Risk-based PLM

Tooling and
Machinery Design and
Manufacturing
A white paper by

Richard Harpster

and

Dr. Suresh C. Rama

 Risk-Based PLM For Tooling and Machinery Design and Manufacturing
Key Words: FMEA, Machinery FMEA, MFMEA, Process FMEA, PFMEA, Design Validation Plan, Design Verification
Plan, Usage Risk Assessment, URA™, Application FMEA, Process Validation Plan, failure mode and effects analysis,
failure mode, Requirements Risk Assessment, RRA®, Class, Risk-Based PLM, RBPLM®.
SUMMARY & CONCLUSIONS
The Machine Tool Industry has struggled for years trying
to implement Risk-Based PLM tools. The requirement
for their proper implementation has received additional
emphasis with the introduction of ISO 9001:2015 and its
requirement for the implementation of risk-based thinking
when managing the business.
The purpose of this paper is to describe an ISO 9001:2015
compliant Risk-Based PLM System currently being
implemented at Valiant TMS, a global Machine Tool
Builder. The system is applicable to any company in the
Machine Tool Industry. The paper will cover applying
Risk-Based PLM tools from the definition of Customer
Requirements through to the installation and maintenance
of the machine tool. Special attention will be paid on how
to properly implement the Machinery FMEA (MFMEA)
and the common mistakes made when doing so. The
obstacles experienced by Valiant TMS while
implementing Risk-Based PLM will also be discussed.
1 WHAT IS RISK?
Risk has two components. The first component is the
consequences of an event when it occurs. The
consequences can take on many forms including financial
loss or in the worst-case bodily injury. The second
component of risk is the probability of the event
occurring. Consequently, one can reduce the risk of a
particular event by taking steps to mitigate the
consequences when the event occurs or to reduce the
probability of the event.
2 ISO 9001:2015 AND “RISK-BASED THINKING”
The main difference between ISO 9001:2015 and ISO
9001:2008 is the use of risk-based thinking was implicit
in the ISO 9001:2008 standard while there are
documented requirements for its use in the ISO
9001:2015 standard. The ISO 9001:2015 standard
requires the company to implement risk-based thinking to
determine the potential causes of process and QMS
failures and to implement actions to eliminate or reduce
the probability of the causes to an acceptable level.
By design, the ISO 9001:2015 standard is non-
prescriptive and offers only general guidelines on how to
implement risk-based thinking. This has created a lot of
confusion within Machine Tool Builders who want to be
compliant with the standard and the auditors attempting to
audit to it. The core requirements of the ISO 9001:2015
standard with respect to risk-based thinking required for
companies seeking compliance to ISO 9001:2015 1 are:
1. Determine the processes needed for the QMS system;
2. Define the inputs and outputs of the QMS processes;
3. Determine the sequence and interaction of the QMS
processes;
4. Define the risks created by the QMS processes;
5. Prioritize actions to reduce or eliminate the sources
based on the levels of risks that they are causing.
6. Use risk-based Plan-Do-Check-Act (PDCA) process
to evaluate process changes to reduce or eliminate the
sources of risk.
3 SOURCES OF RISK
There are five major sources of risk that all Machine Tool
Builders face. The first is exposure to harm due to
incorrect or incomplete customer requirements. Talk to
any Machine Tool Builder for almost any industry and
you will hear the problems that incomplete, incorrect or
changing Customer Requirements cause them in terms of
increased costs and delivery times. There are many
reasons for why it is so difficult to properly define
Customer Requirements including the many different
customer requirement types and the quantity of
requirements per type.
The problem of reducing risk due to Customer
Requirements gets even more difficult when a company is
attempting to design and manufacture a single piece of
machinery for multiple customers. Since different
customers can have different requirements, it is not
uncommon that a company cannot come up with a set of
Customer Requirements that represent the needs and
wants of all customers. The Machine Tool Builder finds
itself facing the risk of losing some of its customers due
to the selection of Customer Requirements it decides to
attempt to fulfill.
The second source of risk exposure that the Machine Tool
Builder faces is incorrect Machine Tool Design
Requirements. Machine Tool Builders cannot design to
the language contained in customer requirements.
Consequently, the Customer Requirements must be
translated to design requirements in the language of the
Machine Tool Builder. Unfortunately, it is almost
impossible to define a set of design requirements that
when Machine Tool is built to them will result in Machine
Tool that meets all the customer requirements. This is
due to the fact that the multiple Customer Requirements
defined can be competing, conflicting or beyond the
limits of technology.

The third source of risk exposure that the Machine Tool

Builder faces is that the Machine Tool is not designed to
meet all the design requirements. The problem can be
that like the customer requirements, the multiple design
requirements that must be met to meet them can be
conflicting, competing and beyond the limits of
technology.

The fourth source of risk exposure that the Machine Tool

Builder faces is that the Machine Tool is not built to the
design specifications. There can be many reasons for this
including out of specification materials and components
received from outside suppliers. Another source of the
exposure to the risk is the assemblers making errors while
building the Machine Tool.

The fifth source of risk exposure that the Machine Tool

Builder faces is improper installation, maintenance and
usage of the Machine Tool. Of all the sources of risk
exposure, this can be the most difficult source to limit.

4 THE VALIANT TMS RISK-BASED PLM SYSTEM

The Valiant TMS Risk-Based PLM System is a risk-based

product life cycle management system designed for
Machine Tool Builders. The major objective of the
Valiant TMS Risk-Based PLM System is to reduce the
Machine Tool Builder’s risk exposure due to the five Figure 1: The Valiant TMS Risk-Based PLM System
sources previously defined.

The Valiant TMS Risk-Based PLM System (Figure 1) is
comprised of 6 core processes. They are:
1. Define Customer Requirements;
2. Define Design Requirements;
3. Design Machine Tool;
4. Design Usage Instructions;
5. Design Manufacturing Process;
6. Build Tool Using Manufacturing Process.
There are four core risk management tools in the Valiant
TMS Risk-Based PLM System. They are the
Requirements Risk Assessment® (RRA®), Machinery
FMEA, Usage Risk Assessment™ (URA™) (aka
Application FMEA or Customer Process FMEA) and
Process FMEA on building of Machine Tool.
Performed prior to the release of design requirements to
the Machine Tool designer, the Requirements Risk
Assessment® (RRA®) is designed to reduce risk exposure
due to improperly or incompletely defined Customer
Requirements captured through the Voice of the
Customer (VOC) as well as improperly or incompletely
defined Machine Tool Design Requirements.
One important role of the RRA® is to assess the feasibility
of the Customer Requirements and Machine Tool Design
Requirements. It is very important for the Machine Tool
Builder to know if there are any Customer or Machine
Tool Design Requirements that the Machine Tool Builder
lacks the current capability of meeting them. The
possible exposure to risk is very high under these
conditions if the Machine Tool Builder accepts the job
and fails to develop the required capabilities. The
potential types of harm include large financial losses,
damage to reputation and damage to the
Customer/Machine Tool Builder relationship.
The RRA® is also used to assist in the performance of
additional activities including Machine Tool Design
Validation, Customer Requirement change control,
Design Requirement change control and Rapid Integrated
Problem Solving (RIPS®).
Performed prior to the release of the design specifications
to Machine Tool manufacturing, the Machinery FMEA is
designed to reduce risk exposure due to improperly
defined Machine Tool Design Specifications. The
Machinery FMEA is also used to assist in the
performance of additional activities including Machine
Tool Design Verification, Machine Tool design
specification change control and RIPS®). The Machinery
FMEA also drives the performance of the Usage Risk
Assessment™ (URA™) and Process FMEA on the
manufacturing process used to manufacture the Machine
Tool.
Performed prior to the release of the installation, usage
and maintenance instructions to the customer the URA™
is designed to reduce risk exposure due to improperly
installed, used and maintained Machine Tools. The
URA™ is sometime referred to as a Process FMEA on
the use of the Machine Tool by the customer.
Information provided by the URA™ is used to assist in
Machine Tool installation, usage and maintenance
instruction creation, instruction change control and
RIPS®.
Performed prior to the release of the manufacturing
process for manufacture of the Machine Tool, the Process
FMEA is designed to reduce risk exposure due to
improperly manufactured and assembled Machine Tool.
The Process FMEA is also used to assist in Machine Tool
manufacturing and assembly instruction creation,
instruction change control and RIPS®.
5 MACHINERY FMEAS AND COMMON MISTAKES
Unfortunately, the majority of MFMEAs are done
incorrectly. The are many reasons for this. Following are
six different mistakes commonly found in a typical
MFMEA.
Figure 2: MFMEA – Requirement, Failure Mode, Failure
Effects and Severity (SEV) Rating Columns
The most important column of the MFMEA is the
“Requirements” column used to capture the Machine Tool
Design Requirements (Figure 2). The number one
mistake when performing MFMEAs is improperly or
inadequately completing this column.
Figure 3: Common MFMEA Mistakes – Construct BOM In
Requirements Column
One of the most common mistakes made when
completing the “Requirements” column of the MFMEA is
to use the column as a Bill of Materials and list all sub-
assemblies and components along with their function
(Figure 3).
A second mistake made when performing a MFMEA is
filling out the Failure Cause column of the before the
Machine Tool design has been documented. The
MFMEA is a risk assessment of the Machine Tool Design
before its release. Consequently, you must have a
Machine Tool design to assess before you can perform an
MFMEA. It is not uncommon to have customers require
the completion of the initial MFMEAs and Usage Risk
Assessments (aka Application FMEA or Customer
Process FMEA) before the Customer Requirements for
the Machine Tool have been finalized. A proper MFMEA
cannot be performed under these conditions.
Figure 4: Common MFMEA Mistakes – Enter Conditions of
Machinery/Tooling in Cause Column
A third mistake made when performing a MFMEA is to
list objectionable tooling conditions in the ‘Failure
Cause” column. (Figure 4) Objectionable conditions of
the Machine Tool are “Failure Modes” of the Machine
Tool design and not “Failure Causes”.
Figure 5: Common MFMEA Mistakes – Mitigation Controls In
Design Controls Column
A fourth mistake made when performing a MFMEA is to
list Preventative Maintenance items in the Design
Controls column. (Figure 5) MFMEA Design Controls
are always methods for assessing the adequacy of the
Machine Tool design.

Figure 6: MFMEA – Mitigation Controls
The Machine Tool designer would like to be able to create
Machine Tools that do not physically change over time.
Unfortunately, this not possible and the performance of
the Machine Tool can change when these physical
changes happen. The Mitigation Controls are controls
either performed by the Machine Tool or the Machine
Tool user to prevent the presence of physical changes that
can result in reduced machine tool performance (Figure
6). This column is very valuable in defining the required
preventative maintenance that must be done by the user.
Figure 7: Common MFMEA Mistakes – No Mitigation Controls
Column
A fifth mistake made when performing the MFMEA is to
exclude the Mitigation Controls column from the
MFMEA form (Figure 7).
Figure 8: MFMEA – Use DVP Derived from MFMEA To
Determine OCC and Calculate RPN
The next step in performing the MFMEA process is to
perform the Design Controls identified in the MFMEA
(Figure 8). The results of the performance of the Design
Control(s) are used to determine the probability of
exposure to harm due to the design requirement not being
met because of the Machine Tool design specification
condition identified in the Failure Cause column. A
rating corresponding to the probability is placed in the
Occurrence Rating (Occ) column. The OCC rating is then
used to calculate the RPN which is SEV x OCC x DET.
A sixth mistake is to use the RPN value to determine
which sources of risk to address. A better method is to
use the Risk Matrix (Figure 9).
Figure 9: MFMEA – Use Risk Matrix to Determine Class
Column Entries
The Risk Matrix can take on different forms. All Risk
Matrices have zones base on Severity of Harm. The
example Risk Matrix provide has a Safety/Legal Zone
(S/L) and Return/No Buy Zone where the S/L Zone
represents a much higher level of harm. The SEV and
OCC ratings are used to look up the Class Symbol in the
Risk Matrix. If there is no Class Symbol for the SEV and
OCC combination, the risk is considered acceptable and
no improvements to the Machine Tool design are
required. Items in the highest harm zone furthest to the
right should be worked on first.
Figure 10: MFMEA – Class Column Populated
It is very important to understand that it is the Class
column and not the RPN that is used to determine what
must be worked on in the MFMEA. In the above
example, the row with the RPN of 168 would not be
worked on while the row with the RPN of 96 would
(Figure 10). One should never use RPN thresholds.
6 OBSTACLES TO RISK-BASED PLM IMPLEMENTATION
There are four major obstacles facing the Machine Tool
Builder when attempting to implement Risk-Based PLM
properly. They are:
1. Previous poor experiences with Risk-Based PLM
tools;
2. Customer lack of knowledge about Risk-Based PLM
tools;
3. Supplier lack of knowledge about Risk-Based PLM
tools;
4. Lack of time and resources to complete.
7 OBSTACLE #1: PREVIOUS POOR EXPERIENCES WITH
RISK-BASED PLM TOOLS
Most people within the Machine Tool industry have not
had a good experience with Risk-Based PLM tools. The
most common Risk-Based PLM tools used by the industry
are the MFMEA and Process FMEA on the use of the
Machine Tool by the customer (URA™).
The MFMEA is typically done too early to be performed
correctly or too late to be of value. The MFMEA is rarely
used to drive a Design Verification Plan to assess the
adequacy of the Machine Tool design. Finally, most
MFMEAs when complete look more like Process FMEAs
on the use of the Machine Tool.
Most machine tools have considerable complexity. The
typical MFMEA lacks sufficient detail to properly address
the complexity of the Machine Tool that the MFMEA is
being performed on.
When the MFMEA is done incorrectly and at the wrong
time, the value of the MFMEA process is severely
degraded. The vast majority of MFMEAs created by the
Machine Tool Builder have historically been performed to
meet a paper deliverable requirement rather than to
improve the quality of the Machine Tool design.
The Machine Tool Builder typically does a much better
job of performing the Process FMEA on the use of the
Machine Tool by the customer than they do performing
the MFMEA on the design of the Machine Tool.
Although there can be several reasons for this, the most
common is that it is much easier to define the mistakes
users can make in the use of the Machine Tool to cause it
to function incorrectly than attempting to define all the
design mistakes that may have been made to cause the
failure. Like the MFMEAs, the Process FMEA
performed on the use of the Machine Tool by the
customer typically lacks sufficient detail to cover the
complexity of the Machine Tool.
8 OBSTACLE #2: CUSTOMER LACK OF KNOWLEDGE
OF RISK-BASED PLM TOOLS
The most common problems that occur as a result of lack
of Customer knowledge of Risk-Based PLM Tools are
improper timing for their creation and improper methods
used for selection of the high-risk items identified by the
Risk-Based PLM tools to work on.
When it comes to improper timing a common problem is
the Customer deliverable timing charts requiring the
MFMEA and PFMEA to be completed too early. The
purpose of the MFMEA is to assess the adequacy of the
Machine Tool in meeting the Machine Tool Design
Requirements. Due to the highly compressed delivery
time structure of Machine Tool industry, some
Customers’ deliverable timing charts call for completion
of the first version of the MFMEA before the Design
Requirements for the Machine Tool are approved by the
customer.
The purpose of the Process FMEA (aka Usage Risk
Assessment or Application FMEA) on the use of the
Machine Tool is to assess the adequacy of install, usage
and maintenance instructions for the Machine Tool. Like
the MFMEA, Customer deliverable timing charts can
cause problems when they require the completion of the
Process FMEA on the use of the Machine Tool before
Machine Tool design has been finalized.
Selection of what to work on can also be a problem when
the Customer does not understand Risk-Based PLM tools.
Many Customers use RPN thresholds to determine what
to work on in the MFMEA and Process FMEA on use of
Machine Tool by the Customer instead of the Class
Column. If RPN thresholds are used instead of the Class
Column, there is high likelihood of the Customer wanting
the Machine Tool builder to work on the incorrect issues.
9 OBSTACLE #3: SUPPLIER LACK OF KNOWLEDGE OF
RISK-BASED PLM TOOLS
If the Machine Tool Builder must integrate Machine
Tools designed by suppliers into their Machine Tool
deliverable, the Machine Tool Builder can find itself
unable to use the Risk-Based PLM tools properly because
the suppliers have not properly used the applicable Risk-
Based PLM tools and consequently have not provided the
appropriate documentation. The solution to this problem
is not always easy.
The best case is the supplier takes it upon itself to learn
how to use the tools correctly. The next best solution is
that the supplier is willing to answer questions show you
can obtain the information normally found in properly
constructed Risk-Based PLM documents created by the
 supplier. The worst case is the supplier refuses to learn or
work with the Machine Tool Builder. In this case, the
Machine Tool Builder may have to find a new supplier
unless the supplier has been selected by the customer.
10 OBSTACLE #4: LACK OF TIME AND RESOURCES TO
COMPLETE
The Machine Tool industry has a highly compressed
delivery schedule. It is not uncommon to require the
delivery of over 100 Machine Tool stations in less than a
year. Machine Tool Stations can be extremely complex
with hundreds or thousands of components. The question
becomes how does the Machine Tool Builder properly use
Risk-Based PLM tools given the volume of Machine
Tools the Risk-Based PLM tools must be used on?
The answer is you must leverage your knowledge.
Whenever a Machine Tool Builder places a component in
a Machine Tool it should trigger a best practice design
response, manufacturing response and usage response.
The various Risk-Based PLM tools are used to measure
the adequacy of these responses and determine where
changes are required to optimize the Machine Tool’s
risk/benefit ratio.
A computer-based tool must be found or created by the
Machine Tool Builder that enables the Machine Tool
Builder to leverage these best practice responses. There
are many Risk-Based PLM software tools on the market.
The Machine Tool Builder must perform the necessary
research and find the appropriate one that fits their
business.
11 CONCLUSION
The implementation of risk-based-thinking using Risk-
Based PLM Tools in the Machine Tool design and build
process can lead to a significant improvement in Machine
Tool quality, on time delivery and Machine Tool builder
profitability. Although the rewards of the successful
implementation of risk-based thinking are considerable,
obstacles to its successful implementation can be
significant and come from many sources including the
Machine Tool Builder’s customers, suppliers, past
experiences with Risk-Based PLM tools and time and
resource limitations. Despite these barriers, successful
companies understand that proper management of risk is a
critical key to success.
REFERENCES
1. International Standard ISO 9001:2015: Quality
Management System Requirements, 09-15-2015.
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BIOGRAPHIES
Richard Harpster is president of Harpco Systems Inc.
which he founded in 1987. Harpco Systems specializes in
providing software, training and consulting for Risked
Based Product Lifecycle Management (RBPLM®). Over
the past 30 years Mr. Harpster has helped hundreds of
companies implement improved risk-based design and
manufacturing systems in a wide variety of industries. He
is a recognized expert in the application of FMEAs and
invented several new concepts including the linking of
Design FMEAs to Process FMEAs in 1990 which became
an automotive industry standard eighteen years later. His
latest inventions in the field of RBPLM® include
Requirements Risk Assessment™ (RRA®), Multiple
Integrated Cause Analysis (MICA™) and Rapid
Integrated Problem Solving (RIPS®). He has published
several papers on the topic of RBPLM®.
Prior to starting Harpco Systems, Richard spent 14 years
at Ford Motor in a wide variety of positions including
Plant Manager. His education includes a B.S.E.E. from
Penn State University, M.S.E.E from the University of
Detroit and an M.B.A. from Eastern Michigan University.
He is a registered PE in the State of Michigan.
E-mail: richard.harpster@harpcosystems.com
Dr. Suresh C. Rama is currently Director of Global
Engineering and Innovation at Valiant TMS – a global
Automation Company. Dr. Rama holds a Ph.D. M.E. from
Texas A&M University along with an M.B.A. from
Michigan State University. Dr. Rama has extensive
experience in implementation of lean quality systems
including Six Sigma. He has extensive experience in large
scale deployment of Design for Six Sigma including
understanding and responding to the Voice of the
Customer. With experience in academia and industry, he
has unique perspectives on Innovation and Value
Engineering. He has mentored several Blackbelts in Rad
X Shainin and Lean Six Sigma techniques during his
tenure in FCA-Chrysler. In his involvement in the Design
for Six Sigma deployment initiative, he promoted best
practice usage of FMEAs. Recently, in his role to improve
efficiency and effectiveness of automation systems and
tool designs at Valiant TMS, he has championed the
transformation of current practices into a risk-based
methodology by promoting systems thinking and FMEAs.
He is using these ideas to manage several Business
Process Improvement initiatives, including
implementation of a Company-wide PLM system.
E-mail: suresh.rama@valiantmachine.com