Validation Outsourcing: Getting the Most Out of Your Client?Contractor Relationship

Published on: 
BioPharm International, BioPharm International-07-01-2003, Volume 16, Issue 7

Supplementing your existing staff with experienced contractors when your process is ready for validation can help you avoid common validation mishaps - if you know the ingredients of successful project management.

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 detail.

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.

Step 1. Be prepared for the contractor's arrival. Take appropriate measures to ensure the space provided to the contractor is conducive to project work. Ensure that computers are set up and have network connections and email, that access cards are available, and necessary supplies are on hand on the first day.

Step 2. Cultivate trust and commitment to the project by establishing a good, two-way communication channel between the project manager and the contractor.

Step 3. Conduct a tour of the work area and the plant. At the start of the project, be sensitive to contractor needs in their new work environment. In larger facilities, a single plant tour may be insufficient.

Step 4. Introduce the contractor to both the validation staff and the others who are involved in the project.

Step 5. Provide general training material to the contractor. Focus on providing training material on daily operations, such as the validation master plan, templates for protocols, and gowning procedures. We have all read standard operating procedures that left us confused or that are forgotten until we are actually using the procedure. It is important that clients focus on specific procedures that are used in later stages of the outsourcing project.

Step 6. Share your organizational charts. Project charts that show your company's hierarchy visually summarize staff roles; provide a guide for contractors when they need to determine appropriate communication channels; and inform contractors about key project players.

Project implementation. At this point, hours or days have been well spent crafting a solid, up-front foundation for the contractor. The objective of the project implementation phase is twofold: Delineate project needs, and provide further validation or project-specific training.

Step 1. Reiterate the proposal. Confirm that the contractor understands your expectations. Review equipment lists, deadlines, and milestones.

Step 2. Discuss the significance of the project: Is the validation a small-scale effort, or is it a corporate-wide goal? This determination influences other aspects of the project.

Step 3. Identify project dependencies; that is, inform the contractor of the people who directly affect the validation effort, typically through lateral relationships. Ensure that the contractor has met these people and knows how to contact them.

Step 4. Allocate time and staff to provide training. A contractor can review the material received and be trained "in the trenches" on specific procedures.

Step 5. To avoid delays, inform the contractor where equipment is stored and how to sign out equipment.

Step 6. Take a backseat. Let contractors do their jobs; that's what you pay them for.

Project maintenance. As a validation effort unfolds, there are victories and causalities, but the momentum of the project must continue at a quick pace. People need to stay motivated, positive, and excited about their work and validation. Project participants turn to their leader for support. Success tips for orchestrating project maintenance include

  • Take a backseat, but be a backseat driver. Keep aware of the progress and direction of the project.

  • Stay involved and communicate. Engaging in face-to-face discussions with a contractor can provide you with deeper insight into the details of the validation project.

  • Continue to foster the necessary lateral relationships (project dependencies). As the project unfolds, so do the relationships.

  • Energize staff by stating and restating the benefits of the contractor's effort. Focus on the benefit of the finished project.

  • Use mishaps and deviations as opportunities to reflect and learn.

  • Give recognition when deserved. Encouragement - a simple "good job" - can motivate the whole team.

Guiding Successful Projects

This four-phase outsourcing strategy has several steps that can occur simultaneously, driven by the time scheduled for the project. But information from each step is important to your company and to the outcome of the project. By capturing the information from each step, you ensure that you know your contract and contractor and that you are aware of the project progress at each stage.

Experience teaches that successful validation efforts - those that maintain regulatory compliance - are achieved by orderly and timely commencement and continued project management. Staffing a validation department, however, can be difficult if qualified candidates are limited. Too few personnel or staff without the proper experience will affect the polished plan you want. As many companies have discovered, the capabilities of validation contractors can be used to supplement your current staff and facilitate successful validation projects. BPI