ITRiskManagement计算机风险管理研讨.pptx

;2;An Example from the beginning;CHAZOP Control System Hazards and Operability Studyo Computer Hazards and Operability Study;Time goes ahead… a new …?philosophy?;NOT NEGLECTING ANY ASPECT OF THE PROBLEM;Terminologies sometimes misused;Multidisciplinary Team;PREVENTIVE APPROACH; General Case;Risk Management - Methologies;A fundamental referenceISO ?Family? 31000;Scheme;14;Categorizing techniques into: LOOK-UP METHODS SUPPORTING METHODS SCENARIO ANALYSIS FUNCTION ANALYSIS CONTROLS ASSESSMENT STATISTICAL METHODS;;GMP – ?Quality Risk Management?;Scheme;ICQ Q9 - Contents;ICH Q9 Annex 1 – Suggested methodologies;Q9 Annex II: Potential applications for quality risk management;;Q9 II.4 QRM for facilities, equipment and utilities;Revised Annex 11;Annex 11 - Risk Management;;Objectives;GAMP 5: Chapter 5 e Appendix M3 Science Based Quality Risk Mgmnt; ;GAMP – FMECA;Risk Management ; ;Risk Management;Risk Management;Risk Management; Functional Risk Management;Process RiskMgmnt;Conclusions;Risk Management is NOT about: ? making do with insufficient time, money, or people ? providing an excuse not to do the right things ? deciding what to do based on what might be observed during an inspection. Risk Management does NOT provide an excuse to be out of compliance with applicable regulations.;Risk Management IS about: ? knowing the processes, ? understanding what’s truly important, ? not spending time on a low risk activity, process, event, or system BECAUSE IT JUST DOESN’T MATTER! ? focusing our money, time, energy, and people on the things that are really important; ? focusing our efforts and resources on the things that provide quality assurance to customers.; Everything done to same level of detail despite level of risk (tends to be high level of detail) Supplier activity/deliverables (reworked) ;Thank You very Much For any kind of Question: Annalidia.vignoli@