Masters in Business Administration-MBA Semester IV

OM0006 – Maintenance Management – 2 Credits

Book ID: B1148
Assignment Set-1 (30 Marks)
Note: Each question carries 10 Marks. Answer all the questions.

1. Preventive Maintenance is an approach developed to reduce the likelihood of

the failure of critical equipment to the minimum possible. Elaborate with an
example.
Sol:
Reducing Risk without Wasting Resources: Doing Risk Management Right Using ISO 14971 can
help companies make risk management the core of medical device development.

ISO 14971, “Medical Devices—Application of Risk Management to Medical Devices,” was first
published in 2000. The risk management standard radically changed the process of understanding
and controlling the risks associated with medical devices. In doing so, it presented a significant
challenge to manufacturers. However, too often risk management was treated as yet another box to
be checked. When that happens, this invaluable thread that can tie the entire life cycle together,
dramatically improve productivity, and, most importantly, ensure the safety of the devices we
produce, becomes a drain on resources dreaded by members of the design team and a potential
source of failed audits. If the announcement of a risk analysis meeting elicits groans and excuses
for not attending, the company's risk management process is probably inefficient and very possibly
does not comply with the standard.

It would be a mistake to assume that risk management procedures comply with the standard just
because a notified body or other auditor has not issued any findings. Just like manufacturers,
auditors have been and still are learning what ISO 14971 requires over time. However, those
auditors have been exposed to the best and worst of what risk management can be. Due to this
exposure, auditors expectations of an ISO 14971–compliant system are increasingly more rigorous.
To stay ahead of those growing expectations, it is critical to understand the intent of each element
of risk management and how those elements provide value to the rest of the development,
production, and postproduction processes.

As a first step toward achieving that level of understanding, this article looks at the process of
identifying hazards, estimating the associated risks, and controlling those risks to acceptable levels.

Identification of Hazards

One of the most common sources of confusion is misunderstanding exactly what constitutes a
hazard. Hazards (as defined in ISO 14971 and ISO/IEC Guide 51) are potential sources of harm.2
Too frequently, the resulting harms are included in the list of hazards. Blending the cause with the
result can lead to significant confusion as the process continues.

Hazards include types of energy such as potentially harmful voltages, excessive heat, or masses.
They can also include circumstances (called hazardous situations in ISO 14971) such as chaotic
environments or operation by untrained or poorly trained persons. None of those hazards, in and of
themselves, necessarily results in harm. But each under the right circumstances (trigger events for
the purposes of this article) can become sources of injury.

Unfortunately, too many manufacturers ignore what should be the primary source for identifying
hazards: product safety standards. Too often, product development processes simply treat
standards identification and compliance as another task that needs to be done without thought of
the purpose or value.
 Device safety standards are critical throughout the risk management process. They identify
commonly recognized hazards associated with medical devices. They may identify hazards related
to general categories of medical devices. For example, IEC 60601-1 identifies hazards associated
with most electrically operated medical devices.3 In addition, standards may identify hazards
associated with specific technological aspects. The ISO 10993 series identifies and guides in the
evaluation of biocompatibility hazards.4 Others identify hazards associated with specific types of
devices. IEC/ISO 80601-2-30, for example, identifies hazards associated with automated
noninvasive sphygmomanometers.5 Failing to use such standards as the primary input to the risk
management process increases the probability that hazards might not be identified. It can also
cause manufacturers to ignore the primary set of risk-reduction techniques (also contained in those
standards).

Hazards alone do not have severities —injuries or harms do—and hazards don't have varying
levels of likelihood. Hazards either exist for a device or do not. A hazard becomes a harm when a
trigger event occurs.

Severity Estimation

As a rule, once the potential sources of harm (i.e., hazards) have been identified, determining what
harms they can cause is noncontroversial. What is important to remember is that different trigger
events may result in different harms (even for the same hazard), and trigger events frequently can
cause different levels of harm, each with its own likelihood. For each specific trigger event, it is
usually possible to identify at least one harm and severity. However, different trigger events for a
given hazard may well result in more than one harm or severity.

Although identifying harms and their severity does not, as a rule, lead to disagreements in a risk
analysis meeting, they can. Most often, such discussions center around the possible severities that
can result. If a single trigger event could cause various levels of harm, the most severe should be
selected because it would carry the greatest risk (since the trigger event determines likelihood,
which would be constant).

In the end, the decision to add another line item in the risk analysis should be based on whether
each harm would have an independent mitigation or risk-reduction technique. If a risk does have a
different mitigation, it should be addressed separately.

Finally, although reaching consensus on the harms that could occur and the associated level of
severity is not difficult, it is wise to involve a clinician for validating those determinations.
Clinicians are also invaluable in understanding the use environment and how medical personnel
are likely to interact with the equipment, both of which are critical to usability
engineering.

Likelihood Estimation

Those familiar with the most recent edition of ISO 14971 will note that the term likelihood has
been replaced by probability in the standard. However, using the term probability in the context of
risk estimation can be dangerous because it implies a level of detail and accuracy that simply
cannot exist. Even if it were possible to accurately calculate the probability of a given harm, when
a value was assigned (such as a number between 1 and 5) or the appropriate column or row of a
risk threshold table was identified, that accuracy is lost.

In short, quantifying whether a harm could occur is always an estimate, and the term likelihood
better reflects the fact that it represents an estimation. Spending significant resources to achieve
high levels of accuracy with high confidence intervals is almost always a waste of those resources.
Therefore, for purposes of this article, the term likelihood is used as a reminder that we are making
educated estimations.

For every identified potential source of harm (hazard), there are typically multiple trigger events
that could bring a hazard into contact with a person or cause a hazardous situation. Any potential
harmful voltage or chaotic environment could cause a person to make an error. In either case, the
result could be an injury (harm). For example, trigger events that would cause potentially
hazardous voltages would include the following:

• An exposure of these voltages such that they can be touched.

• A failure of insulation.
• A spill of conductive fluids.
• A high leakage current (unintended flow of electric current).

Therefore, for the hazard of “potentially harmful voltage,” the risk analysis would branch out to
identify each trigger event that could lead the voltage to cause harm. Although trigger events can
be identified using any number of techniques, a variation on failure mode analysis can be one of
the most useful.

While failure modes and effects analysis (FMEA) should never be used as the primary risk
analysis tool, by definition, parts of that process are ideal for identifying failure-related trigger
events. Traditionally, FMEA focuses on the failure of component parts of the design and identifies
the resulting effect of the failure. Failure mode effects and criticality analysis (FMECA) adds the
ranking of the effect in terms of severity or importance. However, in using failure mode analysis as
an input to risk analysis, the resulting effect of the failure and its criticality are identified in the risk
analysis. So the analysis used as an input to that process need only identify the trigger events
(although they can be identified here and transferred into the risk analysis). Failure mode analysis
can be applied far more broadly than simply looking at component failures.

However, even though the process of identifying trigger events can be modeled on a traditional
FMEA, caution is strongly advised. By its very name and traditional application, an FMEA implies
that only failures are identified. ISO 14971 clearly states that harms that result from normal
operation of the equipment as well as those caused by failures must be identified and the
associated risks mitigated to acceptable levels. Do not allow the similarities between a trigger
event analysis and a traditional FMEA to lead the risk analysis team to focus on failures alone.

Trigger event identification (using a failure mode–type analysis) can be applied to more than the
device's hardware. It can also apply to software, user interfaces (foreseeable misuse), the
environment in which it will be used, manufacturing errors, poor maintenance, misleading
marketing information, or even statements by salespersons. In short, all trigger events that could
result in injury need to be identified, and trigger event analysis can be applied to each hazard
category.
Making hardware, software, usability, manufacturing, maintenance, marketing, and sales as part of
trigger event analyses is a way to organize the collection of trigger events and the estimated
likelihood. Now they can all be brought together in the top-level risk analysis document.

It should be noted that a preferred method for combining the severity of an injury and the
likelihood that it will occur is a tabular or graphic method. Using this method, a table is created
with one axis labeled with descriptions of different levels of likelihood and the other with
descriptions of the various levels of severity (see Table I). Avoiding numeric values helps avoid
the traps associated with the use of numbers and calculations (risk priority number or RPN
method). However, for the purpose of this article and in order to quickly and clearly demonstrate
the concepts being discussed, the RPN method is used.

Using the numeric approach, each identified trigger event should be associated with the likelihood
that it will occur. Likelihood is represented using a ranking of (for example) 1 through 5, with 1
being highly unlikely to occur and 5 being a relative certainty. Caution is advised when assigning
likelihood rankings. Many individuals (especially those with strong mathematics backgrounds)
spend extended periods of time attempting to accurately assign probabilities or to differentiate
which ranking a given trigger event should be assigned. Generally such discussions are not
productive considering that each ranking represents an extremely broad range of actual
probabilities and, in the end, the ranking given is at best an estimate.

It is important to keep in mind that ISO 14971 requires that the level for each risk be estimated
twice. The standard requires estimating the risk both before risk-reduction techniques (frequently
called mitigations) have been implemented and then again after risk-reduction techniques have
been put in place. It is common during the initial (premitigation) estimation of risk that extended
disagreements over likelihood rankings occur. As mentioned earlier, if these discussions are
focused on the accuracy of the likelihood, resources are almost certainly being wasted.

In addition, design engineers often argue that the likelihood that a harm will occur is extremely
small “because it will comply with the appropriate standards.” However, compliance with
standards is a risk-reduction technique and is therefore not applicable for premitigation risk.
Typically, engineers are trained to associate problems with solutions. But protracted discussions
about likelihood are almost always a waste of time during initial risk estimation.

Designers are not the only members of the risk analysis team that can be misled in the likelihood
estimation process by their background and training. Commonly, quality engineers and regulatory
personnel attempt to use resources such as the FDA medical device reports (MDR) database or the
European Union vigilance database to estimate premitigation likelihood. These databases can
certainly provide useful information in identifying trigger events and harms, but they have no
value in estimating the likelihood that an injury will occur without a risk-reduction technique being
employed. Presumably, at least, all devices on the market have had risk mitigations implemented
or they would not have been allowed on the market by regulators. As a rule, the information
available from such resources is a better indication of the acceptable level of risk for devices that
have had all risks reduced. In other words, the devices in these databases represent broadly
acceptable levels of risk assuming that the injuries that have occurred did not result in recalls, other
regulatory action, or extensive lawsuits.

What makes more sense in terms of efficiency is to remember that without any risk-mitigation
technique employed (initial risk level), the likelihood of injury is extremely high or at least
inestimable. ISO 14971 says that when we cannot estimate likelihood, we should default to the
highest level of likelihood. Will this result in an unacceptable risk? Of course. But that's OK
because we haven't tried to reduce it to acceptable levels yet. What we have accomplished, though,
is reducing or eliminating long, drawn out, and completely unproductive arguments (see Table II).
For most risks, simply identify the appropriate requirement from a consensus safety standard as the
mitigation. That will make the risks acceptable (see Annex D item D.5.5 of the standard).

After the trigger events associated with each hazard have been identified and the likelihood of an
event is estimated, the harms that would occur and their severity must be identified. As a rule, this
phase of the process goes fairly smoothly with minimal disagreement. Generally the team can
quickly agree on how badly an individual would be harmed based on the hazard.

Risk Quantification

Once the trigger event has been identified and its likelihood and the severity of the resulting harm
estimated, the risk can be quantified. This can be done through any number of techniques, but this
example will simply multiply the likelihood and severity.

However, it is important to remember that the resulting risk ranking has little or no meaning
outside the analysis in which it is used. Although determinations from previous risk analyses for
similar devices can be used as an input or guide, it cannot be directly transferred from device to
device or from analysis to analysis. The only value a risk ranking provides is as a tracking method
to determine the relative level of risk before and after mitigation techniques are identified and
applied, and whether the value has been reduced to an acceptable level.

Risk Evaluation

The steps described so far complete the

initial or premitigation risk estimation phase (see Table III). The risk values derived for each harm
must now be considered to determine whether it is higher than the acceptability threshold for the
device. For those cases in which the risk level exceeds the threshold, risk-reduction techniques
must be implemented to reduce those risks to acceptable levels.

In determining a policy for the acceptability of risk, many manufacturers have implemented a
concept from an informative annex of the standard. The annex was intended only to demonstrate
how society perceives risk: the three-region risk chart, which includes acceptable risks,
unacceptable ones, and risks that are as low as reasonably practicable (ALARP). This chart was
provided in the original edition of ISO 14971 to show that there are some risks that everyone
would consider unacceptable, some that would be thought of as acceptable by the general public,
and, of course, some on which reasonable individuals might disagree. It was never meant to be a
model for determining the acceptability of risks. ALARP is intended to be used in risk
management only as a policy requiring that some risks that qualify as acceptable (but that are close
to the acceptability threshold) should be further reduced if possible.

The standard requires that risks be identified only as acceptable or unacceptable. Introduction of a
third undefined level of acceptability adds confusion but no value. In most cases in which the
concept of ALARP has been misapplied, it is used to label this middle region. Processes using this
method typically say that risks in the ALARP zone require a risk-benefit analysis. They also say
that risks below this zone are broadly acceptable and require no risk reduction, and that risks above
ALARP are unacceptable. The problem with this approach is that it eliminates risk-benefit analysis
as a tool for many risks such as those associated with high-risk but high-reward procedures (e.g.,
open-heart surgery). However, if a simple two-region risk acceptability model is used, risks are
either acceptable and need not be reduced further, or they are unacceptable and action must be
taken to either reduce the likelihood of the trigger event (most common) or the severity of the
harm. Risk-benefit analysis then becomes what it was intended to be by ISO 14971: a way to show
that otherwise unacceptable risks are acceptable only because significant benefit is provided that
could not exist without that risk.

It should also be noted that when risks are near but still below the acceptable risk threshold, ISO
14971 says that we should evaluate whether additional risk mitigations can be
employed.

This concept is intuitively obvious. As discussed, all risk estimations are just that—estimations
that inherently carry the potential for error. When those errors might result in a risk that is
acceptable but near the acceptability threshold, additional reduction in that risk is advised to ensure
an adequate margin. A historic evaluation (as required by subclause 3.2 of the risk management
standard) can provide insight on the accuracy of your risk management process and help in
determining when additional mitigations are appropriate for otherwise acceptable risks.

Risk Reduction

For those risks that are unacceptable based on the manufacturer's policy or method for evaluating
risk, risk-reduction techniques must be implemented to reduce the level of risk to acceptable
levels. Those techniques include design features to reduce the likelihood of the trigger event or the
severity of the harm that would result. Where design solutions are not practicable, manufacturers
might implement guards that prevent access to the harm. When neither design solutions nor guards
are practicable, warnings may be provided through labeling or instructions. Remember that
warnings are an acceptable solution for reducing risk only when design solutions or guards (which
could be considered a design solution) are not reasonably practical. Resorting to warnings without
documenting why design or guard solutions are not reasonable may lead to objections by
regulators and auditors. Moreover, in court, the manufacturer may be characterized as having
resorted to a perceived cheap solution rather than taking appropriate action to protect patients,
clinicians, and bystanders.

However, if the manufacturer has effectively used device safety standards, it won't need to start a
desperate search for practical risk-reduction techniques. The standards used to identify hazards
associated with the device provide risk-reduction techniques for each of those hazards.
Furthermore, ISO 14971 says that when manufacturers comply with the requirements of those
safety standards, the hazards (and risks) associated with each requirement are presumed to be
broadly acceptable and no further mitigation is required. This means that for each hazard and
associated risk derived from standards, compliance with the requirement is identified as risk
mitigation and sets the postmitigation risk level well within the company's acceptable risk range.

Note that this approach has not estimated the postmitigation likelihood in these cases; it is not
necessary. The severity of the harm (determined in the premitigation analyses) and the resulting
risk level (broadly acceptable) are known. Therefore, the likelihood that would drive the level of
risk can be calculated. When standards are used properly, hazards, harms, and mitigations are
identified. This eliminates the need to make likelihood estimates either pre- or postmitigation. For
most medical devices (depending on the number of standards available for the device), well over
90% of the hazards and the levels of risk can be identified and reduced to acceptable levels
thoroughly, and with minimum time expenditure.

The techniques outlined here won't eliminate the need to think “outside of the standard” and
identify hazards and risks that are unique to a device being evaluated. New features and creative
solutions to common problems always have the potential to give rise to unique risks that must also
be made acceptable.

Conclusion

ISO 14971 requires that manufacturers identify any new hazards and risks that might have been
created by risk-reduction techniques. For virtually all of the risk reductions derived from standards,
there will be no additional risks created (or they would be addressed by other requirements in those
standards). However, when manufacturers develop their own unique risk mitigations, this type of
analysis is critical.

In the end, thoroughly understanding the risk management process and its purpose as well as
implementing standards as an integral part of that process, can significantly improve both the
effectiveness and efficiency of a device company's risk management efforts.

2. Explain briefly with examples, six maintenance scheduling principles.

Sol:
Follow these planning, scheduling principles

In the first two issues of Reliable Plant, I outlined why planning frustrates many companies and
why many planners do not plan. I explained that serious frustration stems from incorrectly
encouraging supervisors to wait on planning for all reactive work. I also wrote that planners
commonly help jobs in progress to the extent that they have no time left to plan new work.

With these major issues addressed, this column enumerates all of the principles of a successful
planning and scheduling program. The six planning principles and six scheduling principles listed
on this page form the essence of my “Maintenance Planning and Scheduling Handbook”.

Planning Principle 1 requires keeping planners independent from the supervision of the
individual crews. Supervisors commonly grab planners to help on jobs, making them unavailable
for planning.

Planning Principle 2 is to have the planners (now available for planning) concentrate on planning
future work rather than merely helping deal with delays of jobs already in progress. This principle
takes advantage of the repetitious nature of most maintenance work and moves jobs up a learning
curve.

Planning Principle 3 recognizes that planners can only practically retrieve prior job feedback to
improve jobs if the file or computer system tracks jobs at the component level (e.g., a valve instead
of a system).

Planning Principle 4 utilizes the expertise of an experienced technician as a planner (with perhaps
limited history review) to estimate job labor hours. This avoids time-consuming techniques of
building estimates.
Planning Principle 5 has this planner utilize the skills of the field technicians and avoid extra time
giving more procedural information than necessary on initial job plans.

Planning Principle 6 reminds us that the purpose of planning is to reduce delays and help
technicians spend more time on jobs.

Planning also involves scheduling because reducing delays during individual jobs allows
supervisors to assign more jobs. Scheduling answers the question of how many jobs to assign.
While the planning principles address major issues, the scheduling principles are more of a
framework.

Scheduling Principle 1 obligates each job plan to estimate labor hours and craft skill levels.

Scheduling Principle 2 encourages not interrupting jobs already in progress through proper
prioritization of work.

Scheduling Principle 3 commits crew leaders to forecast labor hours for craft skills available for
the next week.

Scheduling Principle 4 combines all of the forecast crew labor hours with the estimated labor
hours of the planned jobs, generally in order of job priority.

Scheduling Principle 5 has crew leaders schedule and assign daily work (even though the
planning department allocates the week’s goal of work).

Scheduling Principle 6 establishes the importance of measuring schedule success. Measuring this
outcome helps management insure that planning and scheduling does take place.

Finally, maintenance must acknowledge reactive work. Management must assure crew leaders that
for urgent work, it is OK to work an unplanned job and it is OK to break a schedule. Planning must
not constrain crews from immediately beginning work on urgent jobs. Nevertheless, planning can
abbreviate its efforts on urgent work and many times produce a helpful job plan before
maintenance begins work.

Allowing crews to work unplanned work and break schedules is vital to consider, especially for
reactive plants. If it is OK to work on unplanned jobs and break schedules, where is the
productivity gain? Actual experience shows that simply starting each crew every week with a
sufficient allocation of work as a goal significantly boosts crew productivity, usually in excess of
50 percent.

This column and my previous two are most appropriate for readers that already recognize the value
of a planning program. My column in the January/February issue will address and quantify the
value of maintenance planning. Future articles after that will review the principles in greater depth
and will also handle individual issues that commonly arise in planning efforts.

3. Write a note on:

a) Productive Maintenance.
b) Predictive Maintenance.
c) Condition Based Maintenance.
 Sol:
a) Total Productive Maintenance

One of the most recognizable symbols in modern manufacturing is the “TPS House” diagram as
shown below. The diagram is a simple representation of the Toyota Production System (TPS) that
Toyota developed to teach their supply base the principles of the TPS. The foundation of the house
represents operational stability and has several components, one of which is Total Productive
Maintenance.

Working with little inventory and stopping production when there is a problem causes instability
and a sense of urgency among workers. In mass production, when a machine goes down, there is
no sense of urgency; excess inventory will keep the operation running while maintenance fixes the
problem. In lean production, when an operator shuts down production to fix a problem, the line
will soon stop producing, creating a crisis and a sense of urgency. A properly implemented and
maintained Total Productive Maintenance System (TPM) will provide the needed stability for lean
production.

A little more than 30 years ago, an automotive supplier company in Japan (Nippondenso) realized
that until you address and systematically eliminate the causes of poor equipment performance, you
cannot deliver to your customers “just in time,” improve quality levels, lower operating costs or
improve profits. In 1969, the ideas of Total Productive Maintenance, facilitated by Seiichi
Nakajima, helped take the Toyota Production System to the next level. Since the Toyota
Production System was focused on the absolute elimination of waste to reduce manufacturing cost,
TPM was designed to systematically identify and eliminate equipment losses (downtime,
inefficiency, defects). In implementing lean manufacturing practices, machine availability plays an
important role. Preventive maintenance is a key aspect in ensuring machine availability. This
practice achieves maximum efficient usage of machines through total employee involvement.

Toyota has created an organizational culture that encourages employee participation, which is
essential for successful TPM. Group activities are promoted among the shop-floor team members.
The knowledge base of all the employees is used to improve equipment reliability and productivity
thereby lowering maintenance and operating costs. Two other important aspects of TPM are
training and open communication between operators and engineering. Production personnel are
trained to perform routine maintenance.

The traditional approach to preventive maintenance is a clear-cut division of labor.

• Machine operators perform routine maintenance functions.

• Maintenance technicians are responsible for specialized maintenance and for improving
maintainability.
• Engineering is responsible for improving the process.

This practice is not capable of achieving the TPM targets, as there is a lack of communication
between operating and maintenance teams.
Nippondenso came out with an alternative approach of appointing a machine technician (MT) that
supports communication between operators and maintenance. The responsibilities of the MT were
to perform minor maintenance and repair tasks. These MTs underwent classroom training on tool
finishing and fitting as well as on-the-job training. On-the-job training gave them exposure to
machines and helped them gain expertise in their area.

There are two different types of philosophies of TPM. Firstly, there is the centralized maintenance
approach. This requires maintenance personnel to be cross-trained, thus providing flexibility of
using a number of workers for scheduling maintenance tasks. This flexibility is essential because
as workers move up in seniority level, there is a tendency to opt for convenient shifts instead of
third shift.

The second approach is decentralization. As personnel become more experienced in one functional
area, they gain more expertise. Sometimes it requires six months of training before a person
becomes proficient in a new area. Thus, frequent job rotations may result in under-utilization of
skills gained through training. A good example of this type of approach is at Honda Motors for its
three departments – suspension assembly, facilities and engine assembly. Each department has a
separate maintenance team. The reasons for this shift were the need for 12 to 18 months of training
in each area, and local regulations required maintenance to take place only on weekends and
shutdowns.

Toyota has a centralized maintenance function with cross-trained employees. The benefits of
decentralized maintenance are derived from the use of MTs. These MT’s are experts in their areas.
However, availability of limited maintenance personnel necessitates cross-trained employees.

Toyota also collects data for analysis and trend establishment. Sufficient data on the trend and
pattern of equipment’s performance should be available for identifying and setting up standards
and procedures for preventive maintenance. This data would also be useful in determining costs of
preventive maintenance and repairs, run-to-failure vs. preventive maintenance, and failure history.

Organizations also need to evaluate the impact of organizational structure and processes on
preventive maintenance. Change in these can have an overwhelming impact on employee morale,
efficiency and effectiveness. As Toyota has shown, preventive maintenance management calls for
long-term commitment to the goal and pays dividends in the long run.

b) Predictive Maintenance
Predictive maintenance (PdM) techniques help determine the condition of in-service
equipment in order to predict when maintenance should be performed. This approach
offers cost savings over routine or time-based preventive maintenance, because tasks
are performed only when warranted.

Predictive Maintenance or condition-based maintenance, attempts to evaluate the condition of

equipment by performing periodic or continuous (online) equipment condition monitoring. The
ultimate goal of Predictive Maintenance is to perform maintenance at a scheduled point in time
when the maintenance activity is most cost-effective and before the equipment loses performance
within a threshold. This is in contrast to time- and/or operation count-based maintenance, where a
piece of equipment gets maintained whether it needs it or not. Time-based maintenance is labor
intensive, ineffective in identifying problems that develop between scheduled inspections, and is
not cost-effective.

The "predictive" component of predictive maintenance stems from the goal of predicting the future
trend of the equipment's condition. This approach uses principles of statistical process control to
determine at what point in the future maintenance activities will be appropriate.

Most PdM inspections are performed while equipment is in service, thereby minimizing disruption
of normal system operations. Adoption of PdM can result in substantial cost savings and higher
system reliability.

Reliability-centered maintenance, or RCM, emphasizes the use of predictive maintenance (PdM)

techniques in addition to traditional preventive measures. When properly implemented, RCM
provides companies with a tool for achieving lowest asset Net Present Costs (NPC) for a given
level of performance and risk.

Technologies

To evaluate equipment condition, predictive maintenance utilizes nondestructive testing

technologies such as infrared, acoustic (partial discharge and airborne ultrasonic), corona
detection, vibration analysis, sound level measurements, oil analysis, and other specific online
tests. New methods in this area are to utilize measurements on the actual equipment in
combination with measurement of process performance, measured by other devices, to trigger
maintenance conditions. This is primarily available in Collaborative Process Automation Systems
(CPAS). Site measurements are often supported by wireless sensor networks to reduce the wiring
cost.

Vibration analysis is most productive on high-speed rotating equipment and can be the most
expensive component of a PdM program to get up and running. Vibration analysis, when properly
done, allows the user to evaluate the condition of equipment and avoid failures. The latest
generation of vibration analyzers comprises more capabilities and automated functions than its
predecessors. Many units display the full vibration spectrum of three axes simultaneously,
providing a snapshot of what is going on with a particular machine. But despite such capabilities,
not even the most sophisticated equipment successfully predicts developing problems unless the
operator understands and applies the basics of vibration analysis.

Acoustical analysis can be done on a sonic or ultrasonic level. New ultrasonic techniques for
condition monitoring make it possible to “hear” friction and stress in rotating machinery, which
can predict deterioration earlier than conventional techniques. Ultrasonic technology is sensitive to
high-frequency sounds that are inaudible to the human ear and distinguishes them from lower-
frequency sounds and mechanical vibration. Machine friction and stress waves produce distinctive
sounds in the upper ultrasonic range. Changes in these friction and stress waves can suggest
deteriorating conditions much earlier than technologies such as vibration or oil analysis. With
proper ultrasonic measurement and analysis, it’s possible to differentiate normal wear from
abnormal wear, physical damage, imbalance conditions, and lubrication problems based on a direct
relationship between asset and operating conditions.

Sonic monitoring equipment is less expensive, but it also has fewer uses than ultrasonic
technologies. Sonic technology is useful only on mechanical equipment, while ultrasonic
equipment can detect electrical problems and is more flexible and reliable in detecting mechanical
problems.

Infrared monitoring and analysis has the widest range of application (from high- to low-speed
equipment), and it can be effective for spotting both mechanical and electrical failures; some
consider it to currently be the most cost-effective technology.

Oil analysis is a long-term program that, where relevant, can eventually be more predictive than
any of the other technologies. It can take years for a plant's oil program to reach this level of
sophistication and effectiveness. Analytical techniques performed on oil samples can be classified
in two categories: used oil analysis and wear particle analysis. Used oil analysis determines the
condition of the lubricant itself, determines the quality of the lubricant, and checks its suitability
for continued use. Wear particle analysis determines the mechanical condition of machine
components that are lubricated. Through wear particle analysis, you can identify the composition
of the solid material present and evaluate particle type, size, concentration, distribution, and
morphology.

c) Condition Based Maintenance:

Condition-based maintenance (CBM), shortly described, is maintenance when need arises. This
maintenance is performed after one or more indicators show that equipment is going to fail or that
equipment performance is deteriorating.

Condition-based maintenance was introduced to try to maintain the correct equipment at the right
time. CBM is based on using real-time data to prioritize and optimize maintenance resources.
Observing the state of the system is known as condition monitoring. Such a system will determine
the equipment's health, and act only when maintenance is actually necessary. Developments in
recent years have allowed extensive instrumentation of equipment, and together with better tools
for analyzing condition data, the maintenance personnel of today are more than ever able to decide
what is the right time to perform maintenance on some piece of equipment. Ideally condition-based
maintenance will allow the maintenance personnel to do only the right things, minimizing spare
parts cost, system downtime and time spent on maintenance.

Challenges:

Despite its usefulness, there are several challenges to the use of CBM. First and most important of all, the
initial cost of CBM is high. It requires improved instrumentation of the equipment. Often the cost of
sufficient instruments can be quite large, especially on equipment that is already installed. Therefore, it is
important for the installer to decide the importance of the investment before adding CBM to all equipment.
A result of this cost is that the first generation of CBM in the oil and gas industry has only focused on
vibration in heavy rotating equipment.

Secondly, introducing CBM will invoke a major change in how maintenance is performed, and potentially
to the whole maintenance organization in a company. Organizational changes are in general difficult.

Also, the technical side of it is not always as simple. Even if some types of equipment can easily be
observed by measuring simple values as vibration (displacement or acceleration), temperature or pressure, it
is not trivial to turn this measured data into actionable knowledge about health of the equipment.

Value potential

As systems get more costly, and instrumentation and information systems tend to become cheaper
and more reliable, CBM becomes an important tool for running a plant or factory in an optimal
manner. More optimal operations will lead to lower production cost and lower use of resources.
And lower use of resources may be one of the most important differentiators in a future where
environmental issues become more important by the day.
A more down to earth scenario where value can be created is by monitoring the health of your car
motor. Rather than changing parts at predefined intervals, the car itself can tell you when
something needs to be changed based on cheap and simple instrumentation.

It is Department of Defense policy that condition-based maintenance (CBM) be "implemented to

improve maintenance agility and responsiveness, increase operational availability, and reduce life
cycle total ownership costs".