The Building Blocks of Work-as-Prescribed

Work-as-Prescribed – how we translate the desired activities into a set of process and procedure – relies on an understanding of how people think and process information.

The format is pivotal. The difficulties we have in quality are really not much different from elsewhere in society in that we are surrounded by confusing documentation and poorly presented explanations everywhere we look, that provide information but not understanding. Oftentimes we rely on canards of “this is what is expected,” “this is what works” – but rarely is that based on anything more than anecdotal. And as the high incidence of issues and the high cost of training shows, less than adequate.

There is a huge body-of-knowledge out there on cognitive-friendly design of visuals, including documentation. This is an area we as a quality profession need to get comfortable with. Most important, we need to give ourselves permission to adapt, modify and transform the information we need into a shape that aids understanding and makes everyone a better thinker.

Work-as-Prescribed (and work-as-instructed) is the creation of tools and technologies to help us think better, understand more and perform at our peak.

Locus of Understanding

Looking at the process at the right level is key. Think of Work-as-Prescribed as a lens. Sometimes you need a high-powered lens so that you can zoom in on a single task. Other times, you need to zoom out to see a set of tasks, a whole process, or how systems interact.

This is the locus of understanding, where understanding happens. When we take this position, we see how understanding is created. Adopting the locus of understanding means going to the right level for the problem at hand. When we apply it to Work-as-Prescribed we are applying the same principles as we do in problem-solving to developing the right tools to govern the work.

We are conducting knowledge management as part of our continuous improvement.

An important way to look is distributed cognitive resources, which means anything that contributes to the cognitive work being done. Adjusting the locus of understanding means that you can, and should, treat an SOP as a cognitive resource. Some of the memory is in your head and some is in the SOP. Work-as-prescribed is a cognitive resource that we distribute, routinely and casually across the brain and our quality system in the form of documents and other execution aids.

Other tools, like my favorite whiteboard, also serve as distributed cognitive resources.

So, as our documents and other tools are distributed cognitive resources it behooves us to ensure they are based on the best cognitive principles possible to drive the most benefit.

As an aside, there is a whole line of thought about why some physical objects are better at distributed cognitive resources than electronic. Movement actually matters.

Taking it even further (shifting the locus) we can see the entire quality system as a part of a single distributed cognitive system where cognitive work is performed via the cognitive functions of communicating, deciding, planning, and problem-solving. These cognitive functions are supported by cognitive processes such as perceiving, analyzing, exchanging, and manipulating.

Cognitive Activity in Work-As-Prescribed

The tools we develop to provide distributed cognitive activity strive to:

Provide short-term or long-term memory aids so that memory load can be reduced.
Provide information that can be directly perceived and used such that little effort is needed to interpret and formulate the information explicitly.
Provide knowledge and skills that are unavailable from internal representations.
Support perceptual operators that can recognize features easily and make inferences directly.
Anchor and structure cognitive behavior without conscious awareness.
Change the nature of a task by generating more efficient action sequences.
Stop time and support perceptual rehearsal to make invisible and transient information visible and sustainable.
Aid processibility by limiting abstraction.
Determine decision making strategies through accuracy maximization and effort minimization.

Driving Work-As Prescribed

As we build our requirements documents, our process and procedure, there are a few principles to keep in mind to better tap into distributed cognitive resources.

Plan for the flow of information: Think about paths, relationships, seams, edges and other hand-offs. Focus on the flow of information. Remember that we learn in a spiral, and the content needed for a novice is different from that of an expert and build our documents and the information flow accordingly. This principle is called Sequencing.

Break information down into pieces: Called, Chunking, the grouping together of information into ideally sized pieces. When building Work-As-Prescribed pay close attention to which of these chunks are reusable and build accordingly.

The deeply about context: How a tool is used drives what the tool should be.

Think deeply about information structures: Not all information is the same, not every example of Work-as-Prescribed should have the same structure.

Be conscientious about the digital and physical divide: Look for opportunities to integrate or connect these two worlds. Be honest of how enmeshed they are at any point in the system.

We are building our Work-as-Prescribed through leveraging our quality culture, our framework for coordinating work. Pay attention to:

Shared Standards – Ways we communicate
Invisible Environments – Ways we align, conceptually
Visible Environments – Ways we collaborate
Psychological Safety – Ways we behave
Perspectives – Ways we see (and see differently)

Principles in Practice

When design process, procedure and task documentation leverage this principles by build blocks, or microcontent, that is:

about one primary idea, fact, or concept
easily scannable
labeled for clear identification and meaning, and
appropriately written and formatted for use anywhere and any time it is needed.

There is a common miscomprehension that simple means short. That just isn’t true. Simple means that it passes a test for the appropriateness of the size of a piece of content of providing sufficient details to answer a specific question for the targeted audience. The size of the content must effectively serve its intended purpose with efficiency, stripping off any unnecessary components.

We need to strive to apply cognitive thinking principles to our practice. The day of judging a requirements document by its page length is long over.

Constituents of cognitive thinking applied to Work-As-Prescribed

The RACI (and RASCI) Chart

What is a RACI chart?

A RACI chart is a simple matrix used to assign roles and responsibilities for each task, milestone, or decision. By clearly mapping out which roles are involved in each task and at which level, you can eliminate confusion and answer the age-old question, “Who’s doing what?”

RACI is a useful complement to a process map, since it can get into more detailed and specific activities than a high-level process map. Think of a process map at one level of abstraction and RACI as the next level of detail

What does RACI stand for?

RACI stands for Responsible, Accountable, Consulted, Informed. Each letter in the acronym represents a level of task responsibility.

When to use RACI

RACI’s are best used in procedures as part of the responsibilities section or to start each section in a long procedure.

RACI’s are great tools that can help:

Design or re-design processes more efficiently by highlighting decisions
Clarify overlapping, redundant, “bottle-necked,” or inconsistent responsibilities
Structure and distribute responsibility and authority
Establish clear lines of communication
Reduce duplication of efforts; pinpoint what can “come off the plate”

RACI definitions

A RACI is a matrix of tasks or deliverables and the roles associated with them.

Each box in the matrix identifies that role’s function in the task

Responsible – primary role performing the work
Accountable – role primarily responsible for the work getting done (and done correctly)
Consulted – roles providing input into the task or deliverable. Consulted means prior to the decision/activity.
Informed – roles to be informed of the outcome of the task or deliverable so that they may fulfill execute their role in the process or other process.

I’m a big fan of adding Supporting, and doing a RASCI. Supporting is very helpful in identifying individuals who provide support services, and often capture indirect accountabilities.

Key point – only one Responsible and one Accountable role for any task or deliverable. In some processes, Responsible and Accountable may be the same role

How to create a RACI

Follow these 3 steps, using the RACI chart example below as your guide:

Enter all responsibilities in the procedure across the top row.
List all procedural steps/tasks, milestones, and decisions down the left column.
For each step, assign a responsibility value to each role or person on the team.

Ensure the following:

Every task has one Responsible person (and only one!).
There’s one (and only one!) Accountable party assigned to each task to allow for clear decision-making.
If you have a lot of C and I roles on your matrix, make sure you have an easy and lightweight way to keep them informed in the procedure.

Some points to consider:

Have a representative from each of the major functions that participate in the process
Reach consensus on all Accountabilities and Responsibilities
Consider the emotional aspects of documenting “A”s and “R”s, including job justification
Eliminate excessive “C”s and “I”s
Consider the organization’s culture

Review the RACI chart vertically to:

Avoid under- or over-committing positions or team members
Eliminate unnecessary gates and bottlenecks
Designate appropriate skill sets

Review the RACI chart horizontally to:

Clarify any ambiguous division of labor
Ensure adequate continuity across decisions and process steps
Ensure accountability and authority to get the job done

Although the RACI is a simple tool, the process of creating it and having it agreed is a political process.

Developing RACI charts surfaces many organizational issues because it confronts the three elements of roles and responsibilities:

Role Conception: what people think their jobs are and how they have been trained to perform them
Role Expectation: what others in the organization think another person’s job is and how it should be carried out
Role Behavior: what people actually do in carrying out their job

Example

	Deviation Creator	Area Responsible	QA	Investigation Team	Site Head
Take real-time action to minimize and contain the effect of an event	R	A	I	–	–
Assemble cross functional team for Triage	R	A	I	–	–
Determine if the event is a deviation	R	C	A	C	–
Define batch association strategy	C	R	A	I	–
Define Containment	C	R	A	C	–
Create Deviation in eQMS in 24 hr	R	A	I	–	–
Gather Data	C	A/R	C	C	–

Flow Chart

The flow chart is a simple, but important, graphic organizer. Placing the states or steps of an event or process into the correct sequence allows you to reach conclusions and make predictions.

However, its simplicity means we don’t always work to be consistent and can benefit from a little effort to ensure users are aligned.

I am a huge fan of including flow charts in all process and procedure documents.

Steps for Building a flow chart

Capture

Capture the events or steps of the process. Resist the urge to arrange them sequentially and concentrate on capturing the events/steps only.

Cull

If there are more than eight steps in a flow chart we start creating cognitive overload. If a process or procedure has more than eight steps you need to:

Ensure the steps are at the right level, sometimes we have substeps represented and we can cull that. Ensure they are all on the same level of process/procedure/task.
Decide we need to break the procedure into multiple documents. This is a great way to decide what work instructions are necessary.
Look for opportunity for process improvement.

Sequence the events and draw the flow chart

The focus now shifts to temporal relations. The correct sequential arrangements of steps or events helps to reach conclusions about past events and prepare for future events.

Example

I’m writing the procedure for my mornings, I capture the following:

Eat breakfast
Take shower
Take dog out
Get dressed
Decide on tea
Heat water
Drink tea
Read for 30 minutes
Deal with morning email
Snuggle with dog

Taking a look at the list I realize that not everything is on the same level of process/procedure/task and end up with a shorter list.

Breakfast
Take shower
Take dog out
Get dressed
Read for 30 minutes
Deal with morning email
Snuggle with dog

Notice how I combined all the tea stuff into a breakfast category. When brainstorming my list I put a lot of weight on tea, because it is important to me (yes I have been using tea as a training example since 2005, I just love tea).

I can then put them in sequence:

When I was making things sequential I realized that two of my activities (read and dog snuggle) were concurrent, so I combined them as one step.

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.