AMS Beef Export Verification Program QSA Requirements

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AMS Beef Export Verification Program QSA
Requirements

• Livestock and Seed Program

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• Review the Joint Statement for Resumption of
  Trade in Beef and Beef Products USDA Marketing
  Program
• Review the know Specified Product Requirements
• Quality System Assessment Program
• Implementation Plan
• Who can apply for Service

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• Details the conditions and modalities the two
  countries must meet in order to resume two-way
  trade in beef.

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• The operational details of the Beef Export
  Verification (BEV) Program managed by U.S.
  Department of Agriculture's (USDA) Agricultural
  Marketing Service (AMS) will be further worked
  out by U.S. experts and Japanese, major points of
  which are as follows

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• Specified risk materials (SRMs) must be removed
  from animals of all ages
• SRMs spinal cords, distal ileum (two meters
  from connection to caecum), vertebral column
  (excluding the transverse processes of the
  thoracic and lumbar vertebrae, the wings of the
  sacrum and vertebrae of the tail) of all ages.

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• USDA will verify the control program of each
  facility managed by a HACCP (Hazard Analysis
  Critical Control Point) or SSOP (Sanitation
  Standard Operating Procedures).

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• Beef items including offal and variety meats must
  be derived from bovine animals verified to be 20
  months of age or younger.

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• Bovine animals included in the BEV Program must
  be traceable to live animal production records
  which indicate 20 months of age or younger
• Records that will be used to verify this
  requirement by AMS must meet at least one of the
  following criteria

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Joint Press Statement for Resumption of Trade of
Beef and Beef Products

• Individual Animal Age Verification
• Group Age Verification
• Insemination Age Verification
• Animals enrolled in an Approved USDA Process
  Verified Animal Identification and Data
  Collection Service that includes age

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This information was last updated 10/22/2004
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This information was last updated 10/22/2004
184421
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This information was last updated 10/22/2004
184421
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Quality System Assessment Program

• This Procedure provides the requirements of a
  USDA Quality System Assessment (QSA) Program.
  ARC 1002 Procedure
• It also provides the criteria used in the
  objective evaluation of USDA QSA Programs that
  are submitted for approval.

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QSA Purpose

• Evaluations are conducted by the Agricultural
  Marketing Service (AMS), Livestock and Seed (LS)
  Program, Audit, Review, and Compliance (ARC)
  Branch

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1
3
5
AMS APPROVED
Application Is submitted
Onsite Evaluation Conducted by AMS
Approved by AMS
AMS Web Listing
Successful Audit
Qualified AMS Auditor Conducts Desk Audit
Surveillance Audits Conducted
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2
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QSA Scope

• This Procedure applies to marketing programs for
  agricultural products, including services, that
  are submitted to the ARC Branch for verification
  and monitoring
• It is limited to programs or portions of programs
  where specified product requirements are
  supported by a documented quality management
  system

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QSA Scope

• The extent of controls included in these programs
  may include all phases of production and
  marketing from genetic development through retail
  distribution, or any portion as described in the
  scope of the submitted program

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QSA Scope

• Scope of a BEV Program for Japan would include
  records which indicate the age of the animals
  meet the Specified Products Requirement, 20
  months of age or younger - Harvest operations

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QSA References

• ARC 1000 Procedure, Quality Systems Verification
  Programs General Policies and Procedures
• ARC 1002 Procedure, USDA Quality System
  Assessment (QSA) Program
• Applicable ARC Branch Program Procedure (ARC
  1030X)

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QSA Frequency

• All approved programs will be audited at least
  twice per fiscal year (October 1 to September
  30).

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QSA Frequency

• However, more frequent audits may be conducted
  for any of the following reasons(1) if either
  numerous major or minor non-conformances are
  identified during an audit (2) if customer
  complaints indicate an ongoing problem

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QSA Frequency

• (3) to satisfy specific requests as declared by
  customers, trading partners or other financial
  interested parties or (4) as directed by the
  AMS

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QSA Internet Listing

• Approved programs will be listed on the
  applicable Program website or on the USDA QSA
  Program website at http//www.ams.usda.gov/lsg/arc
  /qsap.htm
• Information about the approved program will be in
  accordance with the applicable Program Procedure.
  .

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QSA Internet Listing

• The approved program listing on the USDA QSA
  Program website will include the following
  information
• Company name
• Company contact information
• Program requirements
• Report reference number (approval number) and
• Renewal date

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QSA Program Requirements

• Companies must submit a documented program that
  addresses the program requirements as outlined in
  the following clauses (Clauses 1 to 5). This
  would include activates at associated locations

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QSA Program Requirements

• 1. Quality Management Systems
• 2. Management Responsibility
• 3. Human Resources - Competence, Awareness, and
  Training
• 4. Product Realization
• 5. Measurement, Analysis, and Improvement

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QSA - 4. Product Realization

• Receiving / Purchase Process (ISO 7.4)
• Identification and Traceability
• Preservation of Product
• Control of Monitoring and Measuring Devices

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QSA - Product Realization Receiving

• The company must ensure that product purchased or
  received from outside establishments and used in
  the program conform to specified product and
  receiving requirements. (ISO 7.4.1)
• The company must ensure the adequacy of specified
  product requirements prior to their communication
  to the supplier. (ISO 7.4.1)

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QSA - Product Realization Receiving

• The company must evaluate and select suppliers
  based on their ability to supply product that
  conforms to the specified product requirements.
  (ISO 7.4.1)

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QSA - Product Realization Receiving

• The type and extent of control applied to the
  supplier and the purchased product shall be
  dependent upon the effect of the purchased
  product on the final product. (ISO 7.4.1)

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QSA - Product Realization Receiving

• The company must establish and implement the
  inspection or other activities necessary for
  ensuring that product purchased or received from
  outside establishments and used in the program
  conform to specific product requirements. (ISO
  7.4.3)

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QSA - Product Realization Receiving

• The company must have a documented procedure
  addressing products purchased and / or received
  from outside establishments.

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QSA - Product Realization Receiving

• The documented procedure must describe
• All product purchased and/or received from
  outside establishments regardless of its use
  within the program
• The specified receiving requirements for
  acceptance of products to be used in the program

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QSA - Product Realization Receiving

• The criteria and process for supplier selection,
  evaluation, and re-evaluation and
• The process used to ensure that purchased product
  and/or product received from outside
  establishments and used in the program conform to
  specific product requirements.

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QSA - Product Realization Receiving

• The company must maintain records of the results
  of supplier evaluations and any necessary actions
  arising from the evaluation.
• The company must maintain records to provide
  evidence of conformity to the receiving process
  and of the effective operation of the receiving
  process.

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QSA - Product Realization Identification and
Traceability

• The company must have a documented procedure to
  identify product (raw materials and/or finished
  product) by suitable means throughout product
  realization, where appropriate.

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QSA - Product Realization Identification and
Traceability

• The documented procedure must describe the method
  for
• Identifying the product throughout product
  realization
• Controlling and recording the unique
  identification of the product and
• Identifying the product status with respect to
  monitoring and measurement requirements.

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QSA - Product Realization Identification and
Traceability

• The method for identifying the product must
• Be unique to the program. When applicable,
  animals must be identified with ear tags or other
  permanent identification and
• Be such that the identification will transfer
  through all phases of product realization, from
  receipt into the program through production to
  delivery.

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QSA - Product Realization Identification and
Traceability

• The company must maintain records of all products
  as identified and records of all changes of
  identities.

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QSA - Product Realization - Control of Monitoring
and Measuring Devices

• The company must determine the monitoring and
  measurement to be undertaken to provide evidence
  of conformity to specified product requirements.
• The company must determine the monitoring and
  measurement devices needed to provide evidence of
  conformity to specified product requirements.

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QSA - Product Realization - Control of Monitoring
and Measuring Devices

• The company must establish processes to ensure
  that monitoring and measurement can be conducted
  and are conducted in a manner that is consistent
  with the monitoring and measurement requirements.

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QSA - Measurement, Analysis, and Improvement

• The company must plan and implement the
  monitoring, measurement, analysis, and
  improvement processes needed
• To demonstrate conformity of the product
• To ensure conformity of the QMS and
• To continually improve the effectiveness of the
  QMS.

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QSA - Measurement, Analysis, and Improvement

• The plan must include a determination of
  application methods, including statistical
  techniques, and the extent of their use.
• When statistical methods are used to control
  product quality or integrity, the basis for those
  procedures must be clearly defined.

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement
• Customer Satisfaction
• Monitoring and Measurement of Processes
• Monitoring and Measurement of Product
• Control of Non-conforming Product within the QMS
• Improvement

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement of Processes
• The company must apply suitable methods for
  monitoring and, where applicable, measurement of
  the QMS processes.
• These methods must demonstrate the ability of the
  processes to meet product requirements.

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement of Processes
• When product requirements are not achieved,
  correction and corrective action must be taken,
  as appropriate, to ensure conformity of the
  product.

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement of Product
• The company must monitor and measure the
  characteristics of the product to verify that
  product requirements have been met. This must be
  conducted at appropriate stages of the product
  realization process.

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement of Product
• The company must ensure that product requirements
  have been meet prior to product release and
  service delivery, unless otherwise approved by a
  relevant authority and, where applicable, by the
  customer.

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QSA - Measurement, Analysis, and Improvement

• Monitoring and Measurement of Product
• The company must maintain records to verify
  evidence of conformity to product requirements.
  Records must indicate the person(s) authorizing
  release of product.

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QSA - Measurement, Analysis, and Improvement

• Control of Non-conforming Product within the QMS
• The company must ensure that non-conforming
  product (raw material and/or finished product) is
  identified and controlled to prevent its
  unintended use or delivery.

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QSA - Definitions

• Specified Product Requirements the requirements
  listed within the applicable Program Procedure or
  as stated by the company. Example
• ARC 1030B Procedure, USDA Bovine Export
  Verification Program for Mexico

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QSA Documentation Requirements

• Clause 1.2.2 - Quality Manual
• Documented Procedures
• Clause 3 Training of personnel
• Clause 4.2 Receiving of product from outside
  sources (Purchasing Procedure)
• Clause 4.3 Identification and traceability
• Clause 5.3 Control of non-conforming product

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QSA Documentation Requirements

• Records
• Clause 3 training, education, skills and/or
  experience
• Clause 4.2 results of supplier evaluations and
  any necessary actions
• Clause 4.2 evidence of conformity to the
  receiving process and its effective operation

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QSA Documentation Requirements

• Records
• Clause 4.3 product identification and changes
  of identities
• Clause 4.5 results of calibration and
  verification
• Clause 5.2.1 customer perception

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QSA Documentation Requirements

• Records
• Clause 5.2.4 evidence of conformity to
  specified product requirements
• Clause 5.3 non-conforming product and
  subsequent actions taken
• Clause 5.4.2 corrective actions
• Clause 5.4.3 preventative actions

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QSA Documentation Requirements

• Any other documents necessary to ensure the
  effective operation and control of the QMS.

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Implementation of a Export Verification Program -
Beef

• Which Includes Live Animal Records Requirement
  for AGE

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Purchase Procedures to Evaluate and
Ensure Inspection and Receiving Records of
Monitoring
Producer
Feed Lot
QSA Program
Live Animal AGE Records Requirements
Harvest
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Purchase Procedures to Evaluate and
Ensure Inspection and Receiving Records of
Monitoring
Producer
QSA Program
Feed Lot
Live Animal AGE Records Requirements
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LIVE ANIMAL AFFIDAVIT
Live Animal AFFIDAVIT

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QSA Approved Facilities

• Slaughter Facilities Submit documentation for
  live animal purchases and updated segregation
  plans.
• Processor Submit updated documentation address
  requirements for receiving, control, labeling,
  and training.

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QSA Approval Process - BEV

• Approval Process
• Review submitted documentation from all
  facilities
• New slaughter or processing facility - Conduct
  onsite audit
• Approved Facility - Conduct onsite audit with a
  scope of live animal purchase and program changes

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AMS BEV Program

• Who can apply for program review
• Slaughter Facility
• Processor
• If live animals requirements included in the
  scope
• Individual Feedlot
• Producer, producer group

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AMS BEV Programs

• Updates to the program will be posted on the AMS
  website as they become available.
• Will post final ARC Procedure for Export
  Verification Beef Specific Product Requirements
  for Japan

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Web sites

• USDA - http//www.usda.gov/
• AMS - http//www.ams.usda.gov/
• Livestock and Seed - http//www.ams.usda.gov/lsg/
  
• ARC Branch - http//www.ams.usda.gov/lsg/arc/audit
  .htm
• USMEF - http//www.usmef.org

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Contact Information for QSA or BEV

• James L Riva [phone]
• James.Riva_at_usda.gov
• Samantha Simon [phone] Samantha.Simon_at_usda.
  gov
• Dana Stahl [phone]
• Dana.Stahl_at_usda.gov