AOAC Laboratory Accreditation Guidelines: An Educational Series Developed for CANNRA

Virtual Educational Training (16 hours)

CANNRA Member Price: $1,490 (includes online access to the ALAG document and training course certificate); any additional participants from the same organization will receive 50% discount ($745). Please register attendees below and AOAC will remit an invoice for payment.

Course Description:

The new AOAC Laboratory Accreditation Guidelines (ALAG) document (https://www.aoac.org/aoac-accreditation-guidelines-for-laboratories-alacc/) developed by the Analytical Laboratory Accreditation Criteria Committee (ALACC)  includes testing of cannabis for the first time in its scope.  This educational/training series has been developed for CANNRA to help its members understand various parts of the ALAG and related requirements in eight 2-hour sessions to be presented remotely (virtually). The participants will be able to ask questions during each session.  The last session will have an extended Q&A part with all instructors.

Who should attend:

Anyone (both technical and administrative staff) interested in understanding the ISO 17025:2017 standard and practical requirements for its implementation in laboratories, including special considerations for cannabis testing.

Instructors:

  • Brad Stawick, AOAC INTERNATIONAL, Sr. Director of AOAC Research Institute, Chair of the ALACC Chemistry Subcommittee
  • Susan Audino, S. Audino & Associates, LLC, Chair of the ALACC Cannabis Subcommittee
  • Deborah McKenzie, AOAC INTERNATIONAL, Deputy Assistant Executive Director & Chief Standards Officer
  • Shane Flynn, AOAC INTERNATIONAL, Sr. Director of AOAC Proficiency Testing Program
  • Veronica Kays, AOAC INTERNATIONAL, Manager of Science Programs

Proposed schedule: 2 virtual sessions (4 hours) once a week (e.g. one afternoon) for 4 weeks – the actual schedule will be discussed with the participants and adjusted to their needs as much as possible; sessions will be recorded.

Training Session Outline:

Session 1: Introduction

After a brief introduction to accreditation including the roles of Accrediting Bodies (AB), laboratories, and regulators, an overview of Sections 1-6 of the ISO 17025:2017 standard and the ALAG, including scope, normative references, terms & definitions, general requirements, structural requirements, and resource requirements.

Session 2: Process Requirements

This session will cover the technical requirements (sample handling and submission, technical records, measurement uncertainty, reporting results, complaints, and control of data & information management) of the ISO 17025 standard and the ALAG, except for method validation, which will be addressed in session 4. 

Session 3: Management System Requirements

Section 8 of the ISO 17025 standard addresses general system requirements, such as documents and records, risk, improvement, internal audits, and management review.  These are concepts for the foundation of the laboratory quality management system (QMS).

Session 4: Method Validation

One area of the standard that causes a great deal of confusion is method validation.  The ALAG provides a great deal of guidance on this topic.  There are several types of approaches allowed in the standard depending upon the nature of the method.  This “fit-for-purpose” approach is flexible but can be confusing.

Session 5: Proficiency Testing, Validity of Results, and Nonconforming Work

Likely the main concept people think about related to quality in the laboratory is quality control (QC).  QC can take on many roles, but fundamentally it is something that is done that indicates an activity worked in the laboratory.  It may be a blank, a duplicate, or a spike.  Those only provide feedback to the laboratory compared to itself.  Proficiency testing (PT) compares the performance of the laboratory with its peer laboratories.  Finally, when QC of any type fails, the laboratory must investigate the nonconforming work.

Session 6: Case Study in the Food Testing Industry

The ALAG document began back when ISO 17025 was ISO Guide 25 to make it more meaningful to the food testing industry.  That guidance document was from the Food Laboratory Accreditation Working Group (FLAWG), which is ALACC now.  Over the years, the ALAG has evolved to meet the needs of a changing standard and a growing, maturing industry.  Since the cannabis appendix of ALACC is in its first round, “lessons learned” related to food testing will be shared and discussed.

Session 7: ALAG Appendix F: Cannabis (Part I)

The ALAG document has several industry segments within its scope and includes an appendix for each segment.  Appendix F contains the Cannabis-specific requirements.  This session will cover the first 2/3 of Appendix F.

Session 8: ALAG Appendix F: Cannabis (Part II), Wrap-Up

The final 1/3 of Appendix F will be covered.  After that, there will be an extended Q&A time including all instructors.