The Subject Matter Expert

A subject matter expert (SME) is typically an expert on a division of a process, such as a specific tool, technology, or set of process steps. A process may have multiple subject matter experts associated with it, each with varying degrees of understanding of the over-arching process.

SMEs should have depth in their subject area. A great way to identify them is to look for individuals who have a proven track record as formal or informal mentors. To be effective, the SME must be approachable and able to show others the “how” and “why” behind their work. Building expertise, and thus building SMEs, is a fundamental part of a learning organization.

The archetype SMEs has the following attributes:

  • Are really, really smart and know more about their subjects than anybody else in your universe
  • Are willing, able, and looking forward to serving as experts
  • Can tell you what they know in a logical way
  • Understand why it is important for other people to know what they know
  • Are approachable and often fun to work with
  • Love to teach their subjects and make great presenters or facilitators
  • Stay current in their areas of expertise
  • Know when to refer you to someone else
  • Possess situational awareness
The Subject Matter Expert

Subject matter experts are a huge part of knowledge capture.

SME’s help drive Innovation through their strong knowledge of what-was and what-is in order to provide a solid foundation to comprehend what-could-be.

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.

Bibliography

  • 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: http://doi-org.esc-web.lib.cbs.dk:8443/10.1177/1059601195202007
  • 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.

Perform an Audit of your own Expertise

One of the dangers in any organization is that the hard-won know-how of our experts remains locked in their brains and is not shared. To beat this tendency, knowledge management should be a continuous activity in any quality system. So why not start by documenting your own knowledge as an expert?

SubjectAnswer these QuestionsThings to clarify
Foundational KnowledgeWhat reference materials do you use?

How do you track technical trends?
Should a knowledge recipient own any of these reference materials? What are the best websites? Are there particular journals that you fi nd useful? What about associations?
Technical/ScientificWhat kinds of problems do people come to you to solve?  

What are the biggest risks in the project, process, or system you manage?
Can you describe a problem brought to you recently? What technical mistakes is a novice likely to make in that project or process?
Professional NetworkWhom do you ask about technology trends and innovation?

Whom do you contact for information about government regulations?
What is this go-to person’s complete contact information? What medium does he or she prefer (email versus telephone)? What is his or her background? How do you know this person?
OrganizationalWho are the major stakeholders in the project, process, or system you manage?

What are the biggest mistakes newcomers make in trying to get projects going here?
What are the positions of the major stakeholders? Where are there competing priorities? Can you give me an example of a newcomer mistake and suggest how to avoid such mistakes?
InterpersonalRegarding team leadership, what criteria do you use to select team members?

How do you ensure the team is connected to the overall business strategy?

On a general level, how do you motivate people who report to you?
Why do you use these particular criteria? Have you ever chosen unwisely? What communication strategies are most effective? Can you give an example of what has really helped?

Once you’ve documented this knowledge, identify who else needs to know it, and then ensure the knowledge is transferred.

PIC/S on Change Review and Effectiveness

Starting from the end, let’s review some of the requirements in the new draft PIC/S guidance.

Prior to change closure

RequirementImportant Points
Changes meet their intended objectives and pre-defined effectiveness criteria. Any deviations from those criteria are adequately assessed, accepted and managed/justified. Whenever possible, quantitative data are leveraged to objectively determine change effectiveness (e.g. statistical confidence and coverage).Clearly delineating what effective means as a date is critical to generate data.

CQV activities can tell you if the intended objective is met. Effectiveness reviews must be made up of:

Sufficient data points, as described in the implementation plan, gathered to a described timeline, before an assessment of the change is made.

The success criteria should be achieved. If not, reasons why they have not been achieved should be assessed along with the mitigation steps to address the reasons why, including reverting to the previous operating state where appropriate. This may require the proposal of a subsequent change or amendment of the implementation plan to ensure success.

Data and knowledge gathered from implementation of the change should be shared with the development function and other locations, as appropriate, to ensure that learning can be applied in products under development or to similar products manufactured at the same or other locations
As part of the quality risk management activities, residual risks are assessed and managed to acceptable levels, and appropriate adaptations of procedures and controls are implemented.These are action items in the change control.

As part of the closure activities, revise the risk assessment, clearly delineating risk assessment in two phases.
Any unintended consequences or risks introduced as a result of changes are evaluated, documented, accepted and handled adequately, and are subject to a pre-defined monitoring timeframe.Leverage the deviation system.

Prior to or after change closure

RequirementImportant Points
Any post-implementation actions needed (including those for deviations from pre-defined acceptance criteria and/or CAPAs) are identified and adequately completed.If you waterfall into a CAPA system, it is important to include effectiveness reviews that are to the change, and not just to the root cause.
Relevant risk assessments are updated post-effectiveness assessments. New product/process knowledge resulting from those risk assessments are captured in the appropriate Quality and Operations documents (e.g. SOPs, Reports, Product Control Strategy documents, etc.)Risk management is not a once and done for change management.
Changes are monitored via ongoing monitoring systems to ensure maintenance of a state of control, and lessons learned are captured and shared/communicated.Knowledge management is critical as part of the product management lifecycle.

Lessons learned are critical.