REGU08005 2017 Risk Management and Design Control
This module will enable students to understand the role of Risk assessment through the design process and product lifecycle.
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 assignments will be given.
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
|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
|Independent Learning||Online||Independent Learning||5||Weekly||5.00|
Required & Recommended Book List
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
as per booklist
Website: https://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30