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The Role of Calibration Tolerance

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43 views4 pages

The Role of Calibration Tolerance

Uploaded by

maslinda alias
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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The Role of Calibration Tolerance

 Calibration tolerance is the acceptable deviation during the calibration process. A


tighter tolerance (e.g., ±0.5°C instead of ±2°C) means you are aiming for higher
accuracy during calibration.
 Why tighter tolerance helps:
o It reduces the allowable range for deviations, increasing the likelihood that the
incubator operates closer to the desired setpoint.
o It minimizes the impact of drift or instability in the system, assuming all other
factors (e.g., expanded uncertainty) remain controlled.

However, tighter tolerance alone does not ensure that the incubator performs as expected in
real-world use. Calibration addresses the instrument's accuracy at specific points but
doesn’t fully account for performance issues such as:

 Uniformity of temperature distribution.


 Stability over time.
 Effects of load changes.

2. Calibration Tolerance vs. Expanded Uncertainty

To ensure confidence in the incubator's performance, the expanded uncertainty of the


calibration must also be smaller than or compatible with the tighter tolerance. A few key
principles:

 Guard bands: To ensure compliance, the calibration should leave a buffer between
the expanded uncertainty and the tolerance. For example:
o Tolerance: ±1°C
o Expanded Uncertainty: ±0.25°C (preferably, uncertainty should be less than
25% of the tolerance).
 Risk of non-conformance: If the expanded uncertainty is too large relative to the
tolerance, it increases the risk that the true temperature exceeds the specified range,
even if calibration appears within tolerance.

3. Does Tighter Tolerance Guarantee Performance?

No, tighter calibration tolerance does not fully guarantee performance because:

a. Calibration vs. Real-World Use

 Calibration ensures the incubator meets specifications under controlled conditions. In


real-world operation, external factors such as load variations, environmental changes,
and uniformity can cause deviations.

b. Stability and Uniformity


 Incubators must maintain temperature stability (e.g., ±0.5°C over time) and
uniformity (e.g., minimal temperature variation across shelves).
 Even if the incubator is calibrated to a tight tolerance, poor stability or uniformity can
compromise its performance.

c. Drift Over Time

 Calibration ensures accuracy at a specific time, but equipment may drift between
calibrations due to wear and environmental conditions. Regular monitoring and
interim checks are essential.

4. Recommendations

To ensure the incubator's performance:

a. Choose Appropriate Tolerance

 Set a calibration tolerance that aligns with your process requirements. For critical
microbiological applications, tighter tolerances are better (e.g., ±0.5°C instead of
±2°C).
 Ensure the expanded uncertainty of the calibration is significantly smaller than the
tolerance (e.g., 4:1 ratio of tolerance to uncertainty).

b. Verify Performance Post-Calibration

 Perform regular performance verification after calibration, including checks for:


o Temperature stability: Monitor how well the incubator holds the setpoint over
time.
o Temperature uniformity: Verify temperature consistency across the chamber
using multiple probes or sensors.
o Recovery time: Check how quickly the incubator returns to the set temperature
after opening/closing the door.

c. Routine Monitoring

 Use independent data loggers or probes to track the temperature during operation.
These devices provide real-time feedback on whether the incubator maintains
conditions within specification.

d. Adjust Maintenance and Calibration Frequency

 If tighter tolerances are required, calibrate the incubator more frequently to mitigate
drift risks.
 Perform preventive maintenance to ensure that components like fans, seals, and
sensors are functioning properly.
5. Conclusion

Setting tighter calibration tolerances reduces the margin of error but does not ensure the
incubator will perform as expected unless:

 The expanded uncertainty is sufficiently small.


 The incubator's stability, uniformity, and long-term performance are regularly
verified.

For critical applications, calibration should be part of a broader quality control program,
including periodic performance checks and environmental monitoring.

4o

Calibration Acceptance Criteria

Calibration passes if:

Measured Error+Expanded Uncertainty≤Test Limit\text{Measured Error} + \text{Expanded


Uncertainty} \leq \text{Test Limit}Measured Error+Expanded Uncertainty≤Test Limit

AND

Measured Error−Expanded Uncertainty≥−Test Limit.\text{Measured Error} - \text{Expanded


Uncertainty} \geq -\text{Test Limit}.Measured Error−Expanded Uncertainty≥−Test Limit.

This ensures the true value (including uncertainty) lies within the allowable range defined by
the test limits.

2. Known Values

 Measured Error (EEE): 0.85970.85970.8597


 Test Limit (TTT): ±8.00\pm 8.00±8.00
 Expanded Uncertainty (UUU): ±0.50\pm 0.50±0.50

3. Evaluate the Upper and Lower Limits

 Upper Limit:

E+U=0.8597+0.50=1.3597E + U = 0.8597 + 0.50 = 1.3597E+U=0.8597+0.50=1.3597

Since 1.3597≤8.001.3597 \leq 8.001.3597≤8.00, the upper limit is within the test
range.

 Lower Limit:
E−U=0.8597−0.50=0.3597E - U = 0.8597 - 0.50 = 0.3597E−U=0.8597−0.50=0.3597

Since 0.3597≥−8.000.3597 \geq -8.000.3597≥−8.00, the lower limit is also within the
test range.

4. Result

The measured error, considering the expanded uncertainty, lies within the test limits of ±8.00\
pm 8.00±8.00. Therefore, the calibration passes.

5. Additional Notes

 While the calibration passes, ensure that the uncertainty UUU is acceptable relative to
the test limit. Ideally, UUU should be much smaller than the tolerance (e.g., a 4:1
ratio).
 Document both the measured error and uncertainty in the calibration report to ensure
traceability and compliance with ISO/IEC 17025.

Let me know if you need further clarification!

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