REGU08005 2017 Risk Management and Design Control

General Details

Full Title
Risk Management and Design Control
Transcript Title
Risk Mgmt & Design Control
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_E08 202100 Certificate in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality

This module will enable students to understand the role of Risk assessment through the design process and product lifecycle.

Learning Outcomes

On completion of this module the learner will/should be able to;


Analyse the concept of Risk Management


Describe a basic Risk management system and its components


Explain the application and requirements of Design & Risk Management under 21CFR 820


Explain the application and requirements of Design & Risk Management under ISO14971


Describe the risk management tools used to help manage risk in the product lifecycle

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module:

• Design Process Inputs

• Design Process Outputs

• Design Process Review

• Human Factors Engineering

• IS014971 -Risk Management Standard

• EU/US Risk Management Regulations

  • Tools and Techniques for Risk Management
  • The Product Lifecycle

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 FMEA Continuous Assessment Written Report 50 % Week 3 3,4,5
2 Online forums/Blogs Continuous Assessment Essay 30 % Week 6 2,3,4,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 20 % Week 10 1,2,3,4,5

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2016-11-21 Strategy and Risk Management: An Integrated Practical Approach Wiley
ISBN 1940235219 ISBN-13 9781940235219

Employees make dozens of day-to-day decisionsand any one of them could come back to haunt you, even when the decision does not seem to have hidden or unknown ramifications. That is why your organisation must have a protocol in place for identifying and mitigating all major business risks long before it is needed.

At the strategic level, risk management and strategic management are intertwined. Using this book, learn how to apply powerful tools and approaches to make your planning processes more effective and flexible and build a set of decision-making processes based on plain language. Author, Ron Rael, uses quality concepts/language (TQM & Six Sigma) to define the Enterprise Risk Management (ERM) process and value of prevention, while showing how these elements are both necessary and highly desired in an organisations strategic decision-making.

ERM extends to your everyday business decisions because employees take actions and make daily choices that could have a detrimental effect on your profits and businesss longevity and future. This book will

  • provide a best practices view on the latest developments in ERM
  • deliver how-to guidance on developing ERM processes at the enterprise and department levels
  • facilitate enterprise-wide ERM participation via practical information and examples
  • deliver cross-functional management and implementation of ERM

Module Resources

Non ISBN Literary Resources

as per booklist

URL Resources

Website: drh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30