Sample Quality Audit Report
Sample Quality Audit Report
Executive Summary
MicroVote General Corporation (MicroVote) is an EAC registered voting system manufacturer
based in the Indianapolis, Indiana metropolitan area and has been registered with the U.S.
Election Assistance Commission (EAC) since 2007. On September 8-9, 2014, the Election
Assistance Commission conducted a quality assurance audit of MicroVote in order to collect
sufficient data to assess the manufacturer’s quality systems and their compliance with the
quality assurance requirements of the EAC certification program and the 2005 Voluntary Voting
System Guidelines.
The quality assurance audit found that while MicroVote had very recently developed and
incorporated a quality assurance manual into their company processes, the manual needs to be
strengthened, fully implemented with the backing and support of senior management and
backed up with internal procedures that would allow independent auditors to determine if
MicroVote is actually meeting their stated quality goals.
This report provides six specific recommendations for MicroVote in order for the company to
improve overall quality management and quality assurance and to bring their current process
more in line with the intention of the requirements of VVSG Section 8. These
recommendations are detailed in the Audit Recommendations Section of this report.
Introduction
On September 8-9, 2014, the Election Assistance Commission conducted a quality assurance
audit of MicroVote at the company headquarters in Indianapolis, Indiana. Participating in the
audit for EAC were Brian Hancock, Director, Testing and Certification, Jessica Myers, Program
Specialist, Mark Skall, Technical Reviewer and Tom Caddy, Technical Reviewer.
The quality assurance audit was performed pursuant to Section 2.3.1.4 and Section 8 of the EAC
Testing and Certification Program Manual as well as Section 8 of the 2005 Voluntary Voting
System Guidelines (VVSG).
This report, along with the attached appendices, documents the audit findings, conclusions and
recommendations and will be forwarded to MicroVote and included as an attachment to the
MicroVote EMS 4.1 Test Report in order to assist the manufacturer with meeting the
requirements of VVSG Section 8 and improving their overall operations and quality control.
Purpose
The EAC conducted the audit because of ongoing questions about the quality assurance
practices of the manufacturer based on concerns noted by NTS Laboratories and previous EAC
experience on MicroVote test campaigns.
Scope
This audit was conducted in order to collect sufficient data to assess the manufacturer’s quality
systems, their compliance with the quality assurance requirements of Section 8 and the
configuration management requirements of Section 9, Volume 1 of the 2005 Voluntary Voting
System Guidelines (VVSG), and to compare MicroVote quality practices to IT industry standard
QA practices.
Quality assurance demands a degree of detail in order to be fully implemented at every step.
Planning, for example, could include determining specific levels of quality or measurable results
that the organization wants to achieve. Checking could involve testing and other objective
measurements to determine whether the goals were met, rather than mere subjective
evaluation of quality. Acting could mean a total revision in the manufacturing process to correct
a technical or cosmetic flaw or very small changes to improve efficiency or accuracy.
Quality assurance verifies that any product, regardless whether it is new or modified, is
produced and offered with the best possible materials, in the most comprehensive way and
with the highest standards. Quality assurance provides the mechanism to exceed customer
expectations in a measurable and accountable process.
ISO 9000 is a family of standards published by ISO, the International Organization for
Standardization, related to quality management systems and designed to help organizations
ensure that they meet the needs of customers and other stakeholders while meeting statutory
and regulatory requirements related to the product. ISO 9001 is a global quality management
standard dealing with the requirements that organizations wishing to meet the standard must
fulfill. As of 2011, more than a million organizations worldwide were certified to the ISO 9001
standard. While not a panacea for every quality related problem an organization may face, the
principles of ISO 9001 have been the guiding force in organizational quality since the early
1990’s.
ISO 9001 defines quality as something that can be determined by comparing a set of inherent
characteristics with a set of requirements. If those inherent characteristics meet all
requirements, high or excellent quality is achieved. If those characteristics do not meet all
requirements, a low or poor level of quality is achieved. Quality assurance (QA) is defined as a
set of activities intended to establish confidence that quality requirements will be met. QA is
one part of quality management. A quality management system (QMS) is a set of interrelated
or interacting elements that organizations use to direct and control how quality policies are
implemented and quality objectives are achieved.
While not requiring ISO 9001 certification from voting system manufacturers, the 2005 VVSG
recognizes the importance of quality assurance in voting systems with the specific requirements
related to quality contained in Section 8.
“Quality assurance provides continuous confirmation that a voting system conforms with
the Guidelines and to the requirements of state and local jurisdictions. Quality assurance is
a vendor function that is initiated prior to system development and continues throughout
the maintenance life cycle of the voting system. (Emphasis added) Quality assurance
focuses on building quality into a voting system and reducing dependence on system tests at
the end of the life cycle to detect deficiencies, thus helping ensure the system:
• Meets stated requirements and objectives
• Adheres to established standards and conventions
• Functions consistently with related components and meets dependencies for use
within the jurisdiction
• Reflects all changes approved during its initial development, internal testing, national
certification, and, if applicable, state certification processes.”
VVSG Section 8.2 defines the general requirements for quality assurance:
“The voting system vendor is responsible for designing and implementing a quality
assurance program to ensure that the design, workmanship, and performance requirements
are achieved in all delivered systems and components. At a minimum, this program shall:
Because determinations of quality can often be subjective, the EAC uses the Quality Audit
Checklist to focus auditors and to provide a general basis for determining if the
manufacturer meets the quality requirements of the VVSG and the general principles of
quality outlined in ISO 9001.
MicroVote is a small company with approximately 15 full time equivalent employees, including
the Chief Executive Officer and President. Additional temporary staff is hired prior to each
election and may or may not receive updated voting system/election training from MicroVote.
Source code change control is managed via a Microsoft Team Foundation Server. Commercial
Off-the-Shelf (COTS) component and end-of-life (EOL) components as well as supplies and
vendors are managed by the MicroVote Chief Operating Officer. Internal testing is conducted
under the QA department who develop their own test cases. It was unclear how validation of
these test cases was performed by MicroVote. Hardware EMC testing has just recently (3-4
months) been contracted out to Technicolor Laboratory Service, located in the Indianapolis
area.
A unique and potentially problematic scenario exists because MicroVote owns the Intellectual
Property (IP) rights to their software, while the IP rights to the hardware that runs the voting
system is owned by Bill Carson, Technical Support Specialist of Carson Manufacturing Company,
Inc. (Carson). Carson is the sole manufacturing facility for the MicroVote system and, like
MicroVote, is located in the Indianapolis metropolitan area. . This relationship led the EAC audit
team to also review the Carson quality process at their facilities on September 9, 2014. Because
no voting system products were being manufactured by Carson at the time of the EAC visit, EAC
audit team concentrated on a review of the Carson quality program.
The EAC audit team met with Carson staff, reviewed documentation related to the quality
system and toured the manufacturing area of the facility. The Carson Quality Manual reviewed
by EAC was Revision C, dated November 1st, 2011. No updates or revisions have been
incorporated since that time. No separate quality unit or department exists at Carson. Currently
no quality manager has been designated, and currently, all quality functions default to the
company Chief Executive Officer (Barbara Ferguson, President and CEO).
Audit Results
This section details the results of the quality audit by highlighting findings noted by the audit
team in their quality audit checklist. The EAC quality audit checklist contains five major sections
covering:
formal design reviews are not a part of the MicroVote process, record keeping for this
function is not applicable at this time. General review of product functionality is a joint
effort between the Director of Software Development and the Director of Customer Service.
Lack of a design review policy may be partially related to the fact that the MicroVote
product has remained essentially unchanged at least since its initial certification efforts as
part of the NASED program in 2006. Any design review done is therefore ad hoc in nature.
MicroVote noted that they may develop a formal product design and review policy if the
EAC recommends such an activity.
Section 13.0 notes that “In the case of significant [Emphasis added] conditions adverse to
quality, the root cause of the condition shall be determined and action planned to correct
and preclude repetition.” As with the rest of this document, no detailed process for
implementing a root cause analysis was defined leaving open questions of the consistency
and quality of root cause analysis. In addition, MicroVote should clearly define terms used
in this section such as “significant” in order to be clear on what level of system anomaly
would initiate root cause analysis.
Customers are notified of non-conforming products either via email, telephone or by mail
through the United States Postal Service.
5. Labeling
The EAC auditors were unable to find detailed policies and procedure related to product
labeling and the EAC Mark of Certification although Section 9.0 of the Quality Manual states
that: “Labeling shall be verified during customer acceptance testing.” This is surprising given
that the EAC has provided the basis for such procedures in EAC Notice of Clarification (NOC)
2008-002 EAC Mark of Certification available on the EAC web site.
Audit Recommendations
In consideration of the findings outlined in this audit report, the EAC recommends MicroVote
take the following six (6) steps to improve overall quality management and quality assurance
and to bring their current process more in line with the intention of the requirements of VVSG
Section 8:
1. While formal ISO 9001 certification is not recommended at this time, the EAC does
recommend that MicroVote develop a formalized organizational quality management
system based on the principles of ISO 9001. Quality management is defined as all
activities carried out by the organization to direct, control and coordinate quality. The
activities should at a minimum include formulating a quality policy, and setting quality
objectives. This recommendation can best be met by one or more MicroVote staff
members receiving formal training in ISO 9001 concepts via one of the numerous
commercial ISO training organizations.
2. Augment and fully implement the new organizational quality manual. The quality
manual documents an organization's quality management system (QMS) and should:
3. Conduct regularly scheduled internal quality audits in order to monitor and measure
your QMS, document any nonconforming procedures or products and perform
corrective action to improve the nonconforming process or product.
4. Develop a systematic process for the review of new product design and design changes
to already developed products. This process should include specific measurements to
determine if design objectives are being met as well as a system of maintaining records
of all design reviews.
5. Develop and implement detailed root cause analysis procedures to satisfy the
requirements of Section 13.0 of the MicroVote Quality Manual.
6. Undergo another EAC quality assurance audit within one year of the date of this report
to allow the EAC to assess MicroVote progress in meeting the recommendations of this
audit.
Although the above recommendations are purely voluntary, the EAC strongly suggests that
MicroVote implement the recommendations for the following reasons:
ISO 9001 is the standard best practice specification for QMS in use worldwide. ISO 9001
has a track record of saving money, streamlining operations and reducing waste, and
increasing customer satisfaction.
As the EAC moves towards improving and truncating the certification process through
the use of Manufacturer Declaration of Conformity (DoC), it is likely that ISO 9001
certification will eventually become a requirement for all EAC registered manufacturers
in order to provide some additional assurance to the DoC and ultimately, to MicroVote
customers.
The EAC requests that an initial written response to this report be submitted within 45 days of
the receipt date of this document.
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
1 Organizational Quality
Management System
1.1 Does this organization operate under a
corporate quality policy?
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
2
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
3
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
4
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
5
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
Descriptive title
Description and clear
identification of the product
being tested.
Date of test.
Identification of the test method
used.
Clear and unambiguous
description of the results of the
test (Pass/Fail).
Signature and title of individual
accepting responsibility for the
content of the record/report.
6
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
7
Manufacturer: Microvote Date: 9/8/14 – 9/9/14
Question QA Reference Evidence (Note any additional evidence or comments may be Yes, No, or NA
included in a supplementary notebook).
5 Labeling
5.1 What are the organizational policies on
labeling (both marks of certification and
other required labels such as URL)?