Display Related Directives to this directive.

Preamble to DOE G 414.1-2, Quality Assurance Management System Guide

Quality Assurance (QA) Management System Guide Enhancements:

DOE Elements and DOE contractors should consult this Guide in order to develop and implement
effective management systems that are consistent with the Department's quality expectations and that
support the Safety Management System Policy, DOE P 450.4.

The revised Quality Assurance Management System Guide includes enhancements arising from
experience with implementing the DOE QA rule 10 CFR 830.120 and DOE O 414.1 (formerly DOE
5700.6C). We also evaluated the guidance in light of key policy initiatives, directive changes, and other
changes that have occurred within DOE since the original Guide was issued April 1994. For example,
the changes that address Integrated Safety Management (DOE P 450.4, DOE P 450.5, 48 CFR
970.1001, 49 CFR 970.5204-2, and DOE M 411.1-1) were evaluated to ensure the guide
compliments and supports this safety initiative.

The Quality and Safety Management Special Interest Group (QSM SIG) participated in the
development of this Guide with DOE leadership. DOE sponsors the QSM SIG to support
implementation of the quality Order and rule. The QSM SIG operates as a peer networking resource
and is available to DOE and contractor personnel for sharing lessons learned, advancing the quality of
our products and services, and obtaining advice or assistance with quality management system
development and implementation. The QSM SIG coordinator can be contacted at 423-576-3316 or
www.orau.gov/qsm.

From our evaluation and coordination with user groups, specific major improvements have been made
to the guide as follows:

Clarified the scope of the guidance to include the QA Order, DOE O 414.1, and the QA rule,
10 CFR 830.120.

Included discussion on implementing quality and safety management (ISM) systems in an
integrated manner with the SAFETY MANAGEMENT SYSTEM POLICY, DOE P 450.4,
and the LINE MANAGEMENT ENVIRONMENT, SAFETY, AND HEALTH
OVERSIGHT POLICY, DOE P 450.5.

Discussed the use of a single management system or work process for similar requirements.

Identified links to the expanded guidance for management and independent assessments (DOE
G 414.1-1).

Discussed the flow-down of quality requirements from 10 CFR 830.120 and DOE O 414.1 to
suppliers/subcontractors.

Added information pertaining to the identification and control of suspect/counterfeit items
(S/CI) and links to expanded guidance for S/CIs.

Expanded information on the grading process to include programmatic and mission-critical
considerations and a description of the steps in implementing the grading process.

Expanded the description of identification, tracking, and resolution of quality problems.

Added guidance on procurement processes for nuclear safety applications.

Relocated all the references, standards, and requirements documents to the rear of the guide.

Recommended Actions for Implementing DOE G 414.1-2

The Office of Nuclear Safety Policy and Standards (EH-31) recommends DOE Elements and
contractor organizations take the following actions to ensure maximum benefit from the management
system approach defined in this guide:

Make this Guide available to the senior management position responsible for establishing and
maintaining the quality management system and the integrated safety management system
(ISMS). The Guide should also be made available to employees responsible for
implementation of these systems.

Use the Guide to review new and existing DOE and contractor quality management systems in
conjunction with the INTEGRATED SAFETY MANAGEMENT SYSTEM GUIDE, DOE G
450.4-1. This is especially important where a single process is used to satisfy the QA and
SMS expectations.

The DOE and contractor quality management systems should be reviewed to verify

they are integrated with the Safety Management System established by DOE P 450.4;

appropriate national/international standards have been adopted and identified to implement the
QAP;

processes for implementing the Quality Improvement criteria to adequately address steps for
response, tracking, correction/resolution, reporting, and closure of findings from all sources,
including those from external sources (e.g., the DOE Office of Oversight, EH-2, and
Federal/State regulators) as required by the Department's Implementation Plan for DNFSB
Recommendation 98-1;

the senior management position responsible for the QAP is identified; and,

that the QA criteria have been adequately applied to the radiation protection programs
developed for 10 CFR 835.

DOE G 414.1-2
06-17-99

QUALITY ASSURANCE
MANAGEMENT SYSTEM GUIDE
for use with
10 CFR 830.120 and
DOE O 414.1

U.S. Department of Energy
Washington, D.C. 20585

FOREWORD

This Department of Energy (DOE) Guide is approved by the Office of Nuclear Safety Policy and
Standards (EH-31), Office of Environment, Safety, and Health, and is available for use by all DOE
Elements and their contractors.

Beneficial comments (recommendations, additions, deletions, and any pertinent data) or questions
regarding this document should be sent to

Gustave E. Danielson, Jr.
Office of Nuclear Safety Policy and Standards
EH-31 /270CC
U.S. Department of Energy
19901 Germantown Road
Germantown, MD 20874-1290
Phone (301)903-2954
Fax (301)903-6172
E-mail: bud.danielson@eh.doe.gov

DOE Guides are part of the DOE directives system and are issued to provide supplemental information
regarding the Department's expectations of its requirements as contained in rules, Orders, Notices, and
regulatory standards. Guides may also provide acceptable methods for implementing these
requirements. Guides are not substitutes for requirements, nor do they replace technical standards that
are used to describe established practices and procedures for implementing requirements.

Guides are used to identify government and non-government standards that DOE finds acceptable for
implementing its requirements. Applicable standards and a list of references providing other sources of
information are included at the end of this document.

This Guide is available electronically on the DOE Explorer System at the following address:
http://www.explorer.doe.gov:1776/htmls/

ACKNOWLEDGMENTS

This Guide was prepared by a working group under the policy direction of the DOE Office of Nuclear
Safety Policy and Standards. Contributions to this Guide were also made by other DOE personnel,
including members of the Quality and Safety Management Special Interest Group and the Quality
Assurance Working Group. The following individuals were directly and substantively involved in the
development of this Guide:

POLICY DIRECTION Gustave E. Danielson, Jr.,
Office of Nuclear Safety Policy and Standards

WORKING GROUP

Ray Laskey, Working Group Leader
BNFL Inc.

Paul Chimah
DOE Albuquerque Operations Office

Ron Farchmin
West Valley Nuclear Services Company, Inc.

Gene Langston
Science Applications International Corp.

Charles H. Moseley, Jr.
Lockheed Martin Energy Systems

Keith Rademacher
Foster Wheeler Environmental Corp.

Dennis E. Ryder
Pacific Northwest National Laboratory

Denise Viator
Oak Ridge Associated UniversitiesAdditional support provided to the Working Group by:

Glenn Beyer
Mason & Hanger/Pantex Plant

Suzanne Broussard
DynMcDermott
Petroleum Operations Co.

David H. Brown
DOE Richland Operations Office

Steve Byers
Fluor Daniel Hanford, Inc.

MacArthur Eld
DOE Strategic Petroleum Reserve
Project OfficeKen Gidlow
Dyn Mc Dermott
Petroleum Operations Co.

Joe King
DOE Office of Defense Programs

Steve McGrath
University of California

Jackie White
DOE Oakland Operations Office

Joe Yanek
Westinghouse Savanna River Corp.

CONTENTS

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . .i

ACKNOWLEDGMENTS. . . . . . . . . . . . . . . . . . . . . . . . ii

I. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . .1

II. APPLICATION . . . . . . . . . . . . . . . . . . . . . . . .1
2.1 Quality. . . . . . . . . . . . . . . . . . . . . . . .1
2.2 Integrated Safety Management . . . . . . . . . . . . .2

III. DISCUSSION. . . . . . . . . . . . . . . . . . . . . . . . .3

IV. GUIDANCE. . . . . . . . . . . . . . . . . . . . . . . . . .3
4.1 PROGRAM. . . . . . . . . . . . . . . . . . . . . . . .3
4.1.1 Introduction . . . . . . . . . . . . . . . .3
4.1.2 Responsibilities . . . . . . . . . . . . . .4
4.1.3 Graded Approach. . . . . . . . . . . . . . .5
4.2 PERSONNEL TRAINING AND QUALIFICATION . . . . . . . . .6
4.2.1 Introduction . . . . . . . . . . . . . . . .6
4.2.2 Responsibilities . . . . . . . . . . . . . .6
4.2.3 Qualification of Personnel . . . . . . . . .6
4.2.4 Training . . . . . . . . . . . . . . . . . .7
4.2.5 Training Plans . . . . . . . . . . . . . . .8
4.3 QUALITY IMPROVEMENT. . . . . . . . . . . . . . . . . .8
4.3.1 Introduction . . . . . . . . . . . . . . . .8
4.3.2 Identification of Quality Problems . . . . .9
4.3.3 Resolution of Quality Problems . . . . . . 10
4.3.4 Quality Improvement. . . . . . . . . . . . 10
4.4 DOCUMENTS AND RECORDS. . . . . . . . . . . . . . . . 11
4.4.1 Introduction . . . . . . . . . . . . . . . 11
4.4.2 Documents. . . . . . . . . . . . . . . . . 11
4.4.3 Records. . . . . . . . . . . . . . . . . . 12
4.5 WORK PROCESSES . . . . . . . . . . . . . . . . . . . 12
4.5.1 Introduction . . . . . . . . . . . . . . . 12
4.5.2 Work Performance . . . . . . . . . . . . . 12
4.5.3 Item Identification and Use Control. . . . 13
4.5.4 Item Protection. . . . . . . . . . . . . . 13
4.5.5 Equipment Control. . . . . . . . . . . . . 14 4.6 DESIGN . . . . . . . . . . . . . . . . . . . . . . . 14
4.6.1 Introduction . . . . . . . . . . . . . . . 14
4.6.2 Design Input . . . . . . . . . . . . . . . 14
4.6.3 Design Process . . . . . . . . . . . . . . 15
4.6.4 Design Output. . . . . . . . . . . . . . . 15
4.6.5 Design Verification. . . . . . . . . . . . 15
4.6.6 Design Changes . . . . . . . . . . . . . . 16
4.6.7 Suspect/Counterfeit Items. . . . . . . . . 16
4.7 PROCUREMENT. . . . . . . . . . . . . . . . . . . . . 16
4.7.1 Introduction . . . . . . . . . . . . . . . 16
4.7.2 Procurement Documents. . . . . . . . . . . 17
4.7.3 Supplier Qualification . . . . . . . . . . 17
4.7.4 Supplier Performance Monitoring. . . . . . 17
4.7.5 Inspection . . . . . . . . . . . . . . . . 18
4.7.6 Supplier Documentation . . . . . . . . . . 18
4.7.7 Suspect/Counterfeit Items. . . . . . . . . 18
4.7.8 Procurement of Safety Grade Items Nuclear Facilities/Activities19
4.8 INSPECTION AND ACCEPTANCE TESTING. . . . . . . . . . 19
4.8.1 Introduction . . . . . . . . . . . . . . . 19
4.8.2 Process. . . . . . . . . . . . . . . . . . 19
4.8.3 Control of Measuring and Test Equipment. . 20
4.9 MANAGEMENT ASSESSMENT. . . . . . . . . . . . . . . . 21
4.9.1 Introduction . . . . . . . . . . . . . . . 21
4.9.2 Responsibility . . . . . . . . . . . . . . 21
4.9.3 Process. . . . . . . . . . . . . . . . . . 21
4.9.4 Results. . . . . . . . . . . . . . . . . . 22
4.10 INDEPENDENT ASSESSMENT . . . . . . . . . . . . . . . 22
4.10.1 Introduction . . . . . . . . . . . . . . . 22
4.10.2 Performing Organization. . . . . . . . . . 23
4.10.3 Process. . . . . . . . . . . . . . . . . . 23
4.10.4 Results. . . . . . . . . . . . . . . . . . 24

Attachment 1: References. . . . . . . . . . . . . . . . . Page 1

QUALITY MANAGEMENT SYSTEM
GUIDE
for use with
10 CFR 830.120 and DOE O 414.1

I. INTRODUCTION

To accomplish the Department of Energy (DOE) missions and objectives, DOE and its contractors are
responsible for a wide range of work activities including basic and applied research; product
development; design, construction, operation, modification, decommissioning, and environmental
remediation of DOE facilities and sites; and the management and oversight functions relating to these
activities. This work must be accomplished safely while minimizing potential hazards to the public, site
or facility workers, and the environment. The criteria of 10 CFR 830.120, Quality Assurance, and
DOE O 414.1, QUALITY ASSURANCE (formerly DOE Order 5700.6C, QUALITY
ASSURANCE), are used to provide a quality management system for accomplishing and assessing
DOE's work in accordance with all requirements. The system is compliant with and integrated with the
safety management system (ISMS) required by DOE P 450.4, SAFETY MANAGEMENT SYSTEM
POLICY. The quality management system provides processes and tools for ensuring that the ISMS
achieves its objectives. A comprehensive management system will result from the integrated quality and
safety management expectations so that the DOE mission is accomplished safely and DOE/contractor
performance can be objectively assessed.

II. APPLICATION

2.1 Quality

This Guide provides information on principles, requirements, and practices used to establish and
implement an effective Quality Assurance Program (QAP or quality management system) in accordance
with the requirements of 10 CFR 830.120 and DOE O 414.1, henceforth referred to as the rule and
Order. This Guide also describes the relationship of quality assurance to other processes that aid
compliance with ISMS requirements. This Guide will also assist the user in obtaining customer
concurrence on the QAP.

The quality requirements described in this Guide are interrelated and include criteria for managing,
achieving, and assessing work. Implementing the quality requirements will contribute to improved
safety, management, and the reliability of DOE products and services. This interrelationship precludes
an organization from implementing only selected requirements and ensures the integrated approach
required by DOE P 450.4, SAFETY MANAGEMENT SYSTEM POLICY. A selective approach to
implementing the criteria would create an incomplete system and could lead to quality failures (i.e., a
failure to meet customer requirements and mission objectives). Similarly, a quality management system
limited in scope to "nuclear safety class" or "hazard category 1" items could fail by ignoring the related
activities necessary to accomplishing the mission and their effect on the safety and health of the public,
workers, and the environment.

The methods and references described in this Guide are not mandatory and do not add, modify, or
delete any requirements identified in the rule and Order. An organization may select alternative
methods to document and implement its management system as long as the requirements of the rule and
Order are satisfied. Ultimately, the content of the management system must be based on an
organization's unique set of overall responsibilities and customer expectations.

2.2 Integrated Safety Management System (ISMS)

Effective implementation of the rule and Order quality requirements will also provide processes and
tools to support principles and functions of the Safety Management System Policy (DOE P 450.4) and
related portions of the DOE Acquisition Regulation (DEAR, 48 CFR 970.5204-2). The quality rule
and Order and the Safety Management System Policy, DOE P 450.4, have been selected as DOE
management systems. DOE P 450.4 expresses a fundamental expectation that all work be performed
safely. The DOE fundamental quality expectation is that all work meets established requirements. In
this regard, the quality management system ensures compliance with the approved standards set, so that
the expectation for safe work within controls is met. This also ensures that workers, the environment,
and the public are reasonably protected from harm. The DOE Quality and Safety requirements share a
management systems approach to achieving their objectives. As such, they offer many opportunities for
sharing a single document (QAP or ISMS description) to describe how the organization intends to
implement the requirements. Likewise, a single process (e.g., procedures and plans) that satisfies
quality and safety requirements should be employed. Shared attributes of Quality and Safety
Management Systems include
expectations for implementation (DEAR 970.5204-2 (c)),
documentation of the Management System (ISMS Principle 7 Operations Authorization),
clear roles and responsibilities (ISMS Principle 2),
balanced priorities (resources) (ISMS Principle 4),
feedback and improvement (ISMS Core Function 5),
line management responsibility (ISMS Principle 1),
competence and qualifications (ISMS Principle 3),
standards and controls for work (ISMS Principle 5 and Core Function 4), and
graded and tailored controls (ISMS Principle 6).

The quality management system also supports implementation of DOE P 450.5, LINE
ENVIRONMENT, SAFETY AND HEALTH OVERSIGHT POLICY. The Quality Improvement,
Procurement, and Assessment criteria offer processes to ensure that DOE oversight of its contractors is
effectively planned and implemented and that it achieves the desired results.

THE INTEGRATED SAFETY MANAGEMENT SYSTEM GUIDE, DOE G 450.4-1, contains
more information on safety management principles, supporting attributes, and references on the subject.

III. DISCUSSION

The quality attained in a product or service is described by the extent to which that product or service
satisfies the requirements, needs, and expectations of the customer. (As used in this Guide, the term
"customer" includes all entities that supply to or receive products and services from the organization,
including DOE, regulators, stakeholders, public, contractors, suppliers, and employees.) The attainment
of quality is the responsibility of each member of an organization. The quality requirements of 10 CFR
830.120 and DOE O 414.1 provide the framework for a results-oriented management system that
focuses on performing work safely and meeting mission and customer expectations while allowing the
organization to become more efficient through process improvement.

The concept of developing a management system to simultaneously satisfy the requirements of a nuclear
safety rule, those of an integrated management systems policy and regulation, and an overall quality
management system for items and services produced by an organization may at first appear inconsistent
or unworkable. Experience has shown, however, that designing a system to a minimum performance
level will inevitably result in less than minimum results. The development and implementation of a quality
management system, integrated throughout the organization, will improve performance and provide
assurance that the requirements of DOE O 414.1, Nuclear Safety Management Rules (10 CFR 830
and 835), and the DOE Safety Management System Policy /Acquisition Regulation (DOE P 450.4, 48
CFR 970.5204-2, and 970.1001) are being satisfied.

IV. GUIDANCE

4.1 Program

4.1.1 Introduction

The principal factor representing the performance of an organization is the quality of its products and
services. The QA Order and rule require that an organization develop, document, and maintain an
effective QA program, hereafter referred to as a quality management system. The goal of the quality
management system is delivery of safe, reliable products and services that meet or exceed the
customer's requirements, needs, and expectations. To do so, the quality management system should
describe methods for planning, performing, and assessing the adequacy of work, including work
assigned to parties outside the organization. The quality management system is intended to support and
function with the Department's ISMS.

The quality management system should focus on properly and safely accomplishing the mission, as
outlined, for example, in the organization's strategic plan. Therefore, every component and employee
of the organization is included within the quality management system's scope, which addresses the
organizational structure, functional responsibilities, levels of authority, and interfaces.

DOE Orders and other requirements documents prescribe a variety of management systems to assist
DOE offices and contractors in achieving their missions and goals. A formal management system that
has been established for a facility or activity should be compared to the criteria of the rule and Order to
ensure that the appropriate requirements have been addressed.

The government-wide philosophy of using performance expectations in combination with national and
international consensus standards is consistent with the Technology Transfer Act of 1995 (PL 104-113)
and OMB Circular A-119. The rule and Order requirements are stated as performance expectations
and do not specify methods for achieving the desired performance. Consequently, organizations should
identify, document, and use appropriate standards to develop and implement the management system.
In many cases, the particular standards to be adopted are specified by the customer. Organizations
with multiple customers must often develop their management system using several standards. Clearly
defined standards will also support Safety Management System Policy Principle 5, Identification of
Safety Standards and Requirements.

For example, a single facility may adopt ISO 9001 for corporate reasons, ASME NQA-1 for an
EPA/NRC regulation, and "QC-1" for nuclear weapons activities. DOE has a process for "tailoring"
standards to fit the work and associated hazards described in DOE G 450.3-3, TAILORING FOR
ISM APPLICATIONS. The user is cautioned that tailoring may not be used to circumvent
requirements of the QA rule or DOE P 450.4. The standards ultimately selected should suit the
products and services of the organization and its customers. Several of these standards are included in
the references.

4.1.2 Responsibilities

Management is responsible for leadership and commitment to quality achievement and improvement
within a framework of public, worker, and environmental safety. Management retains the primary
responsibility and accountability for the scope and implementation of the management system.
However, every individual in the organization is responsible for achieving quality in his or her activities.
Senior management should require and cultivate the achievement and improvement of quality at all
levels of the organization and ensure that the QAP is understood and implemented.
The QA rule and Order and the SMS Policy emphasize that management should promote effective
achievement of performance objectives by

establishing task assignments;
identifying lines of communication;
determining and providing the necessary resources and environment to accomplish the required
activities;
ensuring employees are trained appropriately and are capable of performing task assignments;
obtaining timely, objective feedback on the effectiveness of planning and work to meet
performance measures; and
involving all employees to ensure that improvements are identified and implemented to enhance
performance.

4.1.3 Graded Approach

The scope, depth, and rigor of the management system's application of requirements to a specific
activity should be determined by the use of a grading process. The purpose of grading is to select the
controls and verifications to be applied to various items and activities consistent with their importance to
safety, cost, schedule, and success of the program. Grading is encouraged if a single or uniform
method of applying a requirement across a facility or activity does not add value or reduce risk. The
grading process provides the flexibility to design controls that best suit the facility or activity. The
grading process is not used to obtain exemptions from the requirements of 10 CFR 830.120 or DOE O
414.1.

The grading process should be used to evaluate hazards or risks and to determine the appropriate
controls to address those hazards or risks. This process is accomplished by deliberate quality planning
and is based on facility-specific or activity-specific factors, such as

the relative importance to safety, safeguards, and security;
the magnitude of any hazard or risk involved;
the life-cycle stage of a facility;
impact/consequences on programmatic mission of a facility;
the particular characteristics of a facility or activity;
the nuclear safety classification or hazard category of the item or activity;
adequacy of existing safety documentation;
complexity of products or services involved; and
history of problems at a site or facility.

The varying degrees of the controls applied should be dependent upon function, complexity,
consequence of failure, reliability, repeatability of results, and economic considerations. Risk is a
fundamental consideration in determining to what extent controls should be applied. Risk is a
quantitative or qualitative expression of possible impacts or loss (e.g., project, financial, safety) that
considers both the probability of an event causing harm or loss and the consequences of the event.
Determination (or estimation) of the probability or likelihood of the occurrence should be a part of the
risk expression. For example, procurement of nuclear safety class items (ref. DOE-STD-3009-94)
would require more rigorous supplier controls to meet procurement requirements, than that needed for
facility area lighting fixtures. Estimates and qualitative expressions are useful for management issues
where quantitative data is unavailable. Process systems, repetitive activities, and hardware are typically
more suitable for quantitative expressions of risk.

The first step in the grading process is to identify the consequences and probability of a failure. The
second step is to identify the specific requirements to be applied. The third step is to determine the
depth, extent, and degree of rigor necessary in the application of requirements. The final step is to
communicate and implement the selected requirements and degree of rigor by means of documented
procedures and controls.

The logic, method of implementation, and basis for grading should be documented in the quality
management system, periodically reviewed in light of changes that may have occurred, and if
appropriate, revised to reflect those changes.

4.2 Personnel Training and Qualification

4.2.1 Introduction

A fundamental requirement for effective accomplishment of any mission is that all personnel be capable
of performing their assigned tasks. Qualification and training processes ensure that personnel achieve
and maintain the required capabilities. Principle 3 of the SMS Policy contains a similar expectation for
personnel to possess the experience, skills, and abilities commensurate with their responsibilities.

4.2.2 Responsibilities

Management should commit resources to facilitate the training and qualification processes for personnel
in their organizations, and to ensure that personnel hired or transferred into positions meet the
appropriate requirements. Each level of the organization should adequately describe its training and
qualification needs. These descriptions should include requirements, interfaces, training methods,
training responsibilities, and duties of line and training organizations.

4.2.3 Qualification of Personnel

Policies and procedures that describe personnel selection, training, and qualification requirements
should be established for each function. These should include the minimum applicable requirements for
education, experience, skill level, and physical condition. For example, the OSHA terms "competent,
qualified, certified, and designated" each have pre-requisites based in approved standards. Physical
condition used in this context means such human attributes as visual acuity and hearing, which are
necessary to properly perform the job.

Before personnel are allowed to work independently, management should ensure those personnel have
the necessary experience, knowledge, skills, and abilities. Personnel may be qualified based on

previous experience, education, and training;
a performance demonstration or test to verify previously acquired skills;
completion of a training or qualification program; and/or
on-the-job training.

4.2.4 Training

Training should help personnel acquire knowledge of the correct and current processes and methods to
accomplish assigned tasks. It should also enable personnel to understand the fundamentals of the work,
the associated hazards, the context within which the work is performed, and the reasons for any special
work requirements.

Training goals, lesson plans, and other training materials should be consistently developed, reviewed by
experienced personnel, approved by management, and used to effectively deliver training. Training
materials should be controlled to ensure that the latest approved versions are used. Instructors may be
training providers or qualified members of the organization. Instructors should possess technical
knowledge, experience, and training development and instructional skills. Instructor training should be
based, in part, on the results of instructor evaluations and training on new methods and equipment.

Training effectiveness should be monitored. Worker performance should be evaluated to ensure that
the training program conveys all required knowledge and skills. Feedback from personnel
performance, former trainees and supervisors, accidents, and assessments should be used to determine
effectiveness of training. The results of these evaluations should be used as the basis for improving the
training program and is an example of the SMS Policy feedback and improvement function.

Training can be grouped into three general categories: project/task-specific, site/facility-specific, and
institutional.

1. Project/task-specific training should impart the knowledge required for personnel to perform
their assigned duties safely and successfully. This training may include project/task goals and
schedules, implementing procedures, safety and hazard controls, methods, requirements,
process metrics, and skills. Project/task-specific training requirements should be defined by
project managers, and workers.
2. Site/facility-specific training should convey the safety, emergency plans, security, and operations
information necessary for personnel to prepare for and perform their assigned duties in the
site/facility. Management is responsible for defining training requirements and ensuring that the
training is administered.
3. Institutional training should convey general information about the organization's mission, vision,
goals, and management system. It may also include general knowledge or skills training.

4.2.5 Training Plans

Training plans should be prepared for all functions, including those personnel responsible for managing,
planning, and controlling work. Initial training should prepare personnel to perform the job. Continuing
training should maintain and promote improved job performance. Training plans can contribute to
employee satisfaction and an interest in self-enhancement, thereby motivating personnel to develop
enhanced technical, managerial, or other skills capabilities, and to track and document such
development.

Managers and workers should consider all types of available training when preparing their training
plans. Training plan content should also be based on current facility, site, or organization procedures;
technical and professional references; and past organization/industry experience. Training plans should
consider changes in hazard conditions, technology, work methods, and job responsibilities. Training
plans should also specify the type of training records to be maintained.

4.3 Quality Improvement

4.3.1 Introduction

An effectively planned and implemented quality management system is one that

uses feedback information to improve items, services, and the processes that produce them;
prevents or minimizes quality problems; and
when necessary, corrects problems that occur.

As used in this Guide, a quality problem is a collective term that may be a deficiency in

an activity, product, service, item characteristic, or process parameter;
a non-compliance with a legal, contractual, or other requirement; or
the existence of a substandard condition or a suspect/counterfeit item.

Quality problems may be identified by the organization or by an external source (customer/regulator).
Corrective action is the identification of cause and the resolution of a quality problem after its
occurrence to prevent its recurrence. Preventive action ensures, through appropriate design,
inspection, procurement, and other process controls and assessment activities, that a quality problem
does not occur. DOE and contractor organizations should prioritize and focus their resources on
preventive actions and on those quality problems that have the greatest potential for

posing adverse risks to the environment and human health;
impacting the safety and reliability of operations and products; and
affecting the ability to meet customer requirements.

Quality improvement is a management process that is carried out to improve an item, service, product,
or process. All aspects of work activities and the management system are subject to continuous
improvement through an assessment and feedback process. Feedback originates from workers,
customers, and suppliers. The process should include the use of lessons learned from the local
organization and other organizations. Identified improvement actions should also be shared with other
organizations. Management should track the actions to ensure they are providing the anticipated
improvements. Quality improvement processes will support SMS Policy feedback and improvement
Core Function 5, Line Management ES&H Oversight Policy, and the Department's commitment to
develop corrective action plans for safety issues reported by the Office of Oversight (EH-2). [Also see
sections 4.3.4, 4.9, and 4.10]

4.3.2 Identification of Quality Problems

A quality problem should be identified, documented, and evaluated to determine significance. Usually,
identification of a problem comes in the form of feedback from workers and from internal and external
customers. Effective feedback from multiple sources is the foundation for processes designed to
prevent, identify, and correct problems. The least desirable form of feedback results from accidents or
unplanned events that self-disclose the quality problem. If the quality problem is likely to affect safety
or mission significantly, the impacted items or processes should be controlled to prevent their further
use. Problems that are not likely to be significant, and that cannot be readily corrected on the spot,
should be identified and documented (e.g., by logging), and handled in an expedient manner that may
not follow the more formal processes for quality problem documentation (e.g., nonconformance report)
and dispositioning. The method for determining the significance of a problem and the process for
handling problems should be documented in the quality management system.

The QAP or other documentation should define the conditions governing the issuance and removal of
stop work orders

4.3.3 Resolution of Quality Problems

A quality problem resolution process should consist of

identifying a condition adverse to quality,
evaluating its significance,
analyzing the problem and determining its causes,
reporting the planned actions to the organization identifying the problem,
taking prompt corrective (remedial) action and documenting that action,
taking steps to prevent recurrence,
replicating the actions where appropriate,
verifying implementation,
documenting closure, and
determining effectiveness of the corrective and preventive actions for significant problems.

Management should be involved in approving corrective/preventive actions for significant quality
problems and following them through to closure.

Quality problems identified by internal and external sources (e.g., DOE Office of Oversight, DOE
Office of Enforcement and Investigation, or customers) should be tracked through resolution. The
Department's Corrective Action Tracking System (CATS) is used to report corrective actions and their
status for Office of Oversight safety issues. Specific expectations for CATS and corrective action plans
will be available shortly after publication of this guide on the Office of Environment, Safety, and Health
website at: http://tis.eh.doe.gov/ism/. The planned corrective/preventive actions and progress through
to closure should be reported to the identifying organization when requested.

Quality problem resolution typically involves

documenting dispositions for repairing, reworking, inspecting, or testing items;
replacing or returning an item to its supplier, scrapping the item, or using it as is;
changing process parameters or procedures;
eliminating substandard conditions, or
changing the management system or methods for achieving compliance.

4.3.4 Quality Improvement

Improvement in quality is a disciplined management process based on the premise that all work can be
planned, performed, measured, and improved. Management should ensure that the focus is on
improving the quality of products, processes, and services by establishing priorities, promulgating
policy, promoting cultural aspects, allocating resources, communicating lessons learned, and resolving
significant management issues and problems that hinder the organization from achieving its objectives.
Management should balance safety and mission priorities (SMS Policy Principle 4) when considering
improvement actions.

Management should encourage employees to develop and explore new ideas for improving products,
processes, and services. Effective improvement processes require each employee to participate and
cannot be delegated to a particular person or group. Management commitment can be demonstrated
by empowering workers to

identify process problems,
develop alternative approaches for addressing problems (e.g., reducing process variability or
cycle time),
implement the approved solution,
evaluate the improvement, and
provide lessons learned to other organizations.

Quality problems and other quality-related information, both positive and negative, from various internal
and external sources, should be reviewed and analyzed to identify improvement opportunities in the
quality management system, processes, items, products, or services. Implemented improvements
should be monitored and methods established to verify their effectiveness.

4.4. Documents and Records

4.4.1 Introduction

Documents and records are required to effectively manage, perform, and assess work. Documents and
records should include applicable requirements to indicate that work (including safety) has been
properly specified and accomplished. Management should identify any documents and records that
must be developed and controlled. Management should commit the resources necessary to accomplish
the document and record requirements.

4.4.2 Documents

Documents are required by organizations, projects, or programs to control policy, administrative,
and/or technical information. A document may describe work to be done, data to be used at different
locations or by different people, or, in changing situations, data to be controlled from time to time for
reference purposes. A document control system should be established to supply such documents
necessary for personnel to safely and correctly perform their assigned responsibilities. Document
systems ensure that the mechanisms developed to implement the safety management functions of DOE
P 450.4 are properly prepared, controlled, and available for managers and the workers.
4.4.3 Records

A record contains information that is retained for its expected future value. Records should be sufficient
to support technical and regulatory decisions. Records may be in a variety of forms (e.g., electronic,
written or printed, microfilm, photographs, radiographs, or optical disks). Records are compiled into a
records management system that ensures appropriate records are maintained. The system should
include provisions for records retention, protection, preservation, change, traceability, accountability,
and retrievability. While in storage, records should be protected from damage, loss, and deterioration.

The hardware and software required to ensure retrievability and usability of archived records should be
maintained.

The records management system should have schedules for records retention and disposition in
accordance with the requirements of DOE O 200.1, INFORMATION MANAGEMENT
PROGRAM.

4.5 Work Processes

4.5.1 Introduction

All work should be regarded as a process. Each work process consists of a series of actions planned
and carried out by qualified workers using specified work processes and equipment under
administrative, technical, and environmental controls established by management to achieve an end
result.

4.5.2 Work Performance

Management should ensure that the following are clearly identified and conveyed to workers prior to
beginning work:

customer and data requirements for the work and final product (ISMS Core Function 1);
acceptance criteria applicable to work and final product (ISMS Core Function 1);
hazards associated with the work (ISMS Core Function 2);
technical standards applicable to work and final product (ISMS Core Function 1and 3); and
safety, administrative, technical, and environmental controls to be employed during the work
(ISMS Core Function 3).

Management should ensure that those under their supervision have the skills (including knowledge and
understanding of the capabilities of the processes being used), equipment, work process documents,
and resources needed to accomplish their work. Line management and workers should cooperate to
identify processes that can be improved (ISMS Guiding Principles 1 and 3).

Procedures, work instructions, or other means used to define work processes should be documented.
The scope and detail of documentation should be commensurate with the complexity and importance of
the work, the skills required to perform the work, and the hazards and risks or consequences of quality
problems in the product, process, or service (ISMS Guiding Principle 6). Control of processes, skills,
hazards, and equipment should be clearly specified, understood, and fully documented (ISMS Guiding
Principle 5, Core Function 3).

Workers are responsible for the quality of their work. Workers should do their work correctly the first
time, in accordance with established procedures and work instructions (ISMS Core Function 4). Since
workers are the best resource for contributing ideas for improving work processes, products, and
services, they should be involved in work process design, process evaluation, and providing the
feedback necessary for improvement (ISMS Core Function 5).

4.5.3 Item Identification and Use Control

A process for the identification and control of items should be established and implemented to:

prevent the use of incorrect or defective items,
identify and control suspect/counterfeit items, and
provide for the control and maintenance of items.

"Item" is a collective term that may include hardware, samples, software, or data. The identification
and control process should apply from manufacture or receipt through delivery, installation, or use. The
process should also provide for the identification and configuration control of installed or replacement
items in accordance with specified requirements.

Physical identification of items is preferred. Suitable identification information includes the unique part,
lot, heat, model, version, or serial numbers on the item, or in records traceable to the item, or both.

4.5.4 Item Protection

Work processes should be established and implemented to protect items in accordance with specified
technical standards and administrative controls to prevent their damage, loss, or deterioration. Work
processes should specify protective methods for sensitive or perishable items, such as special handling,
shipping, and storage controls for precision instrumentation and limited shelf-life items, and for items
requiring special protective environmental controls, such as temperature and humidity controls.

4.5.5 Equipment Control

Work processes should be established and implemented to ensure that equipment used for process
monitoring and data collection are of the proper type, range, and accuracy. Such equipment should be
calibrated according to technical standards and maintained to ensure continuing data quality and
process capability. (See also Section 4.8.3.)

4.6 Design

4.6.1 Introduction

A formal design process should be established that provides control of design inputs, outputs,
verification, configuration and design changes, and technical and administrative interfaces appropriate to
the importance of the design. Design work should be based on sound engineering judgement, scientific
principles, and applicable codes and standards.

The design of items, such as structures, systems, and components that involve a higher-than-normal
level of risk (including those items important to safety), should be subject to more definitive design
process control and verification requirements. For example, selection of the applicable design control
requirements for a facility should be guided by safety analyses that establish

the identification and functions of safety (safety class and safety significant) structures, systems,
and components and
the significance to safety of functions performed by those structures, systems, and components.

Designs should provide for appropriate inspection, testing, and maintenance to ensure continuing
reliability and safety of the items. The design should consider the expected use and life expectancy of
the items in order to allow appropriate disassembly and disposal requirements to be addressed.

Design records should include documentation of design input, calculations and analyses, engineering
reports, design output, design changes, and design verification activities.

4.6.2 Design Input

Design input should be based upon contractual requirements and customer expectations, and should be
technically correct and complete. Design input may include such information as design bases, health
and safety considerations, expected life cycle, performance parameters, codes and standards
requirements, and reliability requirements.

4.6.3 Design Process

The design process should translate design input into design output documents that are technically
correct and compliant with the end-user's requirements. Aspects critical to the performance, safety, or
reliability of the designed items should be identified during the design phase. Design output documents
should be prepared to support other processes, such as dose and risk assessments, procurement,
manufacturing, assembly, construction, testing, inspection, maintenance, and decommissioning.

Technical and administrative design interfaces should be identified and methods established for their
control.

Computer software used to originate or analyze design solutions during the design process should be
validated for the intended use; otherwise, status of the code validation should be identified and
documented prior to use.

The design organization should perform design analyses and checks to ensure that design output
documents meet design input requirements and that any changes have been approved and documented.

4.6.4 Design Output

The completed design should be recorded in design output documents, such as drawings,
specifications, test/inspection plans, maintenance requirements, and reports. As-built drawings and
shop drawings should be maintained after production or construction to show actual configuration. The
administrative interface process should clearly indicate responsibilities for design output documents
including: as-built mark-up and updating during construction and operation phases, and the
requirements for document control and records management.

4.6.5 Design Verification

Design verification is a formal, documented process for ensuring that the resulting items will comply with
the requirements. Design verification methods include, but are not limited to, technical reviews, peer
reviews, alternate calculations, and qualification testing. When appropriate, the verification process
may consider previous verifications of similar designs or verifications of similar features of other designs.

Design verification should be performed by technically knowledgeable persons separate from those
who performed the design. Interim verifications may occur at predetermined stages of design
development. The extent and number of design verifications should be based on a graded approach
and should depend on the designed product's complexity and importance to safety and project success.

Organizations rely on verified design output to support other work, such as procurement, manufacture,
construction, or experiment. When the verification cannot be achieved in time for these activities,
unverified portions of the design should be identified and controlled. Design verifications should be
completed before relying on the system, structure, or component to perform its function and before
installation becomes irreversible.

4.6.6 Design Changes

Design changes, including field changes and nonconforming items dispositioned for "use-as-is" or
"repair," should be controlled by measures commensurate with those applied to the original design.
Temporary modifications should receive the same levels of control as the designs of permanent
modifications.

4.6.7 Suspect/Counterfeit Items

DOE G 440.1-6 , Section 4.3, provides design organization guidance to help avoid the procurement
and use of suspect/counterfeit items. Additional guidance is provided for evaluating suspect/counterfeit
items that may have been installed.

4.7 Procurement

4.7.1 Introduction

The procurement process should ensure that items and/or services provided by suppliers meet the
requirements and expectations of the end-user. The procurement process should be planned and
controlled to ensure that

the end-user's requirements are accurately, completely, and clearly communicated to the
supplier;
supplier, designer, and end-user requirements are met during the production phase; and
the proper product is delivered on time and maintained until use.

The selection of procurement requirements should be commensurate with the importance of the
purchased items or services. Management controls exist for DOE procurement and subcontracts
through applicable DOE Orders, the Department of Energy Acquisition Regulation (the DEAR) in 48
CFR Part 9, and Federal Acquisition Regulations (FAR) in 48 CFR Parts 1 to 99. The requirements in
10 CFR 830.120(c)(2)(iii) and Criterion 7 of DOE O 414.1 should not be interpreted to require the
development of redundant procurement management systems, but rather to ensure that existing
procurement management systems adequately respond to end-user requirements.

The procurement process of DOE nuclear facility contractors should include a determination of the
applicability of 10 CFR 830.120 to the supplier or subcontractor. If applicable, procurement
documents and contracts for items and services provided to facilities covered by 10 CFR 830.120
should include a statement informing the supplier or subcontractor that they are subject to 10 CFR
830.120 and the enforcement actions under 10 CFR 820. Suppliers and subcontractors are not
required by 10 CFR 830.120 to submit their QAPs to DOE for review and approval; rather, it is left to
the contractor to determine the methods for ensuring that procured items and services meet
requirements and perform as expected.

4.7.2 Procurement Documents

Procurement documents should clearly state test/inspection requirements and acceptance criteria for
purchased items and services. Procurement documents should include any specifications, standards,
and other documents referenced in the design documents. Critical parameters and requirements, such
as submittal, product related documentation, problem reporting, administrative documentation,
personnel or materials qualifications, tests, inspections, and reviews, should be specified.

4.7.3 Supplier Qualification

Potential suppliers should be identified early in the design and procurement process in order to
determine their capabilities. Prospective suppliers should be evaluated to verify their capability to meet
performance and schedule requirements. An effective evaluation method is an assessment of personnel
and processes conducted at the supplier's facilities (a quality assurance program evaluation). This
method may be used in combination with

a review of the supplier's history for providing identical or similar items or services;
a review of shared supplier quality information;
an evaluation of certifications or registrations awarded by nationally accredited third parties;
and
an evaluation of documented qualitative and quantitative information provided by the supplier.

The method or combination of methods chosen should provide adequate confidence that the supplied
item or service will meet requirements.

4.7.4 Supplier Performance Monitoring

The qualified supplier's performance should be evaluated periodically during the life of the contract to
confirm its continuing capabilities. Suppliers should be monitored to ensure that acceptable items or
services are produced and schedule requirements are being met. Monitoring may include

surveillance of work activities,
inspection of facilities and processes,
review of plans and progress reports,
processing of change information,
review and disposition of nonconformances, and
selection, qualification, and performance monitoring of sub-tier suppliers.

4.7.5 Inspection

The procurement process should provide for identifying the need for inspections and tests.
Requirements for inspections and tests should be obtained from design documents. Inspections should
be adequate to ensure conformance with purchase requirements, including verification that specified
documentation has been provided by the supplier. The inspection should verify that items were not
damaged during shipment. Inspection may include the following methods:

inspections of materials or equipment at the supplier's plant,
receipt inspection of the shipped items,
review of objective evidence such as certifications and reports, and
verification or testing of items prior to or following shipment.

Critical or important acceptance parameters and other requirements, such as inspection/test equipment
or qualified inspection/test personnel, should be specified in design documentation. In addition, the
risks associated with the possibility of obtaining suspect/counterfeit items should be evaluated and, if
appropriate, measures implemented to identify them. DOE G 440.1-6 provides additional guidance on
this subject.

4.7.6 Supplier Documentation

Supplier-generated documents should be accepted through the procurement system and controlled and
processed by the end-user organization according to the provisions of Criterion 4 of DOE O 414.1
(Documents and Records). These documents may include certificates of conformance, drawings,
analyses, test reports, maintenance data, nonconformances, corrective actions, approved changes,
waivers, and deviations.

4.7.7 Suspect/Counterfeit Items

The selection of suppliers and the purchase of commercial-grade materials should be evaluated to
prevent the procurement of suspect/counterfeit items and to detect them before they are released for
use. Information in DOE G 440.1-6, Section 4.1, should be used to minimize the possibility of
procuring suspect/counterfeit items.

4.7.8 Procurement of Safety Grade Items for Nuclear Facilities/Activities

Items procured for safety applications in nuclear activities, structures, systems, or components should
be either

purchased from a supplier whose quality assurance program has been evaluated and found
acceptable or

purchased as commercial-grade items for dedication to the safety service.

Commercial-grade items intended for use in nuclear safety applications should be procured in
accordance with documented processes using recognized consensus standards. Critical design
characteristics should be identified during item selection. Critical design characteristics and
appropriateness of the item for use should be verified by

testing the item,
inspecting the item, and
evaluating the supplier's ability to consistently supply the item at a level of quality that meets the
safety and reliability requirements for the item.

4.8 Inspection and Acceptance Testing

4.8.1 Introduction

Inspections and tests are accomplished to verify that physical and functional aspects of items, services,
and processes meet requirements and are fit for use and acceptance. Inspections and tests should be
identified early in the design process and specified in the design output documents.

The type of item and the length of time it is expected to remain in storage should be considered during
inspection planning.

Personnel should check items prior to their use to ensure that the items are correct and suitable for their
intended application. Personnel should check their process output to verify that it meets or exceeds
specified requirements.

4.8.2 Process

Inspection/test planning should be performed. Appropriate sections of approved codes or standards
may be used for acceptance requirements and inspection/test methods. Inspection/test planning should
contain provisions for at least the following:
identification of characteristics to be examined;
required qualifications of individuals who perform the examination;
a description of examination methods, including equipment and calibration requirements;
acceptance and rejection criteria;
suitable environmental conditions;
required safety measures; and
mandatory hold points, when applicable.

Inspections/tests should be performed by technically qualified personnel who have the authority to
access appropriate information and facilities in order to verify acceptance. These qualified personnel
should be independent of the activities being inspected/tested and should have the freedom to report the
results of the inspections/tests. Inspection/test results should be evaluated and verified by authorized
personnel to document that all requirements have been satisfied. Final acceptance should be verified
and documented by the organization having final responsibility for the item or process.

Inspection and test records should, at a minimum, identify

item tested,
date of test,
tester or data recorder,
observations,
results and acceptability, and
action taken concerning quality problems noted.

The inspection/test process should identify the status of items, services, and processes requiring
examination to ensure only those with acceptable inspection and test results are used. The process
should provide for review and reinspection/retest of changed inspection/test parameters.

Final inspections are usually distinct from inspections conducted during the work process. Final
inspection confirms the item, service, or process is ready for acceptance testing and/or operation. As
such, it includes completeness, cleanliness, identification/markings, calibration, alignment/adjustment,
adequate records, or other characteristics indicating conformance to requirements.

4.8.3 Control of Measuring and Test Equipment

Measuring and Test Equipment (M&TE) used for inspection, tests, and monitoring or data collection
should be calibrated and maintained using a documented process. M&TE should also be checked
prior to its use to ensure that it is of the proper type, range, accuracy, and that it is uniquely identified
and traceable to its calibration data.

Procedures should be established for testing, retesting, adjusting, and recalibrating the M&TE. M&TE
should be calibrated to standards traceable to the National Institute of Standards and Technology
(NIST) or other nationally recognized standards when available and appropriate. If no nationally
recognized standards exist, the bases for calibration should be documented.

4.9 Management Assessment

4.9.1 Introduction

Managers at every level should periodically assess the performance of their organizations and functions
to determine how well it meets customer requirements and expectations, and mission objectives, so that
improvements can be made. This assessment should address the use of human and material resources
to achieve the organization's goals and objectives. The management assessment should also include an
introspective evaluation to determine if an integrated management program exists and if it focuses on
meeting both customer requirements and strategic goals (ISMS Core Function 5). Management
assessments conducted by DOE and contractor "line" managers support implementation of DOE P
450.5, LINE ENVIRONMENT, SAFETY, AND HEALTH OVERSIGHT.

DOE has developed expanded guidance on this subject that should be consulted for planning and
performance of management assessments (ref. DOE G 414.1-1).

4.9.2 Responsibility

Managers perform management assessments. Direct participation by managers is essential to the
success of the assessment process because they are in a position both to evaluate the organization as a
total system and to effect change. Delegating management assessment to a consultant or internal audit
group is inconsistent with the requirement and will diminish its value to the manager. Personal
involvement by the manager will naturally yield the most meaningful information for that manager to use
in taking actions to improve organizational performance.

4.9.3 Process

Strengths and weaknesses affecting the achievement of organizational objectives should be identified so
that meaningful action can be taken to improve processes. Those areas that present the greatest
consequences of failure and the greatest benefit from improvements if implemented should receive
particular emphasis. Management assessments should focus on identifying and resolving both singular
and systemic management issues and problems that may prevent customer requirements and
expectations from being met. For example, senior managers may use the process to determine the
degree to which the ISMS is achieving the Department's safety objective. Criteria set forth in the
Presidential Award for Quality or the Malcolm Baldrige National Quality Award is another example of
broad management issues that may be used for management assessments. Results from internal or
external (e.g., Office of Oversight or Office of Enforcement and Investigation) independent
assessments should be used as input to the management assessment. These independent assessments
often contain indicators of potential management issues.

Managers should assess their processes for planning; organizational interfaces (internal and external to
the organization); integration of management systems (e.g., safety, quality, project); use of performance
metrics; training and qualifications; and supervisory oversight and support. Effective management
assessments include an evaluation of such conditions as the state of employee knowledge, motivation,
and morale; communication among workers; the existence of an atmosphere of creativity and
improvement; and the adequacy of human and material resources.

Direct observation of work is an effective, preferred assessment method that will make the manager
aware of interactions at a work location. Other methods that are useful when combined with
observation include worker and customer interviews, safety and performance documentation reviews,
and drills or exercises.

Performance measurement is an effective way to integrate assessment methods into daily operations
and strengthen the alignment of purpose between management and workers. Performance
measurement should be based on objective standards, clearly defined goals, results-oriented metrics,
and meaningful review and feedback processes.

4.9.4 Results

Management assessment results should be documented and used as input to the organization's
improvement process. Periodic review of performance metrics at appropriate management levels and
with customers is effective in validating organizational performance.

4.10 Independent Assessment

4.10.1 Introduction

Senior management should establish and implement a process to obtain an independent assessment of
the organizations' programs, projects, contractors, and suppliers. The purpose of this type of
assessment is to evaluate the performance of work processes with regard to requirements, expectations
of customers, and efforts required to achieve the mission and goals of the organization The results of
independent assessments provide an objective form of feedback to senior management that is useful in
confirming acceptable performance and should be used for identifying improvement opportunities
(ISMS Core Function 5).

The independent assessment process should use a performance-based approach to focus on results.
Performance-based assessments are conducted on activities that

relate directly to final objectives,
emphasize safety and reliability, and
measure item or service performance.

Independent assessments conducted by DOE and contractor line organizations support implementation
of DOE Policy P 450.5, LINE ENVIRONMENT, SAFETY, AND HEALTH OVERSIGHT. DOE
line organizations should apply the independent assessments to their work and the work of their
contractors. Contractor line organizations should apply the independent assessments to their work and
the work of their subcontractors.

Separately, the Secretary of Energy has established the Office of Oversight to conduct independent
assessments of DOE and contractor safety performance. DOE and contractor organizations should not
consider the Office of Oversight function as satisfying the QA rule/Order requirements for independent
assessment.

DOE has developed expanded guidance on this subject that should be consulted for planning and
performing independent assessments (DOE G 414.1-1).

4.10.2 Performing Organization

Independent assessments advise senior management on the quality of items, services, and processes
produced by or for the organization. Consequently, the persons or organization conducting
independent assessments should report to a sufficiently high level in the overall organization. This is to
ensure organizational independence from the work and access to levels of management authority
capable of directing subordinate levels to take actions in response to the assessment results.

In addition, personnel performing independent assessments should have the necessary technical
knowledge to accurately observe and evaluate activities being assessed. They should have no direct
responsibility for the work or organization they are assessing. The manager directly responsible for the
work should be considered as a customer of the assessment product (e.g., feedback resulting from
observations of performance).

4.10.3 Process

The type and frequency of independent assessments should be based on the status, complexity, risk,
and importance of the activities or processes being assessed. The criteria used for assessments should
describe acceptable work performance and should promote improvement of the process or activity.
Assessments should also address management processes that affect work performance, such as
planning, program support, training, and the performance of SMS Policy Core Safety Functions.

Independent assessments may include methods such as monitoring operations, inspections, peer and
technical reviews, audits, surveillances, customer interviews, or combinations thereof.

The assessment should focus on improving output quality and process effectiveness by emphasizing
improvement methods. Independent assessment personnel should base the evaluation on the approved
system and not reinterpret or redefine the requirements. Assessments that are intended to evaluate the
appropriateness of the approved system (or to interpret/define requirements of the system) may be
performed, but only with the direction of senior management.

Assessors' responsibilities include

evaluating work performance and process effectiveness;
evaluating compliance to the management system requirements;
identifying abnormal performance and potential problems;
identifying opportunities for improvements;
documenting and reporting results; and
verifying satisfactory resolutions of reported problems.

The independent assessment process should include verification of the adequacy of corrective actions,
including actions identified to prevent recurrence or to otherwise improve performance.

Independent assessments that confirm acceptable performance in areas of an organization may reduce
frequency and depth of future assessments. Areas of poor or questionable performance should receive
increased attention.

4.10.4 Results

Documented assessment results should be presented to the organization that was assessed and
provided to the appropriate levels of management for review. Strengths and weaknesses affecting the
quality of process outputs should be identified so that management can take meaningful action to
improve quality.

Management should evaluate the assessment results to identify improvement actions and determine
whether similar quality problems may exist elsewhere in the organization. Lessons learned from
assessment results should be communicated to other organizations with similar activities or concerns.

Management should track improvement actions until a resolution has been implemented and verified as
completed.
REFERENCES

The following references provide acceptable methods for implementing many of the requirements of 10
CFR 830.120 and DOE O 414.1. No single reference fully meets all the requirements. The principles,
recommended approaches, and applications contained in these references may be used with 10 CFR
830.120 and DOE O 414.1 to develop an effective management system to achieve quality. The latest
date of the reference is provided; however, the QAP developer may use any issue of the reference
appropriate to the QAP work.

A. RELATED POLICIES, RULES AND ORDERS

10 CFR Part 830, Nuclear Safety Management

10 CFR 830.120, 4-5-94, Quality Assurance Requirements

48 CFR Part 46, Quality Assurance (note: part 46 is part of the FAR)

48 CFR Parts 1-99, Federal Acquisitions Regulations System

48 CFR Part 970, Department of Energy Acquisition Regulations (DEAR), DOE Management and
Operating Contracts.

DOE O 414.1, QUALITY ASSURANCE, dated 11-24-98

DOE P 450.4, SAFETY MANAGEMENT SYSTEM POLICY, dated 10-15-96

DOE P 450.5, LINE ENVIRONMENT, SAFETY AND HEALTH OVERSIGHT, dated 6-26-97

DOE O 360.1, TRAINING, dated 5-31-95

DOE O 200.1, INFORMATION MANAGEMENT PROGRAM, dated 9-30-96

B. RELATED QUALITY MANAGEMENT SYSTEM STANDARDS

DOE G 414.1-1, IMPLEMENTATION GUIDE FOR USE WITH INDEPENDENT AND
MANAGEMENT ASSESSMENT REQUIREMENTS OF 10 CFR 830.120 AND DOE ORDER
5700.6C QUALITY ASSURANCE, dated August 1996

DOE G 440.1-6, IMPLEMENTATION GUIDE FOR USE WITH SUSPECT/COUNTERFEIT
ITEMS REQUIREMENTS OF DOE 440.1 WORKER PROTECTION MANAGEMENT, 10 CFR
PART 830.120; AND DOE 5700.6C QUALITY ASSURANCE, dated June 1997

DOE GPG-FM-017, March 1996, Good Practice Guide, QUALITY ASSURANCE

DOE-RW-0333P, December 1998, Quality Assurance Requirements and Description for the Civilian
Radioactive Waste Management Program

DOE-STD-1082-94, October 1994, Preparation, Review, and Approval of Implementation Plans for
Nuclear Safety Requirements

CAO-94-1012, Carlsbad Area Office Quality Assurance Program Description, dated 9/98, Rev. 2

CAO-94-1010, Carlsbad Area Office Quality Assurance Program Plan, Rev. 0

ANSI/ANS-3.2-1994, Administrative and Quality Assurance Requirements for Operating Nuclear
Power Plants.

ANSI/ASQ Z 1.13-1999, Quality Guidelines for Research

ANSI/ISO/ASQC-Q9001-1994, Quality Systems -Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing.

ANSI/ISO/ASQC-Q9002-1994, Quality Systems -Model for Quality Assurance in Production and
Installation.

ANSI/ISO/ASQC-Q9004-1994, Quality Management and Quality System Elements - Guidelines

ANSI/NCSL Z540-1-1997, Calibration Laboratories and Measuring and Test Equipment, General
Requirements

ASME NQA-1-1997, Quality Assurance Program Requirements for Nuclear Facilities,
Part 1, Requirements and Part 3, Nonmandatory Appendices

ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environment Data
Collection and Environmental Technology Programs

DOE-NE-STD-1004-92, February 1992, Root Cause Analysis Guidance Document

DOE-ER-STD-6001-92, June 1992, Implementation Guide for Quality Assurance Programs for
Basic and Applied Research (to be superseded by ANSI/ASQ Z1.13-1999)

International Atomic Energy Agency (IAEA) Safety Guide 50-SG-Q1, 1995, Establishing and
Implementing a Quality Assurance Programme

C. RELATED REFERENCES

American Society for Nondestructive Testing Standard SNT-TC-1A

ANSI/ISO/ASQC Q10011-1-1994, Guidelines for Auditing Quality Systems - Auditing

ANSI/ISO/ASQC Q10011-2-1994, Guidelines for Auditing Quality Systems - Qualifications Criteria
for Quality Systems Audits

ANSI/ISO/ASQC Q10011-3-1994, Guidelines for Auditing Quality Systems - Management of Audit
Programs

ANSI/ISO/ASQC Q10012-1-1992, Quality Assurance Requirements for Measuring Equipment, Part
1: Meteorological Confirmation System for Measuring Equipment

ANSI/ISO/ASQC-14001-1996, Environmental Management Systems - Specification with Guidance
for Use

ANSI/ISO/ASQC-14004-1996, Environmental Management Systems - General Guidelines on
Principles, Systems, and Supporting Techniques

ANSI/ISO/ASQC-14010-1996, Guidelines for Environmental Auditing - General Principles

ANSI/ISO/ASQC-14011-1996, Guidelines for Environmental Auditing - Audit Procedures - Auditing
of Environmental Management Systems

ANSI/ISO/ASQC-14012-1996, Guidelines for Environmental Auditing - Qualification Criteria for
Environmental Auditors

ASME NQA-3-1989, Quality Assurance Program Requirements for the Collection of Scientific and
Technical Information for Site Characterization of High-Level Nuclear Waste Repositories

ASQ Energy Division, 1982, Quality Surveillance Guidelines and Quality Surveillance Handbook,
ASQC Quality Press

DOE G 450.3-3, TAILORING FOR INTEGRATED SAFETY MANAGEMENT APPLICATION,
dated February 1997

DOE G 450.4-1, INTEGRATED SAFETY MANAGEMENT SYSTEM GUIDE FOR USE WITH
DOE 450.4 SAFETY MANAGEMENT SYSTEM POLICY, AND DEAR SAFETY MANAGEMENT
SYSTEM CONTRACT CLAUSE, Volumes 1 and 2, dated November 1997

DOE-EH-0135, June 1990, Performance Objectives and Criteria for Technical Safety Appraisals at
Department of Energy Facilities and Sites

DOE-HDBK-XXX-98, Design Considerations (Draft)

DOE/HR-0066, Total Quality Management Implementation Guidelines.

DOE-STD-1027-92, December 1992, Hazard Categorization and Accident Analysis Techniques
for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports DOE-STD-1048-92,
December 1992, Performance Indicators Guidance Document

Electric Power Research Institute Guideline EPRI NP-5652, 1988 Revision, Guidelines for the
Utilization of Commercial Grade Items in Nuclear Safety Related Applications

Electric Power Research Institute Guideline EPRI TR-102260, Supplemental Guidance for the
Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items

ISO/IEC Guide 25, 1990, General Requirements for the Competence of Calibration and Testing
Laboratories

Malcolm Baldrige National Quality Award Criteria, U.S. Department of Commerce Technology
Administration, National Institute of Standards and Technology

USNRC NUREG-0800, Revision 0, August 1990, Standard Review Plan, Section 17

NUREG 0856, 1983, Final Technical Position on Documentation of Computer Codes for High-Level
Waste Management

NUREG/CR-5151, February 1989, Performance-Based Inspections

Presidential Award for Quality, Federal Quality Institute

Quality Improvement Tools, 1989, Juran Institute, Wilton, CT.

Quality Management Graded Approach, A Working Paper, September 1993, Training Resources
and Data Exchange (TRADE), Oak Ridge Associated Universities

USNRC Regulatory Guide 1.28, Rev. 3, August 1985, Quality Assurance Program Requirements

USNRC Regulatory Guide 1.33, Rev. 2, February 1978, Quality Assurance Program Requirements
(Operations).