ISO 31010:2019 Risk Management – Foundation Course

This ISO 31010 Foundation Course is one of deGRANDSON’s three ISO 31010 courses and is designed to provide learners with basic knowledge of risk assessment techniques and their general application.

ISO 31010 and 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.

Who should take this course?

This course is intended for:

• anyone involved in assessing or managing risk;
• people who are involved in developing guidance that sets out how risk is to be assessed in specific contexts;
• people who need to make decisions where there is uncertainty including:
  • those who commission or evaluate risk assessments,
  • those who need to understand the outcomes of assessments, and
  • those who have to choose assessment techniques to meet particular needs.

What does the course cover?

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 …
  • Brainstorming
  • 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

What course materials are included in the course?

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

How is the course delivered?

deGRANDSON’s risk management courses are delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq). 

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

What previous qualifications are required for the course?

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.