Case for Quality Leadership Engagement Playbook · 2021. 1. 19. · Expert Advisors: • Segolene Balling, Grant Thornton, LLP • Ashley Johnson, Grant Thornton, LLP • Ramakrishna

MDICMEDICAL DEVICEINNOVATION CONSORTIUM

A Report of the Case for Quality Collaborative Community (CfQcc), Convened by the Medical

Device Innovation Consortium (MDIC)

January 14, 2021© 2021 Medical Device Innovation Consortium

Leadership Engagement PlaybookLeading practices and tools to help leaders move

their companies from a culture of compliance to a culture of quality

Medical Device Innovation Consortium | mdic.org



Table of ContentsAuthors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4About the Medical Device Innovation Consortium (MDIC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6What’s Inside the Playbook? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Facilitate a Culture of Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Appendix A. Pilot Considerations for Facilitating a Culture of Quality . . . 13

Develop a Quality Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Appendix B. Pilot Considerations for Developing a Quality Strategy . . . . 17

Make Quality a Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Appendix C. Pilot Considerations for Making Quality a Priority . . . . . . . . . . 22

Measure the Value of Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Appendix D. Pilot Considerations for Measuring the Value of Quality . . . 26

Be Proactive, Not Reactive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Clearly Define Quality at the Individual Level . . . . . . . . . . . . . . . . . . . . . . . . 30

Encourage Quality Behaviors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Use Quality Benchmarking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Use Quality Metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Appendix E. Pilot Considerations for Using Quality Metrics . . . . . . . . . . . . . 38

Recognize and Reward Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

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Medical Device Innovation Consortium | mdic.org Authors | 3



AuthorsMDIC has assembled a Working Group comprising member organizations and other subject matter experts to guide work on this project.

Industry:• Paul Arrendell, Worldwide Vice President, Quality Management, Jabil Healthcare

• Robin Dinardo, Senior Director, Strategy and Process Improvement, DePuy Synthes Companies of Johnson & Johnson

• Neil Kelly, Senior Manager, Regulatory Affairs, Hologic, Inc.

• Jackie Kunzler, Senior Vice President, Chief Quality Officer, Global Quality, Compounding, and Product Improvement Research, Baxter

• Joseph Sapiente, Vice President, Quality Assurance and Regulatory Affairs, Hologic, Inc.

• Sara Sulfridge, Senior Director, Quality Strategy, Baxter

• Medha Trivedi, Senior Director, Global Quality and Operations, Stryker Corporation

• Jason Amaral

Government:• Andrea Bell-Vlasov, PhD, FDA | CDRH | OIR

Expert Advisors:• Segolene Balling, Grant Thornton, LLP

• Ashley Johnson, Grant Thornton, LLP

• Ramakrishna Pidaparti, Area Vice President, QARA, Medical Devices & Life Sciences, L&T Technology Services

• Pat Shafer, Managing Director, FTI Consulting

• Steve Silverman, Vice President Technology & Regulatory Affairs, AdvaMed

• Jacqueline Torfin, President/Principal Consultant, Quality Leadership Consulting, LLC

• George Zack, Principal and Co-founder, Two Harbors Consulting

MDIC:• Alan Baumel, Program Director, Case for Quality

• Stephanie Christopher, Former Program Director

On behalf of the Medical Device Innovation Consortium (MDIC) Case for Quality Working Group

Medical Device Innovation Consortium | mdic.org Disclaimer | 4



DisclaimerThe views and opinions expressed in this publication are those of the authors and do not necessarily reflect the views and policies of their respective employers, its management, subsidiaries, affiliates, professionals, or any other agency, organization, or company. The views and opinions in this publication are subject to change and revision.

The general recommendations in this document:

• Do not imply FDA concurrence for specific applications

• Do not represent the opinion or policy of the FDA or of the companies represented

• Do not necessarily reflect the official policy or position of MDIC

© Medical Device Innovation Consortium 2021

Medical Device Innovation Consortium | mdic.org About MDIC | 5



About the Medical Device Innovation ConsortiumThe Medical Device Innovation Consortium (MDIC) is the first public-private partnership created to advance the medical device regulatory process for patient benefit.

MDIC was formed in 2012 to bring the U.S. Food and Drug Administration (FDA) and industry together to share vital knowledge that can help bring safe, affordable, and effective devices to patients and providers more quickly. MDIC membership and participation is open to nonprofit, industry, and government organizations that are substantially involved in medical device research, development, treatment, or education; or in the promotion of public health; or that have expertise or interest in regulatory science.

MDIC has been designed to pursue several strategies that support its mission:

• Create a forum for collaboration and dialogue

• Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues, and to request, evaluate, and implement project proposals

• Provide and enable implementation of tools from these projects that drive cost-effective innovation

The activities and outputs from MDIC are intended to:

• Ensure that innovative technology is readily available to U.S. patients

• Provide industry and government with methods and tools that may be used to expedite medical device development and the regulatory process

• Reduce the risk and expense of clinical research

• Reduce time and cost of medical device development

MDIC members provide guidance and leadership through collaboration to develop solutions for regulatory, scientific, health, and economic challenges within the medical device and diagnostic industry.

MDIC Case for Quality Collaborative Community (CfQcc)The Case for Quality Collaborative Community (CfQcc) offers a unique opportunity for medical device stakeholders to work together to enhance device quality and patient safety. This program allows the FDA to identify device manufacturers that consistently produce high-quality devices. This enables the Agency to allocate its resources to assist other manufacturers with increasing the level of quality in their devices. As the Convener of CfQcc, MDIC helps the FDA with recognizing and supporting practices that encourage consistent quality manufacturing. Participating stakeholders include medical device companies, healthcare providers, payer organizations, trade associations, and educational institutions.

Medical Device Innovation Consortium | mdic.org Background | 6



BackgroundThe Culture of Quality ImperativeA culture of quality in life sciences organizations transcends compliance and serves as a clear, competitive differentiator. In an industry facing increasing competition, regulations, and customer demands, and a mandate for innovation, today’s life sciences leaders are committed to cultivating a culture of quality.

Driven by payers (including the Centers for Medicare and Medicaid Services), the life sciences industry is moving from a reactive to a proactive approach to quality. This requires, in part, a commitment to measuring quality investments. Life sciences organizations, more and more, are being measured and paid based upon clinical outcomes and the quality of their products and services.

According to an article by Grant Thornton, beyond the commitment to patients, cultivating a culture of quality in the life sciences industry is especially critical today for four key reasons:

1. Organizations are trying to stop the loss of value due to poor quality.

2. The FDA expects organizations to commit to quality and is advancing the business case for quality.

3. A culture of quality enables companies to meet the needs of customers. The increasing patient voice in medicine, customer awareness of quality issues, and the power of patient advocacy groups are key drivers of quality.

4. Real-world data provide opportunities to measure quality effectively. This makes it easier to assess quality performance.

Today’s life sciences organizations are recognizing the need for a strong culture of quality. They are embracing a fundamental shift in attitude and investing in efforts to create a culture of quality.

In a CfQ survey conducted by the MDIC for this playbook, 90% of organizations reported that their leaders actively promote quality across activities and functions. Nearly two-thirds (63%) prioritize high-quality performance over costs and competing priorities. Most organizations proactively encourage understanding of how quality applies to jobs and performance reviews. Figure 1 on the next page highlights survey results.

WHY INVEST IN A CULTURE OF QUALITY?

1. Reduce cost of poor quality2. Meet FDA expectations3. Hear customer voice4. Improve quality measures

Moving beyond compliance

https://www.grantthornton.com/library/articles/advisory/2019/beyond-compliance-improvement.aspx



Culture of Quality Initiative

Survey Results: Moving Beyond Compliance Toward Quality

PERCENTAGE OF RESPONDENTS0 20 40 60 80 100

KEY Strongly Agree or AgreeNeutral or Disagree

Promote quality

Prioritize quality over costDefine/establish quality and

employee roleInclude quality in

performance reviewsEmploy objective quality

performance measuresEngage to understand behaviors

that drive qualityEffectively communicate

quality strategyFocus on prevention over reaction

Formally measure cost of quality

Benchmark and share best practices

9% 91%

10% 90%

37% 63%

16% 84%

10% 90%

22% 78%

33% 67%

43% 57%

53% 47%

61% 39%

Figure 1. MDIC Case for Quality (CfQ) Leadership Engagement Survey Results

Background | 7

What’s Inside the Playbook? | 8Medical Device Innovation Consortium | mdic.org


Best Practices for a Culture of Quality This playbook describes 10 best practices for moving from a culture of compliance to a culture of quality:

#1: Facilitate a Culture of Quality

#2: Develop a Quality Strategy

#3: Make Quality a Priority

#4: Measure the Value of Quality

#5: Be Proactive, Not Reactive

#6: Clearly Define Quality at the Individual Level

#7: Encourage Quality Behaviors

#8: Use Quality Benchmarking

#9: Use Quality Metrics

#10: Recognize and Reward Quality

Piloting Best Practices for a Culture of QualityAs you develop and improve your culture of quality, you will need to determine which concepts, processes, techniques, and practices to implement. Tailor your approach to your company.

Start by prioritizing the best practices in the playbook. Select one or two best practices that you believe will have the greatest impact on performance. Then pilot the selected best practice(s).

We recommend the following framework for executing your pilot:

1. Identify the scope of the pilot.

2. Capture your baseline based upon appropriate measures.

3. Conduct the pilot by systematically applying the best practice(s).

4. Measure progress.

5. Adjust the pilot based upon progress and challenges.

WHAT’S INSIDE?

• Best practices collected from industry

• Small, medium, and large company contributions

• Medical device, in vitro diagnostics, and pharmaceutical perspectives

• Concepts, processes, and techniques for adoption

What’s Inside the Playbook?We encourage life sciences organizations to adopt, improve upon, and share performance improvements. Collaboration provides an opportunity to raise the level of quality across the industry, ultimately bringing greater value to manufacturers, providers, and patients.

The CfQcc developed the playbook by identifying and prioritizing approximately 20 leading practices. They analyzed the 20 practices and narrowed down the list to the 10 key best practices that appear in this playbook. These 10 practices became the basis for the survey referenced above. The team then collected content from a variety of industry sources to create this playbook.

What’s Inside the Playbook? | 9Medical Device Innovation Consortium | mdic.org


General Guidance on Piloting the Best PracticesHere is some general guidance for piloting the 10 best practices described in the playbook.

Start by prioritizing the best practices and selecting one or two that you believe will have the greatest impact on performance. Using your company’s own piloting procedures or the guidance below, tailor the approach to your company.

Scope Once you’ve identified the best practice(s), further scoping includes determining which sites or functions will be participating and for how long. Selecting a reduced scope provides several benefits: a more focused, enthusiastic group of participants; reduced cost; reduced risk; and easier measurement. A small, successful pilot can go a long way toward generating excitement and improved outcomes.

BaselineThe purpose of the pilot is to test implementation of the best practice(s) and inform improvements in order to drive the greatest benefit. Understanding where the pilot group is starting from is essential in order to measure improvement.

Identify measures that relate to the factors targeted for improvement (e.g., product quality, customer satisfaction, or cost of quality). Take an initial baseline measurement for each, ensuring that the baseline measurement isn’t being taken at an extraordinary time. Use a mix of long-term measures (such as turnover) and more immediate measures (such as process cycle times).

Conduct Apply the best practices in a structured, systematic way. Conduct a formal kickoff meeting with pilot participants, explaining the purpose, what will be measured, how the pilot will be run, and each person’s or group’s role and responsibility. Hold periodic meetings to make sure participants are following the process, answer questions, and collect ongoing feedback. Make adjustments as needed during the pilot and document these.

MeasurementReport measures periodically and at the end of the pilot. Answer these questions:

• Has the best practice improved performance in the expected areas?

• Are there any unintended consequences?

• How do the participants feel about the piloted practice?

• Are the participants willing to promote a broader implementation of the practice?

Continuous Improvement If the best practice(s) has (have) led to improvement, make plans to adopt it (them) on a wider scale, leveraging learnings from the pilot. Perhaps some elements were more successful than others. Adopt the successful elements and leave out what was not effective. Use learnings to fine-tune broader adoption. Continue to measure performance to continuously improve or fine-tune the practice(s).

SECTION 1: Facilitate a Culture of Quality | 10Medical Device Innovation Consortium | mdic.org


SECTION 1

Facilitate a Culture of Quality

EXECUTIVE SUMMARY

Facilitate a culture of quality by taking three essential steps:

1. Commit to quality.

2. Establish core values of quality.

3. Invest in quality.

In order to implement a successful culture of quality in a life sciences organization, leaders must back the commitment to quality with action.

IntroductionProblems with quality quickly translate into lower levels of customer satisfaction, higher costs, and shrinking revenues. Leaders must believe that a culture of quality is essential to long-term success and competitive advantage.

A culture of quality starts at the top of the organization. Leaders must define what quality means within the organization and ensure clear and consistent communication about quality throughout the entire organization.

Facilitating a culture of quality, especially across multiple locations and divisions, is a transformative process. Quality must no longer be the sole responsibility of a single department, but rather the responsibility of each functional team.

A healthy culture in the life sciences industry today requires a close examination of the role of quality. This includes aligning cross-functional metrics and expanding human resource processes to support change and the recruitment of the next generation of quality professionals. A healthy culture also requires a holistic approach to culture, which takes into account factors associated with instilling a consistent culture across the entire organization.

A Grant Thornton article noted that large, global life sciences organizations must “address the challenge of embedding their culture across different geographic locations and employees from varying ethnic backgrounds.”

“Organizations need to define a core set of values and create an adoption plan in a way that allows behaviors to be mapped to specific countries or regions. Embedding your culture across different regions will require communicating in a manner that resonates with employees in that location.”

—Grant Thornton article, “Quality culture: Beyond compliance to improvement”






Best PracticesFacilitating an effective culture of quality driven by leaders requires a multifaceted approach involving all areas of the organization.

1. Understand your current state. Conducting a quality culture gap analysis may be a good place to start to move forward in fostering a performance-driven culture of quality. The analysis should answer some key questions:

• What is the current status of the quality culture on the shop floor, and in the warehouse, laboratory, and office areas?

• What is the organization’s vision for its culture of quality?

• What are some key milestones in achieving a culture of quality?

• What are the organization’s core goals for its culture of quality?

2. Define what quality means for your organization. The definition of quality is unique to every organization. When defining quality for your organization, consider the needs of your customers, ideally supported by customer data. Incorporate all facets of quality in your definition, including compliance, measurement, accountability, and performance.

Grant Thornton analysts noted that organizations need to “define a culture of quality in terms of values, behavior, and expectations.” Leaders must realize that developing a culture of quality is a journey and that generating positive outcomes requires investment.

3. Demonstrate quality behaviors. Leaders can drive an organization-wide commitment to quality by leading through example. Embrace the change needed to make the shift to a quality culture as a competitive advantage. Engage in open dialogue and be willing to be transparent about the changes needed—and their impact on employees. Make quality a way of life in the day-to-day operations of your organization and make it visible in your leadership.

Data from Grant Thornton’s 2019 Return on Culture survey showed that employees lack confidence in leaders’ commitment to the organization’s culture. For example, 76% of executives surveyed said that their organization has a defined value system that is understood and well communicated, but only 31% of employees surveyed believed the same to be true. Leaders must buy into and support a culture of quality. They must live the quality values. Without leadership commitment, it will be challenging to get employees to adopt a culture of quality.

4. Communicate frequently and consistently. Transforming a culture takes time and continuous effort. Consistently and frequently communicate the organization’s commitment to quality to employees so that they know what is expected of them and are engaged in the process. Examples of ways to communicate include newsletters, updates on quality efforts, and conversations in regular team meetings to share ideas, events, or experiences.

Leaders should leverage existing mechanisms to ensure that quality objectives are aligned with the organization’s overall goals and objectives and cascaded to all employees. They should ensure that structures are in place for continuous review and engagement.

Measurement of your objectives is critical to communicating the success of your quality culture investments and initiatives. Identify core key performance indicators and regularly analyze results so that adjustments can be made to resources, goals, and strategies.


https://www.grantthornton.com/Insights/culture/return-on-culture.aspx



5. Instill accountability for quality and empower employees.Go beyond just talking the talk. Hold all employees accountable for a commitment to quality. Two ways to ensure that the organization is meeting quality standards are regular performance reports and review of targets for milestones and goals.

Also, leaders must empower employees to embrace a culture of quality over compliance. Leaders must transform the organization from a mindset of monitoring the statistics of workforce productivity to one of encouraging and implementing new ideas on how to be more productive.

6. Develop incentives. Incentives for employees may be one way to help drive engagement in instilling a culture of quality. Evaluate your current processes, including performance evaluations, job descriptions, mentoring programs, and other initiatives. In an industry burdened by regulations, awards can help drive engagement and change.

7. Promote quality in recruiting and onboarding. Reflect the commitment to quality as a core value in your recruiting and onboarding processes:

• Include questions in the interview process that can help assess a candidate’s approach to quality and how they facilitated improved quality performance in previous roles.

• Introduce new hires to your organization’s quality values, goals, and expectations during the onboarding process.

• Define behaviors and standards for meeting quality objectives in the organization.

• If possible, include a senior manager in the training session to communicate the importance of quality at all levels of the organization.

8. Stay current. Quality and compliance are constantly evolving in the life sciences industry. Staying current on trends, regulations, and emerging technology can help inform your organization’s culture of quality and move it forward. Share updates widely with your teams and adjust quality strategies as needed.

9. Strategize for the short-term and long-term. Culture requires formal short- and long-term strategies. Both strategies should encompass many aspects of culture, including resources, tactical changes, technology adoption, training, change management, incentives, and reporting.

10. Invest in skills that advance quality.Invest in enhancing the skillsets of employees. This may include the ability to leverage next-generation technology solutions or advanced skills in risk management, data analytics, and more.

Appendix A has pilot considerations for facilitating a culture of quality.

“Quality is not an act. It is a habit.” —Aristotle

APPENDIX A: Pilot Considerations for Facilitating a Culture of Quality | 13Medical Device Innovation Consortium | mdic.org


KEY TAKEAWAYSLeaders play a key role in facilitating a culture of quality. They provide a unity of purpose while also establishing the direction of the organization. Leaders must create and maintain an organizational environment in which employees can become engaged in achieving the organization’s quality goals.

This includes consistent and continuous messaging by leaders, rewarding employees who are advancing quality performance and demonstrating quality behaviors, measuring performance, and weaving quality into every facet of day-to-day business life. Good leadership is essential in improving quality across the organization.

APPENDIX A.

Pilot Considerations for Facilitating a Culture of QualityScopeIdentify a particular department that is interested in learning about and improving its own culture of quality. This may be a team that has difficulty in results accountability or has frequent nonconformances.

BaselineDesign an anonymous survey for the team members. Ask questions about how they view the quality culture.

ConductCollate the results. Each level of leaders represented should share the results with the team as well as reiterate the commitment to quality. Have open conversations and identify one or two actions that can have an immediate impact. For example, create an incentive to identify and stop a nonconformance as early in the process as possible.

MeasurementMeasure the number of nonconformances within each process step and track this over an appropriate amount of time. Report nonconformances frequently. Use an anonymous survey to measure how the team feels about the culture of quality as quality improves.

SECTION 2: Develop a Quality Strategy | 14Medical Device Innovation Consortium | mdic.org


SECTION 2

Develop a Quality Strategy

EXECUTIVE SUMMARY

Building an effective quality strategy starts with the mission. The strategy drives action in support of the mission. This best practice provides a framework for developing a strategy to guide the actions and behaviors that will enable the organization to achieve the mission:

1. Define the mission in concrete terms.

2. Gather data.

3. Create and articulate the strategy.

4. Identify the goals.

5. Ensure proper alignment with mission and actions.

IntroductionA quality strategy goes beyond product quality. It embodies patient safety, design, process control, regulatory compliance, and the quality management system. It leverages leadership, best practice sharing, employee ownership, incentives, peer involvement, credible communications, and tools and training. An effective quality strategy requires a collaborative process, usually involving a wide array of stakeholders focusing on culture, continuous improvement, and patient experience.

Like all strategies, a quality strategy in a life sciences organization is a set of principles, values, and actions that help an organization achieve its mission and vision. Objectives in a life sciences organization typically include improved customer satisfaction, safety and effectiveness of devices, and better business outcomes.

In a world where access to information is fast and widespread, life sciences organizations face increased customer scrutiny. An effective quality strategy is particularly important.

A strategy answers why one does something. It creates a path between the highest-level drivers (mission, vision, quality policy, etc.) and actions and behaviors (Figure 2). Leaders must effectively communicate the strategy in order to drive the desired outputs.

Implementing a Quality Strategy

• Leadership• Best practice

sharing• Employee

ownership• Incentives• Peer involvement• Credible

communications• Tools and training

Behaviors

OutputsHighest-level

statements of purpose

MissionVision

Quality PolicyStrategy

Figure 2. The Components of Quality Strategy

SECTION 2: Develop a Quality Strategy | 15Medical Device Innovation Consortium | mdic.org


Best Practices1. Align your company’s goals and strategy with your mission. A quality strategy is part of quality planning. Your company’s goals and strategy should be aligned with your company’s mission. For example:

Mission: Be the global leader in developing and distributing products that provide effective patient outcomes that enhance well-being in ophthalmology.

Strategy: Focus on the design, development, and distribution of safe and effective products; grow the business with innovation and appropriate cost reduction measures by eliminating waste; and be a workplace that develops our employees, their families, and our community.

Goals: To improve by xx% in:

• Quality and patient safety

• Business growth

• Employee satisfaction

2. Follow the five-step process to create your quality strategy. The high-level process for creating a global quality strategy consists of five main steps (Figure 3):

Define theMission

Ensure Alignment

Define & Articulate Strategy

IdentifyGoals

Gather Data

1. Define the mission.

The mission (for both quality and the company overall) should outline high-level objectives, defined in terms that are measurable and achievable.

2. Gather data from key stakeholders.

A strategy cannot be developed in a vacuum. Gather and use data to help shape the strategy to align with or address internal and outside interests. Stakeholders are interested parties such as patients, caregivers, doctors, regulators, and business partners. Data can come in various forms such as through formal listening systems Corrective and Preventive Action (CAPA) (complaints, inspection processes, etc.) or informal channels (through best practice sharing, business meetings, board meetings, etc.).

Data should also cover the external and internal context of the organization. External context considerations can include things such as legal issues, technological or industry advancements, economic environment, and global market share/scope. Internal context considerations can include things such as performance of the organization, culture and values, and people and organizational structure.

3. Define and articulate the strategy.

With the mission in mind, use the data in step two to shape a series of principles and actions that will allow the organization to achieve the best outcome with reasonable use of resources and appropriate levels of risk.

Figure 3. The Five-Step Quality Strategy Process



4. Identify goals.

Using the previous year’s achievements and the output of the earlier steps, define a series of goals that together will reflect the accomplishment of the mission. Goals should be sufficiently exhaustive to cover all drivers of success. Use the SWOT (strength, weakness, opportunity, threat) method and risk-ranking methods to evaluate and plan priorities.

5. Ensure proper alignment.

Confirm that the newly defined goals, strategy, and values align. Measure progress against the goals to evaluate the effectiveness of the strategy. Some course correction may be necessary, especially if internal or external factors change.

Periodically review and update the quality strategy. Continuously monitor actions related to the quality strategy, including through periodic quality management review.

As part of the quality strategy, leaders and managers should routinely talk openly about quality performance expectations and create a culture where going beyond basic quality guidelines is a consistent behavior. This will create a strong core of employees for whom high-quality performance is important on a personal level.

Include the essential actions that help drive and sustain quality in a company’s culture:

• Information sharing

• Employee ownership

• Employee incentives

• Leadership emphasis

• Credible messages

• Quality management systems

• Tools and training programs

Develop and deploy work streams that support quality behaviors and point out those quality behaviors in action.

Appendix B has examples of pilot work streams and other considerations for developing a quality strategy.

SECTION 2: Develop a Quality Strategy | 16

KEY TAKEAWAYSStrategy is the link between the highest-level objectives (mission, vision, and quality policy) and the behaviors and actions of employees, partners, and suppliers. Strategies are developed through a structured process, starting with the mission. Monitoring performance against strategy-derived goals is necessary to ensure that the strategy is effective.



APPENDIX B: Pilot Considerations for Developing a Quality Strategy | 17

APPENDIX B.

Pilot Considerations for Developing a Quality StrategyOne approach to developing a quality strategy is to develop and deploy work streams that support quality behaviors in the following areas:

• Product awareness

• Visual management

• Continuous quality improvement

• Recognition

• Communication

Product AwarenessDevelop an enhanced understanding of your products:

• The conditions they treat

• How, where, and when the products are used

• Potential consequences to patient safety if a product does not function properly

Why do it

• To help employees understand the impact of their work on products and services

How/What tools to use

• Structured and effective product education

• Patient and clinician experiences and stories from using products

• Quality and patient forums and events

• Design for reliability and manufacturability

• Understand internal and external customer requirements (critical to understanding quality)

Visual Management Ensure that all employees understand how their work impacts business performance and goals in their work area. Employees can see actual performance versus the target and can engage in improving performance.

Why do it

• Metrics show the health of the business:

o Are we on track to hit our goals?

o Are there issues that require our help to improve?

• Metrics enable immediate detection of problems and development of solutions before they become larger issues.




• Policy deployment

• Communication boards

• Lean-Sigma tools (e.g., 5S)

• Clearly defined metrics, clearly cascaded through the organization

• System and process to cascade metrics and measurements

Continuous Quality ImprovementPromote a culture of employee accountability, ownership, and empowerment through continuous improvement and problem-solving, resulting in the greatest possible product reliability and quality.

Why do it

• To educate and ensure all employees understand:

o The company’s approach to quality and compliance

o The balance between quality and quantity

o The importance of effective “closed-loop” problem-solving (proactive and reactive)


• Structured and effective quality and compliance training

• Structured problem-solving approach (e.g., PDCA and A3)

• Lean methodology

• Five whys

• Lessons learned

RecognitionRecognize and reward employees for exhibiting desired behaviors: accountability, courage, patient focus, and prevention.

Why

• Harnesses the energy and capability of the entire workforce to identify positive work

• Promotes teamwork and creates positive momentum toward the quality culture


• A structured recognition program

• Informal and formal peer-to-peer recognition

• Global recognition

• Team meetings and town hall meetings




CommunicationDevelop ongoing structured communications to ensure that clear, consistent, and impactful messages reach the target audiences.

Why do it

• Connect to the minds and hearts of stakeholders

• Promote quality behaviors and tie behaviors to patients

• Build awareness and understanding of the quality culture

• Share good practices and lessons learned


• Leadership communication and support

• Videos, posters, and digital signage

• Quality/patient forums and events

• Structured interpersonal and ongoing communications through goal setting, huddles, and one-on-one meetings

• Employee engagement


SECTION 3: Make Quality a Priority | 20Medical Device Innovation Consortium | mdic.org


SECTION 3

Make Quality a Priority

EXECUTIVE SUMMARY

Quality should not be prioritized separately from other business objectives. There are several approaches to prioritizing and embedding quality and moving away from a compliance mindset. One approach, covered here, is to focus on the data, customer requirements, and quality and safety, and then address compliance issues. In some cases, addressing compliance issues requires working with health authorities to change regulatory science.

IntroductionIn our industry, compliance is always top of mind, sometimes at the cost of quality. Continuous improvement may introduce risk and cost. Failure to pursue quality and continuous improvement has been proven to increase cost and risk.

Creating an environment where quality is a priority and not just a set of discrete activities requires all industry partners and regulators to adopt a paradigm shift. When quality is a priority, it is ubiquitous; science and data continuously drive the right decisions and improvements.

When prioritizing quality activities is done without manufacturing or other business drivers, we can actually destroy the culture of quality that we are all trying so hard to create. By embedding quality throughout the organization and integrating it across the entire business, alignment is inherently driven between business goals, quality goals, and priorities.

Best PracticesThree key behaviors will help life sciences organizations establish a new environment where quality is no longer separate or unique or mistaken as a compliance-only set of activities.

1. Use the data. Our laser focus on regulations and compliance has sometimes caused us to undervalue scientific data and principles in decision-making. Correct this by adopting a science-first policy. Every decision should be scientifically justified, even if the decision is not aligned with the regulation.

When the data direct you to the same solution that the regulations require, then reasoning is consistent and sufficient. If, however, the decision dictated by the data conflicts with the regulation, then we must have a conversation with the FDA to force the evolution of the industry. Using data allows the industry to naturally arrive at a proper focus on the end user instead of being limited to compliance-based solutions.

Key Aspects of Making Quality a Priority

• Challenge current compliance mindset

• Weave quality into the fabric of the organization

• Take quality beyond compliance



2. Create new experiences. Employees dedicated to the design, development, production, and sustainability of our products are trained to adhere to compliance-based rules. These rules often translate into check-the-box thinking, which limits growth, accountability, and innovation.

Leaders should create an environment in which employees gain experiences where innovation is promoted, quality beyond compliance is encouraged, and decisions are made rooted in scientific data. These experiences will create new beliefs. This will lead to positive emotions, which result in new behaviors that build a quality culture focused first on doing the right thing for patients.

3. Communicate for sustainable change.This new environment will change our industry and demand a culture of quality. We must communicate in a way that aids the sustainability of this culture. Too often, we communicate the “how” first, thinking that this will speed adoption and make it easier for others to understand. If, however, we do not first communicate “what” then “why” and then “how,” we take away the ability to think critically about the change. This results in a prolonged timeline for adoption.

Figure 4 depicts a model of change, adapted from Scott and Jaffe, that should be considered a vital framework for understanding the process of change. The model provides insights on how you can manage change successfully by minimizing the resistance to change.

People must progress through the stages of change, in this order:

• Denial: People ignore change.

• Resistance: People oppose change.

• Exploration: People encourage change.

• Commitment: People are empowered by change.

Appendix C has pilot considerations for making quality a priority.

SECTION 3: Make Quality a Priority | 21

Figure 4. A Sample Model of Change (adapted from the Scott and Jaffe Change Model by Cynthia Scott &

Dennis Jaffe in their article Survive and Thrive in Times of Change)

EXPLORATIONThe How

RESISTANCEThe Why

DENIALThe What

COMMITMENTThe When

KEY TAKEAWAYSThe life sciences industry needs to think differently and lead the change to move our priorities beyond compliance activities to continuous improvements and innovative solutions. Improvements and solutions must be based on scientific data, not just regulatory requirements.

Don’t prioritize quality separately from the rest of the organization. Promote continuous improvement and innovation by encouraging and growing the concept of quality beyond compliance to a culture of quality.

Challenge the regulations. Have the courage to speak directly with regulators, basing these conversations on scientific data. Remain courageous and persevere in the quest to think critically and do what is right in providing the highest quality products for patients and meeting the expectations of providers, employees, industry, and regulators.



APPENDIX C.

Pilot Considerations for Making Quality a PriorityScopeIdentify a specific product line or business unit multifunctional team that has a strong desire or incentive to participate in a pilot on moving from a culture of compliance to one of continuous improvement.

BaselineThe purpose of the pilot is to test implementation of the practice and inform improvements in order to drive the greatest benefit. Understanding where the pilot group is starting from is essential in order to measure improvement. Identify measures that relate to those factors targeted for improvement (e.g., product quality, customer satisfaction, and the cost of quality). Take an initial baseline measurement for each factor, making sure that the baseline measurement isn’t being taken at an extraordinary time. Use a mix of long-term measures (such as turnover) and more immediate measures (such as process cycle times).

ConductApply the best practices in a structured, systematic way. Conduct a formal kickoff meeting with pilot participants. Explain the purpose, what will be measured, how the pilot will be run, and each person’s or group’s role and responsibility. Hold periodic meetings to ensure that participants are following the process, answer questions, and collect ongoing feedback. Make and document adjustments as needed during the pilot.

MeasurementReport measures periodically and at the end of the pilot. Answer these questions:

• Has the best practice improved performance in the expected areas?

• Are there any unintended consequences?

• How do the participants feel about the piloted practice?

• Are the participants willing to promote a broader implementation of the practice?

APPENDIX C: Pilot Considerations for Making Quality a Priority | 22

SECTION 4: Measure the Value of Quality | 23Medical Device Innovation Consortium | mdic.org


SECTION 4

Measure the Value of Quality

EXECUTIVE SUMMARY

Measuring the value of quality (costs and benefits) helps drive top-line and bottom-line results. Doing so requires:

1. A framework for capturing costs and benefits

2. An awareness of hidden cost drivers (internal, upstream, and downstream)

3. A mechanism for reporting and responding to the value metrics

IntroductionLife sciences organizations typically measure the cost of poor quality or the cost of quality. Since quality can drive reputation, customer loyalty, and competitive advantage, we should measure the value of quality.

The return on investment in quality may take time to materialize, although there are scenarios where the benefits might be immediate. These scenarios include when actions are necessary to gain license approval or avoid a costly recall.

Measuring, reporting, and acting upon financial measures of quality will help manufacturers prioritize investment in quality programs and distinguish themselves with customers and shareholders. Measuring value will also help align the company with value-based healthcare decisions.

Best Practices1. Define a value of quality framework. Define a value of quality framework, using categories such as those shown in Figure 5.

ExternalCosts

COSTS

InternalCosts

AppraisalCosts

PreventionCosts

CostSavings

IncreasedRevenue

BENEFITS

Cost of Poor Quality

Investment inGood Quality

Benefit ofGood Quality

Value of Quality

Figure 5. Sample Categories in a Value of Quality Framework. Source: MDIC Value of Quality White Paper

https://mdic.org/wp-content/uploads/2016/08/Value-of-Quality-Draft-Whitepaper-16-Nov-2016-V1.6.pdf



2. Capture the true costs of quality. The true costs of poor quality are often hidden from view. Explore the root cause of failure, as cost drivers may occur upstream and have far greater impact than evidenced by the symptom. Also, look beyond the manufacturing environment. Downstream impacts (to providers, patients, and even regulators) will likely impact manufacturers, immediately and long into the future.

Costs can be categorized as internal failure costs and external failure costs. Failure costs impact manufacturers, healthcare providers, and regulators.

The impact on manufacturers

Internal failure costs are contained within the manufacturing ecosystem. Examples are scrap rates and rework. External failure costs are related to failures occurring outside the manufacturing environment. Examples are warranty claims and complaints.

The impact on healthcare providers

Though typically not part of a manufacturer’s quality dashboard, product quality has a significant impact on providers. While it’s impractical for manufacturers to track the impact on providers, it’s important to be aware of the types and magnitude of this impact.

Hospital value analysis committees are likely to consider device quality a key purchase criterion. Discussions with hospital system administrators indicate that device reliability (or lack thereof) can have profound cost implications, including income loss related to missed procedures, service costs, costs related to having to repeat procedures, and in some cases, legal fees. The American Hospital Association has indicated that the inclusion of the product unique device identifier (UDI) in the clinical data set will enable hospitals to easily identify which devices are performing well and which might drive snowballing costs.

The impact on regulators

Over a two-year period, FDA medical device recalls went from 1,065 devices in FY2013 to 2,850 devices in FY2015. As a result, the FDA’s field organization spent approximately 28,000 hours monitoring medical device recalls. These hours did not reflect the time spent by the Center for Devices and Radiological Health (CDRH) in the final classification of recalls and editing press releases.

More recently, the FDA’s field staff spent close to 36,000 hours on “compliance follow-up” inspections and sample analysis domestically and internationally. Compliance follow-up inspections are repeat inspections at firms to confirm corrections to prior violations. If firms concentrated on quality beyond compliance, many of these repeat inspections could be avoided, saving time for both the government and industry.

3. Develop a quality dashboard.Measuring and reporting the financial impact of good or poor quality helps leaders prioritize issues and supports development of a business case for investing in good quality.

Establish a framework for using metrics on the value of quality and a governance mechanism. The metrics framework, with common definitions of cost drivers and measures of benefit displayed in a quality dashboard, facilitates

Examples of Failure CostsInternal Failure Costs• Net cost of scrap• Re-inspection of

reworked products• Redesigns

External Failure Costs• Repairs and replacements

beyond warranty period• Liability from defective

products• Lost sales from a

reputation for poor quality

SECTION 4: Measure the Value of Quality | 24



communication and a common understanding of quality performance. The governance mechanism facilitates evaluation of and actions on quality signals. Also, these analyses and reports may support periodic performance analysis, effective quality management reviews, and continuous improvement efforts.

4. Leverage the value of quality metrics.With improved data collection and reporting capability, managers and leaders can use cost of poor-quality metrics to continuously inform quality performance and identify areas where corrective or preventive action can be taken. Studying cost trends can help drive quality improvement projects.

Make cost of quality metrics a component of periodic management review, either as part of an overall management review or a dedicated quality management review. Senior leaders should understand the quality of the organization’s products as well as the financial impact of poor quality.

The primary audience for cost of quality metrics is likely senior leaders who can immediately internalize the meaning of the financial impact and translate that into an enterprise desire to improve quality and reduce costs. These metrics, however, should also be shared with everyone who is responsible for designing, manufacturing, and distributing medical devices. Monitoring quality investment costs at a granular level, and measuring the related benefit to the company, providers, and patients, will provide the best input for targeting investment in quality.

Appendix D has pilot considerations for measuring the value of quality.

SECTION 4: Measure the Value of Quality | 25

KEY TAKEAWAYSAn effective quality program requires more than reporting metrics, including a strong push from leadership at the start. Continued focus is needed, keeping the conversation about the value of quality and its impact within the company, and across the broader healthcare ecosystem. In the life sciences industry, good quality has meaning far beyond quarterly profits. It translates directly into better health and safety for patients.

APPENDIX D.

Pilot Considerations for Measuring the Value of QualityDuring the pilot, measure the cost of quality in terms of internal and external failure costs. Examples are included in Table 1. Work with your cost accounting team to define the costs (which costs are included in each type of failure) and collect data.

Inte

rnal

fai

lure

co

sts

Net cost of scrap

Net cost of spoilage

Rework labor and overhead

Re-inspection of reworked products

Retesting of reworked products

Downtime caused by quality problems (CAPAs, Complaints, NCRs)

Disposal of defective products

Analysis of the cause of defects in production

Re-entering data because of keying errors

Debugging software errors

Redesigns

Redos: Engineering, Tooling, Programming, Gauges

Ext

erna

l fai

lure

co

sts

Cost of field servicing and handling complaints

Warranty repairs and replacements

Repairs and replacements beyond the warranty period

Product recalls

Liability arising from defective products

Returns and allowances arising from quality problems

Lost sales arising from a reputation for poor quality

ScopeChoose a cross-functional team for one business unit in order to provide the most value and encourage organization-wide support and implementation.



APPENDIX D: Pilot Considerations for Measuring the Value of Quality | 26

Table 1. Examples of Internal and External Failure Costs. Source: MDIC Value of Quality White Paper

https://mdic.org/wp-content/uploads/2016/08/Value-of-Quality-Draft-Whitepaper-16-Nov-2016-V1.6.pdf



BaselinePerform an initial tally of costs. Data will likely come from multiple sources (manufacturing sites, service centers, and finance), so it may take some time to round up the initial figures. Until there is confidence in the data, it will make sense to keep the cost of quality pilot output as a separate, standalone report. This will prevent the cost of quality pilot results from getting prematurely mixed in with “official” reports.

ConductAs you collect the costs, be aware that some companies report costs of quality as high as 30% of revenues.

Use available technology to capture metrics and report them in a dashboard. Choose several cost of quality metrics that will show a variety of costs.

APPENDIX D: Pilot Considerations for Measuring the Value of Quality | 27



SECTION 5: Be Proactive, Not Reactive | 28

SECTION 5

Be Proactive, Not Reactive

EXECUTIVE SUMMARY

Life sciences organizations can benefit by integrating a proactive (rather than reactive) approach to quality in three areas:

1. New product development

2. Supplier selection and process capability

3. Continuous improvement

IntroductionPreventive actions are well understood and adopted within quality management systems; however, organizations need to look at prevention more broadly. Prevention extends well beyond product design to all areas of the enterprise. It should be part of the culture of quality.

Designing and producing a high-quality product is easier and less costly than fixing a deficient product at the end of the process. Quality should be designed into the product and process, not only measured after the fact through inspection. Get it right the first time.

Best Practices1. Use quality by design in the new product development cycle. Many high-functioning industries design for quality, manufacturability, serviceability, and reliability during the new product development phase within R&D. This preventive and proactive philosophy involves establishing quality teams (design quality assurance or new product introduction quality assurance) that work as part of the new product development team. These teams work closely with design engineers so that the quality culture is pushed upstream into the product lifecycle.

Feedback from current generation products that are actively manufactured in plants is taken back to the R&D teams. The R&D teams can then prevent current field and production issues with the new design with tools such as design failure modes and effects analysis (FMEA), process FMEA, or hazard analysis.

2. Choose suppliers with the process capacity to get it right the first time.Making a quality product starts with quality materials. Partnerships with suppliers must start early in the development process.

In the short-term, high-performing suppliers facilitate quality by sending quality parts into the factory via the supply chain. Suppliers with high-performing capability are strong partners who contribute to a quality culture across the supply chain. This can drive preventive measures.

Design and produce

a high-quality product

the first time.



Achieving right first-time performance requires designing for manufacturability up front and an ongoing ability to control the manufacturing process. Putting the controls upstream prevents a bad product from progressing through the manufacturing process (fail fast), greatly reducing rework and scrap, and lowering manufacturing costs.

3. Continuously improve. A continuous improvement program facilitates a proactive instead of a reactive problem-solving culture. At its core, continuous improvement is designed to empower employees to solve problems that they encounter in their day-to-day work and gradually improve the efficiency of their work processes. This changes the employee’s role and responsibilities from being a passive actor to being an active participant of the business processes. This enables a proactive culture in an organization.

Continuous improvement drives the improvement of both processes and products and services. Organizations that apply continuous improvement principles are better able to align their products and services to customer values and deliver higher quality products and services.

Continuous improvement provides a framework for reaching the next level of excellence. Practicing continuous improvement means never being satisfied with current accomplishments and always looking for things that can be proactively changed and improved.

SECTION 5: Be Proactive, Not Reactive | 29

KEY TAKEAWAYSCompared with life sciences organizations that are constantly reacting and using their resources to firefight issues, organizations that engage in preventive measures across the entire lifecycle and the entire enterprise and have a culture of continuous improvement have:

• Better quality performance

• A stronger culture of quality

• A more engaged workforce

• Lower costs of quality



SECTION 6

Clearly Define Quality at the Individual Level

EXECUTIVE SUMMARY

Leaders can cultivate a culture of quality where individual employees understand their roles and impact on product and service quality by:

• Setting clear quality objectives that are clearly traceable to individual performance objectives

• Defining value statements that further reinforce the importance of the quality objectives

• Providing regular training and hosting related events that reaffirm the importance of the quality objectives and how quality impacts providers and patients

• Defining measures of quality that support the goals and objectives and are clearly tied to the work performed

IntroductionWhen each member of an organization understands how their actions impact the final product, there is more opportunity to cultivate a culture of quality and improve quality outcomes. Doing these things improves patient care. The connection between quality and patient care is fostered through:

• Effective quality planning activities

• Connecting value statements to objectives and the specific work performed

• Training

• Connecting the objectives, value statements, activities, and training to appropriate performance measures

Best PracticesWhile each organization may have a different approach to communicating that quality is everyone’s job, there are common themes in organizations that have successfully done this. One consistent, overriding theme is the need for a clear connection between the organization’s quality goals and objectives and the work performed by an employee. Organizations often achieve these connections through a variety of quality planning activities.

1. Plan for quality.Quality planning starts by setting clear objectives (connected to the overall mission) and defining the activities that will move the organization and employees toward achieving the objectives. Quality plans should include specific actions, timelines, and targets for each group or individual within the group.

2. Develop value statements.Successful organizations, however, do not stop fostering this connection with quality planning. They look to further create a culture of quality by focusing on behaviors that all employees understand. These include identifying value statements—a slogan and a credo or a motto—as part of training. Value statements ensure that each person understands how their role and the work they perform directly impacts product quality and patients, the culture, and continuous improvement efforts.

SECTION 6: Clearly Define Quality at the Individual Level | 30

KEY TAKEAWAYSOrganizations can further implement a culture of quality by fostering a clear understanding of how each individual and their responsibilities impact quality. Leaders help drive this by defining clear quality objectives that are traceable to the individual’s objectives and job tasks. Further ingrain quality into the organization by connecting quality objectives and the individual’s objectives and job tasks to value statements, training activities and events, and measures.



SECTION 6: Clearly Define Quality at the Individual Level | 31

Here are some examples of value statements.

Example #1:

“We all speak up when we notice something wrong in a blame-free environment.”

“We all share and implement ideas to continuously improve processes and procedures.”

“We all understand how our actions affect patients.”

“Quality isn’t someone else’s responsibility. Quality begins with you. So, what can you do?”

Example #2:

Be Customer Focused to make the safety and quality of our products for patients and clinicians a priority.

Be Aware of the process, the product, how it’s used, and how we can impact quality.

Be Courageous to highlight potential and existing problems.

Be Accountable for everything you do.

Example #3:

Comply with company policies and procedures at all times.

Know our specific job function.

Learn from our mistakes.

Create an empowered environment for people to speak up when concerned or unsure.

3. Train employees on quality.Organizations that are successful in creating the connection between employees and quality further instill this through regular training activities and/or events. They provide a variety of training, including:

• Traditional “classroom” training

• Regular daily activities, such as review of the quality impact of their job as a part of shift turnover or “lunch and learn” events

• Larger events such as “Patient Days,” where patient users of products and services visit the organization to connect the activities performed by individual employees.

4. Measure quality. Also, organizations should connect the objectives, value statements, activities, and training to measurable outcomes that are a part of insights into the effectiveness of the quality system and, therefore, quality. Examples of such measures could be:

Our goal is to improve quality metrics at every site that results in:

• Zero recalls or field actions

• Zero FDA 483 observations or major nonconformances

• Zero past due CAPAs or late Medical Device Reports (MDR) and Vigilance Reports



SECTION 7

Encourage Quality Behaviors

EXECUTIVE SUMMARYIdentify and encourage quality behaviors by:

• Initiating a personal pledge to follow those behaviors

• Creating a new environment that supports the behaviors

• Creating a reward system to reinforce the behaviors

IntroductionCulture is expressed through the behaviors of an organization’s employees, who should have an opportunity to shape those behaviors. Nurturing the desired behaviors requires a clear definition of the behaviors as well as an ecosystem that supports them.

Best Practices1. Consider a commitment to quality through a personal pledge, acknowledged and signed by all employees. Often these pledges will support the quality policy or value statements already established in an organization. Also, they outline specific expected behaviors and actions. No matter how high-level the quality policy or value statements, this pledge is best when it uses “I” statements.

Examples include:

• I always put the safety of patients first.

• I follow through on making decisions based on facts and data.

• I work to resolve identified quality and compliance concerns.

• I take the time needed to do my work right the first time.

2. Establish a new environment to sustain quality behaviors.The environment should include creating new experiences (such as embedding quality goals into the corporate goals), creating an opportunity to discuss the goals and expectations to allow time for critical thinking and new thoughts, and helping others find the “why” in their actions.

3. Set up a reward system that reinforces the desired behaviors. Work with human resources to identify permissible rewards and work them into the overall performance review system. Companies can also provide ad hoc rewards and recognition. Clearly define rewards and recognition at the outset of the program, and consistently provide awards.

SECTION 7: Encourage Quality Behaviors | 32

KEY TAKEAWAYSCulture doesn’t have to just happen. You can cultivate the culture of quality that you desire. A deliberate focus on culture can have a profound positive impact.



SECTION 8

Use Quality Benchmarking

EXECUTIVE SUMMARYIdentify best practices for use in your company through benchmarking. Participate in consortia to improve the benchmarking experience, benchmark over time, and look outside the life sciences industry to industries with extensive expertise in benchmarking.

IntroductionQuality benchmarking is an essential tool for developing requirements and setting goals in an organization. It is the process of comparing the cost, cycle time, productivity, or quality of a specific process or method with a similar process or method. Benchmarking goes beyond a determination of the industry standard; it breaks the activities down to process operations and looks for the best in class for a particular operation.

Organizations can then use information collected through benchmarking as the basis for targets, strategies, and implementation to:

• Identify key improvement opportunities and performance gaps through process analysis

• Encourage excellence through adaptation of best practices

• Reduce barriers through demonstrated success

Best PracticesFor an organization to realize the full benefits of quality benchmarking, its current performance, processes, and practices must be clearly understood and managed. Performing a quality benchmarking exercise requires investment in time and effort, so it is essential that leaders champion the benchmarking process (Plan, Collect, Analyze, Adapt) all the way through and incorporate continuous quality improvement in their culture (Figure 6).

Best practices include:

1. Participate in consortia.There may be existing consortia that your company can join, or for new topics, consider creating a new consortium of medical device manufacturers. The advantages include a potentially larger sample size, improved data quality and consistency, richer sharing of information, and reduced risk due to establishment of sharing agreements.

2. Benchmark often.Benchmarking once is not enough as practices evolve over time. Consider benchmarking periodically, once every three to five years, or based on specific triggers (e.g., after a major change driven by revised regulations).

SECTION 8: Use Quality Benchmarking | 33

Figure 6. Components of the Benchmarking Process

Identify a critical issue and potential partners

PLAN COLLECT

ANALYZEADAPT

Gather process descriptions and numeric

data

Implementand trackprogress

Identifygaps and

document



3. Benchmark against companies in different industries. The most common form of benchmarking is to target like-for-like companies for ease of comparison. It can be useful to look outside the life sciences industry for clearly differentiated practices. For example, the aerospace and automotive industries have been addressing safety for decades. There may be lessons to learn from them.

SECTION 8: Use Quality Benchmarking | 34

KEY TAKEAWAYSThe effectiveness of the quality benchmarking process rests heavily on standardization and consistency across teams. Analyze benchmarking results to see how they fit within the culture and structure of other organizations.

Benchmarking is not one size fits all. Create an action plan tailored to your organization’s needs. This will enable the organization to move from theory into change implementation and improvement.

Successful organizations use benchmarking to continuously identify and implement best practices in their business. For many of these organizations, the value of quality benchmarking accompanied by implementing changes often results in significant bottom-line savings as well as improved top-line revenues.



SECTION 9

Use Quality Metrics

EXECUTIVE SUMMARYDeveloping and aligning cross-functional quality metrics drives continuous improvement and enables your organization to use predictive indicators (as opposed to lagging outcomes). Create clear metrics scorecards to track performance against company objectives and understand when a metric can reinforce bad behaviors.

IntroductionOrganizations use metrics in many ways. Generally, metrics should not only be measurable, they should also be:

• Actionable

• Trackable over time

• Maintained and updated regularly

• Tied to business objectives

Best Practices1. Consider the three phases of metrics and measure leading indicators.There are three basic phases in setting up a metrics program (Figure 7), which can grow as the business matures.

• Align to high-level objectivesMetrics Strategy • Embed into key processes• Align to high-level objectivesMetrics Strategy • Embed into key processes

• Align to high-level objectivesMetrics Strategy • Embed into key processes• Define standards in quality metrics• Focus internally

Metrics Definition• Move from lagging to leading• Include customer data

• Align to high-level objectivesMetrics Strategy • Embed into key processes• Aggregate from individual• Target various levels in the organization

Metrics Reporting• Enable real-time collection• Utilize dashboard tool with drilldown

SECTION 9: Use Quality Metrics | 35

Figure 7. The Three Phases of a Metrics Program



Proactively manage quality by measuring leading indicators (Figure 8).

• Supplier Quality• Materials Acceptance• Culture of Quality

• Complaints• Adverse Events

+ LEADING

Product

LAGGING –

Quality Management System

IN-PROCESS

• Quality by Design/ Process Analytical Technology

• Recalls• Batch/Lot Acceptance

• CAPA Effectiveness

VALUE CHAIN

• On-time Reporting

• CAPA Aging• Overdue CAPA

2. Follow the hierarchy of metrics.Start with metrics for key performance indicators at the strategic level. Use these to inform progress against the strategic objectives. All lower-level metrics cascade from these.

Check the health of the quality management system with management review metrics. Use predictive measures at the operational level to drive behaviors and actions to avoid quality issues and build quality into the products. Figure 9 provides a sample hierarchy of metrics.

Developmentcycle time

On-time trendingand analytics

Predictive milestone alerts

KeyPerformance

Indicators

ManagementReview

OperationalMetrics

Customersatisfaction

Defects permillion

Process quality(deviations)

Prescriptionrenewals

Safetytrends

Patient-reportedoutcomes

Speed Quality Patient

SAMPLE HIERARCHY OF PERFORMANCE METRICS

LEAST

MOST

ST

RA

TE

GY

MOST

LEAST

OP

ER

AT

ION

AL

Figure 8. Leading and Lagging Indicators

Figure 9. The Hierarchy of Metrics




In general, organizations tend to focus on easy-to-measure indices of performance and ignore impactful metrics that can be more difficult to collect. Impactful metrics, such as milestone delays, can also uncover difficult-to-tackle issues. Also, many organizations measure and report at the end of the value chain, which is too late to effectively manage product quality. Measuring early and throughout the value chain will identify opportunities to avoid or rapidly correct quality issues.

Although organizations have been devising ways to measure quality for decades, many have not elevated the measurement of quality to an enterprise-wide effort. Most efforts focus on measuring quality within specific supply chain or product development processes, or they focus exclusively on results or finished products. Full transparency is achieved only through an ecosystem approach to measurement.

Appendix E has pilot considerations for using quality metrics.

KEY TAKEAWAYSDefine a formal measurement program in order to evaluate the success of your organization. Identify core metrics and key performance indicators and regularly analyze results. Make adjustments in resources, goals, and strategies based on results. Share your measurement objectives with employees so that they can understand how they will be evaluated when it comes to quality.




APPENDIX E.

Pilot Considerations for Using Quality MetricsTable 2 presents examples of internal and external customer data that can be included in a quality scorecard.

Quality metricWhat behavior are we measuring (what’s the point?)

Final metricFinal goal = >90 % of final score

Major errors (test invalidated)

How many tests have errors (a measure of our operational proficiency)?

Major testing errors (test invalidated)

Number of tests invalidated/ Total number of tests completed within the month

≤�0.36 20%

Company-caused returns

How many times do we have an error that results in a return?

First pass yield or right first time

Number of any (internally discovered or externally discovered) product failures caused by company error in that month/Total number of products manufactured in that month

≤�0.76 20%

Released lots delivered by Product Delivery Operations (PDO)

Are we meeting what we originally promised the customer for a due date?

Released lots delivered by PDO

Number of lots completed within the due date/Number of total lots sent to clients

> 98% 40%

Quality event (QE) monthly records closed by due date

Are we closing the (negative) QE within the prescribed time frame?

QE on-time monthly closure

Total number of defined QE/Number of those QE that were due

≥�90% 10%

Late QEs Are we ensuring that QEs that are not closed within the prescribed time frame are getting closed as quickly as possible?

Number of QE >30 days overdue/Total number of QE records generated over a rolling 12-month period

Broken into >365; >120, ≤365; >60, ≤120; >30, ≤60 days

≥�90% 10%

APPENDIX E: Pilot Considerations for Using Quality Metrics | 38

Table 2. Internal and External Customer Data to Include in a Quality Scorecard



SECTION 10: Recognize and Reward Quality | 39

SECTION 10

Recognize and Reward Quality

EXECUTIVE SUMMARYRecognizing and rewarding desired behaviors are important in motivating employees to achieve a quality culture. Recognition should come from three distinct levels in the organization: peer group, immediate management, and organization leaders.

IntroductionEmployees trust leaders when expectations for safety, quality, and customer satisfaction are clear and employees are recognized for their roles. Trust may manifest as reflexive actions of doing the right things for patients, employees proactively asking for feedback, and employees voluntarily looking for ways to improve performance. Grow and improve the recognition and reward processes until they become commonplace throughout the organization.

Best PracticesRecognition must come from all levels of the organization. Table 3 details the actions that individuals in each category can take to provide recognition.

1. Facilitate peer-to-peer recognition. Establish a blame-free culture in which employers are willing to provide feedback to their colleagues. Build off existing programs and create a flexible program to recognize employees for their work toward achieving a culture of quality.

2. Empower managers to recognize their employees.Managers should look for opportunities to recognize employees who are behaving in ways that facilitate quality. They should use positive messages about quality that are framed to support business goals and objectives.

3. Motivate employees to achieve a culture of quality.Leaders can help ingrain the culture of quality by sharing customer stories and creating awareness of the company’s products. They should also use the energy of the entire workforce to create the culture of quality.

Doing these things will create positive momentum toward a culture of quality.

RECOGNITION SOURCES

Peer group Immediate management Company leadership

• Blame-free culture

• Willing to provide feedback to colleagues

• Flexible recognition program

• Build off existing programs

• Look for opportunities to recognize desired behaviors

• Drive a positive quality message to support business goals and objectives

• Share customer stories and create product awareness

• Utilize energy and capability of entire workforce to create quality culture

• Create positive momentum

Table 3. Organization-wide Recognition Sources and Actions



SECTION 10: Recognize and Reward Quality | 40

KEY TAKEAWAYSEstablish clear communication for peer-to-peer recognition programs to ensure that employees feel comfortable giving and receiving positive and constructive feedback to their colleagues. Managers should spend time in the work areas providing timely recognition and feedback to employees and groups that exhibit behaviors consistent with a culture of quality.

Leaders should exhibit and communicate the value of a culture of quality by promoting an enterprise-wide program. They should also share examples and stories that highlight the culture of quality, empowerment, and recognition.

Medical Device Innovation Consortium | mdic.org Conclusion | 41



Conclusion By establishing a culture of quality, life sciences organizations can move beyond compliance and:

• Meet FDA expectations

• Meet the needs of customers

• Improve financial results

• Facilitate innovation

• Achieve a competitive advantage

The Leadership Engagement Playbook describes 10 best practices for moving from a culture of compliance to a culture of quality and provides a framework for piloting best practices. Leaders can use the playbook to invest in a culture of quality, share their performance improvements, and shift out of a culture of compliance. This will increase the level of quality across the industry, enabling medical devices to provide more value for manufacturers, providers, and patients.

Contact InformationFor more information, please contact:

Alan Baumel, Program Director, Case for Quality,

at [email protected]


Documents

Case for Quality Leadership Engagement Playbook · 2021. 1. 19. · Expert Advisors: • Segolene Balling, Grant Thornton, LLP • Ashley Johnson, Grant Thornton, LLP • Ramakrishna