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

Attributable within a Process

Attributable is part of ALCOA that tells us that it should be possible to identify the individual or computerized system that performed the recorded task. The need to document who performed the task / function, is in part to demonstrate that the function was performed by trained and qualified personnel. This applies to changes made to records as well: corrections, deletions, changes, etc.

This means that records should be signed and dated using a unique identifier that is attributable to the author. Where author means the individual who created or recorded the data.

Understanding what role the individual is playing in the task is critical. There are basically six: Executor, Preparer, Checker, Verifier, Reviewer and Approver.

Procedure is Work-as-Prescribed

Written procedures with their step-by-step breakdown are a fundamental tool for ensuring quality through consistent execution of the work. As a standardized guideline for tasks, procedures serve many additional purposes: basis of training, ensuring regulatory requirements are met, ensuring documentation is prepared and handled correctly.

As written prescriptions of how work is to be performed, they can be based on abstract and often decontextualized expectations of work. The writers of the procedures are translating Work-as-Imagined. As a result, it is easy to write from a perspective of ideal and stable conditions for work and end up ignoring the nuances introduced by the users of procedures and the work environment.

The day-to-day activities where the procedures are implemented is Work-as-Done. Work-is-Done is filled with all the factors that influence the way tasks are carried out – spatial and physical conditions; human factors such as attention, memory, and fatigue; knowledge and skills.

Ensuring that our procedures translate from the abstraction of Work-as-Imagined to the realities of Work-as-Done as closely as possible is why we should engage in step-by-step real-world challenge as part of procedure review.

Steven Shorrock calls this procedural level “Work-as-Prescribed.”

Work-as-Prescribed gives us the structure to take a more dynamic view of workers, the documents they follow, and the procedural and organizational systems in which they work. Deviations from Work-as-Prescribed point-of-view are not exclusively negative and are an ability to close the gap. This is a reason to closely monitor causes such as “inadequate procedure” and “failure to follow procedure” – they are indicators of a drift between Work-as-Prescribed and Work-as-Done. Management review will often highlight a disharmony with Work-As-Imagined.

The place where actions are performed in real-world operations is called, in safety thinking, the sharp-end. The blunt-end is management and those who imagine work, such as engineers, removed from doing the work.

Our goal is to shrink the gap between Work-as-Imagined and Work-as-Done through refining the best possible Work-as-Prescribed and reduce the differences between the sharp and the blunt ends. This is why we stress leadership behaviors like Gemba walks and ensure a good document change process that strives to give those who use procedure a greater voice and agency.

Process, Procedure and Task

A task is the steps for doing a particular piece of work.

Procedure are activities made up of a series of tasks.

A process is an upper level description of a series of activities required to accomplish an objective. Processes are made up of procedures or tasks. They have inputs and outputs.

Process	Procedure	Task
Flow of sequences of activities that transform input elements into results	Specific and required way to carry out a process	Describe the correct steps to perform a specific task
What we do By Whom Where it takes place When it happens	How the work must be performed	How to accomplish a specific task within a process with very detailed directions
Orchestration the work	Mandatory method	Mandatory guidance
Can link to 0, 1 or more procedures	It may consist of 0, 1 or more task instructions	Focus on the instructions of 1 task
Transversal by business units	Cross functional or only 1 business unit	Only 1 business unit
Participate more than one role	Participate more than one role	Participate only one role
Encapsulates activities	Explains how to do but doesn’t get to all the details of how it is done	All of the detail of all the steps to follow in an activity
Provides the workflow model at the highest level using BPMN	Document with both narrative and images, usually in the form of use cases and workflow diagrams	Document with the maximum detail that explains step by step the instructions that must be carried out in an activity

Process, Procedure and Task Differences

This is the middle of a traditional document hierarchy and form the Functional set of documents,