Be an internationally-certified Risk Management Professional
deGRANDSON’S Risk Management courses — Foundation, Advanced, and Expert Levels — provide you with the Tools, Skills, and Knowledge necessary to plan, implement, and maintain a Risk Management Programme for your organization.
If you search ISO standards for ‘risk management,’ you will find several standards, some of which are published as guidance documents to management system standards (e.g., ISO 27005 in support of the Information Security Standard, ISO 27001) and this Standard, ISO 31000.
ISO 31000, Risk Management – Guidelines
While its title might suggest that it contains practical advice on managing risk, it does not. ISO 31000 is devoted to exploring a framework for understanding risk when defined as the ‘effect of uncertainty on objectives.’ And so, for direction and practical advice on the management of risk (i.e., actual guidelines), we must look elsewhere.
ISO-IEC 31010, Risk Assessment Techniques
This International Standard was prepared by IEC Technical Committee 56: Dependability, in co-operation with ISO Technical Committee 262: Risk Management. It is published as a double logo standard, i.e., ISO/IEC.
It provides guidance on the selection and application of various techniques that can be used to help improve the way uncertainty is taken into account and to help understand risk.
The techniques are used:
- where further understanding is required about what risk exists or about a particular risk;
- within a decision where a range of options, each involving risk, need to be compared or optimized;
- within a risk management process leading to actions to treat risk.
The techniques are used within the risk assessment steps of identifying, analyzing, and evaluating risk as described in ISO 31000 and, more generally, whenever there is a need to understand uncertainty and its effects.
FDA Guidance Document Q9(R1) Quality Risk Management
On 03-May-23, the Food and Drug Administration (FDA) announced the publication of a final guidance for the industry entitled “Q9(R1) Quality Risk Management.” The guidance was prepared under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality. Annex I: Quality Risk Management Methods and Tools lists the recommended tools and methods. These are…
- Basic Risk Management Facilitation Methods
- Failure Mode Effects Analysis (FMEA)
- Failure Mode, Effects, and Criticality Analysis (FMECA)
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Hazard Operability Analysis (HAZOP)
- Preliminary Hazard Analysis (PHA)
- Risk Ranking and Filtering
All of these tools and methods are included in our Foundation Course.
This course is intended for:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
- Medical affairs
- Legal Professionals
This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …
- Module 0: Introduction and background to the Course
- Module 1: Introduction to Risk Management, includes …
- ISO 31010 – knowledge and Application
- Terms & Definitions
- Risk Management Principles
- Risk Management Framework
- Risk Management Process – overview
- Module 2: The Risk Management Process (ISO 31000)
- The Universal Risk Management Process Model
- Module 3: Risk Assessment Techniques: Foundation (ISO-IEC 31010), including …
- Checklists – various types
- FMEA– Failure Mode and Effects Analysis (general)
- dFMEA – Design FMEA
- pFMEA – Process FMEA
- uFMEA – User FMEA
- FMECA – Failure Mode Effects and Criticality Analysis
- FTA – Fault Tree Analysis
- HACCP – Hazard Analysis & Critical Control Points
- HAZOP – Hazard and Operability Study
- Pareto Charts – the 80/20 Rule
- Risk Register
- Risk Matrix – Consequence/Likelihood Matrix
- SWIFT – Structured What-If Analysis
These include examples. illustrative figures and a set of Hazard Analysis Templates, namely:
- Risk Management Process
- Terms and Definitions for ISO 14971
- Example Design FMEA
- Example Process FMEA
- Example User FMEA
- Example FMECA Rating Table
- Note: Choice of Tools used for Riak Assessment
- Note: HACCP Principles and Hazard Analysis
- Note: Supply Chain Integrity Best Practice
- Fig 1: Hazards – Sequence of Events – Hazardous Situations
- Fig 2: Example of Risk Chart
- Fig 3: Example of Qualitative 3 x 3 Risk Matrix
- Fig 4: Example of Semi-quantitative 5 x 5 Risk Matrix
- Fig 5: Sequence of events and risk – Safety
- Fig 6: Sequence of events and risk – Information Security
- Fig 7: Production and Post-production Information Sources
- Fig 8: Example of the application of the P1 x P2 Approach
- Form – SWIFT What-If Analysis
- Form – Hazard Identification Checklist
- Form – Preliminary Hazard Analysis
- Form – Event Tree Analysis with probabilities
- Form – FMEA Team Start
- Form – Design FMEA Scope Worksheet
- Form – Process FMEA Scope Worksheet
- Form – FMEA Worksheet (Word file)
- Form – FMEA Worksheet (Excel file)
- Example HACCP Plan
All Modules have a full resume and scaling capabilities. This means, for example, you can…
- Start a Module at work on your Work Station running on Windows 11,
- Continue the Module on the train home on your iPad running on iOS 16 and,
- Complete the Module at home on your Notebook PC running on Windows 10
For this course, the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years work experience, with at least 2 at managerial/supervisory level, is recommended.
A working knowledge of ISO 13485 and relevant regulations is needed to get the maximum benefit from this Course.
You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
Check out our other Risk Management Courses.
ISO 31010 Risk Management Techniques – Advanced (coming soon)
ISO 31010 Risk Management Techniques – Expert (coming soon)
ISO 14971 Risk Management – Advanced