Decoding Quality Management Systems Quality defines the character of any product or process. To better manage and extend brand reputation, organizations need a holistic, long-term view of enterprise quality management systems to tamp down costs and drive profitable growth by keeping customers loyal and satisfied.

Executive SummaryWhether building a new product or improving processes or services, quality is the bedrock of an organization’s long-term success. In fact, qual-ity increasingly defines the brand. Consider that of the estimated 250,000-plus new products launched annually, between 85% and 95% fail;1 clearly, to build a successful brand, companies must make the most of the 5% to 15% of prod-ucts that gain market acceptance — tough odds, indeed, for building a winning business.

Although multiple factors can cause product fail-ure, quality is considered by most experts to be among the leading contributors. And if or when products fail, companies need to understand the role that quality played and and calculate the resulting cost to their reputation and brand image. Building in quality from the get-go is criti-cal to market success and is typically attained by deploying quality management system (QMS) applications that help to continually improve pro-cess efficiency and effectiveness to drive high performance.

This white paper offers insights into the QMS land-scape, highlights challenges of selecting the right solution and partner, details leadership dilemmas, and provides sound advice on how to make qual-ity job one across the enterprise.

A QMS Primer Several factors — including an ever-evolving product manufacturing landscape, internal orga-nizational challenges and a dynamic global business climate — are driving organizations across industries to transform product and pro-cess quality, as well as keep closer tabs on supplier quality (see Figure 1, next page). Market pressures remain intense, both in heavily regulated indus-tries, such as life sciences, medical devices and food and beverage, as well as in industries such as automotive and industrial manufacturing.

These pressures are driving organizations to strive for the highest level of quality in all aspects of their operations. However, they must overcome many challenges along the way to achieving that goal, as well as strong cost competitiveness and rapid speed of delivery.

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In the manufacturing world, QMS applications provide the foundation for enforcing quality policy and processes across the extended enter-prise. Organizations often approach QMS as a means to not only meet regulatory and compli-ance requirements but also better manage and achieve operational goals, such as enhanced product quality, continuous business efficiency and accelerated time-to-market. QMS maturity plays a significant role in enhancing shopfloor manufacturing operations, product and process quality performance, and overall organizational performance.

Figure 2 illustrates the role of QMS across the value chain, revealing how these systems touch every functional area, from product planning and definition to customer engagement. It also highlights how QMS addresses key quality areas, including advanced product quality planning (APQP), statistical process control (SPC), audit, corrective action and preventive action (CAPA), non-conformance (NC), customer complaints and regulatory compliance.

Globalization Resource availability Changing customers Continued drive for value Government regulations/ activism

Need to address evolving specifications & protocols Global alignment on quality Data management issues Recalls Compliance challenges Claims challenges

Increased competition Value war Complex portfolio Increased global opportunities External failures

Evolving Industry Landscape

Internal Challenges

Business Climate

Plan and Define

Research and Development

Process Design and Development

Product and Process Validation

Production/Manufacturing/Assembly

and Packaging

Warehousing and Distribution

Customer

QMS Touchpoints

Quality policy Document management Risk management

Quality by design Good laboratory practice AQL checks/ in-process checks

Manufacturing scale-up Supplier selection BoM and process flow

APQP/PPAP Supplier quality Audit management Change control

Inspection and calibration Statistical process control Product traceability Non-conformance/ deviation handling CAPA/CAR/SCAR

Quality of service Compliance specifics Customer complaints

Forces Driving Product and Process Quality

Role of QMS across the Value Chain

Figure 1

Figure 2

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Quality Process and Application Challenges At many organizations, quality is looked upon as a separate department rather than as a shared responsibility; as a result, it is often addressed in a reactive and inefficient manner. In these cases, quality remains a “just fix the issue” concern rather than an investment in sustaining competi-tiveness. However, winning organizations have demonstrated that continued outperformance requires a collective effort, in which every indi-vidual who is part of the quality process shares responsibility for meeting customer requirements.

Most manufacturers lack an integrated view on quality or a consensus on which functions to centralize, source, localize or share across the enterprise. Most also lack enterprise-wide gov-ernance; instead, each business unit has its own mandate for budgeting and prioritizing quality. To coordinate quality across the enterprise, senior management must tap an executive with direct responsibility for quality improvements within all functional areas of the organization.

Quality processes — whose values are intercon-nected and correlated — must be integrated to fully leverage the data capabilities of applications that manage quality. An integrated view estab-lishes a culture of collaboration across functional groups; for example, a production part approval process (PPAP) requires close collaboration not only between the purchasing and quality func-tions but also with the external supplier.

Organizations have built a complex set of dis-parate applications over the years to manage enterprise-wide quality processes. These siloed applications — including homegrown applications, spreadsheets, point solutions and applications based on outdated technology — are often not integrated with one another and lack broader functional capabilities to support the business.

Most of these applications are also heavily cus-tomized and are non-intuitive; moreover, the same application is often used differently across vari-ous business units and geographies, and different applications are sometimes used for the same

process to address internal and external qual-ity. There is no single dominant application, and little or no integration among applications. This fragmentation, incompleteness and lack of consis-tency have resulted in operational inefficiencies, increased cost and end-user dissatisfaction.

Further complicating matters, multiple applica-tions are often required to manage closely linked areas such as audit management, non-confor-mance (NC) handling and corrective action and

preventive action (CAPA). This forces users to manually manage the linkage between an audit finding and its respective CAPA.

Organizations wrestling with the complexity of duplicate quality functionality and processes across legacy systems usually attempt to simplify and consolidate applications into standardized platforms that help eliminate unnecessary costs, as well as position enterprise QMS as a strategic business capability for the future.

With the emergence of millennial workers — tech-savvy, mobile-centric, socially-networked employees who will dominate the workforce by the end of this decade — the relevance and effec-tiveness of addressing quality issues now requires organizations to meet a fast-rising and accelerat-ing benchmark for minimum digital competency. This includes adopting an enterprise QMS, made possible by the new digital-centric world.

With the emergence of millennial workers, the relevance and effectiveness of addressing quality issues now requires organizations to meet a fast-rising and accelerating benchmark for minimum digital competency. This includes adopting an enterprise QMS, made possible by the new digital-centric world.

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Selecting a QMS: An Executive DeterminationWith minimal data or experience, business leaders need to evaluate if or how a QMS they are consid-ering delivers the following capabilities:

• Greater visibility and escalation of operational quality issues.

• The ability to address potentially risky opera-tional trends.

• Adaptation to regulatory changes and corre-sponding business initiatives.

• The ability to impact quality procedures across business units or operating sites.

• Coordination of quality control across suppliers and extended partners.

A QMS investment requires a systematized pro-gram approach to scoping, implementation and management across system lifecycles. The follow-ing factors should also be considered:

• The ability to bridge process gaps.

• Simplification of the existing technology landscape and adoption of newer technology.

• Effort vs. benefits.

• Sunk investments.

• Growth strategy and business objectives.

Based on these factors, business leaders should identify quality improvement opportunities by assessing current process and application gaps. The decision to grasp these opportunities and commit to a future course must be viewed in light of practical constraints, current and future needs, business continuity and the ability of the organi-zation to handle change.

The future course of action can be determined by evaluating several possible hypotheses (see Figure 3).

Key Factors Impacting QMS Hypotheses

The selected hypotheses will directly impact the key considerations outlined above. In Figure 3, Hypothesis 4 will have maximum impact on these key factors and will offer the greatest level of bene-fits with respect to the effort required. Meanwhile, Hypothesis 1 and 2 will involve sunk costs for cus-tomization or future upgrades to maintain the systems or applications. While Hypothesis 1 offers fewer long-term benefits, Hypothesis 3 helps close the process gap through out-of-the-box (OOTB) functionality; it does not, however, deliver greater

Evaluating QMS Investments

Figure 3

Hypotheses Outcomes

Existing New

Min

imal

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nge

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ess

Gap

s

Systems Gaps

Existing New

Min

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Systems

• Leverage additional features of current systems.• Harmonize processes and systems. • Integrate current systems with necessary process changes.

• Invest in new “best-in-class” enterprise QMS with significant process improvements for all dimensions. • Introduce new functionalities as and when required in QMS.

• Continue with current system. Build a custom integration tool to extract information from other systems. • Retain current process definitions.

• Use recent QMS solutions and retain current process definitions.

• Huge effort required to build integration tool for disparate systems. • Possibility of continued process and system mismatch. • User acceptance likely to be questionable.

• New solutions cover only partial functionality, requiring continued existence of some functional silos. • Process complexity might decrease due to system enablers. •User acceptance likely to be mixed.

• Huge effort required to build integration tool for disparate systems. • Possibility of continued system and process complexity. • May involve further customization.

• QMS covering multiple dimensions provides an integrated quality environment. • Significant process improvements, leading to key business benefits. • User acceptance likely to be high.

42 4

1 3

2t

4

1e

3

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benefits than Hypothesis 4, and it provides little long-term flexibility. The results of all four hypoth-eses are summarized in Figure 4.

Evaluating QMS Applications Because enterprise QMS centralizes various func-tions (i.e., audit management, NC handling, etc.), it can help improve quality management across geographies and divisions through process stan-dardization and automation. It creates a single platform for cross-functional communications and collaboration that synchronizes and ingrains quality across the value chain.

Organizations are revisiting their quality strate-gies and are in the early stages of centralizing the quality function. QMS providers are beginning to

adopt elements of social networking, real-time analytics and mobility, and are also working on their next generation of products, as a result of:

• Cloud-based technology, which has the potential to drastically reduce costs.

• Modular platforms that can accelerate return on investment (ROI) before the full implemen-tation is completed.

• Digital transformation.

Multiple niche and stand-alone players offer QMS, as well as enterprise system vendors that are incorporating QMS into enterprise resource plan-ning (ERP), product lifecycle management (PLM) and manufacturing execution system (MES) appli-cations suites.

Figure 4

Hypotheses Assessment: Evaluating Potential Outcomes

Factors Hypothesis 1 Hypothesis 2 Hypothesis 3 Hypothesis 4

Solution capability to bridge process gaps (through OOTB or minimal customization)

Simplification of technology landscape

Effort vs. benefits Low benefitHigh benefit

Sunk investments Current system with customization

Current system with future upgrades

Growth strategy and business objectives

Depends on adoption level

√

Plan and Define

Research and Development

QMS for R&D and Product Development QMS for Manufacturing and Distribution

PLM

ERP

CRMCRM

MES

Product and Process Validation Production/

Manufacturing/Assembly and Packaging

Process Design and Development

Warehousing and Distribution Customer

Where QMS Fits in the Manufacturing Value Chain and Technology Landscape

Figure 5

√

√

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√!

To choose the right approach, organizations need to understand the QMS landscape and their own specific needs.

• PLM-based QMS is advantageous when PLM investments have already been made. Gener-ally, PLM-based QMS is best for organizations that engineer complex products with a focus on time-to-market. PLM helps integrate the func-tions of quality from design through manufac-turing by employing a lifecycle approach; this approach ensures that feedback from sources such as non-compliance and corrective actions is routed to engineering to help address quality issues. PLM couples model-based develop-ment and simulations, helping organizations to better leverage visualization and variation analyses that greatly impact quality, as well as reduce cost of quality (compared with physical prototypes). In this scenario, a separate QMS must be tightly integrated to leverage these benefits.

• ERP-based QMS makes sense if the organi-zation is in the middle of an ERP deployment. Among the primary benefits of ERP-based QMS is the use of a single platform, which reduces the need for multiple systems and costly inte-gration. For large organizations, an ERP-based QMS is usually included as part of the broader ERP deployment.

• MES-based QMS is best suited for an organi-zation that is highly focused on manufacturing, has already established operational excellence, has a continuous improvement group seeking to enhance quality processes and manufactur-ing performance, and has harmonized quality processes. Many MES vendors include com-plementary QMS functionalities within their solution sets.

• Best-of-breed QMS applications provided by niche players typically represent the unique quality needs of a manufacturing organization. Their solutions generally offer reduced time-to-value, lower costs and high flexibility compared with dedicated PLM and ERP systems.

Business executives need to evaluate the advan-tages and disadvantages associated with the various solution types from a long-term strategic standpoint to make a business case and forecast

the impact of the QMS build-vs.-buy decision. Application types can be classified as point and enterprise applications.

Point applications are typically offered as cus-tomized off-the-shelf (COTS) or OOTB and are implemented to address a particular need, such as production part approval process (PPAP) or audit management; they address an immediate problem within a functional area of the organiza-tion. Enterprise applications, on the other hand, address the needs of the organization across departments and functions, and include more than one solution. They are scalable, configurable and flexible enough to address future QMS needs.

Selecting a Best-Fit Enterprise QMSCommon challenges that organizations face when deciding on a QMS include:

• Making the fundamental design choices required to get the entire QMS challenge right.

• Keeping QMS lean, simple and agile so that the right information gets to the right employees at the right time.

• Ensuring the QMS fully meets regulatory requirements and reduces compliance con-cerns.

When selecting an application, organizations need to begin with a long-term vision of their QMS strategy. In the short term, a point application often seems to be the most viable, cost-effective option; however, organizations with a long-term quality vision need to ensure that the solution will evolve to meet their needs as they grow.

Over time, organizations typically invest in mul-tiple point applications; however, the associated costs (maintenance and support, training, licens-ing, etc.) are often greater than expected due to needed customizations. Eventually, organizations move to an enterprise-wide application, under-

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When selecting an application, organizations need to begin with a long-term vision of their QMS strategy.

mining the time, effort and investment in the point solution. When making their application selection, organizations should weigh the follow-ing parameters:

• Functionality.

• Industry fit.

• Ability to integrate with the organization’s internal systems, as well as those of its customers, partners and suppliers.

• Scalability and flexibility.

• Software pricing/licensing model.

• Vendor’s ability to provide service and support across geographies.

• Ease of use.

Moving ForwardIn today’s digital world, it is increasingly important for business leaders to assess and understand the potential for a QMS initiative to enhance sustainable competitive advantage and profitable growth. Effective QMS programs build and support quality policies and processes across organizational functions to not only fulfill the company’s quality vision but also enable the enterprise to be future-ready.

The success of the quality initiative to adopt and implement an enterprise QMS requires the unwavering commitment and dedicated support of executive leadership. Evaluation conclusions need to be supported by evidence and assessed against criteria or standards agreed upon by busi-ness executives. Justifying a decision involves the following steps:

• Analysis of an evaluation’s findings and synthesis of various sources of information to reach a deeper understanding.

• Interpretation of the findings to convey evidence in relevant ways that leadership can truly appreciate.

• A comparison of investigative findings and interpretations with agreed-upon criteria and standards.

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Footnotes1 “The Most Memorable Product Launches of 2010,” Forbes, http://www.forbes.com/2010/12/03/most-

memorable-products-leadership-cmo-network.html.

Develop a flexible, industry-leading QMS solution to support accelerated growth.

Leverage technology as a competitive advantage.

Deliver efficient QMS solution that enables organizations to win.

Strengthen QMS implementationadvantage across all business units and geographies.

Business Objectives for QMS

Figure 6

References

• Peter De Boeck, Ulrich Huber, Kasper Jahn, Henrik Jørck Nielsen, “Reinventing the QMS: Adding Agility and Robustness to Control and Compliance,” McKinsey & Co., 2014.

• “Beyond Compliance: The Strategic Role of Quality Management Systems,” Forrester Research, Inc.

• Joan Schneider and Julie Hall, “Why Most Product Launches Fail,” Harvard Business Review, April 2011, https://hbr.org/2011/04/why-most-product-launches-fail.

About CognizantCognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world’s leading companies build stronger busi-nesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfac-tion, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 218,000 employees as of June 30, 2015, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.

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About the AuthorsAmit Joshi is a Consulting Senior Manager within Cognizant Business Consulting’s Engineering and Manufacturing Practice. He has over a decade of experience in operations and consulting with manu-facturing companies. Amit holds an M.B.A. from IIM, Calcutta, and a bachelor’s in technology from NIT, Kurukshetra. He can be reached at Amit.Joshi2@cognizant.com.

Kalpesh Agarwal is a Consulting Manager within Cognizant Business Consulting’s Engineering and Manufacturing Practice. He has over a decade of experience in operations and consulting for manufac-turing companies. Kalpesh holds an M.B.A. from SP Jain, Mumbai, and a master’s in food technology. He can be reached at Kalpesh.Agarwal@cognizant.com.

Hardik Kansupada is a Director within Cognizant Business Consulting’s Engineering and Manufacturing Practice. He has over 18 years of experience in leading and managing strategic engagements, working with C-level executives and end users. Hardik has a master’s in computer information systems from the University of Houston. He can be reached at Hardik.Kansupada@cognizant.com.