Quality Assurance
QUALITY ASSURANCE IN THE DEPARTMENT OF ENERGY
DOE has established Quality
Policy, Principles
and Value Added
Requirement Attributes that apply to all
work and are focused on performance, customer
expectations, and improvement. When properly
implemented, the principles and requirements
form a management system to plan, perform,
assess, and improve work. The requirements
are performance oriented and offer unlimited
implementation flexibility. The DOE quality
management system moves beyond the traditional
quality assurance requirements that had become
narrowly focused on safety systems, paper,
compliance, and inspections. The management
system is designed to link with an organization's
strategic plan to support mission achievement
and the delivery of products and services.
The Department's commitment to environment,
safety, and health also relies, upon work
being conducted within an effective management
system. DOE line managers and contracting
officers must understand these two fundamental
purposes for the QA requirements and ensure
the QA Order and rule are specified in each
major contract (including those contracts
using the Work Smart Standards process to
satisfy DOE Acquisition regulation 48 CFR
970.5223-1).
The Department uses two requirements documents
to express identical sets of requirements
for two distinct organizational groups. The
first, Order 414.1C, applies to practically
all DOE organizations and all contractors
whose contract includes the Order. The second
is a regulation, 10 CFR 830 (including 10
CFR 830 Subpart A), that applies to nuclear
facility contractors indemnified under the
Price Anderson Amendments Act and suppliers
of items and services to those nuclear facilities.
Fundamentals
of the DOE Quality System
The quality assurance program is a management
system involving all organizational components
and should not be regarded as the sole domain
of any single group. The Order and Rule reflects
the concept that all work is a process that
can be planned, performed, assessed, and improved.
The basic requirements are broken into three
categories:
| MANAGEMENT |
| PERFORMANCE |
| ASSESSMENT |
This format permits managers, those performing
the work, and those assessing the planning implementation,
and results of the work to focus on their unique
responsibilities in carrying out the provisions
of the quality assurance program. The three
categories capture the range of activities common
to all work, from organizing and staffing to
assessing results and providing feedback for
process improvement.
Application of the QA basic requirements extends
from the planning and conduct of basic and applied
research, scientific investigation, and engineering
design to operations, maintenance and repair
of facilities, and eventual environmental restoration.
These basic requirements reflect a comprehensive
way of doing business throughout the life cycle
of DOE programs and projects.
DOE's goal is to achieve continuous improvement.
This requires a culture that encourages setting
and maintaining high standards, identifying
and resolving problems, accepting recommendations
for improvement, and fostering mutual respect
and effective communication between DOE and
its contractors. DOE and contractor management
are responsible for continuously pursuing enhancements
to safety and reliability--not just complying
with a minimal set of requirements.
Many DOE Orders assist contractors and DOE
Field Offices to achieve their objectives, but
prior to 1991 there was no single DOE Order
that defines how to integrate these requirements
and other policies into a management system.
The basic requirements of the QA Order represent
functional categories that interrelate these
other DOE Orders and policies; in effect, pulling
together all work performed by an organization.
Management should review existing requirements,
policies, and operating procedures in light
of this Order; care should be taken not to create
redundancies. The Safety Management System Policy,
P 450.4 further strengthens integrating safety
with the work process. The QA basic requirements
are to be applied to the implementation of SMS
Policy. These two management systems are also
to be integrated to ensure Quality Assurance
and Safety Management policies effectively work
together to achieve quality and safety in the
Department's work.
Guidance developed specifically for the Order
and Rule, and used in combination with it, assists
management in developing quality assurance programs
that satisfy the basic requirements. The guidance
interprets the Order's basic requirements as
they apply to different types of work performed
by DOE, such as reactor operations, basic and
applied research, and environmental restoration.
Other guidance such as international and U.S.
consensus standards, should be used provided
it results in acceptable performance. Organizations
should use standards and guides as sources of
information that provide ways to meet the basic
requirements. The format, such as the number
of criteria of an organization's quality assurance
program, should be based on the organization's
individual needs; and is only important if it
affects the organization's performance. DOE
and contractor management must assume a different
leadership role than in the past when DOE defined
quality solely in terms of conformance to standards.
Today quality is defined in terms of satisfying
the customer in the most resource-efficient
manner. The scope of employee's work must be
expanded to include value-added activities,
such as finding new and innovative ways to improve
the quality of their work. The following policy,
principles and value-added attributes are articulated
in the Order and Rule.
Quality Policy
It is the policy of the Department of Energy
to establish quality requirements to ensure
that risks and environmental impacts are minimized
and that safety, reliability, and performance
are maximized through the application of effective
management systems commensurate with the risks
posed by the facility or activity and its work.
The Department implements this policy through
the QA Order and the QA rule directives to ensure
quality assurance requirements are clearly specified
for the broad spectrum of work performed by
DOE and its contractors.
Objective:
The objective of the QA requirements are to
establish an effective management system (i.e.,
quality assurance programs) using the performance
requirements coupled technical standards where
appropriate that ensure:
a). Senior Management provides planning,
organization, direction, control, and support
to achieve DOE's objectives;
b). Line organizations achieve quality;
c). Line organizations minimize environment,
safety, and health risks and impacts while
maximizing reliability and performance;
d). Line organizations have a basic management
system in place that is consistent with the
principles and functions of the Integrated
Safety Management System Policy (DOE P 450.4);
and,
e). Each DOE element reviews, evaluates, and
improves their overall performance and that
of their contractors using a rigorous assessment
process based upon an approved Quality Assurance
Program (ref. 48 CFR 970.1100).
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Underlying Quality
Principles
These principles are consistent with Integrated
Safety Management Policy, P 450.4 and support
ISM implementation.
- Define Policies and Objectives--Ensure they
are Understood and Accepted.
Management must set expectations for the organization
as a whole before employees can do their jobs,
satisfy their customers, and strive to improve
the quality of their work. This is accomplished
by developing and implementing specific policies
and objectives that reflect the operating
philosophy of the facility's management. Once
these policies and objectives have been established,
all managers must take the necessary actions
to ensure that each employee shares their
vision of the organization's purpose.
- Specify Roles and Responsibilities--Ensure
they are Understood and Accepted.
Each employee must take responsibility for
the work they perform. Everyone contributes
to the quality and to meeting the performance
objectives established by management. It is
management's obligation to ensure that the
employees understand what is being asked of
them. Individual and team performance is the
key to achieving management's objectives.
- Specify and Communicate Expectations--Identify
and Allocate Resources to Achieve Them.
Management must identify resources and capable
individuals for carrying out the organization's
work. Management must provide employees with
the material and training necessary to accomplish
their tasks. Before taking responsibility
for their work, employees must possess the
following:
1. knowledge of management's expectations
2. knowledge of why the task is being performed
3. empowerment to carry out assigned tasks
- Strive to Improve.
Management is responsible for creating an
environment that encourages employees to improve
the quality of the work and work processes
with which they are associated. Employees
must consistently seek new, more innovative
ways to increase quality, efficiency, and
effectiveness.
- Ensure People are Competent at the Work
They Do.
Management must ensure that each employee
is capable of performing his/her assigned
tasks. Employees should be afforded the appropriate
education and training, including professional
development and on-the-job training.
- Ensure the Right People have the Right Information
at the Right Time.
Decision-making must be based on accurate
information. Information that is the basis
for the decision-making process must be available
to employees when they need it.
- Seek and Use Relevant Experience.
Management must make use of information, such
as new technology or lessons learned, from
internal and external organizations that could
potentially affect its operations. By recognizing
the failures and successes of the past, management
will be better prepared to promote a culture
committed to excellence.
- Plan and Control the Work.
Work must be carefully planned and controlled
to ensure that management's objectives are
met. This requires needs to be thought out,
organizational goals identified, lines of
communication established, and required manpower
provided.
- Use the Right Material, Tools, and Processes--Control
any Changes to Them.
Management must ensure that the right material,
tools, and processes are in place and are
used so that the organization's products and
services are of the highest possible quality.
- Assess Work to Ensure It Meets Expectations.
All employees must critically assess their
efforts and determine if they have accomplished
what they set out to do as part of meeting
management's expectations. As a way of providing
additional assurance that the product and
service quality has been attained, a system
of assessments must be established and implemented
by management. In carrying out these assessments,
work performance should be measured against
defined standards. The assessments must be
performed by competent individuals who are
performance-oriented and focused on improving
the product and service quality.
- Identify and Remedy Errors and Deficiencies.
All problems must be identified, documented,
analyzed, resolved, and followed up. Management
must be committed to preventing problems where
problems are viewed as opportunities for improvement.
- Periodically Review Management Processes
to Improve Effectiveness and Efficiency.
Management, at all levels, must continually
assess its systems and processes. These management
assessments should be conducted to determine
the effectiveness of the management process,
rather than establishing compliance with organizational
and statutory requirements. They should address
broad categories of management issues, such
as the mission of the organization, employee
understanding of the mission and of management's
objectives, customer expectations, and if
the expectations are being met in the most
cost-efficient manner.
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Value-Added
Attributes of the QA Requirements
- Senior Management Ownership
Senior management must take full ownership
of the quality assurance program. These managers
should establish policies and objectives focused
on achieving the organization's mission while
improving the quality of the organization's
products and services. They must create an
environment that promotes quality and the
improvement of quality throughout the entire
organization.
- Line Organization Responsibility
People who perform the work have the greatest
affect on item and process quality. They should
be empowered. They determine the extent to
which management's objectives are met. Individual
employees should seek ways to improve the
quality of their work by suggesting product
and process improvements.
- Effective Assessment
The self-assessment process consists of three
types of assessments: worker, management,
and independent. Worker assessment deals with
the individual taking responsibility for their
work as part of their work ethic. As work
is performed, workers should critically assess
their efforts and determine if they have accomplished
what they set out to do, that is, meet management's
objectives.
Management assessment identifies, corrects
and prevents management problems that hinder
the achievement of the management's objectives.
The assessments focus on broad categories
of management issues to determine the effectiveness
of the integrated management system.
Independent assessment expands traditional
audit techniques to include a myriad of tools
that allow independent assessment personnel
to better focus on real issues that affect
the organization's performance. In their role
of assessing item quality and process effectiveness,
independent assessment personnel act on behalf
of and as an advisor to, senior management.
Personnel performing assessments should be
technically qualified and performance-oriented.
- Quality Results
A measure or the success of an organization
is the quality of the services and products
it provides. Product and service quality,
rather than rigorous programs, procedures,
and documentation, is the organization's primary
measure of success.
- Cost and Schedule
To achieve quality products and services,
managers must take into account resource considerations,
such as cost and schedule. These considerations
must be an integral part of management's decision-making
process.
- Training and Qualification
Every individual must be capable of doing
his/her job. The Order requires that all personnel,
including managers, receive the appropriate
training to ensure they are capable of performing
their assignments.
- Quality Improvement
Problem prevention is more desirable than
problem correction. The Order emphasizes that
DOE and DOE contractor management is responsible
for continuously pursuing enhancements to
their products and services--not just complying
with the minimum set of requirements. Everyone
must strive to find new and innovative ways
to ensure that the quality of products and
services are continually improved. Process
and product problems must be identified, documented,
and corrected with the goal of promoting higher
levels of quality.
- Graded Approach
Not all items, processes and services have
the same effect on safety and reliability.
The rigor with which the QAP should be applied
must be determined using a graded approach.
Specific information should be considered,
such as the relative importance of safety,
safeguards, and security; the management of
any hazard; life cycle stage; programmatic
mission; characteristics of the facility;
consequences of failure; complexity or uniqueness
of design or fabrication; special controls;
ability to demonstrate functional compliance;
quality history; degree of standardization;
impact on the environment; and impact on cost
or schedule or both.
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This
page was last updated on
July 11, 2008
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