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U.S. Department of Energy ORDER
Washington, D.C. DOE O 414.1B

Approved: 04-29-04
Review: 04-29-06

SUBJECT: QUALITY ASSURANCE

1. OBJECTIVES.
a. To ensure that the quality of Department of Energy (DOE), including National
Nuclear Security Administration (NNSA), products and services meet or exceed
customers’ expectations.

b. To achieve quality assurance (QA) for all work based upon the following
principles:

(1) That quality is assured and maintained through a single, integrated,
effective quality assurance program (i.e., management system.

(2) That management support for planning, organization, resources, direction,
and control is essential to QA.

(3) That performance and quality improvement require thorough, rigorous
assessment and corrective action.

(4) That workers are responsible for achieving and maintaining quality.

(5) That environmental, safety, and health risks and impacts associated with
work processes can be minimized while maximizing reliability and
performance of work products.

c. To establish quality process requirements to be implemented under a QA Program
(QAP) for the control of suspect/counterfeit items and safety issue corrective
actions.

2. CANCELLATIONS. This Order cancels the following.

a. DOE O 414.1A, Quality Assurance, dated 9-29-99.

b. Portions of DOE O 440.1A, Worker Protection Management for DOE Federal
and Contractor Employees, dated 3-27-98, as follows:

(1) Attachment 1, paragraph 8, Suspect and Counterfeit Item (S/CI) Controls,
and

(2) Attachment 2, paragraph 22, Suspect and Counterfeit Item (S/CI) Controls.

Cancellation of an Order does not, by itself, modify or otherwise affect any contractual
obligation to comply with the Order. Canceled Orders that are incorporated by reference
in a contract must remain in effect until the contract is modified to delete the
requirements in the canceled Orders.

3. APPLICABILITY.

a. Primary DOE Organizations, Including NNSA Organizations. Except for the
exclusions in paragraph 3c, this Order applies to all Primary DOE Organizations
(see Attachment 1 for a complete list of Primary DOE Organizations). This Order
automatically applies to Primary DOE Organizations created after it is issued.

(1) This Order includes a requirement to integrate multiple QA Program
drivers imposed by QA regulations [Title 10 (Code of Federal Regulations
(CFR) 830], the Nuclear Regulatory Commission, and other Federal
agencies. The Order includes supplemental activity-specific requirements
for work that also may need to comply with QA regulations. This
integration requirement supplements but does not supersede or alter
compliance with any QA regulations. In the event of a conflict between
this Order and any nuclear safety regulation, the regulation prevails. [See
QAP integration requirement, paragraph 4a(4).]

(2) Note that only the NNSA Administrator can direct NNSA employees.
Wherever this Order gives direction to NNSA employees, it should be
understood that this direction is provided only for the convenience of the
Administrator and is not intended to assume or replace the authority of the
Administrator’s direction.

b. Contractors.

(1) Except for the exclusions in paragraph 3c, the Contractor Requirements
Document (CRD), Attachment 2, sets forth requirements of this Order that
will apply to contractors whose contracts include the CRD.

(2) This CRD must be included in contracts that require or involve
responsibility for work or operations at DOE sites or facilities. This
includes work that may take place outside the physical boundaries of a
DOE facility, such as design or analysis services.

(3) Secretarial Officers (SOs) are responsible for notifying contracting officers
which contractors are affected by this Order. Once notified, contracting
officers are responsible for incorporating the CRD into the contracts of
affected contractors via the laws, regulations, and DOE directives clause of
the contracts.

(4) As the laws, regulations, and DOE directives clause of site/facility
management contract states, regardless of the performer of the work,
site/facility management contractor with the CRD incorporated into its
contract is responsible for compliance with the requirements of the CRD.

(a) An affected contractor is responsible for flowing down the
requirements of this CRD to subcontractors at any tier to the extent
necessary to ensure the contractors’ compliance with the
requirements.

(b) In doing so, the contractor will not unnecessarily or imprudently
flow down requirements to subcontractors. That is, the contractor
will both—

1 ensure that it and its subcontractors comply with the
requirements of the CRD to the extent necessary to ensure
the contractor’s compliance and

2 incur only costs that would be incurred by a prudent person
in the conduct of competitive business.

c. Exclusions.

(1) This Order does not apply to the DOE/NNSA Naval Reactors Program in
accordance with Executive Order 12344, statutorily prescribed by Public
Law 98-525 [42 United States Code (U.S.C.) 7158, note].

(2) This Order does not apply to the Bonneville Power Administration (BPA),
in accordance with Secretarial delegation Order Number 00-033.00A to the
BPA Administrator and Chief Executive Officer, dated 9-27-02.

4. REQUIREMENTS.

a. QAP Requirements. Each DOE organization must develop and implement a QAP
that—

(1) Implements quality assurance criteria as defined in paragraph 4b using a
graded approach and describing how the criteria and graded approach are
applied (see paragraph 6 for compliance references).

(2) Uses voluntary national or international consensus standard where
practicable and consistent with contractual or regulatory requirements and
identifies the standard used. Appropriate standards include the following.

(a) ASME NQA-1-2000, Quality Assurance Requirements for Nuclear
Facility Applications (for nuclear-related activities);

(b) ANSI/ISO/ASQ Q 9001-2000, Quality Management System -
Requirements (for non-nuclear activities); and

(3) Applies additional standards, where practicable and consistent with
contractual or regulatory requirements and as necessary to address
unique/specific work activities (e.g., development and use of safety
software or establishing the competence of a testing and calibration
laboratory.

(4) Integrates quality management system requirements, Suspect/Counterfeit
Items Prevention Process (see Attachment 3), and the Corrective Action
Management Program (see Attachment 4 ) as defined in this Order with
other quality or management system requirements in DOE directives and
external requirements, including as applicable—

(a) DOE P 450.4, Safety Management System Policy, dated 10-15-96.

(b) DOE P 450.5, Line Environment, Safety and Health Oversight,
dated 06-26-97.

(c) NNSA Quality Management Policy, QC-1, (quality management
system for the nuclear weapons complex and weapons-related
activities.

(d) DOE/RW-0333P DOE Office of Civilian Radioactive Waste
Management, Quality Assurance Requirements and Description.

(e) DOE/CBFO-94-1012, DOE Carlsbad Field Office, Quality
Assurance Program Description, (for the Waste Isolation Pilot
Plant and related activities.

NOTE: This integration requirement does not establish or imply a
hierarchy of quality requirements or programs.

b. Quality Assurance Criteria. The QAP must address the following management,
performance, and assessment criteria.

(1) Management/Criterion 1—Program.

(a) Establish an organizational structure, functional responsibilities,
levels of authority, and interfaces for those managing, performing,
and assessing work.

(b) Establish management processes, including planning, scheduling,
and providing resources for work.

(2) Management/Criterion 2—Personnel Training and Qualification.

(a) Train and qualify personnel to be capable of performing assigned
work.

(b) Provide continuing training to personnel to maintain job
proficiency.

(3) Management/Criterion 3—Quality Improvement.

(a) Establish and implement processes to detect and prevent quality
problems.

(b) Identify, control, and correct items, services, and processes that do
not meet established requirements.

(d) Review item characteristics, process implementation, and other
quality-related information to identify items, services, and
processes needing improvement.

(4) Management/Criterion 4—Documents and Records.

(a) Prepare, review, approve, issue, use, and revise documents to
prescribe processes, specify requirements, or establish design.

(b) Specify, prepare, review, approve, and maintain records.

(5) Performance/Criterion 5—Work Processes.

(a) Perform work consistent with technical standards, administrative
controls, and hazard controls adopted to meet regulatory or
contract requirements using approved instructions, procedures, etc.

(b) Identify and control items to ensure their proper use.

(d) Calibrate and maintain equipment used for process monitoring or
data collection.

(6) Performance/Criterion 6—Design.

(a) Design items and processes using sound engineering/scientific
principles and appropriate standards.

(b) Incorporate applicable requirements and design bases in design
work and design changes.

(d) Verify/validate the adequacy of design products using individuals
or groups other than those who performed the work.

(e) Verify/validate work before approval and implementation of the
design.

(7) Performance/Criterion 7—Procurement.

(a) Procure items and services that meet established requirements and
perform as specified.

(b) Evaluate and select prospective suppliers on the basis of specified
criteria.

(c) Establish and implement processes to ensure that approved
suppliers continue to provide acceptable items and services.

(8) Performance/Criterion 8—Inspection and Acceptance Testing.

(a) Inspect and test specified items, services, and processes using
established acceptance and performance criteria.

(b) Calibrate and maintain equipment used for inspections and tests.

(9) Assessment/Criterion 9—Management Assessment. Ensure that managers
assess their management processes and identify and correct problems that
hinder the organization from achieving its objectives.

(10) Assessment/Criterion 10—Independent Assessment.

(a) Plan and conduct independent assessments to measure item and
service quality and the adequacy of work performance, and to
promote improvement.

(b) Establish sufficient authority and freedom from line management
for independent assessment teams.

(c) Ensure that persons conducting independent assessments are
technically qualified and knowledgeable in the areas to be
assessed.

5. RESPONSIBILITIES. QAP implementation, assessment, and improvement are senior
management responsibilities.

a. Deputy Secretary. Provides leadership for QA implementation issues and quality
problem resolution with the support of the Office of Environment, Safety and
Health.

b. Secretarial Officers.

(1) Ensure that Headquarters, field elements, and contractors implement
requirements of this Order in an integrated manner and coordinate the
resolution of quality issues among these organizations.

(2) Develop, approve, and implement QAPs governing the work of their
organizations, including safety software development/use in accordance
with the requirements defined in paragraph 4 of this Order;
Suspect/Counterfeit Items Prevention requirements (Attachment 3); and
the Corrective Action Management Program requirements (Attachment 4).
Identify the senior management position specifically assigned this
responsibility.

(3) Provide direction and resources for implementing the requirements for
work within their purview.

(4) Review and approve new and revised field element QAPs. The scope and
rigor of a review must be graded according to the status of prior quality
performance (e.g., past regulatory/contract noncompliance, performance
metrics, or any third-party QAP certification.

(5) Review and approve new and revised contractor QAPs within their
purview or delegate authority to the field element manager. The scope and
rigor of a review must be graded according to the status of prior quality
performance (e.g., past regulatory/contract noncompliance, performance
metrics, or any third-party QAP certification.

(6) Review/resolve differences of opinion and approve or reject QAPs within
90 days of receipt.

(7) Report management assessment results periodically to the Deputy
Secretary (through the Under Secretary) describing the effectiveness of
QA implementation.

(8) Provide the contracting officer necessary information and direction in
order to specify—

(a) each procurement requiring application of the CRD to this Order
(Attachment 2) and 10 CFR 830 Subpart A,

(b) requirements for flow down of provisions of the CRD to
subcontractors or subawards, and

(9) Approve CAMP Corrective Action Plans (CAPs) developed by the field
element manager (FEM) within 60 calendar days from the date the
assessment report was issued.

c. Field Element [Footnote 1] Managers.

(1) Develop and implement approved QAPs governing the work under their
purview, including software development/use, in accordance with
requirements defined in paragraph 4 of this Order; suspect/counterfeit
items (S/CI) prevention requirements (Attachment 3); and CAMP
requirements (Attachment 4). Identify the senior management position
assigned this responsibility.

(2) Submit QAPs to the appropriate SOs for review, resolution of differences
of opinion, and approval.

(3) Review and where delegated authority to do so, approve new and revised
QAPs for contractors within their purview. The scope and rigor of review
must be graded based on the status of the contractor’s prior quality
performance (e.g., past regulatory/contract noncompliance, performance
metrics, or any third-party QAP certification). QAPs must be reviewed
and approved or rejected within 90 days of receipt.

(4) Perform independent assessments of contractor organizations to evaluate
the adequacy and QAP implementation effectiveness. The frequency and
scope of assessments must be graded based on the status of prior quality
performance and any third-party QAP certification. Other suitable
methods may be used in combination with independent assessments.

____________________
Footnote 1: Field element = Operations offices, service centers, site offices, area offices,
field offices, and regional offices of federally staffed laboratories.
______________________________

(5) Periodically report management assessment results to their organizations’
SOs describing the effectiveness of field element and contractor QA
implementation.

(6) Prepare and implement a CAP to address all findings in the CAMP
assessment report and enter, track, and report the status of the CAP in the
Corrective Action Tracking System (CATS).

(7) Complete the CAP and conduct follow up review on the effectiveness of
the corrective actions in resolving and preventing recurrence of all
findings. Approve the effectiveness review report and follow up report
recommendations.

d. Contracting Officers. Include the CRD in contracts falling within the scope of this
Order in a timely manner, as directed by the SO.

e. Assistant Secretary for Environment, Safety and Health. Acts as DOE’s
independent element responsible for safety aspects relative to public and worker
health and safety and environmental protection. The Assistant Secretary has the
following quality assurance responsibilities in addition to SO duties prescribed in
paragraph 5b.

(1) Quality Policy.

(a) Develops and maintains QA policy requirements (including this
Order and 10 CFR 830 Subpart A, Quality Assurance), guides, and
standards for all DOE work.

(b) Provides advice and assistance (including QAP reviews) to DOE
elements and contractors concerning implementation of this Order.

(c) Serves as central point of contact for coordination within DOE and
liaison with other agencies and groups for the development of QA
policy, requirements, guides, and standards.

(d) Reviews proposed statutes, regulations, standards, DOE Directives,
and Defense Nuclear Facility Safety Board documents for
applicability to and potential impact on DOE quality programs.

(2) Quality Program Support.

(a) Identifies and proposes resolutions for crosscutting QA issues
within the Department to improve implementation.

(b) Submits to the Deputy Secretary periodic updates on the
effectiveness of QA policy implementation across the Department.

(d) Manages the DOE S/CI prevention process (Attachment 3.

(e) Manages the DOE Safety Software Quality Program.

(3) CAMP and Corrective Action Tracking System (CATS.

(a) Manages CAMP and develops and maintains CAMP policies,
procedures and guidelines.

(b) Maintains CATS and assists FEMs in accessing and editing CAP
data. Maintains a CAMP website that provides background and
information on the program.

(c) Coordinates status and maintenance of CAMP with SOs, FEMs,
and assessing organizations, including periodic reports on program
status.

(d) Sponsors and co chairs the DOE Corrective Action Management
(CAM) Team.

(e) Manages crosscutting issues as directed by the Secretary or Deputy
Secretary.

f. Director, Office of Independent Oversight and Performance Assurance.

(1) Conducts various independent assessments of SO, field element, and
contractor implementation of this Order and 10 CFR 830 Subpart A,
Quality Assurance (see DOE O470.2B, Independent Oversight and
Performance Assurance Program, dated 10-31-02), including aspects of
QA related to environment, safety, health, safeguards, and security.

(2) Reports assessment results to the appropriate Under Secretary, the
Assistant Secretary for Environment, Safety and Health, and the assessed
organization.

6. REFERENCES. The following provide guidance and requirements for implementing this
Order.

a. DOE G 414.1-2, Quality Assurance Management System Guide for Use with
10 CFR 830.120 and DOE O 414.1, dated 6-17-99.

b. DOE G 414.1-1A, Management Assessment and Independent Assessment Guide
for Use with 10 CFR, Part 830, Subpart A, and DOE O 414.1A, Quality
Assurance; DOE P 450.4, Safety Management System Policy; DOE P 450.5, Line
ES&H Oversight Policy, dated 5-31-01.

c. DOE G 440.1-6, Implementation Guide for Use with Suspect/Counterfeit Items
Requirements of DOE O 440.1, Worker Protection Management;
10 CFR 830.120; and DOE 5700.6c, Quality Assurance, dated 6-30-97.

d. DOE M 411.1-1C, Safety Management Functions, Responsibilities, and
Authorities Manual, dated 12-31-03.

e. Quality Assurance Standards for Safety Software in Department of Energy
Nuclear Facilities, dated 9-30-03
(http://www.deprep.org/2003/AttachedFile/tb03s30g_enc.pdf).

7. DEFINITIONS.

a. Assessment. A review, evaluation, inspection, test, check, surveillance, or audit,
to determine and document whether items, processes, systems, or services meet
specified requirements and perform effectively.

b. Graded Approach. The process of ensuring that the level of analyses,
documentation, and actions used to comply with requirements are commensurate
with—

(1) the relative importance to safety, safeguards, and security;
(2) the magnitude of any hazard involved;
(3) the life-cycle stage of a facility or item;
(4) the programmatic mission of a facility;
(5) the particular characteristics of a facility or item;
(6) the relative importance to radiological and non-radiological hazards, and
(7) any other relevant factors.

c. Item. An all-inclusive term used in place of appurtenance, assembly, component,
equipment, material, module, part, structure, product, software, subassembly,
subsystem, system, unit, or support systems.

d. Process. A series of actions that achieves an end result.
e. Quality. The condition achieved when an item, service, or process meets or
exceeds the user’s requirements and expectations.

f. Quality Assurance. All those actions that provide confidence that quality is
achieved.

g. Quality Assurance Program. The overall program or management system
established to assign responsibilities and authorities, define policies and
requirements, and provide for the performance and assessment of work.

h. Safety. An all-inclusive term used synonymously with environment, safety, and
health to encompass protection of the public, the workers, and the environment.

i. Safety Software. Includes the following.

(1) Safety System Software, which performs a safety system function as part
of a structure, system, or component (SSC) that has been functionally
classified as safety class (SC) or safety significant (SS). Includes
human-machine interface software, network interface software,
programmable logic controller (PLC) programming language software, and
safety management databases that are not part of an SSC but whose
operation or malfunction can directly affect SS and SC SSC function (see
10 CFR 830.2.

(2) Safety Analysis and Design Software, which is not part of an SSC but is
used in the safety classification, design, and analysis of nuclear facilities to
ensure the proper accident analysis of nuclear facilities; the proper analysis
and design of safety SSCs; and the proper identification, maintenance, and
operation of safety SSCs.

j. Service. Work, such as design, construction, fabrication, decontamination,
environmental remediation, waste management, laboratory sample analysis, safety
software development/validation/testing, inspection, nondestructive
examination/testing, environmental qualification, equipment qualification,
training, assessment, repair, and installation.

k. Suspect/Counterfeit Items (S/CI). An item is suspect when visual inspection or
testing indicates that it may not conform to established Government or
industry-accepted specifications or national consensus standards or whose
documentation, appearance, performance, material, or other characteristics may
have been misrepresented by the supplier or manufacturer. A counterfeit item is
one that has been copied or substituted without legal right or authority or whose
material, performance, or characteristics have been misrepresented by the supplier
or manufacturer. Items that do not conform to established requirements are not
normally considered S/CIs if nonconformity results from one or more of the
following conditions (which must be controlled by site procedures as
nonconforming items):

(1) defects resulting from inadequate design or production quality control;
(2) damage during shipping, handling, or storage;
(3) improper installation; deterioration during service;
(4) degradation during removal;
(5) failure resulting from aging or misapplication; or
(6) other controllable causes.

l. Work. A defined task or activity such as research and development, operations,
environmental remediation, maintenance and repair, administration, safety
software development/validation/testing and use, inspection, safeguards and
security, data collection and analysis.

8. CONTACT. Address questions concerning this Order to Office of Quality Assurance
Programs, 301-903-2954.

BY ORDER OF THE SECRETARY OF ENERGY:

KYLE E. McSLARROW
Deputy Secretary

ATTACHMENT 1. PRIMARY DOE ORGANIZATIONS TO WHICH DOE O 414.1B IS APPLICABLE

This Order is applicable to the following DOE organizations and their associated field elements:

Office of the Secretary
Chief Information Officer
Departmental Representative to the Defense Nuclear Facilities Safety Board
Energy Information Administration
National Nuclear Security Administration
Office of Civilian Radioactive Waste Management
Office of Congressional and Intergovernmental Affairs
Office of Counterintelligence
Office of Economic Impact and Diversity
Office of Electric Transmission and Distribution
Office of Energy Assurance
Office of Energy Efficiency and Renewable Energy
Office of Environment, Safety and Health
Office of Environmental Management
Office of Fossil Energy
Office of General Counsel
Office of Hearings and Appeals
Office of Independent Oversight and Performance Assurance
Office of Intelligence
Office of Legacy Management
Office of Management, Budget and Evaluation/Chief Financial Officer
Office of Nuclear Energy, Science and Technology
Office of Policy and International Affairs
Office of Public Affairs
Office of Science
Office of Security
Office of Security and Safety Performance Assurance
Office of the Inspector General
Secretary of Energy Advisory Board
Southeastern Power Administration
Southwestern Power Administration
Western Area Power Administration

ATTACHMENT 2. CONTRACTOR REQUIREMENTS DOCUMENT

DOE O 414.1B, Quality Assurance

Regardless of the performer of the work, the contractor is responsible for complying with the
requirements of this Contractor Requirements Document (CRD). The contractor is responsible
for flowing down the requirements of this CRD to subcontractors at any tier to the extent
necessary to ensure the contractor’s compliance with the requirements. In doing so, the
contractor must not unnecessarily or imprudently flow down requirements to subcontracts. That
is, the contractor will ensure that it and its subcontractors comply with the requirements of this CRD
and only incur costs that would be incurred by a prudent person in the conduct of
competitive business.

When the contractor conducts activities or provides items or services that affect, or may affect,
the safety of Department of Energy (DOE), including National Nuclear Security Agency
(NNSA), nuclear facilities, it must conduct work in accordance with the quality assurance QA
requirements of 10 CFR 830 Subpart A.

This CRD includes a requirement to integrate multiple Quality Assurance Program (QAP)
drivers imposed by QA regulations [see Title 10 Code of Federal Regulations (CFR) 830], the
Nuclear Regulatory Commission, and other Federal agencies. The CRD includes supplemental
activity-specific requirements for work that also may need to comply with QA regulations. This
integration requirement supplements but does not supersede or alter compliance with QA
regulations. If this CRD conflicts with any nuclear safety regulation, the regulation prevails.
[See QAP integration requirement, paragraph 2a(4).]

1. OBJECTIVES.

a. To ensure that the quality of Department of Energy (DOE), including National
Nuclear Security Administration (NNSA), products and services meet or exceed
customers’ expectations.

b. To achieve QA for all work based upon the following principles:

(1) That quality is assured and maintained through a single, integrated,
effective quality assurance program (i.e., management system).

(2) That management support for planning, organization, resources, direction,
and control is essential to QA.

(3) That performance and quality improvement require thorough rigorous
assessment and corrective action.

(4) That workers are responsible for achieving and maintaining quality.

(5) That environmental, safety, and health risks and impacts associated with
work processes are minimized while maximizing reliability and
performance of work products.

c. To establish quality process requirements to be implemented under a QAP for the
control of suspect/counterfeit items.

2. GENERAL QUALITY REQUIREMENTS.

a. Quality Assurance Program Development and Implementation. A contractor must
assign and identify a senior management position responsible for the development,
implementation, assessment, and improvement of a QAP that—

(1) Implements QA criteria as defined in paragraph 3 of this CRD and
suspect/counterfeit items (S/CI) prevention requirements as defined in
paragraph 4 using a graded approach and describing how QA criteria and
graded approach are applied. (See paragraph 2c of this CRD for guidance
on compliance.)

(2) Uses the appropriate voluntary national or international consensus standard
where practicable and consistent with contractual or regulatory
requirements, and identifies the standard used. Appropriate standards
include the following.

(a) ASME NQA-1-2000, Quality Assurance Requirements for Nuclear
Facility Applications (for nuclear-related activities);

(b) ANSI/ISO/ASQ Q 9001-2000, Quality Management System -
Requirements (for non-nuclear activities); and

(4) Integrates quality or management system requirements as defined in this
CRD with DOE directives and similar external requirements. Similar
requirements include the following.

(a) DOE P 450.4, Safety Management System Policy, dated 10-15-96;

(b) DOE P 450.5, Line Environment, Safety and Health Oversight,
dated 06-26-97;

(c) NNSA Quality Management Policy, QC-1, (quality management
system for the nuclear weapons complex and weapons-related
activities);

(d) DOE/RW-0333P, DOE Office of Civilian Radioactive Waste
Management, Quality Assurance Requirements and Description,;

(e) DOE/CBFO-94-1012, DOE Carlsbad Field Office, Quality
Assurance Program Description, (for the Waste Isolation Pilot
Plant and related activities); and

(f) NOTE: This integration requirement does not establish or imply a
hierarchy of quality requirements or programs.

b. Quality Assurance Program Approvals and Changes. The contractor must—

(1) Submit a QAP to DOE for approval before beginning work under a DOE
contract.

(2) Implement the QAP as approved and modified by DOE.

(3) Indicate in the submittal any third-party certification affecting the QAP.

(4) Revise an existing QAP that was approved in accordance with previous
versions of this CRD (e.g., CRD to DOE O 414.1A, Quality Assurance,
dated 9-29-99) to address enhancements required by this CRD.

(5) Regard a QAP as approved by DOE 90 days after DOE receipt, unless
approved or rejected by DOE at an earlier date, and include any
modification made or directed by DOE.

(6) Submit QAP changes made the previous year annually to DOE for review
and approval. In the submittal, identify the changes, the reason for the
changes, and the basis for concluding that the revised QAP continues to
satisfy the requirements of this CRD.

(a) The contractor may make changes to an approved QAP at any
time.

(b) Editorial changes made to correct spelling, punctuation, grammar,
etc., do not require explanation.

c. Quality Guidance Usage. The contractor must consider QA guidance in
developing and implementing a QAP. The following guidance documents [most
recent revision] are available at http://www.directives.doe.gov/.

(1) DOE G 414.1-2, Quality Assurance Management System Guide for Use
with 10 CFR 830.120 and DOE O 414.1, dated 6-17-99;

(2) DOE G 414.1-1A, Management Assessment and Independent Assessment
Guide for Use with 10 CFR, Part 830, Subpart A, and DOE O 414.1A,
Quality Assurance; DOE P 450.4, Safety Management System Policy;
DOE P 450.5, Line ES&H Oversight Policy, dated 5-31-01; and

(3) DOE G 440.1-6, Implementation Guide for Use with Suspect/Counterfeit
Items Requirements of DOE O 440.1, Worker Protection Management;
10 CFR 830.120; and DOE 5700.6c, Quality Assurance, dated 6-30-97.

3. QUALITY ASSURANCE CRITERIA. The QAP must address the following
management, performance, and assessment criteria.

a. Management/Criterion 1—Program.

(1) Establish an organizational structure, functional responsibilities, levels of
authority, and interfaces for those managing, performing, and assessing
work.

(2) Establish management processes, including planning, scheduling, and
providing resources for work.

b. Management/Criterion 2—Personnel Training and Qualification.

(1) Train and qualify personnel to be capable of performing assigned work.

(2) Provide continuing training to personnel to maintain job proficiency.

c. Management/Criterion 3—Quality Improvement.

(1) Establish and implement processes to detect and prevent quality problems.

(2) Identify, control and correct items, services, and processes that do not meet
established requirements.

(3) Identify the causes of problems and include prevention of recurrence as a
part of corrective action planning.

(4) Review item characteristics, process implementation, and other
quality-related information to identify items, services, and processes
needing improvement.

d. Management/Criterion 4—Documents and Records.

(1) Prepare, review, approve, issue, use, and revise documents to prescribe
processes, specify requirements, or establish design.

(2) Specify, prepare, review, approve, and maintain records.

e. Performance/Criterion 5—Work Processes.

(1) Perform work consistent with technical standards, administrative controls,
and hazard controls adopted to meet regulatory or contract requirements
using approved instructions, procedures, etc.

(2) Identify and control items to ensure proper use.

(3) Maintain items to prevent damage, loss, or deterioration.

(4) Calibrate and maintain equipment used for process monitoring or data
collection.

f. Performance/Criterion 6—Design.

(1) Design items and processes using sound engineering/scientific principles
and appropriate standards.

(2) Incorporate applicable requirements and design bases in design work and
design changes.

(3) Identify and control design interfaces.

(4) Verify/validate the adequacy of design products through individuals or
groups other than those who performed the work.

(5) Verify/validate work before approval and implementation of a design.

g. Performance/Criterion 7—Procurement.

(1) Procure items and services that meet established requirements and perform
as specified.

(2) Evaluate and select prospective suppliers on the basis of specified criteria.

(3) Establish and implement processes to ensure that approved suppliers
continue to provide acceptable items and services.

h. Performance/Criterion 8—Inspection and Acceptance Testing.

(1) Inspect and test specified items, services, and processes using established
acceptance and performance criteria.

(2) Calibrate and maintain equipment used for inspections and tests.

i. Assessment/Criterion 9—Management Assessment. Ensure that managers assess
their management processes and identify and correct problems that hinder the
organization from achieving its objectives.

j. Assessment/Criterion 10—Independent Assessment.

(1) Plan and conduct independent assessments to measure item and service
quality, to measure the adequacy of work performance, and to promote
improvement.

(2) Establish sufficient authority and freedom from line management for
independent assessment teams.

(3) Ensure that persons conducting independent assessments are technically
qualified and knowledgeable in the areas to be assessed.

4. DOE-WIDE SUSPECT/COUNTERFEIT ITEMS (S/CI) PREVENTION PROCESS.

The process is operated by the DOE Office of Environment, Safety and Health as a
service to DOE and its contractors, and provides for collecting, analyzing, and
disseminating S/CI information; notifying Secretarial Officers (SOs) when specific
actions must be taken to investigate and resolve S/CI quality and safety issues; and
tracking and reporting the status of corrective actions.

NOTE: This service does not relieve the contractor from complying with the
requirements defined in this CRD.

a. Supplemental Quality Management System Requirements for S/CIs. An S/CI
prevention process must be developed and implemented as a part of the
contractor’s QAP and must be commensurate with the facility/activity hazards and
mission impact. The QAP must be applied to identifying, analyzing, and
removing S/CIs, and preventing them from being supplied to DOE/NNSA and its
contractors. The QAP must address the following elements for S/CI prevention.

(1) Preventing the introduction and use of S/CIs through engineering
involvement, design, procurement, testing, inspection, maintenance,
evaluation, disposition, reporting, trend analysis, and lessons learned work
process controls.

(2) Training and informing managers, supervisors, and workers on S/CI
processes and controls (including prevention, detection, and disposition of
S/CIs).

(3) Identifying and disposing of S/CIs on site.

(4) Restricting S/CI use to only those items that have been found acceptable
through engineering analysis and formal disposition process.

(5) Collecting, maintaining, disseminating, and using the most accurate,
up-to-date information on S/CIs and associated suppliers using all
available sources. S/CI information sources include the following.

(a) Government-Industry Data Exchange Program (www.gidep.org);

(b) Institute of Nuclear Power Operators (www.inpo.org);

(d) DOE S/CI website (http://tis.eh.doe.gov/paa/sci/).

(6) Identifying the management point of contact responsible for these
activities to ensure that the DOE Office of Environment, Safety and Health
has a viable recipient for S/CI information notices.

b. Work Process Controls. Work processes must be developed and implemented
using available S/CI information, and must include the following elements.

(1) Engineering involvement in the development of procurement
specifications; during inspection and testing; and when replacing,
maintaining, or modifying equipment.

(2) Procurement processes that prevent introduction of S/CIs by—

(a) identifying technical and QA requirements in procurement
specifications;

(b) accepting only those items that comply with the procurement
specifications consensus standards, and commonly accepted
industry practices; and

(3) Inspection, identification, evaluation, and disposition of S/CIs installed in
all safety applications [Footnote 1] and other applications that create potential hazards.

(4) Engineering evaluations and disposition of S/CIs installed in safety
applications/systems or in applications that create potential hazards. The
evaluations must consider potential risks to the public and worker and
cost/benefit impact, and include a schedule for replacement (if required).

_____________________
Footnote 1: Safety applications are those whose failure could adversely affect the environment,
safety,
or health of the public or workers. This term includes safety systems in nuclear facilities (see 10 CFR 830.2).
__________________________________________________________

(5) Ensuring that S/CIs identified in non-safety applications during routine
maintenance and/or inspection are reported, evaluated, and dispositioned to
prevent future use in safety applications.

(6) Contacting the DOE Inspector General (IG) before destroying or disposing
of S/CIs and their documentation to determine whether to retain them for
criminal investigation or litigation.

(7) Testing procured or installed S/CIs as necessary using approved
engineering test methods.

(8) Reporting S/CIs to responsible DOE/NNSA line management offices; the
Office of Environment, Safety and Health; and the IG. [ DOE O 231.1A,
Environment, Safety, and Health Reporting, dated 8-19-03, and DOE
O 221.1, Reporting Fraud, Waste, and Abuse, dated 3-22-01.]

(9) Conducting trend analysis and issuing lessons learned reports for use in
improving the S/CI prevention.

ATTACHMENT 3. SUSPECT/COUNTERFEIT ITEMS PREVENTION

1. DOE-WIDE SUSPECT/COUNTERFEIT ITEMS (S/CI) PREVENTION PROCESS. A
DOE-wide S/CI prevention process is operated by the DOE Office of Environment,
Safety and Health as a service to DOE and its contractors, and provides for—

a. collecting, analyzing, and disseminating S/CI information;

b. notifying Secretarial Officers (SOs) when specific actions must be taken to
investigate and resolve S/CI quality and safety issues; and

c. tracking and reporting the status of corrective actions.

d. NOTE: This service does not relieve organizations from complying with the
requirements of this Attachment.

2. SUPPLEMENTAL QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR
S/CIs. An S/CI prevention process must be developed and implemented as a part of the
organization’s QAP and commensurate with the facility/activity hazards and mission
impact. The QAP must be applied to identifying and analyzing S/CIs, removing them,
and preventing S/CIs from being supplied to DOE/NNSA and its contractors.

a. For guidance in compliance with requirements see G 440.1-6, Implementation
Guide for Use with Suspect/Counterfeit Items Requirements of DOE O 440.1,
Worker Protection Management; 10 CFR 830.120; and DOE 5700.6c, Quality
Assurance, dated 6-30-97. The QAP must address the following for S/CI
prevention:

(1) preventing the introduction and use of S/CIs through engineering
involvement, design, procurement, testing, inspection, maintenance,
evaluation, disposition, reporting, trend analysis, and lessons learned work
process controls;

(2) training and informing managers, supervisors, and workers on S/CI
processes and controls (including prevention, detection, and disposition of
S/CIs);

(3) identifying and disposing of S/CIs on site;

(4) restricting the use of an S/CI to only those items that have been found
acceptable through engineering analysis and formal disposition process;

(5) collecting, maintaining, disseminating, and using the most accurate,
up-to-date information on S/CIs and suppliers using all available sources
including—

(a) Government Industry Data Exchange Program (www.gidep.org);

(b) Institute of Nuclear Power Operators (www.inpo.org);

(d) DOE S/CI website (http://tis.eh.doe.gov/paa/sci/).

b. Identifying the management position responsible for these activities and for
serving as a point of contact with the Office of Environment, Safety and Health.

3. WORK PROCESS CONTROLS. Work processes must be developed and implemented
using available S/CI information and must include the following elements.

a. Engineering involvement in the development of procurement specifications;
during inspection and testing; and when replacing, maintaining, or modifying
equipment.

b. Procurement processes that prevent introduction of S/CIs by—

(1) identifying technical and QA requirements in procurement specifications;
(2) accepting only those items that comply with procurement specifications,
consensus standards, and commonly accepted industry practices;

(3) inspecting inventory and storage areas to identify, control, and disposition
S/CIs.

c. Inspection, identification, evaluation, and disposition of S/CIs that have been
installed in safety applications and other applications that create potential hazards.

d. Engineering evaluations and disposition of S/CIs installed in safety
applications/systems or in applications that create potential hazards. Evaluations
must consider potential risks to the public and workers cost/benefit impact, and a
schedule for replacement (if required).

e. Ensuring that S/CIs in non-safety applications identified during routine
maintenance and/or inspection are reported, evaluated, and dispositioned to
prevent future use in safety applications.

f. Contacting the DOE Inspector General (IG) before destroying or disposing of
S/CIs and their documentation to determine whether to retain them for criminal
investigation or litigation.
____________________

Footnote 1: Safety applications are those whose failure could adversely affect the environment, safety, or health of the public or workers. This term includes safety systems in nuclear facilities (see 10 CFR 830.2).
_____________________________________________

g. Testing procured or installed S/CIs as necessary using approved engineering test
methods.

h. Reporting S/CIs to responsible program offices; the Office of Environment, Safety
and Health; and the IG in accordance with DOE O 231.1A, Environment, Safety,
and Health Reporting, dated 8-19-03, and DOE O 221.1, Reporting Fraud, Waste,
and Abuse, dated 3-22-01.

i. Conducting trend analysis and issuing lessons learned reports for use in improving
the S/CI prevention.

ATTACHMENT 4. CORRECTIVE ACTION MANAGEMENT PROGRAM

1. OBJECTIVE. To prescribe process requirements and responsibilities for DOE line
managers to effectively perform corrective actions that resolve safety issues arising
from—

a. Findings identified by the Offices of Independent Oversight and Performance
Assurance; Environment, Safety, and Health (ES&H); and Emergency
Management (DOE O 470.2B, Independent Oversight and Performance
Assurance Program, dated 10-31-02);

b. Judgment of needs identified by Type A accident investigations (DOE O 225.1A,
Accident Investigations, dated 11-26-97); or

c. Other sources as directed by the Secretary or Deputy Secretary, including
crosscutting safety issues.

2. REQUIREMENTS.

a. Reporting Findings. The assessing organization (see paragraph 1) submits the
final assessment report within 10 calendar days of issuance to the—

(1) applicable field element managers (FEMs) and Secretarial Officers (SOs);
and

(2) Office of ES&H along with a synopsis of assessment report findings.

b. Corrective Action Plan (CAP) Development, Approval, and Review.

(1) Development. The FEM in consultation with the appropriate SO must
prepare a comprehensive CAP in writing to address assessment findings
and field and Headquarters corrective actions for each finding. Guidance
for implementing these requirements is outlined in Appendix G of DOE
G 450.4-1B, Integrated Safety Management System Guide. Note that
DOE O 470.2B, Independent Oversight and Performance Assurance
Program, dated 10-31-02, includes additional reporting requirements.

(a) When findings and/or corrective actions to be addressed apply to
more than one SO, a lead SO must be appointed by mutual
agreement or be appointed by the Deputy Secretary to coordinate
and approve the CAP.

(b) When findings and/or corrective actions to be addressed involve
multiple sites or organizations, to include DOE Headquarters
organizations or other elements, the lead SO must designate a lead
FEM as overall manager to coordinate and develop the CAP and
track and report CAP data in the Corrective Action Tracking
System (CATS) database.

(c) Other responsible sites/organizations must forward their portions
of the CAP to the designated lead FEM for consolidation and
submission. Failure to provide this information will be brought to
the attention of the lead SO for action.

(d) For each finding, the CAP must address—

1 extent of conditions,

2 causal factors that led to the finding,

3 detailed descriptions of corrective action(s) to resolve the
finding, and

4 a general outline for the conduct of the proposed
independent corrective action effectiveness review (see
paragraph 2d).

(e) For each corrective action the CAP must include a detailed
description, deliverable(s) that will signify completion, a single
responsible manager accountable for timeliness and effectiveness
of the correction action, and planned completion date.

(2) Approval. The CAP must be prepared on a schedule that will allow for
review and approval by the SO or designee within 60 calendar days from
the date the transmittal forwarding the formal final
assessment/investigation report was issued.

(a) The SO or designee must approve the CAP and all proposed
corrective actions from responsible sites/organizations for each
finding.

(b) When a finding addresses a deficiency in DOE policy, the
applicable DOE policy organization (e.g. Assistant Secretary for
Environment, Safety and Health, Office of Science, etc.) must
develop and implement appropriate corrective actions. Corrective
actions must be included in the CAP addressing all other findings
in the assessment report or a separate CAP must be developed by
the policy organization for approval, tracking and reporting.

(d) When a proposed CAP cannot be submitted to the SO for approval
within the required 60 days or the SO does not approve the
proposed CAP, the DOE CATS User’s Guide outlines a process to
formally request an extension from the SO.

(3) Review. The SO or designee must forward copies of an approved CAP to
the organization that conducted the assessment for review and to the
Office of ES&H.

(a) The organization that conducted the assessment must review the
approved CAP and provide comments to the SO and FEM within
30 calendar days from the date the approved CAP was transmitted.

(b) The SO must evaluate comments from the organization that
conducted the assessment and provide written response on how the
comments will be addressed. If the SO decides the CAP must be
revised, the FEM must be notified to revise and resubmit the CAP
for SO approval within a specified timeframe not to exceed 60
calendar days from the date the SO directed the revision. The
revised CAP must be submitted to the organization that conducted
the assessment for review and a copy provided to the Office of
ES&H.

(c) Disagreements that cannot be resolved between the organization
that conducted the assessment and the SO must be elevated
through the organizational level of management hierarchy up to the
Office of the Secretary, if necessary for resolution.

c. Tracking and Reporting Implementation.

(1) The FEM—

(a) is responsible for implementing the approved CAP and ensuring
timely and effective completion of all corrective actions;

(b) must enter, track and report the status of the CAP and associated
corrective actions to closure in the DOE CATS database (see
http://tis.doe.gov/portal/catsentry.html and guidance for accessing
and using CATS outlined in the DOE CATS User’s Guide and
CATS Data Dictionary online at
http://tis.eh.doe.gov/ism/cats.html;

(c) must enter CAP and corrective action data as stated in the
approved CAP for each finding in CATS within 10 working days
after approval.

(d) must ensure that all corrective actions are tracked and their status
reported to completion and verification.

(2) Completion of each corrective action must be annotated in the CATS
Descriptive Status and Completion Date fields.

(3) Other sites/organizations who forwarded portions of the CAP and
corrective actions to the lead FEM [see paragraph 2b(1)(c)] must track and
provide the FEM updates of their portions of the CAP and corrective
actions to completion and verification within the timeframes specified in
this Order.

(4) The FEM must update the CAP Status field and Descriptive Status fields
frequently basis (e.g., monthly) and enter the date at the beginning of each
update.

(5) Requests for CAP changes in CATS (i.e. planned corrective action
completion date) must be approved by the SO who approved the CAP and
submitted as outlined in the CATS Users Guide.

(6) Information in CATS will be used to provide periodic (e.g. quarterly)
status reports to assist senior DOE management in monitoring the status of
the CAMP.

d. Corrective Action Effectiveness Review.

(1) Purpose.

(a) Evaluation of findings and implementation of corrective actions is
conducted to correct the underlying causes for corrective action
failure to prevent recurrence of the same or similar assessment
findings.

(b) Effectiveness reviews will—

1 determine whether completed corrective actions have or
have not effectively resolved and prevented recurrence of
the same or similar findings at the performance level;

2 identify additional actions necessary to effectively resolve
the findings and prevent recurrence; and

3 collect effectiveness data for subsequent analyses and
sharing of lessons learned.

(2) Conduct of Reviews.

(a) Upon completion of corrective actions, the FEM must initiate a
follow up review to verify closure and effectiveness in ensuring
resolution of each finding and preventing recurrence. A formal
review report approved by the FEM must be completed within 6
months after the CAP completion date (the date when all corrective
actions for all findings listed in the CAP have been completed).

NOTE: This requirement is effective on the approval date of this
Order for all CAPs that have not been approved, CAPs that have
been approved but are not complete (all corrective actions in the
CAP are not complete and there is not a CAP Completion Date),
and all future CAPs. The FEM will determine—

1 how the review is conducted,

2 who conducts the review,

3 what specific completed corrective actions are reviewed for
each finding,

4 when the review is initiated, and

5 how the review report will be formatted.

(b) Other sites/organizations that tracked and provided updates of their
responsible corrective actions to completion and verification must
coordinate effectiveness review activities with the lead FEM for
consolidation and submission.

(c) For each finding, the FEM will select for review a sufficient
number of completed corrective actions to allow an objective,
accurate assessment of effectiveness in resolving the finding and
preventing recurrence. Standards for conducting effectiveness
review include the following.

1 A 100 percent review of all corrective actions is not
required to determine effectiveness.

2 Review can be initiated at any time during CAP
implementation.

3 Reviews are initiated based on

a severity of a finding,

b length of time needed to review selected corrective
actions,

c availability of resources to review corrective
actions, and

d length of time before all corrective actions for the
finding are to be completed.

4 Reviews are performed by Federal and/or contractor
personnel who are not associated with the findings or
corrective actions.

5 Mechanisms used to conduct effectiveness reviews are
determined by the FEM and may include

a document reviews,

b performance analyses,

c work observations/facility tours,

d performance testing, interviews,

e trending of performance,

f monitoring performance metrics based on
operational data,

g tracking performance utilizing targeted assessments,
and

h performing tailored scheduled assessments to gather
the data.

(3) Reporting and Follow Up.

(a) A formal report documenting the results of the effectiveness
review must be completed and approved by the FEM no later than
6 months after the CAP completion date (the date all corrective
actions are completed).

(b) If the FEM determines that additional time is required to
successfully complete the effectiveness review, the Effectiveness
Review Approval Date field in the CAP Data section of CATS
must be updated to read, “See CAP Status,” and an explanation
must be entered into the CAP Status field in the CAP Data section.

(c) The report includes an executive summary outlining overall scope,
results, conclusions, rating and recommendations. A separate
report form for each finding describing which corrective actions
were reviewed, review activities and results, conclusions, rating
(i.e. effective, partially effective, ineffective) and any
recommendation for completion is to be attached to the executive
summary.

(d) FEM approval of the report must be recorded in the Effectiveness
Review Approval Date field in the CAP Data section of CATS. A
review results and follow up actions must be outlined in the
Effectiveness Review Results field.

(e) Upon FEM approval, report recommendations must be
implemented and followed up as directed by the FEM. The report
and supporting documents must be retained in accordance with the
local records management process.

(f) If the FEM revises the completed CAP based on report
recommendations, the CAP revision with additional or revised
corrective actions, as applicable, must be approved by the SO.

(g) Upon approval, CAP revisions must be entered into CATS and
tracked to successful completion. Guidance for entering the
revisions is outlined in the CATS User’s Guide.

e. Lessons Learned.

(1) At any time during the CAMP process, the FEM must develop and
implement, lessons learned identified from the assessment findings,
corrective actions in response to the findings, and results of corrective
action effectiveness reviews, as applicable.

(2) The FEM must evaluate proposed lessons learned to determine if they are
applicable to the wider DOE community and distribute the information to
a select list of recipients through the DOE Lessons Learned Information
Services Web site (http://tis.eh.doe.gov/ll).

f. Corrective Action Management (CAM) Team.

(1) The CAM Team, a cross-organizational working group of representatives
from Headquarters and field offices, must be maintained to support and
coordinate effective line management implementation of the CAMP.

(2) A charter outlining mission, functions, operations, membership, and
leadership of the team must be maintained. The CAM Team is sponsored
by the Office ES&H and co-chaired by a SO representative and the Office
of Environment, Safety and Health.