Operating Model
Transcript: GOSO OPERATING MODEL Right to Operate Right to Operate One key element of robust Quality Systems, and Products is the analysis and mitigation of risk One widely employed tool is the use of Failure Mode Effects Analysis. As our businesses grow in this new high technology environment - Cyber Security is the new and growing threat. A key customer request of suppliers today is to have a Business Continuity Plan to help identify, mitigate and plan for events that may disrupt supply of products to the market. Background Risk Analysis/ Compliance Process Product Business Inputs Input, Process, Output Details FMEA Process Process pFMEA dFMEA Business Continuity Plan Output Output According to the principles of a sustainable development Roche is striving for a continuous improvement in the areas of safety, security, health and environmental protection. This can be achieved by changing behavior, by adapting equipment to the most recent standards, and developing new innovative processes. However, a sustainable effect can only be obtained within a longer time frame. For RSS, our SHE Officers include: Michelle Venturini – SHE Officer, Madison Minh Cao – SHE Officer, San Jose Sridhar Agraharam – SHE Officer, Santa Clara Varsha Premsagar – SHE Officer, Cape Town Background SHE Standards Roche SHE - K Directives http://we.intranet.roche.com/sites/she/services/group_she_documents/group_directives/pages/default.aspx REACH http://ec.europa.eu/environment/chemicals/reach/reach_en.htm California Prop 65 https://oehha.ca.gov/proposition-65 Inputs Input, Process, Output Details SHE Safety Audit Property Loss (XL Gaps) Audit Process Process Audit Report SHE Handbook Safety Procedures Safety Work Environment Outputs Output Quality pays – naturally for patients, but also for the overall quality of the healthcare system. Roche is continuously working on the production of safe, effective and high-quality products and services which are in harmony with valid regulations. At all Roche sites, we adhere to strict quality standards at every organizational level, including, for example, plant technology or occupational or site safety. It is not only all our employees who are committed to adhering to and working toward attaining our quality goals, our quality systems are also checked regularly and optimized. Background Quality Standards & Audits Inputs Input, Process, Output Details Click the hexagons to get links of supporting documents. Quality System Internal Auditing QSIT https://www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm List and Link of Process Process Audit Reports ISO/MDSAP Certificate Robust Quality System Outputs Output Documents Links Divisional Quality Standards: http://we.intranet.roche.com/sites/DIA-QR/content/GQR-Tools/Pages/Directives-Standards-Guidelines-New-Documents.aspx ISO 13485 V 2016 https://www.iso.org/standard/59752.html FDA CFR Part 820 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm MDSAP https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm Manuals List of Manuals RSS SJ Quality Manual Global Operations highest priority goal is to provide a planned, predictable continuous supply of quality products to our customers. Growth is driven by the introduction of new products into the production plant. Background Product Manufacturing Product Forecast Customer Requirements Product Requirements Input Input, Process, Output Details Planning, Production and Testing Product Development Process (PDP) Process Process Quality Product DMRI - New Product Output Output People PEOPLE Human Resources business processes for finding, developing and enabling our highly capable people and talent include: 1. Short-Term Assignment Board http://na.intranet.roche.com/sites/sequencing/content/functions/operations/pages/default.aspx 2. Talent Assessment and Succession Planning http://we.intranet.roche.com/sites/GroupHR/projects/hr-excellence/commmaterials/Pages/Learning-Burst-4.1.aspx 3. Career Development site http://cts.vresp.com/c/?RocheTissueDiagnosti/ce44fe44be/TEST/23bb6a711a 4. People Practices (Including Check-Ins, People Development, Staff Ratings) http://we.intranet.roche.com/sites/GroupHR/services/PeoplePracticesPublishing/Pages/LandingPage.aspx 5. Jobs @ Roche http://we.intranet.roche.com/t/en/SitePages/Services.aspx?TagId=ri88581 Background Highly Capable People List of Documents 1. RocheNet Site for Operations Inputs Input, Process, Output Details http://na.intranet.roche.com/sites/sequencing/content/functions/operations/pages/default.aspx 2. Employee Resource Page http://na.intranet.roche.com/sites/sequencing/content/functions/Operations/Pages/Administration.aspx Process Output Output Development Plan: https://docs.google.com/document/d/1pmCBWAanAmCPGWLiuZfW6KDqFBQLPtCdJbORCBqnAak/edit?usp=sharing Please refer to Roche Intranet for background on GEOS. Strategic Human