ML17354A537
| ML17354A537 | |
| Person / Time | |
|---|---|
| Site: | Saint Lucie, Turkey Point  |
| Issue date: | 09/18/1996 |
| From: | FLORIDA POWER & LIGHT CO. |
| To: | |
| Shared Package | |
| ML17354A533 | List: |
| References | |
| NUDOCS 9706250277 | |
| Download: ML17354A537 (20) | |
Text
@PL TOPICAL QUALITYASSURANCE REPORT DESIGN CONTROL RR913 T R 3.0 Rev.
12 Draft B Date 09/18/96 Pae 1
ot 10 3.1 GENERAL RE UIREMENTS A Quality Assurance Program shall be established for design-related activities.
The design control program shall ensure that the design is defined, controlled and verified; that applicable design inputs are specified and correctly translated into design output documents; that design interfaces are identified and controlled; that design adequacy is verified by persons other than those who designed the item; and that design changes, including field changes, are governed by control measures commensurate with those applied to the original design.
Design records shall be developed to provide evidence that the design process and design verification were performed in accordance with the requirements of FPL's Quality Assurance Program.
Design records shall include design output documents and the important steps in the design effort. The intent of this documentation is to allow a technically qualified person to understand how the design was developed, and to allow that person to verify the design based on the design documentation and engineering data sources referenced therein.
Documents'nd databases designating safety related and quality related items and any revisions thereto shall be controlled in accordance with the FPL QA Program requirements.
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FPL TOPICAL QUALITYASSURANCE REPORT DESIGN CONTROL RR913 TQR 3.0 Rev.
12 Draft B Date 09/18/96 Pa e 2
or 10 3.2 IMPLEMENTATION The controlling document for the identification of safety related items shall be the FSAR.
Where the FSAR is not definitive for a specified plant, Nuclear Engineering shall-develop and maintain documents/databases identifying those items which are safety related (e.g.,
plant equipment database,
, drawings, etc).
These documents/databases shall clearly identify the boundaries of safety related systems and may take the form ofidentifying boundaries on engineering drawings. For quality related items, Nuclear Engineering shall specify explicitly those aspects of design, manufacture, procurement, installation, and testing that shall be subject to the FPL QA Program requirements, as appropriate, in the design output documents (e.g.,
Plant Change/Modification package).
The design organization's Quality Assurance Program for design control shall be approved by the FPL Quality Assurance Department prior to the release of approved design output by the design organization.
The design organization is the organization responsible for approval of design output. Quality Instructions shall be developed to delineate design control requirements governing design-related activities performed by Nuclear Engineering and for delegating activities to contractor organizations.
Design data approved by the design organization shall be transmitted in design output documents such as specificati'ons,
- drawings, and other documents defining technical requirements or in correspondence which may reference these documents.
Transmittals shall identify the status of design information or documents
- provided, and where necessary, identify incomplete items which require further evaluation, review, or approval.
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TOPICAL QUALITYASSURANCE REPORT TQR 3.0 DESIGN CONTROL RR913 Rev.
12 Draft B Date 09/18/96 Pa e
3 or
'10 A standard PC/M and numbering system shall be established and used at each plant to ensure that all PC/Ms are handled in a uniform manner and properly documented.
Nuclear Engineering shall forward, the approved PC/M to the applicable Plant Vice President.
Internal plant coordination and review of design control documents shall be controlled by approved instructions.
3.2.1 Design Process The design organization shall specify and document its design activities to the level of detail necessary, to permit the design to be developed in a correct manner and to. permit verification that design output documents satisfy design input requirements.,Design
- methods, materials,
- parts, equipment and processes, including those associated with commercial grade items that are essential to the function of the item. shall be selected, reviewed and approved for suitability of application by the design organization.
Design inputs shall be identified, documented, reviewed and approved'y the design organization.
They shall be specified to the level of detail necessary to permit the design activity to be carried out in a correct manner, and to provide a consistent basis formaking design-related decisions, performing design verification and evaluating design. changes.
Changes.-to approved design inputs, including the reason for the changes, shall be approved, documented and controlled by the design organization.
The design organization shall identify aspects of manufacture, construction, inspection and testing critical to achieving the function of the item.
Quality standards and quality requirements shall be specified on design output documents.
Changes from approved quality-requirements specified in design output, including the reason for the changes, shall be approved, documented and controlled by the design organization.
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APL TOPICAL UALITYASSUIUNCE'REPORT DESIGN CONTROL RR913
'TQR 3.0 Rev.
12 Draft B Date 09/18/96 Pae 4
ot 10 Design analyses shall be controlled and documented.
Approved design output documents and approved changes thereto shall"be relatable to the design input by documentation in sufficient detail to-permit verification. The design organization shall establish procedures to review industry design experience.
As appropriate, this experience shall be made available to cognizant design personnel.
3.2;2 Design Change Control Changes to approved design output documents, including field changes, shall be justified,, subjected to control measures commensurate with those applied to the original design, and shall be reviewed and approved by the same design organization that approved the original design unless other organizations are specifically desi'gnated:
Where a significant design change is necessary.
because of an incorrect design, Nuclear Engineering shall determine the cause of the incorrect design.
As necessary, design and verification procedures shall be reviewed and modified to correct the cause of the incorrect design.
Design changes shall be reviewed to ensure that implementation of the design change is coordinated with any necessary changes to operating procedures and practices, and required Nuclear Assurance activities, such as inspections and surveillances.
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TOPICAL QUALITYASSURANCE REPORT DESIGN CONTROL RR913 TQR 3.0 Rev.
12 Draft B Date 09/18/96 Pa e 5
ox 10 3.2.3 Design Interface Control Quality Instructions shall establish interface controls between participating organizations and between the various technical disciplines within the design organization.
These Quality Instructions shall include the assignment of responsibility, and. be in sufficient detail to cover the preparation,
- review, approval, release, distribution and xevision of design output documents.
For interdisciplinary design, approval. documentation of eachinvolved discipline of the design organization shall appear on the design output document or on a separate document directly traceable to the design output.
The design organization shall designate a discipline(s) responsible for resolution of the comments ofparticipating organizations.
The designated discipline(s) approval of a design output shall also document resolution of the comments of participating organizations.
3.2.4 Design Verification Design control measures shall be established to independently verify the design inputs, design
- process, and that design inputs are correctly incorporated into design output.
The design organization shall develop instructions that govern design verification. These instructions shall require that the design organization identify and document the verification method utilized and that the documentation clearly identify those individuals performing the design verification.
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TOPICAL UALITYASSURANCE REPORT DESIGN CONTROL RR913 TQR 3.0 Rev.
12 Draft B Date 09/18/96 Pa e 6
or 10 Design verification shall be performed by technically qualified individual(s) or group(s) other than those who performed the design.
The original designers and verifiers may both be from the design organization.
Design verification by the designer's immediate supervisor shall be limited to those instances where the supervisor is the only qualified individual available within the design organization.
These instances are further restricted to designs where the supervisor did not specify a singular design approach, or did not restrict design methods or alternatives, or did not specify design inputs (unless the specified design inputs have already been independently verified).
Justification for verification by the designer's immediate supervisor should be documented along with the extent of the supervisor's involvement in the design.
The design organization shall be responsible for determining the extent of design verification and methods to be employed.
The, methods.may include one or more of the following:
the performance of design
- reviews, the use of alternate calculations, or the performance ofqualification tests.
This shall apply to original design and to changes to approved design output.
Where reverification is not required for a design
- change, the bases shall be documented by the design organization.
Cursory supervisory reviews and mathematical checks for calculation accuracy do not satisfy the independent design verification requirement.
Design verification shall normally be completed prior to release of design output for procurement, manufacture or release by the design organization for use in design activities by a
participating organization.
Verification shall be conducted based on. the status of design at the time of release of design documents.
Where this timing cannot be met, verification may be deferred provided that the unverified portion of the design output, and all design output documents, structures, systems and components based on the unverified
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TOPICAL UALITYASSURANCE REPORT T R30 DESIGN CONTROL RR913 Rev.
12 Draft B Date
'09/18/96 Pa e 7
or 10 portion of design are identified and controlled.
In all cases verification shall be completed prior to relying on any affected;items to perform their design functions.
3.2.5 Computer Programs/Software Organizations developing software or utilizing purchased or FPL developed computer programs/software in the performance of activities affecting quality as defined in the TQAR, shall maintain instructions or procedures to effect the following:
a.
That such programs/software within the scope of the quality assurance program are identified and included in a computer software index. The controlled distribution of this index, electronic or hard copy, shall include h M, D
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Operations.
The method for determining which programs/software fall within the scope of the QA program shall be described in these procedures or instructions; b.
That such programs/software are verified for their particular use using benchmark problems, alternate calculations, comparison with other code or experimental results, requirements and/or design weview reviews or similar methods; That such programs/software have been. qualified for.,their specific application sufficient to ensure valid results; That such. programs/software are provided with user instructions sufficient for a technically competent individual to follow; That configuration controls are provided to assure that such programs/software changes or. modifications are documented and controlled; That errors in such programs/software are identified, evaluated, provided with a disposition and corrected.
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TOPICAL QUALITYASSUI~CE REPORT TQR 3.0 0
DESIGN CONTROL RR913 Rev.
12 Draft B Date 09/18/96 Pa e 8
or 10 3.3 RESPONSIBILITIES a.
Determining and documenting which items are nuclear safety related or quality related; b.
The review and coordination of design interfaces; c.
Assuring that design documents are reviewed for possible design interfaces; that interface problems are resolved and that design criteria and design interface changes are reviewed by participating organizations prior to approval of design documents; d.
Preparing design documents, including performing the safety evaluation or screening to determine if the proposed design change involves an Unreviewed Safety, Question or,a change to the Technical. Specifications; e.
Performing design verification, including evaluation of the effects of proposed'design changes on overall design adequacy (design integration);
f.
Providing Nuclear Engineering approval of design documents; g.
Updating design documents and drawings according to applicable procedures; h.
Coordinating the NRC interface for 10 CFR 50.59'reports.
3.3.2 The Plant-Qte Vice President is responsible for:
a.
Reviewing, tracking the status of, and maintaining a file on.proposed PC/Ms; Reviewing proposed PC/Ms for inclusion of appropriate quality criteria, standards, and hold points, including human. factors considerations for design changes involving the Control Room or Remote Shutdown Panel; reviewing completed PC/Ms, after implementation for compliance with governing procedures, including a review of all endorsements, sign-offs, completion of required acceptance testing/inspection, and any necessary changes to operating practices and procedures;
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TOPICAL UALITYASSURANCE REPORT TQR 3.0 DESIGN CONTROL RR913 Rev.
12 Draft B Date 09/18/96 Pa e
9 of 10 d.
maintaining design documents as Quality Assurance records.
e.
assuring that all plant design changes and drawing changes are coordinated through Nuclear Engineering; f.
determining whether or not a proposed design change affects nuclear safety; g.
approving or disapproving implementation of the proposed design change after receipt of a recommendation from the Plant Nuclear Safety Committee (PNSC) or Facility Review Group (FRG);
ensuring'nvironmental Services is included in the proposed PC/M review ifthe design change may have an adverse impact on the environment; reviewing design changes to ensure that the implementation of the design change is coordinated with any necessary changes to operating practices and procedures.
3.3.3 The Plant Nuclear Safety Committee (PNSC) or Facility Review Group (FRG) is responsible for:
a.
Reviewing all proposed PC/Ms for plant systems or equipment related to nuclear safety; Rendering a determination in writing (PNSC/FRG meeting minutes) as to whether or not the proposed design change constitutes an Unreviewed Safety Question.
RR917 3.3.4 The Director Nuclear Assurance is responsible for:
a.
reviewing PC/Ms and other FPL originated design specifications for inclusion of appropriate quality criteria, standards, hold points, and Nuclear Assurance activities.
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TOPICAL QUALITYASSURANCE REPORT T R 3.0
,DESIGN CONTROL RR913 Rev.
12 Draft B Date 09/18/96 Pa e
10 Of 10 3.3.5 The Company Nuclear Review Board (CNRB) is responsible for:
a.
Reviewing Safety Evaluations for design changes to verify that the design changes did'not constitute an Unreviewed Safety Question.
CNRB review of evaluations involving screening rather than 'Safety Evaluation is not mandatory; b.
Reviewing, proposed design changes which involve an Unreviewed Safety Question or a change in Technical Specifications or License.
3.3.6 Each direct report to the President, Nuclear Division and Department Heads of organizations supporting the Nuclear Division shall be responsible for:
a.
identification of computer programs/software used to accomplish activities affecting quality;.
b.
establishment ofdepartmental instructions which prescribe the methods and techniques used to meet the QA program requirements for control of computer programs/software.
3.3.7 IN II ~y I I I (IT) Operations is responsible for evaluating all hardware or operating system software changes or problems occurring on computer systems under 84 IT Operations control to determine ifthe answers produced or the integrity of data maintained in databases may be affected.
If 84 IT Operations determines applications may be affected, then he/she R@ IT Operations is responsible for notifying user departments.
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