USDA-FSIS Sanitation Standard Operating Procedures

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USDA-FSIS Sanitation Standard Operating
Procedures

• Elizabeth A. Krushinskie, DVM, PhD
• VP, Food Safety Production Programs
• U.S. Poultry Egg Association

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Overview

• Sanitation Standard Operating Procedures are
  written procedures that an establishment develops
  and implements to prevent direct contamination or
  adulteration of product.
• The establishment must also maintain daily
  records sufficient to document the implementation
  and monitoring of the SSOPs and any corrective
  actions taken.

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Overview

• The establishment is required to maintain these
  written procedures on file, and they must be
  available to FSIS upon request.
• It is the establishments responsibility to
  implement the procedures as they are written in
  the SSOPs.

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Overview

• If the SSOPs fail to prevent direct contamination
  or adulteration of product, the establishment
  must implement corrective actions that include
  appropriate disposition of product, restoration
  of sanitary conditions, and measures to prevent
  recurrence.

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Overview

• It is the Agencys responsibility to review the
  SSOPs, daily records, and to make direct
  observations of SSOP procedures and any testing
  being done
• FSIS has the authority to take regulatory control
  actions if product is deemed to be adulterated or
  contaminated

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Sanitation Standard Operating Procedures (SSOP)

• 9CFR 416.11 416.17
• 416.11 General Information
• 416.12 Development of SSOPs
• 416.13 Implementation of SSOPs
• 416.14 Maintenance of SSOPs
• 416.15 Corrective Actions
• 416.16 Record Requirements
• 416.17 Agency Verification

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Sanitation Standard Operating Procedures (SSOP)

• 416.11 General Rules
• Each official establishment shall develop,
  implement, and maintain written standard
  operating procedures for sanitation (Sanitation
  SOPs) in accordance with the requirement of this
  part.

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416.12 Development of SSOPs

• 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).

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416.12 Development of SSOPs

• 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 SSOPs as
  specified and will maintain the SSOPs in
  accordance with the requirements of this part.
  The SSOPs shall be signed and dated upon
  initially implementing the SSOPs and upon any
  modification to the SSOPs.

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416.12 Development of SSOPs

• 416.12(c)
• Procedures in the SSOPs 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.

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416.12 Development of SSOPs

• 416.12(d)
• The SSOPs shall specify the frequency with which
  each procedure in the SSOP is to be conducted and
  identify the establishment employee(s)
  responsible for the implementation and
  maintenance of such procedure(s).

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416.12 Development of SSOPs

• The establishment has the responsibility to
  develop written SSOPs that contain the procedures
  that cover the entire establishment and all
  shifts of operation
• There are not separate SSOPs for different
  operations or different shifts

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416.12 Development of SSOPs

• FSIS Inspection Verification
• The basic verification procedure (01A01) is
  performed by FSIS only once, when a new plant is
  requesting a Grant of Federal Inspection to begin
  operations or when major changes to a plants
  existing written SSOPs have been made
• Verifies that the SSOP plan meets the regulatory
  requirements of 416.12
• There is no need to perform this procedure again

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416.12 Development of SSOPs

• There are additional ongoing FSIS verification
  procedures (416.17) once a plan has been
  initially reviewed addressing
• Implementation of SSOP (monitoring)
• Maintenance of SSOP (effectiveness)
• SSOP Corrective Actions
• SSOP Recordkeeping

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416.13 Implementation of SSOPs

• 416.13(a)
• Each official establishment shall conduct the
  pre-operational procedures in the Sanitation SOPs
  before the start of operations

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416.13 Implementation of SSOPs

• 416.13(b)
• Each official establishment shall conduct all
  other procedures in the Sanitation SOPs at the
  frequencies specified.

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416.13 Implementation of SSOPs

• 416.13(c)
• Each official establishment shall monitor daily
  the implementation of the procedures in the
  Sanitation SOPs

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416.13 Implementation of SSOPs

• If an establishment writes a procedure in its
  SSOP, it must implement that procedure and
  monitor it daily.
• In other words, the establishment is responsible
  for doing what it said it would do

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416.13 Implementation of SSOPs

• FSIS Inspection Verification
• 01B01 Procedure
• Pre-operational recordkeeping review
• Monitoring records
• Corrective actions
• Ensure compliance to regulatory requirements
• Ensure that the establishment has recorded its
  monitoring activities and corrective actions

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416.13 Implementation of SSOPs

• FSIS Inspection Verification
• 01B02 Procedure
• Pre-operational observation review
• Observe the establishment conducting its
  monitoring procedures
• Perform an organoleptic examination of some of
  the establishments facilities, equipment, and
  utensils to assess sanitary conditions (hands on)
• Compare FSIS findings with plant records

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416.13 Implementation of SSOPs

• FSIS Inspection Verification
• 01C01 Procedure
• Operational recordkeeping review
• Monitoring records
• Corrective actions
• Ensure compliance to regulatory requirements
• Ensure that the establishment has recorded its
  monitoring activities and corrective actions

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416.13 Implementation of SSOPs

• FSIS Inspection Verification
• 01C02 Procedure
• Operational observation review
• Observe the establishment conducting its
  monitoring procedures
• Perform an organoleptic examination of some of
  the establishments facilities, equipment, and
  utensils to assess sanitary conditions (hands on)
• Compare FSIS findings with plant records

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416.13 Implementation of SSOPs

• FSIS Inspection Verification
• Is the establishment implementing the
  pre-operational procedures in the SSOP prior to
  the start of operations as written?
• Is the establishment implementing the operational
  procedures in the SSOP as written?
• Is direct contamination or adulteration of
  product, or are unclean direct product contact
  surfaces observed by FSIS or the establishment?
• Has the establishment taken the appropriate
  corrective actions?

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416.13 Implementation of SSOPs

• Environmental Sampling
• Pre-op sanitation swabs (total plate count)
• Bioluminescent swabs (ATPase systems)
• If environmental sampling is included in the
  SSOP, FSIS will verify that the establishment is
  collecting samples, reviewing sample results, and
  taking appropriate corrective actions as needed.

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416.14 Maintenance of SSOPs

• 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.

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416.14 Maintenance of SSOPs

• Each establishment has two primary
  responsibilities
• To evaluate the effectiveness of all SSOPs that
  have been implemented
• To revise the SSOP as needed to ensure that it is
  reflective of the operation and that the SSOP is
  effective

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416.14 Maintenance of SSOPs

• The methods used within the establishment to
  evaluate the effectiveness of their SSOP plans is
  not prescribed and will vary from plant to plant
• The regulations only require that an
  establishment perform an evaluation of the
  effectiveness of their SSOPs and make changes as
  necessary

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416.15 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).

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416.15 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 described
  therein.

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416.15 Corrective Actions

• These regulations require the establishment to
  take corrective actions when the SSOPs fail to
  prevent contamination or adulteration of product
• There are three parts to each corrective action
  and all three of these requirements must be met
  and recorded each time a failure occurs

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416.15 Corrective Actions

• The three regulatory requirements are
• Appropriate disposition of products that may be
  contaminated
• Restoration of sanitary conditions
• Prevention of recurrence of direct contamination
  or adulteration of products

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416.15 Corrective Actions

• The establishment is not required to notify FSIS
  when a failure occurs, but is required to
  implement corrective actions that will meet all
  requirements of 416.15

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416.16 Record Requirements

• 416.16(a)
• Each official establishment shall maintain daily
  records sufficient to document the implementation
  and monitoring of Sanitation SOPs and any
  corrective actions taken. The establishment
  employee(s) specified in the SSOPs as being
  responsible for the implementation and monitoring
  of these procedures shall authenticate these
  records with his or her initials and date.

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416.16 Record Requirements

• 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.

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416.16 Record Requirements

• 416.16(c)
• Records required by this part shall be maintained
  for at least 6 months and made accessible 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.

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416.16 Record Requirements

• 416.16 requires the establishment to maintain
  daily records sufficient to document the
  implementation and monitoring of the SSOPs and
  any corrective actions taken.
• The establishment has until the beginning of the
  same shift the following day to complete these
  records.

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416.16 Record Requirements

• FSIS Inspection Verification
• Recordkeeping procedures (01B01 and 01C01) are
  used to verify that an establishment is meeting
  the regulatory requirements
• FSIS can take regulatory control actions when
  noncompliances result in direct contamination or
  adulteration of product or food contact surfaces

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FSIS Enforcement Actions

• The Rules of Practice regulations (500.3 and
  500.4) describe the enforcement actions that can
  be taken if the establishments SSOPs do not meet
  regulatory requirements.

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FSIS Enforcement Actions

• FSIS may take a withholding action or impose a
  suspension without prior notification if
• Adulterated or contaminated product is shipped
• Basic regulatory requirements are not met
• There are repetitive SSOP failures