Webinar:
Improve Your Risk
Management with 2
Fundamental Practices
Anthony Washington
Seapine Solutions Specialist
What is Risk?
A probability or threat of damage, injury, liability,
loss, or any other negative occurrence that is
caused ...
The Cost of Not Managing Risk
 Baxter
 Recall and destroy 200,000 infusion pumps in use
 Assist customers in finding re...
Managing Risk
 Identify Risk
 Use Subject Matter Experts (SMEs)
 Risk Severity
 Establish Probability of Occurrence
 ...
Controlling Risk
PRODUCT
Eliminate
Mitigate
Accept
Managing/Controlling Risk
Managing/Controlling Risk
FMEAs vs. RCAs
 FMEA
 Proactive
 Identify what COULD happen and Mitigate
 RCA
 Reactive
 Identify what DID happen an...
FMEAs
 Why FMEAs
 Better designs
 Evaluate proposed changes
 Improve testing
FMEA Example 1 - WysiPump
FMEA Example 2 - WysiPump
Conducting FMEAs with TestTrack
 Timing – use workflows
and automation rules
 Ownership
 Team composition
 Traceability
Conducting RCAs
 SME or cross-functional
team
 Gather relevant data
 Identify potential
causes
 Identify potential
sol...
Conducting RCAs with TestTrack
 Analysis
 Searching
 Modular mesign
 Traceability
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FMEA RCA Risk Management webinar

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FMEA RCA Risk Management webinar

  1. 1. Webinar: Improve Your Risk Management with 2 Fundamental Practices Anthony Washington Seapine Solutions Specialist
  2. 2. What is Risk? A probability or threat of damage, injury, liability, loss, or any other negative occurrence that is caused by external or internal vulnerabilities, and that may be avoided through preemptive action. Risk = Severity x Occurrence x Detection www.businessdictionary.com
  3. 3. The Cost of Not Managing Risk  Baxter  Recall and destroy 200,000 infusion pumps in use  Assist customers in finding replacement devices  $400 - $600 million estimated losses Business Week, Jan 2013
  4. 4. Managing Risk  Identify Risk  Use Subject Matter Experts (SMEs)  Risk Severity  Establish Probability of Occurrence  Ability to Detect  Assign to someone
  5. 5. Controlling Risk PRODUCT Eliminate Mitigate Accept
  6. 6. Managing/Controlling Risk
  7. 7. Managing/Controlling Risk
  8. 8. FMEAs vs. RCAs  FMEA  Proactive  Identify what COULD happen and Mitigate  RCA  Reactive  Identify what DID happen and develop Corrective Action
  9. 9. FMEAs  Why FMEAs  Better designs  Evaluate proposed changes  Improve testing
  10. 10. FMEA Example 1 - WysiPump
  11. 11. FMEA Example 2 - WysiPump
  12. 12. Conducting FMEAs with TestTrack  Timing – use workflows and automation rules  Ownership  Team composition  Traceability
  13. 13. Conducting RCAs  SME or cross-functional team  Gather relevant data  Identify potential causes  Identify potential solutions  Document and implement changes
  14. 14. Conducting RCAs with TestTrack  Analysis  Searching  Modular mesign  Traceability

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