are the observed conditions contaminating product?,Make a decision about what you see and take action if necessary,39,01C02 Procedure,When you observe direct contact,surfaces or product contaminated,you,should,take a regulatory control action,notify the establishment of the regulatory control action,document the noncompliance on an NR,verify that the corrective actions meet the requirements in 416.15,40,Pop Quiz,How do you perform an SSOP procedure to verify monitoring?,41,Pop Quiz,ANSWER:,Review the SSOP to be familiar with procedures,Determine if you will conduct the 01(Recordkeeping)or 02 procedure(Review and Observation),Go into the plant and verify the companys monitoring activities,See if procedures and frequencies are being followed,Determine compliance/noncompliance,42,Implementation 416.13,Establishment responsibilities,developing written procedures,implementing the procedures in the,SSOPs,monitoring those procedures,43,Implementation 416.13,(a)Each official establishment shall conduct the,pre-operational procedures in the Sanitation,SOPs before the start of operations.,(b)Each official establishment shall conduct all other procedures in the Sanitation SOPs at the,frequencies specified.,(c),Each official establishment shall monitor daily,the implementation of the procedures in the,Sanitation SOPs.,44,Implementation 416.13,Inspection verification questions,Is the establishment implementing the pre-op procedures in the SSOP prior to operations?,Is direct contamination or adulteration of product,or unclean surfaces observed by FSIS or the establishment?,45,Implementation 416.13,Inspection verification questions,Is the establishment conducting the procedures in the SSOP as written?,Does the SSOP contain monitoring frequencies?,If SSOP does not contain monitoring frequencies,is the establishment monitoring the procedures daily?,46,Noncompliance exists,if the establishment does not conduct procedures at specified frequencies,if the procedures are not conducted appropriately to prevent contaminating or adulterating product,if procedures are not being monitored at the specified frequencies,Implementation 416.13,47,Example,Implementation 416.13,48,Maintenance 416.14,Each official establishment shall routinely,evaluate the effectiveness of the Sanitation,SOPs and the procedures therein in,preventing direct contamination or,adulteration of product(s)and shall revise,both as necessary to keep them effective,and current with respect to changes in,facilities,equipment,utensils,operations,or,personnel.,49,Maintenance 416.14,Establishment responsibilities,evaluate the effectiveness of the,SSOPs,revise the,SSOPs,as needed to keep them effective,50,Example,Maintenance 416.14,51,Maintenance 416.14,Inspection verification questions,Has the establishment routinely evaluated the effectiveness of the,SSOPs,?,If changes were made,have the,SSOPs,been revised to keep them effective?,Does the establishment routinely review the SSOP records to determine trends?,52,Example,Maintenance 416.14,53,Workshop II,Monitoring,54,Corrective Actions 416.15(a),Each official establishment shall take appropriate,corrective action(s)when either the establishment,or FSIS determines that the establishments,Sanitation SOPs or the procedures specified,therein,or the implementation or maintenance of,the Sanitation SOPs,may have failed to prevent,direct contamination or adulteration of product(s).,55,Corrective Actions 416.15(b),Corrective actions include procedures to ensure,appropriate disposition of product(s)that may be,contaminated,restore sanitary conditions,and,prevent the recurrence of direct contamination or,adulteration of product(s),including appropriate,reevaluation and modification of the Sanitation,SOPs and the procedures specified therein or,appropriate improvements in the execution of the,Sanitation SOPs or the procedures specified,therein.,56,Gather Information,Review the SSOP,review the company operations,and records,for compliance with 416.15,ask questions,Assess(or evaluate)that information,Make a decision about regulatory compliance,Corrective Actions 416.15,57,Pop Quiz,When you conduct the 01 or 02 procedure in,order to verify regulatory compliance,what,are you doing?,58,Pop Quiz,ANSWER:,You are verifying the companys SSOP:,Implementation/Monitoring,Maintenance/Effectiveness,Corrective Actions,Recordkeeping,59,Corrective Actions 416.15,Establishment responsibilities,implement corrective actions when FSIS or establishment determine,SSOPs,fail,ensure the corrective actions are implemented,restore sanitary conditions;,make appropriate disposition of product;and,prevent recurrence,60,Pop Quiz,When is it necessary for an establishment to take corrective actions(416.15)?,Only when found during monitoring,Only when it is found it is by the inspector,Every time the SSOP fails to prevent direct product contamination/adulteration,61,Pop Quiz,ANSWER:,Every time the SSOP fails to prevent direct product contamination/adulteration,62,Corrective Actions 416.15,Inspection verification questions,Does the establishment implement corrective actions that restore sanitary conditions?,Does the establishment implement corrective actions that prevent recurrence?,Does the establishment ensure appropriate disposition of product?,63,Corrective Actions 416.15,Noncompliance exists:,if the corrective actions did not restore sanitary conditions,if the corrective actions did not include the appropriate disposition of product,if the corrective actions did not include measures to prevent recurrence,64,Example,Corrective Actions 416.15,65,Workshop III,Corrective Actions and Evaluation,66,Recordkeeping 416.16(a),Each official establishment shall maintain daily,records sufficient to document the,implementation and monitoring of the Sanitation,SOPs and any corrective actions taken.The,establishment employee(s)specified in the,Sanitation SOPs as being responsible for the,implementation and monitoring of the,procedure(s)specified in the Sanitation SOPs,shall authenticate these records with his or her,initials and the date.,67,Recordkeeping 416.16(b),Records required by this part may be,maintained on computers provided the,establishment implements appropriate,controls to ensure the integrity of the,electronic data.,68,Recordkeeping 416.16(c),Records required by this part shall be,maintained for at least 6 months and made,accessible available to FSIS.All such,records shall be maintained at the official,establishment for 48 hours following,completion,after which they may be,maintained off-site provided such records,can be made available to FSIS within 24,hours of request.,69,Recordkeeping 416.16,Establishment responsibilities,maintain daily records to document,implementation and monitoring of,SSOPs,any corrective actions taken,ensure integrity of electronic data,maintain records for 6 months,stored on-site for 48 hours,stored off-site after 48 hours,70,Gather Information,Review the SSOP,review the company operations,and records,for compliance with 416.16,Assess(or evaluate)that information,Make a decision about regulatory compliance,Recordkeeping 416.16,71,Recordkeeping 416.16,Inspection verification questions,Are the,SSOPs,available to FSIS upon request?,Are the records completed prior to the