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.

Brain-Friendly Principles for Document Design

Whether creating Work-as-Prescribed in our documents, or Work-as-Instructed in our training materials, it is important to consider good cognitive practices. If we start from two principles we quickly can start doing some amazing things.

Organize resources so it’s easy to understand. Reduce cognitive load by breaking information down into small, digestible chunks and arranging them into patterns that make sense to the individual. Always start by giving an overview so individuals know how all the smaller chunks fit together.
Use visuals. The brain has an incredible ability to remember visual images so you must exploit that as you look for ways to reinforce key learning points. Create tools that are primarily visual rather than word-based. Use images in place of text (or at least minimize the text). Use videos and animations to help people understand key concepts.

We can drive a lot of effectiveness into our processes by structuring information to make complex documents more transparent and accessible to their users. Visual cues can provide an ‘attention hierarchy’, making sure that what is most important is not overlooked. People tend to find more usable what they find beautiful, and a wall of text simply looks scary, cumbersome, and off-putting for most people. I am a strong advocate of beauty in system design, and I would love to see Quality departments better known for their aesthetic principles and for tying all our documents into good cognitive principles.

Cognitive Load Theory

Cognitive load theory (CLT) can help us understand why people struggle so much in reading and understanding contracts. Developed by John Sweller, while initially studying problem-solving, CLT postulates that learning happens best when information is presented in a way that takes into consideration human cognitive structures. Limited working memory capacity is one of the characteristic aspects of human cognition: thus, comprehension and learning can be facilitated by presenting information in ways minimizing working memory load.

Adapted from Atkinson, R.C. and Shiffrin, R.M. (1968). ‘Human memory: A Proposed System and its Control Processes’. In Spence, K.W. and Spence, J.T. *The psychology of learning and motivation*, (Volume 2). New York: Academic Press. pp. 89–195

Structure and Display

Information structure (how the content is ordered and organized) and information display (how it is visually presented) play a key role in supporting comprehension and performance. A meaningful information structure helps readers preserve continuity, allowing the formation of a useful and easy-to-process mental model. Visual information display facilitates mental model creation by representing information structures and relationships more explicitly, so readers do not have to use cognitive resources to develop a mental model from scratch.

Leveraging in your process/procedure documents

Much of what is considered necessary SOP structure is not based on how people need to find and utilize information. Many of the parts of a document taken for granted (e.g. reference documents, definitions) are relics from paper-based systems. It is past time to reinvent the procedure.

The Epistemic Interactions of Knowledge Management

The first four phases of knowledge management are all about identifying and creating meaning and then making that meaning usable. Knowledge management is a set of epistemic actions, creating knowledge through interaction. This interaction is a way of creating a partnership between what happens in the head with everything in the world – Work-as-Imagined and Work-as-Done.

There are really four themes to a set of epistemic actions:

Foraging: Locating resources that will lead to understanding
Tuning: Adjusting resources to align with desired understanding
Externalizing: Moving resources out of the head and into the world
Constructing: Forming new knowledge structures in the world

These epistemic actions are all about moving from Work-as-Imagined through Work-as-Prescribed to enable Work-as-Done.

Knowledge Management is really about the embodiment of information, knowledge, and even wisdom through these epistemic actions to apply change upon the world.

Four Themes Mapped to Firts 4 Phases of Knowledge Management

Theme	Epistemic Interaction	Means
Foraging Locating resources that will lead to understanding	Searching	Searching happens when you need information and believe it exists somewhere. Searching depends on how we articulate or information needs.
	Probing	“Tell me more.” Probing happens when the information you have isn’t quite enough. You are probing when you take the next step, move to the next level, and obtain more salient specifics. Probing is about drilling down and saying “show, explain, and reveal more about this.” We can probe to reveal new patterns, structures and relationships. It brings to light new information that helps us to reconsider what we already know.
	Animating	Animating is when we initiate and control motion in an information source. It includes learning-by-doing.
	Collecting	Collecting is how we gather foraged information and tuck it away for future use.
Tuning Adjusting resources to align with desired understanding	Collecting
	Cloning	Cloning lets us take information from one situation and use it in another.
	Cutting	Cutting is the way we say “this matters”, that “I need this part, but not the rest.”
	Filtering	Filtering reduces complexity by reducing clutter to expose salient details.
Externalizing Moving resources out of the head and into the world	Annotating	Annotating is how we add context to information. How we adapt and modify the information to the needed context.
	Linking	Connecting bits of information together. Forming conceptual maps.
	Generating	Introducing new knowledge into the world.
	Chunking	Grouping idenpendent yet related information together.
Constructing Forming new knowledge structures in the world	Chunking	Grouping idenpendent yet related information together.
	Composing	Producing a new, separate structure from the information that has its own meaning and purpose.
	Fragmenting	Taking information and breaking it apart into usable components.
	Rearranging	The art of creating meaningful order.
	Repicturing	Changing the way the information is represented to create understanding.

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

Know the Knows

When developing training programs and cultural initiative sit is useful to break down what we really want people to know. I find it useful to think in terms of the following:

know-how: The technical skills to do the work
know-what: The ability to perform functional problem-solving, to adapt the process and innovate
know-who: networking and interpersonal skills, with social/emotional intelligence, for empathy or social network capacities
know-where: institutional and system knowledge of how the work fits into a larger ecosystem
know-who/how: strategic and leadership skills, for political ‘ nous’ in setting agendas, managing institutions, mobilizing resources;
know-why: creation of meaning, significance, identity, morality, with practical intuition for creative arts, sports, everyday social exchange.

To build all six elements requires a learning culture and a recognition that knowledge and awareness do not start and end at initial training on a process. We need to build the mechanisms to:

Communicate in a way to continually facilitate the assimilation of knowledge
Incorporate ongoing uses of tools such as coaching and mentoring in our processes and systems
Motivate the ongoing enhancement of learning
Nurture the development and retention of knowledge

We are striving at building competence, to be able to grow and apply the knowledge and abilities of our workers to solve problems and innovate.

Training, Development, Knowledge Management, Problem-Solving – these are a continuum but too often we balkanize responsibility of these in our organizations when what we need is an ecosystem approach.