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Defining the Customer in a Regulatory Agency
A white paper from the FDA Quality Resource
and Development Team
September 15, 2004
This document is also available in
PDF
I. Introduction
This document supports the implementation of quality
systems within FDA components by clarifying the concept of “customer”
of a regulatory agency.
When an FDA component develops a quality system, the
FDA Quality Systems Framework (reference #1) requires the
component to do an analysis of customers and their needs. Section 1.3
of the Framework outlines the requirements for identifying customers
of the products or services that you provide. A customer is defined in
the Framework as “a person or organization (internal or external) that
receives a product or service anywhere along the product’s life
cycle.”
In carrying out its public health mission
(reference #3) , FDA clearly understands that the American public
is the primary customer of the agency’s work and the products we
regulate. However, we also see many other groups as customers:
Congress, the Department of Health and Human Services or other
government agencies, healthcare groups, and healthcare providers. The
industries that we regulate may also be customers of FDA regulatory
activities, processes, or work products.
Identifying specific customers of an organizational
unit or activity can be a complex process. The Customer Identification
Exercise in Appendix A provides a consistent methodology for FDA
components to follow when identifying their customers. The exercise
will help you
1) identify both your internal and external
customers, and
2) prepare to analyze the relationship between your
customers and your work products as you develop your quality system.
Once you identify your customers, you will be able to
determine quality metrics for a particular interaction or process and
link the metrics to your component's quality objectives. Appendix B
will aid you in coming to terms with the role of industry as a
“customer.”
II. Types of Customers
A. Internal customers
Quality expert W. Edwards Deming says that everyone in
an organization has a customer; if that is not understood, then they
do not understand their job. Internal customers are persons or units
within an organization that receive your products, services, or
information. Many times you will find your immediate customers to be
part of your organization, component, or even unit rather than a party
external to FDA (see section B below). Internal customers within your
own unit may be referred to as “process partners.”
Some examples of internal customers:
-
Product review team members (including Regulatory
Project Managers), Regulatory Information Specialists and
consult/collaborative reviewers are internal customers working in a
collaborative process to assure both maximum review efficiency and a
complete Administrative Record.
-
Functional branches frequently have an internal
customer relationship such as when an investigative report is handed
over to a compliance branch for enforcement evaluation.
-
The Office of Shared Services (OSS) provides
services to its customers, in this instance to an internal customer.
When a Center, ORA or Office of the Commissioner employee contacts
ERIC (the Employee Resource and Information Center ) requesting some
sort of service, for example, a computer password change or a
request for building and maintenance service such as a leaky
ceiling, then OSS views that employee as a customer.
-
When an investigator needs information while on an
inspection and contacts an application reviewer, the reviewer needs
to treat the investigator as an internal customer.
B. External customers
Any customers outside of FDA are called external
customers. Many FDA employees do not interact directly with external
customers, but they must know how their work products or services may
be related to external customers’ requirements downstream in the work
process.
The Food and Drug Administration serves four primary
customer groups – (1) the general public (consumers), (2) health
professionals, (3) other Federal, State and local government agencies,
and (4) regulated industry. These four broad categories encompass
the populations that we serve and work with most often. You
may be involved with other customers such as academia, legal firms,
trade associations, or the media. Unlike in some private sector
contexts, FDA’s definition of customer does not relate to an exchange
of money or a purchase, a buying decision, to define a group as an
external customer.
Some examples of external customers:
-
The general public is almost always the ultimate customer of our
services and product, albeit frequently in an indirect fashion,
through our mission to protect and advance the public health
(reference #2) . However, the public may be the direct
customer when a Public Affairs Specialist is presenting
information to an interest group or when an investigator is
responding to a consumer complaint.
-
Health professionals and patient advocacy groups are
generally indirect customers. For some FDA employees, they may be
direct customers: the recipients of training or information
programs, or users of the consumer and health professional complaint
reporting processes in the agency.
-
Relationships with other government agencies may be
complicated. A state agency could be a recipient of an FDA analysis,
a partner in embargoing regulated products with suspected
violations, or a sub-contractor by receiving payment to perform
inspections on behalf of FDA.
-
FDA has previously, in the context of Executive
Orders in the 1990’s, referred to regulated industry as a customer,
“compelled customer,” or stakeholder. The idea of regulated industry
as a customer has been an uncomfortable one for FDA but as our
understanding of quality systems grows, we may be able to expand our
vocabulary to adopt more fitting references to industry. Regulated
firms may be direct customers—receiving an Inspectional Observations
Form 483 from an investigator, or indirect—an industry member who
analyses other companies’ 483s for their own benefit. The term
‘industry’ may encompass industry groups or associations as well as
individual firms.
III. Customer Interactions
A. Developing standards
The standards described below represent the agency's
effort to identify the needs and concerns of customers. The standards
are based on measured performance attributes—a set of criteria that
expresses customer requirements and expectations. Performance
attributes are organized into two categories.
(1) Process Attributes —transaction-related
characteristics represented by internal operations, such as
procedures, policies, and functions.
-
Consistency in policies and procedures –
holding to the same principles or practices across the organization.
-
Convenient feedback mechanisms – feedback
(output that is responsive to input) arrangements that are easy to
use or get to.
-
Frequent communication, including follow-up
– any form of communication on a regular basis, where the
effectiveness of that communication is enhanced by taking action
following that communication.
-
Manages resources well – careful control
and use of resources, human as well as fiscal, to maximize their
impact and effectiveness.
-
Problem solving and attempts to remove barriers
– proposed solutions or considerations to resolve something
that is an obstruction or prevents progress.
-
Prompt handling of complaints – immediate
or quick management of charges of dissatisfaction.
(2) Quality Attributes —image-related characteristics
that describe the contact between the customer and the organization.
-
Accessibility – ability or freedom to
approach, communicate with, or make use of.
-
Courteousness – respect or consideration.
-
Flexibility – capability to adapt to or
change requirements.
-
Knowledgeable – familiarity with or
understanding of facts and/or conditions.
-
Listens well – gives attention and/or
careful consideration to what is said.
-
Reliability and Trustworthiness –
dependable, confidence in character, abilities, and truth
-
Timeliness – information and/or responses
are provided early or on time.
The following FDA standards were developed by FDA in
the 1990’s and apply to the major customer groups.
All FDA Customers should receive:
-
Fair, courteous and professional treatment;
-
Information that is accurate and current;
-
Timely responses to requests;
-
Reasonable access to appropriate staff;
-
Confidence that efforts are made to assure that
regulated products in the marketplace are in compliance with FDA
laws and regulations;
-
Two-way communication;
-
Opportunities for collaboration and partnerships, as
appropriate;
-
Participation in the agency’s decision-making
process; and
-
Consideration of their opinions and concerns by the
agency.
In addition,
-
Consumers should receive accurate and timely health
information about regulated products.
-
Health Professionals should receive timely
information that will assist them in advancing and protecting the
public health.
-
Other Government Agencies should receive:
-
cooperation from the FDA in maximizing efficient
use of resources, eliminating duplication of efforts and carrying
out collaborative efforts.
-
technical assistance, training and guidance.
-
Regulated Industry should receive:
-
timely review of product applications;
-
professional treatment in resolving disputes;
-
fair application of laws and regulations in
enforcement activities;
-
fair and consistent inspections and product
application reviews; and
-
respect in the agency’s performance of duties and
responsibilities.
IV. Next Steps
After identifying their customers, your unit’s next
task in developing a quality system is to determine customers’ needs
in relation to the products or services you provide to them. Because
FDA work products and services may have many internal and external
customers, you may have or perceive conflicts between your customers’
needs. For example:
-
internal customers may desire process attributes
such as speed, low cost, or efficient use of resources. These
demands may impact the product attributes needed by the
ultimate (internal or external) user of your products.
-
user fees may be provided with the requirement to
provide pre-market reviews in a agreed upon time frame. Some contend
that a more efficient review process occurs at the expense of the
public health. However, it is possible for FDA to improve our review
efficiency with compromising the work product—the review decision.
When your unit begins the needs-identification step,
your manager is your resource for accounting for and explaining
different customer needs.
References
-
FDA Staff Manual Guide: FDA Quality System Framework
for Internal Activities, version. 1.0., September 2004.
-
Malcolm K. Sparrow, The Regulatory Craft (Brookings
Institution Press, 2000)
-
FDA Mission Statement:
http://www.fda.gov/opacom/morechoices/mission.html
-
FDA Customer Service Standards: http://www.fda.gov/comments/standard.html
-
U.S. Food and Drug Administration Customer Service
Plan, 1998
-
Mark Moore, Creating Public Value: Strategic
Management in Government (Harvard University Press, 1995)
Appendix A - Customer Identification Exercise
1. Purpose of Exercise
Under the FDA Quality System Framework for Internal
Activities, as part of the design and implementation of a quality
system, FDA units identify their customers and their requirements.
This exercise is designed to help FDA units successfully accomplish
that task. The goal of a quality system is to ensure that customers
receive quality services and/or products from your organization, so it
is critical that the customer be defined and that the employees
understand the link between their work and the customers’ needs.
As a regulatory agency, FDA also interacts directly
and indirectly with the regulated industry. As part of a customer
analysis, FDA units will explore their relationship to the regulated
industry.
Once customer identification is accomplished, the unit
will solicit and understand the customers’ needs; confirm that
product/service characteristics meet the customers’ needs; develop
appropriate metrics; and ensure that personnel understand the impact
of their activities on the product/service and the customer. This
exercise sets up the foundation for these additional activities.
2. Responsibilities for presenting the exercise
(a) Unit manager
Prior to the exercise, the manager should
-
choose a facilitator, and
-
assist facilitator in identifying general categories
of work products/customers, especially if quality problems exist.
During the exercise, the manager should
-
explain to participants why the exercise is being
done and what, if any, quality issues have been noted. Any problem
discussions should be factual and blame-free.
-
share program information and management directives
that establish priority consideration, i.e. why a particular
category is important, and
-
add comments if significant customers, products and
/or services were not identified, especially if they have
information that may not have been communicated but should have
been.
After the exercise and in a timely fashion, the
manager should follow-up on any action items agreed upon during the
exercise.
(b) Facilitator
Prior to the exercise, the facilitator should prepare
an evaluation form for the participants.
During the exercise and following the exercise outline
in the available PowerPoint presentation (see §4.), the facilitator
should,
-
lead participants in brainstorming exercise and
capture ideas on flipcharts or other visual format
-
instruct and facilitate participants in how to
categorize ideas, and
-
lead discussions.
3. Outline of exercise
(a) Techniques - Group participation techniques of
brainstorming, categorization, prioritization, and discussion should
be used in the exercise.
(b) Objectives – The following objectives are met by
the exercise:
-
identify products and services,
-
identify immediate, secondary, and indirect
recipients (customers) by examining work processes, process inputs,
and from whom you receive feedback, and
-
Note relationships to and between various customers
identified (including industry)
-
Identify any conflicts between your customers
(c) Outputs - Outputs of the exercise should include
-
list of customers for various products and services
(customers and/or customer relationships may vary during a
product’s life cycle).
-
statement(s) on relationship to industry, if any,
for those products and services
-
priorities for processes, products or services,
and/or customers to be addressed by the quality system
-
action items as needed
You may also have notes on value of products to the
customer, initial ideas of customer needs or how they are obtained,
etc. These ideas should be retained for determining the Framework
requirements concerning identifying customer needs.
4. Supporting tools
-
PowerPoint presentation (available from QRGT
contacts)
-
QRGT white paper: “Defining the Customer in a
Regulatory Agency”
-
Information on brainstorming, process mapping,
etc. (available from QRGT contacts)
Appendix B - Industry as a Customer
For regulatory agencies, defining the regulated
industry as a customer can be problematic. Traditional notions of
customer service, e.g. “the customer is always right,” may
conflict, or seem to conflict, with FDA’s regulatory responsibilities
or enforcement duties. However, FDA meets its regulatory
responsibilities while providing guidance and assistance. This
document discusses FDA’s relationship with industry as a spectrum of
customer interactions. Regardless of the customer definition, FDA
treats all customers, including regulated industry, in a fair,
courteous, and professional manner.
1. Providing Services –FDA’s customer relationship
with industry will differ depending on the transaction involved. At
one end of the spectrum, industry clearly is a direct customer of
FDA’s products or services. For example, when FDA develops guidance
documents representing the agency's current thinking on a particular
subject, we provide clarity and understanding to firms that
manufacture FDA regulated products. With this information, industry
has a better understanding of the agency’s expectations about their
products, and this may enable companies to manufacture products more
efficiently or approach regulatory milestones with greater certainty.
In addition to guidance FDA provides training to
assist companies to understand our regulatory processes and
requirements. In some cases, we tailor presentations to companies that
have had little or no previous contact with FDA. In other cases, we
target audiences seeking an advanced understanding in a specific
regulatory area. We may even offer suggestions that assist industry
with solving a specific technical problem in their research,
application, or product.
During the last decade, FDA began using regulatory
strategies based on a mix of traditional and nontraditional tools.
This strategy included outreach programs that encouraged communication
between the agency and industry about FDA’s new compliance
initiatives. These strategies help the agency leverage its scarce
inspectional and enforcement resources by improving the dialogue
between the agency and industry, and helping industry customers
achieve voluntary compliance with the Federal Food, Drug, and Cosmetic
Act and agency regulations. Thus, industry clearly is a customer of
the guidance documents and educational programs that we develop.
Other activities at FDA may have less obvious, but no
less important significance to the regulated industry. For example, we
conduct internal training in many regulatory areas to promote
increased competency and greater review consistency among our review
staff. Although this training is targeted at FDA reviewers, the
regulated industry is also one of the beneficiaries. Likewise, when we
conduct research to develop industry standards and methods, industry
is a customer of this activity since this research assists them during
the product development or agency review phase.
2. Enforcement – Enforcement actions
occupy the other end of the industry-as-a-customer spectrum. Here,
industry is not viewed as a customer in the traditional sense. For
example, when FDA conducts a civil or criminal enforcement action
against a firm for violating a law or regulation, the firm bears
little resemblance to a customer. In such cases, we sometimes refer to
industry as a “compelled customer.” Yet even when FDA conducts an
enforcement action, we none-theless should meet certain customer
service standards, such as communicating clearly in a professional and
timely manner. Moreover, we need to be aware of indirect customers who
benefit from the information generated by our enforcement actions. For
example, when we issue a Form FDA 483 or regulatory letter, or publish
the details of an enforcement action, we are also publicizing how we
intend to apply our regulatory standards. This information may, in
turn, be used by a much larger audience that relies on this
information to improve their processes, procedures, or methods.
When FDA operates in an enforcement mode, there are
limits to the scope of customer service that we should provide. We
have already mentioned that “the customer is always right” concept is
inappropriate. However the FDA all-customers service standard includes
“participation in the agency’s decision-making process.” Although we
provide opportunities for discussion during an inspection, for formal
dispute resolution, and for replies to FDA actions, FDA does not
extend this customer-service standard to industry in enforcement
matters. The importance of these limits is illustrated by the
experiences of two Federal agencies responsible for criminal
enforcement of their laws. During the mid-1990s the U.S. Customs
Service (now the Bureau of Customs and Border Patrol) and the Internal
Revenue Service instituted policies to promote customer service,
customer satisfaction, and partnering with customers. Although these
initiatives yielded important benefits, enforcement officers and
criminal investigators viewed these initiatives as an effort to
downplay enforcement as an agency priority, which, in turn, triggered
a decline in enforcement efforts by these agencies. As Dr. Malcolm
Sparrow warns in The Regulatory Craft, regulatory agencies
“should not permit a customer orientation to lead to exclusion or
neglect of enforcement capabilities.”( reference #1, p.63 )
3. The Middle Ground – FDA also
conducts activities in which our relationship with industry falls
somewhere between the traditional concept of a customer and the
enforcement mode. Examples of activities that lie in this broad middle
ground include vaccine lot release or alternative to lot release
decisions, letters placing a product application on clinical hold,
application reviews, requests for information, labeling negotiations,
and pre-launch review of advertising. In some cases, our relationship
to industry will vary depending on the nature of the regulatory
interaction; we will strive to consider appropriately the needs of
regulated customers while fulfilling our agency mandate.
Note: This paper does not intend internal customer
relationships to be applied to the chain-of-command or supervisory
relationships.
See discussion in main paper, section III.B.
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GMP Final Report
Date created: September 29, 2004 |
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