Medical Device Link.

IVD manufacturers hire consultants for various reasons. The challenge lies in selecting and making the most effective use of the right consultant.

The need for consulting services is prompted by unplanned, time-sensitive, or crisis situations, when a company may face extreme pressure to find specialized experts quickly. Under such circumstances, a company will often focus on fixing the immediate problem rather than on managing the contracted consultants. After all, the consultants have been hired for their expertise and should know what to do to get the job done.

Unfortunately, applying consulting resources—no matter how skilled or experienced—without proper direction and management rarely gets companies the results they want. To get the highest quality of service, while meeting budget and time constraints, companies need to establish guidelines and consistent processes for managing consultants.

This article discusses a quality framework for managing consulting services that encompasses two interrelated components:

• Project and Performance Management. Managing all consulting assignments—from project definition and planning, through implementation and project completion—to ensure that the company’s needs have been met.

• Organizational Learning. Developing a system of tracking and learning from successes and failures to better equip companies to select qualified consultants.

This framework provides broad guidelines for developing a quality plan for managing consulting services, or for enhancing existing quality plans. Such a quality plan should be scaled to meet the company’s consulting needs. In addition, it should be part of a larger company-wide quality management system. For example, it can supplement the company’s supplier quality plan, which oftentimes does not effectively address the unique aspects of consulting services.

Project Ownership and Accountability

Ownership and accountability are essential to addressing organizational challenges, especially those that call for the use of external consultants. To ensure that the consultants and company are working toward a common goal, companies should assemble a project committee. The committee should include a project owner, project stakeholders, and a project manager.

Project Owner. The project owner is the individual ultimately responsible for the project’s success. As such, the project owner should be a senior manager who understands the needs of the organization, has decision-making authority, and can garner the necessary resources (both human and financial) and support to make any necessary changes. The project owner is responsible for the following tasks:

• Leading the assessment of organizational needs and the internal capability to address those needs.

• Determining the feasibility of hiring external consultants to address the organizational challenges.

• Defining the project objectives and expected outcomes.

• Defining the consulting budget and timeframe, as well as the expected quality of results.

• Providing leadership and setting a tone for collaboration among all participants.

Project Stakeholders. Consulting projects often cross many functional areas. To assure project success, it is important to identify and analyze the influence of specific individuals or groups on the project and obtain their “buy-in” from the beginning. Considering the project concerns, expectations, and goals of potential stakeholders can help the company identify key stakeholders. In addition to involving stakeholders at the beginning of a project, a company needs to decide how involved they will be throughout the consulting project.

Project Manager. The project manager is responsible for developing and executing a management framework to carry out the project objectives. The project manager should ensure that external consulting resources are appropriately integrated into the project and that all project participants understand and work toward a common vision. Specific responsibilities of the project manager are discussed in each project phase that follows.

Phase 1: Defining the Consulting Project

Assess Organizational Needs and Internal Capability. The reasons that companies look to outside consultants are unique. They range from simple needs and a specific service (e.g., designing and delivering a specific training course), to more-complex needs that require in-depth diagnosis and analysis (e.g., developing company-wide quality system improvement). Even though two projects may appear similar, the solutions may differ depending on the company’s experience with similar issues, its response to crisis and change, the available resources and how it chooses to use these resources, and its overall organization. These factors become especially relevant for more-complex needs.

A well-defined set of guidelines and goals can enhance a company’s consulting experience.

Creating an assessment checklist can help companies evaluate essential information and options to decide whether external consulting services are necessary. This assessment should be led by the project owner and should include the project stakeholders and the project manager. All three positions should work to identify project objectives and expected outcomes.

Phase 2: Planning for the Consulting Project

Develop a Statement of Work. Once the organizational needs and internal capability assessment has been conducted and the company has decided to engage the services of external consultants, it is critical to prepare a statement of work (SOW). The SOW should achieve the following goals:

• Give a clear description of the project, its objectives, and anticipated outcomes and deliverables.

• Explain what is expected of the consultants.

• Describe the importance and complexity of the work.

• Guide both the consultant and the company on what they are accountable for and how the project will be managed.

• Ensure that there is no confusion about what is to be achieved so that the project does not go off track.

The project manager should prepare the SOW with information from an overall project plan, which should be reviewed with all project team members. In addition, the SOW should be reviewed with the individual who will be responsible for day-to-day management of the consultant’s activities. Although the SOW should be defined before hiring the consultants, it should also be reviewed and revised as needed during the consulting.

Identify and Select Qualified Consultants. Although systems to track both successes and failures with consultants can take time to develop, if done appropriately, they provide a valuable tool for managing consulting services.

A company should begin with a review of its consulting experiences. Conduct a formal evaluation of the consultants’ performance with a sampling of project owners, stakeholders, project managers, and team members from diverse projects. Chances are, the same consultants have worked on different company projects. By establishing and maintaining an electronic database of consultants and their performance at different stages in projects, the selection process can be streamlined significantly.

Plan for Knowledge Transfer and Project Sustainability. The following actions should be considered to ensure project and organizational sustainability:

• Be clear about the capability you want transferred from the consulting team to yours.

• Identify which staff members are to be involved in the project.

• Contract with staff members and their managers for time required and learning outcomes.

• Include both consultants and staff members on the initial project team to ensure a seamless transition after the consultants’ assignments end.

• Be sure the consultants create a written record of their work through documentation and regular reports.

Prepare for the Consulting Work. Before a consultant begins work, the appropriate company personnel should be clear about the role and purpose of the work. The consultant should not be seen as a threat to employees’ jobs or even as a source of interference.

If the consultant will work on premises, have the work area ready ahead of time. If the project consists of analyzing reports, documents, or problems, the material to be analyzed should be prepared before the consultant arrives or available when the consultant requests it. A company should be prepared to pay fees if the consultant must handle these logistics.

Finally, the consultant should report to the project manager and be teamed up with a project leader or other team member who will be responsible for managing the consultant’s day-to-day activities.

Phase 3: Managing the Consulting Project

Change is inevitable in any project. Successful project management requires effective monitoring, control, evaluation, and communication. Mistakes should be identified quickly and corrected. All of these activities are the responsibility of the project manager.

The quality and effectiveness of the consulting project should be evaluated periodically. Managers might consider holding a midterm project review with people involved in or affected by the project, as well as soliciting feedback from stakeholders.

Good monitoring requires good communication. A communication plan should be established for larger, more-complex projects. The project manager should maintain regular communication with the consultant and the entire project team to ensure that all team members understand the expectations as outlined in the project plan and the SOW. Regular team meetings should be held to review progress and any unexpected changes that may affect the project.

The project manager and team must be willing to acknowledge any problems that arise during the project and take steps to overcome them. Although the proper course of action will depend on the situation, the following are key types of corrective action:

• Rearranging the Workload. If a milestone is going to be missed, the preferred option is to rearrange the workload. This may mean completing the work in a different order or finding an alternative way of reaching a milestone.

• Adding More Resources. Another option is to dedicate more resources to the project. However, this will increase the project cost and may not yield the expected level of quality.

• Moving Milestone Dates. Rescheduling current and future milestones may be acceptable if this does not affect the overall timeline.

Phase 4: Completing the Consulting Project

When the project is completed, the company should review and record the consultant’s performance. The following questions should be considered:

• How effective was the consultant at meeting the project objectives?

• Did the consultant work within the SOW or venture out side, the scope of the project?

• How well did the consultant keep the project manager or team leader informed of work progress and problems?

• How well did the consultant work with the company’s staff?

• What was the quality of the project?

• How effective was the consultant at proposing solutions to challenges encountered during the project?

• Would the company hire the consultant again? If so, for what types of future projects?

Conclusion

A quality plan for managing consulting services should provide companies with a consistent process for deciding whether bringing in a consultant is the best way to address a particular challenge. The company and senior management should be prepared to hire a consultant if the challenge warrants this.

In addition, the company should have a plan to enact the consultant’s recommendations into the organization. If the wrong consultant has been hired, or if the consultant is not performing as expected, there should be room for corrective actions to be taken. In the end, the company should be willing and able to learn from its consulting experiences.