Originally Published IVD Technology October 2004
Consulting services
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| IVD manufacturers hire consultants for various reasons. The challenge lies in selecting and making the most effective use of the right consultant. |
External consultants offer a reservoir of talents and skills from which IVD
manufacturers can draw what they need to solve almost any problem. The wealth
of advisory expertise and experience currently available is traceable in part
to the recent phenomenon of downsizing—when companies trim their payrolls
by encouraging senior employees to accept attractive early—retirement packages
and dangling voluntary separation incentives in front of enthusiastic younger
employees who could not pass them up. Once active in the consulting field, these
entrepreneurs rapidly become acquainted with the best and worst practices in
the industry and can help firms adapt the best practices to their needs.
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 fix.
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 took
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. If it reveals that the document
control system is antiquated, experts in document management must be called
in. Perhaps the audit will confirm a breakdown of the entire quality management
system. If general disarray is the case, then a firm with experience in managing
large quality system remediation projects should be contacted.
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.
The company must anticipate the support the consultants will require if they
will be working on-site, including office space, supplies, administrative assistance,
and access to the manufacturer’s computer system. Although consultants
typically bring their own laptops (an indispensable tool for traveling experts),
they will need modem lines and printers. Access to the client’s e-mail
and on-line documentation systems can increase their efficiency.
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. The opinions of others who have used consultants are usually
the best and most reliable source of information.
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 that 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 résumés
of suitable candidates for the client to approve.
Similarly, when the business cards of individual consultants include the phrase
“and Associates,” it means that they are prepared to draw from a network
of other independents to form a team tailored to the needs of the client.
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.
If management lacks confidence that the firm could work effectively with a proposed
set of consultants, then that proposal should be ruled out. Successful consulting
is a human relationship as much as a contracted service. It is important that
the client have full trust in the consultant.
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. More than one regulated company has streamlined its new
product development or manufacturing processes right out of compliance on the
basis of advice that failed to consider regulatory requirements.
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. If the manufacturing company’s president does not
take an active role in developing and maintaining the quality system, middle-level
managers cannot be expected to greet the project with much enthusiasm.
Negotiating the Contract
As with any contracted service, the company’s supplier qualification process
must be followed. The assessment of the consulting firm’s ability to deliver
results—including a summary of the relevant knowledge, skills, and education
of each consultant—must be documented. 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. Resisting
any tendency to regard it as someone else’s problem, the company should
consider the morale of a team of people working away from home for an extended
time.
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.
On-site project management resources should be included in the contract for
a large initiative. Bringing in more than one consulting firm to work on the
same project may be a bad idea. Of course such a situation has great potential
to be a management headache, but more to the point, consulting firms are sensitive
about sharing proprietary processes with other consultants, who are potential
competitors. If the project requires additional consulting resources, the manufacturer
would do well to obtain an advance cooperation agreement or, better, allow the
principal firm to subcontract and manage the second crew.
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. It is 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. On the other hand, those that will have to live with
the remediation solutions need to be kept involved in the decision making.
Ignoring unwelcome advice is human nature. However, 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 that 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 ©2004 IVD Technology
