At the heart, data integrity is a lot about culture. There are technical requirements, but mostly we are returning to the same principles as quality culture and just keep coming back to Deming. A great example of this is the use of the fraud triangle and human error.
The fraud triangle was developed by Donald Cressey in the 1950s when investigating financial fraud and embezzlement. The principles Cressey identified are directly relevant to data integrity, and to quality culture as a whole.
Falsification Triangle
Element
Exists When
To Break
Incentive or Pressure
Why commit falsification of data? Managerial pressure or financial gains are the two main drivers here to push people to commit fraud. Setting unrealistic objectives such as stretch goals, turnaround time or key performance indicators that are totally divorced from reality especially when these are linked to pay or advancement will only encourage staff to falsify data to receive rewards. These goals coupled with poor analytical instruments and methods will only ensure that corners will be cut to meet deadlines or targets.
Management must lead by example – not through communication or establishing data governance structures but by ensuring the pressure to falsify data is removed. This means setting realistic expectations that are compatible with the organization’s capacity and process capability.
Rationalization or Incentive
To commit fraud people must either have an incentive or can rationalize that this is an acceptable practice within an organization or department.
Staff need to understand how their actions can impact the health of the patient. Ensure individuals know the importance of reliable and accurate data to the wellbeing of the patient as well as the business health of the company.
Opportunity
The opportunity to falsify data can be due to encouragement by management as a means of keeping cost down or a combination of lax controls or poor oversight of activities that contribute to staff being able to commit fraud.
Implement a process that is technically controlled so there is little, if any, opportunity to commit falsification of data.
Mistakes are human nature – we all have fat finger moments.
This is why we build our processes and technologies to ensure we capture these
errors and self-correct them. These errors should be tracked and trended, but
only as a way to drive continuous improvement. It is important to have the
capability in your quality systems to be able to evaluate mistakes up-to-and
including fraud.
It helps to be able to classify issues and determine if there are changes to governance, management systems and behaviors necessary.
Events should be classified based on how intentional they are
Human error should be built into investigative systems. Yes, whenever possible we are looking for technical controls, but the human exists and needs to be fully taken into consideration.
The best way to ensure data integrity is the best way to build a quality culture.
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.
A theme of this year for me has been focusing more and more
on the difference between the product integrity focused approach to quality
that folks in my profession normally focus in on and a more excellence focused
approach. The two are not in opposition, but I can’t help feeling that the
product integrity exclusiveness of many pharmaceutical quality professionals is
holding us back.
This is especially on my mind coming back from ASQ WCQI and
thinking about just how few of my pharma colleagues identify with that
organization There are a whole host of reasons (including the fact that many
people don’t associate with ANY professional association) but I can’t help but
contemplate how do we make the excellence side of quality more relevant to not
just pharmaceuticals but to wider questions of just what is quality anyway?
I’ve discussed the need to realize that we have different types of domain knowledges, but just what is this domain we call quality and is it truly its own discipline?
Disciplines can be modeled as a system comprising an “activity scope” that is enabled by a “knowledge base” but conditioned by a “guidance framework”.
From Rousseau, et al “A Typology for the Systems Field”
The guidance framework typically involves multiple worldviews. The same subject matter can be studied from different worldviews, and the theories around a given subject can be interpreted differently from different worldview perspectives. You can see this in the various flavors of continuous improvement or better yet, the presence of a sustainability push within the society.
The knowledge base is the data, theories and methodologies that drive the discipline
The activity scope describes the range of activities in a disciple, including the professional practice.
We’re probably truly multi-disciplinarian, in that the we draw from multiple other disciplines, a short list includes: Engineering, Computing, Control Theory, Mathematics, Information Theory, Operations research, system theory, Management sciences, a whole range of social sciences and more than I can think.
What does this mean?
I am more thinking aloud than anything at this point, but I think it’s important to work on developing the QBOK along a guidance framework, knowledge base and activity scope methodology. Then as we develop sub-body of knowledges we drill down from there, either in a very knowledge base way (such as the CMQ/OE) or in an activity scope (like the CPGP). I often feel that the way we develop these are more hit-and-miss and could do with some coherence – the biomedical auditor and hazop auditor are great examples of wanting to meet a very narrow need and thus being very very specific to a small set of the knowledge base.
I guess I’m striving towards applying theory to our practice a little more deliberately.
Some of the technical forums (Human Development and Leadership comes to mind) seem especially designed to pull information from one or two different originating disciplines and adapt it to the knowledge base. I think this process would be added by a coherent understanding of our guidance framework and just what the activity scope we are trying to address as discipline.
In short I am just thinking that a little more coherence, strategy and transparency would aid us as a profession. As I heard in many a conversation last week, we should probably as an organization be better at what we preach.
Rousseau, D., Wilby, J., Billingham, J., & Blachfellner, S. (2016). A Typology for the Systems Field. Systema 4(1), 15-47
Wageeh, N. A. (2016). The Role of Organizational Agility in Enhancing Organizational Excellence: A Study on Telecommunications Sector in Egypt. International Journal of Business and Management, 11(4), 121
Situational awareness is built on perception. Problem-solving requires it. Perception is a building block of agile-thinking and pretty much everything else we need to do to succeed in today’s idea-based businesses.
As individuals we should be striving to develop perception, and as organizations we need to be developing training and practices to reinforce. There are few aspects we need to build.
Look inward to analyze previous mistakes
How often have you or some expert said “No one could have predicted that” or “It wasn’t my job to see the warning signs.” Rarely do you hear them acknowledge their own responsibility with comments such as “I didn’t think about how that change could affect our organization” or “I didn’t ask for more information.”
When a problem arises consider the decisions we’ve made and the role you and your team played. Did you miss warning signs? Is there an incentive to overlook what was going on? What are your weak spots and how can you fix them to prevent future problems?
Take an outsider’s view:
If you’ have ever encountered the “things aren’t done that way” response to new solutions, push harder. There is usually no logical reason why a change can’t be made, and there is a bad habit that needs to be broken.
Look for signs, symptoms and syndromes
Signs – something is not right or expected
Symptoms – some signs are symptoms, but usually signs point to symptoms, an underlying problem or set of problems
Syndrome – false beliefs that can generate symptoms, usually part of a wider set of causes
Solid focus on both external and internal signifiers of quality culture. A little basic but very worth reinforcing.
And then I left, skipping the last keynote to get to the airport.
Good conference this year. Overall I felt that many of my choices for sessions ended up being more basic than I thought, but there is a lot of value in that. I will hopefully make the time to turn my thoughts into better blog posts.
Investigations of a Dog 