tools in the toolbox - 2018 albuquerque€¦ · tools in the toolbox resources to strengthen data...
TRANSCRIPT
![Page 1: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/1.jpg)
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
![Page 2: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/2.jpg)
Tool #1:
Best Practices For Submission of
Actionable Human and Animal Food
Testing Data Generated in State and
Local Laboratories
![Page 3: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/3.jpg)
Analysis. Answers. Action. www.aphl.org
![Page 4: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/4.jpg)
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
![Page 5: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/5.jpg)
Analysis. Answers. Action. www.aphl.org
Quality Management System
Activities
Pre-analytical
AnalyticalPost-
Analytical
![Page 6: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/6.jpg)
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.
![Page 7: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/7.jpg)
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
![Page 8: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/8.jpg)
Analysis. Answers. Action. www.aphl.org
Post-Analytical Phase
Reports
Data Packages
Record Creation
& Retention
![Page 9: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/9.jpg)
Analysis. Answers. Action. www.aphl.org
Communication is Key!
Program-Specific
Requirements
Identify Customer
Needs
Evaluation of Lab Data
![Page 10: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/10.jpg)
Analysis. Answers. Action. www.aphl.org
Checklist
Review a
laboratory QMS
against key
recommended
elements
![Page 11: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/11.jpg)
Tool #2:
Human & Animal Food Testing
Laboratories Best Practices Manual
![Page 12: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/12.jpg)
Analysis. Answers. Action. www.aphl.org
![Page 13: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/13.jpg)
Analysis. Answers. Action. www.aphl.org
Which to use?
OR
![Page 14: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/14.jpg)
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
![Page 15: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/15.jpg)
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
![Page 16: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/16.jpg)
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
![Page 17: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/17.jpg)
Analysis. Answers. Action. www.aphl.org
Chapter 3: Proficiency Testing
• Proficiency Testing Best Practices
• ILAC requirements for Proficiency Testing
• Specific Accreditation Standards
![Page 18: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/18.jpg)
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
![Page 19: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/19.jpg)
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?
![Page 20: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/20.jpg)
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
![Page 21: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/21.jpg)
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!
![Page 22: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/22.jpg)
Tool #3:
PFP Compliance Checklist
![Page 23: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/23.jpg)
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
![Page 24: Tools in the Toolbox - 2018 Albuquerque€¦ · Tools in the Toolbox Resources to Strengthen Data Robyn Randolph Sr. Specialist, Food Laboratory Accreditation Association of Public](https://reader036.vdocuments.net/reader036/viewer/2022062604/5fb67c2b7a3dec107b2bb0e1/html5/thumbnails/24.jpg)
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