Risk analysis of analytical validations by probabilistic modification of FMEA
► FMEA is a valuable addition to analytical validation. ► Traditional FMEA is modified by replacing categorical scores by probabilities. ► Probabilistic modification of FMEA has added values. ► Frequencies of occurrence of undetected failure modes are now quantified. Risk analysis is a valuable addi...
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| Veröffentlicht in: | Journal of pharmaceutical and biomedical analysis 2012-05, Vol.64-65, p.82-86 |
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| container_title | Journal of pharmaceutical and biomedical analysis |
| container_volume | 64-65 |
| creator | Barends, D.M. Oldenhof, M.T. Vredenbregt, M.J. Nauta, M.J. |
| description | ► FMEA is a valuable addition to analytical validation. ► Traditional FMEA is modified by replacing categorical scores by probabilities. ► Probabilistic modification of FMEA has added values. ► Frequencies of occurrence of undetected failure modes are now quantified.
Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure. |
| doi_str_mv | 10.1016/j.jpba.2012.02.009 |
| format | Article |
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Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure.</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/j.jpba.2012.02.009</identifier><identifier>PMID: 22410502</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Analysis ; Analytical validation ; Analytical, structural and metabolic biochemistry ; Biological and medical sciences ; Chemistry Techniques, Analytical - methods ; Chemistry Techniques, Analytical - statistics & numerical data ; Counterfeit Drugs - analysis ; FMEA ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Human factor ; Medical sciences ; Models, Statistical ; NIR ; Pharmacology. Drug treatments ; Reproducibility of Results ; Risk analysis ; Risk Assessment - methods ; Risk Assessment - statistics & numerical data ; Spectroscopy, Near-Infrared - methods ; Tablets - analysis</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 2012-05, Vol.64-65, p.82-86</ispartof><rights>2012 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c385t-5d9596c114b4445046076a88f6599d74e98476fc3c639ddb1ee170b311432f33</citedby><cites>FETCH-LOGICAL-c385t-5d9596c114b4445046076a88f6599d74e98476fc3c639ddb1ee170b311432f33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpba.2012.02.009$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25811682$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22410502$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barends, D.M.</creatorcontrib><creatorcontrib>Oldenhof, M.T.</creatorcontrib><creatorcontrib>Vredenbregt, M.J.</creatorcontrib><creatorcontrib>Nauta, M.J.</creatorcontrib><title>Risk analysis of analytical validations by probabilistic modification of FMEA</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>► FMEA is a valuable addition to analytical validation. ► Traditional FMEA is modified by replacing categorical scores by probabilities. ► Probabilistic modification of FMEA has added values. ► Frequencies of occurrence of undetected failure modes are now quantified.
Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure.</description><subject>Analysis</subject><subject>Analytical validation</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Biological and medical sciences</subject><subject>Chemistry Techniques, Analytical - methods</subject><subject>Chemistry Techniques, Analytical - statistics & numerical data</subject><subject>Counterfeit Drugs - analysis</subject><subject>FMEA</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Human factor</subject><subject>Medical sciences</subject><subject>Models, Statistical</subject><subject>NIR</subject><subject>Pharmacology. Drug treatments</subject><subject>Reproducibility of Results</subject><subject>Risk analysis</subject><subject>Risk Assessment - methods</subject><subject>Risk Assessment - statistics & numerical data</subject><subject>Spectroscopy, Near-Infrared - methods</subject><subject>Tablets - analysis</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1Lw0AQhhdRbK3-AQ-Si3hKnc1-JAteSmlVaBGkB2_LZncDG9OkZtNC_70bUvUmDMzAPO8wPAjdYphiwPyxnJa7XE0TwMkUQoE4Q2OcpSROOP04R2NICY5TyNgIXXlfAgDDgl6iUZJQDAySMVq_O_8ZqVpVR-981BTD3DmtquigKmdU55raR_kx2rVNrnJXOR_W0bYxrghYv-5zy_Vido0uClV5e3PqE7RZLjbzl3j19vw6n61iTTLWxcwIJrjGmOaUUgaUQ8pVlhWcCWFSakVGU15oojkRxuTYWpxCTkKAJAUhE_QwnA0ffe2t7-TWeW2rStW22XspOMUiaBGBTAZSt433rS3krnVb1R4lBtlLlKXsJcpeooRQ0IfuTuf3-daa38iPtQDcnwDlg6eiVbV2_o9jGcY867mngbPBxcHZVnrtbK2tca3VnTSN---Pbwbtjnc</recordid><startdate>20120501</startdate><enddate>20120501</enddate><creator>Barends, D.M.</creator><creator>Oldenhof, M.T.</creator><creator>Vredenbregt, M.J.</creator><creator>Nauta, M.J.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20120501</creationdate><title>Risk analysis of analytical validations by probabilistic modification of FMEA</title><author>Barends, D.M. ; Oldenhof, M.T. ; Vredenbregt, M.J. ; Nauta, M.J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c385t-5d9596c114b4445046076a88f6599d74e98476fc3c639ddb1ee170b311432f33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Analysis</topic><topic>Analytical validation</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Biological and medical sciences</topic><topic>Chemistry Techniques, Analytical - methods</topic><topic>Chemistry Techniques, Analytical - statistics & numerical data</topic><topic>Counterfeit Drugs - analysis</topic><topic>FMEA</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Human factor</topic><topic>Medical sciences</topic><topic>Models, Statistical</topic><topic>NIR</topic><topic>Pharmacology. Drug treatments</topic><topic>Reproducibility of Results</topic><topic>Risk analysis</topic><topic>Risk Assessment - methods</topic><topic>Risk Assessment - statistics & numerical data</topic><topic>Spectroscopy, Near-Infrared - methods</topic><topic>Tablets - analysis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barends, D.M.</creatorcontrib><creatorcontrib>Oldenhof, M.T.</creatorcontrib><creatorcontrib>Vredenbregt, M.J.</creatorcontrib><creatorcontrib>Nauta, M.J.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barends, D.M.</au><au>Oldenhof, M.T.</au><au>Vredenbregt, M.J.</au><au>Nauta, M.J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Risk analysis of analytical validations by probabilistic modification of FMEA</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>64-65</volume><spage>82</spage><epage>86</epage><pages>82-86</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>► FMEA is a valuable addition to analytical validation. ► Traditional FMEA is modified by replacing categorical scores by probabilities. ► Probabilistic modification of FMEA has added values. ► Frequencies of occurrence of undetected failure modes are now quantified.
Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>22410502</pmid><doi>10.1016/j.jpba.2012.02.009</doi><tpages>5</tpages></addata></record> |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Analysis Analytical validation Analytical, structural and metabolic biochemistry Biological and medical sciences Chemistry Techniques, Analytical - methods Chemistry Techniques, Analytical - statistics & numerical data Counterfeit Drugs - analysis FMEA Fundamental and applied biological sciences. Psychology General pharmacology Human factor Medical sciences Models, Statistical NIR Pharmacology. Drug treatments Reproducibility of Results Risk analysis Risk Assessment - methods Risk Assessment - statistics & numerical data Spectroscopy, Near-Infrared - methods Tablets - analysis |
| title | Risk analysis of analytical validations by probabilistic modification of FMEA |
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