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