Livestock

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Livestock Seed Program
PROCESS VERIFIED PROGRAM
http//ProcessVerified.USDA.Gov James Riva,
Chief Audit, Review, and Compliance Branch
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Standards

• ISO 9000 - Quality Management
• ISO Guide 65 - Certification Bodies
• ISO 19011 Auditing Guidelines

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Livestock and Seed Program Standards
Audit, Review, Compliance Branch (ARC)

• ARC Instruction 1000 Quality Systems
  Verification Program, General Policies and
  Procedures
• ARC Instruction 1001 Guidelines for Process
  Verified Programs

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What is a Process?
Activity that transforms input into output
Activity
Input
Output
Resources People Facilities/Equipment Material M
ethods
Results Products Services Performance
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How is a Process Managed?
Monitor Measure the Process make sure the
inputs are right, the transformation activities
consistently work, and the desired results are
achieved, then - improve the process as needed
Activity
Input
Output
Right Resources Qualified People Right
Facilities/Equipment Correct Materials Proven
Methods
Desired Results Quality Products Quality
Services Customer Satisfaction
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How is a Process Measured?
Efficient No Waste
Effective Desired Results Achieved
Activity
Input
Output
Right Resources Qualified People Right
Facilities/Equipment Correct Materials Proven
Methods
Desired Results Quality Products Quality
Services Customer Satisfaction
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What is a Process?
Activity that transforms input into output
Source Verified
Input
Output
Resources People Facilities/Equipment Material M
ethods
Results Accurate Results System
Performance Efficient and Effective
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Factors for Documenting Processes

• Effect on quality
• Risk of customer dissatisfaction
• Statutory and/or regulatory requirements
• Economic risk
• Effectiveness and efficiency
• Competence of personnel
• Complexity of processes

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Methods for Documenting Processes

• Graphical Representations
• Written Instructions
• Checklists
• Flow Charts
• Visual Media
• Electronic methods

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Measuring Continuous Improvement
Internal audit
Management determines effectiveness by analyzing
all available data and information
Customer satisfaction
Management review
Other data
ISO 90012000
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The QMS must be used for continuous improvement
...
Improve Process through PDCA Cycle
Results Baseline Performance
Plan Do Act Check
Measure/Monitor Results Against Objectives -
Improve Process and Change QMS as Needed to
Achieve and Sustain Desired Results
QMS
Improvement Objective
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Plan Do Check Act Establish the objectives and processes necessary to deliver results Implement the processes Monitor and measure processes and product against polices, objectives and requirements Take actions to continually improve process performance
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P-D-C-A Cycle
PLAN
ACT
How to improve next time
What to do How to do it
Do what was planned
Did things happen to plan
DO
CHECK
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Key PVP Elements

• Documented System
• AMS - Approved Standards
• Product Identification and Traceability
• Internal Audits
• Management Review
• Training
• Statistical Process Control

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Key PVP Elements

• Customer Satisfaction
• Contract Review
• Control of Promotional Materials
• Control of Nonconforming Product

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Process Verified Program Claims

• Source Verified
• Special Feeding Process
• Raising Claims
• Genetics
• Special Handling
• Special Fabrication Processes

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Process Verified Program Claims

• Born and Raised in USA
• 50 Angus
• Corn-fed
• Aged 21 days
• Never fed antibiotics
• No added hormones

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Auditor Locations
Sioux Falls
Chicago
Washington
Kansas City
Denver
Los Angeles
Dallas
Auditor Locations
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ARC Branch Audited Program Locations
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PVP Program Requirements

• Two-parts requirements for Process Verified
  Programs.
• System performance defined by program - What
  process is Verified Seed Testing Lab
• Documentation requirements determined by
  analysis of quality system. Quality System
  Documentation

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System Performance

• Individual or lot traceability to U.S. origin.
• Defined by program
• Identifiable at each step. IP
• Segregation from non-program products.

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Traceability

• Ability to determine the source of a product for
  the purpose of determining compliance with a
  contract or specification requirement.
• Create an auditable document trail.
• Affidavits OK if confirmed by onsite records.

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Document Requirements

• Auditable trail of documents
• Control of product throughout the process
• Must show status at each phase
• Sufficient to verify all activities
• Retained for at least one year

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Suggestions...

• Flow charts
• Sale receipts
• Shipping manifests
• Purchase orders
• Maps
• Pictures

• Training records
• Field history records
• Detailed procedures
• Documented Instructions
• Records

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Sample Flowcharts
Cow/Calf
Feeding
Slaughter Fabrication
Wholesale
Retail
Source Verified, Corn Fed, Non-Hormone Treated
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Inspection Test StatusGrow/Finish/Harvest/Reta
il

• Inventory records
• Tattoos, Tags - Identification
• Purchase records
• Transportation records
• Feed records

• Barn records
• Information from previous production phase
• Farm plans
• Maps, pictures

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USDA Monitoring
Begin Marketing
Program Approval
Compliance Audit
Adequacy Audit
Operate Test
Document Program
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Quality Audit

• Review of documentation, quality management
  systems, and products to determine conformance to
  customer or program requirements.
• Quality system audits.

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Auditor

• Person qualified and authorized to conduct an
  audit.
• ARC Branch Audit Staff
• BS Degree or equivalent qualifying experience.
• Extensive training in quality system auditing.
• Minimum 5 years specialized industry experience.
• ISO Lead Auditor Training.
• ISO 190112002 auditing experience.
• Food Security Training
• ISO 14000 Environmental Management Systems

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Objective evidence

• Documents, records, or observations which support
  a finding.
• Information gathered during interviews with
  program employees

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Nonconformance

• Deviation from a standard, requirement, or
  procedure.
• Major HOLD POINT compromises the integrity of
  the product or program.
• Minor CIP isolated incidence of nonconformance
  not affecting product or program integrity.

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Corrective/Preventive Action

• Corrective action
• Immediate response to resolve nonconformance.
• Involves disposition of product.
• Preventive action
• Long term actions to prevent reoccurrence.
• Involves system change.

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Auditing Philosophy...

• If its not in writing or the auditor didnt see
  it, it didnt happen.
• Review of OBJECTIVE EVIDENCE.

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Approval

• Written authorization from USDA for the Process
  Verified Program to market with references to the
  USDA and their marketing program.
• Issued by LS Program.

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COST OF THE SERVICE

• Cost Recovery Basis
• Hourly Rate of 94.00 per hour
• Initial Program Document Review
• Travel Time to locations
• Onsite Audits
• Report Preparation Time
• Travel Expenses, Per Diem

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REQUEST SERVICE

• For information on ARC Branch auditing services
• Contact James Riva - Washington ARC Office
• [phone] James.Riva_at_usda.gov
• Samantha Simon Quality Manager
• [phone] Samanta.Simon_at_usda.gov