THE IMPORTANCE OF A SUCCESSFUL QUALITY ASSURANCE (QA) PROGRAM
FROM A RESEARCH MANAGER'S PERSPECTIVE
Wade H. Ponder
Chief, Technical Services Branch
EPA/ORD/NRMRL/APPCD
Research Managers' Responsibilities for QA - One responsibility of research managers is to
ensure that data from research projects are acquired, processed, reported, and used in accordance
with the Quality Assurance (QA) requirements established by the organization. When
management does not take QA seriously or when QA requirements are not fully implemented in
an organization, the results can be embarrassing, damaging, or dangerous to the organization as
well as its customers or clients. The literature and news media report often the results that occur
when QA is not a priority or when QA requirements are not implemented properly.
Notable QA Failures - QA has uncounted successes, but our nature is to focus on its failures.
Unfortunately, there is a long list of failures to consider. Three examples have been taken from
this long list to reinforce the points I wish to make about QA from a research manager's
perspective:
1.	On December 3, 1999, Tamara Lytle, a staff writer for "The Orlando Sentinel," published an
article which stated that an Air Force report concluded that five rocket launches, from August
1998 through May 1999, failed due to cutbacks in QA staff by the contractors, poor engineering
and workmanship by the contractors, and lax monitoring by U.S. military managers. Further, it
was reported that one contractor had reduced QA staff on the projects by more than 60% in the
years preceding the failures. The five failures cost U.S. taxpayers more than $3 billion and
delayed the deployment of military payloads that were designed to help the U.S. catch terrorists
as well as commercial payloads intended to enhance mobile communications capabilities.
2.	The news media have provided extensive coverage of the conflicts between Ford Motor
Company and the Firestone Company related to the failure of Firestone tires on Ford's Explorer
Sport Utility Vehicle. Robert Polz wrote an article on tire failures in "Reliability Engineering"
in which he critiqued and commented on an article entitled "Tire Failures, SUV Rollovers Put
Quality on Trial," published in the December 2000 issue of American Society for Quality's
Quality Progress magazine. Polz states that, if the failures are design-related, it is the province
of reliability engineering to determine the root cause(s) of the failures. However, if the failures
are production-related, then QA should spearhead the assessment. Since the cause is uncertain
in the Ford/Firestone case, Polz concludes that both disciplines should work together as a team
to determine the cause(s). Meanwhile, the National Highway Transportation Safety
Administration (NHTSA) has already received more than 1400 complaints, with reports of 88
fatalities and 250 injuries.
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3, On January 26,1986, the Space Shuttle Challenger exploded during take-off. The first cousin
of Mike Smith, the pilot of Challenger, at that time was a member of the NRMRL/APPCD staff.
Today, more than 16 years later, I still have displayed in my office a decal commemorating the
Challenger's crew and its mission. Investigations have identified the failure of o-rings in the
external fuel tanks as the cause of the catastrophic explosion that doomed the Challenger and its
crew. In the hours before launch, engineers familiar with the design of the external fuel tanks
and their o-rings recommended and strongly urged that the Challenger not be launched on
January 26, because the ambient temperature was less than the safe minimum temperature for
the o-rings to function safely and effectively. Since the engineers took these actions in an
attempt to delay the launch, it may be concluded that the QA requirements for safe launch and
operation of the Challenger were known but not adhered to. The result was the loss of all of
Challenger's crew members, and America's Space Shuttle program was put on hold for about
2 years.
The EPA QA Analogy - So, what analogy, if any, is there between these high visibility
examples in which QA was not a priority or QA requirements were not followed and QA in
EPA? To be sure, EPA does not design or build rockets that might explode on their launch pads,
design or build consumer products that might injure or kill users, or provide QA for products,
systems, or devices, such as those on the Space Shuttle, that could fail and injure or kill people.
However, it could be argued that EPA does, in fact, have analogous QA responsibilities. The
Agency is charged with the protection of public health and the environment, and meeting that
responsibility requires extensive research programs which generate data. It is estimated that
EPA and the regulated community spend about $5 billion annually collecting environmental
data. In addition to data, EPA generates information, software, and other tools which are
ultimately used to justify, establish, and defend national and state standards for pollutant
emissions and exposures. These emission and exposure limits are designed, first and foremost,
to protect the health of the American public. If EPA had undertaken this mission and tried to see
it through without adequate management and staff attention to QA, it is possible that regulatory
decisions could have been made on the basis of flawed data and information and that public
health and the environment might not be protected as well as they could have been.
Suggested Requirements for EPA Managers - To its credit, EPA has spent a lot of time and
staff effort developing and putting in place an impressive Quality Management Plan (QMP)
guidance document which delineates QA requirements for all Agency organizations involved in
the acquisition, processing, and publication of research data and information. The guidance
document is used by EPA's National Laboratories and Offices to prepare their QMPs.
However, as indicated in the QA failure examples above, the effectiveness of any QMP is
dependent on the commitment that management and research staff alike make to its
implementation. From a management perspective, this commitment requires that research
managers understand Agency QA requirements; establish an effective QA program to ensure that
data are of known quality which is acceptable for the intended use of the data; and provide
support, guidance, and oversight to principal investigators (Pis) in meeting QA requirements. It
is also important that managers lead by example in the QA area:
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1.	Managers should make sure that other managers and Pis are aware that they view QA as
an essential, integrated component of the research programs;
2.	Managers should provide adequate resources (people and money) to support an effective
QA program;
3.	Managers should encourage collaborative, non-confrontational interactions between Pis
and QA professionals; and
4.	Managers should maintain oversight so that issues which have the potential for adversely
affecting research and QA objectives can be negotiated and corrected quickly.
How QA Works in NRMRL/APPCD - The Air Pollution Prevention and Control Division has
established a QA Team to support its four research branches. The QA Team is housed in the
Technical Services Branch and consists of a team leader (who is a QA professional) and five
team members (three of whom are QA professionals). The other two members are a
professional who manages the QA contract for the team and a Senior Environmental Employee
who assists the Team with QA data base management and reports preparation. The four QA
professionals conduct all QA reviews and audits (with contractor assistance, as needed). QA
Team members share QA work among themselves to maintain a reasonable balance of
workloads. They also spend up to 30% of their time working directly with the research
branches' Pis helping to plan, conduct, and oversee research projects. (Of course, no QA Team
member is ever allowed to conduct QA reviews of research work in which he/she has been
involved.) In FY 2001, the QA Team reviewed 63 QA planning documents/research products
with an average turnaround time of 5.7 days. The Team members also reviewed 121 journal
articles and reports in FY 2001. To date in FY 2002, the QA Team has completed the following
reviews:

Items Reviewed in FY 2002
Number Reviewed Through 3/19/02
1.
Journal articles and reports
32
2.
Test plans, QAPPs, Reports, Protocols
52
3.
Funding packages
20
4.
Responses to Pis' revisions
10
5.
SOPs
2
6.
QMPs
1
When QA Team members are involved to this extent with the Pis and their research activities,
there is a high probability that differences of opinion will occur. Given that, I would like to
emphasize the need for managers to lead by example, specifically item 3 under Suggested
Requirements for EPA Managers, above; i.e., "Managers should encourage collaborative,
non-confrontational interactions between Pis and QA professionals." The QA philosophy in
NRMRL/APPCD is that the QA Team will aid the researchers in any way possible to produce a
timely, high quality product. To implement this philosophy and avoid the counterproductive
trap of being viewed as the "QA police," we have borrowed and employed the five "Basic
Principles" from the Zenger-Miller team training course work:
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1.	Focus on the situation, issue, or behavior, not on the person.
2.	Maintain the self-confidence and self-esteem of others.
3.	Maintain constructive relationships.
4.	Take initiative to make things better.
5.	Lead by example.
The use of these principles by the QA Team members in their interaction with Pis has resulted in
the QA Team's maintaining the respect and cooperation of the Pis so that almost all interactions
between them are positive and helpful. Infrequently, when QA Team members and Pis reach an
impasse, the QA Team's Branch Chief and the Pi's Branch Chief meet with the QA Team
member and the PI involved in the dispute. In these meetings, it is essential that the same "Basic
Principles" be employed. Using this philosophy and the "Basic Principles," only three or four
meetings involving the Branch Chiefs have occurred in the last 7 years. During this time, no QA
issue between a QA Team member and a PI has been elevated to the Division Director for
resolution.
Conclusion - For the last 7 years, one of my responsibilities has been to supervise
NRMRL/APPCD's QA Team. Through that experience, I have concluded that the collaborative,
non-confrontational spirit exhibited by the members of the QA Team in their interactions with
Pis and managers is a major component of a successful, productive QA program. As a research
manager, I am very proud of the contributions the QA Team members make to the Division, the
Laboratory, and the Agency. I consider it a privilege to be associated with them.
!
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TECHNICAL REPORT DATA
NRMRL-RTP-P-674 (Please read Instructions on the reverse before completing)
1. REPORT NO. 2.
EPA/600/A-02/065
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
The Importance of a Successful Quality Assurance (QA)
Program from a Research Manager's Perspective
5. REPORT DATE
6. PERFORMING ORGANIZATION COOE
7. AUTHOR(S)
Wade H. Ponder
8. PERFORMING ORGANIZATION REPORT NO.
9. PERFORMING ORGANIZATION NAME AND ADDRESS
See Block 12
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
NA (Inhouse)
12. SPONSORING AGENCY NAME AND ADDRESS
EPA, Office of Research and Development
Air Pollution Prevention and Control Division
Research Triangle Park, NC 27711
13. TYPE OF REPORT AND PERIOD COVERED
Oral presentation; 3/02
14. SPONSbRING AGENCY CODE
EPA/600/13
15. supplementary notes appq) project officer is Wade H. Ponder, Mail Drop E343-03, 919/
541-2818. For 21st Annual National Conference on Managing Environmental Quality
Systems, Phoenix, AZ, 4/8-12/02.
16. ABSTRACT f
The paper discusses the Air Pollution Prevention and Control Division s
Quality Assurance (QA) program and the approaches used to meet QA requirements in the
Division. The presentation is a technical manager's perspective of the Division's
requirements for and approach to QA in its research programs. The presentation will
include the design of the QA Team, the roles of members of the QA Team, training and
technical aids provided by the QA Team to promote understanding of and adherence to
Agency QA requirements, the interactions of the QA Team members with principal inves-
tigators, and examples of effective conflict resolution.
17. KEY WORDS AND DOCUMENT ANALYSIS
a. DESCRIPTORS
b. I DENT IFIERS/OPEN ENDED TERMS
c. COSATI Field/Group
Environmental Engineering
Quality Assurance
Research
Design
Roles
Education
Conflict
Teams
Training Aids
Conflict Resolution
05E
13H, 14D
14F
14G
05J
051
18. DISTRIBUTION STATEMENT
Release to Public
19. SECURITY CLASS (This Report)
Unclassified
21. NO. OF PAGES
20. SECURITY CLASS (This page)
Unclassified
22. PRICE
EPA Form 2220-1 (9-73)

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