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.

Process Owner Deliverables

Process Owner implementations require a lot of work, but when used can drive maturity in an organization. To ensure success, it is important to have clear deliverables. Below are a few recommendations:

Task	Demonstrated by
Ensuring process objectives are met	Gap Assessment against relevant external (e.g. regulations, standards, benchmarks) and internal (e.g. policy, strategy) obligations Process Definition Document and Resource Requirements Plan
Developing, deploying, and managing process documentation	Process and procedure documented (e.g. SOP, WI, etc)
Determine training requirements	Role-based curricula in place
Determining, implementing and monitoring metrics	Metrics plan in place and in use
Improving process performance	Improvement plan in place and in use
Representing Process to Leadership	Communication plan in place and in use
Representing the process during internal audits and third-party audits and inspections	Inspection readiness plan in place and in use

The Program Level in the Document Hierarchy

A fairly traditional document hierarchy, in line with ISO 9001 and other standards looks like this:

This process tends to support best an approach where there is a policy that states requirements to do X, a procedure that gives the who, what, when of X, and work instructions that provide the how of X, which results in a lot of records providing X was done.

But life is complicated, and there are sets of activities that combine the Xs in a wide variety, and in complicated environments there may be multiple ways to bundle the Xs.

This is why I add a layer between policy and procedure, called the program, which is a mapping requirement that shows the various ways to interpret the requirements to specific needs.

The program document level shouldn’t be a stranger to those in the GMP world, ICH Q11 control strategy and the Annex 1 contamination control strategy are two good examples. What this document does is tie together processes and demonstrates the design that went into it.

The beauty of this document is that it helps translate down from the requirements (internal and external) to the process and procedures (including technology), how they interact, and how they are supported by technical assessments, risk management, and other control activities. Think of it as the design document and the connective tissue.

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