Issues in quality

Engineering
P R SUBRAMANIAM,
GANDHI INSTITUTE OF ENGINEERING AND TECHNOLOGYUNIVERSITY GUNUPUR, INDIA

Keywords Quality, Techniques, Statistical process control

Abstract
Today, for the realization of the full success potential of a business, but even more critically for
the survival of a business, developing industries are on the race track to competitors for better
products and in a nutshell, more value for the customer. The importance of ensuring good
quality of its products and services to gain customers, striving to ensure company survival is a
more powerful motive for many companies. Quality engineering solutions an
emerging paradigm is being implemented in the present scenario of developing technologies
in business of emanating industries. Traditional testing and quality control is not enough since a
quality control team is involved at the last stages of production, and its task is to detect defects
in an almost ready product. If some drawbacks are revealed, the product may have to be
redesigned, requiring much time and additional expenses. Such methodology has proven to be
inefficient.
Analysis, management, development and maintenance of different systems in accordance with
high standards, is Quality engineering. The application of this approach in manufacturing or
software development processes ensures the quality of the output by minimizing defects from
the very beginning thus reducing potential losses. It implies that each stage of the product
development cycle is under a rigorous check of quality engineers. Moreover,
quality maintenance is provided long after the product is delivered.
This paper reviews evolving trends and issues focusing on quality engineering. Radical changes
in customer expectation necessitate reform in the technology of design and manufacturing
which is becoming more crucial in satisfying individual customer. This also calls for special
attention to the engineering aspects of quality. Brief reviews on recent improvements in
famous quality tools viz; statistical process control, quality function deployment, and design of
experiment are described. General trends in quality engineering research show the tools are
being enhanced, integrated, computerized and broaden their application bases, where possible
opportunities for further investigation are indicated. Among others these include contributions
in multiple-response optimization, intelligent quality systems, multivariate SPC, and practical
and simple guidelines for actual implementation of various tools.

Introduction

Quality keeps advancing with the application of quality tools and techniques beyond the
traditional approach.
Quality issues are now the concern of all organizations including the services and public sectors.
Quality tools, techniques, concepts and methodologies have been enhanced, to suit new
challenges. Managers often tend to have an overwhelming concern with the management and
conceptual aspects of quality compared to the hard technologies of quality (quality
engineering) despite the latter's tremendous role in ``creating'' quality. Much progress has been
made in quality engineering and this is scattered in various technically publications. The
purpose of this paper is to put quality engineering into perspective and to highlight its
importance, as well as to present some issues in the frontiers of quality engineering.

The paper begins with an overview of quality definitions and evolution of quality paradigms.
This is followed by a comparison of quality management and quality engineering. Advances in
the prominent quality engineering tools and techniques, particularly statistical process control
(SPC), design of experiment (DoE), Taguchi methods and quality function deployment (QFD) are
then presented.

Definitions of quality and customer focus

The bottom line of some definitions of Quality by various quality gurus is compiled in Table I
below:

Quality Guru/Authority Definition

Dr. Walter A. Shewhart “on Target with minimum variance” 
Dr Juran “fitness for use”
Philip Crosby   “Conformance to requirements”
WE Deming “Should be aimed at the needs of the consumer, present and
future”.
Armand Feigenbaum “Total quality control Best for the customer”.

ISO 9000:2005 “The degree to which a set of characteristics fulfils

requirements”
Dr. Kaoru Ishikawa “ to develop, design, produce and service a quality product which
is most economical, most useful and always satisfactory to the
consumer”
Dr. Genichi Taguchi “loss imparted by the product to society from the time the
product is shipped.”

It can be seen from these definitions that quality is an evolving notion. The development in
thought process has been evident, over time, in the various attempts made to define quality
and is seen through the evolution of definitions. We can see it has become a more embracing
entity, more holistic as it embraces not just product quality, but also those elements/ factors
that can impact on quality. Additionally, attention now needs to be paid to all quality
dimensions – not only product quality, but also business quality (including our environmental
and ethical stance) and organisational quality (including our effective and efficient operation).
Attention now needs to be paid to all quality parameters, not only conformance to
specification, but also the quality of design and quality of use. In other words you can have a
great product, but it’s no good if it breaks down shortly after use.

Quality is an ever evolving perception by the customer of the value provided by a product.  It is
not a static perception that never changes but a fluid process that changes, as a product
matures (innovation) and other alternatives (competition) are made available as a basis of
comparison. One of the easiest ways to judge the customers' acceptance towards quality is that
a customer look into your eyes and says "WOW!"? "That met the requirements!" or "There
were no defects there!" or "That had all the value I wanted!" or "The degree of excellence was
acceptable!

Figure-1
Professor Noriaki Kano created a Model while studying the contributing factors to customer
satisfaction and customer loyalty as shown in figure-1. His model clearly explains how
requirements and features influence satisfaction.

As per Noori (1993) a quality approach to excellence is ensuring customer delight. The
organization should make the customer feel special and deal with the customer as a matter of
priority rather than as a secondary issue. 

Watson defined “service and caring creating customer satisfaction” is quality and the level of
service quality and customer satisfaction is connected to customer perceptions and customer
expectations.

Customer-centric quality is the focus of all the above. Customer centric is a way of doing
business with your customer in a way that provides a positive customer experience before and
after the sale in order to drive repeat business, customer loyalty and profits. On the other hand,
for a poor quality manufacturer, instead of repeat customers, faulty/defective products will
return for repair or replacement.

Quality concepts and tools will be used everywhere in society to improve the quality of
products, services, and life. Basic skills of quality management like process analysis, data
collection and analysis methods, process auditing, and teamwork will be deployed universally.
In addition, some of the advanced quality tools, such as design of experiments, quality function
deployment, and failure mode effects analysis, will be used by professionals in many other
fields. Business professionals to be active in the future must apply the skills in strategic business
opportunities to higher-level projects and take a leap using the tools in that direction, for
communication, strategic thinking, information retrieval, and interpersonal skills preparing to
wield digital hammers and use electronic nails the tools of the shrinking global marketplace
now.
Many of the commonly used key terms pertaining to quality are quality control (QC), quality assurance
(QA), statistical quality control (SQC), total quality control (TQC) and total quality management (TQM).
Quality Assurance is a proactive process and is prevention in nature whereas Quality Control is a reactive
process and is detection in nature. Minimize variation and run to optimum target is SPC. SQC is typically
the measuring and recording of data against specific requirements for a product ensuring they meet the
necessary requirements. Both play an integrated role in seeing operational success achievement. TQM
expresses about continuous improvement in the processes while TQC is about maintaining the quality
standards throughout the process. Armand Feigenbaum was the first to introduce the concept TQC what
eventually led to TQM. Dr. Kaoru Ishikawa`s definition of quality control, "Total Quality Control is a
thought revolution in management, to practice quality control is to develop, design, produce and service
a quality product which is most economical, most useful and always satisfactory to the consumer. To
meet this goal, everyone in the company must participate in and promote quality control, including top
executives, all divisions, within the company and all employees."

TQM is described as a collective, interlinked system of quality practices that is associated with
organizational performance and customer satisfaction [1-3].Total quality management (TQM) principles
and techniques are now a well-accepted part of almost every manager's “tool kit” [4]. According to Choi
and Eboch, TQM is a pathway to organizational performance and customer satisfaction. There are four
areas of management practices within the TQM system to assess: management of process quality,
human resources management, strategic quality planning, and information and analysis. An integrated
TQM can be viewed as a composite of the following seven constructs i.e. top management commitment;
quality measurement and benchmarking; process management; product design; employee training and
empowerment; supplier quality management and customer involvement and satisfaction. TQM is a
proven systematic approach to the improvements of the organization’s overall business process,
including quality of products and services [5]. The transformation to a TQM organization depends on the
extent to which firms successfully implement certain quality management practices. TQM practices
include top management support; customer relationship, supplier relationship, workforce management,
quality information, product/ service design, and process management
Evolution of quality in manufacturing

The following section briefly traces the Birth of Quality Management Principles in
manufacturing quality. This is illustrated in Fig-2

The roots of quality management go back to the guild system in medieval times, with master
craftsman status representing higher quality goods and services. Fast-forward to the industrial
revolution, where quality evolved to focus on factory inspections and removing defective
goods. During World War II Deming successfully applied Shewhart’s statistical quality control
methods to war manufacturing, where statistical process control helped the armed forces
speed up inspections without sacrificing safety. Post World War II Shewhart cycle of plan-do-
study-act was the basis for the modern plan-do-check-act cycle. In coming decades,
manufacturers continued to refine quality management methods, going beyond inspection to
focus on strategies that also incorporated processes and people. Throughout the 50s and 60s,
Japan’s quality focus allowed manufacturers to produce increasingly higher-quality goods at
lower prices. The Toyota Production System was developed during this period, focusing on
minimizing inventory and waste. This development represents one of the earliest modern forms
of a Quality Management System (QMS).

Over the time, post-war economic boom, companies actually had to shift the focus towards
customer satisfaction to make consumers happier and win their heart for business growth. By
the 1970s, Japan was outcompeting the U.S. in automobiles and electronics manufacturing. U.S.
Companies began losing market share, leading to cost-cutting and import restriction strategies.
Not surprisingly, these methods did nothing to improve the quality of goods. With the American
economy suffering from its inability to compete on quality, Total Quality Management was
born, setting the stage for a flourishing of quality and operational excellence strategies in the
U.S. In the 21st Century TQM was a major early force in quality management; it has largely
faded from view in recent decades in favor of newer approaches such as Six Sigma and lean
manufacturing. Where is quality headed from here? We’re seeing a few considerable shifts:
Integration: Technology now makes it possible for companies to break down barriers between
departments. As companies move in this direction, they’re also integrating the QMS with
processes like safety and sustainability, which are also tied to customer satisfaction.
Big Data: Today’s QMS captures more data than ever, allowing companies to leverage
sophisticated reporting and business intelligence tools to build a competitive advantage.
Risk Management: Companies are realizing that risk management and quality are inseparably
linked. Risk awareness is growing among quality managers, something reflected in the risk-
based approaches now being leveraged in recent iterations of ISO 9001.We’ve come a long way
in improving quality. Now the question is how to build on that success. No matter how a
company approaches it, it’s clear that data and statistical analysis will remain front and center.
 Integrated
design and

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Improvement in

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product quality

Improve Qu
Focus on profit Statist d Customer-
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and ical designs driven
production Statistic Process quality
Organizati thr
quotas al focus
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Figure-2

Quality management and quality engineering

Quality management and quality engineering are complementary to each other. Different levels
of the skills are required by the respective managers and engineers. Though some quality
engineering books also briefly address the quality management issues, a clear contrast is
extremely important between the two aspects of quality for further development and
understanding on issues affecting each aspect. Widely promoted quality management
philosophy is TQM. The roots of Total Quality Management (TQM) can be traced back to early
1920s and this concept was further developed in Japan in the 40s led by Americans.TQM is an
integrated management philosophy and set of practices that emphasizes, among other things,
continuous improvement, meeting customer’ requirements, reducing rework, long-range
thinking, increased employee involvement and teamwork, process redesign, competitive
benchmarking, team-based problem-solving, constant measurement of results, and closer
relation-ships with suppliers (Ross,1993). Committed leadership, Adoption and communication
of TQM, Closer customer relationships, Closer supplier relationships, Benchmarking, Increased
training, Open organization, Employee empowerment, Zero-defects mentality, Flexible
manufacturing, Process improvement, Measurement are some of the TQM factors. Different
studies still produced different sets of TQM factors, which may have arisen from the definitional
or methodological approaches taken by various researchers. TQM was deemed a failure when it
did not yield the expected results because of many reasons like lack of top management
commitment, ignoring customers etc. Broad areas of management support on the TQM
implementations are allocation of budget and resources, control through visibility, monitoring
progress, organizational change. TQM is now becoming recognized as a generic management
tool and The involvement of top management in quality issues should not overshadow the role
and contribution of engineering towards quality.
Training on the ISO 9000 quality management system and the management biased TQM alone
should not be regarded as sufficient. The engineering aspects of quality deserve more attention.
Our review shows quality engineering as being employed for reducing unit manufacturing cost
and cost incurred after sale. Taguchi techniques and statistical process control tools is an
interdisciplinary science involving engineering design, manufacturing operations and cost
incurred after sale to improve performance and reduce functional variations caused by
environmental conditions, deterioration and manufacturing imperfection. Quality engineering
is to produce products that are robust to all factors. Quality control activities consist of i) Off-
line quality control and ii) on-line quality control. Off-Line Methods explores techniques to
ensure design optimization at every stage whereas on-line Methods explore techniques to
ensure process control.

Top Quality Gurus Dr. Joseph M. Juran, Dr. W. Edwards Deming, Philip B. Crosby, Armand V.
Feigenbaum, Dr. Kaoru Ishikawa who have shaped quality as we know it today made significant
contributions on the management aspects of quality. Dr. Genichi Taguchi significantly
contributed on the engineering aspects of quality

Six Sigma is another effective tool of quality management. The methodologies and procedures
involved in both TQM and Six Sigma appear quite similar but a thin line of difference does exist
between them. Six-Sigma is a relatively newer concept than Total Quality Management but not
exactly its replacement. Six-Sigma focuses on improving quality by minimizing and eventually
eliminating defects from the system. Six Sigma, focuses on first identifying and eventually
removing various defects and obstacles which might come in the way of organization’s success.
Six-Sigma involves specially trained individuals whereas total quality management does not
require extensive training. The process of Six Sigma is based on customer feedbacks and is more
accurate and result oriented. Experts predict that six sigma will outshine total quality
management in due course of time. Understanding the process fluctuation, the elements
influencing it and reduction of process variation by using a set of statistical tools is the concept
of Six Sigma. Six Sigma includes five steps: Define Measure, Analyse, Improve, and Control.

Lean thinking is sometimes called lean manufacturing, the Toyota production system The Lean
concept originated from the Toyota production system to improve the efficiency and
effectiveness of process performance. Lean has been described variously as a philosophy, an
approach, a technique and a transformational management strategy to achieve improvement in
production processes. The Lean methodology aims to maximize value for customers while
minimizing waste. Waste, is defined as anything not necessary to produce the product or
service. Lean’s emphasis is on flow. The five essential steps in lean are a) Pinpoint value, b)
Pinpoint the value stream, c) Improve flow, d) Permit customer pull, e) Perfect the process.

Quality is the concern of everybody in organizations. Quality professionals in future should be

specialized in quality skills to provide quality information and manage the quality system. They
should have technical expertise on key quality technologies such as metrology, quality database
administration and quality tools like quality function deployment, statistical process control,
and design of experiments besides essential competencies: creative thinking and ability to
innovate in order to provide advice on quality techniques.(Plsek1998)
Issues in quality engineering

The Quality Engineering and management are very important in the development and delivery
phases. Out of all the development and delivery phases Testing is one of the phases that are
often cut out focusing on testing phase is essential. Underestimating testing phase is dangerous
as it may lead to serious consequences in the future. We are building the product so well that
we can test it in a short period of time should never be the phrase mentioned.

Some aspects of testing that are sometimes neglected are:

1. Little time allocated for testing.

Full scale testing, even it takes a longer time is important to locate errors, then correct the
errors, test again, pass all the tests and sign it off. Testing is not even something that you do
once and be done with it: it’s a cyclical effort until the tests pass. Testers should be available for
the whole time so that they can quickly respond when developments come back to be tested
again.
2. Scope of testing too narrow. Testing the end use is not enough. Expecting end users to
understand how the product works from the beginning is not right as they might be doing it
wrong because they don’t know any better. Different testing approaches should be tried and
encourage trying “creative” ways in order to realize whether your product is trouble-free.
Testing should cover all aspects and events, not just the expected ones.
3. Formal procedure not established. Complete adequate testing by each department or
organizational sector should be carried out to say that they are happy.
4. Inexperienced testers. Companies having a permanent testing unit to test all kinds of
developments and products are better. In absence of testing knowledge in house, companies
should hire qualified and trained testers with a particular background or skill – especially when
new systems are being implemented. Better results are obtained from testing if testers have
the knowledge they need to test and feel supported.
5. Lousy documentation. The testing cannot be serious unless there is something in writing that
tells what is done and what the outcome was. As a minimum, following should be recorded:
a) Who performed the test;
b) Date of tests;
c) Environment testing carried out. (Development, Quality assurance, etc.)
d) Main data points used in the testing;
e) Test result.
f) If a test has failed, record reasons for its failure.
This is the type of data that the developers will need in order to make the appropriate changes
and solve the problem.
Quality management issues facing the manufacturing industry

Most companies today have an inherent understanding of how quality impacts different areas
of business. However, there seems to be difficulty in gauging how quality management plays a
role outside of traditional quality functions, such as audit management, inspections, and
compliance. Quality management issues facing the manufacturing industry are

 How has your organization nurtured a culture of quality over the last year?
 Have you made gains in assessing metrics and key performance indicators?
 Do you still have disparate QMS solutions in place?
 Is your technology architecture ready to handle exponential data growth?
 Is your organization poised to close the loop on quality management?
 How best to identify where quality is impacting the value chain
 How to architect business processes that promote communication and collaboration
across these touch points
 How to best deploy a technology strategy that supports these business processes.

HOW HAS YOUR ORGANIZATION NURTURED A CULTURE OF QUALITY OVER THE LAST YEAR?

Whether you call it top-level support or executive buy-in, leadership is absolutely critical to
nurturing a successful culture of quality. The LNS Research 2012-2013 Quality Management
Survey reiterates the familiar theme of a lack of employees taking ownership of quality issues.
Of all of the top five quality management issues facing the manufacturing industry, this issue
remains a primary concern. Over 50% of executives surveyed by LNS Research reported that
their organization views quality as a department, not a responsibility throughout the enterprise.
Personnel working outside of quality management depend upon executive leadership to foster
a complete, holistic culture of quality. Without such support, quality initiatives will likely
produce minimal gains. 

QUALITY TO ALL DEPARTMENTS

Successful quality management does not occur in a vacuum; all departments have a stake in
continually improving quality management systems. Today’s global manufacturing industry
demands that companies redefine the role that quality departments take within the corporate
chain of command. Buy-in from employees on the shop floor is as critical as buy-in from senior
management. Quality management initiatives can influence internal business processes greatly,
so companies should foster a culture of quality awareness that extends to every quality-related
department.

ENTERPRISE QUALITY MANAGEMENT

Does compliance seem like a never-ending race through a rapidly changing maze? Does
successful risk mitigation seem like a pipe dream? To reduce the amount of effort and
resources needed to meet regulatory compliance Quality Management Software helps to win
the compliance race and realize lower risk. Enterprise’s business should be ready to be
transformed by a QMS software that provides best-in-class data visibility with open integration
capabilities? Quality team should have a deep knowledge of quality issues and QMS software
utilization, so that they can provide timely deployments and understanding, educate customer
support.

Are you ready to free yourself from the maze and enjoy the peace of mind that comes from
implementing an effective, time-tested quality risk mitigation solution?

For transforming the company’s quality management processes implementing a proven

powerful and robust enterprise quality management and compliance platform is essential. Such
QMS software’s puts a map to quality success by addressing quality challenges. The platform
should: a) Manage the cost of quality and identify areas of potential growth, b) Aggregate tools
and data for quality processes, c) Close the loop across the value chain, d) Boost compliance for
ISO 9001, IATF 16949, ISO 13485, ISO 13485, AS9100 and more.
In addition, free digital library of resources be hosted that provide insights into quality
management issues, including research, white papers, webinars and much more. These
resources should be designed to help businesses to better address quality compliance
challenges, risk, data visibility and other aspects of quality control, latest quality issues and how
businesses are addressing the trends that are revolutionizing industries.

Quality and Compliance: Organizations should cultivate an enterprise-wide quality and

compliance hub, allowing to proactively managing quality and compliance issues rather than
merely reacting to them.
Quality Management for Manufacturing
Quality management is integral to every part of the manufacturing process, from conception to
the delivery of the final product. Quality management for manufacturing can seem like a
daunting task alongside the challenge of balancing manufacturing processes that demand
exacting precision with managing coordination between engineering and operations,
maximizing global supply networks and carrying out efficient administrative processes.

Effectively managing quality and compliance in manufacturing means making it part of the
process toward operational excellence. Manufacturers often find this difficult, however,
because their quality management tools based on homegrown or legacy systems are not up to
the challenge and compel them to take a reactive approach – treating quality and compliance
like mere items on their list of priorities. Not only is this outdated approach a hindrance to long-
term growth goals, but it can also be costly and dangerous.

Software that provides solutions to quality management for manufacturing of all types
regardless of the complexities of manufacturing operations and unique compliance challenges
is essential. It should raise the bar for quality management systems. Quality management
software should optimize the connections between people, processes and technology, both
inside your own operation and in relation to your upstream and downstream partners whether
you are in general manufacturing or a specialized industry such as aerospace and defense,
automotive, medical devices or food and beverage. With one integrated software solution, it
should enhance quality management for manufacturing, including ISO 9001, ISO 14000,
AS9100, IATF 16949, ISO 13485, FDA GxP, FDA 21 CFR Part 11 and HACCP/ISO 22000.
By utilizing the best-in-class quality management software, businesses can enable an
environment of continuous improvement, moving from running around a maze of quality and
compliance issues to leading the way out. Quality management software’s ability should not
only streamline, harmonize and centralize quality and compliance data but also result in faster,
improved processes and workflows in the fast-paced global economy.

Transforming ISO 9001:2015 Compliance: ISO 9001 is the backbone of quality management for
manufacturing today, and meeting the ISO 9000 family of standards is considered a
fundamental requirement in most manufacturing settings.

IQS transforms ISO 9001:2015 compliance by taking an enterprise approach,

turning your quality management system into a strategic tool for your business.
IQS solutions streamline processes and documentation control in quality
management for manufacturing, allowing you to analyze enterprise-wide quality
and compliance data in real time and keep pace with your global competition no
matter what your industry.

RISK MITIGATION
Doing business is risky, but not using technology to help address risk throughout your business
and supply chain is riskier. Thomson-Reuters found that increasing numbers of companies are
capitalizing on technology to reduce risk. Software can provide a powerful framework for best
practices. QMS software drives compliance with regulatory requirements and conformance to
quality standards, significantly reducing risk and improving processes. QMS software provides
unique, real-time insights into the business, allowing pinpointing potential risk, analyze its
impact on the firm and then develop strategies to eliminate or mitigate the risk.
DATA VISIBILITY
Data visibility is the heart of solid decision-making across any organization, but
the generation of massive data sets is worthless without a way to aggregate and
analyze those data. Make no mistake: data is the key differentiator for business,
especially when it comes to quality management issues. In Harvard Business
Review, authors Andrew McAfee and Erik Brynjolfsson showed that companies
that utilize their data to make decisions are 5 percent more productive and 6
percent more profitable than those that do not.

QMS software provides high visibility of every phase of the product lifecycle,
even providing insights into your supply chain.

Plagued by nonconformance challenges: 

Nonconformance is a fact of life, but the right technology to quickly identify the
cause and delineate an effective, realistic solution. Manufacturers have been
tracking and managing nonconformance procedures for decades. Doing so is not
only a requirement in many highly-regulated environments, it’s also a necessary
tool for reducing the cost of poor quality in process-heavy industries like
automotive, aerospace and defense, oil & gas, and medical device.

The traditional methods for managing nonconformances have lost their place in
manufacturing. Organizations competing at a global scale or in industries with
complex products cannot continue to do so with disconnected, manual
spreadsheet-based methods. These organizations need to take an automated,
centralized, and standardized approach.

Effective issue tracking is crucial to nonconformance management optimization.

Distributed organizations typically lack standardization in this area, and
consequently spend inordinate amounts of time overcoming redundancies and
inefficiencies. Issue tracking software solves this problem by streamlining
nonconformance procedures from an enterprise-wide perspective.

Issue tracking software eliminates the challenges of coordinating different

classes of disparate quality management data from around the organization. It
provides real-time data throughout the various stages of correcting
nonconformance’s, while enabling quality management teams to adapt workflows
to more rapidly solve nonconformance issues.

An integrated, real-time platform that consolidates the strengths of disparate

nonconformance and issue tracking software on one unified EQMS solution.

ISSUE TRACKING SOFTWARE

NONCONFORMANCE OPTIMIZATION
takes manual and paper-based nonconformance management methods out of
the picture. It empowers professionals from the shop floor to the executive suite
with the actionable information required to manage and prevent
nonconformances.

Rules can be set on the integrated platform, so quality management personnel

are given and assigned access to data at the appropriate stage of the
nonconformance process. IQS equips key personnel with the ability to conduct
root-cause analyses and then forward results to quality managers via a single
system. The holistic solution helps global companies benefit from local problem
solving and improvements.
From a management perspective, leadership at the plant level and higher can
view nonconformance data to identify trends in performance. This catalyzes
continuous improvement efforts across the entire organization.

IQS Nonconformance Software allows you to:

 Define and analyze each nonconformance and assign risk priority
numbers.
 Ensure disposition efforts are effective by assigning responsibility for
verification.
 Provide automatic look-up of information regarding nonconformance from
IQS Inspection & SPC Software allowing you to track the employee or
supplier who produced the nonconforming product.
 Integrate with email to provide serial and parallel workflow approval
routing.
 Tracking and stopping nonconformance used to be a time-consuming
procedure. Compliance management software helps you identify and
correct problems faster than ever.
 HOW COMPLIANCE MANAGEMENT
SOFTWARE PREVENTS NONCONFORMANCE
 Nonconformance has plagued manufacturing since the beginning, and
even today, as machinery becomes more precise, it still crops up as a
regular problem. The costs of nonconformance, from material disposal to
wasted manpower, increases costs and reduces a company’s profitability.
It could even affect consumer safety or brand reputation if nonconforming
parts and products are not identified before they reach consumers.
 In the past, manufacturers have relied on spreadsheets to track
nonconformance, resulting in information being soiled and unavailable
across the global enterprise. Today, savvy businesses make use
of compliance management software with nonconformance modules.
 TRACKING NONCONFORMANCE TO THE
SOURCE
 There can be a variety of causes of nonconformance. In the best case, it’s
an isolated incident caused by easily-corrected user error. But when it
turns out to be a more wide-spread issue, it’s important to have the tools to
track it to the source and inform any other factories or projects that could
be impacted.
 When a specific machine is the source of nonconformance, compliance
management software can show you where else within your organization
that equipment is in use, and the history of when those machines have
 been serviced, calibrated, and repaired. One error may help you uncover a
company-wide need for an equipment audit to prevent future problems.
 When a part or material from a supplier is to blame, you can log
the incident, see which other facilities receive supplies from that source,
and see whether any other complaints have surfaced. This can help you
identify patterns over time and end relationships with unreliable suppliers
who would damage your business.
 COMPLIANCE MANAGEMENT SOFTWARE
PLACES THE DATA INTO THE RIGHT HANDS
 With isolated incidents of nonconformance, it’s often easy to address on
the shop floor. Log the incident, make the necessary adjustments to
prevent a repeat, and move on with the work day. But in the case of
widespread issues, compliance management software helps make sure
that the data gets into the right hands so decisions can be made.
 Back in the day, if you suspected there was an issue with a supplier, you
had to call the other plants and ask around to see if anyone else had
received nonconforming parts. You might have to wait for paper reports to
be faxed or even emailed to you, collect them all and fax, mail, or hand-
deliver them to management.
 Now, with all reports stored in a central location, anyone with the right level
of access can see incident reports from all locations of a distributed
enterprise and collate a report on the nonconformance issue, whether it’s
happening at a local, national, or even global level. Because all incident
reports are being logged with the same software, consistent reporting and
formatting is ensured, making it quicker and easier to track patterns and
grasp the full scale of the issue.
 When it comes to nonconformance, time really is money. The longer it
takes to spot a problem, track it to its source, and take corrective actions,
the more resources are being wasted on producing flawed products.
Compliance management software helps you be quicker and more efficient
in getting your manufacturing back in true.

CLOSE THE LOOP

You want it right the first time – so do we.

Our quality management software has a foundation in closed-loop quality. We

understand that it is very important to get things right from the very beginning so
you can quickly leap forward to success. The goal of business system integration
is to connect the disparate sources of your business data to create a single,
comprehensive view of your organization’s quality throughout the lifecycle of your
products. These data collection and aggregation not only improve internal
processes and boost compliance but also serve to promote stronger partnerships
with trusted suppliers. With our supplier quality software, you can automate the
collection of data from your suppliers, create and maintain a digital traceability
record, identify and address risk and promote increased performance from your
upstream partners. 

You may not be able to function without your supplier network, but that doesn’t
mean you should give suppliers free rein. The cost of poor quality is so closely
related to supplier quality and compliance that manufacturers must give the
proper attention and resources to the optimization of their upstream partnerships.

In the past, it was acceptable to communicate and collaborate with suppliers

through traditional paper-based and unsecure electronic methods. With the utility
and accessibility of technology reaching new levels every year, that’s no longer
the case. Today’s companies need an integrated, real-time quality management
software solution to troubleshoot supplier performance issues thoroughly.

By streamlining communication among suppliers and manufacturing sites, IQS

Supplier Quality Software creates an enterprise-wide supplier management
solution to minimize supplier-related COPQ issues. The solution integrates with
the IQS Enterprise Quality Management Software platform, giving manufacturers
the upstream visibility and control they need.
ISSUE TRACKING: NONCONFORMANCES AND
CORRECTIVE ACTIONS
Delivered through a web-based portal on which suppliers share their data, IQS
Supplier Quality Software lets you track supplier nonconformances in real-time.
The solution helps establish consistent supplier performance procedures aimed
at identifying and analyzing nonconforming lots and supplier components well
before problems arise.
With IQS’s integrated system, manufacturers can extend to their suppliers tools
typically reserved for in-house use such as CAPA. It facilitates collaboration
among suppliers and manufacturing sites to perform root-cause analyses and
coordinate follow-up actions efficiently. This proactive approach to
nonconformance management has significant benefits to overall cost of quality.

SUPPLIER AUDITS AND SCORECARDS

IQS Supplier Performance Software takes the need for outdated supplier audit
methods out of the picture. It consolidates the processes of planning, scheduling,
and conducting audits. The information is on one single system accessible by
both you and your suppliers, enabling visibility and driving accountability into
upstream process and product quality.

The scorecard feature within IQS Supplier Quality Software is vital for
manufacturers managing multiple suppliers simultaneously. Whether you’re
working with dozens or thousands of partner companies, having the ability to
quantify their performance based on real-time metrics and track their
improvements over time is crucial for any proactive quality management strategy.

SUPPLIER PORTAL
One of the greatest bottlenecks to quality and compliance performance
improvements is being able to effectively communicate across the enterprise. In
a true end-to-end quality management environment, “the enterprise” includes
your upstream partners. IQS Supplier Portal Software facilitates communication
via a web-based quality management interface.

The portal is used by customers and employees who need access to certain data
and EQMS functionalities. It can bi-directionally and automatically dispense
quality performance information. By creating customized notifications,
manufacturers can tailor alerts to be non-visible, read-only, or editable. This
fosters improved supplier and customer communication and relationships from
an enterprise-wide perspective.

IQS Supplier Quality Software allows you to:

 Build scorecards to give quality departments a solution for real-time
metrics and track improvements over time.
 Categorize your suppliers with your own codes for supplier type, territory,
ratings and approval levels.
 Define fields and categorize communications to allow for sorting and
analysis.
 Communicate with suppliers and offer EQMS functionality via a web-based
portal.
 Analyze supplier satisfaction and supplier issues to improve business
planning activities.
 Record nonconformances and corrective actions with all necessary
traceability and collaboration.
KEY IQS SOFTWARE SYSTEM FUNCTIONS
 Plug and play, out-of-the-box functionality
 Easy to use and intuitive interface
 Easy configuration
 Intelligent visual form builder templates and pre-configured reporting
 Data visualization and analytics
 Real-time notifications/validation
 Cross browser compatible and mobile friendly
 Collaboration at the form/record level
 Comprehensive security and electronic signatures
MEETING NEW SUSTAINABILITY STANDARDS
EH&S/ISO 14000 compliance is a particular challenge for manufacturing as
different businesses are subject to different standards, which are constantly
evolving as our understanding of manufacturing’s impact on the environment
grows.
IQS software enhances quality management for manufacturing with industry-
specific, enterprise-wide solutions to meet EH&S/ISO 14000 requirements. The
time-consuming and costly processes of maintaining environmental compliance
are efficiently streamlined to track, report and assess environmental safety
parameters in one interface, making compliance management more efficient and
eliminating the risk of issues being overlooked.

COMPLIANCE MANAGEMENT FOR AEROSPACE

AND DEFENSE
The aerospace and defense industry must follow a unique and complex set of
compliance mandates, which are guided by the AS9100 compliance standards.
AS9100 incorporates the ISO 9000 family of standards but goes even further in
the areas of quality and safety. As such, AS9100 compliance has become a
requirement for nearly all aspects of the aerospace and defense industry. IQS
provides an integrated solution to the AS9100 framework, streamlining and
reducing the cost of compliance.
The IQS software solution automates and digitizes the processes of AS9100
compliance, such as audit management, CAPA and document management. By
improving efficiency and reducing the potential for redundancies or oversights,
IQS lets you focus on adding value for your downstream partners and end users.
Keeping pace with quality demands in automotive
The automotive industry is unique in that quality is measured by the end user’s
experience with the final product, even though there may be hundreds or
thousands of supplier relationships behind it. This poses tough quality
compliance standards on suppliers.
IATF 16949 certification has become a basic requirement for consideration as a
supplier, and managing IATF 16949 compliance has become almost impossible
without a robust software solution. IQS IATF 16949 software provides an
integrated solution to different quality management processes in different facets
of automotive manufacturing operations and streamlines the internal
audit process that is a critical part of IATF 16949 compliance.
Taking control of compliance in medical devices
There are few industries more subject to intense compliance standards in quality
management for manufacturing than medical device manufacturing. Innovation
and rapid time to market are critical to success in this competitive sector, but
managing quality and compliance can quickly bog down operations, particularly if
quality management relies on outmoded spreadsheet-based systems or stand-
alone programs.
IQS applies its enterprise-wide approach to provide integrated quality and
compliance management solutions for each of the critical frameworks medical
device manufacturers must manage: ISO 13485 compliance, document
control compliance under the FDA21 CFR Part 11 documentation requirements
and compliance with FDA GxP mandates.
Taking food safety to the next level
For food and beverage manufacturers, a product recall or other food safety-
related issue is a disastrous prospect. Compliance with HACCP/ISO 22000
standards ensures constant monitoring and identification of potential problems,
but it can be challenging to manage because of the differences between HACCP
and ISO 22000 and the need to effectively meet both sets of standards across
supply chains and multiple manufacturing locations.

IQS EQMS takes HACCP/ISO 22000 quality monitoring and management to the

next level. Applying industry experience and expertise, IQS integrates
management of both standards in a single interface, streamlining quality
management processes and reducing compliance costs. The solution can be
deployed across multiple sites as well, effectively bringing all HACCP/ISO 22000
monitoring and management to a single control point, thus ensuring consistent
performance on an enterprise-wide basis.