Fault Tree Analysis (FTA)
This methodology is particularly useful in the field of safety engineering and in the initial stages of developing a medical product, primarily for the purpose of identifying and prioritizing hazardous situations and for analyzing side effects. At the core of the method is hierarchical graphic drawings of possible failure factors for the purpose of systematic targeting of risk thinking and analysis processes. The diagram includes the analysis of each failure configuration, while trying to identify the possible causes (hardware, software, human error, etc.). Failure factors identified will be classified as primary and sub-factors. The analysis is done “from top to bottom” when the first event is also called a “top event”. During this analysis, medical product systems, subsystems, components, materials, assembly methods, software, etc., are examined. In the graphic description, the main event and the sub-event will usually be identified by defining Boolean operators that link the events and examine the probability of the occurrence of the event. This analysis will ultimately lead to a level that is the possible cause of the failure on which risk control can be applied. This process exposes the components of the system in a systematic, picturesque and logical layout that is easy to understand. The basis for conducting such an analysis requires thorough technical understanding and background on the medical / medical devices / apparatus, its components and systems.
Failure Mode and Effects Analysis (FMEA)
The purpose of the FMEA process is to identify, analyze, and evaluate risks, often associated with the development and production of a medical device, drug or medical product. Examples of risks assessed by FMEA are non-quality product risk and its impact on patient health, risk analysis of medical software, computerized system or application, risk analysis of drug production infrastructure, risk analysis of production system or equipment, risk of nonconformities or deviations, production specifications deviation and analysis of risks that affect the safety of use of the planned or produced product. The goal of risk analysis in the FMEA methodology is to document the potential risks and systematic analysis, and to quantify and rank the risks in order to define priorities for corrective and preventative actions, if required at all (depending on the level of risk). The FMEA process should be conducted in conjunction with the most heterogeneous professional teams (engineering, quality, safety, production, procurement, logistics, etc.) and as much data as possible should be gathered prior to the risk analysis process to be a factual basis for decision making. The risk priority number (RPN) will be determined based on different parameters multiplied by each other. For the most part, risk should be addressed at medium and high rating levels. The treatment of the identified risks will be carried out by defining corrective actions, preventive actions and the addition of appropriate and effective risk controls. The main products of the FMEA process are:
- Identification of risks and failures
- Reduction in the severity of the result of a failure
- A reduction in the probability of failure
- Improve the ability to identify a failure in a timely manner
- Treatment of failures and risks in relevant rankings only
- Defining corrective and preventive actions while monitoring and evaluating effectiveness
Summary and Conclusions
Risk management is primarily a part of the quality culture that must be assimilated among the company’s employees and managers. The risk management approach, as part of the quality system in companies manufacturing medicinal products, medical devices, medical equipment and software, is proactive and preventive, striving for continuous improvement and thus constitutes an important part of quality management in the organization. Risk management is a broad organizational activity that combines the different disciplines to identify, investigate, minimize and control the risks and potential damage to the company. Risk management is a regulatory requirement of the Israeli Ministry of Health, the EU and the FDA, and also appears in ISO 13485, which is an effective tool in quality audits and periodic audits carried out by pharma and medical companies . Failure to comply with periodic audits in general, and with risk management and risk assessment in particular, will prevent the company from supplying its medical products, drugs, and medical devices to the target countries and markets and potentially endanger consumers and/or patients.
The bottom line is that proper management of risks in a company that develops and/or manufactures medical devices and medical products, besides protecting the health and safety of the company’s customers, will also contribute to the company profit line and prevent long-term business shocks.
Biochem has been advising biomedical companies for more than 13 years.
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