Advanced QMS For Dummies

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Advanced
QMS
ETQ Special Edition
by Stephanie Diamond
Morgan Palmer,
foreword by
Co-founder and Chief Technology Officer, ETQ
These materials are © 2022 John Wiley & Sons, Inc. Any dissemination, distribution, or unauthorized use is strictly prohibited.
Advanced QMS For Dummies®, ETQ Special Edition
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Foreword
A
s a quality management professional, you know all too well
that your world is in constant flux. With ever increasing
customer expectations, a highly dynamic regulatory envi-
ronment, and supply chains that are more disrupted than ever
before, quality is under pressure on all sides. At the same time, the
legal, financial, and brand reputation consequences for poor qual-
ity are greater than ever before — existential to an organization,
in some cases. Now, more than ever, quality matters in organiza-
tions of all sizes, around the world.
Despite these daunting challenges, a range of opportunities and

achievable goals are available right now to forward-thinking
organizations that understand that maximizing product and ser-
vice quality can be a strategic differentiator. Those quality leaders
are turning to Quality Management System (QMS) software to
achieve their goals. Not only can a world-class QMS help you meet
your regulatory and compliance obligations, but it will also save
your organization money in reduced scrap, rework, warranty, and
recall expenses. It will help build a strong two-way relationship
with suppliers, so you both can act in lock step to any market or
business changes you may encounter throughout the entire prod-
uct lifecycle. It will improve worker training, health and safety,
and will allow you to charge a premium for your products and
services based on the enhanced brand reputation that accrues to
genuinely high-quality products and services. And as your rep-
utation for high quality grows, it will improve your brand in the
market, drive revenue, and improve customer retention.
And all these things are achievable now, as this book will clearly
demonstrate. By leveraging modern QMS software today, you’ll
see immediate value in higher product and service quality while
building a foundation of quality data and advanced analytics that
will help power your company’s digital transformation efforts
into the future.
Foreword iii
It’s past time to move quality from a “scorekeeper” to a “goal
scorer” for your business. We’re confident that this book will pro-
vide a logical and effective game plan to do just that. In the mean-
time, we wish you all the best as you uncover the transformative
powers of advanced quality management.
Yours in quality,
Morgan A. Palmer
Co-founder and Chief Technology Officer, ETQ
iv Advanced QMS For Dummies, ETQ Special Edition
Introduction
T
he importance and potential of improved quality manage-
ment has come to the forefront for manufacturers and sup-
pliers of products and services. The value of a more robust
approach to quality management was magnified by the changes
required by the COVID-19 pandemic and other global issues. As
Morgan Palmer, ETQ CTO, said in the September 2021 issue of
Quality Magazine, “In the past year, the QMS took its place as one of
the essential workers during COVID-19.” You can’t overstate this.
In today’s market, customers are looking for a higher standard

of quality and value. They’re looking for a product that will last
longer, require less servicing, and be more durable. In addition,
they’re looking for a organization that will deliver on its promises
and does so consistently. Meanwhile, manufacturers are seeking
to deliver those higher quality goods and services more efficiently
and more profitably.
One problem is that many organizations don’t have sufficient

data or the processes in place to get insights on the products they
manufacture and make informed decisions. They’re delivering
what they think they should provide or what is required by law.
But they aren’t delivering on the promise of a higher quality stan-
dard based on a single source of truth.
About This Book

Welcome to Advanced QMS For Dummies, ETQ Special Edition.
This book articulates the importance of a more comprehensive
approach to quality management and helps you discover the steps
you need to take to choose a quality management system (QMS)
that will bring a quality culture to your organization and create
more satisfied customers.
We cover several topics, including the following:
»» How the quality team can be the agent of change and

business transformation and how a culture of continuous
improvement can help
Introduction 1
»» What an advanced quality management system (QMS) is and
what it encompasses
»» The four-step Quality Journey to maturity
»» Why removing silos and integrating all your company data is crucial
»» How to accelerate digital transformation
»» Why advanced analytics can make the difference between
big wins and troublesome audit findings or recalls
»» How to create your game plan for QMS
»» More than ten ways an advanced QMS can build and
transform your business
Icons Used in This Book

Throughout this book, different icons are used to highlight impor-
tant information. Here’s what they mean:
The Tip icon adds information that can make doing things faster
and easier.
The Remember icon points out things to remember when search-

ing your memory bank.
The Warning icon alerts you to things you should be aware of that
can be harmful to you or your company.
Sometimes we give you a few tidbits of research or facts beyond

the basics. So if you like to know the technical details, watch out
for this icon.
Beyond the Book

This book will help business leaders like you discover more about
why quality matters and what a quality management system (QMS)
can bring to your organization. If you want resources beyond what
this short book offers, visit www.etq.com to discover more.
2 Advanced QMS For Dummies, ETQ Special Edition
IN THIS CHAPTER
»» Understanding why quality matters
»» Facing quality challenges
»» Building a culture of quality for

continuous improvement
Chapter 1
Presenting Quality
Management
A
s a quality professional, you’re constantly being pressured
to cut costs, increase margins, respond to changing busi-
ness needs, and exceed expectations for the customer
experience. An investment in quality management could be the
answer to the question, “how do we do things faster, smarter, and
more easily?” Quality management is a necessity for every orga-
nization that wants to stay competitive in today’s marketplace. As
a result, leading organizations recognize quality management as
a strategic initiative and are increasing their investment.
A focus on quality helps organizations improve their processes

and products while also improving the overall customer experi-
ence. Deploying a quality management system unlocks oppor-
tunities for organizations to get a competitive edge and reduce
costs. This chapter looks at quality management systems and why
it’s critical for business success in today’s marketplace.
CHAPTER 1 Presenting Quality Management 3
Recognizing Why Quality Matters
Quality matters because it’s essential to your customers. They
decide if your quality meets their standards. They are the final
arbiters, and no amount of effort from you will convince them
otherwise if you haven’t delivered a quality product.
A study by FirstInsight.com bears this out. They found that 53%

of consumers rate quality as the most crucial factor in purchasing
decisions, not price (at 38%).
Reviewing the risks of not pursuing

advanced quality management
Advanced quality management powered by the right quality man-
agement system (QMS) links quality to strategic business objec-
tives. It’s built to ensure that complete, timely, and accurate
quality data is available to the decision-making team empowered
to address quality requirements and processes. As a result of the
QMS, customers are ultimately provided with superior quality,
service, and value. But a QMS is much more than quality manage-
ment, quality control, and quality assurance.
A QMS drives quality throughout the organization and inte-

grates the entire business by assuring quality in all stages of the
product lifecycle, including R&D, production, service, financial
reporting, information technology, and marketing.
A QMS helps the organization meet the demands of all stake-

holders and the needs of the customer. It helps limit a variety of
business risks across an organization. Poor quality can potentially
have a negative impact on all parts of your business. These risks
include:
»» Lost revenue due to product delays, scrap, rework, and

warranty claims and recalls
»» High costs associated with excess waste and scrap
»» Increased compliance costs
»» Failed, time-consuming audits
»» Wasted time spent on managing document revisions,
training employees, and worrying about corrective actions
»» Loss of visibility into supply chain quality
»» Customer dissatisfaction and a move to competitors
»» Tarnished brand reputation and a loss of business valuation
A product recall or FDA finding could set your organization back
to the point where it cannot recover. Proactively putting quality
plans and processes in place using QMS software to prevent qual-
ity issues and recover effectively is a wise investment.
Focusing on regulatory compliance

Can your QMS help with regulatory compliance? The answer is
yes. It can:
»» Identify, access, and evaluate laws and regulations

»» Maintain a central repository of laws, regulations, records,
and associated paperwork for your organization’s legal
obligations
»» Keep records of regulatory body inspections and
implementations
»» Easily stay up to date on changing regulations
Building a culture of quality for

continuous improvement
In recent years, quality has become the gold standard for B2B
buyers and online shoppers. Because their choices are limitless,
they can afford to scrutinize and compare products. Meanwhile,
companies can get stinging customer reviews and social media
pressure to get it right or risk damaging their reputation and trust
with their customers. Business has never before been able to hear
the voice of the customer so directly — and they get the message
Quality has never mattered more than it does today.
A vital first step in establishing a quality management program

is to create a culture of quality. A culture of quality is woven into
the fabric of an organization. It’s not created by regulation or the
supervision of someone else. Instead, it arises from the shared
commitment of everyone in the organization.
Employees’ skills and knowledge become even more critical
because a quality culture requires that every employee contributes
to maintaining quality and continuous improvement. Employees
need to take a proactive approach to continuous improvement.
They should move away from seeing the quality function as the
enforcer of quality and become an agent of change and business
transformation.
Consider some of the ways you can make quality part of the DNA
of your organization:
»» Start at the top; empower management to support and

encourage employees to pursue quality and take ownership
of problems
»» Train your employees in quality management processes
»» Invest in employees who are committed to quality and
understand how QMS data is key to making important
business decisions
»» Promote employee involvement in decisions about quality
»» Make quality metrics available for all stakeholders to see and
understand
»» Make an effort to communicate and educate employees
about why quality matters
»» Communicate your quality standards to your suppliers by
sharing your culture of quality goals and monitoring via
supplier ratings
Taking the Leap to Digital

Transformation
The pandemic accelerated the need for businesses to speed up
digital transformation plans. According to a 2020 McKinsey
Global Survey of executives, the pandemic “accelerated the digi-
tization of their customer and supply-chain interactions and of
their internal operations by three to four years. And the share of
digital or digitally-enabled products in their portfolios has accel-
erated by a shocking seven years.” As a result, the status quo is
being challenged in all parts of your business.
With employees working remotely and some business models
drastically altered, everyone must access, share, and process doc-
uments and workflows. Spreadsheets and paper-based systems
just won’t suffice.
Reviewing the cost of doing nothing

It’s unlikely that doing nothing is ever a sound business strategy.
Ignoring problems until they become insurmountable is a recipe
for disaster. In addition, your competitors are actively trying to
innovate and enhance the customer experience. It also means that
many trends and critical items will be missed and the resulting
negative effects and inevitable audits mean that the cost of doing
nothing will end up proving more costly than using a QMS.
Do you know the cost of poor quality? According to the Ameri-

can Society for Quality (www.asq.org), “poor quality in a thriv-
ing company will be about 10-15% of operations. Effective quality
improvement programs can reduce this substantially, thus making
a direct contribution to profits.” Discover how Kaiser Aluminum
drives a culture of quality by focusing on one key metric here. [link
TBD] https://blog.etq.com/culture-of-quality-webinar.
See the white paper “Why the Cost of Doing Nothing is a Quality
Concern” at https://blog.etq.com/cost-of-doing-nothing.
Leaving paper and SharePoint behind

Are you still relying on spreadsheets and manual processes to
manage quality in your organization? This continued paper chase
is ill-advised. With changes to every part of the business envi-
ronment, using old school procedures puts you in jeopardy and is
wildly inefficient and ineffective. As your business evolves, your
quality management needs to evolve — legacy systems are diffi-
cult to update. Such inefficiencies result in obsolete documents, a
lack of reporting ability, and limited traceability.
Are you considering moving from paper to SharePoint? That may

not be the best choice now or in the future. SharePoint may not
provide the flexibility you need. It’s a flat system that makes
it challenging to drill down to find files you need for an audit.
SharePoint lacks the workflow controls needed to ensure the
review, approval, and training expected of a world-class QMS. It’s
also difficult to get the real-time data you need to answer ques-
tions and make decisions. Most importantly, it’s very difficult to
rapidly adapt as your business changes.
While the old tools may be sufficient for basic compliance needs,
they’ll struggle to drive quality improvement and create the risk
that your quality outcomes will fall behind your competitors who
employ modern QMS software.
Another critically important issue is being able to prepare and

respond to ISO and FDA audits. Manual processes make these
preparations cumbersome and take much more time than they
need to. According to ETQ, those organizations who implement a
QMS say that it cuts their audit prep time in half and dramatically
simplifies the response to an audit. This is crucial when every
moment counts.
Find out more about the costs and risks of relying on manual
and spreadsheet-based processes at https://blog.etq.com/
leave-paper-behind, and compare SharePoint with a QMS at
https://blog.etq.com/qms-vs-sharepoint.
Looking at the promise of Smart

Manufacturing
Smart Manufacturing is part of Industry 4.0. It involves integrat-
ing the entire manufacturing ecosystem so that it can rapidly
respond to any need that arises and manage systems more accu-
rately and autonomously. It’s critical to have an advanced QMS as
a foundational technology in the Smart Factory environment and
in the digital thread to customer experience and services. Design-
ing the QMS system into these transformative platforms leads to
lower costs, increased productivity, and predictive data on quality
optimization. In Chapter 4, we look in more detail at Industry 4.0
and its impact on manufacturing.
Adhering to Quality Standards

Adherence to quality standards is a fact of life for manufacturers.
But if you do a really good job of it, you’re also setting your orga-
nization up to make continuous improvements. Then it becomes
a value driver for the organization.
Dealing with multiple standards
(increasing regulations)
When people think about quality management, they often think
about regulatory compliance. However, it’s not that simple. Qual-
ity standards and regulations pose a host of challenges for manu-
facturers. For example:
»» Most businesses don’t have the luxury of focusing on only

one regulation. They have to think about several, including
ISO 9001 and ISO 13485 and the different role each plays in
the organization. That means that a QMS must have the
ability to adapt and handle many standards.
»» Most businesses face a continuing increase in regulations
(perhaps leading to more standards), which isn’t abating
anytime soon. In fact, six new manufacturing regulations
have been added every month for the last thirty years! So, a
QMS has to be flexible enough to make changes quickly.
»» The continuous changes to standards increase the cost to
comply. Having a QMS that will streamline processes can
help bring down the cost.
The ISO 9001 standard and certification requires documented

quality processes that show an organization can satisfy its cus-
tomers, meet regulatory requirements, and achieve continuous
improvement.
Some common quality management standards include:
»» Industry: ISO 9001

»» Medical devices: ISO 13485, MDSAP, EU MDR, MedWatch/
eMDR
»» Life Sciences: 21 CFR Part 11 and Annex 11
»» Food safety: FSMA, HACCP
»» Several for automotive including IATF 16949 and AEC-Q100
Automating documentation
and audit preparedness
In order to put parameters around quality, several standards
and guidelines (including ISO, Six Sigma, and GMP) have been
put into place. Getting organized to meet industry standards can
create a challenge for your organization if you’re using manual
tactics. Your QMS should have all the tools and processes to make
your compliance easier and faster.
One thing to consider is the fact that there’s increased focus

on management accountability. Make sure your documentation
clearly defines roles and responsibilities.
Having a QMS offers many benefits when it comes to standards

and filing. An important one is audit preparedness. An advanced
QMS gives you:
»» Document control: You can centralize your documents and

ensure a smooth change process.
»» Employee training tracking tools: These tools allow you to
make sure all staff members have the necessary compe-
tence and awareness.
»» Audit management capabilities: These capabilities help
you verify that documented procedures are followed.
»» Reporting and analytics tools: These tools make sense of
all the data and provide a high-level picture of risk (also, you
can easily access data at an auditor’s request).
»» Corrective and preventive action (CAPA): This tracking
allows you to manage problems more efficiently and trigger
any necessary changes to documents, procedures, or quality
requirements.
Looking at Quality Management Systems

Let’s begin by defining a quality management system (QMS). The
American Society for Quality (ASQ) defines a QMS as a formal-
ized operating procedure that systematically documents critical
processes and workflows to help a company achieve its specific
goals and quality objectives to ensure customer satisfaction and
industry or regulatory compliance. QMS software offers a central-
ized means of managing and tracking your quality management
efforts.
QMS systems are based on the idea that any process can cause
defects in a product or service when handled by any business area.
Therefore, a QMS should integrate quality assurance processes
across the full ecosystem.
Selecting an advanced QMS

Today, massive changes to every part of the business environ-
ment have increased the need for an advanced QMS. When you’re
choosing QMS software, be advised that an advanced QMS has
seven criteria:
1. The system must be flexible: You need to be able to

optimize the process for operational excellence.
2. The system should be web-based to eliminate inefficien-
cies: Web-based software enables users to access all forms,
workflows, and applications (including administration)
through a web browser.
3. The look and feel must be configurable: To encourage use
of the system you must be able to configure your QMS to
support your organization’s needs today and in the future.
4. The reporting capabilities must be extensive: It’s critical
that you’re able to make sense of your data. Reporting
capabilities cannot be an afterthought.
5. Integration with other systems must be easy: It’s vital that
you can break down information silos and share data
company-wide.
6. The system must be able to scale: Taking quality
enterprise-wide requires that you can scale as you grow.
7. The end user experience must be flexible: Understanding
user needs means that the system can adapt to the way
you work.
Evaluating your QMS

As you go through the process of choosing a QMS, make sure
that it:
»» Is a highly flexible system that helps to develop a culture of
quality that sets your organization up for continuous
improvement.
»» Integrates with your other internal systems to remove silos
and utilize data from across the organization. (See Chapter 3
for more details.)
»» Effects a complete transition to a digital environment. (Check
out Chapter 4 for more information.)
»» Utilizes powerful analytics capabilities and provides data for
insights and essential business decisions. (See Chapter 5.)
»» Supports secure collaboration with external partners such as
suppliers to bring them fully into the quality management
process.
»» Provides the ability to manage multiple sites in a way that
provides global process harmonization.
»» Is based on a modern product architecture to take advan-
tage of the rapid pace of IT infrastructure evolution.
Throughout this book, we examine why pursuing advanced qual-

ity management should be at the heart of your business strategy
and how advanced QMS software can accelerate this process.
IN THIS CHAPTER
»» Looking at quality challenges
»» Understanding the four stages of the

quality journey
»» Benefiting from cloud-native software
Chapter 2
Addressing Challenges
with the Quality Journey
O
rganizations today face many serious challenges that
change how business is conducted. Businesses are being
buffeted from all sides by severe global issues such as
supply chain disruption and skilled labor shortages. Organizations
face health and safety challenges, risks brought on by climate
change, geopolitical upheaval, and sustainability problems.
Amidst these unprecedented factors is the fact that the quality

environment has its own challenges. They include the:
»» Burden of massive and growing regulations

»» Constant change and heavy business complexity
»» Patchwork collection of manual and aging quality systems
»» Unrelenting demand for higher quality at lower cost
»» Immediate and severe public consequences of poor quality
To meet these challenges, quality professionals are stepping up
to improve their quality management practices to ensure their
organization can thrive. A quality management system can be
a phased investment. In fact, many organizations begin with
standard process improvements to streamline document con-
trol, audits, and corrective action (CAPA). As these processes gain
CHAPTER 2 Addressing Challenges with the Quality Journey 13
acceptance, new capabilities and management controls can be
added to improve supplier quality, new product introduction, and
quality analytics. The next section reviews these steps.
Embarking on a Quality Journey

This section looks at the stages of maturity that an organization
passes through on its journey to exceeding customer expectations.
In working with hundreds of customers, ETQ has observed four

stages of maturity on the quality journey, as shown in Figure 2-1:
Ignite, Accelerate, Expand, and Transform. (The Transform stage
is the culmination of the other three.) It provides a valuable frame-
work for organizations to approach their quality challenges. We
review each stage with you so that you can evaluate where your
organization is at this time.
The Quality Journey
FIGURE 2-1: The four stages of the Quality Journey.
Stage 1: Ignite
This is where most companies start on the Quality Journey, as
they prepare to move away from paper- and spreadsheet-based
processes.
The goal of this stage is to build a strong quality foundation,

streamline key processes such as audits, corrective actions, docu-
ment management and a system to ensure all stakeholders are
trained. At this stage, the organization likely recognizes that
there’s an opportunity to reduce their quality costs while also
improving their ability to maintain compliance.
TACKLING SYSTEM
FRAGMENTATION
Personal care giant Kimberly-Clark replaced over 630 separate and
fragmented quality systems with one globally harmonized QMS from
ETQ and saw an 80% improvement in new product introduction cycle
time investment.
Now, their one quality management system integrates quality, sup-

plier quality, safety, and environmental workflows.
“By digitizing and standardizing our safety, environment, and qual-
ity processes,we have been able to boost employee productivity, prod-
uct quality, and customer satisfaction,” says Benjamin Bollenbacher,
Director, Supply Chain Digital Capabilities, Kimberly-Clark.
Most QMS implementations begin with improving document con-

trol processes, addressing audit management, putting in place
workflows for corrective action management and ensuring all key
stakeholders are trained.
Challenges that face organizations in the Ignite stage include:
»» Manual and disconnected processes

»» A lack of centralized systems
»» A lack of audit follow-up
»» Uncontrolled or inconsistent documentation
»» An absence of training for employees
»» A struggle to achieve regulatory compliance
Do you recognize your organization? Focusing on remediating
these problems will go a long way to promoting trust and main-
taining your brand reputation as you move into Stage 2.
Stage 2: Accelerate
As organizations move to the second stage of the Quality Journey,
they may still experience some of the same challenges as Stage
1. However, they’ve taken strong and positive steps to automate
their quality management systems and improve quality in the
organization. As their quality program matures, their goals will
evolve, and the demands may increase.
In the Accelerate phase, the goal is to enable process flows
between functions and systems, capture data at its source, lev-
erage that data everywhere, and produce actionable information.
Without the right quality management processes in place, trying
to meet these goals can be challenging.
Challenges that organizations face in the Accelerate stage include:
»» Manual data entry across many non-quality systems

»» User unfriendly data silos
»» A lack of standardized practices
»» A perceived lack of visibility
»» An inability to gather customer feedback
»» Inconsistent or time-consuming decision-making
One of the positive changes that results from progressing through
this stage is the ability to manage customer complaints. Customer
complaint management can’t operate in a vacuum. Complaints
aren’t isolated events; they occur due to failures at any number of
points across the business ecosystem. Therefore, customer com-
plaint management must be integrated into a larger QMS frame-
work that includes non-conformance reporting, corrective action
and supplier corrective action reporting, and risk management tools.
The key to progress in this stage is finding solutions that can

integrate with your existing systems and lay the groundwork for
stage 3, for example, customer relationship management (CRM)
and enterprise resource planning (ERP).
Do you think about monitoring customer complaints as a direct

way to lower costs and protect revenue? If not, try it! As part
of your ecosystem, tracking customer complaints is one of the
best ways to discover problems you’re not yet aware of. In fact,
research on ROI shows a 30% reduction in time spent managing
complaints when customer complaints management is integrated
into the larger QMS framework. So don’t overlook this when
you’re evaluating QMS software.
Stage 3: Expand
The goal in this stage is to integrate internal and external stake-
holders (especially organizations’ suppliers) into the quality pro-
cess, extend their quality program to encompass environmental,
health and safety (sometimes known as EHSQ convergence), and
provide value-added data analytics to all processes. At this phase
of the journey, you will map out solutions to more complex qual-
ity and compliance challenges.
Challenges that organizations face in the Expand stage include:
»» Lack of visibility into supplier quality performance

»» The rising costs of coordinating in-process changes with
internal stakeholders
»» Reporting systems that are manual and disconnected from
the quality process (for example, health and safety reporting)
At this stage, organizations can integrate the complete ecosystem

of stakeholders. They can use quality processes to mitigate risks
like supplier defects and recalls.
Organizations in this stage rely on the emerging technology

associated with Quality 4.0, such as machine learning and auto-
mated business optimization solutions. See Chapter 4 for more
information.
Stage 4: Transform
At this stage of the Quality Journey, organizations are looking to
unlock competitive advantages by becoming more proactive, mak-
ing quality a strategic initiative, and focusing on consistent global
harmonization of their integrated quality management system.
To achieve these higher quality goals, organizations will be forced
to leap some significant hurdles to operational excellence.
Challenges that still face organizations in the Transform stage

include:
»» A change in the regulatory environment may impede

products from reaching the market when planned.
»» New teams not participating. Your quality programs may be
experiencing quality-related challenges. The distribution,
services, and customer success teams should be brought
into a closed-loop process to prevent quality escapes and
ensure continuous improvement in new product
development.
Having progressed to the Transformation stage means that you
can meet the challenges your organization faces with the right
tools and insights from analytics gathered across the organization.
Ultimately, as you integrate your QMS with key manufacturing, test

and measurement, or customer relations management systems,
you’ll create a digital thread that connects the shop floor to the top
floor of your organization. By embedding quality assurance at every
stage of the product lifecycle, you can enable improved data-driven
decision making throughout the entire process and produce better,
more consistent products in less time and with less resources. Typical
processes that are automated in this stage include complaints man-
agement, non-conformances and new product introductions or NPI.
No matter where your organization is in the Quality Journey and

what pain points you’re currently experiencing, your goal should
be to find technology solutions that will scale as your quality
management processes mature. Measure where you are on your
quality journey with ETQ’s Quality Journey Assessment tool:
https://www.etq.com/grader/.
Addressing IT Struggles
To have a QMS that solves the needs of their organization, IT
departments have to ensure that a QMS provides:
»» Usability for productivity and speed: The QMS needs to

provide a productive user experience. Staff need to be able
to interact with different aspects of the system. It must be
intuitive across all functional areas. It should deliver fast,
consistent, actionable information that anticipates user
needs and adapts to the needs of each user’s unique
environment.
»» Flexibility to adapt to your business now and in the
future: The QMS should remove barriers that limit collabo-
ration and innovation and provide low or no-code tools to
modify current and create new business processes. It should
easily integrate with other business systems. (See Chapter 3
for more about data integration across the organization.)
Don’t forget that you need to choose a flexible QMS to adapt
easily as your business processes change. It must be easy to
configure layouts and workflows with no coding required. An
advanced QMS should allow you to perform two levels of
“coding.” One should allow business users to configure
specific applications or create new applications. There should
also be a low code scripting language that allows more
advanced administrators to meet specialized requirements.
»» Visibility to allow faster, better decisions that lower cost
and reduce risk: Visibility permits users to get the correct
information at the right time. It should provide secure data
with less administration and integrate quality data into
corporate business intelligence (BI) tools.
»» Scalability to enable an enterprise-wide quality journey:
Using cloud-native technologies, a QMS helps customers
grow by easily supporting more users, more applications,
and more storage.
Benefiting From a Cloud-Native QMS

The ability to use a cloud-native QMS is considered a game-
changer. It enables quality processes across the entire enterprise.
It uses a high-availability architecture, so it performs optimally
and avoids a single point of failure. To understand how it works,
consider the characteristics of a cloud-native application. It is:
»» Cloud-based: It runs in the cloud, so it’s flexible and

available anytime, anywhere
»» Designed with the user in mind: Easy to fit into different
workflows
»» Future-proof: As new services and capabilities become
available, you can easily take advantage of them
There are many benefits gained by using a cloud-native QMS. They

include:
»» Cost savings
»» Increased agility
»» Modernized integrations
»» Easy scalability for any number of users, any volume of data,
and any configuration
»» Advanced analytics capabilities
»» Capabilities to futureproof organizations’ IT infrastructures
RELIANCE NXG
An example of a cloud-native QMS is ETQ Reliance NXG. It is a multi-
tenant platform featuring a cloud-native architecture that uses a vari-
ety of Amazon Web Services’ (AWS) cloud services, and technologies
from cutting-edge providers such as Datadog and other cloud-based
data, security, and analytics platforms.
“Because Reliance is so flexible, so easy to implement, and so rapid,

we’re able to respond to things that happen out-of-the-blue. Reliance
was the unsung hero during COVID,” Cliff Davis, Quality Systems
Development Leader, Rheem.
Go to www.etq.com/etq-reliance-nxg-qms-software/.
A cloud-native QMS can bring organizations to a higher level of

quality. By providing a QMS that’s easy to use and delivers more
information to users, organizations can make better decisions
about quality. This significantly improves productivity and maxi-
mizes the role of quality as a competitive differentiator.
ESTABLISHING THE ROI OF QMS

Determining the ROI of digital initiatives is always hotly debated
among C-level executives. ETQ and research firm Hobson and
Company (www.hobsonco.com) conducted a customer study to
assess the ROI from QMS investments they made in ETQ
Reliance. Here are the top five benefits they found:
• Reduced time spent on document revisions, review, and approval

• Reduced scrap and rework costs with more efficient operations
• Reduced time spent on supporting external audits
• Increased revenue due to improved customer satisfaction, and
brand loyalty with higher quality products
• Time saved scheduling, planning, and reporting audits (as auditor)
Read the full report - Driving ROI: The Business Case for a Proven
Quality Management System (https://blog.etq.com/
driving-roi-business-case-for-qms)
IN THIS CHAPTER
»» Reaping the benefits of integrating your
systems
»» Solving problems across the enterprise
»» Improving productivity and efficiency

across the organization
Chapter 3
Establishing QMS
Enterprise Integrations
T
his chapter looks at the importance of integrating your QMS
with all your enterprise apps so information can flow freely
to create a closed-loop system of continuous improvement
to improve quality and accelerate your organization’s growth.
Building Quality Across the Organization

What does an integrated enterprise-wide QMS mean? You need
three criteria. The system needs to be able to:
»» Share and incorporate relevant data with enterprise-wide

systems
»» Solve quality problems and improve quality processes across
the full product lifecycle
»» Improve productivity and efficiency across the entire
organization
The QMS system needs to share information with all the other
systems in the enterprise. By doing so, it provides a single holistic
solution for all quality management processes.
CHAPTER 3 Establishing QMS Enterprise Integrations 21
In Figure 3-1, you see enterprise systems around a rim with QMS
as the hub. The hub provides a consolidated and standardized
approach for your continuous improvement tools.
FIGURE 3-1: Examples of other systems that need to integrate with a QMS.
The QMS doesn’t just collect and centralize the information; it

enhances it and transforms it into actionable intelligence. It pro-
vides the context that makes the information valuable.
As we refer to Figure 3-1, we see multiple apps that integrate with

a QMS.
Integrating the customer relationship
management (CRM) system
A CRM system is used to manage relationships with customers
by tracking and managing the information it has collected about
them, such as addresses and purchase history. Integration with
the CRM provides you with the capability to do such things as:
»» Close the loop on customer feedback and complaints

»» Alert staff to requests for new features or bring attention to
product defects
»» Synch updates with the CRM to communicate with the
customer
Sharing information with the enter-

prise resource planning (ERP) system
An ERP enables companies to integrate all their business pro-
cesses, such as supply chain, financial, and manufacturing. Inte-
grating the QMS with the ERP lets you do things like:
»» Align QMS data with ERP — the source of truth for data such
as suppliers, customers, and product/materials
»» Automatically update ERP when materials are put on hold or
are released
»» Enter data only once so QMS users don’t have to copy and
paste data or work from offline data sources (such as Excel
exports from ERP)
»» Allow QMS users to access up-to-date information without
needing direct access to the ERP
»» Handle return material authorization
»» Manage credits associated with returned materials
»» Track waste and scrap
»» React to non-conformances and automatically put products
on hold in the ERP
Integrating the manufacturing
execution system (MES)
An MES is used in manufacturing to monitor (in real-time) and
follow raw goods as they’re turned into final products. Sharing
the information between the QMS and the MES helps you to:
»» Minimize the number of production systems employees

need to interact with
»» Report production problems and speed the time to
resolution
»» Launch quality investigations
»» Create more efficient product design and manufacturing
lifecycles
»» Deliver quicker new product introductions
»» Execute better response to market changes
QUALITY CONTROL INTEGRATION

Hexagon, a global leader in sensor, software, and autonomous tech-
nologies has partnered with leading QMS provider ETQ to provide
transformational capabilities that will impact the factory floor. Their
partnership produces an advanced QMS product that will:
• Embed quality assurance at every stage of the product lifecycle to

enable agile product introduction
• Deliver the quality and efficiency of the complete manufacturing
lifecycle
• Deliver higher quality finished product
• Reduce scrap, rework, waste, and warranty costs
• Boost brand image, brand value, and customer loyalty
This integration will be transformative, as it empowers global manu-
facturing harmonization and delivers ubiquitous and democratized
data access.
Integrating product lifecycle manage-
ment software (PLM)
A PLM is a system used to track and design a product from begin-
ning to end. This includes design, production, and disposal. Shar-
ing information between the QMS and the PLM provides the
ability to:
»» Continuously refine products based on manufacturing and

customer feedback
»» Improve customer satisfaction and limit defects between
product versions
»» Optimize controls and improve communication and
collaboration between teams
»» Enable users to add data from the production part approval
process (PPAP) into the PLM workflow. This helps designers
understand whether their existing suppliers can handle the
new version of their product.
Benefiting from Integration with Other

Enterprise Systems
Many benefits accrue to an organization that breaks down its
silos to integrate its data from across the organization. Technical
advances in the ability to collect and analyze data have made an
enormous difference for organizations that want to deliver what
customers really want. Hear experts share examples: https://
blog.etq.com/qms-integration-webinar.
Advantages of integrated systems

These benefits include being able to:
»» Have a single source of truth for the entire organization

»» React to quality events in a timely fashion
»» Eliminate manual data collection and analysis processes,
thus reducing errors
»» Access quality data in real-time to make quick decisions
»» Have a 360-degree view of the entire organization
»» Produce more valuable metrics within a broader organiza-
tional context
Cross-functional benefits
Taking a broader view, the integration of data supports the entire
organization. Following are some specific examples of the ways
data can provide benefits across departments:
»» Marketing and sales: Marketing and sales can use the data
to spread the word about quality and customer success.
Detailing specific wins can bring added credibility to market-
ing collateral and help win sales.
»» Customer service: Customer service can have near
real-time access to quality data to connect support tickets
and provide the customer with detailed instructions for
resolving the issue, which is a competitive advantage.
»» Purchasing: Vendors can be reviewed more thoroughly and
defective inventory can be spotted. Production managers
can speed up inventory return, thereby saving money and
avoiding product delivery delays.
»» Finance: By improving the coordination of quality and
accounting, you can avoid getting billed for a flawed
shipment.
»» Corporate security: Cloud-based enterprise software
enhances security by ensuring that you can rely on the cloud
vendor to provide a layer of protection for your system.
»» Human resources: Safety and health management is a
crucial responsibility of the organization. Tracking employee
incidents can identify needed workplace changes.
Data integration enables you to analyze and identify job
hazards before they happen. You can also break a job down
into operational steps so that you can identify unsafe
practices and make preventive recommendations.
»» Supply chain management: Your communications with
your suppliers are improved by a QMS. For example, a
supplied part with a defect can automatically trigger an
action in the QMS to flag the issue and begin a supplier
corrective action process.
Integrating Your Supply Chain
There’s no question that supply chains continue to become more
complex. In today’s competitive environment, your supply chain
is likely to extend across continents and oceans, and your suppli-
ers will have suppliers of their own. This fact should cause you to
ask yourself how secure your supply chain is. As the saying goes,
you’re only as strong as your weakest link. A single defect can
bring your supply chain to a grinding halt and potentially dam-
age your reputation — or, in some cases, taint an entire industry.
The pandemic spectacularly highlighted the precariousness of

having a non-integrated supply chain. As a result, massive bot-
tlenecks interrupted supply chains around the world. In fact,
according to a 2020 IDG Research survey, 59% of IT decision-
makers surveyed say that they are accelerating their digital trans-
formation efforts.
You need an integrated QMS that provides supplier management

tools that allow you to benchmark performance and communicate
with your suppliers. These include adding data from the produc-
tion part approval process (PPAP), issue resolutions, and ratings.
Make sure your suppliers are part of your quality management

workflows at the appropriate level of security so you have a
greater chance of catching defects early and more quickly address
corrective actions.
Do you think that you’re seeing more recalls than ever before?
You’re right. A recent study by the Public Interest Research
Group (PIRG) showed that the ten most expensive food recalls
have occurred in the past decade. Therefore, you need to be more
focused on your supply chains than ever before.
Recognizing barriers to supply

chain quality
Consider the issues of supplier quality that constrain organiza-
tions today. How many do you recognize as problems you face?
They include:
»» Lack of visibility: Visibility is the cornerstone of supply chain

quality. You need to be sure that you can spot problems as
soon as possible.
»» Inaccurate view of costs: To get a full view of how
suppliers’ quality impacts your costs, you need to go beyond
material costs to include such things as inspection overhead
and other non-material factors. Every mistake increases unit
costs and reduces profitability.
»» Lack of communication: Poor communication creates blind
spots. You need to make sure you have an ongoing audit
process to ensure that agreements are being followed.
»» Outdated technology: Legacy systems that don’t seamlessly
integrate with your current systems put your company at
risk. All systems must work together to ensure that you can
spot problems as early as possible.
»» Security concerns: Integration with suppliers can leave you
and, by extension, your suppliers vulnerable. Using a QMS
helps to minimize the risk substantially. Connected supply
chains require trust and cooperation among partners to
maintain the integrity of the system. A solid QMS and
supplier training goes a long way to ensure that you
promote cybersecurity.
Benefiting from supply chain

integration
By integrating your supply chain with an advanced QMS, you
solve the problems listed above. In addition, it allows you to make
suppliers part of problem resolution. Learn How Wabtec Mas-
ters Supplier Quality to Reduce Cost at https://blog.etq.com/
ge-transportation-case-study.
It’s imperative that you have an ongoing line of communication

with your suppliers so that you aren’t creating a relationship from
scratch when there is a problem.
You accrue significant benefits from integrating your supply

chain with your advanced QMS. These include:
»» Control: Integrate receiving and inspection into internal

processes to catch problems early in the manufacturing
lifecycle
»» Collaboration: Suppliers understand the design specs and
every stakeholder works together to identify and solve
problems
»» Simplified benchmarking: Using updated supplier score-
cards in your advanced QMS allows for simplified
benchmarking
»» The early detection of problems: Evaluate components
and subsystems received from suppliers
»» A central system: Housing compliance certificates in a
central system makes them easy to find and review
»» Centralized supplier corrective action request (SCAR)
tracking: Faster resolution of problems is accomplished with
centralized SCAR tracking
More effective management and enforcement of supplier
quality agreements are possible when you have an inte-
grated supply chain.
FINDING AND FIXING SUPPLIER

PROBLEMS FASTER
Furniture manufacturer Herman Miller, Inc. (HMI) struggled with man-
ual supplier processes across multiple business units and locations.
Originally, its process was to type up a corrective action and mail or
fax this document to the supplier. Then the company would wait until
the supplier called or wrote back for clarification to work through the
problem.
Now an HMI quality team member can assign a corrective action

directly to a supplier and track resolution – all through the QMS.
HMI selected ETQ Reliance because the platform’s powerful flexibility

meant the customer could configure workflows to its specific require-
ments without expensive customization.
Results:
• Corrective action resolution time shortened from 30 days to

14 days
• Fewer defects, customer complaints and reshipments
• Increased customer satisfaction overall
IN THIS CHAPTER
»» Reviewing the meaning of Industry 4.0
»» Looking at how Quality 4.0 impacts your

business
»» Understanding how quality is moving

upstream
Chapter 4
Accelerating Digital
Transformation
M
anufacturing has been undergoing a massive digital
transformation. As a result, factories look very different
from those of the past. Technology has facilitated
efficiency in supply chain optimization, real-time feedback from
intelligent sensors, and analytics to give managers the informa-
tion they need to produce quality products at a lower cost. In
addition, the use of technology like artificial intelligence and
machine learning enables organizations to spot trends and detect
patterns to better understand their production processes.
This chapter looks at the impact of digital transformation and

how it improves the quality of your products and creates customer
loyalty.
Presenting Industry 4.0

You’re probably familiar with the term “Industry 4.0.” It refers
to what is considered the fourth industrial revolution. It’s also
referred to as the “Smart Factory” or “Smart Manufacturing,”
CHAPTER 4 Making the Digital Transformation 31
and can be considered a subset of the broader Industry 4.0 vision.
Significant advances in technology have made it possible for a
business to take major leaps toward transforming itself into a
digital organization with tighter integration with customers and
suppliers.
The first industrial revolution was recognized for introducing

steam and water power; the second was noted for the rise of fac-
tory production lines. The third was recognized for the use of
computers and automation. The full potential of the third revo-
lution will be achieved by market leaders adopting Industry 4.0
today.
What does Industry 4.0 mean? PricewaterhouseCooper (www.pwc.

com/us/en/industries.html) defines it as “the end-to-end dig-
itization of all physical assets and integration into digital eco-
systems with value chain partners.” So, what are some of these
innovations that are transforming manufacturing?
One of the driving factors of digital transformation in this fourth

revolution is data and analytics. The ability to break down silos
and collect data from across the organization enables critical
insights and better decision making. In addition, people can more
easily spot trends and track quality improvements. This is facil-
itated by data analysis in real-time, alerting staff to emerging
problems.
Delving Into Quality 4.0

Quality 4.0 has emerged as a result of the sweeping changes
resulting from Industry 4.0. LNS Research (www.lnsresearch.
com) coined the concept of Quality 4.0 in 2016. The aim of Quality
4.0 is to take the best advances in technology and build on them to
help organizations become more customer-centric as they digi-
tally transform. Industry 4.0 includes:
»» Cloud computing
»» Big data analytics
»» Artificial intelligence and machine learning
»» Smart sensors
»» Automation
»» Mobile devices
»» Internet of things
Moving quality upstream

One of the critical developments of Quality 4.0 is that it helps
move quality upstream. What does that mean? Previously, quality
inspections and the problems they uncover were relegated to the
end of the manufacturing process when it was too late to make
changes without costly delays.
By integrating QMS software earlier into the new product devel-

opment process, your organization becomes proactive based on
manufacturing optimization, supplier quality, and customer feed-
back. Organizations can assess and monitor problems throughout
the manufacturing process, and therefore avoid potential delays
or, worse, a recall. Companies can establish metrics and bench-
marks to analyze product plans across the entire organization.
ADOPTING QUALITY 4.0

According to executives in a 2019 survey by Boston Consulting Group
(BCG) in partnership with ASQ and Deutsche Gesellschaft für Qualität
(DGQ), the adoption of Quality 4.0 should be done as quickly as possi-
ble. They state that “the findings point to the need for organizations to
accelerate their adoption of Quality 4.0. Success requires a multifac-
eted approach that addresses the full range of strategic, cultural, and
technological issues. Organizations that master the challenges will be
rewarded not only with lower defect and failure rates but also with
competitive advantage in the form of greater customer satisfaction
and improved operational efficiency.”
One of the things that the development of Quality 4.0 uncovered
was the lack of qualified talent to support Quality 4.0 efforts. This
is a challenge that organizations have yet to overcome. A solid
training component in an advanced QMS will help skill-up and
retain quality staff.
Working virtually
The issues associated with COVID-19 required manufacturers to
immediately focus on solutions that didn’t require employees to
gather on site. Also, paper-based processes weren’t efficient and
sometimes not possible; organizations had to turn to cloud-based
solutions to conduct business.
Using QMS software, activities like audits were done success-

fully remotely. Users were able to rely on risk management tools,
detailed prescriptive audit agendas, walk-throughs in the form
of detailed questions, and workflows that ensured proper review
cycles.
Focusing on Automation
Quality professionals are well aware of the value that automation
brings. The following sections look at some of the essential qual-
ity processes that must be included when automating your quality
systems and why.
Document control
Your QMS software needs to have document control to manage all
your documents in a centralized framework. Make sure your QMS
solution has:
»» Collaborative cloud-based document control

»» Documents in a single location that can be accessed
anytime, anywhere
»» Defined workflows of processes and procedures
»» The ability to integrate with other enterprise apps
STREAMLINING OPERATIONS TO
MEET QUALITY KPIs
POLARIS Laboratories is a leader in testing and analyzing oils, fuels,
coolants and water-based fluid for equipment reliability. They help
customers address tough fluid analysis challenges by interpreting test
results with the most accurate understanding of wear and perfor-
mance concerns of their equipment. POLARIS wanted to make quality
a company-wide initiative but their prior system prohibited accom-
plishing this. They watched important quality KPIs fall short.
By investing in a comprehensive QMS with ETQ they achieved:
• 50% reduction in corrective and preventive actions (CAPA) resolu-

tion time
• 40% reduction in document revision release time
J.D. Pickett, Manager of Quality and Operational Excellence, POLARIS
Laboratories, said that “The implementation of Reliance has allowed
us to integrate our safety and incident reporting into the same work-
flow as our QMS. This was an unexpected benefit.”
Training management
Training employees is a foundational element to establish and
maintain a culture of quality. Make sure your QMS solution:
»» Has a 360-degree view of employee training

»» Manages employee training requirements
»» Adapts to the unique training and certification needs of each
organization
Audit management
Audit Management is a crucial core application to provide control
over the entire auditing process. Make sure your QMS solution has:
»» All components of the audit management system in a single

location
»» Streamlined phases for audit scheduling, assigning, execut-
ing, and reporting
REDUCING AUDIT MANAGEMENT

COSTS
Avanos is a medical device company focused on delivering clinically
superior breakthrough solutions in the area of chronic and acute pain
and digestive and respiratory care.
In 2016, they adopted the Medical Device Single Audit Program

(MDSAP). This program allows medical device manufacturers, like
Avanos, to conduct a single regulatory audit of their quality manage-
ment systems in order to satisfy the requirements of multiple regula-
tory jurisdictions for countries including Australia, Brazil, Canada,
Japan, and the United States. To ensure compliance they invested in
ETQ Reliance for a unique audit management model that was specific
to MDSAP. As a result of their investment, they realized:
• 315% return on investment

• $253,000 average cost savings per year
According to Alex Rodriguez, Senior Manager, Global Quality
Capabilities, Avanos, “[Our implementation is] a great example of the
flexibility that the ETQ platform offers, and how a previously manual/
paper process can be fully automated and successfully integrated.”
Suppliers, materials, and
chemicals management
You need to have an information repository about your suppliers,
chemicals, and materials to help minimize risks when deliver-
ables don’t meet standards. Make sure your QMS solution can:
»» Track supplier goods in real-time

»» Manage nonconformances and delayed deliveries
»» Collect supplier rating information
Corrective and preventive

action (CAPA)
You need to execute corrective actions automatically. Make sure
your QMS software solution will:
»» Prioritize, filter, track, and execute both internal corrective

actions and external suppliers (SCAR)
»» Improve accountability and visibility
»» Quickly and automatically address adverse events
Avoiding nonconformance
ISO 9001 defines nonconformance as the inability to meet one or
more of the defined standards. To avoid nonconformance, make
sure your QMS software solution can:
»» Manage and track all nonconformities

»» Keep track of deviations throughout the process
»» Integrate customer feedback into the nonconformance
handling processes
FUTURE-PROOFING QUALITY
The unexpected nature of the COVID-19 pandemic and its over-
whelming impact brings into focus the wisdom of future-proofing for
quality. Although many companies consider themselves ready for the
future, that’s not always the case. As a result, things like quality man-
agement can sometimes be put on a back-burner. However, those
businesses that kept quality management in the forefront could avoid
closing plants and laying off workers during a disruptive time such as
the pandemic.
Here are some lessons manufacturers learned about quality and digi-
tal transformation from the pandemic:
• Automation is key to transforming physical tasks. Manufacturers

can reduce the number of people needed for physical tasks (like
inspections) by automating manual processes during a crisis. In
addition, automated data processes ensure that no valuable data
is lost.
• The cloud is essential. The cloud knocks down physical barriers,
thus making physical limitations almost irrelevant. A view into a
supplier’s inventory is possible regardless of location. Employees
can be based anywhere, so talent is easier to find.
A focus on digital transformation and the need for QMS software is

now squarely in focus.
IN THIS CHAPTER
»» Benefiting from advanced analytics
»» Facing challenges of big data
»» Looking at the value of AI and machine

learning
Chapter 5
Focusing on
Measurement and
Analytics
T
he key to understanding the impact of big data is to realize
that it is only as valuable as the decisions made using it.
Therefore, by monitoring data and understanding its pat-
terns and trends, you can turn data into information and infor-
mation into intelligence. It becomes the secret sauce that
organizations use to outperform the competition and satisfy their
customers.
The goal of advanced analytics collected from a QMS is to give

decision-makers the information they need to make the timely
decisions crucial to the performance of their business. You need to
leverage quality data to identify trends, predict future outcomes,
and realize continuous improvement.
This chapter looks at how advanced analytics can provide your

organization with robust data to give you a 360-degree view of
the business and a single source of truth.
CHAPTER 5 Focusing on Measurement and Analytics 39
Examining Analytics for QMS
The ability to use advanced analytics has made a significant
impact on businesses. Consider the problems that manufacturers
face without a good analytics solution:
»» Siloed data with no clear indication of what’s important

»» Higher costs and delayed revenue from being slow to market
»» Inability to discover trends and insights needed for
decision-making
»» Issues are slow to be identified
»» Inability to make data-driven decisions and take action
»» Root causes are hard to determine, and issues can reoccur
»» Knowledge about best practices is lacking
How many of these do you recognize? Solving these problems is
crucial to have the information you need to satisfy your customers
and run a cost-effective business.
Reviewing data challenges for

manufacturers
Advanced data analytics can sometimes make the difference
between a satisfied customer or a product recall. To determine if
you’re confident that you’re making the best use of your data, ask
yourself the following:
»» Are you still relying on the manual collection of data?

The volume of data now available to manufacturers makes it
virtually impossible to manage and analyze it manually.
Without some formal data collection automation tool like a
QMS, essential insights can be lost, and you cede the edge to
your competitors.
»» Are you concerned about whether you can rely on the
accuracy of your data? Unless you have a trusted auto-
mated solution to manage data, you could be using inade-
quate or inaccurate data that could skew your findings.
»» Does an internal stakeholder have ownership of the
data collection process? Ensure that you have a specific
department or project manager overseeing analytics
collection to intervene if standards aren’t met.
Benefits of advanced analytics

Advanced analytics provide the opportunity for you to take a pro-
active approach to quality. This ensures you can identify quality
issues before the product goes through the production process.
Quality is transformed with an analytics solution.
With a quality analytics solution in place, you get:
»» Quality integrated with your business intelligence strategy

»» Better cross-department communication about quality
»» Data-driven analysis for decision-making
»» Faster resolution, leading to reduced incidents
»» Support for continuous updates and improvements
The value of advanced analytics stems from the fact that the data
from various sources can be displayed in optimized dashboards
based on the user’s needs. In addition, it’s stored in the cloud so
that everyone can access it as needed from anywhere, provided
they’re granted access. You can then set your sights on preventa-
tive measures instead of manually wading through data to find
something useful.
Tackling Data Volume for Quality

Management
To tackle the large volume of data you collect every day, you need
a QMS analytics solution that provides a comprehensive view of
the data and how you can use it to create actionable insights. To
accomplish this goal, you need four foundational QMS elements
that are covered in the following sections.
Viewing a quality operational
dashboard
With all the volume of data it collects, your QMS must provide
software tools to visualize and organize the data to be beneficial
to everyone. You need analytics dashboards that are built on qual-
ity management industry best practices. For this reason, look for
a QMS that provides dashboards that are:
»» Pre-built: You want to have several pre-configured dash-

boards that let you get started right out of the gate
»» Quality-focused: You want to make sure you have dash-
boards that are explicitly focused on quality throughout the
organization
»» Easily configurable: You want dashboards that can be
configured to meet the business requirements of your
specific quality operation
Utilizing a quality data lake

You may need a dedicated data lake in which quality data — both
structured and unstructured — resides. This pool of information
draws from a range of sources, including standard and configured
fields and data from other enterprise systems. This pool is the
source from which the data lake draws data for analysis.
Leveraging an insights engine

An advanced QMS should offer an “insights engine” constructed
to leverage leading analytics technologies to optimize perfor-
mance while providing best-in-class data analysis, data visual-
izations, and dashboards.
Deploying a synchronization data layer

A synchronization data layer (SDL) can pull information from
the QMS, transform it into workable data, and deposit it into the
quality data lake for analysis with no performance degradation to
the QMS. This data layer should automatically stay updated with
QMS data even as workflows and processes are updated.
DATA DEMOCRATIZATION
Joel O’Connor, Product Line Owner, IT Director, Johnson & Johnson has
noted the value of ETQ’s Insights function. He said, “ETQ Insights gets
us really excited because it allows us to pull data directly from ETQ
without having to do any data-transformation on it. Now with Insights
a business user can quickly extract data and start working with it. This
is the basis of the next revolution — data democratization; giving
access to our end users and letting them define what they need.”
As you can see, these are complex foundational elements that

must be present in your QMS to ensure that you have the best
solution for your business.
Looking at the Value of AI

and ML in Quality
The advent of artificial intelligence (AI) and machine learning
(ML) has given businesses the ability to analyze the vast amount
of data in ways that manual intervention never could. For exam-
ple, a simple customer survey can yield some information, but
an analysis of social media data that’s constantly updated paired
with internal customer information (CRM) and business intelli-
gence can reveal patterns and trends not detectable manually. The
difference in the value of this data is enormous.
How does AI and its subset ML change the game for manufactur-
ers? These apps take the mountain of data that the QMS extracts
from every part of the system and analyzes it for insights, trends,
and so on. As it does so, it “learns” about the data, which means
that no pre-programming is required. For example, humans
could never write programs to analyze the data by predicting what
would be found ahead of time. Furthermore, because the data is
continually updated, the model is constantly being refined.
Concerning quality, ML and AI play an ever-increasing role in
areas including:
»» Quality control: Equipment can be trained to spot defects

and trace them back to their origin.
»» Supply chain integration: Integrating the supply chain is a
significant development for manufacturers. It allows for the
integration of planning and the ability to spot shortages and
defects before they become a major problem. (For more
about supplier quality, see Chapter 2.)
»» Predictive maintenance: The use of sensors helps manu-
facturers spot equipment problems before they break down,
avoiding costly delays. (Check out Chapter 4 for more about
sensors and Industry 4.0.)
Reducing costs is always crucial to manufacturing. Forbes

reported in 2016 that ML was helping companies increase pro-
duction capacity by up to 20%. In the years since then, the per-
centage has continued to rise.
WHAT’S THE STRUCTURE?

Key to understanding the importance of analytics, let’s briefly look
back at how the use of data evolved. Before social media and the
explosion of data, companies had a few ways to understand their cus-
tomers. They could infer some things based on purchase history, loca-
tion, and demographics. With the development of the web came a
profusion of all kinds of valuable data. However, the data didn’t arrive
in neat little rows. Companies needed to be able to monitor and use
this data in near-real-time. The data came in two broad forms:
• Structured data: Data that came in a standardized format. Think

about data you find in purchase orders, warranty forms, and
usage logs, such as names and addresses.
• Unstructured data: This data showed up in the form of com-
ments on social media platforms, customer reviews, and a host of
data that had never been seen before.
As organizations find ways to leverage both forms of data, we see the

development of significant new applications for advanced analytics to
gain insight into trends. (See Chapter 4 for more information.)
IN THIS CHAPTER
»» Understanding the current state of your
organization
»» Assessing your organization’s needs
»» Finalizing your investment
Chapter 6
Getting Started with
Advanced Quality
Management
Y
our organization is ready for a QMS. Perhaps your data is
siloed, and you’re stuck using paper-based systems and
manual processes. As business processes continue to grow
more complex and regulations increase, you want to take action.
But how to proceed?
A step-wise process helps you ensure that you do your due dili-
gence and execute effectively. This chapter looks at four steps that
you can follow to find the right QMS software for your company.
The four steps are as follows:
Step 1. Evaluating the current situation

Step 2. Determining the needs and assessing implemen-
tation plans
Step 3. Evaluating the options and preparing for post-
implementation success
Step 4. Completing the investment
We look at each in turn.
CHAPTER 6 Getting Started with Advanced Quality Management 45
Step 1. Evaluating the Current Situation
To begin your QMS plan, you need to make an honest evaluation
of your organization’s strengths and weaknesses. This will be a
company-wide initiative, so be prepared to engage all relevant
stakeholders to build consensus.
Make sure you choose your quality management team from across
the business and engage them from the beginning. This way, you
can capitalize on their expertise and relationships across the
company. Also, include them in vendor calls from the beginning,
so that all the essential issues and concerns are surfaced upfront.
Conveying the right message

As you begin to solidify your team, you want to ensure that every
member understands the game-changing benefits a QMS can
deliver. What are the most important messages? Consider the
following:
»» Quality matters: Your team needs to understand why

quality matters. They should be aware of all the benefits
digital transformation can bring so that they can convey to
everyone why they should want to graduate from paper and
manual processes or upgrade from a first generation QMS.
»» Quality is a strategic initiative: The team needs to
understand why quality is a strategic initiative that can
provide great value to your company as a whole.
»» QMS software makes everything easier: Your team needs
to convey to executives that a QMS system can make your
employees’ lives easier and provide a significant ROI. Make
sure you have the metrics to back it up. You’ll need those for
buy-in.
In Chapter 2, we presented the four maturity stages of the Quality

Journey. You may want to look back to that chapter to refresh your
understanding of where your company resides.
Asking the right questions

Does your organization promote a culture of quality? That’s going
to be vital to making continuous improvement. You need to be clear
about your objectives and business needs. Make sure that your list
of goals is tangible and that you know how you’ll measure them.
SPEAKING THE LANGUAGE OF
BUSINESS
One thing you want to consider as you begin this initiative is the ability
of your quality professionals to speak the language of business. What
does this mean? One measure of success when implementing a QMS
is the full approval of upper management. Unless the team can speak
to executives in the language of business — revenue, cost savings,
risk, and return on investment (ROI) — you may not get the buy-in
you want.
If you’re ready to evaluate your organization’s strengths and

weaknesses, you may want to check out the ETQ Quality Fitness
Grader at (https://www.etq.com/grader/) for a brief assess-
ment that can help you determine the state of your QMS founda-
tion and get the ball rolling.
Step 2. Determining Needs and Assessing

Implementation Plans
In this step, you begin to create the plan for change and investi-
gate your potential QMS partners. To assess your implementation
plans you want to begin by:
»» Defining your requirements and key performance indicators

(KPIs)
»» Starting with the basics: These are (1) Document Control, (2)
Training Audits, and (3) Corrective Actions. This helps you get
a good start on what’s important.
»» Considering how you’ll integrate with other business
systems, including suppliers
As you make your list of potential QMS software partners, make

sure to check out sites like G2 (g2.com) and Gartner’s Peer
Insights (www.gartner.com/reviews/home) for validation from
peers and experts.
CHAPTER 6 Getting Started with Advanced Quality Management 47
Step 3. Evaluating Options and Preparing
for Post-Implementation Success
You’ve made your assessments and know where your organiza-
tion ranks, and you’ve mapped out its unique goals. However, it’s
crucial that you understand where to apply your focus and attend
to the most immediate challenges.
You can’t do everything at once, so you need to be clear about

your priorities. The QMS software you choose must meet all your
criteria for performance, costs, and training. To prepare for post-
implementation success you need to:
»» Create your change management strategy

»» Identify your key priorities and be sure you can measure
them
»» Engage and motivate the full team
»» Reinforce your training plans
»» Don’t go it alone! Leverage the resources of your QMS
partners
Do you want a way to help determine the specific areas in which

you should invest? If so, check out the decision criteria checklist
at https://blog.etq.com/decision-criteria-checklist.
Step 4. Completing the Investment

Finally, you’re sure about what your organization needs and the
QMS partner to choose. Now, it’s time to decide to move ahead
with the backing of all your critical stakeholders.
Develop a work plan and build a schedule for onboarding and

training. Keep your ROI business case as the centerpiece of your
project so that executives can see progress toward company goals.
Chapter 7
(More than) Ten Ways
Advanced QMS Can Build
and Transform Your
Business
T
ransforming your business is a tall order. But if you add an
advanced QMS you’ll experience an enormous difference.
Here are (more than) ten benefits you’ll enjoy.
»» Continuous improvement across the product lifecycle

»» Adaptability to changing business conditions
»» Less risk of recall and unfavorable audit and regulatory
findings
»» Data-driven decision-making with integrated enterprise-wide
data and analytics
»» Future-proof software that reduces IT burden and improves
the pace of innovation
»» Quicker product launch cycles
CHAPTER 7 (More than) Ten Ways Advanced QMS Can Build and Transform Your Business 49
»» Lower cost of scrap and waste
»» Lower warranty costs
»» Improved profitability from lower costs and revenue growth
from improved products, stronger brand, faster time to
market, and increased customer loyalty
»» Streamlined compliance with increasing regulations
»» Simplified and reduced costs of audits
»» Reduced supply chain risk by monitoring suppliers more
effectively and speeding the onboarding of new suppliers
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Co-founder and Chief Technology Officer, ETQ

LIMIT OF LIABILITY/DISCLAIMER OF WARRANTY: WHILE THE PUBLISHER AND AUTHORS HAVE

Development Editor: Editorial Manager: Rev Mengle

Despite these daunting challenges, a range of opportunities and

Co-founder and Chief Technology Officer, ETQ

iv Advanced QMS For Dummies, ETQ Special Edition

In today’s market, customers are looking for a higher standard

One problem is that many organizations don’t have sufficient

About This Book

We cover several topics, including the following:

»» How the quality team can be the agent of change and

Icons Used in This Book

The Remember icon points out things to remember when search-

Sometimes we give you a few tidbits of research or facts beyond

Beyond the Book

2 Advanced QMS For Dummies, ETQ Special Edition

»» Facing quality challenges

»» Building a culture of quality for

A focus on quality helps organizations improve their processes

CHAPTER 1 Presenting Quality Management 3

A study by FirstInsight.com bears this out. They found that 53%

Reviewing the risks of not pursuing

A QMS drives quality throughout the organization and inte-

A QMS helps the organization meet the demands of all stake-

»» Lost revenue due to product delays, scrap, rework, and

4 Advanced QMS For Dummies, ETQ Special Edition

Focusing on regulatory compliance

»» Identify, access, and evaluate laws and regulations

Building a culture of quality for

A vital first step in establishing a quality management program

CHAPTER 1 Presenting Quality Management 5

»» Start at the top; empower management to support and

Taking the Leap to Digital

6 Advanced QMS For Dummies, ETQ Special Edition

Reviewing the cost of doing nothing

Do you know the cost of poor quality? According to the Ameri-

Leaving paper and SharePoint behind

Are you considering moving from paper to SharePoint? That may

CHAPTER 1 Presenting Quality Management 7

Another critically important issue is being able to prepare and

Looking at the promise of Smart

Adhering to Quality Standards

8 Advanced QMS For Dummies, ETQ Special Edition

»» Most businesses don’t have the luxury of focusing on only

The ISO 9001 standard and certification requires documented

Some common quality management standards include:

»» Industry: ISO 9001

CHAPTER 1 Presenting Quality Management 9

One thing to consider is the fact that there’s increased focus

Having a QMS offers many benefits when it comes to standards

»» Document control: You can centralize your documents and

Looking at Quality Management Systems

10 Advanced QMS For Dummies, ETQ Special Edition

Selecting an advanced QMS

1. The system must be flexible: You need to be able to

Evaluating your QMS

CHAPTER 1 Presenting Quality Management 11

Throughout this book, we examine why pursuing advanced qual-

12 Advanced QMS For Dummies, ETQ Special Edition

»» Understanding the four stages of the

»» Benefiting from cloud-native software