Risk management report.docVIP

Risk Management Report on Auto-disable Lancet and Common Lancet Date: May 27, 2013 Prepared by: CX He/QM  Contents 1. Scope 3 2. Definition 3 3. General requirements for risk management 5 3.1 Risk management process 5 3.2 Responsibility and authority 7 3.2.1 Risk management plan preparation: 7 3.3 Risk analysis 7 3.3.1 Risk analysis process 7 3.3.2 Intended use/intended purpose and identification of characteristics related to the safety of the medical devices (Step 1) 10 4. Risk Control 28 4.1 Risk reduction 28 4.2 Option analysis (Step 5) 28 4.3 Implementation of risk control measures (Step 6) 28 4.4 Residual risk evaluation (Step 7) 28 4.5 Risk/benefit analysis (Step 8) 29 4.6 Other generated hazards (Step 9) 29 4.7 Completeness of risk evaluation (Step 10) 34 4.8 Overall residual risk evaluation (Step 11) 35 4.9 Risk management report (Step 12) 36 4.10 Production and post production information (Step 13) 36  Scope This risk management is carried out for Auto-disable Lancet and Common Lancet to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of controls. This report is applicable to all stages of the life-cycle of a medical device in accordance with ISO 14971:2007. Definition Harm: Physical injury and/or damage to health or property. Hazard: A potential source of harm Hazardous situation: Circumstance in which people, property, or the environment are exposed to one or more hazard(s) Risk: The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm Post-production: Part of the life-cycle of the product after the design has been completed and medical device has been manufactured Residual risk: Risk remaining after risk control measures have been taken Risk analysis: The investigation of available information to identify hazards and to estimate risks Risk assessment: Overall process comprising a risk analysis and