NNSA POLICY LETTER
Approved: 1-10-17
QUALITY MANAGEMENT SYSTEM
NATIONAL NUCLEAR SECURITY ADMINISTRATION
Office of Management and Budget
CONTROLLED DOCUMENT OFFICE OF PRIMARY INTEREST (OPI):
AVAILABLE ONLINE AT: Quality Management
https://nnsaportal.energy.gov/intranet/na-mb/na-mb-20/pages/nnsa-policy.aspx
http://nnsa.energy.gov
printed copies are uncontrolled
NAP 414.1
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QUALITY MANAGEMENT SYSTEM
1.
PURPOSE. Establish, implement, maintain, assess, and improve the Quality
Management System (QMS) for NNSA federal operations in accordance with DOE
Order (O) 414.1*, Quality Assurance and, by citation, the American version of
International Organization for Standardization (ISO) Standard Requirements Document
ISO 9001-*, Quality Management Systems – Requirements (ASQ/ANSI/ISO
9001:2015).
* Unless otherwise specified, reference is made to the current version of these
documents.
2.
CANCELLATION. NAP 26A, Quality Management System, dated 6-1-16.
3.
APPLICABILITY.
a.
Federal. This policy applies to all NNSA organizations.
b.
Contractors. This policy does not apply to contractors.
c.
Equivalency. In accordance with the responsibilities and authorities assigned by
Executive Order 12344, codified at 50 United States Code sections 2406 and
2511, and to ensure consistency through the joint Navy/DOE Naval Nuclear
Propulsion Program, the Deputy Administrator for Naval Reactors (Director) will
implement and oversee requirements and practices pertaining to this Directive for
activities under the Director's cognizance, as deemed appropriate.
4.
SUMMARY OF CHANGES.
a.
Modified contact information (refer to section 10).
b.
Changed “Office of Quality Management (OQM)” to “Quality Management.”
c.
Added Management System Description (MSD) (refer to Appendix 4).
d.
Added Acronyms (refer to Appendix 5).
e.
Added References (refer to Appendix 6).
f.
Added Document Repositories (refer to Appendix 7).
g.
Added DOE O 414.1-MSD Traceability Matrix (refer to Appendix 8).
h.
Added MSD-ISO 9001:2015 Traceability Matrix (refer to Appendix 9).
i.
Added ISO 9001:2015-ISO 9001:2008 Traceability Matrix (refer to Appendix
10).
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5.
BACKGROUND. Both DOE O 414.1 and ANSI/ISO/ASQ Q9001 stipulate that quality
systems be developed. The QMS referenced in this directive pertains to an Enterprise
Management System for NNSA and is a process-based management system that controls
the quality of customer products and mission requirements. This NAP was developed
using DOE O 414.1, Quality Assurance, as a baseline and tailored to meet the mission
requirements of NNSA. The selection and use of ANSI/ISO/ASQ Q9001 to establish the
QMS is authorized by DOE O 414.1, paragraph 4.A.(2)(C):
“(c) Use appropriate national or international consensus standards in whole or
in part, consistent with regulatory requirements and Secretarial Officer
direction. When standards do not fully address these requirements, the
gaps must be addressed in the QAP.
Examples of currently acceptable standards include:
1 ASME NQA-1-2008 with the NQA-1a-2009 addenda, Quality
Assurance Requirements for Nuclear Facility Applications;
2 ANSI/ISO/ASQ Q9001-2008, Quality Management System-
Requirements; and, [sic]
3 ANSI/ASQ Z 1.13-1999, Quality Guidelines for Research.”
6.
REQUIREMENTS.
a.
The QMS is codified in the MSD (see Appendix 4) which serves as the
description of the Quality Assurance Program (QAP), stipulated in DOE O 414.1.
b.
The NNSA QMS must be in full compliance with federal requirements and
responsibilities of DOE O 414.1, and select and applicable ISO 9001 principles
for quality management systems as identified in Appendix 4.
c.
The QMS must be in compliance with the current version of the NNSA
Enterprise Strategic Vision.
d.
The MSD and associated work processes must be documented and available to all
employees.
e.
Work processes, such as process descriptions outlined in Appendix 4 and those
developed pursuant to paragraph 7.b.1, must be identified, controlled, and
measured to assure that the quality of products and services fulfills customer
requirements.
f.
Management System Assessments (MSAs) of the NNSA QMS must be performed
periodically in accordance with the ISO 9001 requirements for the conduct of
internal audits. Periodic management reviews will be conducted to assess the
status of the QMS and to address improvements to processes, products, and
services. (Appendix 2)
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g.
Subject area-specific quality systems, developed in whole or in part to comply
with DOE O 414.1, Quality Assurance, or specific technical programs or subject
areas within NNSA, will be considered subordinate to the overarching business
process focus of the QMS codified in the MSD. Quality systems must be verified
as to their function and compliance with the pertinent standards around which
they are organized.
7.
RESPONSIBILITIES.
a.
Administrator and Principal Deputy Administrator:
(1)
Establish QMS policy.
(2)
Communicate management’s commitment to the QMS.
(3)
Ensure availability of sufficient resources to support the implementation
and ongoing management of the QMS.
(4)
Conduct periodic management reviews to identify progress of the QMS
and implement any necessary changes to ensure its continuing
improvement.
b.
Deputy Administrators, Associate Administrators, and Field Office Managers:
(1)
Establish a process for implementing the NNSA QMS in their respective
offices and functions that aligns with the NNSA QMS as established in the
MSD.
(2)
Establish organizational quality objectives.
(3)
Develop, approve, and update office procedures and work processes in
accordance with the NNSA QMS requirements stated in the MSD.
(4)
Evaluate the implementation, efficiency, and effectiveness of the NNSA
QMS for their respective offices and functions, using appropriate data
analysis techniques.
(5)
Appoint a representative to serve on the NNSA Management System
Board (MSB). (See Appendix 3)
c.
NA-MB-1.2, Quality Management:
(1)
The Quality Management Director serves as the QMS Executive
Management Representative.
(2)
The Quality Management Director serves as the chair of the NNSA
Management System Board.
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(3)
Ensures that the processes needed for the corporate QMS are established,
approved, implemented, and maintained.
(4)
Establishes an MSA internal audit process to ensure continuing
improvement, as required by DOE O 414.1 and the ISO 9001standard.
(5)
Defines the criteria, scope, frequency, and methodology for the MSAs.
(6)
Reports to top management on the performance of the QMS and any need
for improvement.
(7)
Ensures the promotion of awareness of customer requirements throughout
the organization.
(8)
Acts as liaison with external bodies and customers on matters relating to
the organization’s QMS.
(9)
Designates an MSA manager who:
(a)
Conducts MSAs in accordance with the ISO 9001 standard.
(b)
Verifies through the MSAs that the QMS and subordinate
organization management systems are implemented and effectively
maintained.
(c)
Schedules MSAs, taking into consideration the status and
importance of the processes and areas to be assessed as well as the
results of previous assessments.
(d)
Establishes a documented procedure that defines the
responsibilities and requirements for planning and conducting
MSAs and reporting results.
(e)
Supports the Office of the Administrator in conducting
management reviews of the QMS.
(f)
Maintains records of the MSA schedules and results.
d.
NNSA Management System Board:
(1)
Includes representatives from all Headquarters organizations and field
offices.
(2)
Shares information relating to issues or changes that have a direct impact
on management system implementation or improvement.
(3)
Ensures appropriate integration and alignment of NNSA Headquarters and
field offices with the management system policies and requirements.
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(4)
Advises Quality Management on policy matters pertaining to NNSA's
Management System.
(5)
Prepares options to present to the Management Council on management
system issues the Board cannot resolve.
8.
REFERENCES. Refer to Appendix 6.
9.
ACRONYMS. Refer to APPENDIX 5.
10.
CONTACT. Quality Management, (202) 586-1925.
BY ORDER OF THE ADMINISTRATOR:
Appendixes:
1. ISO Best Practices
2. Internal Audits
3. Management System Board (MSB) Charter
4. Management System Description (MSD)
5. Acronyms
6. References
7. Document Repositories
8. DOE O 414.1-MSD Traceability Matrix
9. · MSD-ISO 9001:2015 Traceability Matrix
10. ISO 9001:2015-ISO 9001:2008 Traceability Matrix
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Appendix 1
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APPENDIX 1. ISO BEST PRACTICES
The ISO best practices can be summarized in four areas: Plan, Do, Check, Act.
Plan: Establish objectives, goals, and processes. The goal of quality management is to build a
structure that supports organizational success. Quality management requires conformance with
agency guidelines, regulations, and statutory requirements; organizational conformance with
established work processes; and responsiveness to customer needs and feedback. Quality
management creates a benchmark so that management can accurately measure the impact and
performance of its collective work processes.
Do: Formalize procedures and implement those procedures. Create and document procedures,
together with workflow training, establish a foundation upon which to build and manage
continuous improvement. Best practices also include clarity in assigned responsibilities,
effective records management, and a management system that captures organizational work
procedures in an information system readily accessible to all. Benefits of quality management
practices include the reduction of obstacles facing the workforce, documentation that facilitates a
fair distribution of workload, and the overall improvement of the work environment.
Check: Monitor and measure. Management review conducted periodically by an organization’s
managers and staff helps ensure work is aligned with mission goals and carried out according to
plan. Management review also serves to break down the stove-piped decision-making in an
organization. Audits by an independent team of reviewers are an additional way to determine if
an organization is following established processes.
Act: Pursue continuous improvement. Improvement occurs first during the development of
work processes and workflow mapping, when efficiencies are recognized and working
relationships clarified. Later, improvement stems from checks on conformance with established
work processes and customer feedback.
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Appendix 2
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APPENDIX 2. INTERNAL AUDITS
MANAGEMENT SYSTEM ASSESSMENTS.
The NNSA Management System Assessment (MSA) is an activity sponsored by Quality
Management. The assessments are conducted to fulfill Quality Management’s responsibilities
and cited requirements under DOE O 414.1D, Quality Assurance, NAP 414.1, Quality
Management System, and ISO 9001:2015, Quality Management System. MSAs are conducted by
trained and certified ISO auditors and involve onsite management system reviews at the NNSA
Headquarters (HQ) facilities in Washington, DC, Germantown, MD, Albuquerque, NM, and the
field offices.
MSAs are a check, at a point in time, of an organization’s management system to verify whether
it is properly implemented, maintained, and whether mission-related processes are being
planned, documented, executed, and subjected to periodic management review. The MSA
objective is to strengthen accountability by ensuring that procedures are established and
followed. MSAs also enhance risk management, resource stewardship, and governance across
all NNSA federal organizations. These MSAs will be conducted in accordance with an
assessment plan and schedule that is developed by the NNSA Management Systems Board
(MSB). The plan will be approved by the NNSA Management Council.
MANAGEMENT SYSTEMS ASSESSMENT PROCEDURES.
Every MSA is unique and the order in which steps are performed may vary or overlap.
However, the MSA typically includes the following steps:
a.
Engagement Memo – Prior to the beginning of an MSA, appropriate organizational
points of contact are notified of the pending assessment and appraised of the MSA
objectives. Certain preliminary information may be requested at this time, such as
organization charts, internal office procedures manuals, etc.
b.
Planning – During this phase of the MSA, background information on the area to be
assessed is obtained from a number of sources in order to learn as much as possible about
the subject area or organization. Applicable policies and procedures are reviewed, as
well as pertinent statutes and regulations. The results of any prior audits of the area will
also be considered. Employees may be interviewed and MSA questionnaires may be
distributed. At length, planning culminates with an MSA scope and schedule, which is
developed in coordination with the subject organization’s staff. Every reasonable attempt
will be made by Quality Management’s assessors to minimize disruption of staff duties
and normal operations.
c.
Entrance Conference – This is a meeting between the managers of the area or
organization being assessed and MSA personnel. The scope of the MSA will be
reviewed again at this meeting and any scheduling changes or MSA-related concerns
addressed. Managers will have an opportunity to share any management system
concerns, and if there is a particular area or activity that a manager would like to have
reviewed, Quality Management will include it in the assessment plan.
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d.
Fieldwork – This phase may include interviewing employees, flow-charting processes,
and testing transactions. Some of the work will be performed in the area under
assessment, and some of the work will be performed in Quality Management’s office.
Appropriate managers (designated by the organization being assessed) will be kept
informed of any findings as the MSA progresses.
e.
Draft Report – Once fieldwork is completed, a draft of the MSA report will be prepared.
The report will describe organizational procedures performed, findings and observations,
as well as any recommendations or opportunities for improvement (OFIs). The draft will
be provided to the manager in charge of the area under assessment and anyone else
deemed appropriate by the manager. The subject organization will be asked to provide
written responses to Quality Management’s recommendations and will, in turn, be
included in the final report.
f.
Exit Conference – This is a meeting between management and the MSA audit personnel
to discuss the results of the assessment and go over the draft report. If management
discovers any factual errors or believes that Quality Management has misinterpreted
anything, staff should inform Quality Management during the exit conference so that
Quality Management may make corrections before the report is seen by anyone else. On
occasion, there may be items that Quality Management does not feel are appropriate to
include in the written report but should be brought to the attention of management.
Quality Management will discuss any such items during the exit conference or include a
specific issues summary in a separate management letter.
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Appendix 3
AP3-1
APPENDIX 3. MANAGEMENT SYSTEM BOARD (MSB) CHARTER
1.
PURPOSE.
a.
To comply with DOE O 414.1, Quality Assurance, and improve the effectiveness,
efficiency, consistency, and accountability in executing its vital roles and
responsibilities, the National Nuclear Security Administration (NNSA) is
implementing a management system in accordance with select and applicable
principles of ISO 9001, Quality Management Systems – Requirements.
b.
The Management System Board (MSB) is a successor organization to the ISO
9001 QMS Steering Committee (ISO-SC). The Steering Committee was
chartered in 2012 to lead change and provide QMS technical expertise in
developing and implementing an ISO 9001 QMS for the NNSA. As stated in its
Charter, the ISO-SC is not responsible for preparing, developing, or implementing
procedures. The Steering Committee Charter is dissolved upon the approval of
the MSB Charter.
c.
The MSB Charter establishes the NNSA MSB and defines its authorities,
applicability and scope, functions, membership, meetings, duration, and any
applicable records to be retained.
2.
APPLICABILITY AND SCOPE.
This charter applies to NNSA Headquarters’ (HQ) program offices and field offices as it
relates to management system policy implementation.
3.
AUTHORITY.
DOE O 414.1; NAP-414.1, Quality Management System; and NNSA BOP-100.1,
Senior Leadership Councils.
4.
GOVERNING COUNCIL AFFILIATION.
The MSB reports to the NNSA Management Council.
5.
FUNCTIONS.
a.
The MSB shares information relating to issues or changes that have a direct
impact on management system implementation or improvement. MSB meetings
promote the sharing of best practices as well as risk reduction or mitigation
activities concerning management systems throughout NNSA.
b.
The MSB advises Quality Management on policy matters pertaining to NNSA’s
management system.
c.
The MSB ensures appropriate integration and alignment of NNSA Headquarters
and field offices with the management system policies and requirements.
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d.
The MSB prepares options to present to the Management Council for
management system issues that Board members cannot resolve.
e.
MSB members act as management system liaisons for their respective offices.
6.
MEMBERSHIP.
a.
The Board is chaired by the Director, Quality Management.
b.
Each HQ program office and field office appoints a member to the MSB, as
determined appropriate by the HQ and field elements.
7.
MEETINGS.
The MSB shall meet quarterly or at the direction of the Chair.
8.
DURATION.
This charter shall continue until the Management Council cancels or amends it.
9.
ASSESSMENT.
The performance and effectiveness of the MSB shall be assessed by its members on an
annual basis and include the following considerations:
•
Meetings conducted as defined in Section 7;
•
Agendas provided in advance of the meeting;
•
Meeting notes containing action items released within three weeks of meeting
adjournment;
•
Completion of action items ensured prior to next meeting – or as agreed and
documented in meeting notes.
10.
RECORDS.
Quality Management shall maintain this charter and all other records associated with the
MSB.
11.
OFFICE OF PRIMARY INTEREST.
Quality Management.
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Appendix 4
AP4-1
APPENDIX 4. MANAGEMENT SYSTEM DESCRIPTION (MSD)
1.
INTRODUCTION
The National Nuclear Security Administration’s (NNSA) Management System
Description (MSD) provides a high-level description of NNSA federal business
operations. The MSD was developed in accordance with select and applicable clauses
(see Appendix 9) from the American version of the International Organization for
Standardization’s (ISO) 9001, Quality Management Systems – Requirements
(ASQ/ANSI/ISO 9001:2015). The MSD and its supporting documentation and
procedures serve the organization by providing for subordinate organizations an MSD of
NNSA’s responsibilities, the associated authorities it operates with, and its management
approaches designed to deliver the NNSA mission.
2.
PURPOSE
NNSA has engaged in multiple reform efforts to improve quality and customer
satisfaction. These reforms were designed to address shortfalls in program and support
functions management. One of the reforms included the development and completion of
an MSD.
The MSD – which satisfies the Quality Assurance Program (QAP) and Quality
Management System (QMS) requirements of Department of Energy (DOE) O 414.1,
Quality Assurance while reflecting select and applicable principles of ISO 9001 –
describes NNSA’s integrated management system, business operations, organizational
structure, and key crosscutting policies and procedures.
3.
SCOPE
The MSD describes the management, technical activities, and business practices
conducted by NNSA federal employees and contracted personnel – in NNSA HQ and
field offices – to ensure the following:
•
Implementation of the functions, responsibilities, and authorities depicted by mission
and function statements;
•
Execution of NNSA responsibilities to support customers as well as other interested
parties; and
•
Identification of the systems and mechanisms by which NNSA may ensure the quality
of products, services, and processes.
Note: Individual program or field organizations may develop and institute additional
operational guides, plans, or their own management systems that are subordinate to this
corporate MSD. Organizations with established management systems should ensure their
guides, plans, MSDs, etc., align – and are modified, as necessary – with this corporate
MSD.
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The following, however, have been determined to be out-of-scope:
•
Validation of Processes for Production and Service Provision
•
Identification and Traceability
•
Customer Property
•
Preservation of Product
Note: For more details, refer to paragraph 9.5.
4.
ORGANIZATION
(DOE O 414.1D Criterion 1)
4.1.
NNSA HEADQUARTERS (HQ)
NNSA manages its mission from its HQ in Washington, DC; Germantown, MD; and
Albuquerque, NM. NNSA HQ is responsible for planning, managing, and overseeing the
entire nuclear security enterprise. All program management and many functional
management responsibilities reside in HQ.
Note: For details, refer to the mission and function statements as described in an NNSA
policy.
4.2.
NNSA FIELD OFFICES
Federal field offices at each NNSA site provide tailored contract management, oversight,
and collaboration with Management and Operating (M&O) partners. In accordance with
program direction, field offices led by a field office manager (FOM) are responsible for
onsite federal oversight and administration of the M&O and other direct contracts.
4.3.
MANAGEMENT AND OPERATING (M&O) PARTNERS
Unlike government agencies outside the DOE, NNSA has a unique arrangement of being
a self-regulator. All of NNSA’s laboratories, production plants, and sites are
government-owned/contractor-operated (GOCO) and run by non-governmental
organizations under an M&O contract (or similar contract). M&O partners are tasked
with producing mission deliverables and meeting performance expectations as authorized
by NNSA officials.
Note: For more details, refer to DOE Order 226.1, Implementation of Department of
Energy Oversight Policy, and NNSA SD 226.1B, NNSA Site Governance.
4.4.
OFFICES
The offices (listed below) function synergistically to carry out the NNSA mission from
HQ (Forrestal and Germantown), the Albuquerque Complex (AC), and field office
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Appendix 4
AP4-3
locations. The NNSA structure is illustrated in the organizational chart provided below
(Figure 1).
Note: For more details, refer to the mission and function statements as described in an
NNSA policy.
Appendix 4 NAP 414.1
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Appendix 4
AP4-5
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5.
INTEGRATED MANAGEMENT SYSTEM
(ISO 9001:2015 clause 9.3.1 and DOE O 414.1D Criterion 9)
NNSA operates as an integrated management system. The effective integration of the
individual NNSA program office, field office, and mission support management systems
allows continuous improvement, resulting in efficiency and effective achievement of
NNSA’s mission. For NNSA, policies and procedures provide a disciplined and
consistent management approach to the accomplishment of work within the requirements
established through laws, executive orders, regulations, DOE directives, and best
management practices. NNSA’s integrated management system fulfills the various
requirements of other management systems such as the:
•
Integrated Safety Management System,
•
Integrated Safeguards and Security Management System,
•
QAP, and
•
QMS.
NNSA also expects that the implementation of quality procedures such as periodic
management review and internal audits will result in continuous improvement and
enhanced risk management.
5.1.
MANAGEMENT OF NNSA
Following the decisions and guidance of the Administrator and the councils and boards,
contract managers, program managers, and functional managers work in an integrated
fashion to ensure the fulfillment of NNSA’s mission. Managers are responsible for
achieving assigned program objectives in a manner that is safe; environmentally sound;
secure; legally, ethically, and fiscally responsible; and compliant with requirements that
fall within the realm of their control. Primary responsibility rests with the lowest level
manager responsible for directing the resources needed to meet a specific requirement or
objective.
5.2.
GOVERNANCE
NNSA’s governance model is a system of strategic management, policy, and
programmatic controls exercised for the stewardship of the organization and execution of
mission. In NNSA, governance is implemented collaboratively by federal and contractor
organizations in pursuit of shared mission objectives. The NNSA governance system is
defined by documented organizational roles, responsibilities, and work processes. The
governance system is implemented through a hierarchal and disciplined structure of
councils, boards, and committees. Each group possesses distinct but interrelated
responsibility and decision making authority and has a membership that includes
appropriate representation of federal and contractor organizations. The governance
system is informed by a matrixed quality management framework designed to reduce and
eventually eliminate nonconformance to program specifications, standards, and customer
Appendix 4
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expectations, yet support and preserve the degree of independence needed for the
contractor to function in a self-regulatory manner.
Note: For more details, refer to NNSA BOP-100.1.
6.
QUALITY MANAGEMENT SYSTEM (QMS)
6.1.
GENERAL REQUIREMENTS
(ISO 9001:2015 clause 4.4.1)
NNSA has developed, documented, implemented, and maintained its Quality
Management System (QMS) to ensure it aligns with select and applicable principles of
ISO 9001. With this alignment, the NNSA QMS is based upon an approach that:
•
Identifies the processes needed for the management system;
•
Determines the sequence and interaction of processes;
•
Establishes the criteria and methods required to ensure effective operation and
management of processes;
•
Ensures the availability of resources and information necessary to support processes;
and
•
Monitors, measures, and analyzes processes to achieve planned results and continual
improvement.
6.2.
DOCUMENTATION REQUIREMENTS
The level and type of documentation established for NNSA is reviewed periodically to
ensure it remains appropriate for the following:
•
Activities performed,
•
Methods used,
•
Complexity of processes and their interactions, and
•
Skills and capabilities required by personnel.
Corporate NNSA procedures are provided in one of five ways:
1.
MSD,
2.
Existing DOE directives,
3.
BOPs,
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4.
Procedures contained in NAPs and SDs, or
5.
Standard Operating Procedures (SOPs).
6.2.1.
NNSA POLICIES
NNSA policies are categorized as follows:
•
NAPs – establish enterprise-wide policies, requirements, and responsibilities unique
to NNSA; apply to all Federal NNSA Elements and to contractor elements when
appropriate.
•
SDs – augment policies, requirements, and responsibilities established in a DOE
directive; apply to all Federal NNSA Elements and to contractor elements when
appropriate.
•
BOPs – establish business procedures that apply to more than one Federal NNSA
Element.
•
Interim Policy Memoranda (IPMs) – establish temporary enterprise-wide policy;
apply to all Federal NNSA Elements and to contractor elements when appropriate.
•
SOPs – establish business procedures that apply to a single Federal NNSA Element.
Note: For more details, refer to NNSA SD 251.1, NNSA Policies, Supplemental
Directives, and Business Operating Procedures.
6.2.2.
QUALITY MANUAL
The MSD establishes NNSA quality management policy and serves as the quality manual
for the organization. The manual includes the scope and description of the QMS and
references documented procedures and external documents.
Note: The MSD is a controlled document subject to select and applicable principles of
ISO 9001 and DOE O 414.1.
6.2.3.
CONTROL OF DOCUMENTS
(ISO 9001:2015 clauses 7.5.3.1, 7.5.3.2, and 8.1)
Procedures are established and maintained at NNSA to control documents within the
scope of the NNSA management system. This includes the processes for preparing,
reviewing, approving, releasing, distributing, changing, revising, tracking, maintaining,
and canceling documents, quality manuals and plans, procedures, forms, and instructions.
Each NNSA organization is responsible for the establishment, maintenance, and control
of organization-unique documents to include distribution of documents of external origin.
Appendix 4 NAP 414.1
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Documents are reviewed and approved for adequacy and accuracy prior to being issued
and work being performed. Approval may rely upon concurrence from technical
authorities and employee representatives performing the tasks, as appropriate. Each
organization maintains the documents, such as procedures, instructions, and forms, or
identifies the repository of the documents. Documents can be in multiple types of media.
Note: Electronic media are recommended, when available.
The documents must be controlled, using – at a minimum – the document’s title or
subject, approval date, and document number. A master list identifying the current
revision status of documents is established and readily available to preclude the use of
invalid or obsolete documents. This control must ensure:
•
Document issues and errors are readily available to essential NNSA management
system personnel and functions.
•
Invalid or obsolete documents are removed from points of issue or use, destroyed, or
otherwise ensured against unintended use.
•
Previous or obsolete versions of documents are identified as such.
Changes, revisions, and cancellations to documents will be reviewed and approved by the
same NNSA organization that performed the original review and approval, unless
designated otherwise.
Note: For details regarding the control of NNSA policies, refer to NNSA SD 251.1.
6.2.4.
CONTROL OF RECORDS
Per NNSA SD 243.1, Records Management Program, Appendix 8, Section 19, records
are defined as:
All books, papers, maps, photographs, machine-readable materials, or other
documentary materials, regardless of physical form or characteristics, made or
received by an Agency of the United States Government under Federal law or in
connection with the transaction of public business and preserved or appropriate
for preservation by that Agency or its legitimate successor as evidence of the
organization, functions, policies, decisions, procedures, operations, or other
activities of the Government or because of the informational value of the data in
them.
Records management is critical to the NNSA mission as it provides evidence (i.e.,
records) of activities, organizations, functions, policies, decisions, procedures, and
operations. The system also maintains and ensures the creation, maintenance, and proper
disposition of records. Records management best practices ensure the protection of the
legal and financial rights of the government and individuals, preserve historical legacy
information, and facilitate the effective retrieval of essential and archived information.
NAP 414.1
1
-10-17
Appendix 4
AP4-9
Note: For more details, refer to NNSA SD 243.1.
7.
LEADERSHIP AND MANAGEMENT
7.1.
LEADERSHIP AND COMMITMENT
(ISO 9001:2015 clause 5.1.1)
By issuing this document and in support of its commitment to quality and customer
satisfaction, NNSA:
•
Establishes, implements, assesses, and reports on the integrated management system
to provide accountability and improve the effectiveness of the organization.
•
Ensures compliance with applicable laws, regulations, and requirements such as the
Federal Managers’ Financial Integrity Act (FMFIA), the Office of Management and
Budget (OMB) Circular A-123, Management's Responsibility for Internal Control,
and NNSA directives.
•
Maintains a QMS that ensures that management:
o
Creates and communicates to employees NNSA’s organizational structure,
strategic objectives, and cultural environment.
o
Establishes processes for setting goals and objectives that support and align
with the organization’s mission and customer needs.
o
Implements performance measures to track achievement of goals and
objectives.
o
Provides trained and qualified personnel and supplies necessary resources.
o
Documents and implements policies, processes, and standards to identify and
manage risks.
o
Promotes continual improvement, use of processes, and practice of risk-based
thinking.
7.2.
CUSTOMER FOCUS
(ISO 9001:2015 clause 5.1.2)
NNSA’s main customers are the Secretary of Energy/DOE and Secretary of
Defense/Department of Defense (DOD). NNSA management ensures customer needs
and expectations are determined, converted into deliverable requirements, and fulfilled
with the intention of meeting or exceeding expectations.
Appendix 4
AP4-10
NAP 414.1
1-10-17
7.2.1.
QUALITY POLICY
The NNSA Quality Policy is:
To ensure NNSA products and services meet or exceed customers’ requirements and
expectations, and to achieve quality work based upon the following principles:
•
Products add value and are appropriate to the purpose of NNSA,
•
Work is conducted through an integrated and effective management system;
•
Management support for planning, organization, resources, direction, and control
is essential to quality assurance;
•
Performance and quality improvement require thorough, rigorous assessments and
effective corrective actions;
•
Personnel are responsible for achieving and maintaining quality; and
•
Risks and adverse mission impacts associated with work processes are minimized
while maximizing reliability and performance of work products.
7.2.2.
NEEDS AND EXPECTATIONS OF CUSTOMERS
The needs of NNSA customers are defined by the programmatic and regulatory
requirements for which NNSA provides advisory services, policy development and
implementation, and oversight functions. Specific needs of NNSA customers are
determined through verbal and written communications, as well as periodic visits to
relevant sites, facilities, and offices to better understand individual processes and product
or service requirements. Once requirements are identified and documented, work – at a
subordinate level – is then executed to fulfill requirements. To continually improve,
NNSA also monitors, measures, and analyzes customer satisfaction. Customer feedback,
satisfaction, needs and expectations, issues, and their impact on the NNSA management
system are reviewed periodically.
Appendix 4
AP4-11
NAP 414.1
1-10-17
7.2.3.
NEEDS AND EXPECTATIONS OF OTHER INTERESTED PARTIES
NNSA management ensures that the needs and expectations of its customers and other
interested parties are determined and incorporated, as appropriate, into planning,
processes, procedures, and product or service requirements. Needs and expectations may
impact NNSA’s ability to deliver on products and services and can often include legal
and regulatory requirements. Other interested parties may include:
•
Government organizations (e.g., White House; OMB; Members of Congress and
various congressional committees; State, Local, and Tribal Governments; foreign
governments),
•
Regulatory or oversight organizations (e.g., Defense Nuclear Facilities Safety Board
(DNFSB), Government Accountability Office (GAO), and Inspector General (IG)),
•
Non-governmental organizations (e.g., corporations, watchdog groups, unions, and
professional or industry associations), and
•
NNSA employees.
7.3.
PLANNING
7.3.1.
QUALITY OBJECTIVES
(ISO 9001:2015 clauses 6.2.1 and 6.2.2 and NAP 26A requirement 6.c.)
NNSA management establishes quality objectives at relevant functions and levels within
the organization. The objectives are derived from the NNSA Quality Policy consistent
with the NNSA Enterprise Strategic Vision. The quality objectives are documented and
reviewed by NNSA management as part of the management review process. The quality
objectives are measurable and consistent with the quality policy, and provide appropriate
focus on continual improvement and customer satisfaction.
Appendix 4
AP4-12
NAP 414.1
1-10-17
7.3.2.
PROCESSES AND PROCEDURES
(ISO 9001:2015 clauses 6.1.1 and 6.1.2 and DOE O 414.1D Criterion 1)
Listed below (in Table 1) are core processes and procedures used by NNSA program and
field offices to perform various functions, activities, and operations that align with NNSA
missions and goals.
Table 1 – NNSA Processes and Procedures
TITLE DESCRIPTION REFERENCE
Corporate
Performance
Evaluation
Process (CPEP)
Uniform and integrated process, which is
facilitated via a Performance Evaluation Plan
(PEP), for evaluating the performance of M&O
contractors.
NAP 540.3
Corporate
Performance
Evaluation Process
for M&O Contractors
Independent
Cost Estimate
(ICE)
Requires Independent Cost Estimates (ICEs) for
projects and programs exceeding predetermined
expected cost thresholds with participation from
organizations external to the program office and –
when appropriate – an Independent Cost Review
(ICR) by the Office of Cost Estimating and
Program Evaluation (CEPE).
NAP-28,
Responsibilities for
Independent Cost
Estimates
Planning,
Programming,
Budgeting, and
Evaluation
(PPBE)
The NNSA PPBE process – similar to PPBE
processes used by other federal government
agencies – is a continuous cycle that consists of
four major activities:
•
Planning,
•
Programming,
•
Budgeting, and
•
Evaluation.
NAP 130.1,
Planning,
Programming,
Budgeting, and
Evaluation (PPBE)
Process
Program and
Project
Management
NNSA has established program and project
management oversight processes to ensure the
experience, diverse perspectives, and thoughtful
programmatic and technical judgment at all levels
are accessible, available, and applied to program
and project activities.
BOP 413.7, Project
Management for the
Acquisition of Capital
Assets
NAP 414.1
1
-10-17
Appendix 4
AP4-13
TITLE DESCRIPTION REFERENCE
Risk
Management
Encourages continuous improvement in agency
decision-making, operations, and performance
by providing:
•
Increased likelihood of successfully
delivering on goals and objectives,
•
Decreased unanticipated outcomes,
•
Improved ability to assess risks associated
with changes,
•
Enhanced ability to communicate to
customers and others regarding NNSA’s
risk management activities, and
•
Improved risk mitigation, particularly
regarding impact of realized negative
events.
DOE G 413.3-7, Risk
Management Guide
7.4.
RESPONSIBILITY, AUTHORITY, AND COMMUNICATION
7.4.1.
RESPONSIBILITY AND AUTHORITY
(ISO 9001:2015 clause 5.3)
The basis for NNSA responsibilities and authorities is provided in the mission and
function statements maintained by the Office of the Associate Administrator for
Management and Budget (NA-MB). Functions, responsibilities, and authorities are
flowed down for implementation through the NNSA management system and various
NNSA NAPs, SDs, BOPs, or SOPs.
Note: For more details, refer to the mission and function statements as described in an
NNSA policy.
Appendix 4
AP4-14
NAP 414.1
1-10-17
7.4.2.
COMMUNICATION
(ISO 9001:2015 clauses 5.2.2 and 7.4)
NNSA management ensures that communication is maintained throughout the
organization regarding the processes of the NNSA management system and their
effectiveness. NNSA has established the following in regards to its communication
practices:
•
What to communicate, including:
o
Progress regarding activities and products;
o
Audit/assessment results;
o
Organizational updates; and
o
Missions and initiatives (e.g., NNSA Strategic Vision, memorandums, etc.).
•
When to communicate, including:
o
Daily,
o
Bi-Weekly,
o
Monthly,
o
Quarterly, and
o
Yearly.
•
Who communicates and with whom to communicate, including:
o
Administrators,
o
Managers,
o
Chief Operating Officers, and
o
Directors.
•
How to communicate, including:
o
Reports (e.g., status reports, audit reports, meeting minutes, etc.);
o
Meetings (e.g., Management Council, NNSA Council, Operations Board.,
town hall, all hands, various working groups and committees, etc.); and
NAP 414.1
1-10-17
Appendix 4
AP4-15
o
Electronic distribution/media (e.g., NNSACASTs, PowerPedia, NNSA
Connects, OneHR, Enterprise Portal (SharePoint) online communication and
collaboration sites, newsletters, procedures, and training).
8.
RESOURCES
8.1.
PROVISIONING OF RESOURCES
(ISO 9001:2015 clause 7.1.1 and DOE O 414.1D Criteria 1 and 7)
NNSA is responsible for providing sufficient resources, including trained and qualified
personnel for performing management work and for verification activities. More
specifically, resources are provided to implement, maintain, and improve the effective
operations of NNSA management system processes, and to enhance customer satisfaction
by meeting or exceeding requirements. Resources are assessed and reviewed on a
periodic basis consistent with a management review process and management’s strategic
planning activities.
8.2.
HUMAN RESOURCES
8.2.1.
ASSIGNMENT OF PERSONNEL
(ISO 9001:2015 clause 7.1.2)
The following criteria are reviewed to determine if personnel are qualified and competent
resources:
•
Education,
•
Training,
•
Observed skills, and
•
Experience.
Assignees to NNSA are expected to provide and support services based on the alignment
of their:
•
Knowledge,
•
Skills,
•
Ability to meet the needs and requirements of the task,
•
Experience with the customer,
•
Current workload, and
Appendix 4
AP4-16
NAP 414.1
1-10-17
•
Availability.
8.2.2.
COMPETENCE, AWARENESS, AND LEARNING
(ISO 9001:2015 clause 7.1.2, 7.2, and 7.3 and DOE O 414.1D Criterion 2)
NNSA management provides for the training of personnel performing activities affecting
quality of services. Training is provided either on- or off-the-job, internally, or
externally, as appropriate.
NNSA offers a wide array of sponsored programs, products, and services to its federal
workforce. The expanse of learning activities underscores NNSA’s commitment to being
a learning organization: actively promoting learning opportunities to enable performance
of NNSA’s dynamic missions. NNSA’s learning program is fully funded to ensure that
organizations can leverage resources and that centrally funded programs and courses are
available to the workforce.
Note: For more details, visit the OneLeadership “NNSA Sponsored Learning
Activities” webpage.
A dynamic website and continuous communications promote awareness of upcoming and
long-range opportunities so that employees and supervisors can consider, plan, and attend
events to increase current job competence and long-range professional development.
Note: For more details, visit the OneLearning Initiative (OLI) website or OneHR &
OneLearning message repository.
Personnel are required to complete an Individual Development Plan (IDP), which is
updated periodically and approved by their supervisor. The IDP is used to identify and
plan for training and developmental activities that reflect career goals and performance
plans of the employee. IDP approval rates are sent semi-monthly to organizational
leaders to promote the importance of employee development. IDPs are aggregated to
form the basis for an Annual Training Assessment (ATA), which tracks NNSA-wide
learning and development needs for employees, groups, and organizations. By
integrating it with IDPs, the ATA forms the basis for fiscal year (FY) allocations. NNSA
also tracks training-related cancellations and denials to discern reasons for training not
supported or attended.
NNSA emphasizes competencies as a means for talent development. For example, a
foundational competency model applicable to the entire NNSA federal workforce will be
deployed during FY2017. Functionally oriented technical competency models and
attendant career paths are being developed, with initial implementation planned for
FY2017.
Note: For details, refer to NNSA SD 360.1, Federal Employee Training.
NAP 414.1
1
-10-17
Appendix 4
AP4-17
For select technical personnel, qualification processes are conducted in accordance with
DOE O 426.1 (Change 1), Federal Technical Capability. Each person assigned to an
NNSA technical position identified by the Federal Technical Capability Program must
meet at least one appropriate qualification. Staff personnel are expected to qualify within
the prescribed qualification period. NNSA technical personnel are responsible for
ensuring their technical qualifications remain current, including arranging for and
meeting requalification requirements. Where a formal requalification requirement does
not exist, maintenance of qualification is accomplished through successful participation
in continuing education as assigned by supervisors and certified by a Qualifying Official,
and verified by the NNSA Federal Technical Capability (FTC) Panel Agent.
Documented procedures are maintained to identify training requirements and ensure
appropriate training of personnel performing NNSA work. Training and qualification
records are created and maintained by the DOE’s National Training Center using the
e-TQP electronic records system.
9.
OPERATIONS
(DOE O 414.1D Criteria 5 and 6)
9.1.
PLANNING OF PRODUCT AND SERVICE REALIZATION
(ISO 9001:2015 clause 8.1 and DOE O 414.1D Criteria 5 and 6)
Planning is required before new services, products, or processes are implemented.
During the planning phase, management or assigned personnel identify requirements for
the following:
•
Product or services;
•
Affected processes, procedures, and resources;
•
Monitoring, measurement, or review requirements;
•
Product or service expectations or acceptance criteria;
•
Deliverable requirements; and
•
Schedule, as applicable.
Appendix 4
AP4-18
NAP 414.1
1-10-17
9.2.
DETERMINATION OF REQUIREMENTS RELATED TO PRODUCTS AND
SERVICES
(ISO 9001:2015 clause 8.2.2 and DOE O 414.1D Criteria 5 and 6)
The product of NNSA is safe and secure execution of its mission objectives. The
requirements of NNSA products and services are defined by the programmatic and
regulatory requirements for which NNSA provides advisory services, policy development
and implementation, and oversight functions. Requirements are incorporated into DOE
and NNSA directives and customer-specific processes and procedures, which NNSA
follows, as necessary, for the creation and delivery of products and services. Other
requirements not detailed in directives, or unique to a given product/service or customer,
are ascertained through communication with the customer and research or knowledge of
industry standards or other relevant resources.
9.3.
REVIEW OF REQUIREMENTS RELATED TO PRODUCTS AND SERVICES
(ISO 9001:2015 clause 8.2.3 and DOE O 414.1D Criteria 5 and 6)
Relevant requirements are identified and discussed with customers, as appropriate. Work
is performed when NNSA and the customer organization have reached agreement in
principle.
9.4.
CUSTOMER COMMUNICATION
(ISO 9001:2015 clause 8.2.1 and DOE O 414.1D Criteria 5 and 6)
NNSA appoints various staff members to serve as leads or points of contact (POCs) for
functional areas or NNSA customer organizations. POCs are responsible for interfacing
with key POCs from customer organizations to establish and maintain awareness of needs
and opportunities for providing assistance or improving support. The NNSA leads and
POCs serve as the primary focal point for communication between NNSA and the
customer’s staff. NNSA staff providing support to a customer interface with the
customer regarding an assigned task or project to ensure customer needs, requirements,
and expectations are met.
9.5.
CONTROL OF PRODUCTION AND SERVICE PROVISIONING
(ISO 9001:2015 clause 8.5.1 and DOE O 414.1D Criteria 5 and 6)
NNSA develops and implements SOPs for use in the creation and delivery of products
and services. SOPs are the responsibility of individual NNSA offices and are controlled
and maintained using best practices consistent with those processes stated in Section
6.2.3. The need for SOPs increases with regulatory requirements driving the product or
service – or the associated level of prescription. Therefore, SOPs are associated with
processes and products or services under NNSA policy development and implementation
or oversight roles.
NAP 414.1
1
-10-17
Appendix 4
AP4-19
The following do not apply to the control of NNSA production and service provisioning:
•
Validation of Processes for Production and Service Provision – NNSA
products/services can be verified, monitored, and measured subsequent to realization.
•
Identification and Traceability – NNSA products or services are discrete, unique
products, and it would not be appropriate nor add value by applying identification and
traceability. Process controls are in place to ensure products remain discrete and
unique.
•
Customer Property – No customer property is maintained by NNSA in the course of
its business operations.
•
Preservation of Product – NNSA products and services are not subject to
deterioration or loss of conformity.
•
Control of Monitoring and Measuring Equipment – No monitoring or measuring
devices are used in product and service realization.
10.
MONITORING, MEASUREMENT, ANALYSIS, AND EVALUATION
(ISO 9001:2015 clause 9.1.1 and DOE O 414.1D Criteria 8 and 10)
NNSA defines, plans, and implements appropriate methods to monitor, measure, analyze,
and improve its processes to ensure product or service conformance and to continually
improve the overall effectiveness of the NNSA management system.
10.1.
MONITORING AND MEASUREMENT
(DOE O 414.1D Criteria 3, 8, and 10)
10.1.1.
CUSTOMER SATISFACTION
(ISO 9001:2015 clause 9.1.2)
Specific needs of NNSA customers are determined through verbal and written
communications, as well as periodic visits to relevant sites, facilities, and offices to better
understand individual processes, thus ensuring the accuracy and quality of products and
services and overall satisfaction of the customer. NNSA monitors, measures, and
analyzes customer satisfaction through various means.
Appendix 4
AP4-20
NAP 414.1
1-10-17
10.1.2.
INTERNAL AUDIT
(ISO 9001:2015 clauses 9.2.1 and 9.2.2 and DOE O 414.1D Criteria 3, 8, and 10)
NNSA conducts periodic internal audits or schedules equivalent audits by other NNSA
offices or external contractors. The purpose of the internal audit is to determine whether
the NNSA management system is being effectively implemented and maintained.
Internal audits are planned and scheduled based on the status and importance of the
activity to be audited. Audits are performed by trained personnel who are independent of
the activity being audited. Because NNSA auditor resources may not always be
available, the internal audit function may be performed by other qualified parties to
assure independence.
The results of the internal audits are documented in a report, which is provided to
management for action. Management personnel responsible for the audited activity are
responsible for defining and implementing corrective action.
Follow-up activities verify and record the implementation of the corrective action, report
the verification results, and close out the audit. Subsequent audits verify the
effectiveness of the corrective actions taken. Results of internal audits and the corrective
action are submitted for management review. NNSA implements its internal audit
program in accordance with Quality Management’s (NA-MB-1.2) Management System
Assessment Guide.
10.1.3.
MONITORING AND MEASUREMENT PROCESSES
(ISO 9001:2015 clause 8.5.1 and DOE O 414.1D Criteria 3, 8, and 10)
NNSA applies methods for monitoring and, whenever applicable, measurement of
management system processes (see Appendix 2). Methods demonstrate the ability of the
processes to achieve planned results. When planned results are not achieved, corrective
action is taken to ensure conformity of the product or service.
10.1.4.
MONITORING AND MEASUREMENT OF PRODUCTS/SERVICES
(ISO 9001:2015 clause 8.5.1 and DOE O 414.1D Criteria 3, 8, and 10)
The primary deliverables for NNSA are documents (e.g., technical evaluations, reports,
memoranda, etc.). At HQ and AC, personnel work with internal and external customers
to understand the requirements for each deliverable and task to satisfy needs.
Deliverables undergo an iterative concurrence process that typically includes subject
matter experts (SMEs), supervisors, customers, or other affected parties, as appropriate,
to ensure requirements are met. Comments are resolved and incorporated into
deliverables, which are finalized and issued.
Appendix 4
AP4-21
NAP 414.1
1-10-17
10.2.
CONTROL OF NON-CONFORMING PRODUCTS/SERVICES
(ISO 9001:2015 clauses 10.2.1 and 10.2.2 and DOE O 414.1D Criteria 3, 8, and 10)
NNSA minimizes the potential for nonconforming products by interfacing with
customers to determine and understand requirements, needs, and expectations prior to
work initiation. NNSA ensures products and services that do not meet requirements are
identified, controlled whenever possible to prevent unintended use or delivery to the
customer, and corrected.
10.3.
DATA ANALYSIS
(DOE O 414.1D Criteria 3, 8, and 10)
NNSA collects and analyzes appropriate data to determine the suitability and
effectiveness of the NNSA management system and to identify improvements. Data is
derived from multiple sources including process metrics, internal audits, external audits,
customer surveys, employee feedback, etc. Data are periodically analyzed during NNSA
management staff meetings or management review meetings to provide information on
customer satisfaction, conformance to requirements, performance of processes, quality of
products and services, and trends, and to derive and implement corrective action.
10.4.
EVALUATION AND CONTINUAL IMPROVEMENT
(ISO 9001:2015 clause 10.3 and DOE O 414.1D Criteria 3, 8, and 10)
NNSA management conducts evaluations and facilitates continual improvement, which is
achieved through the use and execution of the quality policy, objectives, audit results,
analysis of data, corrective and preventive action, and management reviews.
10.5.
CORRECTIVE ACTION
(ISO 9001:2015 clauses 10.2.1 and 10.2.2 and DOE O 414.1D Criteria 3, 8, and 10)
The need for corrective action can be identified via the following:
•
Internal or external audit;
•
Customer or employee identification of unacceptable products, services,
procedures, or process results; or
•
Receipt or acceptance inspection of vendor-provided products or services against
procurement specifications.
Appendix 4
AP4-22
NAP 414.1
1-10-17
NNSA management takes action to correct or mitigate an identified issue and restore a
product, service, procedure, or process to an acceptable level of compliance. Corrective
actions are commensurate with the magnitude of the issue. Corrective action includes:
•
Review of issues (including customer complaints);
•
Identification of root cause;
•
Evaluation of the need for corrective action;
•
Determination and implementation of corrective action, if required;
•
Tracking, verifying, and closeout of corrective action taken; and
•
Follow-up effectiveness reviews.
Note: For more details, refer to DOE O 226.1 and DOE O 232.2, Occurrence
Reporting and Processing of Operations Information.
NAP 414.1
1
-10-17
Appendix 5
AP5-1
APPENDIX 5. ACRONYMS
ACRONYM DEFINITION
AC Albuquerque Complex
BOP Business Operating Procedure
CEPE Cost Estimating and Program Evaluation
DNFSB Defense Nuclear Facilities Security Board
DOD Department of Defense
DOE Department of Energy
FOM Field Office Manager
FRA Functions, Responsibilities, and Authorities
GAO Government Accountability Office
GOCO Government-Owned/Contractor-Operated
HQ Headquarters
ICE Independent Cost Estimate
ICR Independent Cost Review
IDP Individual Development Plan
IG Inspector General
IPM Interim Policy Memoranda
ISO International Organization of Standardization
ISO-SC ISO 9001 Quality Management System Steering Committee
M&O Management and Operating
MSB Management System Board
Appendix 5
AP5-2
NAP 414.1
1-10-17
ACRONYM DEFINITION
MSD Management System Description
NA-MB Office of the Associate Administrator for Management and Budget
NAP NNSA Policy
NNSA National Nuclear Security Administration
OFI Opportunity for Improvement
OMB Office of Management and Budget
PEP Performance Evaluation Plan
POC Point of Contact
PPBE Planning, Programming, Budgeting, and Evaluation
SD Supplemental Directive
SME Subject Matter Expert
SOP Standard Operating Procedure
NAP 414.1
1
-10-17
Appendix 6
AP6-1
APPENDIX 6. REFERENCES
ID TITLE
ASME NQA-1-
2008 (with the
NQA-1a-2009
addenda)
Quality Assurance Requirements for Nuclear Facility Applications
ANSI/ASQ Z1.13-
1999
Quality Guidelines for Research
BOP 100.1 Senior Leadership Councils
BOP 413.7 Project Management for the Acquisition of Capital Assets
DOE G 413.3-7A Risk Management Guide
DOE O 226.1A Implementation of Department of Energy Oversight Policy
DOE O 226.1B Implementation of Department of Energy Oversight Policy
DOE O 232.2
(Admin Change 1)
Occurrence Reporting and Processing of Operations Information
DOE O 414.1D Quality Assurance
DOE O 426.1
(Change 1)
Federal Technical Capability
ISO
31000:2009(en)
Risk Management — Principles and Guidelines
ISO 9001:2008 Quality Management Systems – Requirements
ISO 9001:2015 Quality Management Systems – Requirements
N/A NNSA Office of Quality Management, Management System
Assessment Guide
N/A U.S. Department of Energy National Nuclear Security
Administration Enterprise Strategic Vision, August 2015
Appendix 6
AP6-2
NAP 414.1
1-10-17
ID TITLE
NAP-28 Responsibilities for Independent Cost Estimates
NAP 540.3 Corporate Performance Evaluation Process for M&O Contractors
NNSA SD 226.1B NNSA Site Governance
NNSA SD 243.1 Records Management Program
NNSA SD 251.1
(Admin Change 1)
Policy Letters: NNSA Policies, Supplemental Directives, and
Business Operating Procedures
NNSA SD 360.1 Federal Employee Training
NNSA SD 450.2 Functions, Responsibilities, and Authorities (FRA) Document for
Safety Management
NAP 414.1
1
-10-17
Appendix 7
AP7-1
APPENDIX 7. DOCUMENT REPOSITORIES
TYPE REPOSITORY
BOP https://nnsaportal.energy.gov/intranet/NA-
MB/Active%20Policies/Forms/Active%20by%20Type.aspx
DOE
Guide/
Order
https://www.directives.doe.gov/
Note: After accessing the site above, click “Directives.”
NAP http://www.nnsa.energy.gov/aboutus/ouroperations/managementandbudget/polic
ysystem/nnsapolicies
SD http://www.nnsa.energy.gov/aboutus/ouroperations/managementandbudget/suppl
ementaldirectives
THIS PAGE INTENTIONALLY LEFT BLANK
NAP 414.1
1
-10-17
Appendix 8
AP8-1
APPENDIX 8. DOE O 414.1-MSD TRACEABILITY MATRIX
The applicable requirements from DOE O 414.1 are identified in this appendix to
demonstrate a crosswalk between DOE O 414.1 and the MSD. It contains no additional
requirements.
DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 1 — Management/Program.
a.
Establish an organizational structure, functional
responsibilities, levels of authority, and interfaces for
those managing, performing, and assessing the work.
b.
Establish management processes, including planning,
scheduling, and providing resources for the work.
Appendix 4, paragraph 4,
Organization
Appendix 4, paragraph 7.3.2,
Processes and Procedures
Appendix 4, paragraph 8.1,
Provisioning of Resources
Criterion 2 — Management/Personnel Training and
Qualification.
a.
Train and qualify personnel to be capable of
performing their assigned work.
b.
Provide continuing training to personnel to maintain
their job proficiency.
Appendix 4, paragraph 8.2.2,
Competence, Awareness, and
Learning
Appendix 8
AP1-8-2
NAP 414.1
1-10-17
DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 3 — Management/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.
c.
Identify the causes of problems, and include
prevention of recurrence as a part of corrective action
planning.
d.
Review item characteristics, process implementation,
and other quality related information to identify items,
services, and processes needing improvement.
Appendix 4, paragraph 10.1,
Monitoring and Measurement
Appendix 4, paragraph 10.1.2,
Internal Audit
Appendix 4, paragraph 10.1.3,
Monitoring and Measurement
Processes
Appendix 4, paragraph 10.1.4,
Monitoring and Measurement of
Products/Services
Appendix 4, paragraph 10.2,
Control of Non-Conforming
Products/Services
Appendix 4, paragraph 10.3, Data
Analysis
Appendix 4, paragraph 10.4,
Evaluation and Continual
Improvement
Appendix 4, paragraph 10.5,
Corrective Action
Criterion 4 — Management/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.
Appendix 4, paragraph 6.2,
Documentation Requirements
NAP 414.1
1
-10-17
Appendix 8
AP8-3
DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 5 — Performance/Work Processes.
a.
Perform work consistent with technical standards,
administrative controls, and other hazard controls
adopted to meet regulatory or contract requirements
using approved instructions, procedures, or other
appropriate means.
b.
Identify and control items to ensure proper use.
c.
Maintain items to prevent damage, loss, or
deterioration.
d.
Calibrate and maintain equipment used for process
monitoring or data collection.
Appendix 4, paragraph 9,
Operations
Appendix 4, paragraph 9.1,
Planning of Product and Service
Realization
Appendix 4, paragraph 9.2,
Determination of Requirements
Related to Products and Services
Appendix 4, paragraph 9.3, Review
of Requirements Related to
Products and Services
Appendix 4, paragraph 9.4,
Customer Communication
Appendix 4, paragraph 9.5, Control
of Production and Service
Provisioning
Appendix 8
AP1-8-4
NAP 414.1
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DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 6 — Performance/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.
c.
Identify and control design interfaces.
d.
Verify or validate the adequacy of design products
using individuals or groups other than those who
performed the work.
e.
Verify or validate work before approval and
implementation of the design.
Appendix 4, paragraph 9,
Operations
Appendix 4, paragraph 9.1,
Planning of Product and Service
Realization
Appendix 4, paragraph 9.2,
Determination of Requirements
Related to Products and Services
Appendix 4, paragraph 9.3, Review
of Requirements Related to
Products and Services
Appendix 4, paragraph 9.4,
Customer Communication
Appendix 4, paragraph 9.5, Control
of Production and Service
Provisioning
Criterion 7 — Performance/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.
Appendix 4, paragraph 8.1,
Provisioning of Resources
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Appendix 8
AP8-5
DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 8 — Performance/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.
Appendix 4, paragraph 10,
Monitoring, Measurement,
Analysis, and Evaluation
Appendix 4, paragraph 10.1,
Monitoring and Measurement
Appendix 4, paragraph 10.1.2,
Internal Audit
Appendix 4, paragraph 10.1.3,
Monitoring and Measurement
Processes
Appendix 4, paragraph 10.1.4,
Monitoring and Measurement of
Products/Services
Appendix 4, paragraph 10.2,
Control of Non-Conforming
Products/Services
Appendix 4, paragraph 10.3, Data
Analysis
Appendix 4, paragraph 10.4,
Evaluation and Continual
Improvement
Appendix 4, paragraph 10.5,
Corrective Action
Criterion 9 — Assessment/Management Assessment.
Ensure that managers assess their management
processes and identify and correct problems that hinder
the organization from achieving its objectives.
Appendix 4, paragraph 5,
Integrated Management System
Appendix 8
AP1-8-6
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DOE O 414.1 (ATTACHMENT 2) MSD
Criterion 10 — Assessment/Independent Assessment.
a.
Plan and conduct independent assessments to measure
item and service quality, to measure the adequacy of
work performance, and to promote improvement.
b.
Establish sufficient authority and freedom from line
management for independent assessment teams.
c.
Ensure persons who perform independent assessments
are technically qualified and knowledgeable in the areas
to be assessed.
Appendix 4, paragraph 10,
Monitoring, Measurement,
Analysis, and Evaluation
Appendix 4, paragraph 10.1,
Monitoring and Measurement
Appendix 4, paragraph 10.1.2,
Internal Audit
Appendix 4, paragraph 10.1.3,
Monitoring and Measurement
Processes
Appendix 4, paragraph 10.1.4,
Monitoring and Measurement of
Products/Services
Appendix 4, paragraph 10.2,
Control of Non-Conforming
Products/Services
Appendix 4, paragraph 10.3, Data
Analysis
Appendix 4, paragraph 10.4,
Evaluation and Continual
Improvement
Appendix 4, paragraph 10.5,
Corrective Action
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Appendix 9
AP9-1
APPENDIX 9. MSD-ISO 9001:2015 TRACEABILITY MATRIX
The select/applicable principles from ISO 9001:2015 are identified in this appendix to
demonstrate a crosswalk between ISO 9001:2015 and the MSD. It contains no additional
requirements/principles.
MSD ISO 9001:2015
Appendix 4, paragraph 5, Integrated
Management System
9.3.1 General
(Subparagraph of Management review)
Appendix 4, paragraph 6.1, General
Requirements
4.4.1
(Subparagraph of Quality management system and its
processes)
Appendix 4, paragraph 6.2,
Documentation Requirements
4.4.2 To the extent necessary, the organization shall:
(Subparagraph of Quality management system and its
processes)
7.5.1 General
(Subparagraph of Documented information)
7.5.2 Creating and updating
(Subparagraph of Documented information)
Appendix 4, paragraph 6.2.3, Control
of Documents
7.5.3.1
(Subparagraph of Control of documented
information)
7.5.3.2
(Subparagraph of Control of documented
information)
8.1 Operational planning and control
Appendix 4, paragraph 7.1,
Leadership and Commitment
5.1.1 General
(Subparagraph of Leadership and commitment)
Appendix 9
AP9-2
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MSD ISO 9001:2015
Appendix 4, paragraph 7.2, Customer
Focus
5.1.2 Customer Focus
Appendix 4, paragraph 7.2.1, Quality
Policy
5.2.1 Establishing the quality policy
Appendix 4, paragraph 7.3.1, Quality
Objectives
6.2.1
(Subparagraph of Quality objectives and planning to
achieve them)
6.2.2
(Subparagraph of Quality objectives and planning to
achieve them)
Appendix 4, paragraph 7.3.2,
Processes and Procedures
6.1.1
(Subparagraph of Actions to address risks and
opportunities)
6.1.2 The organization shall plan:
(Subparagraph of Actions to address risks and
opportunities)
Appendix 4, paragraph 7.4.1,
Responsibility and Authority
5.3 Organizational roles, responsibilities, and
authorities
Appendix 4, paragraph 7.4.2,
Communication
7.4 Communication
5.2.2 Communicating the quality policy
Appendix 4, paragraph 8.1,
Provisioning of Resources
7.1.1 General
(Subparagraph of Resources)
Appendix 4, paragraph 8.2.1,
Assignment of Personnel
7.1.2 People
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Appendix 9
AP9-3
MSD ISO 9001:2015
Appendix 4, paragraph 8.2.2,
Competence, Awareness, and
Learning
7.1.2 People
7.2 Competence
7.3 Awareness
Appendix 4, paragraph 9.1, Planning
of Product and Service Realization
8.1 Operational planning and control
Appendix 4, paragraph 9.2,
Determination of Requirements
Related to Products and Services
8.2.2 Determining the requirements for products and
services
Appendix 4, paragraph 9.3, Review of
Requirements Related to Products and
Services
8.2.3 Review of requirements for products and
services
Appendix 4, paragraph 9.4, Customer
Communication
8.2.1 Customer communication
Appendix 4, paragraph 9.5, Control of
Production and Service Provisioning
8.5.1 Control of production and service provision
Appendix 4, paragraph 10,
Monitoring, Measurement, Analysis,
and Evaluation
9.1.1 General
(Subparagraph of Monitoring, measurement, analysis
and evaluation)
Appendix 4, paragraph 10.1.1,
Customer Satisfaction
9.1.2 Customer satisfaction
Appendix 4, paragraph 10.1.2, Internal
Audit
9.2.1
(Subparagraph of Internal audit)
9.2.2
(Subparagraph of Internal audit)
Appendix 4, paragraph 10.1.3,
Monitoring and Measurement
Processes
8.5.1 Control of production and service provision
Appendix 9
AP9-4
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MSD ISO 9001:2015
Appendix 4, paragraph 10.1.4,
Monitoring and Measurement of
Products/Services
8.5.1 Control of production and service provision
Appendix 4, paragraph 10.2, Control
of Non-Conforming Products/Services
10.2.1
(Subparagraph of Nonconformity and correction
action)
10.2.2
(Subparagraph of Nonconformity and correction
action)
Appendix 4, paragraph 10.4,
Evaluation and Continual
Improvement
10.3 Continual improvement
Appendix 4, paragraph 10.5,
Corrective Action
10.2.1
(Subparagraph of Nonconformity and correction
action)
10.2.2
(Subparagraph of Nonconformity and correction
action)
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Appendix 10
AP10-1
APPENDIX 10. ISO 9001:2015-ISO 9001:2008 TRACEABILITY MATRIX
The following matrix was developed and distributed by ISO.
ISO 9001:2015 ISO 9001:2008
1. Scope 1 Scope
1.1 General
4. Context of the organization 4 Quality management system
4.1 Understanding the organization and its context 4 Quality management system
5.6 Management review
4.2 Understanding the needs and expectations of
interested parties
4 Quality management system
5.6 Management review
4.3 Determining the scope of the quality
management system
1.2 Application
4.2.2 Quality manual
4.4 Quality management system and its processes 4 Quality management system
4.1 General requirements
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 General 5.1 Management commitment
5.1.2 Customer focus 5.2 Customer focus
5.2 Policy 5.3 Quality policy
5.2.1 Establishing the Quality Policy 5.3 Quality policy
5.2.2 Communicating the Quality Policy 5.3 Quality policy
5.3 Organizational roles, responsibilities and
authorities
5.5.1
Responsibility and authority
5.5.2
Management representative
5.4.2 Quality management system planning
Appendix 10
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ISO 9001:2015 ISO 9001:2008
6 Planning 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning
8.5.3 Preventive action
6.2 Quality objectives and planning to achieve
them
5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system planning
7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the operation of processes 6.4 Work environment
7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring
equipment
7.1.5.1 General 7.6 Control of monitoring and measuring
equipment
7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring
equipment
7.1.6 Organizational knowledge No equivalent clause
7.2 Competence
6.2.1
General
6.2.2
Competence, training and awareness
7.3 Awareness 6.2.2 Competence, training and awareness
7.4 Communication 5.5.3 Internal communication
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Appendix 10
AP10-3
ISO 9001:2015 ISO 9001:2008
7.5 Documented information 4.2 Documentation requirements
7.5.1 General 4.2.1 General
7.5.2 Creating and updating
4.2.3
Control of documents
4.2.4
Control of records
7.5.3 Control of documented Information
4.2.3
Control of documents
4.2.4
Control of records
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization
8.2 Requirements for products and services 7.2 Customer-related processes
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements for products
and services
7.2.1 Determination of requirements related to the
product
8.2.3 Review of the requirements for products and
services
7.2.2 Review of requirements related to the
product
8.2.4 Changes to requirements for products and
services
7.2.2 Review of requirements related to the
product
8.3 Design and development of products and
services
7.3 Design and development
8.3.1 General 7.3.1 Design and development planning
8.3.2 Design and development planning 7.3.1 Design and development planning
8.3.3 Design and development inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls
7.3.4
Design and development review
7.3.5
Design and development verification
7.3.6
Design and development validation
Appendix 10
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8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development changes
8.4 Control of externally provided processes,
products and services
7.4.1 Purchasing process
8.4.1 General 4.1 General requirements
7.4.1 Purchasing process
8.4.2 Type and extent of control 7.4.1 Purchasing process
7.4.3 Verification of purchased product
8.4.3 Information for external providers
7.4.2
Purchasing information
7.4.3
Verification of purchased product
8.5 Production and service provision 7.5 Production and service provision
8.5.1 Control of production and service provision
7.5.1
Control of production and service provision
7.5.2
Validation of processes for production and
service provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or external
providers
7.5.4 Customer property
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service provision
8.5.6 Control of changes 7.3.7 Control of Design and Development
Changes
8.6 Release of products and services 7.4.3 Verification of purchased product
8.2.4 Monitoring and measurement of product
8.7 Control of nonconforming outputs 8.3 Control of nonconforming product
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Appendix 10
AP10-5
ISO 9001:2015 ISO 9001:2008
9 Performance evaluation 8 Measurement, analysis and improvement
9.1 Monitoring, measurement, analysis and
evaluation
8 Measurement, analysis and improvement
9.1.1 General 8.1 General
8.2.3 Monitoring and Measurement Processes
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit
9.3 Management review 5.6 Management review
9.3.1 General 5.6.1 General
9.3.2 Management review input 5.6.2 Review input
9.3.3 Management review output 5.6.3 Review output
10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement
10.2 Nonconformity and corrective action 8.3 Control of nonconforming product
8.5.2 Corrective action
10.3 Continual Improvement 8.5.1 Continual improvement
8.5.3 Preventive action
