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Risk analysis of analytical validations by probabilistic modification of FMEA
D M Barends1, M T Oldenhof, M J Vredenbregt
1National Institute for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Bilthoven, The Netherlands.
Journal of Pharmaceutical and Biomedical Analysis
|March 14, 2012
Summary
This study introduces a probabilistic modification of Failure Mode and Effect Analysis (FMEA) for analytical chemistry processes. This enhanced risk analysis method quantitatively estimates the occurrence of undetected failures, improving process validation and human error detection.
Area of Science:
- Analytical Chemistry
- Risk Management
- Process Validation
Background:
- Traditional Failure Mode and Effect Analysis (FMEA) uses categorical risk scoring, which can limit the precision of risk assessment in analytical chemistry.
- Identifying and mitigating technical and human-related failures is crucial for robust validation of analytical processes.
- Near Infrared (NIR) spectroscopy is employed for screening suspected counterfeit products, necessitating thorough risk analysis.
Purpose of the Study:
- To propose and demonstrate a probabilistic modification of FMEA for analytical chemistry processes.
- To enhance the quantitative estimation of failure mode occurrence and detection.
- To improve the risk analysis of analytical procedures, including those used in counterfeit screening.
Main Methods:
- Developed a probabilistic FMEA by replacing categorical scoring of occurrence and detection with estimated relative frequencies.
- Maintained categorical scoring for the severity of failure modes.
- Applied the probabilistic FMEA to a Near Infrared (NIR) analytical procedure for counterfeit tablet screening.
Main Results:
- The probabilistic modification of FMEA allows for quantitative estimation of the frequency of undetected failure modes.
- This approach provides a more precise risk assessment compared to traditional FMEA.
- Results from a NIR screening procedure demonstrated the practical application and benefits of the probabilistic FMEA.
Conclusions:
- Probabilistic FMEA offers a more accurate and quantitative method for risk analysis in analytical chemistry.
- This enhanced approach improves the identification and management of risks, including human failures.
- The method is valuable for validating analytical procedures and ensuring the reliability of results, such as in counterfeit detection.
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