APHL is committed to assisting laboratories as they strengthen their data defensibility through robust quality management systems. When regulatory partners are confident in the quality of laboratory data, quicker compliance actions can be taken to protect the food supply. APHL and its partners have developed several resources over the years that work together to outline components of a quality management system compliant with the ISO/IEC 17025 standard.
Data Utilization White Paper
The "Best Practices for Submission of Actionable Human and Animal Food Testing Data Generated in State and Local Laboratories," or Data Utilization White Paper, is primarily designed to advise laboratories that are not accredited or produced data from a method not under scope. The document closely aligns with the ISO/IEC 17025:2017 standard. It is a tool to assist laboratories in building end-users' confidence in the defensibility of their data. The white paper includes a checklist that can be used as a self-assessment tool for evaluating the laboratory's quality management system. The document was last revised in September 2021.
Laboratory Best Practices Manual
In collaboration with the Partnership for Food Protection, APHL and its members developed a document that identifies essential elements critical to the quality of regulatory data. The Human and Animal Food Testing Laboratories Best Practices Manual provides a set of tools, definitions, and references that laboratories can use to improve their operations. Documenting the quality of both sampling and analysis is essential to ensure the defensibility of laboratory-generated data. This document also aligns with the ISO/IEC 17025:2017 standard.
Developed in collaboration with the Partnership for Partnership for Food Protection, the Human & Animal Food Regulatory Compliance Review Checklist is designed to assist a human and animal food testing organization in preparing a data package intended for review by a compliance officer for possible regulatory action. In addition, this checklist is structured to aid compliance officers in the review of data packages. Familiarity with the elements of this checklist will assist regulatory management, inspection and laboratory groups in planning their sample collections and analyses to assure they can provide essential regulatory information. The checklist can also serve as a data package index, to assure that all necessary information is included and easily located. A Word version of the checklist is also available.