{"id":1309,"date":"2023-03-28T23:19:51","date_gmt":"2023-03-28T21:19:51","guid":{"rendered":"https:\/\/bioeducator.eu\/?p=1309"},"modified":"2023-03-28T23:21:49","modified_gmt":"2023-03-28T21:21:49","slug":"wstepna-analiza-ryzyka-idealna-na-start","status":"publish","type":"post","link":"https:\/\/bioeducator.eu\/?p=1309","title":{"rendered":"Wst\u0119pna analiza ryzyka &#8211; idealna na start"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Istnieje wiele metod analizy ryzyka: FMEA, HAZOP, HACCP, <a href=\"https:\/\/bioeducator.eu\/?p=760\">FTA<\/a>. R\u00f3\u017cni\u0105 si\u0119 one od sposobem analizy problemu, obliczeniami i zastosowaniem. Niekt\u00f3re analizuj\u0105 problem odg\u00f3rnie (top-down), przechodz\u0105c od og\u00f3\u0142u do szczeg\u00f3\u0142u, inne oddolnie (bottom-up) od razu skupiaj\u0105c si\u0119 na poszczeg\u00f3lnych elementach procesu. Na wczesnym etapie rozwoju produktu nie posiadamy jeszcze wiedzy na temat tego jak b\u0119dzie wygl\u0105da\u0142 proces produkcyjny lub produkt ko\u0144cowy. Ju\u017c teraz jednak powinni\u015bmy zacz\u0105\u0107 identyfikowa\u0107 ryzyka zwi\u0105zane z produktem i przysz\u0142ym procesem. Z pomoc\u0105 przychodzi wst\u0119pna analiza ryzyka (Preliminary Hazard Analysis, PHA), kt\u00f3rej najwa\u017cniejszym zadaniem jest identyfikacja zagro\u017ce\u0144 i wst\u0119pne oszacowanie ich skutk\u00f3w.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-1024x683.jpg\" alt=\"analiza ryzyka\" class=\"wp-image-1312\" srcset=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-1024x683.jpg 1024w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-300x200.jpg 300w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-768x512.jpg 768w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-391x260.jpg 391w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/thisisengineering-raeng-uOhBxB23Wao-unsplash-1536x1024.jpg 1536w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Na czym polega wst\u0119pna analiza ryzyka?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PHA jest narz\u0119dziem p\u00f3\u0142ilo\u015bciowym. Oznacza to, \u017ce ryzyko oceniamy przypisuj\u0105c rangi np. niskie, umiarkowane, \u015brednie, wysokie. Jest to wystarczaj\u0105ce na wczesnym etapie rozwoju projektu, procesu czy systemu i umo\u017cliwia podj\u0119cie odpowiednich dzia\u0142a\u0144 by ryzyko obni\u017cy\u0107.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Co wa\u017cne PHA jest narz\u0119dziem niezwykle elastycznym, kt\u00f3re mo\u017cna w \u0142atwy spos\u00f3b dopasowa\u0107 do potrzeb projektu czy systemu np. poprzez rozpatrywanie zagro\u017ce\u0144 w r\u00f3\u017cnych kategoriach.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Najcz\u0119\u015bciej PHA prowadzi si\u0119 analizuj\u0105c prawdopodobie\u0144stwo i konsekwencje (nasilenie). Czasami jednak nie posiadamy wystarczaj\u0105cych informacji by oceni\u0107 prawdopodobie\u0144stwo wyst\u0105pienia ryzyka. Taka sytuacja mo\u017ce si\u0119 zdarzy\u0107 na bardzo wczesnym etapie projektu, gdy nasza wiedza nie jest jeszcze wystarczaj\u0105co du\u017ca. W takim przypadku prawdopodobie\u0144stwo mo\u017cemy zast\u0105pi\u0107 niepewno\u015bci\u0105.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jak przeprowadzi\u0107 wst\u0119pn\u0105 analiz\u0119 ryzyka.?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Jak ka\u017cd\u0105 analiz\u0119 ryzyka, r\u00f3wnie\u017c PHA zaczynamy od utworzenia zespo\u0142u. Powinien by\u0107 on jak najbardziej r\u00f3\u017cnorodny by na ka\u017cd\u0105 spraw\u0119 spojrze\u0107 z punktu widzenia os\u00f3b z r\u00f3\u017cnym do\u015bwiadczeniem. Spo\u015br\u00f3d zespo\u0142u wybieramy lidera, kt\u00f3ry b\u0119dzie moderowa\u0142 dyskusj\u0119 i proces burzy m\u00f3zg\u00f3w. Nast\u0119pnymi etapami s\u0105:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ol class=\"wp-block-list\">\n<li>Formu\u0142owanie problemu<\/li>\n\n\n\n<li>Opracowanie sposobu przypisania rang i obliczania ryzyka<\/li>\n\n\n\n<li>Burza m\u00f3zg\u00f3w \u2013 identyfikacja zagro\u017ce\u0144<\/li>\n\n\n\n<li>Szacowanie ryzyka<\/li>\n\n\n\n<li>Opracowanie strategii obni\u017cenia ryzyka.<\/li>\n<\/ol>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"2400\" height=\"1350\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited.jpg\" alt=\"brainstorm\" class=\"wp-image-1313\" srcset=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited.jpg 2400w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited-300x169.jpg 300w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited-1024x576.jpg 1024w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited-768x432.jpg 768w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited-1536x864.jpg 1536w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/jason-goodman-Oalh2MojUuk-unsplash-edited-2048x1152.jpg 2048w\" sizes=\"auto, (max-width: 2400px) 100vw, 2400px\" \/><\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n<ol class=\"wp-block-list\" type=\"1\">\n<li><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Warto zwr\u00f3ci\u0107 uwag\u0119 na ostatni punkt. Celem ka\u017cdej analizy ryzyka jest identyfikacja zagro\u017ce\u0144 i opracowanie sposobu ich obni\u017cenia. Z tego powodu punkt pi\u0105ty jest niezwykle istotny i nie powinno si\u0119 go pomin\u0105\u0107.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jak obliczy\u0107 ryzyko w analizie PHA?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">We wst\u0119pnej analizie ryzyka, ryzyko oceniamy najcz\u0119\u015bciej bior\u0105c pod uwag\u0119 dwa czynniki: prawdopodobie\u0144stwo i nasilenie. Najprostszym sposobem jest wi\u0119c stworzenie dwuosiowej matrycy. Na jednej osi znajdzie si\u0119 prawdopodobie\u0144stwo, na drugiej nasilenie. Matryca mo\u017ce by\u0107 zaprojektowana w zale\u017cno\u015bci od potrzeb. Mo\u017cna zmienia\u0107 ilo\u015b\u0107 rang w ka\u017cdej osi, zakres przypisywanej punktacji. Nale\u017cy to uzgodni\u0107 na samym pocz\u0105tku analizy ryzyka po sformu\u0142owaniu problemu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Je\u017celi uznamy np., \u017ce nasilenie b\u0119dzie mia\u0142o mniejszy wp\u0142yw na ryzyko ni\u017c prawdopodobie\u0144stwo punktacja mo\u017ce wygl\u0105da\u0107 np. tak: nasilenie 1-5, prawdopodobie\u0144stwo 1-15. Wtedy obliczaj\u0105c ryzyko, prawdopodobie\u0144stwo b\u0119dzie mia\u0142o wi\u0119kszy wp\u0142yw na ostateczny wynik.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Poni\u017cej dwa przyk\u0142ady obliczenia ryzyka w PHA:<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"394\" src=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/analiza-PHA-1024x394.png\" alt=\"Wst\u0119pna analiza ryzyka\" class=\"wp-image-1315\" srcset=\"https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/analiza-PHA-1024x394.png 1024w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/analiza-PHA-300x115.png 300w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/analiza-PHA-768x295.png 768w, https:\/\/bioeducator.eu\/wp-content\/uploads\/2023\/03\/analiza-PHA.png 1110w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\">Szacowanie ryzyka w technice PHA.<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Zalety wst\u0119pnej analizy ryzyka<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Wst\u0119pna analiza ryzyka ma wiele zalet, dzi\u0119ki kt\u00f3rym jest cz\u0119sto stosowana, bez wzgl\u0119du na ga\u0142\u0105\u017a przemys\u0142u i analizowane problemy. Nadaje si\u0119 do wielu zastosowa\u0144, nie tylko w rozwoju produkt\u00f3w czy proces\u00f3w. \u015awietnie sprawdza si\u0119 wsz\u0119dzie tam, gdzie kluczowym zadaniem jest identyfikacja zagro\u017ce\u0144 i opracowanie planu ich mitygacji. Jest wi\u0119c \u015bwietnym narz\u0119dziem do zastosowa\u0144 na poziomie korporacyjnym czy biznesowym. Typowym przyk\u0142adem jej zastosowania spoza \u015bwiata in\u017cynierii i rozwoju jest analiza ryzyka zwi\u0105zana z ochron\u0105 danych osobowych.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">W\u015br\u00f3d najwa\u017cniejszych zalet PHA mo\u017cna wyr\u00f3\u017cni\u0107:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Du\u017ca elastyczno\u015b\u0107 narz\u0119dzia<\/li>\n\n\n\n<li>Mo\u017cliwo\u015b\u0107 zastosowania ju\u017c na wczesnym etapie<\/li>\n\n\n\n<li>Proaktywno\u015b\u0107 \u2013 mitygacja ryzyka ju\u017c na wczesnym etapie projektu i rozwoju<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Zastosowanie wst\u0119pnej analizy ryzyka<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Wst\u0119pna analiza ryzyka ma zastosowanie w wielu obszarach i jest wykorzystywana przez wiele ga\u0142\u0119zi przemys\u0142u, przede wszystkim wsz\u0119dzie tam gdzie istnieje wysokie ryzyko operacyjne. Znalaz\u0142a zastosowanie w przemy\u015ble lotniczym, gazowym, rafineryjnym i oczywi\u015bcie farmaceutycznym.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dzi\u0119ki swojej prostocie ma zastosowanie przede wszystkim na pocz\u0105tku projektu, gdy nie posiadamy wystarczaj\u0105cej ilo\u015bci danych i wiedzy by u\u017cy\u0107 innych, bardziej zaawansowanych technik. Wykorzystanie PHA daje wiele korzy\u015bci m.in.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Wczesna identyfikacja zagro\u017ce\u0144 \u2013 od pocz\u0105tku projektu uczestnicy maj\u0105 pe\u0142n\u0105 \u015bwiadomo\u015b\u0107 zmiennych i zagro\u017ce\u0144, kt\u00f3re mog\u0105 napotka\u0107.<\/li>\n\n\n\n<li>Zwi\u0119kszone bezpiecze\u0144stwo \u2013 ju\u017c od pocz\u0105tku realizacji projektu mo\u017cna rozpocz\u0105\u0107 eliminacj\u0119 zagro\u017ce\u0144.<\/li>\n\n\n\n<li>Redukcja koszt\u00f3w \u2013 dzi\u0119ki identyfikacji zagro\u017ce\u0144 na wczesnym etapie pozwala zmniejszy\u0107 koszty zwi\u0105zane z ich eliminacj\u0105 na p\u00f3\u017aniejszym etapie realizacji projektu.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ciekawym zastosowaniem PHA jest jej u\u017cycie do <a href=\"https:\/\/bioeducator.eu\/?p=1143\">oceny krytyczno\u015bci cech jako\u015bciowych<\/a>. Jest to zabieg niezwykle istotny w rozwoju procesu wytwarzania i budowaniu strategii analitycznej. Zwi\u0105zany jest on z zastosowaniem projektowania jako\u015bci w rozwoju lek\u00f3w i wykonuje si\u0119 go na r\u00f3\u017cnych etapach rozwoju produktu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Je\u015bli wi\u0119c rozpoczynasz rozw\u00f3j nowego produktu czy procesu ju\u017c wiesz, \u017ce wykonanie analizy ryzyka technik\u0105 PHA jest jedn\u0105 z pierwszych rzeczy, kt\u00f3re powiniene\u015b wykona\u0107. Pozostaje mi \u017cyczy\u0107 Ci powodzenia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Literatura:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q9%28R1%29_Guideline_Step4_2023_0126_0.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ICH Q9 &#8211; Quality Risk Management<\/a><\/li>\n\n\n\n<li><\/li>\n<\/ol>\n\n\n\n<div class=\"mec-wrap mec-skin-carousel-container \" id=\"mec_skin_295\">\r\n        <div class=\"mec-skin-carousel-events-container\" id=\"mec_skin_events_295\">\r\n        Nie odnaleziono wydarze\u0144!    <\/div>\r\n    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Istnieje wiele metod analizy ryzyka: FMEA, HAZOP, HACCP, FTA. R\u00f3\u017cni\u0105 si\u0119 one od sposobem analizy problemu, obliczeniami i zastosowaniem. Niekt\u00f3re analizuj\u0105 problem odg\u00f3rnie (top-down), przechodz\u0105c&hellip;<\/p>\n","protected":false},"author":1,"featured_media":1312,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","footnotes":""},"categories":[207,166,168],"tags":[],"class_list":["post-1309","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-analiza-ryzyka","category-quality-by-design","category-zarzadzanie-jakoscia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wst\u0119pna analiza ryzyka - idealna na start - Bioeducator.eu<\/title>\n<meta name=\"description\" content=\"Wst\u0119pna analiza ryzyka (Preliminary Hazard Analysis) to technika stosowana na pocz\u0105tku projektu. 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