(A) The purpose of this rule is to set
quality assurance requirements for
facilities licensed under Chapter 3701:1-54 of the Administrative Code. The
quality
assurance requirements of a licensee apply to the design, operation, and
decommissioning, of a facility for items and activities that are important to
safety. The
quality assurance program must include the following
elements: the design, purchase, fabrication, handling, shipping, storing,
cleaning, assembly, inspection, testing, operation, maintenance, repair,
modification of structures, systems, and components, that are important to
safety. The quality assurance requirements also apply to the
operational procedures for ensuring compliance with safety
requirements.
(D) A quality assurance program shall meet
the following:
(1) The licensee, or applicant
for a license, shall document the quality assurance program by written
procedures or instructions and shall carry out the program in accordance with
these procedures throughout the period during which the facility is licensed.
The licensee, or applicant for a license, shall identify the structures,
systems, and components to be covered by the quality assurance program, the
major organizations participating in the program, and the designated functions
of these organizations.
(2) The
licensee, or applicant for a license, through their quality assurance programs,
shall provide control over activities affecting the quality of the identified
structures, systems, and components to an extent commensurate with the
importance to safety and, as necessary, to ensure conformance with the approved
design of each facility.
(3) The
licensee, or applicant for a license, shall base the requirements and
procedures of their quality assurance program(s) on the following
considerations concerning the complexity and proposed use of the structures,
systems, or components:
(a) The impact of
malfunction or failure of the item on safety;
(b) The design and fabrication complexity or
uniqueness of the item;
(c) The
need for special controls and surveillance over processes and
equipment;
(d) The degree to which
functional compliance can be demonstrated by inspection or test; and
(e) The quality history and degree of
standardization of the item.
(4) The licensee, or applicant for a license,
shall provide for indoctrination and training of personnel performing
activities affecting quality as necessary to ensure that suitable proficiency
is achieved and maintained.
(5) The
licensee, or applicant for a license, shall review the status and adequacy of
the quality assurance program at established intervals. Management of other
organizations participating in the quality assurance program must regularly
review the status and adequacy of that part of the quality assurance program
that they are executing.
(6) The
persons and organizations performing quality assurance functions shall report
to a management level that ensures that the required authority and
organizational freedom, including sufficient independence from cost and
schedule considerations when these considerations are opposed to safety
considerations, are provided. The individual(s) assigned the responsibility for
assuring effective execution of any portion of the quality assurance program,
at any location where activities subject to this section are being performed,
must have direct authority, freedom, and access to the levels of management
necessary to perform this function.
(F) A quality assurance
program shall establish requirements for:
(1)
Procurement document control by establishing measures to assure that applicable
regulatory requirements, design bases, and other requirements which are
necessary to assure adequate quality or safety are included or referenced in
the documents for procurement of material, equipment, and services, whether
purchased by the licensee, or by the licensee's contractors or subcontractors.
To the extent necessary, the licensee, or applicant for a license, shall
require contractors or subcontractors to provide a quality assurance program
consistent with the applicable provisions of this rule.
(2) Instructions, procedures and drawings
prescribing activities affecting quality or safety by documented instructions,
procedures, or drawings of a type appropriate to the circumstances and shall
require that these instructions, procedures, and drawings be followed. The
instructions, procedures, and drawings must include appropriate quantitative or
qualitative acceptance criteria for determining that important activities have
been satisfactorily accomplished.
(3) Document control by establishing measures
to control the issuance of documents such as instructions, procedures, and
drawings, including changes, which prescribe all activities affecting quality
or safety. These measures must assure that documents, including changes, are
reviewed for adequacy, approved for release by authorized personnel, and
distributed and used at the location where the prescribed activity is
performed. These measures must ensure that changes to documents are reviewed
and approved.
(4) Control of
purchased material, equipment, and services requirements:
(a) Establishing measures to ensure that
purchased material, equipment, and services, whether purchased directly or
through contractors and subcontractors, conform to the procurement documents.
These measures must include provisions, as appropriate, for source evaluation
and selection, objective evidence of quality furnished by the contractor or
subcontractor, inspection at the contractor or subcontractor source, and
examination of products upon delivery;
(b) The licensee, or applicant for a license,
shall have available documentary evidence that material and equipment conform
to the procurement specifications prior to installation or use of the material
and equipment. The licensee shall retain or have available this documentary
evidence for the life of the facility. The licensee shall ensure that the
evidence is sufficient to identify the specific requirements met by the
purchased material and equipment; and
(c) The licensee, or applicant for a license,
or a designee of either, shall assess the effectiveness of the control of
quality by contractors and subcontractors at intervals consistent with the
importance, complexity, and quantity of the product or services.
(5) Identification and control of
materials, parts, and components by establishing measures for the
identification and control of materials, parts, and components. These measures
must ensure that identification of the item is maintained either on the item or
on records traceable to the item as required, throughout fabrication,
installation, and use of the item. These identification and control measures
must be designed to prevent the use of incorrect or defective materials, parts,
and components.
(6) Control of
special processes by establishing measures to ensure that special processes are
controlled and accomplished by qualified personnel using qualified procedures
in accordance with applicable codes, standards, specifications, criteria, and
other special requirements.
(7)
Licensee inspection by establishing and executing a program for inspection of
quality or safety related activities by or for the organization performing the
activity to verify conformance with the documented instructions, procedures,
and drawings for accomplishing the activity. Individuals other than those who
performed the activity being inspected must perform the inspection.
Examinations, measurements, or tests of material or products processed must be
performed for each work operation where necessary to assure quality. If direct
inspection of processed material or products cannot be carried out, indirect
control by monitoring processing methods, equipment, and personnel must be
provided. Both inspection and process monitoring must be provided when quality
control is inadequate without both.
(8) Test control by establishing a test
program to ensure that all testing, required to demonstrate that the
structures, systems, and components will perform satisfactorily in service, is
identified and performed in accordance with written test procedures that
incorporate the requirements of this chapter and the requirements and
acceptance limits contained in the facility. The test procedures must include
provisions to ensure that all prerequisites for the given test are met, that
adequate test instrumentation is available and used, and that the test is
performed under suitable environmental conditions. The licensee, or applicant
for a license, shall document and evaluate the test results to ensure that test
requirements have been satisfied.
(9) Control of measuring and test equipment
requirements, the licensee, or applicant for a license, shall establish
measures to ensure that tools, gauges, instruments, and other measuring and
testing devices used in activities affecting quality are properly controlled,
calibrated, and adjusted at specified periods to maintain accuracy within
necessary limits.
(10) Handling,
storage and shipping control by establishing measures to control, in accordance
with work and inspection instructions, the handling, storage, shipping,
cleaning, and preservation of materials and equipment to prevent damage or
deterioration.
(11) Inspection,
test and operating status:
(a) Establish
measures to indicate, by the use of markings such as stamps, tags, labels,
routing cards, or other suitable means, the status of inspections and tests
performed upon individual items of the facility. These measures must provide
for the identification of items that have satisfactorily passed required
inspections and tests where necessary to preclude inadvertent bypassing of the
inspections and tests.
(b)
Establish measures to identify the operating status of structures, systems, and
components of the facility, such as tagging valves and switches, to prevent
inadvertent operation.
(12) Nonconforming materials, parts and
components by establishing measures to control materials, parts, or components
that do not conform to their requirements in order to prevent their inadvertent
use or installation. These measures must include, as appropriate, procedures
for identification, documentation, segregation, disposition, and notification
to affected organizations. Nonconforming items must be reviewed and accepted,
rejected, repaired, or reworked in accordance with documented
procedures.
(13) Corrective action
by establishing measures to ensure that conditions adverse to quality, such as
failures, malfunctions, deficiencies, deviations, defective material and
equipment, and nonconformances, are promptly identified and corrected. In the
case of a significant condition identified as adverse to quality, the measures
must ensure that the cause of the condition is determined and corrective action
is taken to preclude repetition. The identification of the significant
condition adverse to quality, the cause of the condition, and the corrective
action taken must be documented and reported to appropriate levels of
management.
(14) Record keeping
requirements, the licensee, or applicant for a license, shall maintain
sufficient records to furnish evidence of activities affecting quality. The
records must include the following: design records, records of use, and the
results of reviews, inspections, tests, audits, monitoring of work performance,
and materials analyses. The records must include closely related data such as
qualifications of personnel, procedures, and equipment. Inspection and test
records must, at a minimum, identify the inspector or data recorder, the type
of observation, the results, the acceptability, and the action taken in
connection with any noted deficiencies. Records must be identifiable and
retrievable. Records pertaining to the design, fabrication, erection, facility
as built diagrams, testing, maintenance, and use of structures, systems, and
components important to safety must be maintained by or under the control of
the licensee until the director terminates the license.
(15) Auditing requirements by conducting a
comprehensive system of planned and periodic audits to verify compliance with
all aspects of the quality assurance program and to determine the effectiveness
of the program. The audits must be performed in accordance with written
procedures or checklists by appropriately trained personnel not having direct
responsibilities in the areas being audited. Audited results must be documented
and reviewed by management having responsibility in the area audited. Follow-up
action, including reaudit of deficient areas, must be taken where
indicated.
(16) Measures for the
identification and control of design interfaces and for coordination among
participating design organizations. These measures must include the
establishment of written procedures among participating design organizations
for the review, approval, release, distribution, and revision of documents
involving design interfaces. The design control measures must provide for
verifying or checking the adequacy of the design.
(a) For verifying or checking processes, the
licensee shall designate individuals or groups other than those who were
responsible for the original design, but who may be from the same
organization.
(b) Where a test
program is used to verify the adequacy of a specific design feature in lieu of
other verifying or checking the processes, the licensee shall include suitable
qualification testing of a prototype or sample unit under the most adverse
testing condition.
(c) The
licensee, or applicant for a license, shall subject design changes, including
field changes, to design control measures commensurate with those applied to
the original design. Changes in the conditions specified in the license
requires prior approval by the
director.