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Analysis. Answers. Action. www.aphl.org
Tools in the Toolbox
Resources to Strengthen Data
Robyn Randolph
Sr. Specialist, Food Laboratory Accreditation
Association of Public Health Laboratories (APHL)
5th Annual Human & Animal Food Laboratory
Accreditation Meeting – Houston, TX
Tool #1:
Best Practices For Submission of
Actionable Human and Animal Food
Testing Data Generated in State and
Local Laboratories
Analysis. Answers. Action. www.aphl.org
Analysis. Answers. Action. www.aphl.org
What is the DA White
Paper?
• A set of best practices that
addresses the minimum
elements of an overall quality
management system.
• Identifies key laboratory
policies and records
• Helps laboratories generate
accurate and defensible data
Analysis. Answers. Action. www.aphl.org
Quality Management System
Activities
Pre-analytical
AnalyticalPost-
Analytical
Analysis. Answers. Action. www.aphl.org
Pre-Analytical Phase
Primary Sample
Required precision
Question to be
answered
Decision unit
Evidentiary Integrity
Representative
Sampling
Defensible data may not be
generated from an
incorrectly collected
primary sample.
Analysis. Answers. Action. www.aphl.org
Analytical Phase
Staff Training and Demonstration of
Capability & Competency
Quality Assurance Plan
Analytical Method(s),
Validation and Verification
Proficiency Testing/
Proficiency Evaluation
Quality ControlAnalytical
Worksheets
Raw Data
Analysis. Answers. Action. www.aphl.org
Post-Analytical Phase
Reports
Data Packages
Record Creation
& Retention
Analysis. Answers. Action. www.aphl.org
Communication is Key!
Program-Specific
Requirements
Identify Customer
Needs
Evaluation of Lab Data
Analysis. Answers. Action. www.aphl.org
Checklist
Review a
laboratory QMS
against key
recommended
elements
Tool #2:
Human & Animal Food Testing
Laboratories Best Practices Manual
Analysis. Answers. Action. www.aphl.org
Analysis. Answers. Action. www.aphl.org
Which to use?
OR
Analysis. Answers. Action. www.aphl.org
By the Chapter
Chapter 1: Pathway to Laboratory Accreditation
Chapter 2: Beyond the ISO/IEC 17025 Standard for Regulatory Testing Laboratories
Chapter 3: Proficiency Testing
Chapter 4: Sampling
Chapter 5: Methods
Chapter 6: Analytical Worksheet Packages
Chapter 7: Reporting
Analysis. Answers. Action. www.aphl.org
Chapter 1: Pathway to Laboratory
Accreditation
• Steps to achieving ISO/IEC 17025
accreditation
• Applicable Quality Standards
• Estimated Costs of Accreditation
Analysis. Answers. Action. www.aphl.org
Chapter 2: Beyond the ISO/IEC 17025
Standard for Regulatory Testing Laboratories
• Additional regulatory elements & practices
• Broken down by major ISO/IEC 17025
headings (e.g. Personnel, Technical
Records, Control of Records).
• APHL Data Acceptance White Paper
Analysis. Answers. Action. www.aphl.org
Chapter 3: Proficiency Testing
• Proficiency Testing Best Practices
• ILAC requirements for Proficiency Testing
• Specific Accreditation Standards
Analysis. Answers. Action. www.aphl.org
Chapter 4: SamplingCritical Elements:
– Intra-agency Communication and
Planning
– Sampling Training
– Establishing Sample Quality
Criteria
– Designing a Protocol for
Representative Sampling
– Evidentiary Integrity
– Laboratory Sampling and Quality
Control
– Determine Global Estimation Error
– Data Quality Assessment Sourced from GOODSamples
Analysis. Answers. Action. www.aphl.org
Chapter 5: Methods
Best Practices for Method Selection
• Is it fit for purpose?
• Is the validation level sufficient?
• Is the method available?
Analysis. Answers. Action. www.aphl.org
Chapter 6: Analytical Worksheet
Packages
• List of elements to include in raw data
worksheets
• Standardized worksheets/data elements
• Will be posted on PFP website
– www.pfp-ifss.org
Analysis. Answers. Action. www.aphl.org
Chapter 7: Reporting
Items to include:• Title
• Laboratory name and address
• Location where laboratory activities were performed
• Unique test report identification
• Customer name and contact information
• Receipt data
• Test item description, condition and identification
• Test date(s)
• Test results and units of measurement
• Identification of the method used
• Additions, deviations or exclusions from the method
• Report date
• Sampling plan or procedure reference, if relvant
• Primary sample collection date, location and condition
• Identification of person(s) completing and authorizing the test report
Talk to your
customer!
Tool #3:
PFP Compliance Checklist
Analysis. Answers. Action. www.aphl.org
PFP Compliance Checklist
• Lessons learned from first labs transitioning to 2017 version• Assist in data
package
preparation
• Aid compliance
review of data
packages
Analysis. Answers. Action. www.aphl.org
Resources
• APHL Accreditation Resources
• List of Proficiency Testing Providers
• Data Acceptance White Paper (January 2019)
• APHL Quality Management Training Series
• APHL Accreditation Resource Repository (restricted
access)
• GOODSamples
• GOOD Test Portions
