Inorganic Preparative Quality Control Requirements
Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs
| Quality Control Requirements | Frequency | Acceptance Criteria | Failure Action |
|---|---|---|---|
All Inorganic Analytical Techniques (except pH) |
|||
| PB | 1 per batch | < EQL, <5% regulatory decision level, or <5% of measured concentration in the sample | Investigate. Determine useability by evaluating against analyte concentration in sample and client DQR. Re-prepare and analyze for failed analytes. |
| BS(a)
-or- |
1 per batch
-or- |
80% to 120% -or- Vendor specs/regulatory requirements/statistical |
Investigate. Determine useability by evaluating against analyte concentration in sample and client DQR. Re-prepare and analyze for failed analytes. |
| Duplicate | 1 per batch | <20% RPD, when result >EQL (10 times IDL, or 100 times the IDL for ICP/MS) for liquids and <35% RPD when result is >EQL (10 times IDL, or 100 times the IDL for ICP/MS) for solid samples. | Evaluate. If lab error, re-prepare and analyze. If matrix driven, evaluate against DQRs, notify client if still unacceptable and discuss in narrative. |
| MS | 1 per batch | Recommended: 75% to 125% or statistical |
Evaluate. If lab error, re-prepare and analyze. If matrix driven, evaluate against DQR, notify client if still unacceptable and discuss in narrative. |
pH |
|||
| Duplicate | 1 per every 10 samples | Recommended: ±0.1 pH units |
Discuss in narrative |
(a) Techniques where the ICV is prepared with the samples, the ICV can serve as the BS.
BS = Blank Spike
EQL = Estimated Quantitation Limit
FLAA = Flame Atomic Absorption Spectrometry
ICP = Inductively Coupled Plasma
IDL = Instrument Detection Limit
MS = Matrix spike
PB = Preparation blank.