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ISO 17025 Measurement Uncertainty Evaluation Checklist for Pharmaceutical Labs

A comprehensive checklist for ensuring ISO 17025 compliance in the evaluation and reporting of measurement uncertainty within pharmaceutical laboratories, focusing on enhancing the reliability and traceability of analytical results.

ISO 17025 Measurement Uncertainty Evaluation Checklist for Pharmaceutical Labs

by: audit-now
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About This Checklist

Accurate estimation and reporting of measurement uncertainty is a critical requirement of ISO 17025 for pharmaceutical laboratories. This specialized checklist is designed to guide laboratory personnel through the complex process of evaluating, calculating, and documenting measurement uncertainty in pharmaceutical testing. By addressing key aspects such as uncertainty sources identification, statistical analysis, and uncertainty budgeting, this checklist ensures that laboratories can provide reliable and traceable measurements with appropriate confidence levels. Implementing this checklist helps pharmaceutical labs demonstrate the reliability of their test results, make informed decisions about specification compliance, and maintain transparency in their analytical processes, ultimately supporting product quality and patient safety.

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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Pharmaceutical Facilities

Occupations

Analytical Chemist
Metrologist
Quality Control Analyst
Method Development Scientist
Laboratory Manager
1
Is the measurement uncertainty within the acceptable limits as per ISO 17025?
2
What is the calculated measurement uncertainty value?
Min: 0
Target: 0.0
Max: 100
3
Describe the process used for evaluating measurement uncertainty.
4
Was a statistical analysis method used in the uncertainty evaluation?
5
How are the results of the measurement uncertainty reported?
6
Has the analytical reliability of the measurement been checked?
7
Is all documentation related to measurement uncertainty complete?
8
What procedures are documented for measurement uncertainty evaluation?
9
How many sources of uncertainty are identified in the evaluation?
Min: 0
Target: 0
Max: 50
10
Describe the uncertainty budgeting process used.
11
Has the measurement uncertainty documentation undergone peer review?
12
When was the last review of the measurement uncertainty documentation conducted?
13
Has all personnel involved in measurement uncertainty evaluation completed the required training?
14
What training programs are available for measurement uncertainty evaluation?
15
How often is the training for measurement uncertainty conducted?
Min: 1
Target: 1
Max: 12
16
Describe the feedback mechanism in place for the training programs.
17
Has the effectiveness of the training programs been reviewed?
18
When is the next scheduled training session for measurement uncertainty?
19
Are all measurement instruments used in uncertainty evaluation calibrated?
20
What procedures are followed for calibrating measurement instruments?
21
How frequently are the measurement instruments calibrated?
Min: 1
Target: 6
Max: 12
22
Describe the documentation maintained for calibration records.
23
Has the calibration of measurement instruments been verified by an independent party?
24
When was the last calibration performed on the measurement instruments?
25
What is the assessed risk level associated with the measurement uncertainty?
26
What strategies are implemented to mitigate identified risks?
27
How many risks have been identified in the measurement uncertainty evaluation?
Min: 0
Target: 0
Max: 20
28
When was the last review of the risk assessment conducted?
29
Are stakeholders aware of the identified risks associated with measurement uncertainty?
30
When is the next risk assessment scheduled for measurement uncertainty?

FAQs

The main steps include: 1) Specifying the measurand, 2) Identifying all significant sources of uncertainty, 3) Quantifying each uncertainty component, 4) Calculating the combined standard uncertainty, 5) Determining the expanded uncertainty, and 6) Reporting the result with its associated uncertainty.

Laboratories should conduct a systematic review of the entire measurement process, considering factors such as sampling, sample preparation, instrument calibration, environmental conditions, operator variability, and method parameters. Techniques like cause-and-effect diagrams (Ishikawa diagrams) can be useful in this process.

Common methods include Type A evaluation (based on statistical analysis of series of observations) and Type B evaluation (based on other information such as calibration certificates, literature data, or expert judgment). Advanced techniques like Monte Carlo simulations may also be used for complex measurement models.

The checklist includes items to ensure that measurement uncertainty is reported in a clear and unambiguous manner, typically as an expanded uncertainty with a stated coverage factor and confidence level. It also addresses the need to consider client requirements and regulatory guidelines when deciding on the format and detail of uncertainty reporting.

While ISO 17025 doesn't specify a fixed frequency, the checklist recommends regular reviews, typically annually or when significant changes occur in the measurement process, equipment, or environmental conditions. It also suggests periodic verification through participation in proficiency testing or inter-laboratory comparisons.

Benefits of ISO 17025 Measurement Uncertainty Evaluation Checklist for Pharmaceutical Labs

Ensures compliance with ISO 17025 measurement uncertainty requirements specific to pharmaceutical testing

Improves the reliability and comparability of test results across different laboratories

Enhances decision-making processes regarding product specifications and quality control

Supports regulatory compliance by demonstrating a thorough understanding of analytical limitations

Increases confidence in the laboratory's analytical capabilities among clients and regulatory bodies