Embed Size (px)
Citation preview
Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed
APHL, AAFCO, AFDO Five-Year Cooperative Agreement
The AAFCO PerspectiveNancy Thiex, AAFCO Lead Investigator and AAFCO Cooperative
Agreement Administrator
Overview
Cooperative Agreement (CoAg) Objectives
Specific Aims & Specific Aims
AAFCO Led Activities
Progress to Date
Upcoming Work
The Volunteers
Questions
Cooperative Agreement Objectives
Laboratory accreditation
Developing laboratory training programs around accreditation topics.
National consensus on the sharing of analytical data
Improving communication among federal, state and local testing laboratories and their associated regulatory and public health programs
Expanding a proficiency testing program for feed laboratories
Strengthening partnerships with clinical laboratories
Cooperative Agreement Specific Aims
CoAg has 9 Specific Aims – General areas of work to accomplish broad objectives
Each Specific Aim has associated Activities designed to accomplish the objective of the Aim. Generally, there are several Activities for each Aim.
CoAg utilizes the committee structure of APHL, AAFCO, AFDO to carry out the Activities.
Each Activity has one of the three associations leading the effort. Volunteers may come from any/all.
Specific Aim 8 -AAFCO Lead
Specific Aim #8: Use association infrastructure to develop an integrated approach to assist food and animal feed testing laboratories to achieve, maintain, and enhance the scope of laboratory accreditation and achieve conformance with applicable program standards as establish by the Secretary.
AAFCO Collaborative Check Sample Program (CCSP) Committee and Advisors
AAFCO Laboratory Methods and Services Committee (LMSC) and Advisors
AAFCO Led Activities– Aim 8
Accreditation of the Collaborative Check Sample Program to ISO/IEC 17043. Workgroup Chair: Dr. Victoria Siegel (IN)
Expansion of the Scope of the Collaborative Check Sample Program. Workgroup Chair: Dr. Victoria Siegel (IN)
Revision of the AAFCO Quality Assurance/Quality Control Guidelines for State Feed Laboratories. Workgroup Chairs: Brenda Snodgrass (OK) and
Louise Ogden (MN)
Specific Aim 2 -AAFCO Lead
Specific Aim #2: Identify, pilot test, and implement nationally the policies and procedures necessary to establish equivalency between federal, state and local food and feed testing laboratories.
Sampling and Sample Handling Working Group administered as a Working Group of: AAFCO Inspection and Sampling Committee AAFCO Laboratory Methods and Services
Committee and Advisors.
AAFCO Led Activities – Aim 2
Convene a Sample Handling Working Group to establish policies and procedures for sample collection, shipment, analysis, storage and retention. Members will be drawn from AAFCO, AFDO, APHL and FDA, as appropriate, and be representative of laboratory and inspection staff. Workgroup Chair: Nancy Thiex
Progress to Date
Accreditation of the AAFCO CCSP to ISO/IEC 17043
The Committee is the Working Group.
Consultant contracts in place.
Face-to-face meetings Jan 22 in Albuquerque, NM
Data Reporting Website was moved to a new host server at FASS to facilitate necessary website improvement.
Contract in place with FASS to translate the website to code compatible with their site.
Accreditation of the AAFCO CCSP to ISO/IEC 17043
QuoData Workshop on Proficiency Testing Data Analysis was attended by Vicki Siegel.
The Check Sample Program Quality Systems Manual first draft is complete and is being converted to a format consistent with the G13 Checklist.
The Quality Oversight Team is established.
A Web Forum for the Quality Oversight Team has been established.
Expansion of the Scope of the AAFCO CCSP PT
Pet Food Add-On complete (quarterly program). Opened for enrollment on Oct. 26, 2012.
The first sample, a poultry meal sample, shipped to 45 labs on February 28, with results due April 10th 2013. Data has been analyzed and reported back to participants. Sixty-one participants reported data for 63 analytes using 156 methods.
The second quarter sample is flaked soy flour and in preparation.
Expansion of the Scope of the AAFCO CCSP PT
Residue Detection Program. Method codes for “heavy” metals and
mycotoxins have been added to the program. Participants are reporting data. Crawford is using the data to develop
approaches to the statistical analysis of residue data.
Drug and Antibiotics Expansion.
Revision of the “QA/QC Guidelines for State Feed
Laboratories” Working Group populated.
Foodshield WorkGroup developed to house documents and facilitate conference call meetings.
Monthly conference calls held for the working group with weekly calls between the Working Group chairs.
Face-to-face meetings Jan 24 in Albuquerque, NM and February 28 in Oklahoma City, OK.
Training Event February 25-29 in Oklahoma City, OK - ISO/IEC Lead Assessor/Auditor Training Course.
Revision of the “QA/QC Guidelines for State Feed
Laboratories” Consensus on format of deliverable & will
include a copy of the ISO/IEC 17025:2005.
Work on writing underway.
Sample & Sample Handling Working
Group Working Group populated.
Consultant contract in place.
Biweekly conference calls held
Foodshield WorkGroup developed to house documents and facilitate conference call meetings.
Face-to-face meeting Jan 25 in Albuquerque, NM
Training Event April 2-5, Dallas, TX “Sampling for Defensible Decisions: Food and Feed” on the basics of the Theory of Sampling
Sample & Sample Handling Working
Group Consensus on deliverable / document(s). Guidelines
for developing a sampling protocol.
Established a listing of state contacts for Sampling Food/Feed
Conducted a survey related to Sampling needs, issues, concerns, resources
Section Headers for main document identified
Definitions have been drafted.
Working on consensus for the content of each Section in the document.
What’s Next –
Getting our ducks in a row!!
Accreditation of the AAFCO CCSP to ISO/IEC 17043
Complete the Quality ManualReview of the Quality Manual by the QOT.Complete audits of the Subcontractors by the
Manager: Sample Preparation Facility and Programmer.
Audits of Manager by the QOT.Preparation and submission of the application
to Accreditation BodyAssessment by the Accreditation Body
Expansion of the Scope of the AAFCO CCSP PT
Residue Detection Program.Develop the residue statistical approachComplete the necessary programming and
website modificationsDevelop the reportPurchase spiked feed materials for the program
Drug and Antibiotics Expansion. Develop the method codesAll of the above
Revision of the “QA/QC Guidelines for State Feed
Laboratories” Complete the writing of the document
Present the finished work to the AAFCO Laboratory Methods and Services Committee.
Deal with any needed revisions.
Market the completed work.
Sample & Sample Handling Working
GroupDeveloping sampling design for food/feed.
Writing guidance document!
Designing training.
Pilot testing.
Review and modify.
Document mechanisms for improving communications between inspection and laboratory staff.
The Volunteers
AAFCO Volunteers to APHL Led Activities – Aim
1 Specific Aim #1: APHL Lead. Design, develop,
document, deliver, manage and implement support programs for ISO/IEC 17025:2005 accreditation of food and animal feed regulatory laboratories. Accreditation Work Group: Food and Feed Testing Subcommittee, AAFCO Representatives are:
Josh Arbough, WV Dept. of Ag Sarah DeDonder, KS Dept. of Ag Heidi Hickes, MT State U, MT Dept. of Ag Kristina McCallum, CO Dept. of Ag Tom Phillips, MD Dept. of Ag Sarah Snodgrass, WV Dept. of Ag
AAFCO Volunteers to APHL Led Activities – Aim
6 Specific Aim #6: APHL Lead. Provide educational
opportunities, resources, tools, and mentoring for laboratories seeking to achieve, maintain, and enhancing the scope of their ISO/IEC 17025:2005 accreditation. Working in concert with IFPTI, expertise will be applied to assess laboratory needs, develop course content, and conduct laboratory training using a multitude of in-person and distance learning. AAFCO representatives to Accreditation Training Steering Committee are:
Brenda Snodgrass, OK Dept. of Ag Louise Ogden, MN Dept. of Ag Aaron Price, Canadian Food Inspection Agency Gale Hagood, MSCL, MSU
Volunteers – Aim 2
Don Burr, FDA CFSAN, FDA Oversight LiaisonJo Marie Cook, FL Dept. of Ag & Consumer ServicesDan Danielson, TN Dept. of AgQian Graves, FDA CFSANGreg Hoffman, PfizerGary Krinke, WI State Lab of HygieneChad Linton, WV Dept. of AgKenneth McManus, MD Dept. of AgEdette Newby, FDA CFSAN
Lawrence Novotny, SDSU retiredChuck Ramsey , EnviroStatBarb Schroder, MN Dept. of AgThomas Scott, FDA WEACYuelian Shen, FDA ORA/OGROPRichard Stephens , FL Dept. of Ag & Consumer ServicesNancy Thiex, Thiex Lab. SolutionsLynn West, WI State Lab of HygieneRon Willett, NC Dept. of Ag
Sampling and Sample Handling Working Group
AAFCO Collaborative Check Sample Program –
Aim 8AAFCO Collaborative Check Sample Program Committee and Advisors
Victoria Siegel, Office of the IN State Chemist, Chair
Andy Crawford, Crawford Science Aaron Price, Canadian Food
Inspection Agency Teresa Grant, NC Dept. of Ag Mary Koestner, MO Dept. of Ag Karen Stephani, NY Dept. of Ag and
Markets Mark LeBlanc, LA Dept. of Ag &
Forestry Nancy Thiex, Thiex Lab. Solutions Dennis McCurdy, FDA CVM Lars Reimann, Eurofins
Gail DeGreeff, Prince Agri-Products Christine Atkinson, AOCS Ken Riter, Nestle Purina Randall Gordon, NGFA Jimmie Ward, Proctor & Gamble Arlene Fox, AOAC Ravinder Reddy, FDA Oversight
Liaison Don Burr, FDA CFSAN, FDA Oversight
Liaison
PT Quality Oversight Team – Aim 8
AAFCO Collaborative Check Sample Program Quality Oversight Team
Victoria Siegel, Office of the IN State Chemist, Chair Andy Crawford, Crawford Science Aaron Price, Canadian Food Inspection Agency Brenda Jackson, NC Dept. of Ag Sharon Webb, UKY, Div. of Regulatory Services Jimmie Ward, Proctor & Gamble Tom McKamey, Silliker Melissa Miller, Covance Erich Jacobsen, Prince Agri-Products Gina Clapper, AOCS Ravinder Reddy, FDA CFSAN, FDA Oversight Liaison Don Burr, FDA CFSAN, FDA Oversight Liaison
Quality GuidelinesVolunteers – Aim 8
Quality Assurance Working Group Brenda Snodgrass, OK Dept. of Ag, Chair Louise Ogden, MN Dept. of Ag, Chair Gale Hagood, MSCL, MSU Aaron Price, Canadian Food Inspection Agency Brenda Jackson and Teresa Grant, NC Dept. of Ag Dennis Givens, Cargill Nancy Thiex, Thiex Laboratory Solutions Hitelia Castellanos, FDA ORA OGROP, FDA Oversight
Liaison Ruiqing Pamboukian, FDA ORA OGROP, FDA Oversight
Liaison
Volunteers Home Bases
Summary
Cooperative Agreement (CoAg) Objectives
Specific Aims & Specific Aims
AAFCO Led Activities
Progress to Date
Upcoming Work
The Volunteers
Questions?
Thank you!!
