The Challenges Ahead for Quality

Discussions about Industry 4.0 and Quality 4.0 often focus on technology. However, technology is just one of the challenges that Quality organizations face. Many trends are converging to create constant disruption for businesses, and the Quality unit must be ready for these changes. Rapid changes in technology, work, business models, customer expectations, and regulations present opportunities to improve quality management but also bring new risks.

The widespread use of digital technology has raised the expectations of stakeholders beyond what traditional quality management can offer. As the lines between companies, suppliers, and customers become less distinct, the scope of quality management must expand beyond the traditional value chain. New work practices, such as agile teams and remote work, are creating challenges for traditional quality management governance and implementation strategies. To remain relevant, Quality leaders must adapt to these changes..

The traditional Value Proposition of quality management is no longer sufficient to meet the expectations of stakeholders. With the rise of a digitally native workforce, there are new expectations for how work is done and managed. Business leaders expect quality leaders to have full command of operational data, diagnosing and anticipating quality problems. Regulators also expect high data transparency and traceability.

The value proposition of quality management lies in predicting problems rather than reacting to them. The primary objective of quality management should be to find hidden value by addressing the root causes of quality issues before they manifest. Quality organizations who can anticipate and prevent operational problems will meet or exceed stakeholder expectations.

Our organizations are on a journey towards utilizing predictive capabilities to unlock value, rather than one that retroactively solves problems. Our scope needs to be based on quality being predictive, connected, flexible, and embedded. For me this is the heart of Qualty 4.0.

Quality management should be applied across a multitude of systems, devices, products, and partners to create a seamless experience. This entails transforming quality from a function into an interdisciplinary, participatory process. The expanded scope will reach new risks in an increasingly complex ecosystem. The Quality unit cannot do this on its own; it’s all about breaking down silos and building autonomy within the organization.

To achieve this transformation, we need to challenge ourselves to move beyond top-down and regimented Governance Models and Implementation Strategies. We need to balance our core quality processes and workflows to achieve repeatability and consistency while continually adjusting as situations evolve. We need to build autonomy, critical thinking, and risk-based thinking into our organizational structures.

One way to achieve this is by empowering end-users to solve their own quality challenges through participatory quality management. This encourages personal buy-in and enables quality governance to adapt in real-time to different ways of working. By involving end-users in the process of identifying and solving quality issues, we can build a culture of continuous improvement and foster a sense of ownership over the quality of our products and services.

The future of quality management lies in being predictive, connected, flexible, and embedded.

Predictive: The value proposition of quality management needs to be predicting problems over problem-solving.
Connected: The scope of quality management needs to extend beyond the value chain and connect across the ecosystem
Flexible: The governance model needs to be based on an open-source model, rather than top-down.
Embedded: The implementation strategy needs to shift from viewing quality as a role to quality as a skill.

By embracing these principles and involving all stakeholders in the process of continuous improvement, we can unlock hidden value and exceed stakeholder expectations.

Deaing with these challenges and implications requires the Quality organization to treat transformation like a Program. This program should have four main initiative areas:

Build the capacity for targeted prevention through targeted data insights. This includes building alliances with IT and other teams to have the right data available in flexible ways but it also includes the building of capacity to actually use the data.
Expand quality management to cover the entire value network.
Localize Risk Management to Make Quality Governance Flexible and Open Source.
Distribute Tasks and Knowledge to Embed Quality Management in the Business.

Across these pillars the program approach will:

Assess the current state: Identify areas requiring attention and improvement by examining existing People, Processes, Policies and Platforms. This comprehensive assessment will provide a clear understanding of the organization’s current situation and help pinpoint areas where projects can have the most significant impact
Establish clear objectives: Establish clear objectives to h provide a clear roadmap for success.
Prioritize foundational elements: Prioritize building foundational elements. Avoid bells-and-whistles for their own sake.
Develop a phased approach: This is not an overnight process. Develop a phased approach that allows for gradual implementation, with clear milestones and measurable outcomes. This ensures that the organization can adapt and adjust as needed while maintaining ongoing operations and minimizing disruptions.
Collaborate with stakeholders: Engage stakeholders from across the organization,to ensure alignment and buy-in. Create a shared vision for the initiative to ensure that everyone is working towards the same goals. Regular communication and collaboration among stakeholders will foster a sense of ownership and commitment to the transformation process.
Continuously monitor progress: Regularly review the progress, measuring outcomes against predefined objectives. This enables organizations to identify any potential issues or roadblocks and make adjustments as necessary to stay on track. Establishing key performance indicators (KPIs) will help track progress and determine the effectiveness of the Program.
Embrace a culture of innovation: Encourage a culture that embraces innovation and continuous improvement. This helps ensure that the organization remains agile and adaptive, making it better equipped to take advantage of new technologies and approaches as they emerge. Fostering a culture of innovation will empower employees to seek out new ideas and solutions, driving long-term success.
Invest in employee training and development: It is crucial to provide employees with the necessary training and development opportunities to adapt to new technologies and processes. This will ensure that employees are well-equipped to handle the changes brought about by these challenges and contribute to the organization’s overall success.
Evaluate and iterate: As the Program unfolds, it is essential to evaluate the results of each phase and make adjustments as needed. This iterative approach allows organizations to learn from their experiences and continuously improve their efforts, ultimately leading to greater success.

To do this leverage the eight accelerators to change.

Balancing Expertise

Quality professionals are often defined by our technical knowledge, and with that can come a genuine and intense love and interest in the work. In the pharmaceutical/med-device work, I work in this is defined by both a knowledge of the science and of the regulations (and that stuff inbetween – regulatory science).

The challenge here is that we start defining ourselves by our role as we progress as representing the highest level of expertise in this technical expertise, which means senior Quality (as in the department) jobs are defined in terms of in service to our function – patient safety and product quality (safety, efficacy, and quality). This can then lead to seeing people as the “means” to that end. This inevitably leads to prioritizing that outcome over people.

Do not get me wrong, results matter, and I am a firm proponent of product quality and patient safety. But this approach is reductionist and does not serve to drive fear out of the organization. How can people be safe if they are considered a means to produce value? We need to shift so that we realize we can only get to quality by focusing on our people.

Quality Culture is Fundamental to Actually Providing Quality

For all I love the hard dimensions of quality (i.e. process, training, validation, management review, auditing, measurement of KPI) I also stress in my practice how the soft dimension of communication and employee participation, and teamwork are critical to bringing about a culture of excellence. Without a strong quality culture, people will not be ready to commit and involve themselves fully in building and supporting a robust quality management system. The goal is to align top management behavior and the emergent culture to be consistent over time with the quality system philosophy or people will become cynical. In short, organizational culture should be compatible with quality values.

Quality culture is justifiably the rage and it is not going anywhere. If you are not actively engaging with it you are losing one of your mechanisms for success.

Quality Culture really serves as a way to categorize an organizational culture that intends to enhance quality permanently. There are two distinct elements characterizing this culture:

A cultural/psychological element of shared values, beliefs, expectations, and commitment toward quality
A structural/managerial element with defined processes that enhance quality and aim at coordinating individual efforts.

Edgar Schein’s Organizaitonal Culture Model

Schein’s model of organizational culture provides a valuable place to start in assessing quality culture:

Visible quality artifacts (e.g. quality assessment tools)
Espoused quality values (e.g. mission statement)
Shared basic quality assumptions (e.g. quality commitment)

The first basic quality assumption to tackle is to answer what do you mean by Quality?

Even amongst quality professionals, we do not all seem to be in agreement on what we mean by Quality. Hence all the presentations at conferences and part of the focus on Quality 4.0 (the other part of the focus is mistaken worship of technology – go back to Deming people!)

Route out the ambiguity that results in:

Uncontrollable fragmentation of quality thinking, discussion, and practices
Superficiality of quality-related information and communication
Conceptual confusion between the quality results and quality enablers, and between quality and many other related factors
Disintegration of the foundation of quality

I like to place front and center the definition of quality from ISO 9000: “degree to which a set of inherent characteristics of an object fulfils requirements.” This definition emphasizes the relative nature of quality (“degree”) that also highlights the subjective perception of quality. The object of quality is defined more generally than for the goods or service products only. The object has its inherent characteristics that consist of all of its features or attributes. “Requirement” means here needs and expectations, which may be related to all interested parties of the object and the interaction. This definition of quality is also compatible the prevailing understanding of quality in everyday language.

For an organization, the definition of quality relates to the organization’s stakeholders. With the definition, we can consider both the quality of the organization as a whole and the quality of the entities being exchanged between the organization and its stakeholders. Products produced and delivered to the organization’s customers are especially significant entities in this context.

Following through with ISO9000’s definition of Quality management implying how the personal, organizational, or societal resources and activities or processes are managed with regard to quality, we are able to the framework for basic quality assumptions in an organization.

Herein usually lies your True North, a term used a lot, that recognizes that quality is a journey: there is no absolute destination point and we will never achieve perfection. Think of True North not as a destination, but as a term used to describe the ideal state of perfection that your organization should be continually striving for.

In espoused quality values we take the shared concept of quality and expand it to performance excellence as an integrated approach to the organizational performance management that results in:

the delivery of ever-improving value to customers and stakeholders, contributing to organizational sustainability
the improvement of overall organizational effectiveness and capabilities
Organizational and personal learning.

We need to have a compelling story around these values.

A compelling story is a narrative that charts a change over time, showing how potential solutions fit into the espoused values. This story can generate more engagement from listeners than any burning platform ever will. By telling a compelling story, you clarify the motivation to develop discontent with the status quo. Let the story show the organization where you have come from and where you might go. The story must be consistent and adopted by all leaders in the organization. The leadership team should weave in the compelling story at all opportunities. They should ask their teams constantly, “What’s next?” “How can we make that even better?” “How did you improve your area today?”

Compelling stories often build on dissatisfaction by positioning against competitors. In the life science sector, it can be more effective to enshrine the patient in the center of the compelling story. People will support change when they see and experience a purposeful connection to an organization’s mission. The compelling story drives that.

Espoused values require strong and constant communication.

Espoused values have more levers for change than basic assumptions. While I placed True North down in assumptions, in all honestly it will for a central part of that compelling story and drive the adoption of the espoused values.

It is here we need to build and reaffirm psychological safety.

In the post “Driving towards a Culture of Excellence” I provided elements of a high-performing culture that count as artifacts of quality, stemming from the values.

Good practices for research and development facilities (WHO draft guideline)

Last month the World Health Organization published a draft guideline on Good practices for research and development facilities.

This arrow pretty much sums it up:

Seriously, not much surprising here. What this guide definitely does is place early research in the framework of Q10 and point out that there is one quality system to rule them all and that level of rigor is based on risk.

Give it a read.

Quality Management as a Program

Quality System Management should be viewed and governed as a program

Program management is commonly defined as “a group of projects that contribute to a common, higher order objective.” The projects in a program are related, and the intent of achieving benefits would not be realized if the projects were managed independently.

Program management includes the practices and processes of strategic alignment, benefits management, stakeholder management, governance, and lifecycle management. Program governance creates the control framework for delivering the programs’ change objectives and making benefit delivery visible to the organization’s control.

There are different styles of program management and what I am focusing on here is what is sometimes called “heartbeat”, which aims to achieve evolutionary improvement of existing systems and processes or organizational change. This program type creates value by reconciling contradicting views and demands for change from various organization actors in order to enhance existing systems and practices while sustaining operations.

Heartbeat program management is all about awareness of the contexts of the program and requires knowledge of strategy, competition, trends in the industry, and differences in management practices between the business units of the company. A good heartbeat program manager is highly concerned about their program’s long-term effects and implications for the company’s business.

Programs exist to create value by improving the management of projects and to create benefits through better organization of projects. The fundamental goals of program management are:

Efficiency and effectiveness: Aspects of management that a proficient project manager should address and benefit from coordination.
Business focus goal: The external alignment of projects with the requirements, goals, drivers and culture of the wider organization. These goals are associated with defining an appropriate direction for the constituent projects within a program as well as for the program as a whole.

Goal	Description
*Efficiency and effectiveness goals*
Improved co-ordination	Assist in identification and definition of project inter-dependencies and thereby reduce the incidence of work backlogs, rework and delays
Improved dependency management	Reduce the amount of re-engineering required due to inadequate management of the interfaces between projects
More effective resource utilization	Improve the effectiveness and efficiency of the allocation of shared resources Assist in providing justification for specialist resources that deliver an overall improvement to program delivery and/or business operations
More effective knowledge transfer	Provide a means to identify and improve upon transferable lessons. Facilitate organizational learning
Greater senior management ‘visibility’	Enable senior management to better monitor, direct and control the implementation process
*Business focus goals*
More coherent communication	Improve communication of overall goals and direction both internally and externally to the program Target management attention clearly on the realization of benefits that are defined and understood at the outset and achieved through the lifetime of the program and beyond Assist in keeping personal agendas in check
Improved project definition	Ensure that project definition is more systematic and objective, thereby reducing the prevalence of projects with a high risk of failure or obsolescence Enable the unbundling of activities in a strategic project-set into specific projects Enable the bundling of related projects together to create a greater leverage or achieve economies of scale
Better alignment with business drivers, goals and strategy	Improves the linkage between the strategic direction of organizations and the management activities required to achieve these strategic objectives Provide an enabling framework for the realization of strategic change and the ongoing alignment of strategy and projects in response to a changing business environment (via project addition/culling, etc.)

The Attributes of a Good Heartbeat Program Manager are the Attributes to a Good Quality Leader

As quality leaders we are often ambassadors to ensure that the quality program is progressing despite the conflicting requirements of the various stakeholders. We need to actively influence quality-related decisions of all stakeholders, including people holding superior positions. Having a well-developed personal network within the organization is particularly helpful.

It is critical to always be communicating about the quality program in a visionary way, to be seen as passionate ambassadors. Playing this role requires constant attention to differing expectations of the stakeholders and various ways to influence stakeholders for the benefit of the quality system. To always be striving to build quality, to advance quality.

As advocates for Quality, it is a core competency to be able to stand up and defend, or argue for, the quality program and team members. This ability to challenge others, including their superiors, in a productive way is a critical ability.

A key focus of the quality program should be on engagement with a conscious and sustained drive to secure buy-in from key stakeholders (including senior management) and win over the hearts and minds of those responsible for execution to make changes feel less painful and inflicted. As quality leaders our aim should always be to engender a climate of comprehension, inclusion and trust, and to draw upon expertise globally to create fit for purpose processes and systems

Effective quality leaders need to be “heavyweight” organizational players.

Core Competencies of the Heartbeat Manager

Contextual awareness
Scenario planning
Political skills
Courage
Networking

A note on program life

Many standard approaches perceive programs to have a finite life. This is constraining given that the strategies themselves, especially as applied to quality, have long lifetimes. I believe that program management has as much to learn from quality management, and there is a lot of value in seeing an indefinite time horizon as beneficial.

Quality management is an evolutionary approach, and utilizing program management methodologies within it should be taken in the same light.

Challenge	Means	Impact to Quality Management	How to Prepare
Advanced Analytics	The increase in data sources and improved data processing has led to higher expectations from customers, regulators, business leaders, and employees. They expect companies to use data analytics to provide advanced insights and improve decision-making.	Requires a holistic approach that allows quality professionals to access, analyze and apply insights from structured and unstructured data Quality excellence will be determined by how quickly data can be captured, analyzed, shared and applied	Develop a talent strategy to recruit, develop, rent or borrow individuals with data analytics capabilities, such as data science, coding and data visualization
Hyper-Automation	To become more efficient and agile in a competitive market, companies will increasingly use technologies like RPA, AI, and ML. These technologies will automate or enhance tasks that were previously done by humans. In other words, if a task can be automated, it will be.	How to ensure these systems meet intended use and all requirements Algorithm-error generated root causes	Develop a hyperautomation vision for quality management that highlights business outcomes and reflects the use cases of relevant digital technology Perform a risk based assessment with appropriat experts to identify critical failure points in machine and algorithm decision making
Virtualization of Work	The shift to remote work due to COVID-19, combined with advancements in cloud computing and AR/VR technology, will make work increasingly digital.	Rethink how quality is executed and governed in a digital environment.	Evaluate current quality processes for flexibility and compatibility with virtual work and create an action plan. Uncover barriers to driving a culture of quality in a virtual working environment and incorporate virtual work-relevant objectives, metrics and activities into your strategy.
Shift to Resilient Operations	Prioritizing capabilities that improve resilience and agility.	Adapt in real-time to changing and simultaneously varying levels of risk without sacrificing the core purpose of Quality	Enable employees to make faster decisions without sacrificing quality by developing training to build quality-informed judgment and embedding quality guidance in employee workflows. Identify quality processes that may prevent operational resilience and reinvent them by starting from scratch, ruthlessly challenging the necessity of every step and requirement. Ensure employees and new hires have the right skill sets to design, build and operate a responsive network environment.
Rise of Inter-connected Ecosystems	The growth of interconnected networks of people, businesses, and devices allows companies to create value by expanding their systems to include customers, suppliers, partners, and other organizations.	Greater connectivity between customers, suppliers, and partners provides more visibility into the value chain. However, it also increases risk because it can be difficult to understand and manage different views of quality within the ecosystem.	Map out the entire quality management ecosystem model and its participants, as well as their interactions with customers. Co-develop critical-to-quality behaviors with strategic partners. Strengthen relationships with partners across the ecosystem to capture and leverage relevant information and data, while at the same time addressing data privacy concerns.
Digitally Native Workforce	Shift from digital immigrants (my generation and older) to digital natives who are those people who have grown up and are comfortable with computers and the internet. Unlike other generations, digital natives are so used to using technology in all areas of their lives that it is (and always has been) an integral, necessary part of their day-to-day.	Increased flexibility leads to a need to rethink the way we monitor, train, and incentivize quality. Connecting the 4 Ps: People, Processes, Policies and Platforms	Identify and target existing quality processes to digitize to offer desired flexibility. Adjust messages about the importance of quality to connect with values employees care about (e.g., autonomy, innovation, social issues).
Customer Expectation Multiplicity	Customer expectations evolve quickly and expand into new-in-kind areas as access to information and global connectedness increases.	Develop product portfolios, internal processes and company cultures that can quickly adapt to rapidly changing customer expectations for quality.	Identify where hyperautomation and predictive capabilities of quality management can enhance customer experience and prevent issues before they occur.
Increasing Regulatory Complexity	The global regulatory landscape is becoming more complex as countries introduce new regulations at different rates. Increased push for localization.	Need strong system to efficiently implement changes across different systems, locations, and regions while maintaining consistent quality management throughout the ecosystem.	Coordinate a structured regulatory tracking approach to monitor changing regulatory developments — highly regulated industries require a more comprehensive approach compared to organizations in a moderate regulatory environment