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AMS Beef Export Verification Program QSA Requirements

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Bovine animals included in the BEV Program must be traceable to live animal ... ARC 1030B Procedure, USDA Bovine Export Verification Program for Mexico. 8/25/09 ... – PowerPoint PPT presentation

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Title: AMS Beef Export Verification Program QSA Requirements


1
AMS Beef Export Verification Program QSA
Requirements
  • Livestock and Seed Program

2
  • 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

3
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.

4
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

5
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.

6
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).

7
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.

8
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

9
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

10
This information was last updated 10/22/2004
184421
11
This information was last updated 10/22/2004
184421
12
This information was last updated 10/22/2004
184421
13
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.

14
QSA Purpose
  • Evaluations are conducted by the Agricultural
    Marketing Service (AMS), Livestock and Seed (LS)
    Program, Audit, Review, and Compliance (ARC)
    Branch

15
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
4
2
16
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

17
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

18
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

19
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)

20
QSA Frequency
  • All approved programs will be audited at least
    twice per fiscal year (October 1 to September
    30).

21
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

22
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

23
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.
    .

24
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

25
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

26
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

27
QSA - 4. Product Realization
  • Receiving / Purchase Process (ISO 7.4)
  • Identification and Traceability
  • Preservation of Product
  • Control of Monitoring and Measuring Devices

28
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)

29
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)

30
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)

31
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)

32
QSA - Product Realization Receiving
  • The company must have a documented procedure
    addressing products purchased and / or received
    from outside establishments.

33
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

34
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.

35
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.

36
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.

37
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.

38
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.

39
QSA - Product Realization Identification and
Traceability
  • The company must maintain records of all products
    as identified and records of all changes of
    identities.

40
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.

41
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.

42
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.

43
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.

44
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

45
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.

46
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.

47
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.

48
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.

49
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.

50
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.

51
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

52
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

53
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

54
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

55
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

56
QSA Documentation Requirements
  • Any other documents necessary to ensure the
    effective operation and control of the QMS.

57
Implementation of a Export Verification Program -
Beef
  • Which Includes Live Animal Records Requirement
    for AGE

58
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61
Purchase Procedures to Evaluate and
Ensure Inspection and Receiving Records of
Monitoring
Producer
Feed Lot
QSA Program
Live Animal AGE Records Requirements
Harvest
62
Purchase Procedures to Evaluate and
Ensure Inspection and Receiving Records of
Monitoring
Producer
QSA Program
Feed Lot
Live Animal AGE Records Requirements
63
LIVE ANIMAL AFFIDAVIT
Live Animal AFFIDAVIT

64
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.

65
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

66
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

67
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

68
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

69
Contact Information for QSA or BEV
  • James L Riva (202) 720-1124
  • James.Riva_at_usda.gov
  • Samantha Simon (202) 720-9757 Samantha.Simon_at_usda.
    gov
  • Dana Stahl (202) 720-2624
  • Dana.Stahl_at_usda.gov
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