TAILIEUCHUNG - Guidance for Industry Q9 Quality Risk Management

Most programs can use their own records to obtain outcome information for at least some of their outcome indicators. For example, homeless shelters can track the number of overnight uses of their facilities. Food distribution programs can track the number of meals they provide or the number of different people they serve. And most programs should be able to use their records to track their response times from client request to service provision. Many programs can also use their own records to obtain information on other intermediate outcomes, such as the percentage of youth who completed the scheduled program, and on the performance of youths while in that. | Guidance for Industry Q9 Quality Risk Management . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER June 2006 ICH Guidance for Industry Q9 Quality Risk Management Additional copies are available from Office of Training and Communication Division of Drug Information HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville MD 20857 Tel 301-827-4573 http cder guidance Office of Communication Training and Manufacturers Assistance HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Rockville MD 20852-1448 http cber . . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER June 2006 ICH TABLE OF CONTENTS I. INTRODUCTION 1 .1 II. SCOPE 2 .2 III. PRINCIPLES OF QUALITY RISK MANAGEMENT 3 .3 IV. GENERAL QUALITY RISK MANAGEMENT PROCESS 4 .3 A. Responsibilities .4 B. Initiating a Quality Risk Management Process .4 C. Risk Assessment . 4 D. Risk Control .5 E. Risk Communication .6 F. Risk Review .6 V. RISK MANAGEMENT METHODOLOGY 5 .7 VI. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 6 .7 VII. DEFINITIONS 7 .9 VIII. REFERENCES 8 .11 ANNEX I RISK MANAGEMENT METHODS AND Basic Risk Management Facilitation Failure Mode Effects Analysis FMEA .12 Failure Mode Effects and Criticality Analysis FMECA .12 Fault Tree Analysis FTA .13 Hazard Analysis and Critical Control Points HACCP .13 Hazard Operability Analysis HAZOP .14 Preliminary Hazard Analysis PHA .14 Risk Ranking and Supporting Statistical ANNEX II POTENTIAL APPLICATIONS FOR QUALITY RISK MANAGEMENT. 16 Quality Risk Management

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