When thinking about root cause analysis it is useful to think of whether the problem is stemming from a cultural level or when it may be coming from an operational. We can think of these problems as hazards stemming from three areas:
Culture/philosophy is the over-arching view of how the organization conducts business from top-level decision-makers on through the corporate culture of an organization.
Policies are the broad specifications of the manner in which operations are performed. This includes the end-to-end processes.
Policies lead to the development of process and procedures, which are specifications for a task or series of tasks to accomplish a predetermined goal leading to a high degree of consistency and uniformity in performance.
Hazards unrecognized (risks not known or correctly appraised)
Hazards forseen (risks anticipated but response not adequate)
Culture/Philosophy Quality not source of corporate pride Regulatory standards seen as maxima
Culture/Philosophy Quality seen as source of corporate pride Regulatory standards seen as minima
Policy Internal monitoring schemes inadequate (e.g. employee concerns not communicated upwards) Insufficient resources allocated to quality Managers insufficiently trained or equipped Reliance on other organization’s criteria (e.g. equipment manufacturer)
Policy Known deficiencies (e.g. equipment, maintenance) not addressed Defenses not adequately monitored Defenses compromised by other policies (e.g. adversarial employee relations, incentive systems, performance monitoring)
Procedures Documentation inadequate Inadequate, or Loop-hole in, controls Procedures conflict with one another or with organizational policy
This approach on problems avoids a focus on the individuals involved and avoids a blame culture, which will optimize learning culture. Blaming the individuals risks creating an unsafe culture and creates difficulties for speaking up which should be an espoused quality value. Focus on deficiencies in the system to truly address the problem.
A task is the steps for doing a particular piece of work.
Procedure are activities made up of a series of tasks.
A process is an upper level description of a series of activities required to accomplish an objective. Processes are made up of procedures or tasks. They have inputs and outputs.
Process
Procedure
Task
Flow of sequences of activities that transform input elements into results
Specific and required way to carry out a process
Describe the correct steps to perform a specific task
What we do By Whom Where it takes place When it happens
How the work must be performed
How to accomplish a specific task within a process with very detailed directions
Orchestration the work
Mandatory method
Mandatory guidance
Can link to 0, 1 or more procedures
It may consist of 0, 1 or more task instructions
Focus on the instructions of 1 task
Transversal by business units
Cross functional or only 1 business unit
Only 1 business unit
Participate more than one role
Participate more than one role
Participate only one role
Encapsulates activities
Explains how to do but doesn’t get to all the details of how it is done
All of the detail of all the steps to follow in an activity
Provides the workflow model at the highest level using BPMN
Document with both narrative and images, usually in the form of use cases and workflow diagrams
Document with the maximum detail that explains step by step the instructions that must be carried out in an activity
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
The Process Owner defines the process, including people, process steps, and technology, as well as the connections to other processes. They are accountable for change management, training, monitoring and control of the process and supporting procedure. The Process Owners owns the continuous improvement of the overall process.
Quality is ultimately responsible for the decisions made and that they align, at a minimum, with all regulatory requirements and internal standards.
Functional Area Management represents the areas that have responsibilities in the process and has a vested interest or concern in the ongoing performance of a process. This can include stakeholders who are process owners in upstream or downstream processes.
A Subject Matter Expert (SME) is typically an expert on a narrow division of a process, such as a specific tool, system, 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.
A Risk Based Approach
The level of review of a new or revised process/procedure is guided by three fundamental risk questions:
What might go wrong with the associated process? (risk identification)
What is the likelihood that this will go wrong? (risk analysis)
What are the consequences? How severe are they if this goes wrong? (risk analysis)
Conducting risk identification is real about understanding how complicated and complex the associated process is. This looks at the following criteria:
Interconnectedness: the organization and interaction of system components and other processes
Repeatability: the amount of variance in the process
Information content: the amount of information needed to interact with the process
What Happens During a Review of Process and Procedure
The review of a process/procedure ensures that the proposed changes add value to the process and attain the outcome the organization wants. There are three levels of review (which can and often do happen simultaneously):
Functional review
Expert review by subject matter experts
Step-by-step real-world challenge
Functional review is the vetting of the process/procedure. Process stakeholders, including functional area management affected by the change has the opportunity to review the draft, suggest changes and agree to move forward.
Functional review supplies the lowest degree of assurance. This review looks for potential impact of the change on the function – usually focused on responsibilities – but does not necessarily assures a critical review.
In the case of expert review, the SMEs will review the draft for both positive and negative elements. On the positive side, they will look for the best practices, value-adding steps, flexibility in light of changing demands, scalability in light of changing output targets, etc. On the negative side, they will look for bottlenecks in the process, duplication of effort, unnecessary tasks, non-value-adding steps, role ambiguities (i.e. several positions responsible for a task, or no one responsible for a task), etc.
Expert review provides a higher degree of assurance because it is a compilation of expert opinion and it is focused on the technical content of the procedure.
The real-world challenge tests the process/procedure’s applicability by challenging it step-by-step in as much as possible the actual conditions of use. Tis involves selecting seasoned employee(s) within the scope of the draft procedure – not necessarily a SME – and comparing the steps as drafted with the actual activities. It is important to ascertain if they align. It is equally important to consider evidence of resistance, repetition and human factor problems.
Sometimes it can be more appropriate to do the real-world test as a tabletop or simulation exercise.
As sufficient reviews are obtained, the comments received are incorporated, as appropriate. Significant changes incorporated during the review process may require the procedure be re-routed for review, and may require the need to add additional reviews.
Repeat as a iterative process as necessary.
Design lifecycle
The process/procedure lifecycle can be seen as the iterative design lifecycle.
Design Thinking: Determine process needs.
Collect and document business requirements
Map current-state processes.
Observe and interview process workers.
Design process to-be.
Startup: Create process documentation, workflows, and support materials. Review and described above
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.
Investigations of a Dog 