{"id":4870,"date":"2019-09-14T16:20:52","date_gmt":"2019-09-14T14:20:52","guid":{"rendered":"https:\/\/www.memmert.be\/why-memmert\/innovation-leader\/iq-oq-pq\/"},"modified":"2019-09-14T16:20:53","modified_gmt":"2019-09-14T14:20:53","slug":"iq-oq-pq","status":"publish","type":"page","link":"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/iq-oq-pq\/","title":{"rendered":"IQ\/OQ\/PQ"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4870\" class=\"elementor elementor-4870 elementor-1268\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b62b1ef elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b62b1ef\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-20fbf75\" data-id=\"20fbf75\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fd3a95 elementor-widget elementor-widget-heading\" data-id=\"3fd3a95\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Fit for TQM and Customer Audits<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db396b8 elementor-widget elementor-widget-text-editor\" data-id=\"db396b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Equipment qualification in the context of quality management or validation is an essential pre-requirement for a large number of companies in deciding on a specific supplier. Apart from the calibration certificate, which is included by default, Memmert also issues IQ\/OQ certificates on request. To support the customers&#8217; own IQ\/OQ certification, we can offer IQ\/OQ documentation.<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ea79add elementor-widget elementor-widget-heading\" data-id=\"ea79add\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Installation Qualification IQ<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2964ba0 elementor-widget elementor-widget-text-editor\" data-id=\"2964ba0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Installation Qualification IQ is the documented proof that facilities and equipment have been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the design qualification. The documentation for an Installation Qualification normally consists of:<\/p>\n<div id=\"c16402\" class=\"csc-default\">\n<div class=\"csc-textpic-text\">\n<p><b>IQ test plan:<\/b>Contains detailed information of the tests to be performed on the respective equipment in the context of the Installation Qualification.<\/p>\n<\/div>\n<\/div>\n<p><b>IQ report:<\/b> After completion of the Installation Qualification IQ, the results are summarised, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bbaf25f elementor-widget elementor-widget-heading\" data-id=\"bbaf25f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">The extent of the Installation Qualification IQ<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44715fc elementor-widget elementor-widget-text-editor\" data-id=\"44715fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"list\">\n<li>Stocktaking of the components delivered, together with a check of the order documents<\/li>\n<li>Testing of manufacturer documentation for conformity (rating plate, delivery note)<\/li>\n<li>Testing of operator documentation for conformity (operating instructions)<\/li>\n<li>Testing of assembly and ensuring installation was performed correctly, based on various plans (insofar as is necessary)<\/li>\n<li>Documented evidence of operating personnel being instructed on operating equipment<\/li>\n<li>Documentation of test data for the initial inspection in accordance with DIN VDE 0700 Part 1 and EN 60335-3<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-82ac0f5 elementor-widget elementor-widget-text-editor\" data-id=\"82ac0f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>After a successfully completed Installation Qualification IQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for the next stage of qualification.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dc842a9 elementor-widget elementor-widget-heading\" data-id=\"dc842a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Operation Qualification OQ<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec7fcfb elementor-widget elementor-widget-text-editor\" data-id=\"ec7fcfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Operation Qualification OQ is a test process that evaluates the correct functioning of a facility or an appliance. During the Operation Qualification OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. The Operation Qualification OQ may only be performed after a successfully completed Installation Qualification IQ. The (successfully) performed Operation Qualification OQ is a prerequisite for the technical acceptance of a facility or appliance. The documentation for an Operation Qualification normally consists of:<\/p>\n<div id=\"c16373\" class=\"csc-default\">\n<div class=\"csc-textpic-text\">\n<p><b>OQ test plan:<\/b> Contains detailed information of the tests to be performed on the respective equipment in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.<\/p>\n<\/div>\n<\/div>\n<p><b>OQ report:<\/b> After completion of the Operation Qualification OQ, the results are summarised, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-708502b elementor-widget elementor-widget-heading\" data-id=\"708502b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">The extent of the Operation Qualification OQ<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5acf839 elementor-widget elementor-widget-text-editor\" data-id=\"5acf839\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Operation Qualification OQ consists of the identification and inspection of the alarm, control and switch functions that have an influence on quality:<\/p>\n<ul class=\"list\">\n<li>Inspection of the display units and signal LEDs<\/li>\n<li>Inspection of temperature control and control fluctuations<\/li>\n<li>Inspection of the over\/undertemperature protection alarm systems<\/li>\n<li>Inspection of the pressure\/vacuum control (if available)<\/li>\n<li>Inspection of the CO2 control (if available)<\/li>\n<li>Inspection of the humidity measurement and control (if available)<\/li>\n<li>Inspection of the fan speed control (if available)<\/li>\n<li>Inspection of the servo motor air flap control (if available)<\/li>\n<li>Inspection of the card reader function (if available)<\/li>\n<li>Inspection of the temperature distribution, based on DIN 12880: 2007-05<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fdd9ca elementor-widget elementor-widget-text-editor\" data-id=\"1fdd9ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>After a successfully completed Operation Qualification OQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for use.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cbb3254 elementor-widget elementor-widget-heading\" data-id=\"cbb3254\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Performance Qualification PQ<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34d20a9 elementor-widget elementor-widget-text-editor\" data-id=\"34d20a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Performance qualification (PQ) of laboratory equipment is an important component of the validation of the entire production process over a certain period of time and for a specific product. Its purpose is to verify and document that the appliances and systems are working reproducibly within the entire specified working range and limits. The appliances and systems are not inspected individually but always as part of the overall or partial process. Even though PQ usually comprises OQ tests under process conditions (e.g. for hot air sterilisers with load), a detailed test plan has to be created based on a comprehensive process description before the validation process is started in any case.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62805bc elementor-widget elementor-widget-heading\" data-id=\"62805bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Performance qualification (PQ) comprises:<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b774434 elementor-widget elementor-widget-text-editor\" data-id=\"b774434\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"list\">\n<li>Documentation under process conditions that the appliance or the entire process with the product produces the expected defined results.<\/li>\n<li>The extent of the PQ can result from the requirements of the operator (requirements specification) or from normative or legal requirements<\/li>\n<li>Physical tests proving that the specified limits regarding homogeneity and stability are adhered to with the product.<\/li>\n<li>Documentation of the procedure and results in the qualification report (with detailed procedure description and, if applicable, picture evidence)<\/li>\n<li>VALIDATION through several repetitions, reproduction of the processes (mostly three times in pharmaceutical and medical technology)<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bea3d84 elementor-widget elementor-widget-text-editor\" data-id=\"bea3d84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Both the preparation time for a performance qualification (PQ) and the actual validation are very time consuming. In case you plan to perform a PQ with the help of Memmert, we would like to ask you to contact us soon. Please contact our quality assurance department at <a class=\"mail\" title=\"Opens window for sending email\" href=\"mailto:info@memmert.be\"><i class=\"fa fa-envelope-o\"><\/i>\u00a0info@memmert.be<\/a><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-12a41b9\" data-id=\"12a41b9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f3c737 nav-sub elementor-widget elementor-widget-global elementor-global-39656 elementor-global-580 elementor-widget-wp-widget-nav_menu\" data-id=\"2f3c737\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wp-widget-nav_menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5>Waarom Memmert<\/h5><nav class=\"menu-why-memmert-en-container\" aria-label=\"Waarom Memmert\"><ul id=\"menu-why-memmert-en\" class=\"menu\"><li id=\"menu-item-5233\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-5233\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/\">Company with tradition<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-5235\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5235\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/our-mission\/\">Our mission<\/a><\/li>\n\t<li id=\"menu-item-5236\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5236\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/history\/\">History<\/a><\/li>\n\t<li id=\"menu-item-5234\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-5234\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/quality\/\">Quality<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-5273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5273\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/quality\/quality-testing\/\">Quality testing<\/a><\/li>\n\t\t<li id=\"menu-item-5272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5272\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/quality\/din-12880\/\">DIN 12880<\/a><\/li>\n\t\t<li id=\"menu-item-5271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5271\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/company-with-tradition\/quality\/validation-steriliser\/\">Validation Steriliser<\/a><\/li>\n\t<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-5237\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5237\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/5-good-reasons\/\">5 good reasons<\/a><\/li>\n<li id=\"menu-item-5238\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5238\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/myatmosafe\/\">myAtmoSAFE<\/a><\/li>\n<li id=\"menu-item-5239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-5239\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/\">Innovation Leader<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-39725\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-39725\"><a href=\"https:\/\/www.memmert.be\/en\/technology-comparison-peltier-vs-compressor\/\">Technology comparison Peltier vs. Compressor<\/a><\/li>\n\t<li id=\"menu-item-5240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5240\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/single-twindisplay\/\">Single\/TwinDISPLAY<\/a><\/li>\n\t<li id=\"menu-item-5242\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5242\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/atmocontrol\/\">AtmoCONTROL<\/a><\/li>\n\t<li id=\"menu-item-5243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5243\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/all-round-surface-heating\/\">All-round surface heating<\/a><\/li>\n\t<li id=\"menu-item-5244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5244\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/direct-heating-in-the-vo\/\">Direct heating in the VO<\/a><\/li>\n\t<li id=\"menu-item-5246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5246\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/climate-friendly-refrigerant-co2-r744\/\">Climate-friendly refrigerant CO2 (R744)<\/a><\/li>\n\t<li id=\"menu-item-5241\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5241\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/heating-cooling-with-peltier\/\">Heating\/cooling with Peltier<\/a><\/li>\n\t<li id=\"menu-item-5245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5245\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/heating-cooling-with-air-jacket\/\">Heating\/cooling with air jacket<\/a><\/li>\n\t<li id=\"menu-item-5247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5247\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/celsius\/\">Celsius<\/a><\/li>\n\t<li id=\"menu-item-5248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5248\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/chip-cards\/\">Chip cards<\/a><\/li>\n\t<li id=\"menu-item-5249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5249\"><a href=\"https:\/\/www.memmert.be\/en\/why-memmert\/innovation-leader\/iq-oq-pq\/\">IQ\/OQ\/PQ<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/nav>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fit for TQM and Customer Audits Equipment qualification in the context of quality management or validation is an essential pre-requirement for a large number of companies in deciding on a specific supplier. Apart from the calibration certificate, which is included [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4866,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-4870","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/pages\/4870","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/comments?post=4870"}],"version-history":[{"count":1,"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/pages\/4870\/revisions"}],"predecessor-version":[{"id":4871,"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/pages\/4870\/revisions\/4871"}],"up":[{"embeddable":true,"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/pages\/4866"}],"wp:attachment":[{"href":"https:\/\/www.memmert.be\/en\/wp-json\/wp\/v2\/media?parent=4870"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}