Uncertainty via Control Charts

Transform routine QC data into a defensible uncertainty budget using Statistical Process Control — the OMCL methodology for ISO 17025 compliance.

SPCUncertaintyQuality Control

Measurement uncertainty isn't a static value—it's a living reflection of your process stability. By leveraging Statistical Process Control (SPC), we transform routine QC data into a defensible uncertainty budget.

01
Process Monitoring

Section 1: Control Charts

A Control Chart is a graphical tool used to monitor the stability of a measurement process. In the laboratory, it provides "real-time" evidence that an instrument (like an ICP-MS) is operating within its expected statistical limits before sample results are accepted.

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Table 1.1: Iron (Fe) Trace Data [ppb]

Run Value Run Value
01101.209103.2
02103.410101.7
0399.811104.1
04102.112102.3
05104.513100.9
06101.814103.8
07102.915102.5
08100.5N=15 | S=1.5
Fig 1.1: X-Chart Performance (Fe 100ppb)
UCL MEAN
TARGET: 100.0 | MEAN: 102.5 | σ: 1.5
02
Mathematical Model

Section 2: Combined Uncertainty

The Relative Combined Standard Uncertainty (uc/x) is the "root" of your uncertainty budget. It mathematically merges independent sources of error—random, systematic, and statistical—into a single, standardized metric that represents the total error of your method.

uc x = RSD2 + RBE2 + RB2 + u(ref)2
Precision

RSD

Random Error: Measures the repeatability of the measurement system. It captures how much individual measurements "drift" from each other.

Statistics

RBE

Standard Error: Represents the uncertainty of the estimated mean, accounting for sample size (n). It answers: "How much do I trust this average?"

Trueness

RB

Relative Bias: Measures systematic error. The distance between your experimental average and the certified target value.

Reference

u(ref)

Uncertainty of CRM: The inherent uncertainty of the certified standard itself, found on the CoA.

03
Precision Component

Section 3: RSD — Relative Standard Deviation

The RSD quantifies the random error (or "precision") of your measurement process. It measures how much individual data points deviate from their own average, expressed as a percentage. A lower RSD indicates a more consistent, repeatable method.

Formula

RSD = S × 100
S Standard Deviation
Mean (average)
100 Percentage conversion

Calculation: Iron (Fe) Dataset

Using the 15 data points from Table 1.1:

Mean (x̄)
102.5 ppb
Std Dev (S)
1.5 ppb

Step-by-step:

RSD = (S / x̄) × 100
RSD = (1.5 / 102.5) × 100
RSD = 0.01463 × 100
RSD = 1.46%
Final RSD
1.46%

This means that the ICP-MS measurement of Iron shows a 1.46% shot-to-shot variability during the analyzed runs — a typical precision for trace-level analysis.

04
Statistical Component

Section 4: RBE — Relative Standard Error

The RBE (also known as Standard Error of the Mean) represents the uncertainty in the estimate of the mean. While RSD tells you how much your data scatters, RBE tells you how much you can trust the average you calculated. More data points = smaller RBE = more confidence in your mean.

Formula

RBE = RSD √n
RSD From Section 3
n Number of replicates

Calculation: Iron (Fe) Dataset

Using the RSD from Section 3 and our sample size:

RSD
1.46 %
Sample Size (n)
15 points

Step-by-step:

RBE = RSD / √n
RBE = 1.46 / √15
RBE = 1.46 / 3.873
RBE = 0.38%
Final RBE
0.38%

With 15 data points, we can be confident that our mean of 102.5 ppb has a statistical uncertainty of only 0.38%. Collecting more samples would reduce this further.

05
Trueness Component

Section 5: RB — Relative Bias

The RB quantifies systematic error (or "trueness"). While RSD measures random scatter, RB measures how far your average result is from the actual target value. This component captures calibration drift, matrix effects, or any persistent offset in your method.

Formula

RB = x̄ - Target Target × 100
Mean of measurements
Target Certified Value (e.g. 100.0)

Calculation: Iron (Fe) Dataset

Comparing our measured mean to the certified target:

Measured Mean (x̄)
102.5 ppb
Target (CRM)
100.0 ppb

Step-by-step:

RB = ((x̄ − Target) / Target) × 100
RB = ((102.5 − 100.0) / 100.0) × 100
RB = (2.5 / 100.0) × 100
RB = 2.50%
Final RB
2.50%

Our ICP-MS measurements are running 2.5% high compared to the certified reference. This systematic bias will be included in the total uncertainty budget.

06
Reference Component

Section 6: u(ref) — Reference Uncertainty

The u(ref) represents the uncertainty of your reference standard itself. No standard is perfect — even certified reference materials (CRMs) have an associated uncertainty stated on their Certificate of Analysis (CoA). This component ensures you account for the "truth" not being perfectly known.

Formula

u(ref) = UCoA k ÷ Target × 100
U Expanded Uncertainty
k Coverage Factor
Target Certified Value

Calculation: Iron (Fe) CRM Certificate

From the Certificate of Analysis for the Iron standard:

Certified Value
100.0 ppb
U (k=2)
±0.5 ppb
k Factor
2

Step-by-step:

u(ref) = (UCoA / k) / Target × 100
u(ref) = (0.5 / 2) / 100.0 × 100
u(ref) = 0.25 / 100.0 × 100
u(ref) = 0.25%
Final u(ref)
0.25%

Even our certified standard has 0.25% inherent uncertainty. This is the baseline "floor" — no measurement can be more accurate than the reference used to calibrate it.

07
Final Calculation

Section 7: Combining All Components

Now we bring together all four uncertainty components using the Root Sum of Squares (RSS) method. This produces the Combined Standard Uncertainty which, when multiplied by a coverage factor (k=2), gives us the Expanded Uncertainty at 95% confidence.

uc x = RSD2 + RBE2 + RB2 + u(ref)2

All four components are independent. RSD is divided by √n (sample replicates).

Scenario A: Single Measurement

Sample measured once (n = 1)

RSD/√n1.46%
RBE0.38%
RB2.50%
u(ref)0.25%
uc = √(1.46²/1 + 0.38² + 2.50² + 0.25²)
uc = √(2.13 + 0.14 + 6.25 + 0.06)
uc = √8.59
uc = 2.93%
Expanded (k=2)
5.86%
100.0 ± 5.9 ppb

Scenario B: Triple Measurement

Sample measured three times (n = 3)

RSD/√n0.84%
RBE0.38%
RB2.50%
u(ref)0.25%
uc = √(1.46²/3 + 0.38² + 2.50² + 0.25²)
uc = √(0.71 + 0.14 + 6.25 + 0.06)
uc = √7.16
uc = 2.68%
Expanded (k=2)
5.35%
100.0 ± 5.4 ppb

Key Insight: Strategy Selection

Strategy
Measuring instead of
Impact
−0.51%
Uncertainty Reduction
Conclusion
Replicates reduce noise (RSD), but the systematic bias (RB) remains the dominant error at 2.50%.
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