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