1. Webinar:
Improve Your Risk
Management with 2
Fundamental Practices
Anthony Washington
Seapine Solutions Specialist

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. 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. Managing Risk
 Identify Risk
 Use Subject Matter Experts (SMEs)
 Risk Severity
 Establish Probability of Occurrence
 Ability to Detect
 Assign to someone

5. Controlling Risk
PRODUCT
Eliminate
Mitigate
Accept

6. Managing/Controlling Risk

7. Managing/Controlling Risk

8. FMEAs vs. RCAs
 FMEA
 Proactive
 Identify what COULD happen and Mitigate
 RCA
 Reactive
 Identify what DID happen and develop Corrective
Action

9. FMEAs
 Why FMEAs
 Better designs
 Evaluate proposed changes
 Improve testing

10. FMEA Example 1 - WysiPump

11. FMEA Example 2 - WysiPump

12. Conducting FMEAs with TestTrack
 Timing – use workflows
and automation rules
 Ownership
 Team composition
 Traceability

13. Conducting RCAs
 SME or cross-functional
team
 Gather relevant data
 Identify potential
causes
 Identify potential
solutions
 Document and
implement changes

14. Conducting RCAs with TestTrack
 Analysis
 Searching
 Modular mesign
 Traceability