Mod 9 - QA QC Program

Module from the Laboratory Analyst Training Curriculum curriculum.

Module 9 — QA/QC Program · Learning Objectives · 1. Build and interpret Shewhart control charts for routine analytical methods. · 2. Participate in interlaboratory round-robin (cross-check) programs. · 3. Apply method precision (r, R) for dispute resolution. · 4. Track instrument calibration, PM, and reagent lot tracking. · 5. Document QA/QC per ISO/IEC 17025 expectations. · Key QA/QC Documents

Standard	Subject
ASTM D6299	Applying statistical quality assurance to lab test data
ASTM D6792	Quality System for Petroleum Analysis Labs
ASTM D7372	Using Specification Limits and Precision
ASTM E691	Conducting Interlaboratory Study
ISO/IEC 17025	General requirements for testing labs
ISO 4259	Precision of Test Methods — Petroleum
Control Chart Elements
Chart	Purpose
X-bar / Individuals	Track mean result vs CL, UCL, LCL
Moving Range (MR)	Short-term variation
Range (R)	Within-run variation on duplicates
EWMA	Exponentially-weighted, trend detection
Zone / Run rules	Western Electric rules for out-of-control
Typical QC Frequency
QC Sample	Frequency
Instrument blank	Each run or daily
Calibration verification	Start + every 10–20 samples
Check standard	Every 10 samples
Duplicate	1 per 20 samples
Retained control sample	Daily
Reagent blank	Each new reagent lot
Method Precision — Reading r & R
Term	Meaning
Repeatability (r)	Same operator, same instrument, short interval (95% CL)
Reproducibility (R)	Different labs, different operators, different days
Site precision (Rsite)	Within-lab, between-operator reproducibility
Use of r/R	Accept or reject dispute results within method tolerance
Interlab Round-Robin Program
Item	Guidance
Frequency	Monthly or quarterly
Providers	ASTM D02 CPC, ISOT, proficiency test orgs
Z-score target	\|Z\| ≤ 2 = satisfactory
\|Z\| 2–3	Questionable — investigate
\|Z\| > 3	Unsatisfactory — corrective action
Nonconformance / CAPA Workflow
Step	Action
1	Identify OOC trigger (zone rule, failed check, rejected RR)
2	Contain: hold affected results pending investigation
3	Root cause: instrument, standard, method, operator
4	Corrective action: repair/recalibrate/retrain
5	Preventive action: update SOP, add check step
6	Document CAPA and verify effectiveness
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Source: Laboratory_Analyst_Training_Curriculum_v1.xlsx · Sheet: Mod 9 - QA QC Program

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