In many companies, lab automation projects have become cooperative activities between lab and IT groups. This is part of the evolution of lab systems; once isolated from the corporate view, the need to integrate lab data into the company’s operations 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 to improve the workflow within the lab and between the lab and other parts of the organization increases (for example, tying LIMS / ELNs to 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 involved in lab automation programs can be managed by a team and the qualifications it needs 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 would enable the reuse of project elements to avoid duplication of existing work, provide a better basis for integration, protect intellectual property, and meet regulatory & legal requirements. While senior managers may not actually define the standards, they can assign the work and ensure that those standards are met during program reviews. This provides the basic infrastructure for program development, just as building codes provide the rules for land development in communities.
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 the use of lab systems evolves.
Once that is done, you have the basis for developing a description of each automation project, and the functional requirements that comprise the basis for developing project plans. Since the lab workers are intimately familiar with the day-to-day operations of the lab and the procedures 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 & Management
The development team, often the IT group sometimes supplemented with outside consultants, is responsible for the implementation phases of the project, including validation, which 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
- Operational Verification
- System put into use
(Note: this is not intended to be an exhaustive list; additional elements including validation, which covers the entire process, may be required.)
In addition, the IT group will be responsible for overall project management.
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 automation increases in the lab, jobs will change, as will the qualification requirements for those positions. Instead of performing tasks in a procedure, automated equipment may do that (robots and programmable autosamplers are already 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.
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 be aware of products and technologies that may be of benefit. A separate group would be used to carry out the implementation. This eliminates the need to hire people to implement programs limited to what they have in their experience rather than what is right for your needs.
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 UniversitySM (www.InstituteLabAuto.org/LAU/) is the initial response for helping lab management and IT groups understand the development environment and product selection in lab automation.