Download - FMEA RCA Risk Management webinar
Webinar:Improve Your Risk Management with 2 Fundamental Practices
Anthony WashingtonSeapine Solutions Specialist
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
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
Managing Risk
Identify Risk
Use Subject Matter Experts (SMEs)
Risk Severity
Establish Probability of Occurrence
Ability to Detect
Assign to someone
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 and develop Corrective Action
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 solutions
Document and implement changes
Conducting RCAs with TestTrack
Analysis
Searching
Modular mesign
Traceability