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.
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:
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.
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.
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.
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.
Magic triangle of a program manager
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
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.
We have these quality systems with lots of levers, with interrelated components. And yet we select one or two metrics and realize that even if we meet them, we aren’t really measuring the right stuff nor are we driving continious improvement.
One solution is to create layered metrics, which basically means drill down your process and identify the metrics at each step.
Lots of ways to do this. An easy way to start is to use the 5-why process, a tool most folks are comfortable with.
So for example, CAPA. It is pretty much agreed upon that CAPAs should be completed in a timely manner. That makes this a top level goal. Unfortunately, in this hypothetical example, we are suffering a less than 100% closure goal (or whatever level is appropriate in your organization based on maturity)
Why 1
Why was CAPA closure not 100% Because CAPA tasks were not closed on time.
Success factor needed for this step: CAPA tasks to be closed by due date.
Metric for this step: CAPA closure task success rate
Why 2
Why were CAPA tasks not closed on time? Because individuals did not have appropriate time to complete CAPA tasks.
Metric for this step: Planned versus Actual time commitment
Why 3
Why did individuals not have appropriate time to complete CAPA tasks? Because CAPA task due dates are guessed at.
Metric for this step: CAPA task adherence to target dates based on activity (e.g. it takes 14 days to revise a document and another 14 days to train, the average document revision task should be 28 days)
Why 4
Why are CAPA task due dates guessed at? Because appropriate project planning is not completed.
Metric for this step: Adherence to Process Confirmation
Why 5
Why is appropriate project planning not completed? Because CAPAs are always determined on the last day the deviation is due.
Metric: Adherence to Root Cause Analysis process
I might on report on the top CAPA closure rate and 1 or 2 of these, and keep the others in my process owner toolkit. Maybe we jump right to the last one as what we report on. Depends on what needs to be influenced in my organization and it will change over time.
It helps to compare this output against the 12 system leverage points.
Donella Meadows 12 System Leverage Points
These metrics go from 3 “goals of the system” with completing CAPA tasks effectively and on time, to 4 “self organize” and 5 “rules of the system.” It also has nice feedback loops based on the process confirmations. I’d view them as potentially pretty successful. Of course, we would test these and tinker and basically experiment until we find the right set of metrics that improves our top-level goal.
Investigations of a Dog 