Course 701: Risk Assessment and Risk Management Training Course Content
This on-line Course, typical duration 5 hours, provides you with a knowledge of best practice in managing risk in a business environment. It includes the study of the ISO 14971 Risk Management Process (risk analysis, risk evaluation, risk reduction, residual risk, etc.) as shown below. And also the practical methods and tools used to manage risk, including FMEA- Failure Mode and Effects Analysis.
Who should take this Course?
- If you are responsible for risk management for your organisation
- If you wish to understand the many aspects of the risk management process
- If you wish to deploy risk management tools effectively
- It is also recommended for management interested in reducing business risks
What does the Course cover?
This is a comprehensive Course based on ISO 14971:2007 – Application of risk management to medical devices and includes …
Module 1. A Study of the Risk Management process
- Risk Assessments (risk identification, risk analysis and risk evaluation)
- Risk Controls (risk reduction, risk acceptance and residual risk)
- Risk Reports and Risk Reviews
Module 2. The practical methods and tool used, including….
- PHA – Preliminary Hazard Analysis
- FTA – Fault Tree Analysis
- FMEA– Failure Mode and Effects Analysis
- HAZOP – Hazard and Operability Analysis
- HACCP – Hazard Analysis & Critical Control Points
For each risk assessment tool completed examples are provided throughout.
How is the Course delivered?
All Lessons have full resume and scaling capabilities. This means, for example, you can…
- Start a Lesson at work on your Work Station running on Windows 10,
- Continue the Lesson on the train home on your i-Pad running on iOS 11 and,
- Complete the Lesson at home on your Notebook PC running on Windows 8.1
How long will it take to complete?
6 hours approximately, including the Certification Examinations. Depending on your expertise and experience, it may take less or more time. And you can take it one Lesson at a time, if you wish. Lessons should take between 20 and 45 minutes.
Are there any prerequisite requirements?
The minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) is recommended.
No evidence of your qualifications is required.
Is there an Examination?
Yes. In addition to the Quizzes at the end of each Lesson, there is at the end of the Course a formal Examination. The decision to award a Certificate is based on the score achieved. The Examination is open-book (you can have the Standard and other notes open beside you), time-limited and taken on-line.