{"id":2814,"date":"2023-05-17T14:29:22","date_gmt":"2023-05-17T13:29:22","guid":{"rendered":"https:\/\/vosfoxmedical.com\/validation\/validation-de-la-methode-dessai\/"},"modified":"2024-10-09T13:01:48","modified_gmt":"2024-10-09T12:01:48","slug":"validation-de-la-methode-dessai","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/validation-de-la-methode-dessai\/","title":{"rendered":"Validation de la m\u00e9thode d&rsquo;essai"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_1448918235\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t<div class=\"section-bg-overlay absolute fill\"><\/div>\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\" style=\"max-width:1300px\" id=\"row-1276323409\">\n\n\t<div id=\"col-127847423\" class=\"col medium-12 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-1736481791\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\"><span style=\"font-size: 100%;\">Validation de la m\u00e9thode d&rsquo;essai<\/span><\/h1>\n\t\t\n<style>\n#text-1736481791 {\n  font-size: 2.75rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1448918235 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: #5a0958;\n}\n#section_1448918235 .section-bg-overlay {\n  background-color: rgba(90, 9, 88, 0.89);\n}\n#section_1448918235 .section-bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/img-thunderstorm.jpg);\n}\n#section_1448918235 .section-bg {\n  background-position: 90% 59%;\n}\n#section_1448918235 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1448918235 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_1448918235 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_1448918235 {\n    min-height: 600px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n<div class=\"row align-bottom\" style=\"max-width:1300px\" id=\"row-789863979\">\n\n\t<div id=\"col-1802550643\" class=\"col medium-12 small-12 large-8 medium-col-first\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1639271484\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1639271484 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-1639271484 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-analytical-testing.jpg);\n}\n#banner-1639271484 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1639271484 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-1639271484 {\n    padding-top: 600px;\n  }\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1802550643 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-1802550643 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-1802550643 > .col-inner {\n    margin: -500px 0px 0px 0px;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<section class=\"section\" id=\"section_941087400\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row row-large align-equal align-right\"  id=\"row-468338249\">\n\n\t<div id=\"col-1229236440\" class=\"col medium-12 small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p class=\"lead\">Comme tous les processus, les tests de contr\u00f4le de la qualit\u00e9 doivent \u00e9galement \u00eatre valid\u00e9s ; il s&rsquo;agit de la validation de la m\u00e9thode d&rsquo;essai.<br \/>\nLes \u00e9tapes sont similaires \u00e0 celles de la validation des processus : IQ, OQ et PQ.<br \/>\nPour les tests tels que l&rsquo;inspection visuelle, seule la QP est applicable.<br \/>\nLa m\u00e9thode de validation diff\u00e8re pour les tests d&rsquo;attributs et de variance.   <\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row row-small\"  id=\"row-921208823\">\n\n\t<div id=\"col-1770673129\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1583831664\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-2052393501\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-2052393501 {\n  width: 60%;\n}\n#text-box-2052393501 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1583831664 {\n  padding-top: 268px;\n  background-color: rgb(255,255,255);\n}\n#banner-1583831664 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-variation.png?fit=863%2C381&ssl=1);\n}\n#banner-1583831664 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1583831664 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t<div id=\"gap-1550361655\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1550361655 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\n  <div class=\"banner has-hover\" id=\"banner-748692696\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-1196765199\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-1196765199 {\n  width: 60%;\n}\n#text-box-1196765199 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-748692696 {\n  padding-top: 280px;\n  background-color: rgb(255,255,255);\n}\n#banner-748692696 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-nested-crossed-grr.png?fit=866%2C404&ssl=1);\n}\n#banner-748692696 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-748692696 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1770673129 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-1770673129 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1554589603\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Processus de validation<\/h2>\n<p>  La qualification de l&rsquo;installation et la qualification op\u00e9rationnelle de l&rsquo;\u00e9quipement d&rsquo;essai sont similaires \u00e0 la validation du processus.<br \/>\nIl est essentiel que l&rsquo;\u00e9quipement soit int\u00e9gr\u00e9 dans le syst\u00e8me de qualit\u00e9, que le logiciel et le microprogramme soient valid\u00e9s et que l&rsquo;\u00e9quipement effectue le test analytique comme pr\u00e9vu (sur des \u00e9chantillons standard).<br \/>\nAu cours de la qualification op\u00e9rationnelle, les r\u00e9glages corrects de la machine pour un type d&rsquo;\u00e9chantillon sp\u00e9cifique sont d\u00e9termin\u00e9s.<br \/>\nVous voulez que les r\u00e9sultats des tests de contr\u00f4le de la qualit\u00e9 soient r\u00e9v\u00e9lateurs de la qualit\u00e9 du produit et des capacit\u00e9s de votre processus de production.<br \/>\nVous devez donc conna\u00eetre les variances li\u00e9es au processus, \u00e0 l&rsquo;\u00e9quipement et \u00e0 l&rsquo;op\u00e9rateur (voir dessin).<br \/>\nLe nombre d&rsquo;\u00e9chantillons et le calcul statistique d\u00e9pendent du type de test et de son effet sur l&rsquo;\u00e9chantillon (voir dessin).<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1554589603 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-1554589603 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-1523259474\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1523259474 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-380588836\">\n\n\t<div id=\"col-1154459648\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>PQ &#8211; Variance GR&amp;R<\/h2>\n<p>  Le nombre d&rsquo;\u00e9chantillons et la m\u00e9thode statistique sont alors d\u00e9finis, les \u00e9chantillons sont test\u00e9s et les r\u00e9sultats sont saisis dans un logiciel statistique.<br \/>\nDiff\u00e9rentes m\u00e9thodes d&rsquo;\u00e9valuation sont possibles, la plus courante \u00e9tant la m\u00e9thode ANOVA.<br \/>\nLa contribution des autres facteurs \u00e0 la variance (contribution de la r\u00e9p\u00e9tabilit\u00e9, de la reproductibilit\u00e9 et du Gauge R&amp;R) est \u00e9valu\u00e9e.<br \/>\nDans le cas des tests de variance Gauge R&amp;R, les r\u00e9sultats sont compar\u00e9s \u00e0 des crit\u00e8res d&rsquo;acceptation pr\u00e9d\u00e9termin\u00e9s.<br \/>\nSi les tests satisfont aux crit\u00e8res d&rsquo;acceptation, la QP est termin\u00e9e.<br \/>\nDans le cas contraire, une enqu\u00eate est men\u00e9e pour d\u00e9terminer les raisons de l&rsquo;\u00e9chec et des mesures correctives sont mises en \u0153uvre.<br \/>\nLes tests de GR&amp;R sont ensuite r\u00e9p\u00e9t\u00e9s jusqu&rsquo;\u00e0 ce que les crit\u00e8res d&rsquo;acceptation soient remplis.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-507303855\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1501232579\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-869219564\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-869219564 {\n  width: 60%;\n}\n#text-box-869219564 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1501232579 {\n  padding-top: 375px;\n}\n#banner-1501232579 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-variance-analysis.png?fit=400%2C300&ssl=1);\n}\n#banner-1501232579 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1501232579 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_941087400 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_941087400 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_941087400 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_941087400 {\n    padding-top: 70px;\n    padding-bottom: 70px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-1822977032\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1822977032 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-261396299\">\n\n\t<div id=\"col-890725497\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1955177079\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-825197196\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-825197196 {\n  width: 60%;\n}\n#text-box-825197196 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1955177079 {\n  padding-top: 369px;\n}\n#banner-1955177079 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-attribute.jpg?fit=900%2C515&ssl=1);\n}\n#banner-1955177079 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1955177079 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-2143785629\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>PQ &#8211; Attribut GR&amp;R<\/h2>\n<p>  Les tests d&rsquo;attributs aboutissent \u00e0 un r\u00e9sultat PASS ou FAIL (pensez \u00e0 l&rsquo;inspection visuelle).<br \/>\nIl est essentiel que ces attributs ne soient pas arbitraires et que tous les op\u00e9rateurs les notent de la m\u00eame mani\u00e8re.<br \/>\nLe contr\u00f4le de la jauge d&rsquo;attributs consiste \u00e0 demander \u00e0 plusieurs op\u00e9rateurs de noter plusieurs fois un ensemble d&rsquo;\u00e9chantillons tel que d\u00e9fini dans une instruction de travail.<br \/>\nCet ensemble d&rsquo;\u00e9chantillons doit contenir un nombre similaire de PASS (r\u00e9ussite) et de FAIL (\u00e9chec).<br \/>\nLes op\u00e9rateurs notent les \u00e9chantillons (r\u00e9ussite-\u00e9chec) par rapport \u00e0 une liste de r\u00e9f\u00e9rence.<br \/>\nDes techniques statistiques permettent de d\u00e9terminer l&rsquo;efficacit\u00e9 du test d&rsquo;attributs.<br \/>\nUn syst\u00e8me de mesure efficace doit pr\u00e9senter une faible variabilit\u00e9 au sein des op\u00e9rateurs (r\u00e9p\u00e9tabilit\u00e9), une faible variabilit\u00e9 entre les op\u00e9rateurs (reproductibilit\u00e9) et une grande concordance entre les op\u00e9rateurs ou les syst\u00e8mes (liste ma\u00eetresse).<br \/>\nLorsque les crit\u00e8res d&rsquo;acceptation pr\u00e9d\u00e9termin\u00e9s ne sont pas remplis, une analyse des donn\u00e9es permet de d\u00e9terminer si l&rsquo;op\u00e9rateur a besoin d&rsquo;une nouvelle formation ou si les instructions de travail doivent \u00eatre r\u00e9vis\u00e9es.<br \/>\nDe nouveaux essais sont effectu\u00e9s jusqu&rsquo;\u00e0 ce que les crit\u00e8res d&rsquo;acceptation soient remplis.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-683789866\">\n\n\t<div id=\"col-848016242\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1658503203\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/vosfoxmedical.com\/services\/\" target=\"_self\" class=\"button primary\"  >\n    <span>Retour \u00e0 la page d&#039;aper\u00e7u du d\u00e9veloppement de la pr\u00e9-prodcution<\/span>\n  <\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":2510,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-2814","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized 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