Transcript Barry L. Carpenter - European Food Safety

Livestock & Seed Program
Beef Export Verification Program
Educational and Informational
Meeting
August 11, 2003
Marketing & Regulatory Programs
1
AMS LS Program
Verification Programs
• Review AMS Verification Programs
• Review requirements of USDA Eligible
Supplier Program
• Review requirements of the USDA Beef
Export Verification Program
August 11, 2003
Marketing & Regulatory Programs
2
Livestock & Seed Program
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Process Verified Program
USDA Supplier Eligibility Program
EU verification programs
National Organic Program
USDA Beef Export Verification Program
August 11, 2003
Marketing & Regulatory Programs
3
Livestock & Seed Program
Audit, Review, and Compliance Branch
USDA Supplier Eligibility
Program
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• The Audit, Review, and Compliance Branch
has been assigned responsibility for
reviewing and approving companies as
eligible suppliers of meat and meat products
for use in USDA, LS Commodity purchase
programs.
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• ARC Branch personnel conduct regular
audits of participating suppliers according
to ARC 1010 Procedure, USDA Supplier
Eligibility Program.
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• Companies who wish to supply products to
USDA LS Commodity purchase programs
must request eligibility under an approved
segregation plan and must ensure all
products intended for use in such programs
meet the material requirements outlined in
the applicable contractual documents.
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• Eligible suppliers are included in the
weekly Internet publication, Official Listing
of Eligible Suppliers for USDA Purchase
Programs, and are listed according to the
specific program that they are eligible to
supply.
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• All meat and meat products destined for use
in USDA, LS Commodity purchase
programs must meet all of the material
requirements, which are outlined in the
applicable contractual documents.
• Only meat and meat products that meet all
of the material requirements may be labeled
as “DOMESTIC ONLY PRODUCT”.
August 11, 2003
Marketing & Regulatory Programs
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USDA Supplier Eligibility
• Companies requesting service will be
audited three times per year upon approval
of submitted documentation
August 11, 2003
Marketing & Regulatory Programs
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Livestock & Seed Program
Audit, Review, and Compliance Branch
Beef Export Verification
Program
August 11, 2003
Marketing & Regulatory Programs
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AMS - Voluntary
Grading
Certification
Process Verification
Combination
Certified Label Claims
Export Certification
FSIS - Regulatory
August 11, 2003
Meat Inspection
Labeling Requirements
Marketing & Regulatory Programs
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AMS - Voluntary
Grading
Certification
Process Verification
Combination
Certified Label Claims
Export Certification
FSIS - Regulatory
August 11, 2003
Meat Inspection
Labeling Requirements
Marketing & Regulatory Programs
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ARC Procedures
• ARC 1000 – QSVP Polices and Procedures
• Cost, frequency, applications, operating
procedures
• ARC 1030 – Beef Export Verification
Program
• Specific requirements of the BEV program
August 11, 2003
Marketing & Regulatory Programs
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Eligible Supplier
• Slaughter or processing facility which
manufactures beef and/or beef products
• Approved Eligible Supplier
• Implementation of a BEV Program
• Quality Documents
• Successful audit
August 11, 2003
Marketing & Regulatory Programs
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Conforming Product
•
Only beef and beef products produced by
eligible suppliers and identified as
meeting the requirements of the BEV
Program may have the FSIS Export
certificate amended to read,
“The shipment contains only meat and
meat products that were derived from
cattle slaughtered in the U.S.”
August 11, 2003
Marketing & Regulatory Programs
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Conforming Product
• Any product (beef, or beef products) that
meets, and can be verified as meeting, the
requirements of the BEV Program
• Such product may be labeled as meeting
requirements of the BEV Program
August 11, 2003
Marketing & Regulatory Programs
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Processed Products
• Processed Beef Products will have a 60-day
transitional period following
implementation of the BEV Program on
September 1, 2003
• For suppliers to finish products that require
extended manufacturing times, to source
BEV compliant product and to clear stocks
August 11, 2003
Marketing & Regulatory Programs
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Processed Products
Transition for Beef Processing plants
November 1, 2003
• Processor not yet included in the BEV
program must ensure to AMS that during
the transition period only beef ingredients
procured prior to September 1 will be used
in products export to Japan
August 11, 2003
Marketing & Regulatory Programs
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Processed Products
• FSIS will certify the following statement for
these types of products
“This is a ready-to-eat beef product that
contains at least 2% cooked meat and has
been subjected to heat or drying and does
not contain products of edible rendering.”
August 11, 2003
Marketing & Regulatory Programs
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Processed Products
• AMS will verify the Processor during the
transition period
• Must meet BEV requirements by November
1, 2003
August 11, 2003
Marketing & Regulatory Programs
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Non-conforming Product
• Product not from cattle slaughtered in the
U.S.
• Product that can not be verified as
• Originating from an Eligible Supplier
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Documentation
• Documents and records prepared and
maintained current that describe and record
the company’s procedures for ensuring
products received, processed, and identified
conform to the BEV Program requirements
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Documentation
• Well defined Quality Manual
• An accumulation of program documents
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HACCP Plans
Labeling Procedures
Segregation Plan
Employee Training Program
Defined Responsibilities
August 11, 2003
Marketing & Regulatory Programs
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Segregation Plan
• Description of the facility’s procedures for
ensuring comformance to the requirements
of the BEV Program
• How is it Identified and Labeled
• Handling of product through system
• Identification of non-conforming product
August 11, 2003
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AMS Surveillance Audit
• Review of eligible supplier’s facilities,
procedures and records
• To determine conformance with the
approved program documentation
• To verify ability to meet all of the
requirements of the BEV Program
• Conducted by USDA, AMS, LSP, ARC
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Requirements
• All beef and beef products identified as
meeting the requirements of the BEV
program must be derived from cattle
slaughtered in the U.S.
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Requirements
• Only eligible suppliers may produce beef
and beef products for the BEV Program
• Eligible suppliers must be listed on the
Official Listing of Eligible Suppliers for the
Beef Export Verification Program
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Requirements
• Only beef and beef products that meet the
requirements of the BEV program may be
identified and labeled as such
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Requirements
• Documentation for finished product must
identify each lot of conforming product by
including the lot number, production date,
production code, number of boxes,
manufacturer, and the statement:
“ Product Meets BEV Program
Requirements”
August 11, 2003
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BEV Program Documentation
Requirements
• Only beef and beef products produced by
eligible suppliers and identified as meeting
the requirements of the BEV Program may
have the FSIS Export certificate amended to
read, “The shipment contains only meat and
meat products that were derived from cattle
slaughtered in the U.S.”
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Documentation
Requirements
• Names and positions of persons with
managerial responsibilities for operation of
the BEV Program
• Written procedures that describe the
company’s procedures for ensuring product
received, processed, and identified conform
with BEV Program requirements
August 11, 2003
Marketing & Regulatory Programs
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BEV Program Documentation
Requirements
• Written segregation plan that describes the
identification, segregation, and labeling of
product
• Complete examples of all forms, tags,
labels, etc. used to track or demonstrate
program conformance
• Issue date or other method identifying the
most current version of all program docs
August 11, 2003
Marketing & Regulatory Programs
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Supplier’s Responsibilities
• Request initial assessment and submit the
following:
• Completed LS Form 313 if necessary
• Cover letter requesting BEV audit
• Program documentation used to ensure
conformance to the BEV program, including a
copy of all written segregation plans.
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Marketing & Regulatory Programs
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Supplier’s Responsibilities
• Ensure that beef and beef products conform
• Properly identify all conforming and
nonconforming product in a manner to
ensure traceability
• Maintain segregation of conforming and
nonconforming product
August 11, 2003
Marketing & Regulatory Programs
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Supplier’s Responsibilities
• Provide and maintain documentation for
finished product
• Ensure employees have been properly
trained and have a complete understanding
of all BEV Program requirements relative to
their area of responsibility
• Monitor information relating to customer
satisfaction
August 11, 2003
Marketing & Regulatory Programs
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Supplier’s Responsibilities
• Address all non-conformances within the
timeframe outlined in the audit report
• Comply with all provisions of this
Procedure, and applicable Rules and
Regulations
• Maintain complete records for verification
BEV program conformance
August 11, 2003
Marketing & Regulatory Programs
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Supplier’s Responsibilities
• Provide access to all areas of an
establishment or facility that is requesting
an eligibility status
• Notify the ARC Branch Washington, DC to
cancel service prior to the next surveillance
audit
August 11, 2003
Marketing & Regulatory Programs
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AMS’ Responsibilities
• Review submitted LS 313, program
documentation, and segregation plans
• Assign a qualified USDA ARC Branch
Auditor upon approval of submitted
documentation
• Conduct audits according to ARC 1000
August 11, 2003
Marketing & Regulatory Programs
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AMS’ Responsibilities
• Prepare a detailed audit report
• Forward the audit report and final decision
to the supplier
• Ensure surveillance audits are performed as
required
• Maintain and publish the Official Listing of
Eligible Suppliers
August 11, 2003
Marketing & Regulatory Programs
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AMS’ Responsibilities
• Conducted according to ARC 1000 and this
Procedure
• All eligible suppliers will be audited three
(3) times per year.
• All eligible suppliers are subject to
unannounced audits.
August 11, 2003
Marketing & Regulatory Programs
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BEV Approval Procedures
• According to ARC 1000
• Approval – Once eligible the supplier will
be posted on the Website
• Company name and Est. Number
• Remain on the Official Listing until a
request is made to be removed or found to
be noncompliant
August 11, 2003
Marketing & Regulatory Programs
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BEV Denying Approval
• Failure to adequately address any
requirement
• Failure to demonstrate capability to meet
any requirement
• Finding of a hold point to stated procedures
• Denying access to facilities, documentation,
or records
• Presenting false or misleading information
August 11, 2003
Marketing & Regulatory Programs
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BEV Suspending Approval
• Failure to follow requirements, or approved
program documentation
• Implementing significant changes with out
written notification to the ARC Branch
• Deliberate misrepresentation of the
eligibility of beef or beef products
• Presenting false or misleading information
to USDA Personnel
August 11, 2003
Marketing & Regulatory Programs
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BEV Suspending Approval
• Confirmed finding of non-conforming beef
or beef products that were utilized in the
BEV program
• Denying access to USDA during any audit
• Failure to respond to non-conformances in
the timeframe provided.
August 11, 2003
Marketing & Regulatory Programs
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Cancellation of Service
• Eligible suppliers may cancel service at any
time.
• Notification in writing
• Removed from Website
• Suppliers who cancel service must reapply
and be reassessed through an onsite audit
prior to returning to the Official Listing
August 11, 2003
Marketing & Regulatory Programs
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AMS Program Verification
Audits conducted according to ISO
19011:2002
August 11, 2003
Marketing & Regulatory Programs
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ISO 19011:2002
• Guidelines for Quality and/or
Environmental Management Systems
Auditing
August 11, 2003
Marketing & Regulatory Programs
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ISO 19011:2002
• Audit criteria 3.2 – set of policies,
procedures or requirements
• Audit evidence 3.3 – records, statements of
fact or other information, which are relevant
to the audit criteria and verifiable. Audit
evidence may be in many different forms
August 11, 2003
Marketing & Regulatory Programs
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ISO 19011:2002
• Audit findings 3.4 – results of the
evaluation of the collected audit evidence
against audit criteria
• Audit conclusion 3.5 – outcome of an
audit, provided by the audit team after
consideration of the audit objectives and all
audit findings.
August 11, 2003
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ISO 19011:2002
• Competence 3.14 – demonstrated personal
attributes and demonstrated ability to apply
knowledge and skills
August 11, 2003
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ISO 19011:2002
• Ethical conduct: the foundation of
professionalism
• Fair presentation: the obligation to report
truthfully and accurately
• Due professional care: the application of
diligence and judgment in auditing
August 11, 2003
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ISO 19011:2002
• Evidence: Based Approach: the rational
method for reaching reliable and
reproducible audit conclusions in a systemic
audit process
August 11, 2003
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Verification
Three Parts
• Physical Review of Locations
• Interviews of Employees and Managers
• Detailed Audit of All Pertinent
Documentation
August 11, 2003
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Reviewing Pertinent Documentation
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Sales Receipts
Shipping Records
Plant ID System
Product Inventory
UPC Codes
Labeling
QC Records
August 11, 2003
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Audit Results
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Audit conclusion 3.5 - Audit findings
Audit findings 3.4 – Audit evidence
Audit evidence 3.3 – records, statements of fact
August 11, 2003
Marketing & Regulatory Programs
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ARC Branch Personnel
• 26 Branch Employees
• 24 ISO Trained Auditors
• Includes DC Staff
• 20 Auditors – Des Moines, IA; St Joe, MO; and
Auditor’s Residences
• Utilize all Branch employees to perform audits
August 11, 2003
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Auditor Locations
Sioux Falls
Chicago
Denver
Washington
Kansas
City
Los Angeles
Dallas
Auditor Locations
August 11, 2003
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ARC Branch
Audited Program Locations
August 11, 2003
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ARC Branch Charges
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Hourly Fee $64.00 per hour
Travel Time
Document Review and Onsite Audit Hours
Travel Cost and Per Diem
Average for USDA Supplier Eligibility $800
August 11, 2003
Marketing & Regulatory Programs
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Scheduling ARC Audits
• Currently auditing 50 Beef and 40 Pork Plants
for School Lunch across the US
• Efficient and Effective
• Schedule lowest cost auditor
• Combine audits and plants
• Prorate travel cost between multiple locations
August 11, 2003
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USDA BEEF EXPORT
VERIFICATION (BEV)PROGRAM
Key Points of AMS Audit Based Programs
ISO 9001:2000
August 11, 2003
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ISO 9001:2000
Key Points
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4 Quality Management System
5 Management Responsibility
6 Resource Management
7 Product Realization
8 Measurements, Analysis, and
Improvement
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BEV Key Points
• Customer Requirements
• Continual Improvement of Quality
Management System
• Process Approach
• Customer Satisfaction
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BEV Key Points – Customer
Requirements
• Beef and Beef Products produced by
suppliers approved under this Program are
derived from cattle slaughtered in the
United States (U.S.).
• Product must be from Eligible Suppliers on
the Official Listing
• Product must be properly identified
August 11, 2003
Marketing & Regulatory Programs
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BEV Key Points – Continual
Improvement of the QMS
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Management Responsibility
•
August 11, 2003
Must identify the names and positions of
management employees responsible for
implementation of the BEV program
Marketing & Regulatory Programs
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BEV Key Points – Continual
Improvement of the QMS
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Resource Management
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August 11, 2003
Properly trained employees
Tags, labels, tracking system
Facilities capable of processing controlled
product
Marketing & Regulatory Programs
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BEV Key Points – Continual
Improvement of the QMS
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Product Realization – Process Control
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August 11, 2003
Quality Manual – Program Documentation
Document Control
Segregation Plans
Labeling of Conforming and Non
Conforming Product
Identification and Traceability
Retention of records
Product Control
Marketing & Regulatory Programs
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BEV Key Points – Continual
Improvement of the QMS
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Measurements, Analysis, & Improvements
– Corrective Action
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August 11, 2003
Plant QC reviews and Checks
USDA Audits conducted according to ARC
1030 and ISO 19011:2002
Programs must address all non-conformances
Initiate Corrective and Preventive Action
Marketing & Regulatory Programs
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BEV Key Points – Customer
Satisfaction
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Input from customers is used to improve
the process
Official Listing for the BEV Program is
accessible to all customers
USDA will supply detailed audit report
which can be shared with customer
Must monitor customer satisfaction as it
pertains to the BEV Program
August 11, 2003
Marketing & Regulatory Programs
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USDA BEEF EXPORT
VERIFICATION PROGRAM
Quality Manual and Program
Documentation Requirements
August 11, 2003
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BEV – Plan-DO-Check-Act
ACT
CHECK
August 11, 2003
PLAN
DO
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BEV – Plan-DO-Check-Act
How to
improve
next time
ACT
CHECK
Did things
happen to
plan
August 11, 2003
What to do
How to do it
PLAN
Do what
was
planned
DO
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General Information
• Plan and Do – A description of the planning
and production steps taken to meet each
requirement.
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General Information
• Check – A description of all quality assurance
methods that will be used to verify
conformances to each requirement. This
includes the monitoring and measuring taken
during the processes. (All results shall be
recorded and made available to the ARC
Branch for review.)
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General Information
• Act – A description of all corrective actions to
be taken if deviations from contractual and
specification requirements occur during
production and all preventative actions taken
to preclude reoccurrences.
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Written Segregation Plans
• Include a detailed description identifying the
segregation of conforming and non-conforming
product throughout the production process.
• Include a detailed description identifying the
labeling of conforming and non-conforming
product throughout the production process.
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Written Segregation Plans
• Include a detailed description identifying the
handling of the conforming and non-conforming
product throughout the production process.
• Include a detailed description of the process
used to initiate the segregation plan if it is not in
effect on a continuous basis.
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Existing Documented Procedures
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Plant HACCP Plans
SOP’s
Plant Production Procedures
Product Specifications, Logs, Yields
Control Procedures
Employee Training Documents
Forms and Records
Quality Control Procedures and Records
August 11, 2003
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Acceptable Formats
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Written Procedures
Flow charts
Tables
Pictures
Drawings
Easy to understand and verify
Dated or Revision number
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Beef Export Verification Program
• Based on ISO Quality Standards and
Guidelines
• Voluntary Programs
• Designed as a Marketing Tool
• User Fee – Cost recovery
August 11, 2003
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Livestock and Seed Program
Audit, Review and Compliance Branch
• Samantha Simon, Manager, Quality System
Verification Programs 202-720-9759
[email protected]
• Dana Stahl, Agricultural Marketing
Specialist 202-720-2625
[email protected]
August 11, 2003
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Livestock and Seed Program
Audit, Review and Compliance Branch
• James Riva, Chief 202-720-1123
• ARC Branch Fax 202-690-3248
• http://www.ams.usda.gov/lsg/arc/audit.htm
• http://ProcessVerified.USDA.gov
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