PIC - M. L. Gildner
FPM - P. B. Hoke
Directives Coordinator
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A hard copy of this document is valid only until the document revision number has changed on the Web. The hard copy should be dated and signed the day it is printed. If you continue working from the hard copy, you should verify its accuracy periodically on the Web or add your name to the distribution list for procedure notification any time a document in this Functional Policy Area changes.
Date Printed:_________________________ Verifier:__________________________
I. PURPOSE
This standard establishes the requirements for developing,
analyzing, and verifying designs, for controlling issuance and
revisions of design documents, and for identifying design interface
activities provided by the Oak Ridge National Laboratory,
engineering organizations or other approved design sources.
II. REQUIREMENT REFERENCES
A. DOE Order 5700.6C, Quality Assurance
B. Y/QD-15, "LMES Quality Program Description"
C. X-AD-7, "ORNL Records Management"
III. SCOPE/LIMITATIONS
This standard applies to design activities required to support
development, production, operations, modifications, environmental
tasks, projects, or programs. The selection of the controls and the
extent of their application to design-related activities are
determined during the planning process. These controls are applied
commensurate with the significance of the activity or facility, or
with the significance of its impact on health, safety, or the
environment.
IV. DEFINITIONS
None
V. REQUIREMENTS
A. Design Criteria
1. Design criteria shall be established that
a. describe the functional and physical requirements of a
project;
b. define the developmental and engineering evaluations
necessary for the establishment of the design basis; and
c. provide guidelines to evaluate, demonstrate, or
substantiate the fulfillment of design objectives.
2. Design criteria are normally based on the specific project
requirements established in the Technical Information
Supplement to the Conceptual Design Report or Preliminary
Proposal or as modified by revisions approved in a Project
Change Memorandum.
B. Design Input
1. The responsible engineering staff, working with the customer
(line) organization, shall identify, document, review, and
approve the applicable design inputs in a timely manner.
These design inputs shall include the known design bases,
performance requirements, regulatory requirements, codes,
standards, design criteria, design parameters, and other
requirements upon which detailed final design is based. The
formality of this process shall be commensurate with the
significance of the activity or facility or with its impact
on health, safety, or the environment.
2. Design inputs shall provide a basis for making design
decisions and verifications and for evaluating design
changes. Changes from approved design inputs shall include
the reason for the changes and shall be identified,
controlled, documented, and approved at the same level as the
level of the initial design input approval.
C. Design Process
1. The responsible design organization shall delineate and
document the planned design activities in a timely manner in
procedures, design standards, technical specifications,
handbooks, or other written instructions. These documents
shall provide design control measures to ensure that
a. detail is sufficient to enable the design process to be
carried out correctly and to permit verification that the
design meets the approved design input requirements;
b. the design documents are verified to be adequate to
support design, construction, and operation;
c. the appropriate standards are identified and documented,
and their selection is reviewed and approved;
d. changes from the specified standards, including the
reasons for the changes, are identified, approved,
documented, and controlled;
e. the design methods, materials, parts, equipment, and
processes that are essential to the function of the
structure, system, or component are selected and reviewed
for suitability of application;
f. the responsible design personnel have available the
applicable information derived from experience as set
forth in reports or other documentation; and
g. Lessons Learned reviews are made for all high risk design
issues.
2. The final approved design output documents with approved
changes shall reflect the design inputs in sufficient detail
to permit design verification and shall identify the
assemblies and/or components that are part of the designed
item. Additional requirements shall be specified when
commercial grade items must be modified or subjected to
additional inspections and testing to meet the requirements
of the application. The resulting component or material shall
be uniquely identified in a manner traceable to a documented
definition of the difference in the requirements.
D. Design Analyses
1. Design analyses and calculations shall be performed and
documented, and the purpose, methods, assumptions,
calculations, design inputs, references, and units shall be
sufficiently detailed so that a technically qualified person
can review and understand the analyses and verify the results
without recourse to the originator. The design analyses shall
be legible and in a form appropriate for reproduction,
filing, and retrieval.
2. Calculations shall be identifiable by subject (including the
structure, system, or component to which the calculation
applies), originator, reviewer, and date, or by other data so
that the calculations are retrievable.
3. Computer programs may be used for design analysis, provided
that they have been verified, are applied within the scope
for which they have been verified, and are used by
individuals who understand their capabilities and
limitations.
4. Computer program changes used for such design analysis or
calculations shall be controlled, and implementation of the
changes shall be verified and approved by authorized
personnel before use. Where appropriate, the program
configuration used shall be retained and shall be traceable
to the analysis.
5. Documentation of design analysis shall identify
a. the objective of the analysis;
b. design inputs and their sources;
c. results of literature searches or other applicable
background data;
d. assumptions and identification of the assumptions that
must be verified as the design proceeds;
e. computer calculations, including computer type, the
computer program used (along with its number, revision,
inputs, outputs, and evidence of or reference to computer
program verification), and the bases that support the
application of the computer program to the specific
physical problem; and
f. reviews and approvals.
E. Design Verification
1. One or more of the following measures shall be applied to
verify the adequacy of design: design reviews, alternate
calculations, or qualification tests (including appropriate
testing for computer programs). The results of design
verification shall be documented, shall identify the
verification method used and the persons performing the
verification, and shall be performed in a timely manner.
Competent individuals or groups other than those who
performed the original design shall perform the verification,
but they may be persons in the same organization.
2. Verification reviews by supervisors may be used to satisfy
the intent of this standard, provided the supervisor did not
specify or rule out a singular design approach, did not
establish the design inputs, and is technically qualified to
perform the verification. The review shall be of sufficient
depth to confirm the technical adequacy of the design and
shall be signed by the reviewer.
3. Design verification shall be performed before releasing the
design documents for procurement, manufacture, or
construction, or before releasing them to another design
organization for use in other design activities except when
this timing cannot be met (e.g., when data are insufficient).
If verification is not completed before release, the
unverified portions of the design shall be identified and
controlled. All verifications must be complete before testing
or functional operation of the component, system, structure,
or computer program.
4. Design verification extent shall be commensurate with its
importance to safety, complexity of design, degree of
standardization, state of the art, and similarity to proven
design approaches. If a design has been verified in
accordance with this standard, the verification process for
identical designs need not be duplicated. However, for each
application the applicability of standard or previously
proven designs for meeting design inputs shall be verified
and documented. Any problems with standard or previously
proven designs shall be considered in making these
verifications. For these applications and their associated
record files, the original design and design verification
measures shall be adequately documented and referenced.
5. Acceptable verification methods include but are not limited
to any one or combination of design reviews, alternate
calculations, and qualification testing.
a. Design Reviews
Design reviews shall be performed to provide assurance
that the final design is correct and satisfactory. Where
applicable, the following considerations shall be
addressed:
(1) Were the design inputs correctly selected?
(2) Are the assumptions necessary to perform the design
analyses adequately described and reasonable and,
where necessary, are assumptions identified for
subsequent reverification when the detailed
activities are completed?
(3) Were appropriate design methods and analyses used?
(4) Were the design inputs correctly incorporated into
the design?
(5) Is the design output reasonable compared to design
inputs?
(6) Are the necessary requirements for design input and
verification specified for interfacing organizations
in the design documents or in supporting procedures
or instructions?
b. Alternate Calculations
Alternate calculations shall be made where required and
shall be performed by alternate methods to verify
correctness of the original calculations or analyses or
the reasonableness of computer analysis. The alternate
calculations shall confirm the appropriateness of
assumptions, the input data used, and the computer
program or other calculation method used in the original
calculations.
c. Qualification Tests
(1) The tests shall be identified where design adequacy
is to be verified by qualification tests. The test
requirements and test configuration shall be clearly
defined, documented, and appropriately approved. To
the extent practical, testing shall demonstrate
adequacy of performance under the expected range of
design and operating conditions (including the most
adverse). Operating modes and environmental
conditions in which the item must perform
satisfactorily shall be considered in determining
the expected range of operating conditions. Where
the test is intended to verify only specific design
features, the other features of the design shall be
verified by appropriate means. Test results shall be
documented, and a designated organization shall
evaluate the results to ensure that test
requirements have been met.
(2) When qualification testing data indicate that the
item must be modified to achieve acceptable
performance, the item shall be modified, the
modification documented, and the item retested or
otherwise verified to ensure its satisfactory
performance. When tests are to be performed on
models or mockups, scaling laws shall be established
and verified. The results of model test work shall
be subject to error analysis, where applicable,
before use in final design work.
F. Change Control
1. The same level of responsible management that approved the
original design documents shall document and approve design
changes, engineering changes, or changes in final designs,
field changes, modifications of operating facilities, and
nonconforming items dispositioned "use-as-is" or "repair."
Changes shall be governed by control measures commensurate
with those applied to the original design. Evaluation of the
effects of design changes on the overall design and on any
design analysis to previously verified designs shall be
determined, verified, and documented. All design documents
shall be appropriately updated and corrected.
2. When an organization originally responsible for reviewing and
approving a design document is no longer responsible, the
owner or designee shall designate a new responsible design
organization. This new design organization shall have
demonstrated competence in the design areas of interest and
have an adequate understanding of the requirements and intent
of the original design. The review of changes shall consider
the impact of previous verifications and shall establish
reverification as required.
3. Should a significant design change be necessary because of an
incorrect design, the design process and verification
procedure shall be reviewed and/or modified as necessary.
G. Interface Control
1. Design interfaces shall be identified and controlled, and the
design efforts shall be coordinated among the participating
organizations. Interface controls shall include the
assignment of responsibility and the establishment of
procedures among participating design organizations for
reviewing, approving, releasing, distributing, and revising
documents that involve design interfaces.
2. Design information transmitted across organizational
interfaces shall be documented and controlled. Transmittals
shall identify the status of the design information provided
and, where necessary, shall identify incomplete items that
require further evaluation, review, or approval. Where it is
necessary to initially transmit design information orally or
by other informal means, the transmittal (e.g., telecon
notes, daily planner, meeting minutes) shall be documented
and confirmed promptly through some designated and controlled
means.
H. Documentation and Records
1. Design documentation and records, which provide evidence that
the design and design verification processes were performed
in accordance with the requirements of this standard, shall
be collected, maintained, and stored.
2. The documentation shall include not only final design
documents such as drawings, specifications, and revisions but
also documentation verifying that the requirements of this
standard were met and identifying the important steps,
including sources of design inputs that support the final
design and analyses that support acceptance criteria, draw
conclusions, or set forth numerical data such as design
pressure and temperature applicable to a facility or project.
VI. RESPONSIBILITIES
A. Division or Discipline Design Manager
1. establishes and maintains procedures and standards to control
design activities in accordance with this standard, ensures
that procedures and standards are implemented, and assigns
design personnel with skills and experience commensurate with
the technical complexity and difficulty of the project;
2. ensures that design inputs are documented in sufficient
detail to support design activities; and
3. ensures that design certification methods are implemented and
that the results are reflected in the final design.
B. Design Engineer (or designee)
1. is accountable for the design and technical aspects of the
project within a specific design discipline; and
2. conducts analyses, performs calculations, and prepares design
documents under design management guidance.
C. Facility Operator (or designee)
establishes requirements, initiates requests for engineering
services, participates in design reviews, approves final design,
and participates in preoperational inspections and tests.
D. Quality Assurance Specialist
1. ensures development and/or revision of functional procedures
related to engineering in the application of this standard,
2. conducts surveillances on work associated with this standard
to determine compliance with functional procedures and
quality assurance requirements, and
3. reviews and/or approves (as required) design documents
generated in the application of this standard.
VII. REQUIRED RECORDS
The documentation generated during the design functions (e.g.,
drawings, checklists, calculations, analyses, verifications) shall
become quality records and shall be processed in accordance with
X-AD-7, "ORNL Records Management."
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
PIC - M. L. Gildner
FPM - P. B. Hoke
Directives Coordinator
Directives Home
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Updated:Wednesday, 12-Feb-97 13:36:19 EST(npn)