Originally Published IVD Technology October 2003
Consulting services
External consultants offer a reservoir of talent and skill from which IVD manufacturers can draw what they need to solve almost any problem.
IVD manufacturers hire external consultants for a variety of reasons, both strategic and tactical. Often, the necessary technical expertise does not reside in-house, or existing resources may not be sufficient to meet a short-term peak in a department’s workload. Perhaps management has decided the organization needs outside help in adapting to changing times, or it may have recognized a need to examine and repair the quality management system in order to head off possible regulatory action. In extreme cases, negotiated agreements with FDA or the U.S. Department of Justice have stipulated hiring an external expert to examine the firm’s quality system and certify that it is in compliance with the quality system regulation (QSR).
Consultants can be especially valuable to firms whose paternalistic hiring and promotion practices have prevented the infusion of outside ideas, resulting in an inbred culture that has found it difficult to keep abreast of evolving CGMP standards. An objective outsider’s report will identify the compliance gaps before FDA finds them. Seasoned veterans operating independently can also help small start-up firms jump-start critical functions into compliance with worldwide regulations by coming on board for short periods as needed.
Services that can be readily obtained from consultants have been reviewed in this space before. This essay focuses on selecting and making the most effective use of the right management consultant. To ground the discussion, the perspective of using consultants to develop a sustainable quality management system compliant with international regulations is taken. However, the steps described here are applicable to various projects undertaken by most types of consultants.
Defining Project Needs
Most failures to achieve satisfactory results from projects assigned to consultants can be attributed to one or both parties not understanding project objectives. If the firm has not explicitly defined what it needs, it is expecting the consulting team to be mind readers. And if its expectations are not communicated to the consultants clearly, chances are the experts will ultimately not solve the problem they were hired to remove.
To upgrade and institutionalize its quality management system, the manufacturer first must determine the existing state of compliance. If the internal audit program has been functioning properly, the data should already be in-house. Should there be doubt regarding the objectivity or completeness of the audit data, the firm should invest in a comprehensive external audit of its practices against the regulatory requirements.
The baseline audit can be planned and conducted as part of the internal auditing program so that the report is not subject to routine FDA inspection. Consultants with prior experience as FDA investigators or corporate quality system auditors can be contracted to perform it. The baseline assessment of the quality system will reveal whether there are serious deficiencies and, if so, how extensive the remediation program needs to be. Because the European IVD Directive takes effect on December 7, 2003, the audit should also assess the state of compliance with its requirements for products intended for the EU market.
Once a baseline assessment is completed, the scope of the project can be defined, the priorities set, and the skills necessary to accomplish remediation determined. If the audit shows weakness in process and software validations, for example, then validation and software experts are needed.
Establishing a Budget
A manufacturer planning a consulting project should be realistic in estimating its cost. Good consultants are not cheap, but their services are not as expensive as fee numbers might suggest. The actual cost depends on several factors, including the supply of and demand for particular skills. Strategic management consultants command higher fees than tactical experts. A client should expect to pay about three to four times what a full-time employee with the same qualifications would receive in salary. Independent consultants must devote a considerable amount of time to marketing, administrative activities, continuing education, and other nonbillable activities that their fees subsidize. However, clients do not have to pay for their benefits and overhead, which are covered by the consultant’s firm. And, like gifted athletes, the best consultants demand and receive a premium for superior services.
The parties must agree up front on expenses to be included in the contract. A manufacturer should be prepared to pay reasonable travel expenses for consultants who will be working away from home. Time spent traveling to and from the client firm is often billed at half the hourly consulting rate. Most consulting firms have their own written travel policies and guidelines; nevertheless, they are usually willing to follow the client’s corporate guidelines. The client should contribute to reducing expenses by providing access to corporate travel discounts and negotiated hotel rates, and assuming the risks associated with advance booking of deeply discounted nonrefundable fares.
Selecting the Right Consultants
Consultants can come from large firms or small firms, or can be independent practitioners. The consulting market includes brokers that specialize in finding the right individual consultants and assembling a custom team of them to suit particular requirements.
Information about consultants can be found in lists and advertisements in trade publications like this one, and on the World Wide Web. Consultants speak at seminars and conferences and are authors of articles in journals and trade magazines. Most consulting firms and many individual consultants maintain Web sites that provide contact information and descriptions of their services and areas of expertise. However, never to be overlooked are recommendations from peers in other companies.
A consulting firm may not have all of the experts the contracting company needs. This is no cause for concern. Most consulting companies employ independent affiliates, specialists who can supplement their in-house resources with additional skill sets as needed. This practice usually results in a better fit for the client than if the firm staffed the project using only its own employees. Once the client’s needs are defined, the consulting firm will provide resumes of suitable candidates for the client to approve.
Once the field of candidates has been narrowed, the company should request proposals from them based on its needs assessment. The proposals received should be ranked according to the candidate’s perceived ability to deliver the necessary results within the client’s time frame and at acceptable cost. The risk and cost of not meeting the deadline should receive as much consideration as the out-of-pocket consulting fees.
Quantifiable decision factors must be supplemented by the company’s sense of the quality of the partnership that could be established with each candidate.
For compliance and quality system consulting, a good mix of former FDA and former industry experts offers a decided advantage. FDA alumni are expert in identifying potential problems and evaluating proposed solutions from the agency’s regulatory perspective. Industry consultants with backgrounds in quality, regulatory, and manufacturing bring an understanding of the practical manufacturing issues being faced and can offer pragmatic yet compliant solutions based on their experience. Companies considering hiring these experts should look for evidence that they have been successful in helping IVD manufacturers establish and maintain a constructive relationship with FDA.
Consultants tend to favor processes they have developed and tested with previous clients. Therefore, their proposals should be studied carefully with this in mind, to make sure they apply to the situation at hand. A canned process that does not fit the client’s needs will inevitably turn out to be a poor investment. Cross-fertilization from other industries can be beneficial, but consultants unfamiliar with the regulated medical device industry could spell potential trouble. Any consultant under serious consideration should have a good working knowledge of the QSR.
The final decision to hire should involve the key stakeholders. Their commitment—including the highest levels of management for an enterprisewide quality system project—is essential for success.
Negotiating the Contract
Work should not begin without a signed contract, including a confidentiality agreement. This is prudent business practice. Consulting firms offer a standard contract, but the client company’s legal department may prefer to draft one of its own. In any case, the client should have its lawyer review any contract before signing.
In the contract, the employing company should be as specific as possible about requirements, deliverables, and due dates, but should also build in flexibility to allow adjustments as each party to the agreement learns new things. Requests outside the scope of the original contract will require an amended agreement.
Working On-Site
In most quality-management system projects, hired consultants will spend time on-site—sometimes a considerable period. They need reasonable office space and enough facilities, equipment, and supplies to be effective. It is in the company’s interest to provide an environment that motivates and stimulates the productivity of expensive experts on hand to render a vital service.
On-site consultants might be encouraged to rub shoulders with house employees performing their day-to-day activities. This depends on the project. In developing a quality system, because it can be difficult to imagine all the necessary linkages and potential pitfalls, consultants can gain an advantage from seeing and experiencing operations firsthand.
At the same time, members of the consulting team need to maintain contact with each other in order to draw a synergetic benefit from the diversity of their backgrounds. The client ought to facilitate their ability to communicate and to meet frequently for discussion of their observations and recommendations.
Consultants cannot help the company that contracted them if they are not admitted to its confidence. Once they have signed individual confidentiality agreements, they should be given access to the people and information relevant to the project. Consultants are professionals who understand the need to respect confidentiality. If they are made to operate with only partial information, their analysis and recommendations may be flawed because of being based on incomplete knowledge of the true situation.
Managing a Consulting Team
Consultants have to be managed, just like any resource. Executives of the client company who are overseeing the consulting project must assign responsibilities carefully and identify a single point of contact on each side for accountability. The client and consulting team should hold regularly scheduled meetings to review progress, resolve issues, and adjust plans as needed. They should also set goals, determine priorities, and measure progress jointly.
Consultants should be encouraged to surface any issues that come to light immediately, so that they are resolved and not allowed to become distractions. Consultants raising concerns ought to be listened to carefully. It is never helpful to dismiss an outside expert automatically as “not understanding the way we do things.” Instead, the client firm must designate one officer as having the authority to make decisions about regulatory issues. This individual can be essential to the success of the project, so an arbitrator with a sufficient degree of authority in the firm should be chosen.
In major compliance initiatives, remediation of identified quality system deficiencies has to take a high priority. Firms must act when a major area of noncompliance is discovered, since product manufactured while the state of noncompliance exists may be considered adulterated. The consultants can provide objective advice on how to address nonconformities, but those that potentially affect product quality should still be addressed through the firm’s corrective action/preventative action, or CAPA, system so that approved procedures are followed in making decisions regarding classification of severity, need for containment, corrective action, and possibly even field action.
Avoiding Common Pitfalls
Long-term success could be jeopardized if certain common mistakes are made as the project progresses.
There is no good in trying to squeeze the project into an unrealistic schedule. No matter what their CVs may say, consultants do not work miracles. Better that upper management, or FDA, be presented with an objective assessment of the facts and an admission that the scope of the project is larger than anticipated. Project managers should devise a realistic plan with concrete milestones that can be monitored, and then commit to it.
Not applying dedicated in-house resources to the project means that remediation will inevitably fall behind schedule. When a significant compliance project is added to employees’ existing workloads, routine demands on time always end up taking priority.
Ignoring unwelcome advice is human nature, but resistance to hearing bad news is an impulse that should itself be resisted. The client must be objective when evaluating the consultant’s recommendations, even if they imply that earlier company decisions were mistaken, and should make sure that underlying rationales are understood. Defensive behavior and interdepartmental finger-pointing within the organization can be a problem.
Upper management cannot be disengaged. In the case of developing a quality system, the communication chain should include the chief executive and high-level company managers who are ultimately responsible for its execution. One of the biggest mistakes firms make is delegating responsibility for quality system remediation solely to the quality assurance or regulatory affairs functions. Visible management involvement at the right level is a key to success.
Letting the consultants conduct all of the remediation activities means that their knowledge will not be internalized by the organization that hired them. A better approach is to hire temporary staff to continue day-to-day activities and dedicate the best permanent employees—including senior managers—to do the remediation work.
Measuring Success
If mutually agreed upon goals are established at the outset, and progress relative to key milestones is measured along the way, success will be readily apparent to everyone. Nevertheless, a compliance project requires independent audits to provide the objective evidence. An interim audit scheduled midway through the project and performed ideally by fresh consultants who have not been working with the team can confirm and reinforce the perception of progress. Later, a final, completely independent audit should verify that the new quality system is in place. When that audit shows that the goals have been met, everyone can
celebrate.
Donald M. Powers, Powers Consulting Services (Pittsford, NY)
Copyright ©2003 IVD Technology
