Process Owners

Process owners are a fundamental and visible difference part of building a process oriented organizations and are crucial to striving for an effective organization. As the champion of a process, they take overall responsibility for process performance and coordinate all the interfaces in cross-functional processes.

Being a process owner should be the critical part of a person’s job, so they can shepherd the evolution of processes and to keep the organization always moving forward and prevent the reversion to less effective processes.

The Process Owner’s Role

The process owner plays a fundamental role in managing the interfaces between key processes with the objective of preventing horizontal silos and has overall responsibility of the performance of the end-to-end process, utilizing metrics to track, measure and monitor the status and drive continuous improvement initiatives. Process owners ensure that staff are adequately trained and allocated to processes. As this may result in conflicts arising between process owners, teams, and functional management it is critical that process owners exist in a wider community of practice with appropriate governance and senior leadership support.

Process owners are accountable for designing processes; day-to-day management of processes; and fostering process related learning.

Process owners must ensure that process staff are trained to have both organizational knowledge and process knowledge. To assist in staff training, processes, standards and procedures should be documented, maintained, and reviewed regularly.

Process Owners should be supported by the right infrastructure. You cannot be a SME on a end-to-end-process, provide governance and drive improvement and be expected to be a world class tech writer, training developer and technology implementer. The process owner leads and sets the direction for those activities.

The process owner sits in a central role as we build culture and drive for maturity.

Sensemaking, Foresight and Risk Management

I love the power of Karl Weick’s future-oriented sensemaking – thinking in the future perfect tense – for supplying us a framework to imagine the future as if it has already occurred. We do not spend enough time being forward-looking and shaping the interpretation of future events. But when you think about it quality is essentially all about using existing knowledge of the past to project a desired future.

This making sense of uncertainty – which should be a part of every manager’s daily routine – is another name for foresight. Foresight can be used as a discipline to help our organizations look into the future with the aim of understanding and analyzing possible future developments and challenges and supporting actors to actively shape the future.

Sensemaking is mostly used as a retrospective process – we look back at action that has already taken place, Weick himself acknowledged that people’s actions may be guided by future-oriented thoughts, he nevertheless asserted that the understanding that derives from sensemaking occurs only after the fact, foregrounding the retrospective quality of sensemaking even when imagining the future.

“When one imagines the steps in a history that will realize an outcome, then there is more likelihood that one or more of these steps will have been performed before and will evoke past experiences that are similar to the experience that is imagined in the future perfect tense.”

R.B. MacKay went further in a fascinating way by considering the role that counterfactual and prefactual processes play in future-oriented sensemaking processes. He finds that sensemaking processes can be prospective when they include prefactual “whatifs” about the past and the future. There is a whole line of thought stemming from this that looks at the meaning of the past as never static but always in a state of change.

Foresight concerns interpretation and understanding, while simultaneously being a process of thinking the future in order to improve preparedness. Though seeking to understand uncertainty, reduce unknown unknowns and drive a future state it is all about knowledge management fueling risk management.

Do Not Ignore Metaphor

A powerful tool in this reasoning, imagining and planning the future, is metaphor. Now I’m a huge fan of metaphor, though some may argue I make up horrible ones – I think my entire team is sick of the milk truck metaphor by now – but this underutilized tool can be incredibly powerful as we build stories of how it will be.

Think about phrases such as “had gone through”, “had been through” and “up to that point” as commonly used metaphors of emotional experiences as a physical movement or a journey from one point to another. And how much that set of journey metaphors shape much of our thinking about process improvement.

Entire careers have been built on questioning the heavy use of sport or war metaphors in business thought and how it shapes us. I don’t even watch sports and I find myself constantly using it as short hand.

To make sense of the future find a plausible answer to the question ‘what is the story?’, this brings a balance between thinking and acting, and allows us to see the future more clearly.


  • Cornelissen, J.P. (2012), “Sensemaking under pressure: the influence of professional roles and social accountability on the creation of sense”, Organization Science, Vol. 23 No. 1, pp. 118-137, doi: 10. 1287/orsc.1100.0640.
  • Greenberg, D. (1995), “Blue versus gray: a metaphor constraining sensemaking around a restructuring”, Group and Organization Management, Vol. 20 No. 2, pp. 183-209, available at:
  • Luscher, L.S. and Lewis, M.W. (2008), “Organizational change and managerial sensemaking: working through paradox”, Academy of Management Journal, Vol. 51 No. 2, pp. 221-240, doi: 10.2307/20159506.
  • MacKay, R.B. (2009), “Strategic foresight: counterfactual and prospective sensemaking in enacted environments”, in Costanzo, L.A. and MacKay, R.B. (Eds), Handbook of Research on Strategy and Foresight, Edward Elgar, Cheltenham, pp. 90-112, doi: 10.4337/9781848447271.00011
  • Tapinos, E. and Pyper, N. (2018), “Forward looking analysis: investigating how individuals “do” foresight and make sense of the future”, Technological Forecasting and Social Change, Vol. 126 No. 1, pp. 292-302, doi: 10.1016/j.techfore.2017.04.025.
  • Weick, K.E. (1979), The Social Psychology of Organizing, McGraw-Hill, New York, NY.
  • Weick, K.E. (1995), Sensemaking in Organizations, Sage, Thousand Oaks, CA.

CVs and JDs and Training Plans

In the post “HR and Quality, joined at the hip” I covered some of the regulations that set the expectations in the pharmaceutical and medical device industries that employees have the appropriate education, experience and training to do their jobs. What is often called the personnel qualification triangle.

A job description is a written document that outlines the duties, responsibilities, contributions, behaviors, outcomes and required qualifications for a specific job in an organization. A good job description is a specification that results from a detailed job analysis. It is used in hiring and performance evaluation. It is also the starting point for determining a good GxP training plan.

In order to providing the specific knowledge, skills, abilities and behaviors that need to be addressed for each employee, the job description needs to specifically call out the roles in the processes an employee will play. Instead of providing broad statements like “participate in CAPAs” or “Manufacture product” it should be more specific such as “create and project manage CAPAs” or “Perform visual inspection.”

I challenge everyone to think broadly about the job description as a tool to drive excellence. Utilized throughout the life of employment, a job description is a powerful tool that can aid managers. Managers have a road map that can help them with their duties of planning, leading, organizing, controlling and staffing. With a road map, the complexities of the organization become easier.

The curricula vitae provides evidence that the employee is fit-for-purpose to the job description. The curricula vitae shows education and experience that demonstrates the possession of knowledge, skills, abilities and behaviors.

The training plan then lays out what the employee needs to bit fit-for-use, to be able to do all the roles in the job description. It includes all the process and role specific training, as well as filling in any gaps that might exist on the curricula vitae.

The Personnel Qualification Triangle of Education, Experience and Training

It is important to note that this may not be a fine equilateral triangle. Experience, for example, can often, but not always make up for education.

Failure Points in the Personnel Qualification Triangle

  • Position and experience descriptions on CVs do not match the corresponding job description. This red flag stems from a lack of coordination between the curricula vitae and job description, which can be particularly concerning when an employee has a job description that requires very specific technical knowledge or oversees other seemingly unrelated areas that their experience would indicate.
  • Employee positions current position is not included in curricula vitae. The curricula vitae should always include the current position. While not a deal breaker, this is perhaps the easiest way to see large gaps in the cv, especially if the employee moves around or up in the same organization.
  • Curricula vitae do not reflect the level of experience expected given the employee’s job title.
  • The roles and responsibilities documented in in the job descriptions do not correspond with those included in SOPs. A reviewer should be able to go from a process to anyone engaged in the process and be able to see the work the individual does reflected.
  • Job titles match. Curricula vitae, job descriptions and what an individual is listed as on an organizational chart need to all match. I usually go as far to check someone’s business card before they go into meet with an inspector or external auditor.

What prevents us from improving systems?

Improvement is a process and sometimes it can feel like it is a one-step-forward-two-steps-back sort of shuffle. And just like any dance, knowing the steps to avoid can be critical. Here are some important ones to consider. In many ways they can be considered an onion, we systematically can address a problem layer and then work our way to the next.


The vague, ambiguous and poorly defined bucket concept called human error is just a mess. Human error is never the root cause; it is a category, an output that needs to be understood. Why did the human error occur? Was it because the technology was difficult to use or that the procedure was confusing? Those answers are things that are “actionable”—you can address them with a corrective action.

The only action you can take when you say “human error” is to get rid of the people. As an explanation the concept it widely misused and abused. 

Human performance instead of human error
AttributePerson ApproachSystem Approach
FocusErrors and violationsHumans are fallible; errors are to be expected
Presumed CauseForgetfulness, inattention, carelessness, negligence“Upstream” failures, error traps; organizational failures that contribute to these
Countermeasure to applyFear, more/longer procedures, retraining, disciplinary measures, shamingEstablish system defenses and barriers
Options to avoid human error

Human error has been a focus for a long time, and many companies have been building programmatic approaches to avoiding this pitfall. But we still have others to grapple with.

Causal Chains

We like to build our domino cascades that imply a linear ordering of cause-and-effect – look no further than the ubiquitous presence of the 5-Whys. Causal chains force people to think of complex systems by reducing them when we often need to grapple with systems for their tendency towards non-linearity, temporariness of influence, and emergence.

This is where taking risk into consideration and having robust problem-solving with adaptive techniques is critical. Approach everything like a simple problem and nothing will ever get fixed. Similarly, if every problem is considered to need a full-on approach you are paralyzed. As we mature we need to have the mindset of types of problems and the ability to easily differentiate and move between them.

Root cause(s)

We remove human error, stop overly relying on causal chains – the next layer of the onion is to take a hard look at the concept of a root cause. The idea of a root cause “that, if removed, prevents recurrence” is pretty nonsensical. Novice practitioners of root cause analysis usually go right to the problem when they ask “How do I know I reached the root cause.” To which the oft-used stopping point “that management can control” is quite frankly fairly absurd.  The concept encourages the idea of a single root cause, ignoring multiple, jointly necessary, contributory causes let alone causal loops, emergent, synergistic or holistic effects. The idea of a root cause is just an efficiency-thoroughness trade-off, and we are better off understanding that and applying risk thinking to deciding between efficiency and resource constraints.

In conclusion

Our problem solving needs to strive to drive out monolithic explanations, which act as proxies for real understanding, in the form of big ideas wrapped in simple labels. The labels are ill-defined and come in and out of fashion – poor/lack of quality culture, lack of process, human error – that tend to give some reassurance and allow the problem to be passed on and ‘managed’, for instance via training or “transformations”. And yes, maybe there is some irony in that I tend to think of the problems of problem solving in light of these ways of problem solving.