Quality Progress - November 2015 - (Page 63)

ONE GOOD IDEA BY KIM NILES Don't Risk It A four-step method for proper risk management RISK MANAGEMENT remains a challenge for organizations despite the avail- be periodically updated. 3. People-oriented barriers: There is should consider using a project-based approach called realize, instigate, substan- ability of high-level International Organiza- almost always some form of political or tiate and know (RISK): tion for Standardization (ISO) standards, change management-oriented barrier in * Realize: Management formally starts the such as ISO 14971 and 31000, and other place when assessing risk. While the use project with everything needed to suc- guidance documents.1, 2 Many reputable of assumptions, different tools and meth- ceed. All reasonable risks and assump- organizations still are not getting it right, ods can help facilitate these situations, tions are realized along with proposed and because they are included in industry dangerous shortcuts are often created. mitigation activities, which are agreed to benchmarking efforts, large sections of en- For example, instead of prioritizing tools tire industries also are not getting it right. and resources around reasonable risks, an When risk management weaknesses individual might do all the work using one as related metrics are established. form that has no hope of promoting the Results and plans for the next phase are are found through audits or other means, hundreds of man-hours are often required to repair the issues. Common risk-assessment types of decisions that should be made. 4. Variation in scope: Scope varies in at a formal phase-gate meeting. * Instigate: Mitigation activities as well agreed on during a phase-gate meeting. * Substantiate: Data are collected over failures can be put into five major categories: what tools and methods are used, and time, and risks are reviewed and ad- 1. Incorrect assessment criteria: This what's included in the assessment. Don't justed as applicable. occurs when criteria used to rate a risk focus on one tool, such as failure mode were not correctly correlated or scaled and effects analysis (FMEA). Mitigation identify risk-based knowledge gained to fit what was being assessed. It can be action levels should be formally adopted. after completion of a product or service. a result of forms that were copied from Some organizations separate risks This might include lessons learned, criti- another organization or product, as- into customer and business risks. For cal success factors, costs and benefits. sumptions, or context not captured and example: Is it a business risk if a vendor Considerations will include transferring considered in the assessment. goes out of business, or is it a customer knowledge to similar products, informa- risk when a patient could be harmed tion storage and communicating success ment tools are typically formed by using due to a late delivery of your product factors. teams, their results are all speculation. as the result of that vendor going out of Decisions are best made using real infor- business? 2. Not life cycle-based: While assess- * Know: A formal report is created to The benefits of conducting proper risk management easily justify why organiza- mation gathered and analyzed over time. 5. Variation in focus: Each type of FMEA Risks also can change over the product's should have a different focus. A process efforts. By using the RISK model, it should life. Risk assessments, therefore, must FMEA should not be focused on the become an ongoing project. QP tions must ramp up their assessment customer at the process level. If an assessment team in the medical device industry is expected to guess how a machine might harm a customer without guidance from NOTES 1. ISO 14971 offers specifications for a manufacturer's process to identify potential hazards related to medical devices, and determine and control associated risks. For more information, visit http://tinyurl.com/iso14971info. 2. ISO 31000 provides guidelines on risk management. a doctor, the end result can be dangerous. Finding a solution As standards include tighter and more complex risk managementbased requirements, organizations KIM NILES is an independent quality and risk management consultant, and a quality program adjunct instructor at San Diego State University and California State University in Dominguez Hills (CSUDH). He has a master's degree in quality science from CSUDH. Niles is an ASQ fellow, as well as an ASQ-certified quality engineer, Six Sigma Black Belt, and a UCSD-certified Master Black Belt. November 2015 * QP 63 http://www.tinyurl.com/iso14971info

Table of Contents for the Digital Edition of Quality Progress - November 2015

Up Front
LogOn
Expert Answers
Keeping Current
Mr Pareto Head
Pop Culture
On the Horizon
Shatterproof
To Measure is to Know
Measure for Measure
Innovation Imperative
Quality in the First Person
Career Corner
Statistics Roundtable
QP Toolbox
QP Reviews
One Good Idea
Back to Basics

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