Outsourcing validation studies can help a company meet deadlines by supplementing existing staff and supporting specific projects.
Securing the maximum benefit from a validation contractor, however, requires a systematic approach and clear communications.
A long-term outsourcing relationship begins with a proposal, which describes your requirements accurately and in sufficient
A proposal enables the client and contractor to work in parallel to accomplish their common goals. Scheduling exercises (such
as practice interviews), delineating project specifics, and building a long-term relationship minimize the gap between client
expectations and what a contractor can achieve.
Creating the Proposal
The precursor to many outsourcing mishaps lies with an inadequate proposal. The proposal sets a project's tone and scope by
emphasizing the goals, timelines or assignment durations, and critical assumptions.
Critical assumptions. A proposal should include a detailed section on critical assumptions - to make the document more accurate and to ensure both
parties begin operating with the same premises - once the contractor is selected. The section on project-related assumptions
can include the following items:
- The proposed budget does not cover equipment rental costs.
- Temperature mapping includes one run per unit.
- Time is not allocated for resolving deviations, which are the client's responsibility.
- The client will provide a workstation that includes a personal computer, email access, a phone and fax, and work supplies.
- Time is allocated for only one review of protocols and reports.
Necessary details. Project managers need to detail the intricacies of their projects rather than presume a contractor can deduce the information
from the proposal. A proposal that is limited, either in its lack of detail or formality, will yield a project that requires
more of the project manager's time and more direction given to the contractor. It is incumbent upon both the project manager
and the contractor to ensure the proposal is a formal accounting of all expected details.
"Soft" skills. Project managers need "people" skills; they need to be able to communicate clearly and succinctly. Soft skills, in an outsourcing
relationship, have their genesis in the proposal. They foster a sense of trust and common respect, a shared level of commitment,
project knowledge, and direction.
Client Contracting Strategy
We recommend a contracting strategy that focuses on a phased plan for hiring contractors, emphasizing both the "hard" and
"soft" components. The four phases are up-front work, an on-site foundation, project implementation, and project maintenance.
Up-front work. Remember this phrase: "Do your homework." Homework in this context can be defined as knowing your contract and your contractors.
Once the decision has been made to hire a contractor, ensure the contractor's capabilities meet your needs - that is, do your
homework. To be compliant and to incorporate industry's best practices, engage in these up-front activities:
Step 1. Hold an informal meeting to gain insight into the contracting company's goals and mission - and most important, its staff
experience. Use this time to ask both detailed and general questions, such as:
- What is your company's history?
- What are some of your current and past projects?
- Does your skill set overlap our needs on this project?
- What is your staff availability?
Step 2. Once you have narrowed the contractor list, ask to review staff resumes.
Step 3. Meet the potential candidates. Invite the contractors to visit your facility, and conduct a short interview. This can be
accomplished in an informal or formal setting. Conduct a plant tour while interviewing, or have the contractors meet some
of your current staff to help you gain a deeper insight into the contractors' relevant work experiences. If time does not
permit such in-depth contact, a telephone interview can suffice.
Step 4. Request a proposal. During proposal generation, it is imperative to develop accurate plans so that clients share pertinent
project details. That information can include equipment lists, timelines, financial restrictions, equipment rentals, and project
expectations. Sharing this knowledge empowers the contractor, and as a result, you receive an authentic, customized proposal.
Step 5. Review and approve the proposal. The proposal sets the tone for the life cycle of the project. Both parties must agree on
the details of the plan.
Step 6. Allocate sufficient time for security measures. The contractor may be subject to specific security measures, such as a background
check. Be sure this time is reflected in the project start date.
On-site foundation. The on-site foundation phase of an outsourcing contract offers an opportunity for active conversations that cultivate a commitment
to the project, foster trust, and establish communication channels. This phase should include ample time for the contractor
to become familiar with your company culture, its style, and the project teammates. On-site initiation can take a half-day,
a full day, or a week, depending on your project requirements. On-site time involves the following steps.