Presented By: Elise Vallet P4 –The Road to Better Risk Identification and Root Cause Analysis EliseVallet AssociateVicePresident,Global QualityRiskManagement, Sanofi 1 SANOFI KEY FIGURES Present in 40countries 4 bn Boxes produced and distributed per year A global healthcare company engaged in the research, development, manufacturing and marketing of healthcare solutions. ~85 bn 112 Galenic units produced per year Industrial sites 45 000 Employees in Industrial Affairs 110 000 employees 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management P4 –The Road to Better Risk Identification and Root Cause Analysis Manufacturing an extremely diverse products portfolio ….. CONSUMER HEALTHCARE RARE DISEASES NUTRACEUTICALS COSMETICS GENERICS MEDICAL DEVICES DIABETES VACCINE MEDICINAL PRODUCTS HUMAN VACCINES INNOVATIVE PRODUCTS ANIMAL HEALTH Quality Risk Management scope within Sanofi All entities, all product types 112 manufacturing sites , 430 CMOs, 50 Distribution centres, 150 commercial affiliates and 26 R&D sites Cosmetics, Neutraceuticals, Generics, CHC, Solid and Injectable drugs, Rare disease , Vaccines Quality Risk Management is integrated in all Quality Systems Dedicated organization Dedicated processes and tools A philosophy based on full transparency 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management Presented By: Elise Vallet P4 –The Road to Better Risk Identification and Root Cause Analysis Dedicated organization A fully integrated network of dedicated managers to lead QRM into the Quality systems within the Quality operations A network of ~300 trained champions on the field to develop and maintain sustainable risk awareness A strong interactive network to continuously improve the QRM system ~ 300 people ~ 25 people Answer site needs Train site personnel Be the expert Support & advice Collect site needs & experience Be part of the network Site RM focal point Share experiences Site Ops Units Critical Risk Management tool QRM Customers /operations needs Training modules QRM network M ANPOWER MEAN S MEDIA 1 2 3 QRM systems & development e-room Global QRM tools & approaches 3.1---- physical working conditions ( noise , temperature, li ghting, tidying …) 3.2---- relational working conditions (working atmosphere, urgence , 2.1 ---- manufacturing, packaging and/or hierarchic al relat io nship , coworkers relationship, counterorder….) 1. 5----mistake, omiss ion analysis equipment and their confusion, carelessness, 3.3---- manufac toring,packaging,sampling workshops, warehouse, la boratory instruments of control : calibration, negligenc e. environement: temperature , humidity , light , Tidying… qualification, mai ntenance 1.4---- numbers (adpated 2.2 ---- other assiociated control equipment to the job) NO N-C OMPLIANC E : like: weighing machine, pH met er, … 1.3---- medical aptitude A. Con fusi on 2.3 ---- utilities equipment for compressair, 1.2 ---- training, know-how, steam, water , electricity : adequate B. Wro ng or mi ssi ng pri nting abilit y, certificat ion capacity, calibration, qualif icat ion, C. Wro ng quantiti es 1.1---- technical , GxP rules , saf et y, maintenance … D. Wro ng com ponent knowledge E . Deviation in the manufacturi ng operation F. Non-compl iance to the specifications of theMarketin g Auth orizati on : 5.8---- Ut ilities : wat er , steam , activi ty, aspect, purity, stability … electricity, compress air ,… G. Other deviation 5.7---- sample for control 5.6---- fi ni shed products aft er rele ase 6.8---- SOPsdescri bingprocessus 5.5---- finished productbefore release 6.7---- organization SOPs 5.4----S emi-finished product sbef ore the 6.6---- st orage instructions sec ondary pack aging 6.5---- process, cleaning, analytical validations 4.3---- anal ytical t rend analysis 5.3----Bulks before the primarypac kaging 6.4---- analy tical instructions 4.2---- calculation 5.2---- On-going products at the preparation 6.3---- SOPs / inst ructions of use of equipment 4.1---- qualityof data . 5.1---- Rawmaterials, process water , 6.2---- inst ructions of pack aging, manufacturing, cleaning pack aging materials. 6.1---- instruc tions of reception, sampling ME AS URES MATERI ALS METHODS 4 5 6 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management Presented By: Elise Vallet P4 –The Road to Better Risk Identification and Root Cause Analysis Dedicated processes and tools Escalation of Quality events process at the heart of QRM to proactively identify potential Quality risks from the field A standardized process for the evaluation and communication of risks at the right level of management A system of alerts management for a multi‐disciplinary coordinated approach and timely risk treatment Risk Management Reporting of critical quality risks with mitigation plans for integration into decision‐making and priority setting . RQN Risks Alerts Risk Management Report (RMR) for each Operational Unit Moderate Low Low or moderate level of control Quality LRP package For each Operational Unit Long Range Plan Senior Management of Operations 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management Presented By: Elise Vallet P4 –The Road to Better Risk Identification and Root Cause Analysis One integrated IS platform 5 interconnected modules for managing Quality systems including QRM Worldwide system deployed in all entities ● Quality Risk Management, ● Quality Third Party Management (subcontractors, suppliers, service providers), ● Audit Management , ● Events and associated CAPAs Management , ● Change control management QRM framework Consolidation of a Bottom‐up and Top down risk management process Risks ultimately managed at the lowest level for ownership and mitigation Integration of risks management at the strategic and tactical level Global Quality Risk areas Risk Profile Interviews Risk domains assessment Global level Trend analysis of Risk domains (Qualitative & Quantitative) Operational Q‐RMR Manufacturing sites, Supply Chain, R&D, IS, Commercial Operations Operational level PHENIX QRM Module (database) 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management Presented By: Elise Vallet P4 –The Road to Better Risk Identification and Root Cause Analysis Our strategy : “Drive the move towards a risk aware mindset in which risk management is an integrated part of the way we do business” Thank you Elise Vallet Associate Vice‐President Global Manufacturing Quality Operations Sanofi [email protected] 2014 PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management Presented By: Elise Vallet
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