Level 6 Graduate Diploma :

Quality and Reliability in Engineering:

PROJECT MANAGEMENT, ELECTRICAL ENGINEERING and MECHANICAL

ENGINEERING.

COURSE MATERIAL

Quality and Reliability

Quality engineering focuses on making sure that goods and services are designed, developed,
and made to meet or exceed consumers’ expectations and requirements. It includes all the
activities related to the analysis of a good’s design and development. Quality engineers also
make sure that the manufacturer makes the goods according to specifications.

The discipline of engineering concerned with the principles and practice of product and
service quality assurance and control.”

Levels and types of quality-- Four Levels of Quality

1. FITNESS FOR STANDARD -inspection oriented -no consciousness to customer/mkt

2. FITNESS FOR USE -Must satisfy customer need for use -Hotel shampoo & body oil

3. FITNESS FOR MARKET -Must achieve low cost as well as 1 & 2 4. FITNESS FOR
LATENT REQ'TS -Listening to the voice of the customer -V-8 engine, Swatch -Uncovering
latent req't adds value ==> need continuous innovation

Reliability engineering is engineering that emphasizes dependability in the life-cycle

management of a product. Reliability is defined as the ability of a product or system to
perform its required functions without failure for a specified time period and when used
under specified conditions. Engineering and analysis techniques are used to improve the
reliability or dependability of a product or system.

Differences between quality and reliability.-- Quality is a much broader aspect than
reliability. Quality covers almost everything from organisation, managements, service,
procedures, people, product, product-life etc. In simple words, Reliability is only a subset of
quality, the others being performance, consistency, efficiency, user experience etc. Whereas,
Quality is the measure of conformance to laid down product specification
Total Quality Control (TQC), System for optimizing production based on ideas developed
by Japanese industries from the 1950s on. The system, which blends Western and Eastern
ideas, began with the concept of quality circles, in which groups of 10–20 workers were
given responsibility for the quality of the products they produced. It gradually evolved into
various techniques involving both workers and managers to maximize productivity and
quality, including close monitoring of staff and excellent customer service. The concept
of kaizen, the notion that improvement must involve all members of a company, is central to
TQC.

Measurement systems & techniques for quality control and improvement-- Tools and
Techniques

Best Practices and Planning Analysis. Best practices and planning analysis should be
employed to produce a reasonable approach or plan of activities for conducting audits and
gathering information.

Stakeholder Review. The plan should be reviewed and approved before conducting quality
audits.

Quality Measurement Techniques. Objective measurement techniques for each quality item
should be used to delineate and prescribe a measurement scale for each quality item. Example
measurement scales are: A score of 1–10, a grade of “A” through “F,” a qualifier in the set of
{poor, fair, average, good, best}, or a label such as “non-existent,” “exists,” “exists and is
being followed.”

Outputs

Assessment Plan. The plan serves as the guide for conducting the assessment. The plan
should identify methods by which information will be gathered, and the sources, individuals
or organizations from which the information will be obtained. The plan should include a
schedule, and should specifically identify the quality items to be assessed during the audit.
The plan should also identify the measurement scale for each quality item.
Quality Assessment and Improvement Process Overview

Assess Quality Process Overview

Assess Quality Items

What is Availability?
Availability is the probability that the system is operational, and ready to use. It can also be
described as the time an asset is expected to function. To calculate availability, compare the
mount of time an asset was available, and the time it should’ve been operating. Here’s the
availability formula:
In an ideal setting, the availability of assets would be 99.999%. In the real world, you should
aim at 90% or higher. Availability can also be expressed as a direct proportion (i.e. 9/10).
Either way, availability equals actual operation time divided by scheduled operation time.
Rarely, availability will be conveyed in time units (i.e., weeks or months). This represents the
average time an asset should work over a given period.
There are several things facility managers can do to improve asset availability. For example,
scheduling programmed corrective maintenance or preventive replacements outside regular
working hours. Using predictive maintenance can prevent an asset from ever being out of
order.
But is that all there is to it? Let’s play with the availability formula a little bit. If you think
about it, “actual working time” equals can also be defined as “uptime”. In the same vein,
“scheduled working time” would then become the sum of uptime and downtime. From here
we have:

Ready for another twist? Think about it. “Uptime” is the time a machine operates between
failures, also known as MTBF. “Downtime” is the total time it is unavailable until failures
are repaired, which is the MTTR.
So, here’s how to calculate availability with MTBF and MTTR:
AVAILIBILITY = MTBF
--------------------------
MTBF + MTTR

It’s now clear that high availability hinges on low downtime. However, if you’re using real
data to estimate actual working time, you’ll probably include times when the asset was
operating in a limited capacity. If you want to know the probability of an asset working
correctly, then we’re talking about reliability.
What is Reliability?
Reliability is the probability a system will produce the correct output, which is not the same
as being available. Imagine a car, an aeroplane, or a helicopter. Do you want them to be
available to travel at all times, or do you want it to be reliable? Obviously, one is not possible
without the other.
Usually, an increase in reliability means increased availability. MTBF is a good indicator
of reliability throughout the asset’s lifetime. This is a simplified way to calculate reliability:

However, the reliability function over time is specified as:

Improving reliability means avoiding failures or malfunctions with customised plans, which
is also known as reliability centred maintenance. A customised approach to ensure reliability
depends largely on two factors: data collection, and knowledge of failure modes.
To achieve the latter, facility managers usually rely on reliability block diagrams, fault tree
analysis and Markov models. For critical assets, FMEA is also an option. Total productive
Maintenance and lean manufacturing propose continuous improvement to increase
reliability.
What is Maintainability?
Time for a quick recap. Availability means the asset is operational. Reliability means the
asset is likely to work correctly. But what happens when a failure occurs?
Failures should cause as little disruption as possible. That’s maintainability – sometimes
called serviceability – which is how easily a system can be repaired or maintained. High
maintainability suggests a low time to repair. Time to repair includes evacuation, diagnosis,
assembly of resources, the repair itself, inspection, and return to service. Or MTTR for short.
While the MTTR is the main indicator to calculate maintainability, it’s not the only one.
We’ve already discussed the maintainability function here, and we suggest you bookmark it
for later. For now, the important takeaway is that improving MTTR will improve
maintainability.
Managers can promote several measures to expedite repairs, including using a real-
time CMMS or Intelligent Maintenance Management Platform. But, perhaps, the most
effective measure to repair with as little disruption as possible is to detect failures early on.
Early detection of failures is more likely to provide cost-effective, agile repairs and much less
hassle.
How to improve system availability and efficiency?
We’ve now established how to calculate availability with the MTBF and MTTR. We’ve
explained that MTBF is a strong indicator for reliability, while MTTR hints at
maintainability. Therefore, improving both reliability and maintainability will increase
system availability.
Availability, as you may recall, is one of the three factors in Overall Equipment
Effectiveness (OEE). Increasing availability will invariably increase your OEE, and
reliability plays into performance improvement as well. So, let’s review a few things you
should do to improve system availability and OEE:
• use predictive maintenance to avoid breakdowns and track changes in
performance;
• early failure detection through predictive and preventive maintenance;
• scheduling of maintenance activities based on MTBF and MTTR;
• effective preventive maintenance practices, based on KPIs and failure
modes analysis.
Reliability, Availability and Maintainability (RAM) analysis determines the likelihood of
plant failure and the time necessary to return the plant to an operational state. This allows the
operator to optimise the design including its configuration, level of redundancy, component
selection and supporting maintenance strategy. As well as suggesting tangible
improvements, a RAM analysis provides confidence that the system will meet its operational
targets and support the through-life viability of a project.

Reliability Requirements and Specifications

One of the most essential aspects of a reliability program is defining the reliability goals that
a product needs to achieve. This article will explain the proper ways to describe a reliability
goal and also highlight some of the ways reliability requirements are commonly defined
improperly.
Designs are usually based on specifications. Reliability requirements are typically part of a
technical specifications document. They can be requirements that a company sets for its
product and its own engineers or what it reports as its reliability to its customers. They can
also be requirements set for suppliers or subcontractors. However, reliability can be difficult
to specify. It is easy to use "qualitative" language such as, "our product needs to exceed
customer expectations" or "our product should be more reliable than its competition." Joseph
Juran, a famous quality pioneer, said, "If you don't measure it, you don't manage it." If an
organization does not specify reliability goals numerically, it loses control over managing its
products' reliability improvements.

What are the essential elements of a reliability requirement?

There are many facets to a reliability requirement statement.
Measurable:
Reliability metrics are best stated as probability statements that are measurable by test or
analysis during the product development time frame.
Customer usage and operating environment:
The demonstrated reliability goal has to take into account the customer usage and operating
environment. The combined customer usage and operating environment conditions must be
adequately defined in product requirements. Using constant values. For example: Usage
temperature is 25o C. This could be an average value or, preferably, a high stress value that
accommodates most customers and applications.
• Using limits. For example: Usage temperature is between -15o C and 40o C.
• Using distributions. For example: Usage temperature follows a normal
distribution with mean of 35o C and standard deviation of 5o C.
• Using time-dependent profiles. For example: Usage temperature starts at 70o C
at t = 0, increases linearly to 35o C within 3 hours, remains at that level for 10
hours, then increases exponentially to 50o C within 2 hours and remains at that
level for 20 hours. A mathematical model (function) can be used to describe such
profiles.
Time:
Time could mean hours, years, cycles, mileage, shots, actuations, trips, etc. It is whatever is
associated with the aging of the product. For example, saying that the reliability should be
90% would be incomplete without specifying the time window. The correct way would be to
say that, for example, the reliability should be 90% at 10,000 cycles.
Failure definition:
The requirements should include a clear definition of product failure. The failure can be a
complete failure or degradation of the product. For example: part completely breaks, part
cracks, crack length exceeds 10 mm, part starts shaking, etc. The definition is incorporated
into tests and should be used consistently throughout the analysis.
Confidence:
A reliability requirement statement should be specified with a confidence level, which allows
for consideration of the variability of data being compared to the specification.

Understanding Reliability Requirements

Assuming that customer usage and operating environment conditions and what is meant by a
product "failure" have already been defined, let us examine the probability and life element
of a reliability specification. We will look at some common examples of reliability
requirements and understand what they mean. We will use an automotive product for
illustration.
Example 1: Mean Life (MTTF) = 10,000 miles
The Mean Life (or Mean-Time-To-Failure [MTTF]) as a sole metric is flawed and
misleading. It is the expected value of the random variable (mean of the probability
distribution). Historically, the use of MTTF for reliability dates back to the time of wide use
of the exponential distribution in the early days of quantitative reliability analysis. The
exponential distribution was used because of its mathematical (computational) simplicity.
The exponential distribution has just one parameter, the MTTF (or its reciprocal, the "failure
rate," which is constant, thus the reason for its simplicity). Few products and components
actually have a constant failure rate (i.e. no wearout, degradation, fatigue, infant mortality,
etc.).
The MTTF might be one of the most misunderstood metrics among reliability engineering
professionals. Some interpret it as "no failure by 10,000 miles," which is wrong! Some
interpret it as "by 10,000 miles, 50% of the product's population (50th percentile) will fail."
The "mean," however, is not the same as the "median," so this is only true in cases where the
product failure distribution is a symmetrical distribution, such as the normal distribution. If
the product follows a non-symmetrical distribution (such as Weibull, lognormal and
exponential), which is usually the case in reliability analysis situations, then the mean does
not necessarily describe the 50th percentile, but could be the 20th percentile, 70th, 90th, etc.,
depending on the distribution type and the estimated parameters of that distribution. In the
case of the exponential distribution, the percentile that matches the mean life is actually the
63.2%! If the intention of using the mean life as a metric is to describe the time by which
50% of the product's population will fail, then the appropriate metric to use would be the B50
life.
Let us use the following example for illustration. A company tested 8 units of a product
manufactured by two different suppliers. The failure results are shown next.
Effects on safety of engineering quality and reliability by:

Accident avoidance using, design aspects, human factors--- Prevention Through Design
(PTD) is a concept that allows organizations to eliminate a project's safety issues during the
design process before the project is completed. Eliminating potential safety hazards in the
design phase of a project can lead to long term cost savings by reducing the risk of accidents
and injuries.

PTD is gaining recognition among safety managers as a cost effective means to enhance
accident prevention programs. Other countries have begun requiring that safety issues be
addressed during the initial design phase of projects. The United States does not require
PTD. However, many businesses leaders support PTD and have developed management
systems that require the implementation of PTD in the early stages of project development.

PTD can greatly improve the safety of your workers. When you apply PTD early in the
design phase, you eliminate safety hazards before they are created. But in order to develop
an effective PTD program, you have to include your safety personnel in the early stages of
the design process. Below is a list of recommendations on when and how to include your
safety team on projects.

Choose Your Team. Your policy should require that a representative from your safety
department be included on the project management team. This ensures that the rest of the
project team understands your commitment to accident prevention. Waiting to address safety
issues at the end of the design process can delay the project and have costly
consequences. Engaging your safety expert during the initial design process can help keep
the project on time, improve your accident prevention program, and lead to long term
savings.

Define Program Requirements. Incorporate accident prevention considerations early in the

design process. There are basic safety concerns that should be addressed in the early stages
of design such as electrical safety, environmental concerns, fire protection, maintenance tasks
and regulatory compliance. Addressing these basic safety concerns early will help the
project team create an effective design.
Design Review. Your safety management team should review all design documents and
provide comments on safety concerns and recommend changes. It takes less time and money
to review documents in the early stages of development than it does to correct construction
after implementation or completion of a project.

What if a project is already underway and your project management team is already on their
third design review? It’s not too late. We recommend obtaining management support by
explaining the accident prevention gains and the savings involved by implementing PTD
during the design process, before it's too late to eliminate the hazards.

Risk analysis

This is a vital part of safety management in the undertaking of any project. Safety risk
management is all about managing risks. Projects come with inherent risk but managing
that risk is what is important. First, it is essential to understand the difference between a
risk and an issue. A risk is something that could happen in the future while an issue is
something that has happened. Risk management allows management to plan ahead, not
necessarily to avoid the risk, but to be as prepared as possible should the risk become an
issue. In health and safety, this could mean the difference between an accident happening
or not. Qualitative and quantitative techniques are important risk analysis tools and help
develop a comprehensive risk management plan.

Event tree analysis-- Originating from decision tree analysis, event tree analysis becomes an
accident-cognition method of deducing possibilities and outcomes in a chronological order.
This approach uses a tree diagram called "event tree" to describe the logical relationship
between probable accidents and potential reasons. Through the qualitative and quantitative
analysis of the event tree, users can find the main reasons of accidents and provide reliable
solutions so as to reach the purpose of speculating and preventing accidents.

Fault tree analysis (FTA) is a top-down, deductive failure analysis in which an undesired
state of a system is analysed using Boolean logic to combine a series of lower-level events.
This analysis method is mainly used in safety engineering and reliability engineering to
understand how systems can fail, to identify the best ways to reduce risk and to determine (or
get a feeling for) event rates of a safety accident or a particular system level (functional)
failure. FTA is used in the aerospace, nuclear power, chemical and
process, pharmaceutical, petrochemical and other high-hazard industries; but is also used in
fields as diverse as risk factor identification relating to social service system failure.

In aerospace, the more general term "system failure condition" is used for the "undesired
state" / top event of the fault tree. These conditions are classified by the severity of their
effects. The most severe conditions require the most extensive fault tree analysis. These
system failure conditions and their classification are often previously determined in the
functional hazard analysis.

Fault tree analysis can be used to:

• understand the logic leading to the top event / undesired state.

• show compliance with the (input) system safety / reliability requirements.
• prioritize the contributors leading to the top event- creating the critical
equipment/parts/events lists for different importance measures
• monitor and control the safety performance of the complex system (e.g., is a
particular aircraft safe to fly when fuel valve x malfunctions? For how long is it
allowed to fly with the valve malfunction?).
• minimize and optimize resources.
• assist in designing a system. The FTA can be used as a design tool that helps to
create (output / lower level) requirements.
• function as a diagnostic tool to identify and correct causes of the top event. It can
help with the creation of diagnostic manuals / processes.
Redundancy

Redundancy is the inclusion of extra components in addition to those being used for the
critical functionality to increase the reliability and availability of the system. The redundancy
can be added in the form of hardware (e.g., dual core lockstep), in the form of software, in the
form of information (e.g., ECC added to memory), and time redundancy

Common mode and common cause failures

Failure, which is the result of one or more events, causing coincident failures in multiple
systems or on two or more separate channels in a multiple channel system, leading to system
failure. The source of the common cause failure may be either internal or external to the
systems affected. Common cause failure can involve the initiating event and one or more
safeguards, or the interaction of several safeguards.
Common cause failures represent events in which multiple failures occur in a short period of
time, due to a common cause. This is often called the underlying effect. Its study and
importance are especially relevant in redundant systems since its effect can completely inhibit
the advantages of this type of complex architecture. Today, "all" functional safety standards
require common cause failures to be taken into account, regardless their industry domain or
application area. The aim of researching uses to be its disposal. In other words, regarding
safety-related applications, it must be usual intending to study and completely eliminate
common cause failures.

Use methods for measuring and improving quality and reliability

General principles of metrology.-- Measurement encompasses different fields such as

communications, energy, medical sciences, food sciences, environment, trade, transportation,
and military applications. Metrology concerns itself with the study of measurements.
Measurement is an act of assigning an accurate and precise value to a physical variable. The
physical variable then gets transformed into a measured variable. Meaningful measurements
require common measurement standards and must be performed using them.

The common methods of measurement are based on the development of international

specification standards. Metrology is also concerned with the reproduction, conservation, and
transfer of units of measurements and their standards. Measurements provide a basis for
judgments about process information, quality assurance, and process control. Measurements
provide a basis for judgments about process information, quality assurance, and process
control. Design and proper operation and maintenance of such a product/system are two
important aspects. Measurement is a significant source for acquiring very important and
necessary data about both these aspects of engineering, without which the function or
analysis cannot be performed properly. Measurements are required for assessing the
performance of a product/system, performing analysis to ascertain the response to a specific
input function, studying some fundamental principle or law of nature, etc. Metrology helps
extract high‐quality information regarding the completion of products, working condition,
and status of processes in an operational and industrial environment. Metrology literally
means science of measurements. In practical applications, it is the enforcement, verification
and validation of predefined standards. Metrology is also concerned with the industrial
inspection and its various techniques.
Metrology also deals with

a. Establishing the units of measurements and their reproduction in the form of standards.

b. Ascertaining the uniformity of measurements.

c. Developing methods of measurement, analyzing the accuracy of methods of measurement.

d. Establishing uncertainty of measurement, and investigating the causes of measuring errors

and subsequently eliminating them. Legal Metrology applies to any application of metrology
that is subjected to national laws or regulations. There will be mandatory and legal bindings
on the units and methods of measurements and measuring instruments. The scope of legal
metrology may vary considerably from one country to another. The main objective is to
maintain uniformity of measurement in a particular country. Legal metrology ensures the
conservation of national standards and guarantees their accuracy in comparison with the
international standards, thereby imparting proper accuracy to the secondary standards of the
country. Applications of legal metrology are industrial measurement, commercial
transactions and public health and human safety aspects. Inspection is defined as a procedure
in which a part or product characteristic, such as a dimension, is examined to determine
whether it conforms to the design specification. Basically, inspection is carried out to isolate
and evaluate a specific design or quality attribute of a component or product. In inspection,
the part either passes or fails. Thus, industrial inspection has become a very important aspect
of quality control. Inspection essentially encompasses the following:

1. Ascertain that the part, material, or component conforms to the established or desired
standard.

2. Accomplish interchangeability of manufacture.

3. Sustain customer goodwill by ensuring that no defective product reaches the customers.

4. Provide the means of finding out inadequacies in manufacture.

5.The results of inspection are recorded and reported to the manufacturing department for
further action to ensure production of acceptable parts and reduction in scrap. Purchase good‐
quality raw materials, tools, and equipment that govern the quality of the finished products.

6. Coordinate the functions of quality control, production, purchasing, and other departments
of the organizations.
7. Take the decision to perform rework on defective parts, that is, to assess the \ possibility of
making some of these parts acceptable after minor repairs.

8. Promote the spirit of competition, which leads to the manufacture of quality products in
bulk by eliminating bottlenecks and adopting better production techniques. Accuracy of
measurement is very important for manufacturing a quality product. Accuracy is the degree
of agreement of the measured dimension with its true magnitude.

Accuracy can also be defined as the maximum amount by which the result differs from true
value or as the nearness of the measured values to its true value often expressed as a %. True
value may be defined as the mean of the infinite number of measured values when the
average deviation due to the various contributing factors tends to zero. In practice, realization
of the true value is not possible due to uncertainties of the measuring process and hence
cannot be determined experimentally. Positive and negative deviations from the true value
are not equal and will not cancel each other. Precision is the degree of repetitiveness of the
measuring process. It is the degree of agreement of the repeated measurements of a quantity
made by using the same method, under similar conditions. Precision is the repeatability of
the measuring process. The ability of the measuring instrument to repeat the same results
during the act of measurements for the same quantity is known as repeatability. Repeatability
is random in nature and, by itself, does not assure accuracy, though it is a desirable
characteristic.

Precision refers to the consistent reproducibility of a measurement. Reproducibility is

normally specified in terms of scale reading over a given period of time. If an instrument is
not precise it would give different results for the same dimension for the repeated readings.

Difference between Precision & Accuracy:

Accuracy gives information regarding how far the measured value is with respect to the true
value, whereas precision indicates quality of measurement, without giving any assurance that
the measurement is correct. These concepts are directly related to random and systematic
measurement errors

Principles of measurement and testing:

Objective measurement provides a scientific basis for communication between professionals,

documentation of treatment efficacy, and scientific credibility
Researchers use measurements to assess characteristics, functions, or behaviors thought to be
present or absent in specific groups of people, process or systems. The application of
objective measures uses structured observations to compare performances or characteristics
across process, (i.e., to discriminate), or within process over time (i.e., to evaluate), or for
prognostication based on current status (i.e., to predict)
It is important to understand the principles of measurement and the characteristics of good
measures to be an effective user of the tools. Standards for implementation of tests and
measures have been established within industry to address quality improvement and ethical
issues for the use of established measures.
The issue of the basic principles of tests and measurements and to provide an understanding
of the rationale for assessing and selecting measures that will provide the information
required to interpret test results properly. A standardized test is a test administered and scored
in a consistent manner. The tests are designed in such a way that the questions, conditions for
administering, scoring procedures, and interpretations are consistent and are administered and
scored in a predetermined, standard manner. A critical starting point is to define what is to be
measured, for what purpose, and at what cost. Standardized measurements meeting these
criteria should then be assessed for reliability and validity pertinent to answering the question
or questions posed by the user. Measurements that are shown not to be valid or reliable
provide misleading information that is ultimately useless.
The initial section of this chapter discusses the process parameters used to evaluate tests and
measures. Principles of evaluation, testing, and interpretation are detailed in the second
section. The fourth section provides guidelines for objective measurement when a
standardized test is not available to measure the behavior, function, or characteristic of
processes.
The complexity and diversity of the tests and measures used in process practice and research
preclude itemized description in a single chapter. A prerequisite for a measure to be objective
requires that adequate levels of reliability have been demonstrated. Measures that have
acceptable levels of reliability must also be shown to have appropriate types of validity to
ultimately be labelled as objective. It is, therefore, imperative that the user be able to
recognize the limitations of tests he or she employs to avoid inadvertent misuse or
misinterpretation of test results.
PROCESS PARAMETERS USED TO EVALUATE TESTS AND MEASURES
The methods developed primarily in the Engineering Processes literature to evaluate
objective measures generally are applicable to the standardized tests and instruments used in
Engineering. The topics discussed in this section are the foundation for all useful measures.
Measurement tools must have defined levels of measurements for the trait or traits to be
assessed and a purpose for obtaining the measurements. Additionally, tests and measures
need to be practical, reliable, and valid.
Levels of Measurement
Tests and measures come in multiple forms because of the variety of parameters measured in
engineering practice and research.
Despite the seemingly overwhelming number of measures, there are classified levels of
measurement that determine how test results should be analyzed and interpreted. The four
basic levels of measurement data are nominal, ordinal, interval, and ratio.
Nominal and ordinal scales are used to classify discrete measures because the scores
produced fall into discrete categories. Interval and ratio scales are used to classify
continuous measures because the scores produced can fall anywhere along a continuum
within the range of possible scores.
A nominal scale is used to classify data that do not have a rank order. The purpose of a
nominal scale is to categorize people or objects into different groups based on a specific
variable. An example of nominal data is diagnosis.
Ordinal data are operationally defined to assign individuals to categories that are mutually
exclusive and discrete. The categories have a logical hierarchy, but it cannot be assumed that
the intervals are equal between each category, even if the scale appears to have equal
increments. Ordinal scales are the most commonly used level of measurement in clinical
practice. Examples of ordinal scales are the manual muscle test scale and functional outcome
measures (e.g., functional independence measure
Interval data, unlike nominal and ordinal scales, are continuous. An interval scale has
sequential units with numerically equal distances between them. Interval data often are
generated from quantitative instrumentation as opposed to clinical observation. It is important
to note that it is statistically possible to transform ordinal data into interval data using Rasch
logit scale methods. This has most notably been utilized in Engineering Processes for analysis
of data.
Examples of interval measurements are range-of-motion scores reported in degrees and the
visual analogue pain scale (continuum from 0 to 10).
A ratio scale is an interval scale on which the zero point represents a total absence of the
quantity being measured. An example is force scores obtained from a quantitative muscle
strength-testing device.
Analysis of nominal and ordinal scales requires special consideration to avoid mis inference
from test results the major controversies surrounding the use of these scales are the problems
of unidimensionality and whether scores of items and subtests can be summed to provide an
overall score. Continuous scales have a higher sensitivity of measurement and allow more
rigorous statistical analyses to be performed. Sensitivity can be defined as the proportion of
processes with a condition.

Purpose of Testing
After the level of the measurement has been selected, the purpose of testing must be
examined. Tests generally serve one of two purposes: screening or in-depth assessment of
specific traits, behaviors, functions, or prognosis.
Screening Tests
Screening tests have three possible applications:
• To discriminate between “suspect” and “normal” procedures
• To identify engineering processes needing further assessment
• To assess a number of broad categories superficially
The advantages of screening tests are that they are brief and sample a broad range of systems,
processes, behaviors. They are limited, however, because of an increased frequency of false-
positive results that is due to the small sample of results obtained. Screening tests should be
used cautiously for diagnosis, modifications, change planning. They are used most effectively
to indicate the need for more extensive testing and resolution of specific problem areas
identified by the screening assessment.
Assessment Tests
Assessment tests have five possible applications:
• To evaluate specific behaviors in greater depth
• To provide information for planning interventions
• To determine implementation of specialized programs
• To provide measurements to monitor progress
• To provide information regarding prognosis
The advantages of assessment measures are that they have a lower frequency of false-positive
results; they assess a representative set of engineering process; they can be used for
diagnosis, upgrades, replacement, repair planning; and they provide information regarding
the functional level of the engineering system tested. The limitations are that an extended
amount of time is needed for testing, and they generally require specially trained personnel to
administer, score, and interpret the results.
Criterion-Referenced Versus Norm-Referenced Tests
Proper interpretation of test results requires comparison with a set of standards or
expectations for performance. There are two basic types of standardized measures: criterion-
referenced and norm-referenced tests.
Criterion-Referenced Tests
Criterion-referenced tests are those for which the test score is interpreted in terms of
performance on the test relative to the continuum of possible scores attainable. The focus is
on what the engineering system can do Individual performance is compared with a fixed
expected standard rather than a reference group. Scores are interpreted based on absolute
criteria, for example, the total number of items successfully completed. Criterion-referenced
tests are useful to discriminate between successive performances of one process. They
are conducted to measure a specific set of process objectives.
Norm-Referenced Tests
Norm-referenced tests use a representative sample of Engineering systems and process which
are measured relative to a variable of standards. Norm referencing permits comparison of a
single process measurement with those scores expected for the rest of the processes. The
normal values reported should be obtained from, and reported for, clearly described
procedures. The normal procedures should be the same as those for whom the test was
designed to detect inefficiencies. Reports of norm-referenced test results should use scoring
procedures that reflect the process position relative to the normal distribution (e.g.,
percentiles, standard scores). Measures of central tendency (e.g., mean, median, mode) and
variability (e.g., standard deviation, standard error of the mean) also should be reported to
provide information on the range of normal scores, assisting with determination of the
clinical relevance of test results.
Practicality
A test or instrument should ideally be practical, easy to use, insensitive to outside influences,
inexpensive, and designed to allow efficient administration. Test administration should be
organized to complete all testing in one process before switching to another. Instructions for
administering the test should be clear and concise, and scoring criteria should be clearly
defined. If equipment is required, it must be durable and of good quality. Qualifications of the
tester and additional training required to become proficient in test administration should be
specified. The time to administer the test should be indicated in the test manual. The duration
of the test and level of difficulty need to be appropriate relative to the attention span and
perceived capabilities of the patient being tested. Finally, the test manual should provide
summary statistics and detailed guidelines for appropriate use and interpretation of test scores
based on the method of test development.
Reliability and Agreement
A general definition of reliability is the extent to which a measurement provides consistent
information (i.e., is free from random error). provide the analogy “it may be thought of as the
extent to which the data contain relevant information with a high signal-to-noise ratio versus
irrelevant static confusion.” By contrast, agreement is defined as the extent to which identical
measurements are made. Reliability and agreement are distinctly different concepts and are
estimated using different statistical techniques. Unfortunately, these concepts and their
respective statistics often are treated synonymously in the literature.
The level of reliability is not necessarily congruent with the degree of agreement. It is
possible for ratings to cluster consistently toward the same end of the scale, resulting in high-
reliability coefficients, and yet these judgments may or may not be equivalent. In instances in
which the scores are fairly homogeneous, reliability coefficients lack the power to detect
relationships and are often depressed, even though agreement between ratings may be
relatively high. Both reliability and agreement must be established on the target population or
populations to which the measure will be applied, using typical examiners. There are five
types of reliability and agreement:
• Interrater

• Test-retest

• Intertrial

• Alternate form
• Population specific
Use of measurement tools.—

A measuring instrument is a device to measure a physical quantity. In the physical

sciences, quality assurance, and engineering, measurement is the activity of obtaining and
comparing physical quantities of real-world objects and events. Established standard objects
and events are used as units, and the process of measurement gives a number relating the item
under study and the referenced unit of measurement. Measuring instruments, and formal test
methods which define the instrument's use, are the means by which these relations of
numbers

are obtained. All measuring instruments are subject to varying degrees of instrument
error and measurement uncertainty. These instruments may range from simple objects such
as rulers and stopwatches to electron microscopes and particle accelerators. Virtual
instrumentation is widely used in the development of modern measuring instruments.

While it may be true that you can never have too many tools, some of the most useful tools
you should have in your toolbox are not chromed or made with safety-grip handles. Some of
these measuring tools are not cheap, but each performs at least one essential function that
professional engineering persons and organizations use on a regular basis and that you may
someday also have a need for. Usually, you discover you need them right in the middle of a
job, so it is a good idea to be pre-emptive and acquire these measuring/testing tools as time
and money permit.

The list of tools used in Engineering is very long and varied, as such the selection of an
instrument will relatively be dependent on the measurement and testing being carried out and
the degree of accuracy required.

Reliability Testing Tools

Some of the tools or programs available in the market to measure software reliability are
mentioned in brief below-

• SOFTREL – It provides multiple products and services to measure software

reliability. Some of the products are ‘Software Reliability Toolkit’,
‘Frestimate Software’, etc.
• SoREL – SoREL tool is used for software reliability analysis and prediction.
This tool offers four types of reliability growth tests i.e. Arithmetical Mean,
Laplace Test, Kendall Test, and Spearmann Test. They allow four types of
 reliability growth models. SoREL allows two types of failure data processing
i.e. inter-failure data and failure intensity data.
• SMERFS – SMERFS stands for Statistical Modelling ad Estimation of
Reliability Functions for Software. SMERFS collects raw data and after
examination, failure and fault detection rates are predicted.

Many of the models mentioned above can be calculated by hand using statistical software,
such as SAS. There are also off the shelf options, such as CASRE (Computer Aided Software
Reliability Estimation Tool), SOFTREL, SoRel (Software Reliability Analysis and
Prediction), WEIBULL++, and more. These tools will provide different models to help with
prediction or estimations.

Undertake on-line inspection and testing using:

Non-Destructive Techniques

What is Non-Destructive Testing:

Testing methods that do not compromise the structural integrity of the parts being tested are
called non-destructive tests (NDT). NDT employs various inspection techniques to evaluate
the components, individually or collectively. It uses different principles in scientific fields
(physics, chemistry, and mathematics) to test the components.

NDT can also be referred to as non-destructive evaluation/examination (NDE) or non-

destructive inspection (NDI).

Let’s imagine a piston in operation inside an engine that is tested for defect or material
degradation. The piston can be cut open to check whether there are any defects inside.
However, once tested, the piston cannot be used in the engine anymore, even if it was found
not to be defective. This is a form of destructive testing.

Instead of cutting it open, the piston can be tested with radiography. We can use ionizing
radiation (X-rays, gamma rays) to detect defects or material degradation in the component. If
it passes the test, the component can still be used. This is a form of non-destructive testing.
NDT is used to test the quality of components and machine condition before or during their
active use. Non-destructive testing is used for condition assessment and quality control in a
wide range of industries, which include (but are not limited to):

• Aerospace – testing castings

• Automotive – to test the durability of piston heads
• Manufacturing – to test the quality of components before it goes into production
• Medical devices – to test the durability and composition of stents

The distinct advantage of NDT is the reusability of the tested components. On top of that,
non-destructive testing can often be employed on components that are still in operation.
Devices and testing equipment used to conduct most methods of NDT are compact and
portable. This makes it easier to test components in a working machine.

There is a plethora of non-destructive testing options available. Which method you’re going
to use depends on the type of component you are testing and what exactly you are looking
for.

Some NDT methods have applications only in niche categories. Below, we discuss the most
common NDT methods that have a broader application.

Visual inspection is by far the simplest non-destructive testing method. It is often classified
as a part of routine maintenance work.

Ultrasonic testing is based on the principle of propagation and reflection of high-frequency

sound waves. It can be used for flaw detection/evaluation, dimensional measurements,
material characterization, and more. Testing is performed with an ultrasonic receiver and
transmitter.

Vibration Analysis

Eddy Current Testing

X-Ray Inspection

These are just a few, and many more are available depending of what is being tested.
Principles of Assessment Discussed Use only reliable assessment instruments and
procedures. Use only assessment procedures and instruments that have been demonstrated to
be valid for the specific purpose for which they are being used. Use assessment tools that are
appropriate for the target population.

A test is considered "good" if the following can be said about it:

• The test measures what it claims to measure consistently or reliably. This means that
if a process were to be repeated again, the results would be similar.
• The test measures what it claims to measure. For example, a test of operational
performance.
• The test is process-relevant. In other words, the test measures one or more
characteristics that are important to the process

The degree to which a test has these qualities is indicated by two technical
properties: reliability and validity.
1 Test Reliability
2 Test Validity

Principle of Assessment: Use only reliable assessment instruments and procedures. In other
words, use only assessment tools that provide dependable and consistent information.

These factors are sources of chance or random measurement error in the assessment process.
If there were no random errors of measurement, the individual would get the same test score,
the individual's "true" score, each time. The degree to which test scores are unaffected by
measurement errors is an indication of the reliability of the test.
Reliable assessment tools produce dependable, repeatable, and consistent information about
people. In order to meaningfully interpret test scores and make useful employment or career-
related decisions, you need reliable tools. This brings us to the next principle of assessment.
Test manuals and independent review of tests provide information on test reliability. The
following discussion will help you interpret the reliability information about any test.
Standard Error of Measurement:
Test manuals report a statistic called the standard error of measurement (SEM). It gives the
margin of error that you should expect in an individual test score because of imperfect
reliability of the test. The SEM represents the degree of confidence that a process "true" score
lies within a particular range of scores. For example, an SEM of "2" indicates that a test
taker's "true" score probably lies within 2 points in either direction of the score received on
the test. This means that if a process receives a 91 on the test, there is a good chance that the
process "true" score lies somewhere between 89 and 93.
The SEM is a useful measure of the accuracy of individual process test scores. The smaller
the SEM, the more accurate the measurement

Test Validity:
Validity is the most important issue in selecting a test. Validity refers to what
characteristic the test measures and how well the test measures that characteristic.

• Validity tells you if the characteristic being measured by a test is related to job
qualifications and requirements.
• Validity gives meaning to the test scores. Validity evidence indicates that there is
linkage between test performance and job performance. It can tell you what you may
conclude or predict about someone from his or her score on the test. If a test has been
demonstrated to be a valid predictor of performance on a specific job, you can
conclude that persons scoring high on the test are more likely to perform well on the
job than persons who score low on the test, all else being equal.
• Validity also describes the degree to which you can make specific conclusions or
predictions about people based on their test scores. In other words, it indicates the
usefulness of the test.

The Uniform Guidelines discuss the following three methods of conducting validation
studies. The Guidelines describe conditions under which each type of validation strategy is
appropriate. They do not express a preference for any one strategy to demonstrate the job-
relatedness of a test.

• Criterion-related validation requires demonstration of a correlation or other

statistical relationship between test performance and job performance. In other words,
individuals who score high on the test tend to perform better on the job than those
 who score low on the test. If the criterion is obtained at the same time the test is given,
it is called concurrent validity; if the criterion is obtained at a later time, it is called
predictive validity.
• Content-related validation requires a demonstration that the content of the test
represents important job-related behaviours. In other words, test items should be
relevant to and measure directly important requirements and qualifications for the job.
• Construct-related validation requires a demonstration that the test measures the
construct or characteristic it claims to measure, and that this characteristic is
important to successful performance on the job.

First, as an example of criterion-related validity, take the position of millwright. Employees'

scores (predictors) on a test designed to measure mechanical skill could be correlated with
their performance in servicing machines (criterion) in the mill. If the correlation is high, it
can be said that the test has a high degree of validation support, and its use as a selection tool
would be appropriate.
Second, the content validation method may be used when you want to determine if there is a
relationship between behaviours measured by a test and behaviors involved in the job. For
example, a typing test would be high validation support for a secretarial position, assuming
much typing is required each day. If, however, the job required only minimal typing, then the
same test would have little content validity. Content validity does not apply to tests
measuring learning ability or general problem-solving skills
Finally, the third method is construct validity. This method often pertains to tests that may
measure abstract traits of an applicant. For example, construct validity may be used when a
bank desires to test its applicants for "numerical aptitude." In this case, an aptitude is not an
observable behavior, but a concept created to explain possible future behaviors. To
demonstrate that the test possesses construct validation support, ". . . the bank would need to
show (1) that the test did indeed measure the desired trait and (2) that this trait corresponded
to success on the job"
Professionally developed tests should come with reports on validity evidence, including
detailed explanations of how validation studies were conducted. If you develop your own
tests or procedures, you will need to conduct your own validation studies. As the test user,
you have the ultimate responsibility for making sure that validity evidence exists for the
conclusions you reach using the tests. This applies to all tests and procedures you use,
whether they have been bought off-the-shelf, developed externally, or developed in-house.
Validity evidence is especially critical for tests that have adverse impact. When a test has
adverse impact, the Uniform Guidelines require that validity evidence for that specific
employment decision be provided.
Develop quality and reliability programme plans

Review and Understand designs for reliability and safety:

Design for Reliability (DFR) is not a new concept, but it has begun to receive a great deal of
attention in recent years. What is DFR? What are the ingredients for designing for reliability,
and what is involved in implementing DFR? Should DFR be part of a Design for Six Sigma
(DFSS) program, and is DFR the same as DFSS? In this article, we will try to answer these
questions and, at the same time, we will propose a general DFR process that can be adopted
and deployed with a few modifications across different industries in a way that will fit well
into the overall Product Development Process. The Synthesis applications can be used
together based on the DFR approach.

Design for Reliability, however, is more specific than these general ideas. It is actually a
process. Specifically, DFR describes the entire set of tools that support product and process
design (typically from early in the concept stage all the way through to product obsolescence)
to ensure that customer expectations for reliability are fully met throughout the life of the
product with low overall life-cycle costs. In other words, DFR is a systematic, streamlined,
concurrent engineering program in which reliability engineering is weaved into the total
development cycle. It relies on an array of reliability engineering tools along with a proper
understanding of when and how to use these tools throughout the design cycle. This process
encompasses a variety of tools and practices and describes the overall order of deployment
that an organization needs to follow in order to design reliability into its products.
The Design for Reliability process

Figure 1 Design for reliability (DfR) activities flow, from Practical Reliability Engineering,
outlines the basic stages or elements of a product generation process.

The six stages span a typical product lifecycle from concept till retirement. The process steps
each include a slightly different focus and set of tools. Let’s briefly examine each step-in
turn.

1. Identify – Goals, Requirements, Specifications, Expectations

The decision during the early stages of product development set the framework of goals,
objectives, requirements, and specifications.

These documents guide the decision making for the remainder of the process.

Understanding and documenting the customer expectations for reliability performance

includes:

• Functional and performance requirements

• Environmental and use profile descriptions
• Duration and Probability of Success expectations
Tools include:

• Benchmarking
• Environment and use studies
• Quality Function Deployment (QFD)
• Risk Assessment Studies
• System Reliability Modeling (RBD, FTA, STA, Petri Nets, Markov, etc.)

2. Design – Creating a Draft Solution

The decisions during the design and development stages involve:

• Material selection
• Component selection
• Industrial design
• Human factors design (user interface and interactions)
• Electrical and Mechanical drawings
• Software/Firmware development

The decision bound the potential future reliability performance.

The DfR tools during this stage focus on enabling each member of the team to make
decisions which fully consider the impact of future reliability performance.

Tools include:

• Finite Element Analysis (FEA)

• Computational Fluid Dynamics (CFD) modeling
• Mechanical and Electrical performance modeling
• FMEA, FMECA, FTA, Hazard Analysis
• Stress-Strength Analysis, Derating Analysis
• Tolerance Analysis
• Hazard and Operability Studies (HAZOPS)
• Reviews of part, material and process selections
 • Non-material failure modes, common cause failures
• Critical to Reliability/Quality list
• Overstress Protection
• Degradation Protection
• Design Reviews
• Design Review Based on Failure Modes (DRBFM)

3. Analyze – Examine the Solution

During the design process, there may be outstanding questions to address.

Such as an uncertainty concerning the degradation of a coating over time, or the capability of
the desired component vendor to meet tolerance requirements.

Many of the tools employed during the design phase also provide a means to refine
understanding concerning reliability. FEA, for example, is an essential tool for physics of
failure modeling and use.

If material samples, coupons, rough subsystem prototypes are available, initial evaluation,
experimentation, characterization may begin.

The focus is to explore, discover, and reveal the design weaknesses in order to allow design
changes to improve the product robustness.

Another part of this step is to check and refine the understanding of the customer
environment and use conditions.

As the design takes shape the team is likely to discover potential failure mechanisms that
require additional environmental and use condition information.

Often new products are an evolution of previous products. The use of past field and warranty
data provides insights on how the range of selection elements of a design individually and
interactively respond to customer use conditions.
An output of the analysis is a refinement of the areas of focus during the verify step. Areas of
high risk or uncertainty may receive additional scrutiny.

Focused or refined measurements provide clearer information for decision making.

4. Verify – Checking the Solution Against the Specifications

This step starts the examination of the question: Is the design meeting the specifications?

If all is well executed to this stage the design and analyze steps created and refined a product
that meets the set of specifications created during the first step of the process.

Products are complex. The verify step often finds additional elements of the design requiring
improvement.

The information provided includes new failure mechanisms (HALT and margin testing),
refined estimates of durability (ALT), and patterns of performance deflation (degradation
analysis). The information allows the team to determine if the design meets the internal
specifications and likely will meet customer expectations.

A couple additional tools are:

• FRACAS
• Sample Size Calculations (statistics)
• Waterfall test sequencing
• Document/Configuration Control
• Measurement System Analysis

5. Validate – Checking the Solution with the Customer

The decision during this step requires customers.

Does the product meet customer expectations? This is one way to view validation, another is
a detailed refinement of the verification process.
Either way, the intent at this point is to make sure the design and process to create the product
based on the design results in products that perform as the customer expects.

The same basic set of tools used during verify may take part in the validate step, yet may
focus on customer specified evaluations or production variation concerns. HALT, HASS,
ALT, FRACAS, etc all may play a role.

Some customers may require or expect a reliability growth or demonstration testing as part of
the validation step.

6. Control – Monitoring and Improving

The decisions during this step focus on supplier and production stability and capability.

Plus, the information coming back from customer provides a means to identify potential
design or process improvement projects.

The work in this step begins as the team establishes the supply and production processes. It
takes shape beginning during the design step and becomes refined as data and information
become available.

Tools such as SPC, control charts, and process capability studies focus on monitoring
variation and adjusting or improving to reduce or maintain an acceptable amount of variation.

Tools may include:

• Process FMEA
• HASS
• ORT
• Testability analysis
• Maintainability analysis
• Failure analysis of field returns or production failures
• Customer surveys
• Call center data analysis
A DfR summary

The basic process is to focus on understanding the customer reliability expectations well
enough to enable the creation and production of products that meet or exceed those
expectations.

Identifying the right set of specifications enables the team to design, analyze and verify while
making decisions that shape the reliability performance.

The steps of design, analyze, and verify may occur sequentially or simultaneously (or nearly
so).

The iterative process of framing decisions, gathering information and checking assumptions
and results permit the team to evolve the design to meet expectations.

Step 1. Make a commitment to safety

Include safety in your company mission statement and involve the executives in setting safety
related goals.
Document these goals so they can be measured and improved.
This change will help get a safety culture going and keep safety top of mind for the entire
organization.
Step 2. Learn the requirements in place for your industry
Check out the resources made available by OSHA and talk to other professionals in the
industry.
Sometimes it pays to bring in an outside consultant for your industry even if it is just a safety
manager from another company like yours.
Document the requirements and advice so you can measure whether or not it gets taken care
of.
Step 3. Identify hazards and risks
Anything with the potential to cause harm should be addressed.
Talk to your employees and assess your own workplace to learn the best places to implement
changes.
Pay attention to; workplace hazards like shop layout, environmental hazards such as dust,
hazardous activities such as using machinery, and finally the current culture of your
company.
Document these along with the items from Step 2 so that these can also be addressed moving
forward.
Step 4. Develop processes and programs
These processes and programs should be specifically tailored to answer the requirements and
issues from Steps 2 and 3.
They should also hold both management and employees accountable to safety.
It is best to have them written and accessible to the employees and some even require a
written program.
The regulations that require a written program are-

• Hazard Communication Program.

• Lockout / Tagout Program (energy control procedures).
• Respiratory Protection Program.
• Personal Protective Equipment (hazard assessment).
• Bloodborne Pathogens Post-exposure Plan.
• Emergency Actions Plans.
• Permit-required Confined Spaces.
• Electrical Safety.
• Fire Prevention Plan.
• Hearing Conservation Program.
• Trenching and Excavation Safety.

These programs can be handled very easily in tools like those provided by BasicSafe.
Step 5. Educate your workforce
Make sure to cover the documents from Step 4 and any other relevant information.
A good rule of thumb is to train-

• New hires
• Individuals who recently transferred or changed assignments
• Any time a new process, substance, or piece of equipment is added
• Any time new hazards are identified
• Any time refresher training is needed or required by regulations
Try to keep the training engaging and to track all training that takes place either in
spreadsheets or training specific EHS tools.
Step 6. Investigate and track all accidents and incidents
Regardless of the severity, this will help you to prevent incidents in the future.
Determine the cause, identify what could be changes, take and track corrective and
preventative measures.
Sometimes this means making changes to your previously developed documents and training.
Step 7. Review your program

Every year you should review your training, procedures, and any written safety
documentation you have to find holes in your program or to improve it.
Go through a similar process as you just completed but probably on a smaller scale.
At this point it pays to have a good auditing tool to work through every aspect of your safety
program.
Step 8. Implement an EHS management software

A good software should have tools to procedures, manuals, training, auditing, incidents, and
more.
Doing so will make your life easier and save your company massive amounts of time and
money related to safety.
Check out Basic Safe to fulfill all your safety and other EHS needs!
Don’t forget to leave us your thoughts in the comments and have a safe week!

Testing and evaluation failure modes. –

FMEA defines the term “failure mode” to identify defects or errors, potential or actual, in a
product design or process, with emphasis on those affecting the customer or end user. A
“failure effect” is the result of a failure mode on the product or system function as perceived
by the user. Failure effects can be described in terms of what the end user may see or
experience. The study of consequences of identified failures is called effects analysis. FMEA
prioritizes failures according to severity, frequency and detectability. Severity describes the
seriousness of failure consequences. Frequency describes how often failures can occur.
Detectability refers to degree of difficulty in detecting failures. FMEA also involves
documenting current knowledge about failure risks. FMEA seeks to mitigate risk at all levels
with resulting prioritized actions that prevent failures or at least reduce their severity and/or
probability of occurrence. It also defines and aids in selecting remedial activities that mitigate
the impact and consequences of failures. FMEA can be employed from the earliest design
and conceptual stages onward through development and testing processes, into process
control during ongoing operations throughout the life of the product or system. A white paper
issued by: Siemens PLM Software White paper | How to conduct a failure modes and effects
analysis (FMEA)

4 Process steps in FMEA

Step 1: Identify potential failures and effects •

Step 2: Determine severity •

Step 3: Gauge likelihood of occurrence •

Step 4: Failure detection • Risk priority number (RPN)

Step 1: Identify potential failures and effects The first FMEA step is to analyze functional
requirements and their effects to identify all failure modes. Examples: warping, electrical
short circuit, oxidation, fracture. Failure modes in one component can induce them in others.
List all failure modes per function in technical terms, considering the ultimate effect(s) of
each failure mode and noting the failure effect(s). Examples of failure effects include:
overheating, noise, abnormal shutdown, user injury.

Step 2: Determine severity Severity is the seriousness of failure consequences of failure

effects. Usual practice rates failure effect severity (S) on a scale of one to 10 where one is
lowest severity and 10 is highest. The following shows typical FMEA severity ratings and
their meanings:

Rating Meaning:

1 No effect, no danger

2 Very minor – usually noticed only by discriminating or very observant users

3 Minor – only minor part of the system affected; noticed by average users
4-6 Moderate – most users are inconvenienced and/or annoyed

7-8 High – loss of primary function; users are dissatisfied

9-10 Very high – hazardous. Product becomes inoperative, customers angered. Failure
constitutes a safety hazard and can cause injury or death.

Step 3:

Gauge likelihood of occurrence Examine cause(s) of each failure mode and how often failure
occurs. Look at similar processes or products and their documented failure modes. All
potential failure causes should be identified and documented in technical terms. Failure
causes are often indicative of weaknesses in the design. Examples of causes include: incorrect
algorithm, insufficient or excess voltage, operating environment too hot, cold, humid, etc.
Failure modes are assigned an occurrence ranking (O), again from one to 10, as shown in the
following table.

Rating Meaning

1 No documented failures on similar products/processes

2-3 Low – relatively few failures

4-6 Moderate – some occasional failures

7-8 High – repeated failures

9-10 Very high – failure is almost certain 9-10 Very high – hazardous. Product becomes
inoperative, customers angered. Failure constitutes a safety hazard and can cause injury or
death.

Step 4:

Failure detection After remedial actions are determined, they should be tested for efficacy
and efficiency. Also, the design should be verified and inspections procedures specified.

1. Engineers inspect current system controls that prevent failure mode occurrence, or detect
failures before they impact the user/customer.

2. Identify techniques used with similar products/systems to detect failures. These steps
enable engineers to determine the likelihood of identifying or detecting failures. Then, each
combination from steps one and two is assigned a detection value (D), which indicates how
likely it is that failures will be detected, and ranks the ability of identified actions to remedy
or remove defects or detect failures. The higher the value of D, the more likely the failure
will not be detected.

Rating Meaning

1 Fault is certain to be caught by testing

2 Fault almost certain to be caught by testing

3 High probability that tests will catch fault

4-6 Moderate probability that tests will catch fault

7-8 Low probability that tests will catch fault

9-10 Fault will be passed undetected to user/customer

Risk priority number (RPN) After the foregoing basic steps, risk assessors calculate Risk
Priority Numbers (RPNs). These influence the choice of action against failure modes. RPN is
calculated from the values of S, O and D as follows:

RPN = S * O * D (or RPN = S x O x D

RPN should be calculated for the entire design and/or process and documented in the FMEA.
Results should reveal the most problematic areas, and the highest RPNs should get highest
priority for corrective measures. These measures can include a variety of actions: new
inspections, tests or procedures, design changes, different components, added redundancy,
modified limits, etc. Goals of corrective measures include, in order of desirability:

• Eliminate failure modes (some are more preventable than others)

• Minimize the severity of failure modes

• Reduce the occurrence of failure modes

• Improve detection of failure modes When corrective measures are implemented, RPN is
calculated again and the results documented in the FMEA.
Investigate the economics of reliability process improvement and the consequences of

catastrophic failure.---

Develop checklists for plant design and installation.---

Step 1: Identify “Stupid Mistakes” That Cause Failure

Understanding the most significant causes of failure is the first step in creating a helpful
checklist. For this blog post, I will use the example of creating a corporate financial report.
Two of the common causes of failure are data source problems and model performance
errors. Addressing these mistakes will form the focus of the checklist.

Step 2: Seek Additional Input From Others

With most types of work, there are other people in your organisation who either do similar
work or who use the results of your work. Ask these people for their ideas on the common
causes of failure or what they would suggest checking. I have found that many people are
willing to offer some thoughts and observations, especially if they are impacted by your
work.

Step 3: Create Simple “Do” Steps

‘Do’ steps are exactly what they sound like – reminders to do a specific action. In the case of
a corporate financial report, you could check the structure and size of the data source files for
validity, using previous reports as a baseline. Likewise, you can check data connections in the
model to ensure that data is flowing through the model correctly.

Step 4: Create Simple “Talk” Steps

This step comes from Gawande’s example of a checklist in the operating room. In his
example, he created a step on the checklist where everyone introduces them by name and
role. In the project management context, ‘Talk’ steps are even more important. The
‘talk’ steps selected for the checklist are designed to prevent the major causes of failure. In
the case of a financial report, one could schedule a short meeting with the stakeholders to
review the draft report before it is approved for release.
 Step 5: Test The Checklist

Following the above steps, you finally have the chance to put your checklist into action.
Expect that your first checklist will have some gaps. Simply take note of those gaps and
continue working through the process. In the example of producing a financial report, a gap
might be to validate the currency and foreign exchange factors of the source files.

Step 6: Refine the Checklist

Based on your experience in Step 5, it is time to refine and improve the checklist. Continuous
improvement is the name of the game in checklist development. As you improve the quality
of your work with checklists, consider sharing your findings with other professionals.

5. Explain Failure Mode, Effect and Criticality Analysis (FMECA) for:

a. design

b. process

c. system.

What is Failure Mode, Effects & Criticality Analysis (FMECA)

FMECA is a bottom-up (Hardware) or top-down (Functional) approach to risk assessment. It is

inductive, or data-driven, linking elements of a failure chain as follows: Effect of Failure, Failure
Mode and Causes/Mechanisms. These elements closely resemble the modern 5 Why technique
in Root Cause Analysis (RCA). The Effect of Failure duplicates the experience of a
user/customer and is then translated into the technical failure description or Failure Mode. The
technical failure description answers the next question “Why”, introducing causes that result in
the failure mode. Each failure mode has a probability assigned and each cause has a failure rate
assigned. If data is not available, probability of occurrence is assigned. The probability depends
on the failure data source documents utilized in the FMECA. Unlike 5 Why, the FMECA is
performed prior to any failure actually occurring. FMECA analyzes risk, which is measured by
criticality (the combination of severity and probability), to take action and thus provide an
opportunity to reduce the possibility of failure.
FMECA and Failure Mode and Effects Analysis (FMEA) are closely related tools. Each tool
resolves to identify failure modes which may potentially cause product or process failure. FMEA
is qualitative, exploring “what-if scenarios”, where FMECA includes a degree of quantitative
input taken from a source of known failure rates.
There are two activities to perform FMECA:
1. Create the FMEA
2. Perform the Criticality Analysis
Measured criticality is the intersection of severity and cause probability rankings. Results are
depicted in four primary criticality zones. Criticality is used to determine product or process
design weaknesses. Two quantitative and one qualitative options exist for FMECA Criticality as
identified below:
1. Quantitative
o Mode Criticality = Item Unreliability x Mode Ratio of Unreliability x
Probability of Loss x Time (life)
o Item Criticality = Sum of Mode Criticalities
2. Qualitative
o Compare failure modes via a Criticality Matrix, which identifies
severity on the horizontal axis and qualitatively derived occurrence on
the vertical axis
o Note: Quality-One suggests a qualitative criticality matrix for the
Quality-One Three Path Model for FMEA Development. Severity is on
the vertical axis and occurrence is depicted on the horizontal axis. This
is often used as an alternative for the Risk Priority Number (RPN) in
FMEA.

Why Perform Failure Mode, Effects & Criticality Analysis (FMECA)

The intent of the Failure Mode, Effects & Criticality Analysis methodology is to increase
knowledge of risk and prevent failure. The tangible benefits of FMECA are offered in the
following categories:
Design and Development Benefits
• Increased reliability
• Better quality
• Higher safety margins
• Decreased development time and re-design
Operations Benefits
• More effective Control Plans
• Improved Verification and Validation testing requirements
• Optimized preventive and predictive maintenance
• Reliability growth analysis during product development
• Decreased waste and non-value added operations (Lean Operation and
Manufacturing)
Cost Benefits
• Recognize failure modes in advance (when they are less costly to address)
• Minimized warranty costs
• Increased sales from customer satisfaction

How to Perform Failure Mode, Effects & Criticality Analysis (FMECA)

The basic assumption when performing FMECA instead of FMEA is the desire to have a more
quantitative risk determination. The FMEA utilizes a more multi-functional team using guidelines
to set Severity and Occurrence. The FMECA is performed by first completing an FMEA process
worksheet and then completing the FMECA Criticality Worksheet.
The general steps for FMECA development are as follows:
• FMEA Portion (see our FMEA page for more details)
o Define the system
o Define ground rules and assumptions to help drive the design
o Construct system Boundary Diagrams and Parameter Diagrams
o Identify failure modes
o Analyze failure effects
o Determine causes of the failure modes
o Feed results back into design process
• FMECA Portion
o Transfer Information from the FMEA to the FMECA
o Classify the failure effects by severity (change to FMECA severity)
o Perform criticality calculations
o Rank failure mode criticality and determine highest risk items
o Take mitigation actions and document the remaining risk with rationale
o Follow-up on corrective action implementation/effectiveness
FMECA can often become time consuming and therefore available resources and team interest
can be an issue as the process continues. Quality-One has developed the FMECA process below
to utilize engineering resources effectively and ensure the FMECA has been developed
thoroughly. The Quality-One approach is as follows:

Step 1: Perform the FMEA

The FMEA is a good starting place for the FMECA. FMEA allows for qualitative, and therefore
creative, inputs from a multi-disciplined engineering team. FMEA provides the first inputs into
design change and can jump start the risk mitigation process. The FMEA information is
transferred into the FMECA Criticality Worksheet. The transferred data from the FMEA
worksheet will include:
• Item Identification Number
• Item / Function
• Detailed Function and / or Requirements
• Failure Modes and Causes with Mechanisms of Failure
• Mission Phase or Operational Mode (DoD specific), often related to the Effects of
Failure

Step 2: Determine Severity Level

Next, assign the Severity Level of each Effect of Failure. There are various severity tables to
select from. The following is used in medical and some aerospace activities. The actual
descriptions can be altered to fit any product or process design. There are generally four severity
level classifications as follows:
• Catastrophic: Could result in death, permanent total disability, loss exceeding $1M, or
irreversible severe environmental damage that violates law or regulation
• Major/High Impact: Permanent partial disability, injuries or occupational illness
resulting in hospitalization of 3 or more personnel, loss exceeding $200K but less
than $1M, or reversible environmental damage causing a violation of law or
regulation
• Minor Impact: Could result in injury or occupational illness resulting in one or more
lost work day(s), loss exceeding $10K but less than $200K, or mitigatable
environmental damage without violation of law or regulation where restoration
activities can be accomplished
• Low Impact: Result in minor injury or illness not resulting in a lost work day, loss
exceeding $2K but less than $10K, or minimal environmental damage
 Step 3: Failure Effect Probability

In some applications of FMECA, a Beta value is assigned to the Failure Effect Probability. The
FMECA analyst may also use engineering judgement to determine the Beta value. The Beta /
Effect Probability is placed in the FMECA Criticality Worksheet where:
• Actual Loss / 1.00
• Probable loss / >0.10 to <1.00
• Possible loss / >0 to =0.10
• No Effect / 0
A failure mode ratio is developed by assigning a proportion of the failure mode to each cause.
The accumulation of all cause values equals 1.00.

Step 4: Probability of Occurrence (Quantitative)

Assign probability values for each Failure Mode, referencing the data source selected. Failure
Probability and Failure Rate data can be found from several sources:
• Handbook 217 is referenced but any source of failure rate data can be used
• RAC databases, Concordia, etc.
If the Failure Mode probability is listed (functional approach) several columns of the FMECA
Criticality Worksheet may be skipped. Criticality (Cr) can be calculated directly. When failure
rates for failure modes and contributing components are desired, detailed failure rates for each
component are assigned.
Next, we must assign Component Failure Rate (lambda). Failure Rates for each component are
selected from the failure rate source document. Where there is no failure rate available, the
qualitative values from the FMEA are used. FMEA may also be an alternative method on new or
innovative designs.
Operating Time (t) represents the time or cycles the item or component will be expected to live.
This is related to the expected duty cycle requirements.

Step 5: Calculate and Plot Criticality

In FMECA, Criticality is calculated in two ways:

• The Modal Criticality (each failure mode all causes) = Cm
• The Criticality of the Item (all failure modes summarized) = Cr
Formulas of each are not provided in this explanation but the essence of the elements of the
calculation is as follows:
• Cm = The product of the following:
 o Failure Rate of the Part (lambda)
o Failure Rate of the Effect (Beta)
o Failure Mode Ratio (alpha)
o Operating Time (units of time or cycles)
• Cr = The summation of all the Cm

Step 6: Design Feedback and Risk Mitigation

Risk mitigation is a discipline required to reduce possible failure. The identified risk in the
criticality matrix is the substitute for failure and must be treated in the same context as a test
failure or customer returned component or item. FMECA requires a change in risk levels /
criticality after mitigation. A defect / defective detection strategy, commensurate to the risk level,
may be required. Acceptable risk management strategy includes the following:
• Mitigation actions directed at Highest Severity and Probability combinations
• Any risk where mitigation was unsuccessful is a candidate for Mistake Proofing or
Quality Control, protecting the customer / consumer from the potential failure
o Detection methods are chosen for failure modes first and if possible
individual causes which do not permit shipping or acceptance
• Action logs and “risk registers” with revision history are kept for follow-up and
closure of each undesirable risk
Other examples of FMECA mitigation strategies to consider:
• Design change. Take a new direction on design technology, change components
and/or review duty cycles for derating.
• Selection of a component with a lower lambda (failure rate). This can be expensive
unless identified early in Product Development.
• Physical redundancy of the component. This option places the redundant component
in a parallel configuration. Both must fail simultaneously for the failure mode to
occur. If a safety concern exists, this option may require non-identical components.
• Software redundancy. The addition of a sensing circuit which can change the state of
the product. This option often reduces the severity of the event by protecting
components through duty cycle changes and reducing input stresses.
• Warning system. A placard and / or buzzer / light. This requires action by an operator
or analyst to avoid a failure or the effect of failure.
• Detection and removal of the potential failure through testing or inspection. The
inspection effectiveness must match the level of severity and criticality.
 Step 7: Perform Maintainability Analysis

Maintainability Analysis looks at the highest risk items and determines which components will
fail earliest. The cost and parts availability are also considered. This analysis can affect the
location of the components or items when in the design phase. Design consideration must be
given for quick access when serviceability is required more frequently.
• Access panels, easy to remove, permit service of the identified components and items.
This can limit down time of important machinery.
•A spare parts list is typically created from the maintainability analysis.

Explain availability, maintainability and life cycles when referring to quality, reliability

a. improvement by monitoring

b. improvement by rectification.

c. improvement by design

Reliability, Availability and Maintainability Study (RAMS)

RAMS refers to Reliability, Availability and Maintainability Study which is a decision-
making tool used to identify how to increase the availability of the system, and thus increase
the overall profit as well as reducing the life cycle costs.

Concept of Reliability
Reliability is defined as the fraction or percentage of time that an item is available to
response to a demand placed upon it. Various techniques are such as Reliability Block
Diagrams (RBDs) and Fault Tree Analysis (FTA) can be used to determine Reliability.

Concept Of Availability
Availability is defined as a fraction or percentage of time that an item has not failed and thus
available for a demand. Based on this particular approach, unavailability can be defined as a
fraction or percentage of time that an item has failed.
Concept Of Maintenance
Active and Reactive maintenance programs are required in order to ensure reliability of
equipment and thus reliability and availability of Safety Instrumented Functions.

Objectives of a RAM Analysis

Our expert team of consultants have been proving Reliability, Availability and Maintenance
studies and analysis for various industries. The main objectives of a RAM analysis, is for it to
be used as a decision-making tool to increase the availability of the system, and thus increase
the overall profit as well as reducing the life cycle costs (inclusive of the cost of maintenance,
lost production, operating etc). RAM analysis can be carried out on systems and facilities of
different types and sizes in various industries ranging from oil and gas, water and waste water
treatment, nuclear, process, manufacturing and many more. Monitoring process
improvements ensures that individuals and groups do not repeat previous mistakes. It
establishes a strong foundation to enhancing your business. By following specific steps,
you can monitor process improvements.

Establish areas of improvement within your current process. Review your current process
step by step and highlight areas of improvement. Capture current baseline metrics. Write
down the metric numbers of your areas of improvement to determine baseline metrics; if an
area of improvement is time, faster or slower, knowing your current time baseline will help
compare it with your new time baseline information.

Determine metric goals. Review the areas of improvement to determine metric

improvement goals.

Prioritize metric goals. Sort your improvement metric goals in order of importance to
monitor. Focusing on specific improvements will ensure your changes are effective.
Monitor process improvements. Compare your baseline metrics to actual process result

changes.

BUSINESS OPERATIONS

What Is Process Improvement?

Process improvement can be defined as the actual improvement of a process—the

efficiency and effectiveness of its inputs and the quality of its outputs.

Processes

A process is any task that needs to be done, and includes all the steps and decisions
involved in completing that task.

Process Improvement

Process improvement involves an actual “improving” of the way a task is completed.

Rather than simply managing crises effectively, process improvement involves actually
“improving” the functions of the task so that the operation is more efficient and crises are
better prevented.

Causation

In order to improve a process, it is first necessary to dissect the causes behind the “crises.”
This knowledge is then used to reduce variation within the process and remove “waste”
activities, meaning those that contribute no value.

Factors

A variety of factors are examined in process improvement, including the materials, the
methods, the machines, and the people who actually do the work.

Benefits
Process improvement provides several benefits to the company. It promotes teamwork
through a common goal, improves customer service through a reduction in defects, and
reduces overhead costs.

What is Continuous Improvement?

First things first, let’s define what continuous improvement means. With its roots in
manufacturing, continuous improvement is a method that strives to locate opportunities for
ensuring efficiency, continuously. This involves the assessment of current processes,
products and services to ensure that output is maximised and waste is minimised.

Continuous improvement benefits internal and external stakeholders, from employees to

customers and investors alike. But, continuous improvement isn’t a one-and-done deal that a
company performs and then forgets. If the name doesn’t give it away, let’s drive this fact
home - the method is continuous, as in, it does not have an end. It’s a method that becomes a
part of a business’ ongoing operations. You can consider it to be like a way of life, rather than
something new you might try once. But, even though it becomes a part of your business, it
still requires strategy and methodology to impact change.

Since continuous improvement becomes a way of operating, this means that everyone must
be on board. So, creating a culture of improvement is a priority to make it work. This can be
done by empowering everyone within an organisation to understand that they can point out
places for development to spark positive change.

Types of Process Improvement

There are various methods for process improvement. We’ll briefly define three kinds and
then move into examples of continuous improvement.

• LEAN Technology: to optimise a production cycle, LEAN improvement is

customer-focused. It defines what customers value from the process most to
determine what can be eliminated from the production of a product to decrease waste
and cut costs.
 • Six Sigma: Six Sigma is a method that focuses on improving the quality of business
processes. It’s aimed at limiting the variation in processes to ensure consistency and
increase performance. It uses statistics to measure deviations from a defined centre
line on a control chart.

• Total Quality Management: With some similarity to Six Sigma, Total Quality
Management (TCM) holds all involved parties responsible for producing quality
outputs. It looks to standardise processes to reduce errors.

5 Continuous Improvement Examples

Now that you understand what continuous process improvement is, it’ll be helpful to see the
theory applied in a business setting.

Here’s a look at five examples of continuous process improvement and where you can use it
during your day-to-day practices:

1. Ideation and Think Tanks:

Initiating regular think tanks and ideation sessions can benefit your organisation. You can
choose to run think tanks with an agenda in mind or at the very least, elicit the attendance of
key personnel so that valuable ideas are discussed. During these sessions, you can explain
how processes are currently being run to see if there are places that need to be improved and
changes to be made. Often, since technology is so intertwined with most business processes,
a starting point is to discuss updates and new technology solutions geared towards
optimisation. For example, automation solutions are becoming increasingly necessary for
businesses to remain competitive.

2. Surveys and Polls:

The people who work within your organisation are the most well-versed to know where
improvements can be made. It’s not only important to gain feedback from customers and
vendors, but important and often overlooked is employee feedback. By polling your team,
you can find out their pain points and find places for improvement. As a business leader, you
spend most of your time on the big picture, so the smaller details that significantly affect your
business’ outputs can go unnoticed without such insight.

3. Monthly Training:

In big businesses, especially, it is common that each employee works within a silo or “swim
lane.” But, both cross-training and automation software can contribute to process
improvement. For example, if you can train employees to know how to do multiple jobs, then
if someone is absent because of sickness or vacation, a process remains unharmed. Another
idea is to implement an automation tool within your organisation to reduce dependency on
key personnel. Not only is the process stored and will automatically run, but as the process
runs, the system documents the steps it is taking to produce its output.

4. Time Audits:

One of the most significant resources wasted within a business is time. Being able to
accurately measure and gauge how much time a process takes on behalf of your employees
can offer insight into where you can optimise a process. It’s as simple as using software to
time a process. Then, you can analyse how long processes take and find ways to eliminate
wasted time. This could be in the form of automating approvals and reducing touch-points,
thereby preventing potential bottlenecks and delays from occurring.

5. Catchball:

Within organisations, processes are rarely started and completed by a single person. As such,
every process needs to have someone who can be held responsible for its execution, but still
requires the input and assistance of multiple people. Catchball is a method of continuous
improvement that requires the person who initiated a process to state its purpose and concerns
to the others involved clearly. In this way, they can then “throw” it out to the group for
feedback and ideas for improvement, yet the single person remains responsible for its
completion.
The above are just some ideas to get continuous improvement going within your
organisation.

Here’s a look at some areas that breed waste within the business that often have room for
improvement:

• Timeliness: System downtimes, approvals and bottlenecks of information

• Errors: Manual data entry errors, invoice errors

• People: Underutilised workforce, excessive management and micromanagement

• Production: Overproduction of printed documents before necessary

All of the above are just baseline examples of what many businesses face. In every case, an
automation tool can assist in eliminating waste and helping with continuous improvement.
The automation tool is designed to be accessible to all relevant parties, and by automating
data and processes, errors are inherently reduced.

Incremental vs Breakthrough Continuous Improvement

Continuous improvement can be made as you go or a full-fledged approach to tackle

significant issues at once:

Incremental Continuous Improvement:

This type of process improvement is done as you recognise problems during a process. The
upside of this type of improvement is that it is relatively cheaper and faster than breakthrough
continuous improvement. Say you are running a process and notice a mistake. This could be a
typo in a brochure or an error in data. You can fix the error as you go; however, to ensure that
the actual process moves forward in its next iteration without the same error requires that you
communicate the change. So, incremental continuous improvement is beneficial so long as
the person who fixes the mistake brings it up to the rest of the organisation.

Breakthrough Continuous Improvement:

Breakthrough continuous improvement happens the other way around. Rather than making a
change during the process itself, it involves targeting the process for improvement and then
strategically approaching the change as a united front. These are typically more substantial
items for correction that require an entire team to implement.

Benefits of Continuous Improvement

Continuous improvement strives to accomplish two main goals, namely, streamline

workflows and reduce waste. Together, these work to reduce costs and optimise outputs,
whether that be the quality of a product or service.

Streamline workflow:

Most processes require multiple touchpoints or parties involved. These always have room for
improvement. Whether it’s from the basis of the data needed or the communication between
the people who play a role in its completion.

Reduce costs/waste:

Project managers and executives have models and data to review the cost of every project.
With continuous process improvement, they can assess where the fees are too high and then
work towards reducing costs and waste to make a process more efficient.

How to Implement Continuous Process Improvement

As mentioned above, continuous process improvement doesn’t always have a clear beginning
and end. Instead, it works best when it is part of the company culture and involves everyone
within an organisation.

Here are some considerations for how to make continuous process improvement the norm
within your business:

1. Manageable improvements:
Set reasonable goals. When setting out for improvement, you want to break down larger
projects into smaller, measurable pieces. This will help to reduce overwhelm, as well as keep
everyone involved on the right track to succeed.

2. Elicit Feedback:

You should continuously seek feedback from customers, stakeholders and employees
throughout your operations. This feedback will not only help locate opportunities for
improvement, but it can also offer new perspectives and breed new ideas.

3. Motivate employees:

Not only should you breed a culture where each employee feels empowered to notice
inefficiencies and offer solutions, but you should also develop a rewarding culture to be
motivational. For example, you can create rewards or develop an accessible system for
employees to share feedback continuously.

The Bottom Line

Continuous process improvement offers a method for your business to get better at any point
in time. Whether you choose to implement incremental or breakthrough changes or a mixture
of both, you can help to reduce waste and optimise outcomes. The above continuous
improvement examples and strategies can help you achieve your business goals.

Like any type of process improvement, you want to remember to track and monitor any
changes to ensure you are following towards improvement, rather than hurting any other part
of the process. Automation software can help to analyse current processes, as well as
implement solutions that optimise operations.

When Should I conduct a RAM Analysis?

RAM analysis can be applied at various stages of the life cycle.

Pre-FEED (i.e. design conceptualisation) – RAM analysis can be used to compare various
design options that are being considered through quantification of the production output of
each option.

Conducting a RAM analysis at this stage, whilst the design is still being finalised is known to
reduce the cost and schedule impact on the project than if conducted at a later stage.

FEED – At the FEED stage, critical equipment’s are identified which could cause significant
production losses. A RAM analysis would normally be conducted on these critical
equipment’s in order to optimise the equipment configuration and identify the requirements
of any further spares or equipment redundancies in order to optimise the availability of the
system.

Detailed Engineering – At the detailed engineering stage it is likely that the design is frozen
with minimal changes. A RAM study at this point would allow the client to identify
performance targets that must be met by the equipment, which can be used as part of the
equipment design specification during procurement.

Process Operation – Whilst the process is in operation, conducting a RAM study using the
data of the as-built facility can bring the benefit of identifying unreliable equipment which
are leading to production losses

7 types of process improvement methodologies

There are seven different business process improvement methodologies your team can use to
help reduce inefficiencies. In most cases, the methodology you choose depends on why you
want to improve your processes and what you’re looking to improve.

1. Six Sigma methodology

Six Sigma is a process improvement methodology that aims to minimize the amount of
variations within the end product. this process uses statistical data as benchmarks to help
business leaders understand how well their processes work. A process is considered
optimized if it produces less than 3.4 defects per one million cycles.
Six Sigma is often used in manufacturing, mainly because it helps minimize defects and
inconsistencies. The goal here is to optimize for consistency, which in the end leads to
customer satisfaction.

There are two main processes used in Six Sigma: DMAIC for existing processes and
DMADV for new processes. Since this article focuses specifically on improvements to
existing processes, let’s dive into the DMAIC process.

What is the DMAIC process?

DMAIC is a Six Sigma process used to optimize existing processes. DMAIC stands for:

• Define the opportunity for improvement.

• Measure the performance of your existing processes.
• Analyze the process to find defects and root causes.
• Improve processes by addressing root causes.
• Control any improved processes and assess future process performance to correct
deviations.
The bulk of the DMAIC process improvement happens during the analysis stage. During the
analysis stage of DMAIC, teams use a fishbone diagram, or an Ishikawa diagram, to visualize
the possible causes of a product defect. The head of the fishbone diagram states the initial
problem—then as you follow along the spine of the fish, each rib lists different categories of
issues that can lead to the initial problem. This type of visual analysis is a good way to
identify the different issues one root cause can create.

2. Total Quality Management (TQM)

Total quality management (TQM) is a customer-focused method that involves continuous

improvement over time. This technique is often used in supply chain management and
customer satisfaction projects.
TQM relies heavily on data-driven decisions and performance metrics. During the problem-
solving process, you use success metrics to decide how you can improve a process.

Here some key features of TQM:

• Customer-focus: The end goal of TQM is always to benefit the end customer. If your
team is focused on improving quality, ask yourself how that process change may
affect how end consumers experience your product.
• Full-team involvement: Unlike other process improvement methodologies TQM
involves the entire team—not just production. As a result, you may end up looking for
ways to optimize more business-centric processes, such as sales and marketing, to
benefit the end consumer.
• Continuous improvement: Continuous improvement in business is the idea of making
small changes with the goal of continually optimizing processes. There's a lot of
variability when it comes to business, and continuous improvement helps your team
adapt when outside circumstances change.
• Data-driven decision making: In order to apply continuous process improvement, you
must continually collect data to analyze how processes are performing. This data can
help identify where there may be inefficiencies and where to focus improvement
initiatives.
Process-focused: The main goal of implementing TQM is to improve processes. Other
process improvement methods like Six Sigma work to minimize the amount of defects, while
TQM works to decrease inefficiencies.

3. Lean manufacturing

This form of process improvement goes by many names, with lean manufacturing being the
most common. It may also be referred to as Lean production or just-in-time production.

The 5 principles of lean

1. Identify value
2. Value stream mapping
3. Create flow
4. Establish pull
 5. Continuous improvement

4. Continuous improvement (kaizen)

The Japanese philosophy of kaizen guides the continuous improvement model. Kaizen was
born from the idea that life should be continuously improved so we can lead more satisfying
and fulfilling lives.
This same concept can be applied to business—because as long as you are continuously
improving, your business can become more successful. The goal of continuous improvement
is to optimize for activities that generate value and to get rid of any waste.

There are three types of waste that kaizen aims to remove:

• Muda (wastefulness): Practices that consume resources but don’t add value.
• Mura (unevenness): Overproduction that leaves behind waste, like excess product.
• Muri (overburden): Too much strain on resources, such as worn out machinery or
overworked employees.

5. Plan Do Check Act (PDCA)

The PDCA cycle is an interactive form of problem solving. It's used to improve processes
and implement change. PDCA was created by Walter Shewhart when he applied the scientific
method to economic quality control. Later, the idea was developed even further by W.
Edwards Deming, who expanded on Shewhart's idea and used the scientific method for
process improvement in addition to quality control.
There are four main steps to the PDCA cycle:

• Plan: Decide on the problem you would like to solve, and create a plan to solve it.
• Do: Test and implement the plan at a small scale.
• Check: Review how the actions in the Do stage performed.
• Act: After reviewing the results of the test, decide whether or not you want to
implement the change at a larger scale.
PDCA is an improvement cycle. This means that these steps can be repeated until your team
reaches the desired result.
6. 5 Whys analysis

The 5 Whys analysis is a process improvement technique used to identify the root cause of a
problem. It's a really simple process in theory: you gather a group of stakeholders who were
involved in a failure, and one person asks: "Why did this go wrong?" Repeat this question
approximately five times, until you get to the root cause of an issue. The 5 Whys analysis
aims to identify the issues within a process, but not human error.
Here's an example:

Problem: There was an increase in customer complaints regarding damaged products.

1. "Why did this happen?" Because packaging was not sufficient enough to protect the
products.
2. "Why was the packaging not sufficient enough to protect the products?" Because the
team testing packaging did not test past a certain level of stress.
3. "Why did the team not test the packaging further?" Because current standard
processes indicated that the testing indicated was sufficient.
4. "Why did the current standard process indicate that this testing was
sufficient?" Because this process was created for a previous product, and not this
current product that is coming back damaged.
5. "Why wasn’t there a new process for the new product?" Because the project template
for launching new products doesn’t include stress testing the new packaging.
You can see from this example that the team asked “Why” until they identified the process
error that needs to be fixed—in this case, adding a “stress test new packaging” step into
their product launch template. When working with stakeholders in processes like this, it's
important to identify the issues, and co-create next steps together so that your production can
improve.

7. Business process management (BPM)

Business process management, or BPM, is the act of analyzing and improving business
processes. Much like any organic being, businesses grow and shift over time. Your team may
have implemented processes that worked when your team was small, but as you grow those
processes may not scale in a way that allows your team to be as efficient as possible.
Most of the time, BPM helps teams identify bottlenecks, ways to automate manual work, and
strategies to improve inefficiencies. There are five main steps to business process
management.

1. Analyze: Look at your current processes and map them from beginning to end. This is
commonly known as process mapping.
2. Model: Draft out what you want the process to look like. Ideally, you'll have found
any inefficiencies in the first step, and you can draft how you would like to solve
them in this stage.
3. Implement: Put your model to action. During this stage, it's important to establish key
success metrics so you can gauge whether or not the changes made were successful.
4. Monitor: Decide whether or not your project is successful. Are the success metrics
you identified in step three improving?

5. Optimize: As the process evolves, continue looking for inefficiencies in your process
and continuously optimize as you go.

Manage process improvements to increase productivity

As a team lead, one of the most valuable things you can bring to your team are clearer
processes and better workflows. When used effectively, process improvement increases your
team's productivity and decreases inefficiencies.
To increase clarity and improve processes, try work management. Work management
tools like Asana can help you take your team’s productivity to the next level by standardizing
processes, streamlining workflows, and keeping your team in sync.

Quality Management Systems and Process in organisations

Need for quality management and Quality Management Principles.—

The Principles of Quality Management

Learn more about these quality basics in order to improve your organization.

Most people would agree that quality is essential to have but difficult to execute. Among the
many tools available, a quality management system (QMS) can provide a roadmap toward
better quality. Without it, a company lacks direction. “The QMS is fundamentally how an
organization does operate, it’s a system for managing quality… It is the way our organization
operates. And if you accept that, then it’s very easy to see the QMS really is the basic
foundation for being successful as an organization.”

It’s almost impossible to develop a quality system without thinking of where we as an

organization want to be strategically.

To get where you want to be, quality management principles can guide the way.

What are the quality management principles? Like quality itself, they may seem difficult to
define. While there may be some disagreement on what these fundamentals are, ISO seems
like a safe place to start.

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management
principles. According to ISO, the seven quality management principles are, in no particular
order:

1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

Let’s take a closer look at these quality management principles and how you can adopt them
to improve your organization.

1. Customer Focus
This almost goes without saying. An organization that doesn’t focus on customers won’t be
around for long. Although a customer focus is critical, many times this can be lost in the
priorities of a quality system and the various processes involved.

The focus should include current—and future—customers. Besides continuously meeting or

exceeding customer expectations, companies should measure customer satisfaction.
Conversely, failing to meet customer expectations should also be tracked. Every function and
department should be involved.

2. Leadership

As with any quality idea, support must start at the top. Without good leadership, an
organization will suffer. Leaders should set a vision and goals for the company.

Think back to an inspiring leader you’ve met. Perhaps this was at work or even at a quality
event. over an underperforming war ship. Morale was low and turnover was high. By uniting
his crew with their

3. Engagement of People

An engaged workforce is one that you want to have. This means the abilities of the staff are
used and valued. It also enables continuous improvement, learning, and discussion of any
issues. With an engaged workforce, staff are held accountable for their actions. Rather being
seen as a passive place to clock in every morning, the job requires everyone in the
organization to be active and engaged in their work.

4. Process Approach

As with so many things in quality, a process approach outlines the steps for success.

This means activities are managed as processes, measured, and connections between
activities are identified. Opportunities for improvement are tracked. Quality doesn’t just
happen. It requires processes behind the scenes to ensure the success of the organization.

5. Improvement
A strong quality system requires change. Without improvement, companies will eventually
be outshined by the competition. Aiming to maintain the status quo does not inspire anyone.

This means the company’s performance and capabilities should be developed on an ongoing
basis. These improvement activities should align with goals, and staff should be encouraged
and empowered to make improvements. When improvements are made, these should be
measured. And finally, celebrated! When things go well, it’s important to acknowledge it.
Quality isn’t all stressful audits and data analysis. Sometimes it’s formal recognition and
praise.

6. Evidence-based decision making

As you may have guessed, gut feelings are not the way forward. Rather, data is king. Of
course, this should be no surprise to the quality professional. Organizations should make sure
data is accessible, accurate, and reliable. It should be analyzed and decisions made based on
it. Still, data analysis should be balanced with practical experience. The numbers tell the
story, but it is important not to discount experience as well.

7. Relationship management

Finally, the people are the important part of any organization, and the relationships between
suppliers and other partners are critical. Suppliers should be selected carefully based on the
ability to create value as well as manage costs. Partners should be aware of plans and
information that would help them in their work. A spirit of collaboration should be the goal.
Coordinating improvement activities can help both parties. Recognizing supplier successes
will also go a long way to maintaining a strong relationship.

ISO 9000 Family for Quality Management standards.

WHAT YOU NEED TO KNOW ABOUT ISO 9001

DOES MY ORGANIZATION NEED CERTIFICATION TO ISO 9001?

Checking that the system works is a vital part of ISO 9001. It is recommended that an
organization performs internal audits to check how its quality management system is
working. An organization may decide to invite an independent certification body to verify
that it is in conformity to the standard, but there is no requirement for this. Alternatively, it
might invite its clients to audit the quality system for themselves.

What is the ISO 9001 Standard?

The ISO 9001 standard is a document that describes all of the requirements needed in order to
create and maintain a quality management system as described in ISO 9000. This is a subtle
difference between ISO 9000 and ISO 9001 that some fail to recognize. So, to explicitly point
it out, the difference between the two (ISO 9000 vs 9001) is summarized as the definition of
quality management system (ISO 9000) and requirements needed to meet that definition (ISO
9001).

Both the ISO 9000 and 9001 standards are based on a number of quality management
principles including a strong customer focus, the motivation, and implication of top
management, the process approach and continual improvement. The seven quality
management principles include the following as described by the ISO:

• Customer focus – Quality management primarily focuses on meeting customer

requirements and striving to exceed customer expectations.
• Leadership – Helping leaders to establish unity of purpose and direction at all levels
and to create conditions to engage members of the organization in achieving the
organization’s quality objectives.
• Engagement of people – Obtaining and maintaining (at all levels throughout the
organization) competent, empowered, and engaged people to enhance the
organization’s capability to create and deliver value.
• Process approach – Delivering consistent and predictable results through the use of
effective and efficient activities that are understood and managed as interrelated
processes that function as a coherent system.
• Improvement – Maintaining an ongoing, organization-wide focus on improvement.
• Evidence-based decision making – Using the analysis and evaluation of data and
information in the decision making process to produce desired results.
• Relationship management – Managing the organization’s relationships with related
parties, such as partners or vendors, for sustained success.

Why ISO 9000 or 9001?

One misconception is that ISO 9000 or 9001 is only for manufactures or large organizations.
As a principles-based standard, ISO 9001 can be applied to any organization regardless of
what type or size it may be. The standard defines the requirements, but it does not dictate the
method of application. The latest version of the standard has been specifically designed to be
more accessible to organizations outside the manufacturing sector.

As with anything, there are ISO 9000/9001 pros and cons.

The application of ISO 9001 when implementing a quality management system can provide
the following benefits the organizations:

• Clear understanding of your objectives and new business opportunities.

• Identifying and addressing the risks associated with your organization.
• Renewed emphasis on putting your customers first.
• Meeting the necessary statutory and regulatory requirements.
• Organizational and process alignment to increase productivity and efficiency.

What is an ISO 9000 Certification?

If you are researching the ISO 9000 requirements or how to become ISO 9000 certified, you
should really be focused on ISO 9001. You see an organization cannot become ISO 9000
certified. First issued in 1987 and last updated in 2015, ISO 9001 is the standard that sets out
the criteria for a quality management system and is also the only standard within ISO 9000
that an organization can certify to. Therefore, it is incorrect to say that an organization is ISO
9000 compliant. However, a business can be ISO 9001 certified or compliant. While an ISO
9001 certification is not regulatory requirement, ISO reports that “over one million
companies and organizations in over 170 countries have certified to ISO 9001.”

An organization must demonstrate the following in order to be ISO 9001 certified:

• The company follows the guidelines within the ISO 9001 standard;
• The company meets its own requirements;
• The company meets its customer requirements and statutory and regulatory
requirements; and
• The company maintains documentation of its performance.
An ISO 9001 certification can enhance an organization’s credibility as it shows customers
that the organization’s products and services meet quality expectations. Additionally, there
are some instances where an ISO 9001 certification is required or legally mandated for
businesses in some industries.

How to Become ISO 9001 Certified?

The ISO 9001 certification process requires an organization to implement ISO 9001:2015
requirements. Once implemented, an organization must successfully complete registrar’s
audit to confirm that the organization system meets those requirements.

The auditor will interview management and staff within the organization to determine
whether or not they understand their role and responsibilities in complying with the ISO 9001
standards. The auditor will also examine the organization’s documentation to validate
compliance with the ISO 9001 requirements. The auditor will then prepare a detailed report
that details the parts of the standard that the organization did not meet.

The organization will need to agree to correct any problems within a specified time frame.
The organization executes remedial activities to ensure that all problems are corrected. Once
these gaps are addressed and confirmed by the auditor, the organization can then be certified.

In order to maintain the ISO 9001 certification, the organization must continue with regular
surveillance and recertification audits.

So, what is ISO 9000? In short, it is a principle-based international standard that describes a
quality management system that organizations can use to be more efficient and improve
customer satisfaction. ISO 9001 is a standard, against which one may be certified, that
specifies the requirements an entity needs to meet in order to achieve a quality management
system within their organization.

Selection of relevant ISO Standard. ---

WHICH IS THE BEST ISO STANDARD FOR MY BUSINESS?

If an organization decides to go for ISO Certification, the questions that popped out are,

• Which ISO Standard is best for my Business?

• Who does issue the ISO Certificates?
 • How to pass the ISO Certification Audit?
• What are the ISO Certification Requirements?

That’s right, Most Business owners, managing directors, or CEOs, initially think that they
can prepare themselves for the ISO Certification requirements. In most cases, they succeed to
clear the Certification audit, but in some cases, they can’t due to the lack of skillset of their
resources. That is where they start to identify the best external ISO consultants who can help
them to implement the system.

Which ISO Standard is best for my Organization/Business?

As you already know, there are hundreds of ISO standards published by ISO, but how to
identify which one is best for your business. The answer is simple, if you are trying to get the
ISO Certificate for the first time, then ISO 9001:2015 is the best standard for starts with.
Because ISO 9001:2015 (Quality Management System) is applicable to all organizations
(Any nature or any size).

If you have a special requirement of ISO Certification, that demanded by your client or for
any government/private tender, based on the requirement or nature of business you can go
with the following ISO standards,

ISO 9001 – Quality Management System – Applicable to all businesses (Service Based and
Product Based)

ISO 27001 – Information Security Management System – Applicable to business which

requires the secured environment to protect the Business Critical Information. Information
might be anything, such that Customer Data, Financial Data, Research Data, programming or
Coding Data, or any data that is critical to keep safe.

In most cases, 90% of IT Companies, Financial Institutes, Banks, R&D, and other big
organizations go with ISO 27001 Certification.
ISO 14001 – Environmental Management System, applicable to businesses or organizations
whose operations impact the surrounding environment and they are looking to meet the local
or international regulatory requirements.

Mostly applicable to Chemical Companies, production/manufacturing companies, mining

companies, chemical companies, pharmaceutical companies, oil & gas agencies, and any
other companies that require presenting their responsibility to save the environment without
harming through their business operations.

ISO 45001 – Occupational Health and Safety Management System – applicable to

organizations, in which the safety of their resources (Manpower) at risk. This also required
for regulatory requirements.

Constructions, manufacturing, Chemical or Mining Companies, where physical risk factor for
human is severed, they have to implement the safety guidelines as per ISO 45001 and get ISO
certified.

Even MNC’s or IT companies also can go with ISO 45001, as their employees may feel
mental risks during and after working hours. It’s the organizational responsibility to protect
their resources as per the legal requirements.

As for other standards, the organizations can go with their client requirements if they have
any particular demands.

Who does issue the ISO Certificates?

There is a myth that the ISO organization issues the ISO Certificates. No, ISO only publishes
the ISO Standards; the ISO Certificates are issued by accredited Certification Bodies. Again,
No government will issue the ISO Certificates, but Certification Bodies that are accredited by
the government or independent Accreditation Bodies issue the Certificates. Every country has
its own Accreditation Bodies and under accreditation body, there are hundreds of
Certification Bodies are working to issue ISO Certificates with proper auditing.

For Example, the USA has more than one accreditation body, such as A2LA, ANAB, IAS,
UAF, and IOAS.
India has only one Accreditation Body that is NABCB (National Accreditation Board for
Certification Bodies).

United Kingdom has the UKAS (United Kingdom Accreditation Services) Accreditation
Body.

Apart from these, there are various independent Accreditation bodies those work with their
own policies and not recognized by IAF (International Accreditation Forum).

How to pass the ISO Certification Audit?

As mentioned above, Certification bodies audit the organizational Management System

before issuing any ISO Certificates. To clear the ISO Certification audit, the organization has
to implement the required documentation, guidelines as per the ISO standards. The
organization can do self-implementation if they have enough skills to do or hire external ISO
Consulting agencies to implement the System. Due to the practice and experience of ISO
Consultants, It is easier to implement and get ISO Certified, but the process is quite Costlier.
But With negotiations, Organization can hire the best ISO Consultants.

What are the ISO Certification Requirements?

As it comes to the requirements of ISO Certification, Organization has to prepare

documentation, train their employees and follow the guidelines mentioned in the ISO
Standards. The requirements are simple and can be integrated easily into your current
management system.

Part of Documentation includes policies, standard operation procedures (SOP), records, roles
and responsibilities, controls, and manuals based on the selected ISO Standards.

For ISO 9001:2015 Certifications, a partial list of the following documents are mandatory,

Scope of the QMS, Quality Policy, Competency Records, design & development Input
records, a record of non-conformity, Internal Audit Program & Results, and Management
review results, etc.

There are set of records and procedures for each department in the organization, to prepare,
maintain and follow as per the required ISO Standard.
Implementing and Maintaining Quality Management Systems based on ISO 9000.

Who can implement a QMS based on ISO 9001?

Organizations that seek to meet the needs and requirements of their customers or other
interested parties, regardless of their size, type, or the industry in which they perform, can
implement and benefit from a QMS based on ISO 9001.

The main principle of ISO 9001 is customer focus. The standard addresses customer focus
(clause 5.1.2) and customer satisfaction (clause 9.1.2) throughout the document in order to
make sure that organizations are aware of the importance of meeting customer requirements.

By fulfilling the requirements of the clauses mentioned above, organizations maintain their
existing customers and attract new ones, which means that organizations will benefit
financially too.

Furthermore, ISO 9001 requires organizations to address risks and opportunities (clause 6.1)
and continually improve their QMS. The standard also encourages organizations to engage
and include the personnel during the implementation of the QMS so they too can contribute
to improve the quality in the organization.

Having a certified QMS based on ISO 9001 will enable organizations to earn the trust of
customers, enter new markets, and improve their business.

In order to be effective and reach its objectives, organizations must integrate the QMS in
everyday processes.

ISO 9001 is designed to enable organizations to use the process approach combined with the
plan, do, check, act (PDCA) cycle. This allows organizations to integrate their QMS with
other management system standards developed by ISO. In addition, the PDCA cycle enables
organizations to continually improve their QMS and it prevents mistakes from reoccurring.

What does ISO 9001 require regarding documentation?

In a way, earlier versions of the standard paved the way to the misconception that ISO 9001
requires a lot of documentation. They were based on the motto “Write what you do, then do
what you write.” For example, the 1987 and 1994 version required 20 documents only for
procedures, while the 2000 and 2008 version required 6.
ISO 9001:2015 requires organizations to document the quality policy and objectives or any
changes that may occur in the QMS. Nevertheless, this version allows organizations to decide
on the extent of documented information that they want to retain or maintain. The reasons for
retaining documented information include:

• Proving conformity to the standard

• Communicating information in the organization
• Maintaining organizational knowledge
• Tracing back changes or measurement used
• Keeping reference for improvement

ISO 9001 is not intended for an identical QMS in all organizations and does not enforce
organizations to implement the QMS in a specific way. While ISO/TS 9002 and ISO 9004
offer guidelines on implementation, organizations are not obliged to follow them. ISO 9001
only sets the requirements that organizations need to meet, but does not state how
organizations should meet those requirements.

ISO 9001 allows the flexibility in many areas. For example, organizations do not necessarily
need to implement the QMS across all their departments. Instead, they can include only the
departments that they see as necessary to be included in the QMS. In addition, ISO 9001 has
requirements that might not be applicable to some organizations. In such cases, organizations
are not obliged to comply with such requirements, as long as they the non-applicability of the
requirement.

Quality management system (QMS) is a set of policies, processes and procedures required
for planning and execution (production/development/service) in the core business area of an
organization (i.e., areas that can impact the organization’s ability to meet customer
requirements). ISO 9001 is an example of a Quality Management System.
A few details about Quality Management Systems:
Some people generically refer to the group of documents as a QMS, but specifically, it refers
to the entire system – the documents just describe it.

A QMS integrates the various internal processes within the organization and intends to
provide a process approach for project execution. A process based QMS enables the
organizations to identify, measure, control and improve the various core business processes
that will ultimately lead to improved business performance.
A complete ISO 9001 Quality Management System must address all the requirements of ISO
9001, including the ISO 9001 documentation requirements.
A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy
example of ISO 9001 applied to making cookies.

The Concept of Quality Management

A Quality Management System in its basic concept is quite simple. It seeks to,
• Recognize interested party requirements including Licenses to Trade, guidelines,
customer requirements, and the chosen management system standard(s).
• Ensure that all requirements have been met.
• Confirm that employees receive applicable training in the quality system
requirements.
• Determine processes, their interaction, inputs and outputs.
• Produce records or evidence that system requirements have been met.
• Measure, monitor and report the performance of the QMS.
• Plan changes to the QMS and take actions to address risks and opportunities as a
result of changes.
• Perform internal audit to analyze the QMS and correct nonconformities.
• Continually improve the QMS.
What A Quality Management System is not
There are many definitions for general quality management systems. Most of them emphasize
the use of some type of system that is repeatable, measurable and constantly improving. In an
ISO 9001 (or other ISO standards) quality system, this structured way of delivering a better
service or product is supported by documented information such as procedures, work
instructions, policies and forms. The key is to provide all those who must execute the quality
system with documented, understandable and workable instructions which define both
expectations, responsibilities and actions to achieve the stated quality goals. Most of the
systems include some type of external and internal auditing process which ensures that the
system is in compliance with requirements.
At its core, a quality management system is an integrative element, uniting diverse aspects of
a company into a unified purpose of delivering products/services in their best form. Rather
than be seen as a cost burden, an effective quality management system is viewed as a key
component of success. Quality management systems focus on:
 • Being centered on the customer or consumer of the good or service, actively
providing that customer with the best value possible.
• Some type of continuous improvement program, which implies that there is not
a “perfect” state, all processes can be continually improved upon.
• An efficiency imperative that says waste must be reduced and all resources
maximized.
• Top management is to support and provide adequate resources to achieve
goals.
• It aids or facilitates a clear understanding of expectations between all
participants.
• Measurement and accurate data collection are incorporated to support data-
driven decision making.
• Documentation of QMS processes is maintained and controlled.

Quality control and management is important to ensure the customer gets the value they
deserve, and quality management standards like those defined by the ISO 9000
family exist to make quality management work better.

• What is ISO 9000?

• What is ISO 9001?
• ISO 9000 for quality management systems
• Why is ISO 9000 important?
• Benefits of ISO 9000
• ISO 9000 certification
• Implementing ISO 9000 with Process Street
• Free ISO 9000 templates
• Relevant ISO/SOP articles

What is ISO 9000?

ISO 9000 is a family of quality management system standards created to help

organizations build, maintain, and continuously improve their quality management
systems in order to provide the best product or service possible for relevant stakeho lders
and customers.

A quick introduction to ISO

The International Organization for Standardization (also known as ISO) is a standard-

setting body with headquarters in Switzerland. It is formed of a number of different
representatives from many standards organizations of all types.

ISO is the organization responsible for creating and maintaining standards like those
found in ISO 9000.

What is the difference between ISO 9000 and ISO 9001?

Confusingly, ISO 9000 refers to both a single standard (ISO 9000) as well as the entire
9000 family of standards. They are all designed for quality management and quality
assurance. The ISO 9001 standard is one of many in the 9000 family.

What about ISO 9001?

ISO 9001 is a specific standard, perhaps the most famous of all of the ISO standards. It
is specifically designed to help companies implement and maintain quality
management systems.

It’s basically a standard that is supposed to help organizations be more efficient and
successfully meet the needs of their customers.

At least one million companies and organizations in 170+ countries are certified to ISO
9001, and even more will informally utilize the standard in one way or another.

ISO 9000 for quality management systems

Quality management is the process of making sure products or services are up to

scratch, and that the recipient of those products or services are satisfied.

Simply put, the goal of quality management is to achieve and maintain a desired level of
quality. That’s what ISO 9000 is all about – putting a system in place that ensures a
consistent level of quality.

What is a QMS?

This is perhaps the most important concept of ISO 9000. A QMS, or quality
management system, can be understood as a set of best practice principles for standard
operating procedures.

The goal of this kind of system is to ensure reliable, predictable outputs for a given
input. With a QMS in place, it’s possible to quantifiably measure the quality of the
various aspects of a business with techniques such as auditing.
A QMS at its core is a collection of documented policies and procedures that clearly
define the ideal way you want the product or service delivered to your customers. Think
of it like a business process management system with a focus on quality control.

No two quality management systems will be the same, and all companies will want to
implement ISO 9000 standards in their own way, according to their own needs
and goals.

Despite this, there are unifying principles that ISO 9000 quality management systems
are designed around, such as the PDCA/PDSA framework.

PDCA (Plan, Do, Check, Act) or PDSA (Plan, Do, Study, Act) are both variants of
the Deming cycle, which is a methodology of continuous improvement.

Certain standards in the ISO 9000 family, such as ISO 9001:2015 were updated to be
more readily functional alongside the PDSA framework.

These changes come alongside other similar structural changes designed to simplify
ISO 9000 implementation.

Annex SL and the management system standard (MSS) structure

Another change to ISO standards has been the introduction of a new, commonly shared
structure known as Annex L (previously known as Annex SL).

Made up of 10 clauses, Annex L is shared by many ISO management system standards,

such as ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.

It replaces ISO’s previous Guide 83 standard, which provided base structure and format
for management system standards.
What this means is, now many different ISO management system standards can be
cross-implemented and integrated together very easily, as they all share the same core
structure.

Understanding ISO’s management system standards is an important step towards

improving efficiency in your organization, especially if you’re already using an ISO
standard.

But why else would you consider implementing any of the ISO 9000 standards?

Why is ISO 9000 important?

ISO 9000 is a family of quality management standards, and quality management, in the
form of a properly enforced QMS, can help an organization to:

• Market their business more effectively

• Exploit new markets
• Streamline onboarding processes
• Manage growth more efficiently
• Implement and reap the rewards of continuous improvement
• Reduce error in production processes
• Improve product or service efficiency
• Reduce waste
• Improve customer and stakeholder satisfaction

Why do I need ISO 9000?

Apart from being an internationally recognized symbol of prestige, a quality
management system implemented with ISO 9000 standards for quality assurance can be
assumed to have reached a consistently high level of customer satisfaction and product
quality.

ISO 9000, specifically standards like ISO 9001, should be seen as ways to
systematically and reliably implement functional quality management systems.

As well as being reliable and proven standards for the general purpose of implementing
a QMS, there are a number of specific benefits that come with using ISO 9000.

Benefits of ISO 9000

As a guide, a recent study undertaken through the American Society for Quality (ASQ)
showed that for every $1 spent on your QMS, you could expect to see an additi onal $6
in revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw
that quality management reduced costs by 4.8%.

Benefits of ISO 9000 standards hit all sectors of an organization, and I’ve outlined the
main benefits below

How ISO 9000 can benefit your business

• For all recurring processes, you ISO 9000 will help to reduce the rate of error.
• By utilizing a respected international standard, your brand image and credibility
will increase.
• Manual work is reduced with process integration and process automation.
 • By using data and evidence from auditing and detailed records, you will improve
organizational efficiency and effectiveness.
• You will save more time from more efficient management of resources.
• You will increase profit potential and market share overall as a result of the
cumulative effects of implementing ISO 9000 standards.
How ISO 9000 can benefit your organization/customers

• Customer satisfaction will rise as you will be equipped to quickly and efficiently
act on feedback.
• ISO 9000 standards for quality management encourage preventative thinking and
planning, meaning you will address issues before they have a chance to arise and
cause problems for customers, or any other sector of business.
• Customers will see ISO 9000 certification as a badge of a high-quality, reliable
vendor.
• Customer satisfaction is a core focus of ISO 9000 standards, so any effective
implementation should see improvements to customer satisfaction.
How ISO 9000 can benefit your employees

• When done right, ISO 9000 standards will help to foster a company culture of
continuous improvement.
• Process ownership and accountability is an important concept of ISO 9000
standards, and as such employees will become more engaged with and feel
responsible for their processes. This in turn improves process quality.
• Improved business performance means more secure jobs.
• Higher workplace happiness and job satisfaction due to roles being clearly
defined and streamlined.
• Onboarding and training becomes more streamlined thanks to improved planning
and organizational structuring for ISO 9000 requirements.

ISO 9000 certification

ISO certification isn’t necessary; you can implement any standard without getting
officially certified and still reap the benefits.

However, certification carries some exclusive benefits, some of which have been
mentioned above. You may also require ISO certification for specific situations, such as
when a client or government body requests it.

To be clear, you can only achieve ISO certification as the result of a successful 3rd
party audit. To succeed in a 3rd party audit, you need to have:

1. Built and implemented a quality management system in accordance with the

principles of the relevant standard.
2. Have an audit performed by a Certified Body (CB or Registrar) to assess the
performance of your QMS against the relevant standard.
3. If you are successful, the certificate will need to be recertified after three years
(and every subsequent three years) to make sure you’re still up to standard ( as
well as any new changes to the standard).
That said, there are other reasons you may want to perform an ISO audit.

ISO 9000 audit process

ISO audits are generally made up of these stages:

• Audit management
• Audit preparation
• Audit process
• Gathering evidence
• Evaluation of audit evidence against audit criteria
• Closing the audit
• Following up
• Competence and evaluation of auditors
Each stage will involve sub-tasks and requirements of its own, depending on the
specific standard being audited to.

Different types of ISO audit

There are three main types of ISO audit, split into two distinct categories:

Internal audits

• First-party
External audits

• Second-party
• Third-party
The important distinctions are between first, second, and third-party audits.

First-party
These are simply internal audits.

Internal audits are conducted by, or on behalf of the organization itself. They’re
typically used for assessing conformity, evaluating effectiveness, analyzing processes,
and identifying areas for improvement.

They can also be done as part of requirements for certain ISO standards, where it is
specified that internal audits need to be carried out.

First party audits can never result in an ISO certification, but they can be used to
prepare for a third-party audit.

Second-party
“External audits” refers to both second and third-party audits.
Second-party audits are done by, or at the request of any organization or interested party
outside of the organization being audited. For example, a customer or a contractor might
request a second-party ISO audit.

They will usually be more formal than first-party audits, because the outcome will more
directly impact the relationship between the organization and the relevant interested
party requesting the audit.

Third-party
Third-party audits are done by external organizations that don’t have any vested or
conflicting interests in the organization being audited.

For example, a third-party audit will typically be done by a certified body or registered
government agency.

The important factor is the independence of the audit organization. They must be
separate from the organization being audited.

Customers can also request third-party audits, usually to make sure certain requirements
are adhered to.

Third-party audits are the only way to get ISO certified. Just so, failing a third -party
audit may lead to a fine or a citation being issued.

ISO has never been easier

Recent changes to ISO standards across the board mean it’s easier than it’s ever bee n to
get started with implementing ISO in your business.

These changes mean you can use Process Street to build and maintain your ISO
management systems like those using ISO 9000 standards.
Using Process Street to implement ISO 9000 standards

If you want to practically implement ISO 9000 standards, you will save yourself time
and money by choosing a BPM software tool to keep everything organized and
streamlined.

Process Street is one such tool, and you can use it to get started with a quality
management system using ISO 9000, as well as managing all of your other workflows
and business processes.

Since 2015 revisions of ISO standards, Process Street has been an ideal solution for
building, managing, implementing, and optimizing standard operating procedures and
ISO standards.

ISO 9001 Internal Audit Checklist for Quality Management Systems

Arguably ISO’s most popular standard, ISO 9001 defines the requirements for
implementing, maintaining, and improving quality management systems.

Maintaining the Benefits and Continual Improvements.

How continuous improvement can build a competitive edge

Continuous improvement is an ongoing effort to improve all elements of an organization. It
rests on the belief that a steady stream of improvements, diligently executed, will have
transformational results.
Delivers large-scale performance-improvement programs that foster culture change and
counsels senior executives making leadership transitions

Helps business leaders transform their organization at scale and build a healthy culture of
high performance and continuous improvement
CULTURECHANGE MANAGEMENTORGANIZATION DESIGN

May 6, 2019What level of impact can continuous improvement achieve? One of our clients
would say ten weeks. Why? That’s how much time they were able to save in their product
testing process—cutting the time by more than 80%—through a large amount of small
changes to how its engineering and testing teams collaborated.

What is continuous improvement?

Continuous improvement is an ongoing effort to improve all elements of an organization—

processes, tools, products, services, etc. Sometimes those improvements are big, often they
are small. But what’s most important is they’re frequent. Companies that excel at continuous
improvement start with the belief that success comes from:

• Innovating “how” they do what they do (big and small).

• Engaging all employees in sharing knowledge and generating

improvement ideas.

• Exploring better ways to deliver to customers and respond to changes

in the external environment.
Core to a continuous improvement mindset is the belief that a steady stream of
improvements, diligently executed, will have transformational results.

What does continuous improvement look like in action?

Fostering a continuous improvement culture is rooted in three practices:

Performance transparency starts with making goals public and cascading those goals
(typically a balanced mix of financial and operational metrics) in a way that is tailored to
individuals at all levels of the organization. Progress toward goals must be transparently
tracked to give the frontline and management clear visibility into what is working and what
needs work.

After conducting our Organizational Health Index (OHI) with one of our industrial clients,
we saw an opportunity to create greater transparency among different areas of their
operations. For instance, the company had capital assets that were poorly utilized, in part
because they were shared across multiple teams that lacked the incentive to maximize the
assets’ usage.

By instituting an easy-to-understand system to track overall utilization, the teams that used
the assets instantly realized that low utilization was a bigger problem than any of them had
realized, and it focused their creativity on finding new ways to make the assets more
productive—leading to a 20% productivity increase in less than two months.

Knowledge sharing is critical to scale best practices across (and up and down) organizations.
One of our clients became adept at deploying small cross-functional teams against any
problem to break down the organizational silos that had previously prevented knowledge
sharing.

The teams would collocate to promote informal and formal knowledge sharing and were
given license to explore every idea and bring in additional expertise as needed. The team had
to work together because no single team completely understood most problems “end-to-end.”
But by working together in multi-week sprints, they were able to achieve 80%+ cycle time
improvements.

Employee involvement is a necessity in continuous improvement organizations. Frontline

employees are closest to the work, and thus typically have the richest insights on how their
work can be done better. Capturing their perspectives is critical.

When our client struggled with morale among frontline managers, they went straight to the
source. Through conversations with frontline management, leaders uncovered issues that
needed to be addressed—insufficient onboarding, limited upward mobility and burdensome
administrative duties that prevented them from effectively leading their teams.

Working with a coalition of frontline managers, the management team developed a set of
focused interventions (many of which were led by managers now empowered to make the
changes they sought) to expand opportunities for mobility, leadership development and
mentorship, and to reduce waste in their daily workload.

Transformational results

Core to a continuous improvement mindset is the belief that a steady stream of

improvements, diligently executed, will have transformational results.
Continuous improvement has helped clients across industries provide greater value to their
customers. Are you looking to gain an execution edge for your company? Get in touch
with us and check out our upcoming blog posts that will dispel several myths on creating
continuous improvement cultures.
Many transformations lose significant value in the target setting and planning phases. Leaders
can take three actions to prevent value leakage from day one.
Designs and manages large-scale organizational transformations, strengthening business
performance through enhanced culture, values, leadership, and talent systems

Nearly one half of value loss occurs early in the transformation, during the target setting and
planning phases. The good news is that our research points to specific indicators that are
especially predictive of value capture—and many of these can be applied before day one.

Here are three actions that leaders should prioritize during the initial stages of a
transformation.

1. Understand the value at stake. Companies often underestimate the true

potential of their transformation. To avoid this mistake, leaders should
complete a comprehensive, fact-based assessment of the business
across all sources of value—from strategy to operations, talent, capital,
growth, and organizational health. This due diligence enables leaders
to confidently set an ambitious yet realistic target that reflects the full
value potential.

2. Set a bold target. When companies set high expectations, people tend to
meet them. In an in-depth review of 15 transformations, we found that
organizations on average delivered 2.7 times more value than their
senior executives thought possible at the start. In fact, the most
successful transformations (based on TRS performance) set financial
targets at 75 percent or higher of trailing earnings.
 An aspirational target signals a meaningful step change in
performance across the organization and sets the tone for what is
possible. After completing a rigorous assessment of the business, one
CEO set a transformation goal of 150 percent of the initial opportunity
range. In his words, "When you set a very aggressive goal, it forces
you out of our comfort zone. You can't do things the way always done
them and achieve those kind of results." This stretch target
communicated a clear departure from the status quo and energized the
company to go all-in on the transformation.

3. Make goals tangible. An ambitious target alone is not enough to

motivate and inspire employees. People need to understand what this
means for their day-to-day roles and what they are expected to do
differently. In other words, broader goals need to be broken down into
bite-sized pieces that are adapted to different employee roles and
functions. For example, one organization set an operational goal of
substantially lowering its cost per unit in order to stay competitive in a
shifting global landscape. After engaging with the transformation
leads, one maintenance supervisor understood that minimizing down-
time on her line would translate to more units produced and a lower
cost per unit. She rallied her maintenance team around this tangible
goal and made it clear how their work tied to the overall transformation
objective of becoming the most efficient producer in the world.

Our survey results suggest a perception gap between the C-suite and
the rest of the organization: Senior leaders are nearly 20 percent more
likely than others to believe that their transformation's goals have been
adapted for employees across the organization. To bridge this gap,
leaders must plan and deliver a tailored communications campaign
across multiple channels to engage wide-ranging groups of employees.
There are no shortcuts to transformation success. Our research reveals that the strongest
indicators for value capture include a rigorous assessment of the current state, an ambitious
financial target, and the ability to make broader goals meaningful to employees. By investing
in these priorities early on, leaders give their organizations the best chance to achieve the full
potential of their transformation.

What can organizations do to engage and retain these employees? We propose three focus
areas based on our research:

1. Value workers and ensure they feel a sense of belonging. Our research
showed that the top three reasons employees left their organization in
the past six months were not feeling valued by the organization (54
percent) or their manager (52 percent) and not having a sense of
belonging (51 percent). This disproportionally affects populations that
are leaving in greater numbers for non-traditional work: 60 percent of
parents reported not feeling a sense of belonging at work—relatively
speaking, 30 percent more than colleagues without children.

In related research, we found that in organizations that improved their

individual and team performance during the pandemic, 60 percent of
leaders increased the amount of time they spent recognizing their
employees.

Valuing employees will ultimately improve performance and reduce

attrition, but it must be genuine and meaningful. For example, a large
consumer packaged goods company encouraged managers to have
regular 1:1 check-ins with direct reports. The more frequent the check-
ins, the more employee engagement scores went up.

2. Empower employees. Autonomy at work is highly valued by

employees looking for non-traditional work opportunities,
particularly women of color. Our research shows organizations where
leaders successfully empower others through coaching are nearly four
times more likely to make good and fast decisions and outperform their
industry peers.

For example, one large retailer gives each of its sales associates the
ability to offer a discount on any store item for whatever reason the
employee deems valid. They trust their people’s expertise and their
 desire to provide the best customer experience. In return, their staff
feels trusted and that their work matters to the company.

3. Encourage setting work-life boundaries. Establishing work-life

boundaries has been particularly hard during the pandemic. As many
employees continue to work from home, they struggle to create and
maintain work-life boundaries because of their responsibilities.,

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