Risk Management System 风险管理系统

Planning is essential before conducting Risk Management
Define Process [3.1]
Process must be established documented, maintained, consider life-cycle, analysis, evaluation, control, production and post-production
• Top Management Involvement with Risk Management
• Effective planning is required [a distinct area of focus] • ’do no harm’-residual risk will not be zero but benefits must outweigh residual risks • Final report Before going to market
Background of Risk Management
Applicability of ISO 14971:2007
• Regulators view is that the Manufacturer is responsible to ensure a safe Medical Device
• IEC 60812 • ISO 14969 • IEC 61025 • ISO 9000-3 • IEC 60300-3-9 • IEC/TR 60513 • EN 12442-1 • And more to come!
In 2003, there were 8 technical or QS standards which had incorporated risk analysis into the process.
• Can be used to develop a systematic process:
To identify the hazards associated with medical devices
To Estimate and evaluate the risks
To Control these risks To Monitor the effectiveness of the control Applied to all stages of the life cycle of a medical device Which can be an integral part of a quality system
Determination of Requiremrnt Review of Requirement Customer Comms
Ops Control Valid of Processes Ident & Tracability Customer Property Pres of Product
“Organizations are usually weak in the area of considering the life-cycle. Risk Management is many times incorrectly limited to Design Control and Complaints or CAPA”
Planning of product realisation Control of Measuring & Monitoring Devices
Customer Related Processes
Design and/or Development
Purchasing
Product & Service Operation
Products for Health Care Sector-Top Management Sets policy for Acceptable Risk
Regulators and Customers
Development Cycle
Needs Assessment
Regulators and Customers
• An increasing number of Technical Standards require RM • It is acknowledged that there is some risk associated with use of medical devices Manufacturers must manage the risk • Risk needs to be considered with respect to the patient, the care-giver and the environment
Applicability of ISO 14971:2007
• The way a risk is perceived also takes into account:
Whether exposure to the hazard seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society. Residual risks need to be balanced against the anticipated benefits of the medical device. Such judgments should take into account the intended use, performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure or the circumstances of use. That some judgments can be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient or the patient’s own opinion
by Tom Kahrmann, Sr. Medical Device Manager, BSI
Discussion Points
• Background of Risk Management • Risk Management 2007, features and changes • 7 Pitfalls to Avoid in Implementing Risk Management • Risk Management Certification
Risk Management 2007
Features of new version
• Life Cycle-from initial concept to final decommissioning and disposal • Robust process definition is needed, and new standard is based on the process model
International Standards Incorporating Risk Management:
• IEC 60601-1:2005 • ISO TS 20993
• ISO 14155 • IEC TS 80002 • IEC 62304 • TEC TS 80001 • IEC 62366 • ISO 13485
Applicability of ISO 14971:2007
• BS EN ISO 14971:2007is a state-of-the-art risk management standard taking into account the factors just mentioned
Applicability of ISO 14971:2007
Resource management
Measurement, analysis and improvement
Feedback
Input
Requirements
Product realization
Output
Product
Medical Device Technology Life Cycle
Risk Management Process
Evidence of Top Management Commitment Demonstrated [3.2]
Qualification of personnel [3.3]
Assignment of qualified personnel Define acceptability policy Periodically review the process Measure effectiveness
Process Approach-9001/13485
Maintaining the Effectiveness of the Quality Management System
Regulators and Customers
Management responsibility
Regulators and Customers
End-of-life Cycle
Feedback
Input
Manufacturing/
Output
Requirements
Utilization Cycle Risk Management
Product

‘throughout’ Product realisation?
Management Systems
Applicability of ISO 14971:2007
• It is not required that the manufacturer have a QMS or certification in any other standard
• Good news: the new standard can be applied to other healthcare industries as informative guidance. While geared toward manufacturers, this could include; Human tissue manufacture Animal care feed and health care products Pharmaceutical manufacturers Etc.
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Risk Management for Medical Devices: ISO 14971:2007