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A Risk Based Thinking Model For Iso 9001 2015 PDF
A Risk Based Thinking Model For Iso 9001 2015 PDF
Bob Deysher
Senior Consultant
or
Author needs to acknowledge that this idea was shown at the NQA Meeting,
Boston Session, August 2014
January 15, 2015 ©2014 QSG, Inc. 15
Risk Definitions
– Probability
• This is the Probability that the harm will occur
As Low As
“Reasonably”
Practical
Generally
Acceptable
January 15, 2015 ©2014 QSG, Inc. 18
Risk Assessment - Qualitative
Process
(Major Elements & Boundaries)
Suppliers Inputs Start Outputs Customers
(By Whom) End (for Whom?)
Process Owners:
Risks
(What Can
Go Wrong?)
Author needs to acknowledge that this idea was shown at the NQA Meeting,
Boston Session, August 2014
January 15, 2015 ©2014 QSG, Inc. 34
Addressing Risk
Act Plan
•How to improve •What to do?
next time? •How to do it?
Check Do
• Did things happen •Do what was
according to plan? planned
Check – monitor/measure
process performance