Game Changer

How Lab Automation is Transforming Traditional Lab Management Structures and Job Requirements

Lab automation projects have become cooperative activities between lab and IT groups. This is part of the evolution of lab systems. The lab, once isolated from the corporate view, now faces the need to integrate lab data into the company’s operations. This has increased the complexity of lab automation programs.

The need for effective teamwork is going to increase as:

Companies become interested in moving away from paper records to fully electronic systems that both improve lab operations and make lab reports more accessible.
The need to reduce operating costs pushes companies to use common software products in different lab environments to reduce implementation, support, and license fees.
The need increases to improve workflow within the lab and between the lab and other parts of the organization, such as tying LIMS/ELNs with ERP systems. This desired improvement in workflow is going to increase the call for systems that can be integrated through standardized communications/data interchange protocols rather than force-fitting systems together.

How does that once-isolated laboratory activity distribute itself over lab management structures and the IT organization? In order to be successful, a company needs to build a lab automation team that takes advantage of the skills of different groups. In large organizations, the team may be built from internal resources; in smaller organizations, outside assistance will be needed. This article takes a look at how the work can be managed by a team and the qualifications needed to make things work.

The role of senior management

In addition to the expected roles of authorizing funding, reviewing proposals, and green lighting projects, senior management has another set of responsibilities: setting the organization-wide policies and practices that form the underlying basis for project/program management. If the goal is to reduce operating and implementation costs in addition to having successful results, then having projects developed according to a common set of standards (policies, practices, and project management criteria) is essential. These standards enable the reuse of project elements so you can avoid duplication of existing work, provide a better basis for integration, protect intellectual property, and meet regulatory and legal requirements. While senior managers may not actually define the standards, they can require that the work is done and ensure that those standards are met during program reviews. This provides the basic infrastructure for program development and management, just as building codes provide the rules for land development in communities.

Lab management

Planning is essential, and within that task, lab managers need to be able to describe the labs’ operations and workflow. The result of that work should be a strategy that details the overall automation scheme, the stages of development, and an evaluation of the processes used in the lab and their suitability for automation (are they readily automated, are there obstacles, are there optimization issues? etc.). In addition, the training requirements for lab personnel need to be determined and periodically reviewed as lab systems and their use evolve.

Once that is done, you have the basis for developing a description of each automation project and the functional requirements that are the basis for developing project plans. Since the lab staff is intimately familiar with the day-to-day operations of the lab and theprocedures they are using, their input into the functional requirements is valuable. These are the documents that you hand off to those who are going to implement the project—often the IT group.

Program development and management

The development team—which can be an internal scientific IT group, a corporate IT group sometimes supplemented with outside consultants—is responsible for the implementation phases of the project, including validation that begins with the development of the functional specification. They will develop the:

Function specification—the implementers’ response to the requirement document
Design document
Development requirements and schedule
Product selection and modification, where required
Testing/QA process
Installation/verification
Acceptance
Training
Operational verification
System put into use

(Note: This is not intended to be an exhaustive list. Additional elements, including validation, that cover the entire process may be required.)

In addition, the IT group will be responsible for overall project management. Ideally this is a cooperative development effort between the lab and IT. The work needs to be reviewed and discussed so that potential problems are caught early enough to avoid them becoming major issues.

Laboratory staff

Those working in the lab—the people all this is being done to support—need to be actively engaged in the process, evaluating what is planned and produced to make sure it meets their needs. As the level of automa-tion increases in the lab, job descriptions will change—as will the qualification requirements for those positions. Instead of performing tasks in a procedure, automated equipment may do that (robotics and programmable auto-samplers are taking on some of that work today). Lab personnel will become responsible for supervising, checking, and managing those automated systems and evaluating the results produced.

A recent survey¹ conducted jointly by the ILA and the Association of Laboratory Managers2 showed:

Lab automation is essential for most labs, but not all.
The skills required to work effectively in labs have changed significantly due to the use of lab automation technologies.
Entry-level scientists are generally capable of working with the hardware/software.
Entry-level technicians often are not.

One statement in particular (number six of the survey) reads, “Staff qualifications are a concern in deploy-ing lab automation technologies.” The possible responses were strongly agree, agree, neutral, disagree, strongly disagree. The results are shown in the following graph.

In a survey conducted by Lab Manager Magazine, 96 percent of 384 respondents rated “educating lab personnel” as important or very important. If lab automation systems are to be successful, those using them have to be well qualified both to work with those systems and to specify the capabilities needed.

Large company or small

This discussion holds regardless of the size of the organization. The difference size makes is that more work will be put on fewer individuals and more outside help will be required. Smaller companies will need to bring in knowledgeable, independent people to provide sanity checks and keep them aware of products and technologies that may be of benefit. A separate group would be used to carry out the implementation. This avoids hiring people to implement programs according to their experience rather than what is right for your needs.

Summary

Lab work is continuing to change, demanding more teamwork and higher levels of qualification to meet those demands. The education of five or ten years ago isn’t enough to keep up. The Institute for Laboratory Automation and Lab Manager Magazine have entered into a partnership to address this issue. Lab Automation University3 was designed to help lab management and IT groups understand the development