リスク管理
Oracle’s Risk Management Resiliency Policy defines requirements and standards for all Oracle Lines of Business (LOBs) plans for and response to business disruption events. It also specifies the functional リスク管理 roles and responsibilities required to create, maintain, test, and evaluate business continuity capability for Oracle across lines of business and geographies. It authorizes a centralized Risk Management Resiliency Program (RMRP) Program Management Office (PMO) リスク管理 and defines the compliance oversight responsibilities for the program. The policy mandates an annual operational cycle for planning, evaluation, training, validation and executive approvals for critical business operations.
Risk Management Resiliency Program
The Risk Management Resiliency Program (RMRP) objective is to establish a business-resiliency framework to help provide an efficient response to business interruption events affecting Oracle’s operations.
The RMRP approach is comprised of several sub-programs: , initial emergency response to unplanned and emergent events, crisis management of serious incidents, Information Technology Disaster Recovery and business-continuity management. The リスク管理 goal of the program is to minimize negative impacts to Oracle and maintain critical business processes until regular operating conditions are restored.
Each of these sub-programs is a uniquely diverse discipline. However, by consolidating emergency response, crisis management, business continuity, and disaster recovery, they can become a robust collaborative and communicative system.
Oracle’s RMRP is designed to engage multiple aspects of emergency management and business continuity from the onset of an event and to leverage them based on the needs of the situation.
The RMRP is implemented and managed locally, regionally, and globally. The RMRP program management office provides executive scorecard reporting on リスク管理 リスク管理 リスク管理 program activities and status within the lines of business.
New ISO 14971: Updates for Risk Management
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes on the risk management process was defined, a substantial re-organization of the standard was performed.
Click here for a Risk Management Procedure aligned with the new ISO 14971:2019.
This includes new terms and more detailed リスク管理 requirements on post-market risk management have been included.
One big substantial changes is related to the annexes of the standard. The last revision contains only three annexes, whereas the remaining ones have been moved to Technical Report (TR) 24971, which is expected to be published in 2020. Specifically, the annexes that remained within ISO 14971 are:
- rationale for requirements,
- risk management process,
- and fundamental risk concepts.
It is expected that TR 24971 will become essential for risk management for medical devices and it will contain all the annexes which are not currently present on ISO 14971.
One of the key リスク管理 activities related to risk management is the risk analysis. There are different methodologies to perform a risk analysis, one of them is the so-called FMEA – Failure Mode Effect Analysis.
General Overview of the ISO 14971:2019
Particular attention was paid on the newly updated ISO 14971:2019 on the benefit-risk analysis リスク管理 of medical devices, so to align the standard with EU MDR (2017/745) and IVDR (2017/746). The new ISO 14971 now requires to perform an assessment of overall residual risk and to determine the criteria for risk acceptability. The methodology to assess the acceptability of the overall residual risk can be different from the acceptability criteria of individual risks.
New terms and definition was also added in the new standard, including benefit, state of the art and reasonably foreseeable misuse.
Important updates was given on cybersecurity side, reinforcing the importance to evaluate the security-related risks that come from connected devices. This attention to cybersecurity is aligned with FDA and other regulatory agency behavior, that in last years have increased the focus リスク管理 on medical device cybersecurity.
Overview of the Risk Management Process
The overall risk management process can be described by the scheme below:
Basically, the risk management process has the goals of
- identification of hazards and hazardous situation
- estimation and evaluation of the risks
- Risk control
- monitoring and effectiveness of the risk control measures
Risk Management Plan
The risk management plan is one of the most important documents of the risk management process. Here below, I summarise within the following table the main contents of the risk management plan:
| Content of the Risk Management Plan |
|---|
| Scope of Risk Management Activities |
| Responsibilities and Authorities |
| Requirements for review of リスク管理 Risk Management Activities |
| Criteria for Risk Acceptability |
| Method for evaluation of the residual risk |
| Methods for verification of リスク管理 リスク管理 risk control measures |
| Post-production risk management activities |
Risk Control according to ISO 14971
Risk Control Measures
We are going to talk about only specific steps of the risk management process. One of them is the リスク管理 Risk Control part of the process.
Risk control options are of fundamental importance in order to reduce the risks. it is essential that risk control measures are going to be implemented following a specific リスク管理 リスク管理 priority order:
- inherently safe design and manufacturing of the device
- protective measures in the medical devices itself or in the manufacturing process
- information for safety and / or training;
When risk reduction through implementation リスク管理 of risk control measures are not feasible, a benefit risk analysis shall be performed and the residual risk shall be evaluated.
Verification of the risk control measures
All the risk control measures which are identified need to implemented and verified. The type of verification performed depends of course on the nature of リスク管理 the risk control measures; typically it can be done through a specific tests, visual inspection, validation activities, etc. It is possible, of course, to combine verification activities conducted in the framework of the design process リスク管理 リスク管理 with verification of the effectiveness of the specific risk control measure.
Residual Risk Evaluation
After the implementation of the risk control measure, the residual risks shall be evaluated by comparing it with the risk acceptability threshold defined in the risk analysis.
It is important to mention that any type of risks need to be reduced as far as possible, including risks that by nature are relatively low. In any リスク管理 case, after the implementation of risk control measures, it is not possible to have any unacceptable risks defined in the risk analysis. If, during lifetime of a device, an unacceptable risk came up, actions on the field (recall, safety notice) shall be implemented to immediately reduce this risk to an acceptable level.
Benefit-Risk Analysis
In case a residual risk is not evaluated as acceptable, a benefit-risk analysis shall be documented リスク管理 to demonstrate that the benefits of the intended use outweight this residual risk.
Risks arising from risk リスク管理 control measures and review of risk control measures
The effect of risk control measures shall be reviewed to evaluate whether new hazards have been introduced and if the risk control measure affects the estimation of リスク管理 the risks for previously identified hazardous situations.
Moreover, the risk control activities shall be reviewed to make sure that these activities are competed and all the risks associated to the identified hazardous situations have been identified.
Conclusions
The most important updates on the newly ISO 14971 is the post-market risk management section. Specifically clause 10 of the standard have been renamed Production and post-production activities and it is now more aligned with Clause 8 of ISO 13485. Clause 10 highlights the necessity of an active process for post-market risk management. It establishes a system to collect production and post-production information and evaluate this information リスク管理 from risk point of view. A very interesting document on postmarked risk management is the one published by リスク管理 リスク管理 AAMI .
In conclusion, the updated ISO 14971 for medical device risk management along with New ISO 20471 on labelling requirements will become important tools for Medtech companies to foster product safety and regulatory compliance.
QualityMedDev Risk Management Documentation
Nobody can deny the importance of risk management in the medical device field. The リスク管理 リスク管理 regulation in the last 10 years shifted completely towards a situation where risk management process is at the core of quality management system and technical documentation for medical devices. In order to support the implementation of an efficient risk management process, QualityMedDev provides different documentation which can definitely help your organization in the implementation, reorganisation or improvement of risk management. In fact, in the QualityMedDev DocShop, the following documentation can be downloaded:
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, to ensure that the risk management process is well defined within your Quality Management System , which can be used as starting point for the practical implementation of the risk management process , which provides you a great example of template that can be used for your risk analysis.
Moreover, QualityMedDev has recently published an e-book focused on risk management process for medical device sectors. Check it out here below and fell free to download it !
QualityMedDev Newsletter
QualityMedDev is an online platform focused on Quality & Regulatory topics for medical device business; Follow us on LinkedIn and Twitter to stay up to date with most important news on the Regulatory field.
QualityMedDev is one of the largest online platform supporting medical device business for regulatory compliance topics. We provide regulatory consulting services over a broad リスク管理 range of topics, from EU MDR & IVDR to ISO 13485, including risk management, biocompatibility, usability and software verification and validation and, in general, support in preparation of technical documentation for MDR.
If you リスク管理 have any topic for which you would like to have more information or you need template or documentation リスク管理 that is currently not available in our QualityMedDev Shop, do not hesitate to contact us and we will do our best to fulfil your request.
Recently we introduced our Compliance Kits related to EU MDR 2017/745 and post-market surveillance activities. These compliance kits include different guidelines, ebooks, templates and procedures that リスク管理 are essentials.
Moreover, do not hesitate to look at our EU MDR E-book collecting a vast number of information on topics related to the European Medical Device Regulation.
リスク管理
Automating Third-Party Security Risk Management
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NTT東日本、リスク管理会社「NTT Risk Manager」を設立、東京海上日動とトレンドマイクロが共同出資
NTT東日本は2022年6月15日、新会社「NTT Risk Manager」（東京都新宿区）を同年7月1日に設立すると発表した。ユーザー企業のリスク管理に必要な要素をワンストップで提供する会社であり、当面の事業内容は、コンサルティング、損害保険の販売、リスク対策サービスの開発・提供、の3つ。コンサルティング以外の要素については、共同出資会社である東京海上日動火災保険およびトレンドマイクロのアセットと知見を活用する。資本金は2億5000万円で、出資比率は非公開だが、NTT東日本が過半数を占める。販売目標は3年後に20億円程度（コンサルティングが7割、保険が1割程度を見込む）。
NTT東日本は、ユーザー企業のリスク管理に必要な要素をワンストップで提供する新会社「NTT Risk Manager」（東京都新宿区、図1）を2022年7月1日に設立する。当面の事業内容は、コンサルティング、損害保険の販売、リスク対策サービスの開発・提供、の3つ（図2）。
図1：新会社「NTT Risk Manager」のロゴ（出典：NTT東日本）
図2：新会社「NTT Risk Manager」の事業内容（出典：NTT東日本）
拡大画像表示
コンサルティング以外の要素については、共同出資会社である東京海上日動火災保険およびトレンドマイクロのアセットと知見を活用する。新会社の概要は記事末の表1の通り。資本金は2億5000万円で、3社による出資比率は非公開だが、NTT東日本が過半数を占める。
販売目標は3年後に20億円程度（コンサルティングが7割、保険が1割程度を見込む）。会社の規模は、初年度10人弱、5年後に30人強を予定する。新会社の代表取締役社長には、一ノ瀬勝美氏（現職は、NTT東日本 ネットワークセキュリティ推進室 室長）が就任する予定（写真1）。
写真1：写真左から、NTT東日本 経営企画部営業戦略推進室室長の加藤成晴氏（出資会社代表者）、新会社の代表取締役社長に就任予定の一ノ瀬勝美氏（現職は、NTT東日本 ネットワークセキュリティ推進室 室長）、新会社の代表取締役副社長に就任予定の白石涼子氏（現職は、NTT東日本 経営企画部営業戦略推進室担当部長）
NTT東日本、リスク管理会社「NTT Risk Manager」を設立、東京海上日動とトレンドマイクロが共同出資
NTT東日本は2022年6月15日、新会社「NTT Risk Manager」（東京都新宿区）を同年7月1日に設立すると発表した。ユーザー企業のリスク管理に必要な要素をワンストップで提供する会社であり、当面の事業内容は、コンサルティング、損害保険の販売、リスク対策サービスの開発・提供、の3つ。コンサルティング以外の要素については、共同出資会社である東京海上日動火災保険およびトレンドマイクロのアセットと知見を活用する。資本金は2億5000万円で、出資比率は非公開だが、NTT東日本が過半数を占める。販売目標は3年後に20億円程度（コンサルティングが7割、保険が1割程度を見込む）。
NTT東日本は、ユーザー企業のリスク管理に必要な要素をワンストップで提供する新会社「NTT Risk Manager」（東京都新宿区、図1）を2022年7月1日に設立する。当面の事業内容は、コンサルティング、損害保険の販売、リスク対策サービスの開発・提供、の3つ（図2）。
図1：新会社「NTT Risk Manager」のロゴ（出典：NTT東日本）
図2：新会社「NTT Risk Manager」の事業内容（出典：NTT東日本）
拡大画像表示
コンサルティング以外の要素については、共同出資会社である東京海上日動火災保険およびトレンドマイクロのアセットと知見を活用する。新会社の概要は記事末の表1の通り。資本金は2億5000万円で、3社による出資比率は非公開だが、NTT東日本が過半数を占める。
販売目標は3年後に20億円程度（コンサルティングが7割、保険が1割程度を見込む）。会社の規模は、初年度10人弱、5年後に30人強を予定する。新会社の代表取締役社長には、一ノ瀬勝美氏（現職は、NTT東日本 ネットワークセキュリティ推進室 室長）が就任する予定（写真1）。
写真1：写真左から、NTT東日本 経営企画部営業戦略推進室室長の加藤成晴氏（出資会社代表者）、新会社の代表取締役社長に就任予定の一ノ瀬勝美氏（現職は、NTT東日本 ネットワークセキュリティ推進室 室長）、新会社の代表取締役副社長に就任予定の白石涼子氏（現職は、NTT東日本 経営企画部営業戦略推進室担当部長）
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