Process Mapping as a Scaling Solution (part 1)

I love a good process map in all it’s permutations. It is important to remember that the various process mapping tools are on a scale on order of detail and complexity.

Tool Name	Description
Process Landscape Diagram	A Process Landscape Diagram is a visual representation that outlines the structure and interdependencies of processes within an organization, providing insight into how these processes work together to achieve strategic goals. This tool helps in understanding process flows and managing business operations more effectively by illustrating connections and hierarchies among various processes.
SIPOC	SIPOC is a visual representation tool for documenting a business process from beginning to end. It provides a high-level overview by summarizing the key components of Suppliers, Inputs, Processes, Outputs, and Customers.
Scope Diagram (IGOE Diagram)	The Scope Diagram, also known as the IGOE Diagram, is used to define and agree on the boundaries of a process, enhancing communication among stakeholders. This diagram illustrates the scope of a project at a high abstraction level and helps identify candidate processes for change. It focuses on the Inputs, Guides, Outputs, and Enablers of a business process, facilitating better understanding and management of the scope by clarifying process boundaries without detailing internal system features.
Process Map	A Process Map is a visual tool used to represent the flow of work and the steps involved in a business process. This tool helps teams understand, analyze, and improve workflows by detailing the processes involved, making it easier to identify inefficiencies and areas for improvement. Process maps are often utilized in project management and continuous improvement efforts to enhance productivity and streamline operations.
Process Flow Diagram	A Process Flow Diagram (PFD) is a diagram commonly used to indicate the general flow of plant processes and equipment. It visualizes the sequential steps and relationships between components in a process, aiming to improve project planning and identify inefficiencies.
Swim-lane Flow Chart	A Swim-lane Flow Chart, also known as a cross-functional diagram, is a type of flowchart that shows the workflow and responsibilities in a process. It visually segments tasks into lanes that clarify who is responsible for each step, making it easier to understand complex processes and identify inefficiencies or redundancies.
Process Flow with RACI matrix	The RACI matrix is a project management tool that clarifies roles and responsibilities of team members by categorizing them into four groups: Responsible, Accountable, Consulted, and Informed. This structure aids in ensuring effective communication and workflow management across various stages of a project, helping teams stay aligned and avoiding confusion.

Process Mapping Tools

Process Landscape Diagram

A process landscape diagram is a high-level visual representation of an organization’s business processes and their relationships. Process landscape diagrams provide a comprehensive overview of an organization’s processes at a macro level and define the scope and relationships between an organization’s business processes. This serves as a simple way to handle process-related communication and serves as a starting point for detailed process discovery.

The process landscape diagram represents processes as ‘black-boxes’, focusing on interrelationships rather than internal details. Thus it shows the structure, grouping, modularity, functionality, and technology of chain processes, business processes, and working processes. Ideally this should include connections to external participants or stakeholders.

Components and Structure

A typical process landscape diagram may include:

Core processes (value chain or end-to-end processes)
Management processes
Support processes
Relationships and dependencies between processes
Connections to external participants or stakeholders

When to do

The process landscape diagram is design to enable organizations to maintain an overview of processes which makes this an excellent centerpiece to your Quality Manual.

ICH Q10 actually has a nice process landscape in it.

SIPOC

I’ve written about SIPOC’s in the past.

SIPOC diagrams are powerful tools in process improvement and management, offering numerous advantages that make them invaluable in various scenarios. These diagrams provide a high-level overview of a process, enabling teams to grasp the big picture quickly and efficiently. By facilitating clear communication and collaboration among team members and stakeholders, SIPOC diagrams help break down silos and foster a shared understanding of complex processes. This clarity often leads to the identification of improvement opportunities and potential problem areas that might otherwise go unnoticed.

One of the key strengths of SIPOC diagrams lies in their versatility. They serve as excellent tools for defining and scoping complex projects, helping teams to set clear boundaries and objectives from the outset. Additionally, these diagrams aid in understanding customer requirements and managing supplier relationships, two critical aspects of any business process. SIPOC diagrams also prove invaluable as training tools for new employees, offering a concise yet comprehensive overview of how a process functions within the larger organizational context.

The use of SIPOC diagrams is particularly beneficial when embarking on new process improvement projects or redesigning existing processes by providing a structured approach to understanding the current state and envisioning future improvements. They’re also extremely useful in situations where the scope of a project is unclear or poorly defined, helping to bring clarity and focus to the team’s efforts.

SIPOC diagrams excel in fostering cross-functional collaboration. By providing a common language and visual representation of a process, they facilitate discussions and decision-making among different departments or stakeholders. This makes them particularly valuable in problem-solving initiatives and when ensuring compliance with regulations and standards. SIPOC diagrams also serve as effective tools for supplier evaluation and performance assessment, helping organizations maintain strong relationships with their supply chain partners.

SIPOC diagrams are most effective when there’s a need to quickly visualize and understand a process without delving into excessive detail. They help teams focus on the essential elements of a process and provide a solid foundation for more in-depth analysis and improvement efforts. Whether used in the early stages of a project, for ongoing process management, or as part of continuous improvement initiatives, SIPOC diagrams offer a simple yet powerful way to enhance understanding, communication, and efficiency across an organization.

I love a SIPOC in a program level document.

Scope Diagram (IGOE Diagram)

IGOE stands for Inputs-Guides-Outputs-Enablers, the basic components of any business process. This model is used to define the scope of a process with an initial, high-level overview of the process in-scope and the problems associated with that process and the relationships between the process-in-scope, upstream or downstream processes, relevant documents, stakeholders etc.

Input is defined as something that is transformed or consumed, input can be information, materials, people
Guide is defined as anything that describes the when, why, or how a process or activity occurs, guides can be policies, strategies, regulations, law
Outputs are the product or result of the change that occurs to the Inputs or the result of the creation of something based on the Guides, outputs can be results, deliverables, products, information, people
Enablers are the resources or assets required to transform an Input into an Output or to create Outputs, enablers can be systems, equipment, tools, assets, facilities, human resources

These diagrams are particularly useful at the outset of a process improvement project, serving as a powerful means to define and agree upon the boundaries of a process. By clearly illustrating the process scope and interactions, IGOE diagrams play a crucial role in setting the right expectations among project stakeholders and establishing a solid foundation for the improvement effort.

One of the key strengths of IGOE diagrams lies in their ability to measure the reach of a process. By explicitly showing how the business interacts with external entities, these diagrams provide a systematic way to assess impact. This can really help identify stakeholders in a project.

Process owners and subject matter experts often turn to IGOE diagrams for high-level root cause analysis. This application allows them to conduct a relatively accurate assessment to determine the focus and scope of an improvement project.

Scope diagrams excel in enhancing communication with various stakeholders. Their intuitive nature and lack of technical jargon make them accessible to a wide audience, facilitating better understanding and alignment among team members and stakeholders. This clarity in communication is particularly beneficial when defining vision and building consensus.

Another significant advantage of scope diagrams is their ability to illustrate process dependencies. By providing a clear picture of the factors that shape processes, these diagrams create a better understanding of potential future process iterations. This insight is invaluable during task prioritization, as the additional information about importance and impact can guide strategic decision-making in the project.

Scope diagrams are most effective in communicating a comprehensive understanding of a process’s scope, boundaries, and interactions with its environment. Whether used at the beginning of an improvement initiative, for aligning stakeholders on process scope and impact, or as a precursor to more detailed process analysis, IGOE diagrams offer a structured and insightful approach to process understanding and improvement planning.

This is a tool we don’t use enough.

Process Map

Process maps are powerful visual tools that provide a clear and comprehensive representation of workflows or processes within an organization. These diagrams illustrate the sequence of steps, activities, and decisions involved in completing a task or achieving a specific outcome. By offering a visual overview of how a process works from start to finish, process maps serve multiple purposes, including identifying inefficiencies and bottlenecks, facilitating communication among team members and stakeholders, and serving as valuable training resources for new employees.

The versatility of process maps makes them indispensable in various business scenarios. At the outset of process improvement projects, these visual aids help teams gain a thorough understanding of the current state of a process before embarking on optimization or redesign efforts. They are particularly useful when defining project scope, as they assist in setting clear boundaries and expectations for process improvement initiatives. For complex processes, maps break down intricate workflows into more manageable, understandable steps, making them easier to analyze and improve.

Process maps excel as communication tools, proving invaluable during team brainstorming sessions by providing a visual aid for discussing and analyzing processes. They also serve as effective training resources for new hires, offering a clear, step-by-step guide to understanding roles and responsibilities within the organization. When documenting standard operating procedures, process maps complement written instructions, enhancing clarity and comprehension.

In problem-solving scenarios, process maps are instrumental in identifying the root causes of issues within a workflow. They allow teams to examine each step of a process for efficiency and effectiveness during process analysis, leading to more targeted improvements. Furthermore, process maps provide a concise way to explain processes to stakeholders who may not be directly involved in day-to-day operations, fostering better understanding and alignment across the organization.

When implementing new systems or technologies, process maps help identify how these tools will impact existing workflows, facilitating smoother transitions and integration. This makes them particularly valuable in organizations focused on continuous improvement, quality management, and operational efficiency.

Process maps are versatile tools that can be employed whenever there’s a need to understand, analyze, improve, or communicate about a process. Their visual nature makes complex information more accessible, promoting better decision-making and more effective process management. Whether used in small-scale departmental improvements or large-scale organizational transformations, process maps remain a fundamental tool in the arsenal of business process management and continuous improvement methodologies.

In my next post in this series I will start with Business Process Notation as a methodology for process mapping.

Global versus Local Process and Procedure and the eQMS

Companies both large and small grapple with how and when to create standard work at the global level, while still having the scalability to capture different GXP activity families and product modality.

I’ve discussed before on document hierarchy and on the leveling of process and procedure. It is really important to level your processes, and this architecture should be deliberate and shepherded.

This really gets to the heart of work-as-imagined and prescribed, and the concept of standard work.

Benefits of Standard Work

Ensures all work is done according to the current best practice
Consistency is the essential ingredient of quality
Allows organizations to scale rapidly
Puts the focus on the process and not an individual or team
Makes improvements easier and faster

Global versus Local Process and Procedure in the Document Hierarchy

Most Quality Hierarchies look fairly similar.

Excluding the Program level (which becomes even more important) we can expand the model in the process band to account for global versus local.

Global and local process within the document hierarchy

Quality Manual and Policy remains global with local input and determine the overall structure of the quality management system.

Global Process is created when a process is majority task and role driven at a global level. It is pan-GXP, pan-modality, pan-geography. It is the standard way of work to drive consistency across and through the organization.

Local Process is created when a process is specific to a specific GXP, product modality, geography.

Procedure, which describes the tasks, can be created off of local or global process. When the global process has localizations (a CAPA is a CAPA but how I build action items may differ across sites), I can build local versions off the global process.

For an example, Document and Record Management.

This approach takes real vision among leaders to drive for consistency and simplicity. This activity is a core component in good system design, no matter the size of the organization.

Principle	Description	Application for Global and Local Process
Balance	The system creates value for the multiple stakeholders. While the ideal is to develop a design that maximizes the value for all the key stakeholders, the designer often has to compromise and balance the needs of the various stakeholders.	The value of standard work really shines here.
Congruence	The degree to which the system components are aligned and consistent with each other and the other organizational systems, culture, plans, processes, information, resource decisions, and actions.	We gain congruence through ensuring key processes are at the global level.
Convenience	The system is designed to be as convenient as possible for the participants to implement (a.k.a. user friendly). System includes specific processes, procedures, and controls only when necessary.	The discussion around global versus local will often depend on how you define convenience
Coordination	System components are interconnected and harmonized with the other (internal and external) components, systems, plans, processes, information, and resource decisions toward common action or effort. This is beyond congruence and is achieved when the individual components of a system operate as a fully interconnected unit.	How we ensure coordination across and through an organization.
Elegance	Complexity vs. benefit — the system includes only enough complexity as is necessary to meet the stakeholder’s needs. In other words, keep the design as simple as possible and no more while delivering the desired benefits. It often requires looking at the system in new ways.	Keep this in mind as global for the sake of global is not always the right decision.
Human	Participants in the system are able to find joy, purpose and meaning in their work.	Never forget
Learning	Knowledge management, with opportunities for reflection and learning (learning loops), is designed into the system. Reflection and learning are built into the system at key points to encourage single- and double-loop learning from experience to improve future implementation and to systematically evaluate the design of the system itself.	Building the right knowledge management into the organization is critical to leverage this model
Sustainability	The system effectively meets the near- and long-term needs of the current stakeholders without compromising the ability of future generations of stakeholders to meet their own needs.	Ensure the appropriate tools exist to sustain, including regulatory intelligence. Long-term scalability.

Pillars of Good System Design for Gloval and Local Process

Utilizing the eQMS to drive

The ideal state when implementing (or improving) an eQMS is to establish global processes and allow system functionality to localize as appropriate.

So for example, every CAPA is the same (identify problem and root cause, create plan, implement plan, prove implementation is effective. This is a global process. However, one wants specific task detail at a lower level, for example GMP sites may care about certain fields more the GCP, medical device has specific needs, etc. These local task level needs can be mainted within one workflow.

The Key is Fit-For-Purpose Fit-for-Use

A fit for purpose process meets the requirements of the organization.

A fit for use process is usable throughout the lifecycle.

Global and localizing processes is a key part of making both happen.

Design Problem Solving into the Process

Good processes and systems have ways designed into them to identify when a problem occurs, and ensure it gets the right rigor of problem-solving. A model like Art Smalley’s can be helpful here.

Each and every process should go through the following steps:

Define those problems that should be escalated and those that should not. Everyone working in a process should have the same definition of what is a problem. Often times we end up with a hierarchy of issues that are solved within the process – Level 1 – and those processes that go to a root cause process (deviation/CAPA) – level 2.
Identify the ways to notice a problem. Make the work as visual as possible so it is easier to detect the problem.
Define the escalation method. There should be one clear way to surface a problem. There are many ways to create a signal, but it should be simple, timely, and very clear.

These three elements make up the request for help.

The next two steps make up the response to that request.

Who is the right person to respond? Supervisor? Area management? Process Owner? Quality?
How does the individual respond, and most importantly when? This should be standardized so the other end of that help chain is not wondering whether, when, and in what form that help is going to arrive.

In order for this to work, it is important to identify clear ownership of the problem. There always must be one person clearly accountable, even if only responsible for bits, so they can push the problem forward.

It is easy for problem-solving to stall. So make sure progress is transparent. Knowing what is being worked on, and what is not, is critical.

Prioritization is key. Not every problem needs solving so have a mechanism to ensure the right problems are being solved in the process.

Common Ownership Challenges

Governance and ownership challenges often arise in an organization for four reasons:

Business stakeholders who resist assuming ownership of their own processes, data and/or knowledge, or have balkanized/siloed accountability
Turf wars or power struggles between groups of stakeholders
Lack of maturity in one or more areas
Resistance to established governance rules

The Business Struggles with Accountability

Processes often have a number of stakeholders, but no apparent owners. This results in opportunity costs as compulsory process changes (e.g. legislative requirements, systems capacity, or company structural changes) or process improvements are not implemented because the business process owner is unaware of the change, or no clear business process owner has been identified which leads to an increase in risk.

Sometimes processes have a number of stakeholders who all think they are the owners of parts of the process or the whole process. When this overlap happens, each supposed owner often identifies their own strategy for the process and issues their own process change instructions to conform to their understanding of the purpose of the business process. These conflicting instructions lead to frustration and confusion by all parties involved.

Lack of accountability in process and system leads to inefficient processes, organizational disharmony, and wasted energy that can be better spent on process improvements.

Turf Wars

Due to silo thinking there can be subdivided processes, owned by different parts of the organization. For example, count how many types of change control your organization has. This requires silos to be broken down, and this takes time.

Lack of Maturity

Governance is challenging if process maturity is uneven across the organization.

Failure to Adhere to Governance

It can be hard to get the business to apply policy and standard consistently.

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.