Quality assurance manual guidance for environmental labs

All laboratories seeking environmental accreditation must provide a quality assurance manual for review and approval by our auditors These resources, including a handy checklist, can help you write or review a quality assurance manual for your lab. Keep in mind that not all points apply to every lab.

References for creating your QA manual

The Quality Assurance Manual section of the Procedure Manual gives tips and instructions for creating a Quality Assurance manual.

Model of a Quality Assurance Manual for a Small Wastewater Treatment Plant Laboratory gives an example QA Manual.

QA manual checklist

Use the checklist below to guide your review of your own manual. Your auditor assesses quality assurance manuals based on the following points, as applicable:

Title page (larger labs)
Table of contents (larger labs)
Lab organization
  • organization chart (larger labs)
Managers identified
  • quality assurance/quality control (QA/QC) responsibilities summarized
Designated Quality Assurance (QA) coordinator
  • if none, someone else designated as primary quality assurance person
QA person's responsibilities summarized
QA responsibilities of staff identified
Overall quality assurance/quality control policy statement
Policy establishing criteria for Data Quality Objectives (DQOs):
  • completeness
  • representativeness
  • defensibility
  • accuracy
Program for determining if DQOs met
  • corrective action when DQOs not met
QA/QC training policy documented
Procedures for sample management:
  • requesting analysis
  • receipt of sample
  • logging of sample
  • storage of sample
  • handling of sample
  • chain of custody
  • criteria for acceptance/rejection
Requirements for meeting:
  • container requirements
  • holding times
  • preservation requirements
List of routinely used methods
Standard operating procedures for in-house methods or modification of standardized methods
Any unique calibration (standardization) procedures documented
Guidelines established for:
  • blanks
  • check standards
  • duplicates
  • matrix Spikes
  • Certified Reference Materials (CRMs) or Standard Reference Materials (SRMs)
Procedures for use of control charts
Procedures for prep/storage of standards
Definitions documented or referenced for:
  • accuracy
  • precision
  • bias
  • other key QA/QC control terms
Equations given for important statistics such as:
  • Standard Deviation from "n" replicates
  • Standard Deviation by pooling "m" duplicate pairs
  • percent recovery from matrix spikes
Procedure for establishing Minimum Detection Limits (MDL)
  • MDLs established for applicable tests
  • relationship between of MDL and reporting limit (RL) explained
Procedures established for data:
  • recording
  • reduction
  • validation
  • entry
  • reporting
  • assessment (if lab responsibility)
  • retention
Requirement for system audits specified
  • both internal and external
  • by whom
Requirement for performance audits specified
  • by whom
  • at least one study per year
Requirements for other audits (larger labs)
  • management system audits
  • data quality audits
QA/QC reports periodically prepared
  • reviewed by responsible individual