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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

Pharmaceuticals

Standard

ISO 17025

Workspaces

Pharmaceutical Laboratory

Occupations

Analytical Chemist
Metrologist
Quality Control Analyst
Method Development Scientist
Laboratory Manager

Measurement Uncertainty Evaluation

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1
Has the analytical reliability of the measurement been checked?

Select the status of the analytical reliability check.

To ensure that the analytical methods used are reliable.
2
How are the results of the measurement uncertainty reported?

Explain the reporting method used for results.

To confirm that results are reported in accordance with ISO standards.
3
Was a statistical analysis method used in the uncertainty evaluation?

Select whether a statistical analysis method was used.

To verify the use of appropriate statistical methods for reliability.
4
Describe the process used for evaluating measurement uncertainty.

Provide a detailed description of the evaluation process.

To ensure that a proper method was followed in the evaluation process.
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5
What is the calculated measurement uncertainty value?

Enter the measurement uncertainty value.

To quantify the measurement uncertainty for analysis.
Min: 0
Target: 0.0
Max: 100
6
Is the measurement uncertainty within the acceptable limits as per ISO 17025?

Select the compliance status.

To ensure compliance with the established measurement uncertainty standards.
7
When was the last review of the measurement uncertainty documentation conducted?

Enter the date of the last review.

To track the currency and relevance of the documentation.
8
Has the measurement uncertainty documentation undergone peer review?

Select the peer review status.

To ensure that documentation has been validated by peers.
9
Describe the uncertainty budgeting process used.

Provide a detailed description of the budgeting process.

To verify that proper budgeting methods are applied in the evaluation.
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10
How many sources of uncertainty are identified in the evaluation?

Enter the total number of identified sources.

To assess the thoroughness of the uncertainty evaluation process.
Min: 0
Target: 0
Max: 50
11
What procedures are documented for measurement uncertainty evaluation?

List the documented procedures.

To confirm that standardized procedures are in place.
12
Is all documentation related to measurement uncertainty complete?

Select the completeness status of the documentation.

To ensure that all required documentation is present for compliance.
13
When is the next scheduled training session for measurement uncertainty?

Enter the date of the next training session.

To track upcoming training sessions for personnel.
14
Has the effectiveness of the training programs been reviewed?

Select the effectiveness review status.

To confirm that training programs are evaluated for effectiveness.
15
Describe the feedback mechanism in place for the training programs.

Provide a detailed description of how feedback is collected and utilized.

To ensure that there is a system for improving training based on participant feedback.
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16
How often is the training for measurement uncertainty conducted?

Enter the number of training sessions conducted per year.

To assess the frequency of training sessions for personnel.
Min: 1
Target: 1
Max: 12
17
What training programs are available for measurement uncertainty evaluation?

Provide details of the training programs offered.

To ensure that appropriate training programs are in place for personnel.
18
Has all personnel involved in measurement uncertainty evaluation completed the required training?

Select the training completion status for personnel.

To ensure that all staff are adequately trained for compliance with ISO 17025 standards.
19
When was the last calibration performed on the measurement instruments?

Enter the date of the last calibration.

To track the recency of calibration activities.
20
Has the calibration of measurement instruments been verified by an independent party?

Select the verification status of calibration.

To confirm the accuracy and reliability of the calibration process.
21
Describe the documentation maintained for calibration records.

Provide details of the calibration documentation process.

To ensure that all calibration activities are properly documented for traceability.
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22
How frequently are the measurement instruments calibrated?

Enter the calibration frequency in months.

To ensure that calibration is performed at suitable intervals to maintain accuracy.
Min: 1
Target: 6
Max: 12
23
What procedures are followed for calibrating measurement instruments?

Describe the calibration procedures in place.

To verify that proper calibration procedures are followed consistently.
24
Are all measurement instruments used in uncertainty evaluation calibrated?

Select the calibration status of the measurement instruments.

To ensure that all equipment is functioning within specified limits and is compliant with ISO standards.
25
When is the next risk assessment scheduled for measurement uncertainty?

Enter the date of the next scheduled risk assessment.

To plan future evaluations of risk associated with measurement uncertainty.
26
Are stakeholders aware of the identified risks associated with measurement uncertainty?

Select the status of stakeholder awareness.

To ensure that relevant parties are informed about potential risks.
27
When was the last review of the risk assessment conducted?

Enter the date of the last risk assessment review.

To track the recency of the risk assessment process.
28
How many risks have been identified in the measurement uncertainty evaluation?

Enter the total number of identified risks.

To assess the thoroughness of the risk assessment process.
Min: 0
Target: 0
Max: 20
29
What strategies are implemented to mitigate identified risks?

Describe the risk mitigation strategies employed.

To ensure that measures are in place to address potential risks effectively.
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30
What is the assessed risk level associated with the measurement uncertainty?

Select the risk level associated with measurement uncertainty.

To evaluate the potential risks linked to measurement uncertainty in the process.

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

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