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QA Manual Review Checklist
Lab Accreditation Unit staff use the following to guide their review of
Quality Assurance (QA) manuals. In using hese points to guide your
own review, keep in mind that not all points apply to every lab.
- 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 QA person
- QA person's responsibilities summarized
- QA responsibilities of staff identified
- Overall QA/QC 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
- SOPs 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 Quality Assurance/Quality 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 two studies per year
- Requirements for other audits (larger labs)
- management system audits
- Data Quality audits
- QA/QC reports periodically prepared
- reviewed by responsible individual
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