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Quality Management

& Change Management


Ensuring a Change for the Better
Quality Management and Change Management: Ensuring a Change for the Better

Executive Summary increases complexity, and the result is a process that may
Change, as the saying goes, is the only constant. This be ineffective if not properly managed at every necessary
also applies to changes to product or process. Regardless aspect. An organization cannot simply change the
of industrywhether automotive, medical, or food for blueprints and hope for the best. The Change Management
examplethere eventually comes a need for change. As process involves various levels of planning and sourcing,
different as these industries may be, a drive for continuous and collaborating with not only internal sources, but
improvement is the common denominator that initiates the external sources as well. The bottom line is, increasing
need for a change. Inevitably, an organization will need to speed and complexity within the change management
change a process or product at some point in its lifecycle in process demands more effective process management.
order to keep up with growing market demand and to keep
pace with the competition. Product Lifecycle Management (PLM) has always been
considered as the driver for change because it manages
While the reasons driving a need for change may vary product data and design processes. The PLM system
whether to offer the latest product upgrade or to correct contains design documentation and new product design,
a defectthe process leading up to change execution such as Advanced Product Quality Planning (APQP);
is often complicated and needs to be managed properly controls and manages changes to production, sources,
in order to result in an effective outcome. The process and product; and is capable of monitoring and tracking
of Change Management is often complexinvolving customer complaints. However, the change process
employees, equipment, various departments, suppliers, requires much more functionality. In what areas is PLM
and more. Add globalization to the equation, which lacking?

Market
Assessment
PLM Lacks:
Conceptual Flexibility
Design Collaboration
Layered Security model
Engineering
and Detailed Robust Compliance Platform
Design
Change
Management/
Release to
Manufacturing
Sourcing and
Suppler
Collaboration
Production
Process
Planning
Market
Rollout/
Launch
Aftermarket
Support and
Service
Product
Portfolio
Management

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Quality Management and Change Management: Ensuring a Change for the Better

Flexibility: To properly create a streamlined and Product Lifecycle: Quality is often checked at post-
efficient Change Management system, flexibility is production, however; it should be tracked at design,
needed to adapt to dynamic changes in products and production, suppliers or contract manufacturers, as
processes. well as post-production. It is imperative to a successful
product outcome that quality is incorporated into every
Collaboration: Having the ability to coordinate step of the product lifecycle, starting from the very
and collaborate across multiple areas and external early stages of product design. However, this is many
resources ensures a successful change because times not the case. Quality is too often an afterthought,
nothing is left out of the quality loop. taken into consideration with the end product. Quality
Management ensures that quality is at the forefront of
Layered Security Model: The Change Management
all change processes. This paper will describe how the
process is not confined to the organization, therefore
QMS proactively ensures that quality is incorporated
the ability to keep all data and intellectual property
into a change.
secure is critical.
Global Network: Globalization adds complexity to
Robust Compliance Management: The ability
the Change Management process. In a global market,
to enforce both internal and external regulatory
product lines are expanded and manufacturing facilities
requirements set forth, for example, by the Food
are located worldwide, leading to multiple product
and Drug Administration (FDA), the Environmental
lifecycles. This leads to a need for better Business
Protection Agency (EPA), as well as Governance, Risk
Process Management (BPM). Globalization leads to
Management, and Compliance (GRC) initiatives, is
faster product lifecycles because increased competition
necessary to promote uniform standards of operations.
shortens product lives, new technology increases
The primary reason for PLM is to control change. This product complexity, and more marketing data expands
makes Change Management a critical PLM function. In product selection. Quality must be linked to the global
todays ever evolving business environment, companies network, to ensure that it is not limited to just the site
without an effective Change Management process cannot level, but spans the enterprise to create a network of
sufficiently adapt to market trends, improve products or compliance. Quality Management ensures collaboration
processes, or remain competitive. Change Management between facilities and brings suppliers or contract
in itself is complex. It involves in-depth data analysis, manufacturers into the quality process.
which defines what will be changed, the parties involved,
Business Systems Integration: Enterprise systems
suppliers to use, materials to purchase, how to calibrate
handle data that is related to a specific operational
machinery, packaging, marketing, departmental approvals,
area, whether production with Manufacturing
along with other factors. And the list goes on.
Execution Systems (MES), inventory with Enterprise
Resource Planning (ERP), suppliers with Supply Chain
Before the Change Management process can begin, an
Management (SCM), or design with PLM. The QMS
organization needs a system with the proper functionality to
has the ability to integrate all of the data from each of
monitor it and track the process from design to production
these systems to allow these separate systems to talk
to postproduction. To be managed efficiently, Change
DEFINE toSOURCE
each other. This ultimately ensures
EXECUTE consistency and
VERIFY
Management needs theDESIGN APPROVE fallsPLAN
proper functionalityPLM
efficiency across the enterprise as nothing is left out of
short in this area. This is where the automated Quality
the quality loop.
Management System (QMS) comes in.
DEFINE DESIGN APPROVE SOURCE
PLAN Furthermore, in manyEXECUTE
cases there are VERIFY
processes that
Not only does the QMS have design management are not directly related to the change process, but are
capabilities, it also enhances other aspects that are nevertheless affected by its results. In this regard, the
involved in a change:
DEFINE DESIGN APPROVE PLANQMS hasSOURCE
the ability toEXECUTE
not only manageVERIFY
the core change

DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY

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Quality Management and Change Management: Ensuring a Change for the Better

process, but to also cross-reference any related quality, secure is critical, as the Change Management process
environmental or health and safety processes, and link is not isolated within a specific part of the organization
them to the core change. For example, incorporating it extends beyond a companys four walls. Quality
employee training, environmental aspects, and job safety Managements robust security model mitigates any risk
analyses are critical functions of the business that may be of external resources seeing information beyond what
affected by a change, but are not part of the core change is required. Additionally, the ability to enforce regulatory
process. By linking these peripheral processes from the requirements is a strong point of an automated QMS.
start, its possible to effectively address these issues during This compliance layer to regulatory standards promotes
the change, as opposed to afterwards or too late. a uniform standard of operations and provides a level of
compliance that is unmatched by any other system.
The QMS is able to incorporate quality into every step of
the Change Management process through integration with With these critical functions, the QMS is an ideal
other key modules along the way. This paper will offer a component of a PLM system and is best suited as the
birds-eye view into the Change Management process, agent of change in the enterprise. Change Management
showing the phases of Change Management from define involves many phases, all designed to follow the product
and design, to approve, plan and source, to change lifecycle and provide change at different functional levels
execution and verification. First, lets describe where that are involved with the product. Lets take a look at the
Quality Management and PLM meet. different phases of the Change Management process and
how quality fits in.
The Intersection between Quality
Management and PLM Quality Management as an Agent of
Quality is prevalent in all aspects of a business, from Change
processes to products. Therefore, the QMS is best suited Typical Change Management processes are broken out
for the Change Management process, as everything that into separate key pieces, each of which play their part
is managed in quality is managed in change. Quality in enhancing efficiency in the process and in essentially
Management is rooted in the automation of workflows, creating a road to quality.
enabling efficient processes, and managing complex
issues. This flexibility in managing complex processes While the QMS seamlessly guides an organization
makes it an ideal complement to many PLM functions. through the phases of a Change Management process,
it DEFINE
incorporates
DESIGNcritical QMS PLAN
APPROVE functions into every
SOURCE stepVERIFY
EXECUTE to
In the previous section, we discussed where PLM needs ensure the end result is of the highest possible quality.
more functionalityspecifically flexibility, collaboration, a DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY

layered security model, and compliance management. Now


DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
lets see where the QMS comes in.
DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
To create a streamlined and efficient change management Lay the FoundationDefine and Design: When
system, flexibility is needed to adapt to dynamic changes conducting a change, it is necessary to go back to the very
in products and markets. Quality management systems first step in the process and begin to lay the foundation
are far better suited for this purpose, with their flexible for quality. A change begins at the design stage with the
workflow and routing capabilities. Furthermore, the ability collection of information from post-market data, whether
to coordinate and collaborate across multiple areas and market research and development, customer complaints,
external resources is key to successful change. The QMS product nonconformance, or auditsthis data helps to
provides visibility into data from multiple sources through identify the need for change. To successfully manage
robust integration layers as well as using intelligent these phases, the QMS provides various key functions to
business rules to enable collaboration across all areas of enhance the process.
the enterprise.
QMS FunctionCorrective and Preventive Action
The QMS is also able to greatly enhance security (CAPA): The post-market data that is necessary to
processes. The ability to keep data and intellectual property determine feedback is retrieved through functions

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Quality Management and Change Management: Ensuring a Change for the Better

such as Complaint Tracking, Nonconforming Materials, in the process. This ability provides the organization
and Audits. It is then filtered through the QMS CAPA with quantifiable evidence that the new change will
system, which is the catalyst for change initiatives. This successfully change the product at the lowest risk level
determines the root cause and the necessary steps possible.
to correct adverse events. Ideally, changes are made
to the initial concept using the data from the CAPA QMS FunctionDesign Risk Management: If
system to recognize areas for improvement. Risk Assessment techniques are used in design, the
organization is more likely to identify risks at an early
QMS FunctionPlanned Deviations: Before a stage. This ability to identify potential failures, using
change is requested, it must be determined whether tools such as Failure Mode Effects Analysis (FMEA),
there is an acceptable deviation in place, and for early in the design process is a crucial aspect of Design
how longotherwise, the executed change may Risk Management. The earlier a potential failure is
cause unnecessary duplication of effort. The ability identified, the less it will cost the organization. Early
to integrate with the QMS to discover any planned discovery also leads to mitigation of in field failure, as
deviations is critical. Integration with the Change the potential failure will be spotted before it is released
Management module ensures that all deviations are in the marketthis reduces the chances of recall, as
defined and then removed once a long-term change is well as hazard to consumers.
DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
put in place.

QMS FunctionDocument Control: The ability to DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY

reference the critical documents that are involved in


DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
the change is another important step of the process.
Documentation such as design files, specifications, Collaborate
DEFINE DESIGN across the PLAN
APPROVE EnterpriseApprove,
SOURCE EXECUTE Plan,
VERIFY
work instruction, job descriptions, and procedures and Source: Once the post-market data has been
will need to be changed as the product or process collected and filtered through, the process can begin
is changed. The ability to link these documents to to move forward. Change Management involves many
the overall Change Management process, and issue departments, suppliers, and various levels of approval
multiple-document change requests is critical in and planning, making it extremely complex. It involves
monitoring and tracking all the information needed to executing change not only internally, but extending
design an effective change. to outside sources, such as suppliers. It also involves
the process of multiple approvals across operational
QMS FunctionProduct Data Management (PDM): areas and integration through various QMS functions.
A crucial element of managing the product lifecycle is To enhance this phase of the process, QMS functions
PDM. Much like Document Control, PDM serves as a effectively manage approvals, action plans, and
centralized repository for product data, and includes suppliers.
design specifications, materials used, operational
instructions, and product labeling and documentation.
PDM controls all changes to product data, which is QMS FunctionConfigurable Review and Approval
essential for effective Change Management. It helps to Workflow: An extremely robust and configurable
track and control all data related to the product through review and approval workflow is necessary in an
the use of an item form, which describes product type, effective Change Management process. The QMS
quantity, and unit cost. provides a centralized resource for managing and
executing change, and has the proven workflow
QMS FunctionRisk Assessment: Before an methodologies that provide a venue for managing
organization can continue forward in the process, change. At this phase, the appropriate people in each
they must determine whether the change thus far step of the process must approve the changethe
is effective. A crucial part of the Define and Design QMS ensures this is the case. Email alone is not
phases is to analyze the impact of the change up to this sufficient for collaboration of this level because in
point through the use of a Risk Assessment. A QMSs many cases there is a need for electronic signatures.
Risk Assessment module analyzes risk in order to Business rules must also be built directly into the
gauge the change effectiveness before moving forward workflow so that durations and due dates can be set for

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Quality Management and Change Management: Ensuring a Change for the Better

different stages of the workflow, which is important if a is sourced, maintained, and calibrated, the change
variety of people are being notified, and ensures work will not be effective. To mitigate this risk, the QMS
is kept on track. provides integration with Calibration and Maintenance
applications. This is beneficial to an organization
QMS FunctionAction Plans: Planning is a strong because it helps keep track of changes to equipment,
point of an effective Change Management process. maintenance records, as well as equipment status.
This process includes the generation of all action
items throughout the workflow. The ability to branch
DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
off parallel process that are linked to the main Change
Management process through action plans ensures
DEFINE DESIGN APPROVE PLAN SOURCE EXECUTE VERIFY
that the necessary work is kept on track and is
distributed throughout the organization instead of being Check your
DEFINE DESIGN WorkExecute
APPROVE PLAN and Verify:
SOURCE Once the
EXECUTE VERIFY

assigned to one person at one time. Action items that organization has all of the elements of the change
the QMS can create and assign in parallel include in place DESIGN
DEFINE up to this point, itPLAN
APPROVE is imperative
SOURCE toEXECUTE
ensure VERIFY
Feasibility Analyses, Training Events, Equipment that the right people are delivering on the change
Changeovers, and Work Orders. and are trained and knowledgeable prior to the
change becoming effective. Involved parties need to
QMS FunctionProject Control: Integration with the collaborate on the change in real time using electronic
QMS Project Control function allows an organization distribution of change notifications to enhance
to create, track and control projects by identifying the communication. Before final shipment or change
project stages, allocating tasks to individuals, and completion, all affected parties must be fully trained.
tracking the progress of each task. The QMS allows In a complex system, there are often many employees
integration with Project Control for proper management and many training materials. Ensuring timely
of the more complex changessuch as during the completion of training cannot be achieved without
process of new product design, APQP, or the business automated tools.
management strategy, Six Sigmaensuring that
quality is not lost in the process.
QMS FunctionEmployee Training: A product or
QMS FunctionSupplier Management: Many process change is only successful if employees are
organizations use a multitude of suppliers in the knowledgeable on executing that change. All involved
development of one product. Visibility into supplier employees must successfully complete training on
qualifications is critical in ensuring that the best changes to the product or process. Integrating Change
possible suppliers are being utilized. Integration with Management with Employee Training applications and
the Supplier Management function is a key component Document Control systems provides a seamless link in
of the QMS. This part of the process involves selecting transferring knowledge to those affected by the change.
the approved parts and suppliers by creating a list Documentation that was created or revised during
based on the overall supplier rating. The Supplier the change will be stored in an integrated Document
Rating list is determined through the use of the QMS Control system linked to an Employee Training
Supplier Rating and Inspection feature. This ability to system. These tools provide the capability to schedule,
rank supplier qualifications allows an organization to require, and track training, ensuring the change is
pick the highest rated supplier for a particular change implemented effectively and all affected employees
or product. Supplier Management integration provides are knowledgeable upon change completion and are
visibility of supplier data from internal systems, third trained on new procedures, work instructions, and
party systems, and equipment and Asset Management similar requirements.
Systems.
QMS FunctionComplaint Handling: Once a
QMS FunctionCalibration and Maintenance: change is complete, the next product lifecycle begins.
The Change Management process also affects an Organizations continually receive post-market feedback
organizations equipment, a main component of the in the form of inquiries, returns, or complaints. The
Source phase. A change in a product could result in a QMS traditionally collects this data through a Complaint
change in production and unless the proper equipment Handling application. An integrated QMS Complaint

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Quality Management and Change Management: Ensuring a Change for the Better

Handling function identifies adverse events, analyzes when defining and designing a new change.
feedback, and collects customer requirements for
future changes. It also provides decision tree analysis Benchmarking Quality throughout the
and captures data with trend reporting for visibility of
change and new design effects. Integrating Change
Product Lifecycle
Quality is intangible, and it means different things to
Management with Complaint Handling closes the loop
different people. It is usually measured by the criteria put
on the process and enables visibility of post-market
in place by those involved in development and by factors
data when defining and designing the next change.
such as customer complaints, audits, and other post
QMS FunctionAudits: While post-market feedback market data. However, much of this information is received
can be a catalyst for change, so can internal reviews after product release when an adverse product may have
of the products and processes. Through use of already been developed, resulting in recall, leading to loss
continuous improvement initiatives such as audits, of revenue and, eventually, loss of brand equity. What if the
organizations can bring about change internally. Using quality of a product was measured during development?
a QMS Audits tool that is integrated with Change Imagine the possibilitiesif issues could be identified
Management provides a link from audit findings to before the product was released. The QMS makes this
potential product or process changes. Not only is the possible through its quality hub concept, known as the
Audits tool able to schedule and track multiple audit compliance dashboard.
plans with various question and checklist profiles, but
it can also trigger other processes based on audit While quality is often seen as a post-market event, it is
findings. This could be a CAPA or a need for a new inherent in everythingdesign, production, supplier, and
change to the product lifecycle. Integrating Audits with marketand should be incorporated accordingly. The
Change Management enables audit data to be utilized key to sustaining quality throughout product or process

How Change Management is applied to Quality Management System

COMPLAINT
HANDLING

NONCONFORMING CORRECTIVE
MATERIALS ACTION

INCIDENTS/
ACCIDENTS

CHANGE PLANNED
AUDITS & MANAGEMENT DEVIATIONS
SURVEYS

PROJECT
CONTROL

PRODUCT
DOCUMENT SUPPLIER CALIBRATION & JOB SAFETY
DATA ASPECTS
CONTROL RATING MAINTENANCE ANALYSIS
MANAGEMENT

TRAINING

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Quality Management and Change Management: Ensuring a Change for the Better

Compliance Metric in Typical Change Management

generates reports on completed projects, complete with


compliance benchmarks associated with the documented
INITIATE
CHANGE
RELEASE TO change process.
CHANGE PRODUCTION
COMPLETE?

Ultimately, a compliance dashboard helps an organization


identify the processes that can be improved, streamline
resources, and shorten change overtime. As a result,
companies see quicker cycle times, error and cost
Action plan
reduction, and product recall risk mitigation. It saves an
organization time, money, and reputation.
Completed?

Planned
Deviations?

INITIATE
Documentation
Approved? RELEASE TO
CHANGE JHA
PRODUCTION
What to look for when using Quality
Updates? Suppliers
Qualified?
Aspects
Uploaded?

Equipment C/O
Completed?

Training
Management for Change
The Change Management process, as shown, is complex,
Completed?

rapidly revolving, and involves various elements, some that


development is to manage and measure quality during the extend beyond a companys four walls. An automated QMS
product lifecycle, not just after product completion. The can effectively manage the Change Management process
QMSs compliance dashboard makes this possible. The with its technology enablers that enhance the different
compliance dashboard ensures that quality is made visible points of the process. Aside from its integrated modules,
by benchmarking steps in the process, creating a quality the QMS is beneficial in other areas.
road map for the user, showing exactly where the process
has been tested and either passed the quality requirements Flexible: Every organizations Change Management
or was flagged and improved to meet requirements. process is different. This makes a QMS that can
The compliance dashboard ensures that quality is at the adapt to individual Change Management processes a
forefront of creation by incorporating quality into every necessity. Look for a QMS that is highly configurable,
aspect of product development. and provides extensive configuration options, and
business rules that are built directly into the software.
Even with modern tools such as the compliance dashboard, A QMS that provides a Web-based designer tool
there are still organizations that use manual Change enhances the process even further by simplifying the
Management processes. The problem herewhile clich design process with the ability to configure workflows,
is apparent. No one is perfect. Human error is a given and forms, and reports, ultimately enabling the user to
will occur at some point. While mistakes from one person personally adapt to the look and feel of the software.
to another may be forgiven, consumers are much less
forgiving about an error that results in a defective product. Scalable: The Change Management process consists
The automated QMS is ideally suited for managing the of various process owners. Look for a QMS with a
change process because quality and compliance become distributed administration model that allows for local
the forefront of all related activities. As the Change control of groups, users, keywords, reports, and
Management process is executed, it is important for quality security. The Change Management process is not
and compliance to be benchmarked at every step in the confined to one area of the organization. It involves
process. both internal and external elements. This makes a
The concept of a QMS compliance dashboard is a QMS that provides filtered access to documents a
business intelligence tool whereby quality can be tracked necessity. This ability limits access to documents
throughout the process in a singular view. As the change based on organizational criteria and provides multi-
is executed, the compliance dashboard displays the level security.
timeline of the change as well as the level of quality at
each phase. Essentially, the compliance dashboard is Localization: Change Management processes span
designed to measure quality and compliance, and take the enterprise, and in many cases there are off shore
actions on quality issues, fixing them prior to their release, locations involved that speak different languages.
and reducing nonconformities in finished products. It also In this case, a QMS that can translate specific
configurations is key to avoiding software language

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Quality Management and Change Management: Ensuring a Change for the Better

barriers. Look for a QMS with localization technology a change. As the change moves forward, weve seen
that enables translation of all design elements including why it is important to have the ability to manage all of
keywords, error messages, home page, action button the various elements that are involved in a change. The
names, and form fields. organization must ensure that all involved employees are
knowledgeable on the change and are fully trained. The
Integration: During Change Management, information QMS not only guides the organization seamlessly through
must also be exchanged with production systems. these steps, it also integrates key tools into the process
The solution here is a QMS that offers a robust set of to enhance it tenfold. QMS functions that are integrated
integrated Application Programming Interfaces (APIs). with Change Management include Complaint Handling,
Look for a QMS that provides connection profiles, Nonconforming Materials, Corrective and Preventive
which will enable integration with third party business Action, Project Control, Supplier Management, Document
systems across the enterprise. Control, Training, Reporting, and Audits. These tools
further enhance PLM functionality and enable enterprise
Using the QMS to guide Change Management not only
change while keeping quality and compliance at the
efficiently takes an organization through each step of the
forefront of the product lifecycle. Finally, the compliance
process; it also provides functionality beyond the steps
dashboard concept benchmarks quality at different points
of Change Management to link outside systems and
of the product lifecycle, ultimately creating a road map of
personnel, mitigate language barriers, and allow the user
quality.
to fully adapt to the look and feel of their system, by adding
their own personal touches.
Product or process development is an extremely complex
process. It can be likened to following a recipe. While there
Quality Management: A Total Solution are various elements involved that serve different functions,
for the Change Management Process there is always that one ingredient that must be included
As demonstrated, the development of a new product to result in a great outcome, every time. In this case, that
or process is extremely complex. The benefits of ingredient is quality. Without it, everything else that was
implementing a QMS to manage the Change Management involved essentially becomes irrelevant and youre left
process are vast. The QMS not only provides flexibility, starting from scratch. Quality Management provides a total
a collaborative environment, security, and compliance quality solution for enhancing the Change Management
management, it also reduces recall risk, enhances process and will ensure success in every change, every
efficiency and provides an organization with the assurance timeultimately resulting in a change for the better.
that the product or process they have developed has been
infused with quality from design to execution and beyond. About EtQ
EtQ is the leading Quality, EHS and Operational Risk and
While the QMS is ideal for managing processes of Compliance management software provider for identifying,
change, its important to note that the intersection between mitigating and preventing high-risk events through
QMS and PLM is integrated. QMS does not replace the integration, automation and collaboration. Founded in
functionality of PLM, but rather serves as an extension 1992, EtQ has always had a unique knowledge of Quality,
of its capabilities. While PLM has many functions that EHS and Operational Risk and Compliance processes, and
are critical to an organization such as PDM and design strives to make overall quality operations and management
processes, an increasing amount of leading edge systems better for businesses. EtQ is headquartered in
companies are now starting to see how QMS enhances Farmingdale, NY, with main offices located in the U.S. and
PLM through integration and collaboration of data, and Europe. EtQ has been providing software solutions to a
they are now using Quality Management to manage their variety of markets for more than 20 years. To learn more
Change Management functions. about EtQ, visit www.etq.com or blog.etq.com. Customer
Complaints, Audits, and many more. EtQ has been
providing software solutions to a variety of markets for 20
Conclusion years. For more information, please visit
This paper has gone through the steps of an effective
http://www.etq.com.
Change Management process, beginning with the
collection of post-market data to initiate the need for

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www.etq.com 800-354-4476
info@etq.com 516-293-0949

EtQ Reliance is a trademark of EtQ, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners.
No endorsement of EtQ by such companies is intended or implied. Copyright 2017, EtQ, Inc.

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