OCM Exists to Mitigate Risk in eQMS Implementations

The last article in this series will look at organizational change management (OCM) best practices to address the “change risks” that are underestimated in electronic quality management system (eQMS) implementations. For a broader understanding of OCM principles and their role in implementations of digital quality management systems, read part one and part two in this series.

OCM Exists to Mitigate Risks!

The things taken for granted in making room for technology change can be the things that lead to failure. For example, the use of a particular browser was not assessed properly in a recent major implementation and the browser was intended to be retired as part of the project. What wasn't considered was that it provided access to a mission-critical application for an important stakeholder group. In this case, the OCM evaluation that would have uncovered this early on was not performed due to budget issues. I'll give you other examples of why OCM is critical in the implementation of a electronic quality management system.

Change Is a Risk?

Most project teams don't address this aspect of organizational change because it is wrongly assumed that people will embrace the change. But change - especially transformative change - has great potential for failure. Chief among the practices that help reduce costly oversights and the risk of non-adoption include the stakeholder assessment, the change impact analysis (CIA), and the OCM plan. The critical roles each of these practices play in digital quality management system implementations are outlined below.

Stakeholder Assessment

As illustrated in the discovery step of the OCM lifecycle covered in article two, this assessment must be done before any meaningful OCM work can begin. OCM methods come from a variety of providers, each with their own unique approach for how this is done. Regardless of the approach, this is where the first impressions of risk start to emerge. The stakeholder assessment is an exhaustive review of who will be impacted directly or indirectly and when and how various groups can influence the outcome of your digital quality management system implementation project. Stakeholders are often mistaken as the project team members, but this is not always the case.

A thorough assessment must be done for all affected regions and sites within your organization and can take weeks to complete. The individual designated as the OCM lead must have full access to the business leaders (for interviews and assessments) to gain a thorough understanding of the current organizational structure as well as any known changes.

The output of a stakeholder assessment includes (but is not limited to):

• Inventory of all functions impacted by the electronic quality management system (and timing as well).
• Alertness level of the functions about the pending changes (i.e., do they have basic awareness, are they highly knowledgeable, etc.).
• Impact and influence of the function on the success/adoption (illustrated in a grid or other visualizable format).
• Intensity of communication and interventions (high, medium, or low touch).
• Resistance management plan (to minimize risk and present strategies to overcome barriers to change).

The output from this assessment is critical to designing communications and developing briefings and workshops and is a cornerstone of the OCM plan. It becomes a significant component of the OCM plan once approved by the business sponsors and project leaders. A common failure point is when representation on the project team is limited to a small group that can't possibly foresee the impact on every function. This is where quality leadership must be active and participative to enable completion of this exercise and the next.

Change Impact Analysis

CIA is critical to understanding risk. It is performed in the discovery step and, while it will vary based on the OCM methods in use, it must be comprehensive as the output is used to define the scope, scale, and intensity of the change. The CIA evaluates change across technology, roles, culture, process, and training and can't be done in isolation; teamwork and collaboration must prevail.

The OCM lead must have full access to the eQMS vendor, technical and process analysts, and leadership. Technical requirements must be finalized, and it is very effective to provide demonstrations, results of pilot applications, and role definitions to stakeholders. If there are changes in job descriptions after the digital quality management system is implemented, leadership must be clear on what changes will occur and who, when, and how people will be impacted.

Organizational Change Management Plan

In the delivery stage of the OCM lifecycle, this is where outputs from all OCM best practices converge. OCM methodologies vary on how this plan is developed, but this where the experience of the OCM lead in this deliverable is critical. Every plan has unique sections and requirements, and the analysis that has been performed, based on the OCM methodology in use, will define the outputs. Regardless of the specific OCM methodology, results of the stakeholder assessment, CIA, surveys, and interview transcripts are required for the OCM lead to interpret and construct a meaningful plan that includes:

• An executive overview (i.e., summary of findings, metrics, and definition of successful change).
• A detailed strategy aligned with organizational goals and mission, and an explanation of how the electronic quality management system intersects.
• The communications plan.
• Interventions (e.g., briefings, learning labs, town halls, etc.).
• The resistance management plan.
• A consolidated schedule of OCM deliverables in the context of the project timeline and milestones.

The OCM plan guides all activities and deliverables to support the digital quality management system implementation project. It should be reviewed and approved by the executive sponsor of the effort as well as project and business leadership. The OCM plan is a living document that is subject to change if the boundaries of the project are revised or there are unforeseen delays.

Real-World Lessons

In a recent digital quality management system implementation project, a stakeholder assessment overlooked a major group of stakeholders outside of the primary region where the project was sponsored. It was discovered late in the project timeline. There was no representation from the group and rollout was deferred, which caused resistance and lack of support from the group leader. The effort to get this group engaged took months and could have been avoided had they been included from the start.

In another case, access to technical resources was restricted during the period the CIA was conducted. Additionally, the CIA was executed despite caveats from the OCM team. The failure to include vital technical knowledge resulted in a minimal view of some serious technology challenges posed by the move to the new platform which delayed the project by three months.

When OCM is not seen as an executive function and proper funding is not allocated to do the work, OCM is often relegated to communications only. For example, when interventions were needed to overcome resistance from a senior level stakeholder during a recent major digital quality management system implementation project, the activities needed to overcome the concerns were not available. This raised great concern that the project had been minimized to emails instead of given the strategic importance it warranted.

Since digital quality management system implementation projects have long lifecycles and multiple stages, OCM is key for the duration and can be seamless when its purposes and roles are clearly understood and funding is committed, with executive and business leadership in lockstep strategically and operationally. Successful outcomes of a project phase give way to the next success. Transformative change takes time and will lead to further organizational progress when there is a sustainable mindset.

Wishing you success in your eQMS efforts!