RISK MANAGEMENT

Risk Management

Risk Management

Question 1

Failure Mode and Effects Analysis (FMEA) is a methodology designed to recognize potential failure modes for a product or process, to evaluate the risk linked with those failure modes, to grade the issues in terms of significance and to spot and carry out remedial actions to address the mainly serious concerns (Smith, 2000).

For each probable cause of failure (Mobley, 1999):

•What is the likelihood that failure will occur?

•What would the consequence of the failure be?

•How likely is such a failure to be detected before it affects the customer?

Based on a quantitative evaluation of these three questions, a risk priority number (RPN) is calculated for each potential cause of failure. Corrective actions aimed at preventing failure are then applied to those causes whose RPN indicates that they warrant priority.

This is essentially a seven-step process (Smith, 2000):

•Step 1: Recognize all the component parts of the products or service.

•Step 2: List all the probable ways in which the components could fail (the failure modes).

•Step 3: Recognize the probable effects of the failures (downtime, safety, repair requirements, effects on customers).

•Step 4: Recognize all the probable causes of failure for each failure mode.

•Step 5: Assess the probability of failure, the severity of the effects of failure, and the likelihood of detection. Rating scales that can be used to quantify these three factors

•Step 6: Calculate the RPN by multiplying all three ratings together.

•Step 7: Instigate corrective actions that will minimize failure on failure modes that show a high RPN.

Question 2

FMEA has had a history of driving prevention in the successful completion of a process. Health Care and more specifically Patient Safety is a major concern as publicity on a few high profile cases where the risks were high in case of a mistake (Vaughan, 1998).

FMEA or Failure Mode and Effects Analysis has been ...