By Allan Marinelli, Quality Validation 360 Inc.
The role of consultants in the biopharmaceutical and medical device industries is significant. Consultants provide experienced resources in crisis situations, when new facilities are being installed, under circumstances requiring a high input of technical expertise, during regulatory emergencies, and during other planned and unplanned situations.
Problems often occur between clients and consultants, with both parties contributing to these situations. Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides to ensure a smooth business interaction that successfully meets the objectives.
This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.
First, we will cover common problems that can occur in consultant-client relationships. Then we will review recommended best practices for engaging a biopharma or medical device consultant, from first meeting to follow-up/closure after the project has been completed. The following topics are addressed:
- Establishing good communication at the outset
- Accounting for the work culture at the site
- Gaining endorsement of the project overview
- Confirming the consultant’s objectives and milestones
- Follow-up and closure
Pitfalls to Avoid
Beginning with their first business interaction on workday #1, communication between the consultant and the client is an important activity that is often poorly executed. Consultants estimate that up to 75% of projects suffer from a lack of information provided by the client to the consultant, or conversely, from the consultant to the client.
The consultant needs sufficient information from the client to do the job requested. And the consultant is penalized when his work is judged by the client to be deficient, inadequate, or inefficient — even when the root cause is a lack of information from the client.
On the other hand, the consultant may provide inadequate information to the client because he is disorganized, lacks focus, or is not qualified to meet the scope of work from the get-go, delivering mediocre performance and simply burning hours to get paid. Problems such as these can fundamentally undermine a project and should be addressed on the first workday, as well as closely followed over subsequent weeks. Concerns should not be communicating two months later, whether by the client or the consultant.
Following are several cautionary examples of problems that have occurred in consultant-client relationships as a result of poor/inadequate communication.
- Unrealistic expectations. One consultant described a previous assignment in which the client was very inexperienced at validation. He arbitrarily decided that 2 hours would be allocated for protocol preparation (since a template was provided), 1 hour for protocol execution, and 1 hour for finalization and internal approval. Thus, the anticipated monthly output of the consultant would be 23 executed protocols — no flexibility, no exceptions. Needless to say, the consultant fell far short of expectations, due to the increasing complexity of projects as the year went on. Communications about expectations may be especially difficult when the respective orientations of the client and consultant are different — for example, a business orientation vs. a technical orientation. The client and the consultant must understand each other and set realistic goals.
- Numerous changes to protocols by company management. One manager described a department in which the hiring manager didn’t understand that validation protocols often require changes and corrections based on the input of the site staff. The site always deferred to the input of related managers, without limitations. In some cases, there were changes upon changes upon changes to protocols, to results, and to discussions — all of which were detrimental to the consultant’s progress. There were no limits on the number or types of changes requested, and many of these were personal grammar/style preferences not relevant to technical understanding of the document.
- Discourteous and disrespectful treatment. Consultants described disrespectful treatment by clients. The consultants were treated as “second class citizens” by employees of the company, and their input and recommendations were generally not accepted or appreciated. This treatment was a direct consequence of department management behavior — management set the tone for the attitudes and behavior of the department.
- Logistical deficiencies. Lack of computer access; lack of office space; changes in office location; substandard working conditions, such as excessive construction noise; lack of availability of required technical information; limited access to validation library; and other logistical problems all can have negative effects on a consultant’s productivity. Making the consultant’s work unnecessarily difficult hurts both the consultant and the client company. Several consultants described working in areas adjoining rooms under construction — work conditions that were unbearably noisy and distracting. In one case, a portable trailer was brought onto the site for contract personnel.
- Inexperienced or substandard technical personnel. When inexperienced personnel are assigned to work with the consultant, the consultant’s productivity suffers. One consultant described an experience where an assigned technician had no knowledge or understanding of GMP documentation practices — data was recorded on scrap paper and then transcribed into permanent notebooks — and thus required significant training. Another consultant described work that was “dry-labbed” by a new technician; the technician was ultimately fired. Several consultants described work that had to be repeated because original data was not correctly recorded. Another technician performed work on one machine, and then copied the same data for six identical machines. His rationale was that since all machines were the same, why repeat the testing! Deficiencies in documentation always cause significant delays in progress of a project.
Best Practices For The Initial Meeting
The following best practices can be thought of as a general, topical agenda for a first workday meeting between a consultant and a client. In preparing this list, feedback from various senior-level consultants and clients has been factored in. (However, this is not an exhaustive list.)
Establish good communication at the outset. Topics of personal interest to the consultant should be discussed. For example, the client can ask the consultant which tasks he prefers to start with. This will ensure that smaller, attainable tasks are completed on time, as opposed to tackling the harder tasks from the get-go.
It is as important for the client to listen to the consultant as it is for the consultant to listen to the client. This two-way communication will help ensure smooth project execution, while minimizing potential hurdles along the way.
Account for the work culture at the site. How the consultant will fit into the client’s organization is another topic often overlooked in consultant-client communication. The following are topics for discussion:
- Is the consultant considered to be, and treated as, an “unofficial” member of the department, or is he considered to be completely external to the department?
- Is the consultant allowed or encouraged to interact with members of the department?
- Is the consultant allowed to ask questions of others in the department, or is his contact to be only with the client manager?
- Will any department personnel, such as technicians, be assigned to work with the consultant to execute consultant protocols? If so, what are the credentials and areas of expertise of the technicians? Their resumes should be provided to the consultant so that their skills may be appropriately used.
- If the consultant relationship is collegial, is the consultant allowed to comment on other activities related to his expertise? One consultant explained that his suggestions regarding a department project (not his own project) on which he had significant expertise were not appreciated and were used against him in a future performance review, leading to his termination.
Documentation practices in the department is another corporate culture topic that is often overlooked. Discussion of department policies regarding documentation is critical for validation and quality organizations.
Gain endorsement of the project overview. To efficiently perform the required functions, a consultant must receive input from the client about the big picture or project overview. This enables the consultant to better understand the scope of work and thus attain alignment between the project overview and scope of work.
In addition, consultants perform more efficiently and effectively when they are aware of the overall project, rather than simply being treated as “a body.” The project overview is generally broken down as follows:
- General project details. The long- and short-term goals of the project should be discussed.
Specific objectives. The specific work expected of the consultant follows from the general through specific project objectives. Providing a general project objective gives the consultant the required tools and overall confidence to attain the project deliverables. The client should also set up a list of attainable, specific objectives for the consultant to work on. The client should prepare this before the consultant is hired, rather than attempting to ponder specific objectives on the fly.
Clarify reporting requirements. Once the consultant has an understanding of the general project objectives and specific expectations, the progress reports the consultant must provide to the client should be discussed. It is important to clarify whether progress reports should be submitted in writing, or discussed verbally as a part of regular meetings.
Most consultants recommend a written project report, regardless of the size of the project. Written reports demonstrate continued progress of the project and how close the consultant is to attaining the list of specific deliverables. These reports serve as protection for both the client and the consultant when disputes over progress occur.
The frequency of progress reports (daily, weekly, monthly, etc.) is another important topic of conversation, as is the level of detail required in progress reports. Keep in mind that too much detail might actually delay progress on the project. A rule of thumb is that, if a project report becomes a project in itself, it is too long. Verbal progress reports might be provided on a daily basis, with written reports provided less frequently (weekly or bimonthly), depending on the project and workload.
The client has a responsibility to review and comment on progress reports. Where warranted, the client is typically expected to respond within 48 hours of the consultant submitting the report. If there is no feedback, the consultant will assume that progress is acceptable and will continue to deliver the specific or projected tasks highlighted in the report. One consultant described an unhappy situation in which sufficient proof of the project deliverables was reported to the client, but the client either forgot to review or did not thoroughly understand the report, and the consultant was haphazardly terminated without merit.
Provide details on follow-up and closure. Upon initial engagement, the consultant should be provided with verbal and written information about the follow-up process, including information about consultant evaluations.
The client must explain how the consultant will be evaluated, at what frequency, and how this will affect the continued extension of the contract. Other relevant performance-related issues should be explained, as well. Planned and periodic consultant evaluations should be performed after a certain number of progress reports, so that both the consultant and the client have the same understanding of the progress, and to ensure that the deliverables are being met as realistically projected. Again, the evaluations serve as protection for both the client and the consultant when disputes over progress occur.
One consultant described his termination as “out of the blue.” There had been no periodic progress reports and no evaluation meetings. He had assumed that his work was acceptable, until one day when he was summoned to the client’s office and let go, despite having worked at the site for two months. The client subsequently told him that he had not provided enough work output during the two-month timeframe, despite having informed the consultant on a weekly basis that his work progress was acceptable and the quality was great.
This article represents a general and brief consolidation of multiple problems expressed by consultants who have been engaged by biopharmaceutical and medical device organizations. In general, the problems demonstrate a fundamental lack of communication between the client and the consultant.
The list of best practices provides a structured format for both the consultant and the client to consider for discussions on the first workday, and over subsequent weeks until the end of the project. To ensure a smooth onboarding process and timely project delivery, the client should be prepared to implement these best practices prior to hiring a consultant. This will increase the probability that a project will be completed within the allowable timeframe specified on the schedule, without loss of quality.
- Marinelli, A., "Consultant Forum #2: Client and Consultant - The First Work Meeting", IVT Forum, Dec. 12, 2016.
About the Author:
Allan Marinelli has more than 25 years of global (Belgium, France, South Korea, China, India, Canada, U.S.) cGMP experience under EMA, KFDA, SFDA/CFDA, WHO, FDA, and other regulators. He is currently the president/CEO of Quality Validation 360 Inc., providing consulting services to the biopharmaceutical, pharmaceutical, medical device, vaccine, and food/beverage industries. Mr. Marinelli has authored peer-reviewed papers and book chapters on validation, risk analysis, environmental monitoring, process/equipment validation, computer systems validation, and cleaning validation. He is an associate member of ASQ (American Society for Quality). He can be contacted at firstname.lastname@example.org.