Posted 07 January 2020 | By David W. Husman, PhD, CPGP, RAC
In the regulated industry, consultants are engaged for a variety of activities ranging from manufacturing, to testing, to quality control and quality assurance, to regulatory affairs. This article discusses the types of reasons for which consultants are engaged and how companies can ensure success in executing the engagement. The author emphasizes points such as hiring the right consultant for a specific task, onboarding a consultant, clarifying and communicating expectations regarding specific projects, getting updates from consultants and having a structured project ending to ensure all deliverables have been received. Introduction In the regulated industry, depending on the size of the organization, between 50 and 90 percent of regulatory affairs operations were outsourced in 2019.1The Contract Manufacturing Organization (CMO) market alone represents more than $3.5 billion annually.2 In today’s business climate, choosing the right consultants for the right reasons can make the difference between positioning the company for success or setting the company up to spend a great deal of money to the frustration of everyone. Communication within the organization is crucial to achieving success before considering reaching out to hire a consultant. It must be clearly understood what is trying to be achieved, how long it may take to achieve success and what success should look like. When choosing to bring in outside help, it is critical to understand the company will be spending a lot of money and, to achieve the goals, the appropriate time and other resources must be devoted to efficiently utilizing the consultants time. The following are three primary reasons clients hire consultants:
knowledge augmentation specific task execution short term resource supplementation/replacement
Knowledge Augmentation When looking to augment the knowledge of an organization, it is critical to both select professionals who possess the requisite knowledge as well as have the ability to clearly and succinctly communicate the knowledge in a manner that members of the organization can receive and utilize it for the long term. The key in selecting the right consultant is to first have a clear concept of what knowledge the organization is lacking and whether there are one or more members of the organization who can both receive instruction and utilize the knowledge brought in from outside the organization. For example, take care to not ask for an advanced level presentation and implementation of a topic without having one or more employees who have a basic understanding of the given topic. This is not to say the company should plan for advanced implementation and not hire consultants with the ability to deliver advanced topics but, rather, recognize what might be more of a “phased” implementation to prepare the organization with the basics before moving on to more involved topics. Developing a comprehensive plan is critical at the onset of the project, one with clearly defined deliverables and timelines and with the assurance all parties understand their roles and the company’s expectations of them. Specific Task Execution Typically, companies bring in outside help to execute specific tasks for one of three reasons:
Business need for timely execution of task while not compromising other business operations One-time execution of a task without specific expertise on staff, e.g., construction project Specialized knowledge necessary for compartmentalized task execution, e.g., specific equipment maintenance or calibration
While there may be other reasons than those listed above, companies need to recognize what they are bringing consultants (or temporary staff) in to accomplish, what knowledge and skills they need (specialized or not) and what the endpoint of the task(s) should look like. There must be a plan for how consultants are to be used while on site, what management/oversight will be necessary, what security concerns outside people raise, if any, and where they will be located for work while on site. Additionally, there should be a clear plan for when and how consultants will leave the site once the task is complete. Critical to plan development is a communication plan clearly delineating who needs to receive an overview and the details of the task execution project. Short Term Resource Supplementation/Replacement The final major category for successfully using a consultant is for short-term resource supplementation, or short-term replacement of staff members. Although listed as short-term, these engagements are typically months long. Typical projects range from vacation coverage, to unexpected termination or loss of employees in key positions for which there was no succession plan. It is important for job descriptions and training programs to already be in place. Plans must clearly ensure that these resources receive the appropriate documented “onboarding” and similar training to what permanent employees would receive. While this training can be limited to the specific activities they will be executing, careful planning for activity execution will still determine the success or failure of this category of consultant. As noted above, companies have a variety of reasons for bringing in consultants for specific task execution—from needing additional “hands,” to needing a specific knowledge set for the short-term or needing to minimize time to completion. While the desires and reasons for bringing in outside help may be good, too often these engagements do not achieve desired outcomes. Too often, companies focus on the hiring process (typically with too great an emphasis on costs) but spend too little time focusing on the onboarding and engagement process with these new hires. There tends to be a mindset saying “the consultant has done this before, so they just know what to do” without full consideration and complete understanding regarding the uniqueness of each company and each engagement. When looking at typical challenges and failures, they tend to fall into the following categories:
misalignment of consultant skills with required activities (too junior or too senior) unrealistic expectations, e.g., solve all our problems, but don’t make any changes) inadequate or incomplete requirements, e.g., since you’re here, can you also look at this? failure of communication both internally and between company and consultant, e.g., hiring authority is not the one managing the consultant and has not communicated what consultant is expected to do failure to understand time of commitments (at least initially) of current staff to fully achieve the benefits of the consultant interaction, e.g., if knowledge is to be transferred, time must be spent to achieve the transfer
How can the likelihood of success be increased? Before looking for consultants, determine what needs to be accomplished. Clarify and communicate goals and expectations to staff. Clearly communicate to the hiring group which specific needs require a consultant. Specifically, communicate to potential consultants what is to be accomplished. There must be clear alignment between what is to be accomplished, what resources are required to meet that need and the ultimate consultant(s) engaged. The US Food and Drug Administration (FDA) lays out some clear requirements for consultants in 21 CFR 211.34 Consultants3 and 21 CFR 820.50 Purchasing Controls.4 21 CFR 211.34 Consultants
Consultants advising on the manufacture, processing, packing or holding of drug products shall have sufficient education, training and experience or any combination thereof to advise on the subject for which they are retained. Records shall be maintained stating the name, address and qualifications of any consultants and the type of service they provide.
21 CFR 820.50 Purchasing Controls
Evaluate and select potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation must be documented. Define the type and extent of control to be exercised over the product, services, suppliers, contractors and consultants, based on the evaluation of results. Establish and maintain records of acceptable suppliers, contractors and consultants.
Purchasing documents shall include, where possible, an agreement that the suppliers, contractors and consultants agree to notify the manufacture of changes in the product or service so that manufacturers may determine whether the changes affect the quality of a finished device. To ensure consultants have appropriate education, training and experience or any combination of those to advise on the subject for which they are retained, companies must know exactly for which subject they plan to retain consultants. This is typically accomplished by either a job description or a specific work order. Misalignment can lead to frustration company staff, failure to execute to achieve the desired outcome, as well as making the company vulnerable to regulatory action. Records of consultant qualifications are required to be created, maintained and available for review during an inspection to demonstrate that consultants have the appropriate qualifications. These records should clearly demonstrate alignment between consultant’s qualifications and the job at-hand. Agreements should also ensure management is notified in a timely manner of any changes that could potentially impact the company’s products. For clinical studies, additional documentation to ensure consultants do not have a financial interest, or other conflicts of interest, in the activities they are providing. Assuming the right consultant has been engaged for the right activities, how can the company maximize its chances for success? Onboarding Good consultants are going to arrive at the company facility on time and expecting to engage their client and getting up to speed on a client’s systems and people as quickly as possible. They recognize the adage of “time is money” and are looking to maximize the client’s return on investment by minimizing wasted time and non-value-added activities. They arrive with a “game plan” based on conversations held during the hiring process and will be checking to ensure they are in alignment with the site’s expectations and timelines. Clients who have worked out basic logistics, such as making sure there are primary and secondary contacts identified, established work spaces for the consultant, determined and scheduled any site required onboarding activities (security pass, system access, safety training, etc.) and have scheduled kick-off meetings with key players, are several steps ahead of those who wait to carry out these activities once the consultant is already on site. For engagements associated with regulatory submissions, expect consultants to request a large amount of information to be delivered in a manner that allows for editing—as necessary—to tailor to the submissions. Those who wait to plan typically find time quickly slipping away and the expected benefits are lost or delayed. The Engagement In the experience of this author, the success or failure of the engagement typically comes down to the engagement of senior management. Absence of leadership from management leads to failure nearly 100 percent of the time, whereas fully engaged management throughout the consulting activities contributes to the success of all engagements. A key goal should always be learning what the consultant’s “new eyes” and experience bring long-term to the organization. Consultants often hear “you have done this before, that’s why I hired you, why do you need to talk to my people?” What many organizations fail to understand is every company is different; they are organized differently, have different systems and have various ways of engaging with employees—from instilling fear to building barricades to active participation. As noted above, good consultants work diligently to minimize their transition from outsider to insider, request a lot of information upfront, ask a lot of questions initially, spend time digesting the information, then propose solutions that will give the organization the best opportunity of success. A “one-size-fits-all” approach is very rarely successful in the long-term. One should expect a combination of consultants working independently as well as requiring the valuable time of key players within the organization. Failure to allow for, and plan for, each step frequently contributes to delays and frustration for all involved. Milestones and Status Updates Well-defined milestones and periodic updates ensure all parties continue to be aware of the consulting activity’s progress and can alert the organization to any impediments to accomplishing the desired outcome. Companies must define the frequency of communication and the types of communication to balance the desire to continuously be aware of the progress of a project, but without causing consultants to spend a significant portion of their time creating non-value-added reports or sitting in endless meetings having little to no positive impact on the consulting activity. Having said that, it is also important to take opportunities to engage in both informal and formal updates. This allows management to determine their operation and the level of engagement or possible “push back” from employees. Updates also allow for changes, as necessary, to ensure success of the engagement. Final Deliverables At the end of the engagement, it is important to have a structured project end to ensure all deliverables have been received, any security passes or system access has been returned/deactivated, as well has giving and receiving feedback. Too often this stage is where engagements go wrong, either from deliverables not providing the expected improvements or deliverables uncovering issues about which the company was either not aware or doesn’t want to hear about. Remember, the consultant was hired for their expertise, honesty and assistance, so it is infinitely better to learn about issues while still able to make changes rather than wait until a regulator uncovers them. If those responsible have been actively engaged with consultants throughout the project, there should be no surprises at the end. With good engagements, it frequently tempting to extend projects to take on new tasks or initiate new projects. The keys here is to not lose the learnings from above. New tasks require updates to job descriptions or work orders, change in scopes in contracts and revised records to support the alignment of skills and tasks.
Key Success Factors
Senior Management engagement at all stages
Timely and complete Communication – internal and external
Defined Goals for Consultant
Alignment between goals and consultant skill sets
Defined Milestones and deliverables
Identification of necessary timing including recognition of potentially significant impact on operations
Detailed plan including process for hiring, onboarding, utilization, deliverables and conclusion
Conclusion Consultation, when well-planned, clearly communicated with specific follow-through, has a high probability for success. The adage “if you thought it was expensive to hire a professional, just look what happens when you hire an amateur,” is always in play. Engaging the right partners for the right activities increases that probability for success. Choosing the wrong partners for the wrong tasks or failing to clearly communicate to all parties involved, leads to a high probability of failure and disappointment. There must be clear and complete internal communication along with a plan for engaging the consultant.
This plan should clearly define an understanding of needs consultant is expected to fulfill. There must be a clear match between needs expected to fulfill and expertise and experience of consultant. Remember, consultants are not magicians, but also if they are expected to make massive changes, expect pushback from those being changed. If there was no integrity in the underlying data, consultants cannot suddenly transform it into reliable evidence of a quality product. Senior management must be actively engaged throughout the project. Take time to fully understand the final deliverables, key project learnings and update all records to reflect the end of the engagement.
Key Trends in the Regulatory Outsourcing Services Market. GEP. May 2019 Langer E and Rader R. "The Outlook for CMO Outsourcing in 2019.” BioPharm International. 32:1;2019. 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. Subpart B: Organization and Personnel. Sec. 211.34 Consultants. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.34. Accessed 7 January 2020. 21 CFR Part 820: Quality System Regulation. Subpart E: Purchasing Controls. Sec. 820.50 Purchasing Controls. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.50. Accessed 7 January 2020.
About the Author David W. Husman, PhD, ASQ CPGP, RAC, is president and principal consultant for David Husman Consulting, LLC. He has more than 30 years of diverse international experience in quality assurance, quality control and regulatory affairs within the pharmaceutical, biopharmaceutical and biotech industries. He is fully versed in all quality systems and has used his expertise to help numerous clients assess, develop and improve their quality programs and compliance with US, EU and worldwide regulatory agency requirements. Husman is certified in Good Manufacturing Practices (CPGP) and regulatory affairs (RAC). He earned his doctorate in biochemistry from Ohio State University. He can be contacted at David@davidhusmanconsulting.com. Cite as: Husman D W. “How to Hire and Engage Consultants for Success.” Regulatory Focus. January 2020. Regulatory Affairs Professionals Society.