- What is Risk Management?
- Why Perform Risk Management?
- Who requires risk management for Medical Device Manufactures?
- Risk Management Terms
- Risk Management Process
- Tools for assessing risk
- Applications of Risk Management
- What is ISO 14971 Risk Management?
|Risk Management Tools at 13485store.com|
ISO 14971:2007 – Application of risk management to medical devices
Risk Management Exercise and PowerPoint
Risk Management Procedure
Risk analysis is a structured tool for the evaluation of potential problems which could be encountered in many situations (riding in an airplane, taking a drug, or using a medical device.) Risk is everywhere, with varying likelihoods and consequences. Risk analysis is now routinely used during the design phase for medical devices to manage risk.
Risk has two components:
- Probability of the occurrence of harm and its frequency
- Impact of that harm and how severe it might be
- Airplane Crash – Low likelihood, high consequences
- Car Crash – More likely, varying consequences
- Spilling food – high likelihood, low consequences
Three rules of risk management:
- Benefits must exceed cost
- Accept no unnecessary risk
- Make decisions at the appropriate level in the organization
- It is required
- It could save a costs of consequences
- Protection from product liability.
- Regulatory submissions checklists (PMA and 510k) used by the FDA include risk analysis.
Risk Management helps ensure the safety of medical devices. There are many risks associated with the design & production of Medical Devices but also in their use. Risk to safety of patients, users, handlers and Regulatory Product liability must all be managed. ISO 14971 is recognized by:
- Manufacturers must conduct and document a risk management process. ISO 13485 refers to ISO 14971 for guidance related to risk management.
- The U.S. Food and Drug Administration (FDA)
- The EU has made it mandatory.
Here are some of the terms discussed in ISO Guide 73:
BUY ISO Guide 73 – Risk management vocabulary
- Intended Use/Purpose – Intended Use/Purpose Use of a Product, Process or Service in accordance with the specifications, instructions and information provided by the manufacturer.
- Harm – Physical injury or damage to health of people, or damage to property or the environment.
- Hazard – Potential source of Harm.
- Risk – Combination of the probability of occurrence of harm and the severity of harm.
- Residual Risk – Risk remaining after protective measures have been taken.
- Risk analysis – Systematical use of available information to identify hazards and to estimate the risk.
- Risk evaluation – Judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society.
- Risk assessment – Overall process of risk analysis and risk evaluation.
- Risk control – The process through which decisions are reached and implemented for reducing risks to or maintaining risks within specified levels.
- Risk management – Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.
- Risk analysis
- Intended use/intended purpose identification
- Hazard identification
- Risk estimation (likelihood x severity)
- Risk management
- Risk evaluation
- Risk acceptability decisions
- Risk control
- Option analysis
- Residual risk evaluation/Overall risk acceptance
- Post-production information
- Post-product experience
- Review of risk management experience
ISO 14971 provides a framework of risk management activities as applied to medical devices. From initial analysis to risk control & evaluation, the probability and frequency of harm can be assessed, analyzed & managed.
- Risk Matrix
- PHA = Preliminary Hazard Analysis
- FTA = Fault Tree Analysis
- FMEA = Failure Mode Effects Analysis
- HAZOP = Hazard Operability Analysis
- HACCP = Hazard Analysis and Critical Control Point
NOTE: Risk Management Worksheet Required for all operations or training and must be completed during planning phase Reviewed before operations/training
- Premarket Notifications
- Change Control
- Failure Analysis
- and similar applications