Process Architecture

Building a good process requires clear ownership and a deliberate plan. There is a fair amount of work that goes into it, which can be broken down as follows:

Category	Sub-category	Basic theme
Planning	Process Measurement	Identify, design, and implement balanced process metrics and measurement
		Implement process metrics and measurement reporting mechanisms
		Identify and implement KPIs (And KRIs) aligned to process
		Evaluate cycle times and identify potential wastes
		Align level and recognition of people involved in the process to align with process
	Customer Experience	Process design with customer interaction trigger mechanisms
		Design process in line with customer expectations
		Identify customer process performance expectations
		Design customer entry points and define transaction types
	Process Change	Identify incremental and re-engineering process enhancement opportunities with staff involvement
		Design process with minimal process hand-off’s
		Create and execute process improvement plans
		Identify process automation opportunities
		Pilot process design to ensure meeting performance objectives
	Governance	Design efficient process with governance & internal control considerations
	Capacity	Conduct demand and capacity planning activities
	Staff Training	Develop and conduct staff training initiatives in line with customer, process, product, and systems expectations
	Staff Training	Develop skills matrix and staff capability requirements in line with process design
	Technology	Define technology enablers
	Alignment	Align process objectives with organizational goals
	Change Management	Engage impacted stakeholders on process changes
Control	Process Measurement	Process performance monitoring
		Report on process and staff performance with utilization of visual management tools
		Obtain continuous customer satisfaction and expectation of process
		Active management of process exceptions
		Monitor staff performance metrics
	Process Change	Identify process improvement opportunities on a continuous basis
	Process Change	Focused process hand-off management and tracking
	Capacity	Demand and capacity planning and monitoring
Governance	Process Change	Process maintenance and continuous update
	Process Change	Define and conform to process documentation standards
	Change Management	Process communication and awareness
	Staff Training	Utilize process documentation knowledge to facilitate staff training

Like any activity, it helps to document it. I use a template like this.

Understanding How to Organize Process

Process drives the work we do. We can evaluate processes on two axis – complexity and strategy – that help us decide the best way to manage and improve the processes.

Process complexity and dynamics are what types of tasks are involved in the process. Is it a simple, repetitive procedure with a few rules for handling cases outside of normal operation? Or is it a complex procedure with lots of decision points and special case rules? Think of this like driving somewhere. Driving to your local grocery is a simple procedure, with few possibilities of exceptions. Driving across the country has a ton of variables and dynamism to it.

While complexity can help drive the decision to automate, I strongly recommend that when thinking about it don’t ask if it can be automated, only ask what would be involved if a human were to do the job or how it is done with current technologies. Starting with the answer of automation leads to automation for automation’s sake, and that is a waste.

Dynamics is how much the process changes – some change rarely while others change rapidly to keep pace in response to changes in product or external factors (such as regulations).

Strategic importance asks about the value the process contributes to meeting requirements. Is the process a core competency, or an enabling process that needs to be accomplished to ensure that you can do something else that meets the core requirements? Needless to say, one company’s strategic process is another company’s routine process, which is why more and more we are looking at organizations as ecosystems.

Processes are in a hierarchy, and we use levels to describe the subdivision of processes. We’ve discussed the difference between process, procedure and task. At the process level we usually have the high-level process, the architecture level, which are the big things an organization does (e.g. research, manufacture, distribute), mid-level processes that are more discrete activities (e.g. perform a clinical study) to even more discrete processes (e.g. launch a study) which usually have several levels (e.g. select sites, manage TMF) to finally procedure and task.

Level of Process	Includes	Key Ways to Address
High-Level Process	How key objectives are met, highly cross functional	Organization design. System Design
Mid-level Process	How a specific set of departments do their major work blocks	Process Improvement
Low-level process	How individuals conduct their work in sub-blocks	Knowledge management, task analysis, training

Levels of Process

To truly get to this level of understanding of process, we need to understand just what our process is, which is where tools like the SIPOC or Process Scope diagram can come in handy.

To understand a process we want to understand six major aspects: Output, Input, Enablers, Controls, Process Flow, People.

Complex and Complicated as Tools for Process Understanding

Simple processes usually follow a consistent, well-defined sequence of steps with clearly defined rules. Each step or task can be precisely defined, and the sequence lacks branches or exceptions.

More complicated processes involve branches and exceptions, usually draw on many rules, and tend to be slightly less defined. Complicated processes require more initiative on the part of human performers.

Complex processes are ones that require a high level of initiative and creativity from people. These processes rapidly change and evolve as time passes. Successful performance usually requires a connection to an evolving body of knowledge. They are highly creative and have a large degree of unpredictability. Most complex processes are viewed at the system level.

Sources

Benedict, T. et al. BPM CBOK Version 4.0: Guide to the Business Process Management Common Body of Knowledge. ABMP International, 2019.
Harmon, Paul. Business Process Change. Morgan Kaufmann, 2019.
Nuland, Y. and Duffy, G. Validating a Best Practice. Productivity Press, 2020

The Great Man Fallacy and Pharmaceutical Quality

Primary Investigator, Study Director, Qualified Person, Responsible Person – the pharmaceutical regulations are rife with a series of positions that are charged with achieving compliance and quality results. I tend to think of them as a giant Achilles heel created by the regulations.

The concept of an individual having all the accountability is nowhere near universal, for example, the term Quality Unit is a nice inclusive we – though I do have some quibbles on how it can end up placing the quality unit within the organization.

This is an application of the great man fallacy – the idea that one person by the brunt of education, experience, and stunning good looks can ensure product safety, efficacy and quality, and all the other aspects of patient and data integrity of trials.

That is, frankly, poppycock.

People only perform successfully when they are in a well-built system. Process drives success and leverages the right people at the right time making the right decisions with the right information. No one person can do that, and frankly thinking someone can is setting them up for failure. Which we see, a lot in the regulatory space.

Sure, the requirement exists, we need to meet it failing the agencies waking up and realizing the regulations are setting us up for failure. But we don’t need to buy into it. We build our processes to leverage the team, to democratize decisions, and to drive for reliable results.

Let’s leave the great man theory in the dustbins where it belongs.

Process and procedure complexity

People are at the heart of any organization. They set the organization’s goals, they manage it, they deal with suppliers and customers and they work together to produce results.

We manage this by processes. Process are on a continuum by how complicated and complex they are. Simpler jobs can be reliably done by following procedure. More complex ones require the ability to analyze a situation – using established rules – and decide which of several alternative paths to follow. In even more complex cases they analyze, diagnose, design, redesign, program, plan or schedule. In some cases, they create new products, processes and new ways of being. Very complex jobs require individuals who can analyze and solve very complex problems.

These complex, knowledge driven processes get difficult to provide as work-as-prescribed. The work involves thought and creativity, and finding the right balance is a continual balancing act of knowledge management.

Seven elements of good problem-solving

Logic

Perhaps more than anything else, we want our people to be able to think and then act rationally in decision making and problem-solving. The basic structure and technique embodied in problem solving is a combination of discipline when executing PDCA mixed with a heavy dose of the scientific method of investigation.

Logical thinking is tremendously powerful because it creates consistent, socially constructed approaches to problems, so that members within the organization spend less time spinning their wheels or trying to figure out how another person is approaching a given situation. This is an important dynamic necessary for quality culture.

The right processes and tools reinforce this as the underlying thinking pattern, helping to promote and reinforce logical thought processes that are thorough and address all important details, consider numerous potential avenues, take into account the effects of implementation, anticipate possible stumbling blocks, and incorporate contingencies. The processes apply to issues of goal setting, policymaking, and daily decision making just as much as they do to problem-solving.

Objectivity

Because human observation is inherently subjective, every person sees the world a little bit differently. The mental representations of the reality people experience can be quite different, and each tends to believe their representation is the “right” one. Individuals within an organization usually have enough common understanding that they can communicate and work together to get things done. But quite often, when they get into the details of the situation, the common understanding starts to break down, and the differences in how we see reality become apparent.

Problem-solving involves reconciling those multiple viewpoints – a view of the situation that includes multiple perspectives tends to be more objective than any single viewpoint. We start with one picture of the situation and make it explicit so that we can better share it with others and test it. Collecting quantitative (that is, objective) facts and discussing this picture with others is a key way in verifying that the picture is accurate. If it is not, appropriate adjustments are made until it is an accurate representation of a co-constructed reality. In other words, it is a co-constructed representation of a co-constructed reality.

Objectivity is a central component to the problem solving mindset. Effective problem-solvers continually test their understanding of a situation for assumptions, biases, and misconceptions. The process begins by framing the problem with relevant facts and details, as objectively as possible. Furthermore, suggested remedies or recommended courses of action should promote the organizational good, not (even if subconsciously) personal agendas.

Results and Process

Results are not favored over the process used to achieve them, nor is process elevated above results. Both are necessary and critical to an effective organization.

Synthesis, Distillation and and Visualization

We want to drive synthesis of the learning acquired in the course of understanding a problem or opportunity and discussing it with others. Through this multiple pieces of information from different sources are integrated into a coherent picture of the situation and recommended future action.

Visual thinking plays a vital role in conveying information and the act of creating the visualization aids the synthesis and distillation process.

Alignment

Effective implementation of a change often hinges on obtaining prior consensus among the parties involved. With consensus, everyone pulls together to overcome obstacles and make the change happen. Problem-solving teams communicates horizontally with other groups in the organization possibly affected by the proposed change and incorporates their concerns into the solution. The team also communicates vertically with individuals who are on the front lines to see how they may be affected, and with managers up the hierarchy to determine whether any broader issues have not been addressed. Finally, it is important that the history of the situation be taken into account, including past remedies, and that recommendations for action consider possible exigencies that may occur in the future. Taking all these into consideration will result in mutually agreeable, innovative solutions.

Coherency and Consistency

Problem-solving efforts are sometimes ineffective simply because the problem-solvers do not maintain coherency. They tackle problems that are not important to the organization’s goals, propose solutions that do not address the root causes, or even outline implementation plans that leave out key pieces of the proposed solution. So coherency within the problem-solving approach is paramount to effective problem resolution.

Consistent approaches to problem-solving speed up communication and aid in establishing shared understanding. Organizational members understand the implicit logic of the approach, so they can anticipate and offer information that will be helpful to the problem-solvers as they move through the process.

Systems Thinking

Good system thinking means good problem-solving.