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An Introduction To Risk Analysis: by Steve Murphy and Marc Schaeffers

This document provides an introduction to risk analysis and Failure Mode and Effects Analysis (FMEA). It discusses how risk analysis is a natural human activity and remains essential for business. FMEA examines design and manufacturing processes to identify risks that could impact customers. The document then provides a brief history of how FMEA was developed and adopted by various industries. It concludes by outlining the key steps for getting started with risk analysis, including defining the process scope and generating a complete process flow.

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47 views

An Introduction To Risk Analysis: by Steve Murphy and Marc Schaeffers

This document provides an introduction to risk analysis and Failure Mode and Effects Analysis (FMEA). It discusses how risk analysis is a natural human activity and remains essential for business. FMEA examines design and manufacturing processes to identify risks that could impact customers. The document then provides a brief history of how FMEA was developed and adopted by various industries. It concludes by outlining the key steps for getting started with risk analysis, including defining the process scope and generating a complete process flow.

Uploaded by

amirkhakzad498
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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An introduction to risk analysis

By Steve Murphy and Marc Schaeffers


An introduction to risk analysis

Risk analysis is a very natural human activity. Imagine yourself as a hunter gatherer
charged with organizing the evening meal. Together with your team you organize a
hunting party and part of that plan will be some intuitive risk analysis. What are the
dangers? You may consider predators, thirst, and injury during the chase. All being
well the precautions you take result in a successful hunt, everybody returns home in
one piece and the tribe eats their evening meal. Risk analysis remains an essential
part of our business activity. We routinely analyze situations and take actions to
minimize business risks and safety concerns. FMEA (Failure Modes and Effects
Analysis) is an effective risk analysis method for design and manufacturing. It
examines your design and manufacturing processes and identifies the opportunities
for marginalities and defects which can result in customer dissatisfaction. Before we
go into the detail why not carry out a simple trial. Walk down your production line
and think to yourself “What can happen to the product here that will impact the
customer? What are we doing about it ?” Ask the production staff what routinely
goes wrong with the process and think “How can that affect the product”.
The FMEA will capture all this knowledge and experience in a structured way and will 2
allow you to take actions which will minimize the risk of a disappointed customer.

A brief history of FMEA

FMEA was developed by the American military at the end of the 1940’s. I understand
their frustrations with munitions malfunctioning led them to develop a methodology
that would eliminate all the potential root causes. A detailed method was
documented: MIL-P-1629. It worked and so it was adopted by the nuclear and
aerospace industry. NASA credited the success of the moon landings to its use. NASA
were also so concerned about contaminated food on space missions that they
developed a very similar technique called HACCP(Hazard Analysis and Critical Control
Points) specifically for the food industry. In the 1970’s slow speed shunts involving
the Ford Pinto were resulting in fatal fires if the petrol tank split. As you can imagine
this was a public relations disaster. To eliminate a reoccurrence for this and other
serious problems the Ford Motor Company implemented FMEA in their design
process. More organizations were using FMEA as a risk analysis tool and in 1993 the
AIAG (Automotive Industry Action Group) incorporated it into the QS9000 standard
for automotive production and its suppliers. QS9000 has become TS16949. While
FMEA was specifically aimed at automotive other industries which demand the
highest levels of reliability, for example semiconductors and oil and gas, have
implemented it. These reliability standards are now extending to white goods and
everyday electronic products. Strictly the current format is FMECA (Failure Modes
and Effects and Criticality Analysis), the Criticality of the defect for the end user is
incorporated into the method. For practical purposes it is a risk analysis and defect
reduction technique that takes into account three things; the SEVERITY of the defect
for the end user, the OCCURRENCE of the potential root cause and our effective
DETECTION or ELIMINATION of this root cause.

Getting started with risk analysis

An important part of any risk analysis is the scope of the process. This may sound
trivial but it is essential to know if your analysis should include, for instance, the
incoming materials store. Then we need to make a complete process flow. This is a
crucial task and should include every step in the process including rework steps. At
each of the process steps we need to identify the possible sources of variation and
potential problems. We need to document defects that may occur on the product.
We also need to list equipment and process problems that may cause defects on the 3

product. In a risk analysis process the creation of a complete process flow and a
complete list of potential problems can take 50% of your time.

Where do the ideas come from?

Traditionally a Brainstorming technique has been used to generate a list of possible


problems at each process or design step. While this is useful it is often more useful
to incorporate all your current sources of variation into your initial FMEA.
These include:
• Inputs from scrap incidents
• Inputs from customer returns
• Inputs from near misses
• Inputs from the next process
• Ideas from the designers
• Ideas from machine operators
• Ideas from the maintenance team
• If you have SPC then consider out of control points
• Incidents on similar equipment
• Advice from industry experts
• Advice from your material and equipment suppliers.

Using these sources will capture a lot of problems and marginalities that already exist
and make your FMEA practical and useful from day one.

The TS16949 FMEA layout

When assessing potential risks in a process it is useful to document the information


in a structured FMEA format. The TS16949 format is widely used and an example is
shown in figure 1
In the first 4 columns you document the process steps, the process requirements,
potential failure modes and the effects of the failures. In the next step you identify
the process problems which can cause the failure and the controls you have in place
to prevent or detect the problems. The final columns contain the corrective actions
taken and the results of these actions.

4
The Severity, Occurrence and Detection are all scaled on a 1 to 10 basis. 1 is the best
rating and 10 is the worst. Multiplying them together gives the Risk Priority Number
(RPN). Our goal is for our actions to lower the RPN, particularly the highest. All this
information is stored in the FMEA. When a cycle of learning is completed the FMEA
will be released. The FMEA is a living document and it will be reviewed and updated
regularly. New causes, failure modes and actions will be added as you learn more
about your process.

About the white paper:

This White Paper “An Introduction to Risk Analysis” is the first of a series of White
Papers on the subject of risk analysis and especially FMEA.
Look at http://www.datalyzer.com/white-papers/ for all the available white papers.

About the authors

Steve Murphy has 30 years of experience within high tech manufacturing including
senior roles within the semiconductor, aerospace and oil and gas sectors. 5

Marc Schaeffers has 25 years of experience with the implementation of quality


systems in industry and is the designer of the DataLyzer FMEA software system.

Both are working with DataLyzer International, a software and consultancy company
specialized in the implementation of FMEA, SPC, MSA and OEE.

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