Name Anil Kumar Joshi

Roll No. 520949950

Course & Semester Master of Business Administration – MBA Semester 4

OM0006 – Maintenance Management

Subject Name & Code
Book ID: B1148

Assignment No. Set – 1 & 2

LC name & Code NIPSTec LTD. 1640

Date of Submission 14.05.2011

Session
 Assignment Set – 1

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. 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. 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".
 Assignment Set – 2

1. Explain Master Production Schedule. Take any product around you and prepare a
detailed Bill of materials for the same.

Sol:
Master production schedule
Introduction: The master production schedule (also commonly referred to as the MPS) is
effectively the plan that the company has developed for production, staffing, inventory,
etc.

It has as input a variety of data, e.g. forecast demand, production costs, inventory costs, etc and
as output a production plan detailing amounts to be produced, staffing levels, etc for each of a
number of time periods.

This production plan:

• operates at an aggregate level (that is it does not usually go into great detail about parts
to be used, etc - hence the name aggregate planning); and
• is cost driven, that is it attempts to meet the specified requirements at minimum cost.
The idea of a master production schedule can best be illustrated by means of an example.

Example: In our example we have just a single product being produced.

Production takes place each period (week) either in the normal (regular) production shift or in
overtime associated with that shift. There is only one shift (i.e. not operating a two/three shift
system - such as with "round-the-clock" working).

Completed items can also be "bought-in" from a subcontractor (at a cost).

We are allowed to hire/fire workers (again at a cost). Backorders are also allowed (recall here
that backorders are customer orders that cannot be satisfied in the required period, but the
customer allows the order to remain open to be fulfilled in a later period). Lost sales are not
allowed.

The diagram below illustrates the situation and the types of factor with which we are dealing
graphically.
The data for the example we consider is as below, where we have shown the initial data entry
screen from the package.

In the above screen we have chosen the "General LP Model". This is the most general of the
options allowed by the package. LP stands for linear programming and is a generalized way of
modeling decision problems. To ease data entry we have not crossed the "Part Time Allowed"
box - if we had then we would have had the option of dealing with part time employees.
We have also not crossed the "Lost Sales Allowed" box - if we had then we would have allowed
lost sales. In general a company may allow lost sales because the company finds that customers
simply do not backorder - i.e. a lost sale is automatic if the product is not immediately available;
or the company is prepared to allow lost sales as it may be better to allow orders to be lost than
to allow such orders to become backorders (thereby incurring backorder costs).

The remaining boxes have been crossed and so we can deal with:
• overtime
• hiring/firing
• subcontracting
• backorders

In our example above we have just 4 periods (weeks) - this is our time horizon (planning
period). We are dealing with employees working hours in each week. Two employee hours are
required to produce one unit of each product and the initial number of employees is 10. At the
start of the planning period there is no initial inventory (nor are there any backorders).

The data for our example entered into the package in the light of the choices made at the initial
screen is as below:

The meaning of each of these lines of data is given below:

Forecast Demand - this is the forecast demand for the product in each of our 4 periods (weeks).

Initial Number of Employee - this is the initial number of employees in each week, here just the
10 employees we have currently.

Regular Time Capacity in Hour per Employee - this is how many regular hours each employee
works per week, here 35 hours
Regular Time Cost per Hour - this is the cost per hour of regular time worked, here £15

Under time Cost per Hour - this is the cost per hour of not using a worker to their full regular
capacity, here zero

Overtime Capacity in Hour per Employee - this is the maximum number of hours each
employee can work in overtime per week, here 10 hours

Overtime Cost per Hour - this is the cost per hour of overtime, here £25

Hiring Cost per Employee - this is the cost of hiring one employee, here £500

Dismissal Cost per Employee - this is the cost of dismissing (firing) one employee, here £2000

Maximum/Minimum Number of Employee Allowed - here we can set limits on the maximum
and minimum number of employees, here M signifies there is no limit on the maximum number
and the minimum number is 8. In general there may be an upper limit on the number of
employees due to physical capacity constraints.

Initial Inventory (+) or Backorder (-) - the initial inventory available or backorders
outstanding, here zero

Maximum/Minimum Ending Inventory - here we can set limits on the maximum and minimum
number of product units in stock at the end of each week, here M signifies there is no limit on
the maximum number and the minimum number is zero. In general there may be an upper limit
because we have a limited space in which to store stock. The minimum number corresponds to
safety stock that may be kept in case of unforeseen demand.

Unit Inventory Holding Cost - this is the cost of holding one unit in stock at the end of each
period, here £3

Maximum Subcontracting Allowed - this is the maximum number of product units we are
allowed to buy in from the external subcontractor, here there is no limit on the amount that may
be bought in. In general there may be a limit on the total amount the subcontractor can supply to
us each period.

Unit Subcontracting Cost - this is the cost of each unit bought from the external subcontractor,
here £60

Maximum Backorder Allowed - this is the maximum number of backorders allowed at the end
of each period, here there is no limit on the number of backorders that can be held at the end of
each period.

Unit Backorder Cost - this is the cost of each backorder outstanding at the end of each period,
here the M signifies that each backorder is very expensive. The effect of M here will be to
ensure that (if at all possible) backorders will be avoided.
Other Unit Production Cost - this is the cost of producing one unit of the product that is not
already accounted for by employee costs - here zero

Capacity Requirement in Hour per Unit - this is the number of employee hours that are
required to produce one unit of the product, here 2 hours

In order to ease understanding of the problem most of the above data items take the same value
in each and every period (week). However it would be perfectly possible for them to have
different values in each week.

Consider for a moment this example as we have defined it so far. We have a single product, are
planning over 4 time periods, have regular time and overtime, can buy from an external
subcontractor, and are allowed to hire and fire employees. Some of the decisions we must make
are shown below:
Period 1 2 3 4
Amount to produce using regular time ? ? ? ?
Amount to produce using overtime ? ? ? ?
Amount to purchase from subcontractor ? ? ? ?
Number of backorders ? ? ? ?
Number to hire ? ? ? ?
Number to fire ? ? ? ?

You can see from this matrix that there are already 24 decisions which we have to make. For
such problems decision models (such as the decision model used within the package) are much
better at decision-making than people. Moreover such models can guarantee to make decisions
at minimum cost, something people cannot do.

Note here that even the (cheap) package used here is extremely flexible in terms of the situations
it can consider.

Solution
The solution to the problem is shown below:
It can be seen that we immediately hire more employees, and that these are employed
throughout the planning period of 4 weeks. Note that the number hired is 10.57 - i.e. it includes
a fraction of an employee. This often happens in aggregate planning and can usually be ignored
(simply round to the nearest appropriate whole number). Reflect that we are producing a plan
for production over a 4 week period. It is unlikely that our demand forecasts will be completely
accurate and hence this rounding need not concern us unduly.

With 10+10.57 = 20.57 employees working 35 hours a week we have a regular time capacity of
20.57x35 = 720 employee hours (approximately) and at 2 hours per unit produced this
corresponds to a regular time production of 360 units - precisely as above, i.e. over the 4 week
planning period we are planning to work all of our employees to their full regular time capacity.
As can be seen above we are planning no overtime or subcontracting.

Note the build into inventory that occurs in various periods. As inventory costs us money let us
be clear about why the above (the minimum cost solution) involves build into inventory. It is to
meet future demand. Demand for the product increases over the 4 week planning period (from
250 to 450 units) and the package has determined that the most cost-effective way to ensure that
this demand is met is to build into inventory in earlier periods. Note that an alternative strategy
to meet this increased demand would be to buy from the subcontractor, were this cheaper the
package would have adopted that strategy.

The costs associated with the package solution can be seen below:

The production and employment strategy given above is the minimum cost strategy since the
package uses linear programming to calculate a schedule for production and staffing that meets
the forecast demand and also satisfies the other constraints that we place upon the problem at
minimum cost. It would be impossible to find the minimum cost solution manually - consider
the solution shown with an increase in employment and with varying amounts built into
inventory - could that ever be produced by a person in the time (fraction of a second) it takes the
package to produce it?

Level and chase strategies

We may be interested in a solution that consists of a fixed number of workers (a level strategy).
This can be seen below where we have fixed the maximum and minimum number of employees
to 10 (the current number) in each and every period.
The solution for this level strategy is shown below.

It can be seen that with this solution we use both overtime and subcontracting but do not build
into inventory. The total cost of 63,400 is much more than the previous (non-level) strategy
which had a total cost of 49475.71
If we change the hire/fire costs to zero and reset the limits on the maximum/minimum number
of employees then we will produce a chase strategy (ramp workforce up/down as required).
This solution can be seen below.
Backordering
In our original situation considered above, with costs for hiring and firing, we were prohibiting
backorders by making them very expensive. Suppose now that backorders cost us £1 per period
(week). The effect of this on the solution is shown below.
It can be seen that we produce nothing - the cheapest solution is simply to allow backorders to
build up over the planning period. This seems silly and for this reason it is usual to insist that
there are no backorders outstanding at the end of the planning period. This is an assumption that
is, by convention, applied and is a reasonable assumption when planning over a relatively long
time period. Moreover unless this is assumed it can happen that the best thing for the company
to do over the planning period is simply to allow backorders to build up (as above).
To ensure that there are no backorders outstanding at the end of the planning period we enter a
zero for "Maximum Backorders Allowed" in the last period (week 4), as below.
The solution is

which is effectively the same as the initial solution we considered. However to illustrate that
backorders can play a role suppose that we:
• have a level strategy with exactly 10 employees in each and every period (week); and
• restrict the subcontractor capacity in each and every period
then the input is as below:
and the output is:

where backorders do occur since production capacity (both regular time and overtime) together
with subcontractor capacity is insufficient to met demand in some periods.
2. Describe Close Work in Work Management Process. Explain components of work
execution.

Sol:
The purpose of this article is to provide you with everything you need to know about Work
Breakdown Structures (WBS) so you can improve the way you plan, manage, and control your
projects and programs.

PMBOK defines a WBS as “a deliverable-oriented hierarchical decomposition of the work to be

executed by the project team, to accomplish the project objectives and create the required
deliverables. The WBS defines the total scope of the project.”

An easier way to think of Work Breakdown Structures is as being similar to a family tree, that
is, they are a tree structure showing the subdivision of components necessary to deliver a project
or program. Work Breakdown Structures are very useful for establishing agreement between
stakeholders and project team members as to the scope of the project.

In a general sense, we can think of WBS as follows:

If we think about starting a project, we begin with a project charter and preliminary scope
statement. This defines the high-level goals and deliverables of the project. We then create the
project scope document which further defines these deliverables into a list of all deliverables
and the requirements of each. The next step is to use this comprehensive list of deliverables to
build the WBS.

The WBS will detail the full scope of the work necessary to finish the project. The WBS can
then be used to estimate the cost of the project, schedule resources, and plan quality gates.
Essentially the WBS will enable you to better manage your project.
Some WBS Examples
The best way to understand work breakdown structures is by means of some examples. We’ll
look at two examples, one which looks at the components that make up a Car, and another
which looks the components that make up a Project. Firstly, lets look at the components which
make up a car.

At the very top of the WBS is the project or program name, in this case Car. The lowest level of
any WBS is always called the work package level. Thus, in the example above, 4.0 Chassis is a
work package to deliver the Chassis in it’s entirety for the car.
Now let’s consider the WBS for the Project:

Here we can see that the project is made up of four phases: Requirements, Design, Build, and
Deliver.

One way to think about these two examples is that the Car example is showing the “what” (the
components of the car), and the Project example is showing the “how” (the components needed
to deliver a generic project).

Getting to a Point Where we can start to plan

We do this using the process of decomposition. Decomposition is a 5-step process:

1. Identify all the major project deliverables. One way to do this is to involve the project
team as a group to identify all the major deliverables from the project scope statement.
2. Organize the WBS (we’ll cover next)
3. Define the WBS components. Here we decompose the major deliverables defined in
step 1 into lower level components.
4. Assign identification codes. This can be done simply by attaching a number to each of
the WBS components. All the examples I’ve used have identification codes attached.
5. Verify the WBS. Here we validate the WBS for correctness. Ask yourself and the team
questions such as “are all the components clear?” Are all components complete? Is each
component absolutely necessary? Does the decomposition sufficiently describe the work
which needs to be done?

It’s a lot of work to do this, but really beneficial if you’re at the early stages of managing your
project or program. By deconstructing the tasks you may identify areas you would not have
otherwise noticed until later in the project execution. This makes you more likely to get
things right up front and stops the teams getting frustrated because you will not be asking them
to change things several times during the project.

Organizing the WBS

PMBOK states that you can organize the WBS in several ways:

• Major Deliverables and subprojects: here the major deliverables of the project or
program are used as the first level of decomposition. This is the approach we used for
the Car example above.
• Subprojects executed outside the project team: you can think of this as being a little
like streams within a program. For example, if on one stream is to rollout the product
globally, then the rollout project manager can define the WBS for this component. Often
a subproject will be contracted out.
• Project phases: using this technique, each phase of the project would be listed in the
first level of decomposition, with the deliverables of each phase listed in the next level.
This is the approach we used for the Project example previously.
• Combination approach: this is a combination of the organizational methods, for
example, you might have subprojects listed on the first level, with the major deliverables
of each listed on the 2nd level.

When to Stop
Don’t go crazy when creating your Work Breakdown Structures. What you’re trying to do is
define the work of the project or program so you can easily plan, manage and control that work.
You should only decompose the plan to a level that allows you to achieve this aim.

WBS and Agile

Having read this far, you may well be thinking that work breakdown structures are very old
fashioned and don’t apply to Agile. However, WBS equally applies to Agile. An agile WBS is
organized around end-user functionality. Here, features are decomposed into Epics, Epics into
User Stories, and User Stories are decomposed into Functionality which can be implemented
within a single iteration. Because an individual user story is atomic, stories can be added or
removed from the WBS provided the sum of the work can still be implemented within one
sprint.
At this point I think I should add a personal note on this. This is theory of Agile work
breakdown structures, but I don’t in practice think it is necessary to do this, as most Agile
methods effectively make this a duplication of effort.
Unique WBS Identifiers
It’s good practice to assign a unique identifier to each level of the WBS. For example, we might
use the following based on the Car example we looked at earlier:

Work Packages
As mentioned previously, the lowest level in a WBS is a work package. Work packages are
components which can easily be given to a person, a team, or a subcontractor, who
then has accountability and responsibility for delivering the work package.
In programs or large projects a work package may be at a level requiring further decomposition
into its own work breakdown structure. The breakdown of the work package might then be done
by the project team for that work package or even an external vendor.
Scope Baseline
Now that you have created the Work Breakdown Structure you are ready to baseline the scope
of the project or program you are managing. The scope baseline for your project or program is
defined as the approved project scope statement, the work breakdown structure, and the WBS
dictionary.
Design Principles when Constructing Work Breakdown Structures
When constructing work breakdown structures there are a couple of guiding principles you need
to know to keep you on track:
• The 100% Rule: The WBS should define the total scope of the project. If it doesn’t do
this then the plans you create from the WBS will by inference have gaps and missing
components.
• Mutual Exclusivity: there should be no overlap between any two elements in a WBS.
If there are, then you run the risk of duplicating work in the project execution
• Include Deliverables, Not Actions: I’m not going to go into details (you’ve done well
to read this far already) but this is one of the best ways to stick to the 100% rule
• Use Common Sense: as mentioned previously, don’t go into too much detail. What
you’re looking for is enough detail so you can plan, manage and control the project.
3. Explain in detail by taking an example the difference between Preventive and
Breakdown Maintenance. Which of them is preferred? Justify your choice.

Sol:
Preventive maintenance (PM) has the following meanings:
1. The care and servicing by personnel for the purpose of maintaining equipment and
facilities in satisfactory operating condition by providing for systematic inspection,
detection, and correction of incipient failures either before they occur or before they
develop into major defects.
2. Maintenance, including tests, measurements, adjustments, and parts replacement,
performed specifically to prevent faults from occurring.
Preventive maintenance can be described as maintenance of equipment or systems before fault
occurs. It can be divided into two subgroups:
• planned maintenance
• And condition-based maintenance.

The main difference of subgroups is determination of maintenance time, or determination of

moment when maintenance should be performed.

While preventive maintenance is generally considered to be worthwhile, there are risks such as
equipment failure or human error involved when performing preventive maintenance, just as in
any maintenance operation. Preventive maintenance as scheduled overhaul or scheduled
replacement provides two of the three proactive failure management policies available to the
maintenance engineer. Common methods of determining what Preventive (or other) failure
management policies should be applied are; OEM recommendations, requirements of codes and
legislation within a jurisdiction, what an "expert" thinks ought to be done, or the maintenance
that's already done to similar equipment, and most important measured values and performance
indications.

To make it simple: Preventive maintenance is conducted to keep equipment working and/or

extend the life of the equipment.
• Corrective maintenance, sometimes called "repair", is conducted to get
equipment working again.

The primary goal of maintenance is to avoid or mitigate the consequences of failure of

equipment. This may be by preventing the failure before it actually occurs which Planned
Maintenance and Condition Based Maintenance help to achieve. It is designed to preserve and
restore equipment reliability by replacing worn components before they actually fail. Preventive
maintenance activities include partial or complete overhauls at specified periods, oil changes,
lubrication and so on. In addition, workers can record equipment deterioration so they know to
replace or repair worn parts before they cause system failure. The ideal preventive maintenance
program would prevent all equipment failure before it occurs.

There is a controversy of sorts regarding the propriety of the usage “preventative.” The
consensus of internet entries concerning the respective usages seems to indicate that
“preventive” is the preferred term.
Breakdown Maintenance - Breakdown maintenance implies that repairs are made after the
equipment is out of order and it cannot perform its normal function any longer, e.g., an electric
motor of a machine tool will not start, a belt is broken, etc.

Under such conditions, production department calls on the maintenance department to rectify
the defect. The maintenance department checks into the fault and makes the necessary repairs.
After removing the fault, maintenance engineers do not attend the equipment again until another
failure or breakdown occurs. This type of maintenance may be quite justified in small factories
which:

1. are indifferent to the benefits of scheduling;

2. Do not feel a financial justification for scheduling techniques; and
3. Get seldom (temporary or permanent) demand in excess of normal operating
capacity. In many factories make-and-mend is the rule rather than the exception.

Breakdown maintenance practice is economical for those (non-critical) equipments whose

downtime and repair costs are less this way than with any other type of maintenance.
Breakdown type of maintenance involves little administrative work, few records and a
comparative small staff. There is no planned interference with production programmes.