[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-245704-105":53,"doc-detail-245704-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","a-model-for-managing-the-risk-of-organisational-change-comah-risk-assessment-case-study","A Model for Managing the Risk of Organisational Change - COMAH risk assessment case study","","The paper presents a case study for implementing a system to manage the risks of organisational change in line with COMAH Regulations at Pharmaron Manufacturing Services UK, a high-hazard pharmaceutical site. It explains why organisational change must be risk assessed, highlights common failure modes in areas such as competence, workload, system adoption, outsourcing, and personnel engagement, and links these failures to severe past incidents and investigations. It then outlines expectations from regulators and HSE guidance for a documented, risk-assessed change process.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/a-model-for-managing-the-risk-of-organisational-change-comah-risk-assessment-case-study/245704/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/a-model-for-managing-the-risk-of-organisational-change-comah-risk-assessment-case-study/245704.png","ImageObject",442,249,{"name":88,"@type":89},"Grenda","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-21","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",13,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What purpose does the organisational change management system serve in the paper?","Question",{"text":109,"@type":110},"It provides a structured approach to assess risks from organisational change and develop an action plan to mitigate them, meeting COMAH regulatory requirements.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Why is organisational change risk assessment especially important for COMAH sites?",{"text":114,"@type":110},"The paper explains that failures in managing organisational change can have detrimental effects in any business, but in high-hazard environments they can lead to catastrophic consequences.",{"name":116,"@type":107,"acceptedAnswer":117},"What expectations are described for managing the risks of organisational change?",{"text":118,"@type":110},"The paper lists requirements such as having a clearly documented standard, risk assessing hazards from proposed changes, identifying Human Factor studies when appropriate, and demonstrating procedure implementation during change management.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},245704,1791746277,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":76},7971474921005,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","A Model for Managing the Risk of Organisational Change  \nLorraine Braben1 & Carolina Padovan Frias2  \n1 Lorraine Braben Consulting Ltd., 2 Pharmaron Manufacturing Services UK  \nSUMMARY  \nThe paper presents a case study for a new system to manage the risk of organisational change in accordance with COMAH Regulations at Pharmaron Manufacturing Services UK, a high hazard pharmaceutical site.  \nKEYWORDS  \nOrganisational Change, COMAH, Risk Assessment  \nIntroduction  \nOrganisational Change is a normal and inevitable part of running a business. Most organisations are in a constant state of change; personnel regularly join, leave or move within the business, internal processes may change, and business pressures initiate reviews to current work practices. Under the Control of Major Accident Hazards (COMAH) Regulations it is a requirement for high hazard process sites to assess the risks arising from such changes and manage them to ensure continued safe operation. Much of the literature on managing organisational change focusses on general management and HR best practice but there is little guidance on how to perform a risk assessment for a high hazard environment. The purpose of an organisational change management system is to provide a system that assesses the risks and develops an action plan to mitigate them. This paper demonstrates how the requirements of the COMAH regulations have been delivered on a pharmaceutical site, Pharmaron Manufacturing Services Ltd., to provide a robust risk assessment which is practical whilst not making excessive demands on the site.  \nPharmaron provides comprehensive pharmaceutical development and manufacturing services on a global basis, offering complete end-to-end chemistry and manufacturing, with a fully integrated platform of services from drug discovery, process development and early-stage active pharmaceuticals ingredient (API) manufacturing, through to commercialisation and large-scale manufacture. The UK site in Cramlington is a lower tier COMAH site, manufacturing APIs and is the only COMAH site within the global organisation.  \nReasons for Implementing an Organisational Change Risk Assessment  \nOrganisational change, large and small, is generally initiated to provide a benefit to the business; for example, restructuring a team or department, implementing a new software system, or developing anew role. Additionally, change may be imposed on the organisation for reasons outside of their control such as new regulations, long-term sickness of key personnel, or staff resignations. In each case, there are many examples where the potential consequences have not been fully considered and the change is poorly managed so it does not deliver as expected. Some typical issues include:  \n• Additional responsibilities are allocated to staff who do not have the competence or experience to handle them effectively.  \n• Workload is increased without considering the impact on existing work responsibilities.  \n• Technical systems are put in without considering the impact on user confidence and time to learn the new system.  \n• Responsibilities are outsourced causing the organisation to lose sufficient understanding of what is being done on their behalf.  \n• The change is implemented without engaging with affected personnel and results in a lack of buy-in to the change.  \nWhilst these types of failure in managing organisational change effectively can have a detrimental effect on any business, for COMAH sites and other high hazard industries they can have catastrophic consequences.  \nPoorly managed organisational change is known to be a contributor to many high-profile incidentsand investigations have demonstrated significant failures in this area, such as:  \n• Hickson & Welch (1992) -A company reorganisation led to an inexperienced team conducting a critical task which led to fires which killed five workers on the site.  \n• BP Texas City (2005) -Staffing cuts at the Texas City refinery meant that there was only ","cbCainds86Sjzfot","https://ap.wps.com/l/cbCainds86Sjzfot","pdf",512735,8,"English","# Introduction\n## Reasons for Implementing an Organisational Change Risk Assessment\n## Expectations for Managing the Risks of Organisational Change","[{\"question\":\"What purpose does the organisational change management system serve in the paper?\",\"answer\":\"It provides a structured approach to assess risks from organisational change and develop an action plan to mitigate them, meeting COMAH regulatory requirements.\"},{\"question\":\"Why is organisational change risk assessment especially important for COMAH sites?\",\"answer\":\"The paper explains that failures in managing organisational change can have detrimental effects in any business, but in high-hazard environments they can lead to catastrophic consequences.\"},{\"question\":\"What expectations are described for managing the risks of organisational change?\",\"answer\":\"The paper lists requirements such as having a clearly documented standard, risk assessing hazards from proposed changes, identifying Human Factor studies when appropriate, and demonstrating procedure implementation during change management.\"}]","A Model for Managing the Risk of Organisational Change - COMAH risk assessment case study | PDF",1789230608]