ML20262G981
| ML20262G981 | |
| Person / Time | |
|---|---|
| Site: | 07201032, 07109378, Holtec |
| Issue date: | 09/14/2020 |
| From: | Jon Woodfield NRC/NMSS/DFM/IOB |
| To: | Soler M Holtec |
| JNWoodhouse NMSS/DFM/IOB 301.415.8727 | |
| References | |
| IR 2020201 | |
| Download: ML20262G981 (13) | |
Text
Digitally signed by Leira Y. Cuadrado-Leira Y. Cuadrado-Caraballo Caraballo Date: 2020.09.15 09:03:47 -04'00'
Leira Y. Cuadrado- Digitally signed by Leira Y. Cuadrado-Caraballo Caraballo Date: 2020.09.15 09:04:27 -04'00'
Inspection History The last and only prior inspection of the Holtec Orrvilon facility in Ohio was November 17-19, 2015 (ML15356A799). The inspection was conducted to determine if fabrication activities were performed in accordance with the requirements of 10 CFR Parts 21, 71, and 72; the applicable Certificate of Compliance, Safety Analysis Report, and Holtecs NRC-approved quality assurance program. The team examined and witnessed selected fabrication, assembly, and test activities and reviewed numerous quality procedures, as well as quality records. Overall, as a result of the inspection, the team assessed that Holtec Orrvilons fabrication activities, and Holtecs oversight of the fabrication activities, were adequate in meeting their QA Program requirements as well as NRC QA requirements. No violations of NRC requirements were identified.
Inspection Purpose The purpose of the Orrvilon inspection was to assess Holtecs compliance with 10 CFR Parts 21, 71 & 72 and to verify that the transportation and storage systems, for which Holtec is the holder of a CoC, can be verified to comply with Part 71 & 72 in design, procurement, and fabrication requirements, as applicable. The focus of the inspection was to determine whether Holtec Orrvilon activities associated with the transportation and storage of radioactive materials are in accordance with their NRC-approved QA program requirements. The Orrvilon facility is a relatively new Dry Cask Storage System (DCSS) and transportation packaging Holtec manufacturing facility and this was only the second inspection by the NRC. The Part 72 DCSS and Part 71 transportation packaging component manufacturing performed at the Orrvilon facility was primarily limited to the fabrication of multipurpose canister (MPC) and transportation packaging basket assemblies from metal Metamic-HT material. The only major production welding currently being performed was on the fabricated MPC and transportation packaging basket assemblies using the friction stir welding special process. Therefore, the scope of the inspection was essentially limited to the Holtec Orrvilon management controls, design controls, and fabrication controls for the MPC and transportation packaging basket assemblies.
Primary Inspection Procedures/Guidance Documents IP-60852, ISFSI Component Fabrication by Outside Fabricators IP-60857, Review of 10 CFR 72.48 Evaluations IP-86001, Design, Fabrication, Testing, and Maintenance of Transportation Packagings NUREG/CR-6314, Quality Assurance Inspections for Shipping and Storage Containers NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material INSPECTOR NOTES: APPLICABLE SECTIONS FROM IPs 60852 & 86001 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314 4.1 Management Controls 4.1.1 Quality Assurance Policy Page 2 of 12
The team reviewed Holtec's Quality Assurance Manual (HQAM) Revision 14 and implementing Holtec Quality Procedures (HQP) and assessed the effectiveness of the Quality Assurance (QA) program implementation at Orrvilon. The team discussed portions of the reviewed documents with selected Orrvilon staff to determine whether activities subject to 10 CFR Part 71 and 72 were adequately controlled and implemented under Holtec's NRC approved QA program.
Further, the team reviewed the Orrvilon quality organization chart and interviewed Holtec QA personnel to assess their organizational independence from cost, schedule, and production activities.
The team reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activities. Specifically, the team reviewed HQP-1.0, "Organization and Responsibilities," Revision 44, and Holtec Standard Procedure HSP-100203,
Training Program," Revision 0. The team reviewed the qualifications and training for selected Quality Engineers to determine if they met the requirements stated in the QA program. In addition, the team reviewed training records of a random selection of employees in quality related positions to determine if they received the required QA indoctrination and annual refresher training. The team found that for every Orrvilon QA staff member's records reviewed, each had completed the required training and attained the applicable qualifications to perform their duties.
The team determined that quality assurance controls at Orrvilon were adequate and in accordance with their NRC approved QAP, with no concerns.
4.1.2 Nonconformance Controls and Corrective Action Controls The team reviewed Holtec's QAM and the following implementing procedures for its nonconformance program, corrective action program, and Part 21 reporting:
- HSP-100401, "Purchase Requisitions," Revision 2
- HSP-101501, "Reporting of Defects and Noncompliances per 10 CFR 21," Revision 0
- HSP-101502, "Nonconformances," Revision 1
- HSP-101601, "Conditions Adverse to Quality and Corrective Action," Revision 2 The team reviewed Orrvilon's nonconformance program to assess the effectiveness of controls established for the processing of nonconforming materials, parts, or components. HSP-101502 requires a Nonconformance Report (NCR) be issued whenever a nonconforming condition is identified on a material, item, component or equipment. The NCR is then reviewed by the Orrvilon QA department for completeness and procedure compliance. An electronic log is maintained for all NCRs.
The team reviewed a sampling of NCRs written since the last inspection at Orrvilon that involved Important-to-Safety (ITS) items that had been dispositioned as use-as-is. The team confirmed that NCRs with this disposition received the required review and approval by Orrvilon Quality Assurance and Holtec headquarters as evidenced on the Orrvilon NCR form and associated Holtec headquarters Supplier Manufacturing Deviation Report (SMDR) form. No concerns were identified by the team in the processing of NCRs by Orrvilon and through Holtec headquarters when required.
The team reviewed the Holtec/Orrvilon corrective action program to assess the effectiveness of controls established for the processing of conditions adverse to quality. Holtec/Orrvilon in HSP-Page 3 of 12
101601 uses a three-tier process for categorizing and documenting conditions adverse to quality (CAQ). All Issues defined as potential CAQs are entered as a Quality Issue (QI) on a Quality Issue Form (QIF) except for manufacturing deviations which use the NCR process.
During the evaluation of the QI, the significance of the CAQ is determined as well as the risk and level of uncertainty. Based on this evaluation, the investigation class is determined and the type of investigation (close to immediate action, apparent cause, or root cause) is performed and completed. Significance Levels range from 1 through 4 with 1-3 categorized as events or conditions that result in major, moderate, or minor impact; respectively. Significance level 4 is considered a low-level problem and 5 only a concern or recommendation.
The team reviewed a sampling of Quality Issue reports on QlFs for compliance to HSP-101601.
For all the QIFs reviewed, conditions adverse to quality were adequately documented. Each QI report included the determination and recording of the significance, risk, and uncertainty levels.
The evaluation of the investigation class (A-D) was documented and the type of investigation was completed. The Qls reviewed included corrective actions and actions to prevent recurrence of the issue as necessary. The team found the actions taken appropriate and completed in a timeframe commensurate with the issue's importance.
The team specifically reviewed the closure of QIF 1926 which was written to address issues found with Measuring & Test Equipment (M&TE) during the previous inspection. The team assessed that appropriate actions were taken to address the issues and the QIF properly closed.
Overall, no concerns were identified with the Holtec/Orrvilon corrective action program and the team assessed that CAQs were appropriately documented, evaluated, corrected, and closed.
The team also assessed how the requirements of 10 CFR Part 21 were being implemented for the fabrication activities being performed at Orrvilon. Orrvilon has responsibility for performing Part 21 assessments for work performed at Orrvilon. The QA department reviews NCRs for potential 10 CFR Part 21 reportability and shall also determine whether a QIF needs to be issued. Orrvilon stated that there had not been any 10 CFR Part 21 reports made by Orrvilon as of the time of the inspection.
The team reviewed the training records of five Orrvilon employees where they had signed off receiving general training in 10 CFR Part 21 per the requirements of HSP-101501.
Holtec/Orrvilon would be responsible for 10 CFR Part 21 when dedication activities are required for safety related or ITS Category A items or services. HSP-100401 contains appendix 8.1 which is a checklist to be attached to a purchase order (PO). The checklist has an item to check if 10 CFR Part 21 reporting applies to the PO. The team reviewed a PO for materials.
HSP-101501, states that the QA Manager shall post a copy of HSP-101501, a copy of 10 CFR Part 21, and Section 206 of the Energy Reorganization Act of 1974 in a conspicuous location on the Holtec (Orrvllon) premises. The postings were posted in accordance with HSP-101501.
The three required 10 CFR Part 21 postings were posted on a bulletin board in the Orrvilon craft lunchroom and on a bulletin board on one side of the shop. The team found the postings to be the current 10 CFR Part 21 issued regulations. No concerns were identified by the team regarding 10 CFR Part 21 assessment, reporting, or posting.
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4.1.3 Documentation Controls Holtec's corporate headquarters in Camden, New Jersey has the primary responsibility for document controls at Holtec International. The Holtec Manufacturing Division (HMD) and Orrvilon have access to controlled documents in the Holtec document control system through the Holtec corporate headquarters electronic computer system. The Orrvilon manufacturing facility is responsible for entering quality records associated with the products it manufactures into the Holtec document control system.
The team reviewed the document control section 6.0 of the HQAM Revision 14 and the HQPs that address document controls to verify they are being properly implemented. The team specifically reviewed the following procedures associated with document control and quality records:
- HQP-6.0, "Document Control," Revision 14
- HQP-17.0, Quality Assurance Records, Revision 27
- HSP-100601; Document Transmittal and Classification, Revision 0 The team reviewed a sample of documents issued and revised by Holtec headquarters to determine if the controls on those documents were adequate and performed in accordance with approved quality procedures. The team reviewed HQP-6.0 and discussed the document control process with Orrvilon QA personnel. The team determined that adequate controls were in place to ensure that 1) document approval could only be performed by qualified personnel; 2) all technical departments reviewed the original issuance of a quality document for applicability to their discipline; 3) revisions must be approved by the original signatories; and 4) old document revisions are clearly separated from the current revision and a database is kept up to date with the current revision number.
The team also briefly discussed the requirements of HQP-17.0 with Orrvilon QA personnel and how the applicable regulatory and procedural requirements for quality record control were being implemented by Holtec's QA program. The team determined that Orrvilon's quality record controls were adequate and met the requirements stated in HQP-17.0 and the applicable regulations.
The team discussed with Orrvilon QA and PM personnel how all MPC basket assembly quality records are compiled into a sub-documentation package which is then added to the final MPC documentation package. The team reviewed a totally completed basket assembly documentation package for a MPC-89 Basket and had no concerns.
The team determined that adequate document control and quality records management exist at Orrvilon. No concerns were identified by the team in the Orrvilon documentation control area.
4.1.4 Audit Program The team reviewed Holtecs internal audit and vendor surveys to determine if Holtec scheduled, planned, and performed internal audits and vendor surveys in accordance with approved implementing procedures. Specifically, the team reviewed the following HSPs and HQAM sections associated with internal audits, surveillances, and vendor surveys:
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- Holtec QA Manual, Section 7.0, Control of Purchased Materials, Equipment, and Services, Revision 14
- Holtec QA Manual, Section 18.0, Quality Assurance Audits, Revision 14
- HSP-100702, Vendor Surveillances, Revision 1
- HSP-100704, Approved Vendor List, Revision 4
- HSP-101801, Certification of Audit Personnel, Revision 0
- HSP-101802, Audits, Revision 3
- HSP-101803, Internal QA Surveillance and Document Reviews, Revision 0 The team selected internal audits from the last five years, particularly related to Orrvilon Manufacturing. The team reviewed the audit and surveillances results to determine if Holtec identified deficiencies and addressed the deficiencies with their corrective action program.
Overall, the team assessed that for the internal audits and vendor surveys sampled, Holtec generally conducted audits with qualified and certified personnel, scheduled and evaluated all applicable elements of their QA program. This included the management review of the QA program.
4.2 Design Controls 4.2.1 Design Development The team reviewed Holtecs processes and procedures to evaluate the design control measures used at Orrvilon Manufacturing for important to safety (ITS) fabrication activities of Holtecs Multipurpose Canister (MPC) spent fuel and transportation packaging baskets. The team reviewed selected drawings (DWGs), specifications, and quality records to verify how Holtec provided control of the design process from the onset of the design development and modifications of Orrvilons fabrication activities. The team focused its review on the translation of the design specification and design drawings to the fabrication drawings and the corresponding design controls that were in place. The team reviewed Holtecs procedures specifically related to design development, and control of modification activities. The team focused its review on Holtecs design activities related to the MPC fuel basket models 68M, 89, 89CBS.
The team reviewed the following Holtec standard procedures and HQAM section associated with design control to verify that Holtec personnel implemented the procedures properly. The procedures are as follows:
- Holtec QA Manual, Section 3.0, Design Control, Revision 14
- HSP-100202, "Project Planning Product Realization and Project Execution," Revision 2
- HSP-100302, "Design Specifications and Design Criteria Documents," Revision 0
- HSP-100501, Engineering Drawings, Revision 4 The team also reviewed selected licensing drawings to verify that Holtec adequately translated the design details of the engineering drawings to the associated fabrication drawings.
Specifically, the team reviewed design specifications, licensing drawings, engineering drawings, and fabrication drawings. The team also compared the licensing drawings to the related fabrication drawings.
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- PS-101, Procurement Specification for the Fabrication of Holtec HI-STORM MPCs, Revision 75
- PS-301, Procurement Specification for the Fabrication of MPC-32ML, MPC-37, and MPC-89 for the HI-STORM FW, Revision 11
- Licensing DWG No. 7195, Assembly, Fuel Basket, MPC-68M, Rev. 17
- Fabrication DWG No. 9220, Assembly MPC-68M Fuel Basket, Sheets 1-14, Rev. 14
- Licensing DWG No. 6507, Assembly, MPC-89 Fuel Basket, Rev. 16
- Fabrication DWG No. 8689, Assembly MPC-89 Fuel Basket, Sheets 1-14, Rev. 14
- Licensing DWG No. 12030, Assembly, MPC-89CBS Fuel Basket, Rev. 1
- Fabrication DWG No. 11873, MPC-89CBS Basket Assembly, Sheets 1-24, Rev. 4 Additionally, the team reviewed engineering change orders (ECOs) related to fabrication modification changes for the MPC-68M (ECO 101-32, Rev. 0) and MPC-89 (ECO 1021-147, Rev. 0).
The team assessed that overall, Holtec was effectively implementing its design control program and that implementing procedures were in place and effective in controlling activities in accordance with the applicable regulations and Holtecs NRC approved HQAM. The team concluded that Holtec processed and developed project plans and fabrication drawings in accordance with the applicable quality procedures.
4.2.2 Modifications Holtec International is responsible for all MPC and transportation packaging basket design modifications and any analysis justifying the changes. Orrvilon would only be concerned when receiving design changes to Holtec fabrication drawings. Orrvilon Project Managers (PM) would know the revision was coming since they would be one of the fabrication drawing revision approvers. Orrvilon PMs review fabrication drawing changes for effects on existing travelers in the field. Travelers would be revised if required. Orrvilon craft have to verify the most current revision of a fabrication drawing they are working with at computer stations in the shop facility prior to every shift. The craft are locked out from charging the project until the revision check is made. The craft would also have access to the revised fabrication drawing itself at the computer station. The craft have read only access to the computer system to check revisions.
If there are no required changes to travelers, nothing would have to be removed from the field as the craft would just use/work to the latest fabrication drawing revision in the computer system.
The team identified no concerns with the Orrvilon process for placing Holtec basket assembly fabrication modifications into production.
4.3 Fabrication Controls 4.3.1 Material Procurement The Metamic-HT material is a metal composite material of proprietary specifications manufactured at the Orrvilon fabrication facility using raw powdered materials. The raw powdered materials have either been purchased commercial grade and dedicated to ITS Category A quality or purchased ITS Category A from a vendor on the Holtec/Orrvilon Approved Vendor List (AVL).
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The team reviewed the following Holtec/Orrvilon procedures and documents specifically related to procuring the raw material used to manufacture the Metamic-HT metal composite product:
- Holtec International Quality Assurance Manual, Section 4.0 Procurement Document Control, Section 7.0 Control of Purchased Material, Equipment, and Services, Section 8.0 Identification and Control of Materials, Revision 14
- HQP-7.0, Control of Purchased Items and Services, Revision 21
- HQP-8.0, Identification and Control of Items, Revision 9
- HSP-100401, Processing of Purchase Orders, Revision 2
- HSP-100402, Purchase Specifications, Revision 2
- HSP-100701, Receipt Inspection, Revision 5
- HSP-100704, Approved Vendor List, Revision 4
- HSP-100705, Procurement of Items and Services from Unqualified Vendors, Revision 2
- HSP-100706, Controls to Eliminate Potential Receipt and Use of Counterfeit and Fraudulent Items, Revision 0
- PS-11, Purchase Specification for Metamic HT, Revision 18
- PS-12, Purchase Specification for Metamic HT Aluminum Powder, Revision 5
- PS-13, Purchase Specification for Boron Carbide Powder, Revision 2
- PS-570, Purchase Specification for the Fabrication of MPCS Using Continuous Basket Shims (CBS), Revision 0 The team reviewed procedures, selected drawings and records, and interviewed selected Orrvilon personnel associated with the in-house manufacturing of the Metamic-HT material, to verify that the procurement specifications for the raw powdered materials met the Metamic-HT design requirements. The team reviewed selected manufacturing travelers for critical shop operations used in the manufacturing of the Metamic-HT metal plate sheets to be used in the assembly of the MPC baskets; including documentation to verify Metamic-HT material traceability from powder to basket assembled piece parts. The team reviewed a dedication report for the aluminum powder procured from an unqualified vendor from China. For all basket assembly cases reviewed at Orrvilon, the team determined that the in-house manufactured Metamic-HT material met the design specifications and the formed plates were traceable to the serial number of the specific Utility Customer MPC CoC model in which it was to be used.
In addition, the team observed quality activities associated with material control in the processing of the Metamic-HT material into plate form. The team reviewed associated process control inspection reports, materials records for the in-process cutting to the required pattern of the stock Metamic-HT plate, and verified that the materials were controlled, verifiable, and traceable from the time of powder purchase through final basket fabrication. No concerns were identified by the team.
4.3.2 Fabrication and Assembly The team interviewed Orrvilon personnel and reviewed documentation of fabrication activities affecting safety aspects of MPC basket assemblies to verify that the activities were performed in accordance with approved methods, procedures, specifications, and purchase order requirements. The team reviewed documentation associated with forming of the Metamic-HT billets, extrusion of the billets into plate, in-process fabrication/waterjet cutting, and assembly operations.
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The team reviewed the following Holtec/Orrvilon procedures specifically related to fabrication and assembly at Orrvilon:
- Holtec International Quality Assurance Manual, Section 9.0 Control of Special Processes, Section 13.0 Handling, Storage, and Shipping, Revision 14
- HQP-9.0, Control of Special Processes, Revision 0
- HQP-13.0, Packaging, Shipping, Handling and Shipping, Revision 2
- HSP-314, Cleaning of Fabricated Components and Finished Products, Revision 15
- HSP-315, Packing, Shipping, Storage of Fabricated and Finished Products, Revision 14
- HSP-621, Powder Batching & Blending of Metamic HT, Revision 19
- HSP-622, Mold Filling & Preparation Procedure, Revision 10
- HSP-623, Cold Isostatic Pressing, Revision 8
- HSP-624, Mold Assembly Washing & De-molding, Revision 10
- HSP-625, Sintering Furnace Operating Instructions, Revision 7
- HSP-626, Metamic HT Extrusion Procedure, Revision 17
- HSP-630, Requirements for Welding of Metamic HT, Revision 13
- HSP-1110, Control and Issuance of Weld Filler Material, Revision 4
- HSP-101503, Manufacturing Condition Control, Revision 3 The team noted that a Holtec/Orrvilon approved traveler was initiated for each Metamic-HT plate configuration to ensure high standards of fabrication and assembly control. Travelers were sufficiently detailed to include recording latest fabrication drawing revisions, latest specification revisions, hold points and witness points, recording Metamic-HT batch ticket number, recording Metamic-HT mix identification number, mix design report, recording plate sample testing information, recording plate sample mechanical strength test results, and steps for performing fabrication work and recording inspection results. Each step of the travelers were signed off by a QC technician when the step was satisfactorily completed.
The team reviewed a sampling of records of completed MPC baskets and observed work in progress of assembling individual Metamic-HT plates into MPC baskets to verify that the process was adequately controlled.
The team was unable to observe the friction stir welding process during the inspection.
However, the team reviewed the latest revisions to the friction stir and GTAW weld procedure specifications and associated weld procedure qualification records. The team reviewed the welding operator performance qualification test records and continuity records for two welders that perform friction stir and GTAW welding. The team determined that the friction stir welding operators were trained, certified, or qualified to perform this fabrication activity based upon review of each individuals training records or certifications.
The team reviewed a purchase order to a weld material supplier and verified the supplier was on the AVL. In addition, the team verified the proper storage of weld filler material on site.
Orrvilon has developed a process for reusing scrape metamic plate since the previous inspection. The team reviewed in detail the process of chipping the scrape material into very fine pieces [called macrodispersoid (MD) granules], material traceability of the reprocessed material, and chemistry testing of it. In addition, the team discussed with Orrvilon staff the Page 9 of 12
controls and testing required to mix MD with new powder to make metamic billets and assessed that the process was adequate.
The team assessed Orrvilons implementation of fabrication practices, assembly processes, and material storage controls to be adequate with no concerns identified.
4.3.3 Test and Inspection The team reviewed the following Holtec/Orrvilon procedures specifically related to testing and inspections at Orrvilon:
- Holtec International Quality Assurance Manual, Section 10.0 Inspections, Section 11.0 Test Control, Section 14.0 Inspection, Operating, and Test Status, Revision 14
- HQP-10.0, Control of Inspection Activities, Revision 9
- HQP-11.0, Test Control, Revision 25
- HQP-14.0, Inspection, Testing and Operating Status, Revision 14
- HSP-101, In-Process and Final Inspection/Verification Procedure for the Fabrication of the MPCs, Revision 63
- HSP-628, Metamic HT Sampling Plan, Revision 9
- HSP-638, Metamic HT Friction Stir Welding (FSW) Visual Inspection Procedure, Revision 0
- HSP-100203, Training Program, Revision 0
- HSP-100901, Written Practice for Qualification of NDE Personnel, Revision 5
- HSP-100902, Control of Welding Activities, Revision 0
- HSP-100903, Control and Qualification of NDE Procedures, Revision 0
- HSP-101001, Qualification of Inspection Personnel, Revision 1
- HSP-101002, Control of Inspection Activities, Revision 0
- HSP-101401, Inspection, Test and Operating Status, Revision 0 The team observed a selected sampling of fabrication activities for the Metamic-HT plate into MPC baskets; which included, in process and final visual examinations as well as in process material storage controls. The team verified that all phases of the fabrication, inspection, and storage processes were properly controlled and implemented. The teams observations or review (if no on-going activities) of fabrication testing and inspection activities included extruding of Metamic-HT billet into plate, waterjet cutting of the plate, MPC basket assembly, friction stir welding of the MPC basket assembly, MPC basket plate mechanical testing, and final basket visual and dimension inspection.
The team toured the Orrvilon facilitys testing laboratory and discussed with a lab technician how they perform a chemical analysis of the Metamic-HT powder mixture to assure that the composite material met the Holtec/Orrvilon proprietary design requirements.
The team reviewed the certifications of selected QC personnel and verified that they were qualified and certified. For observed and reviewed fabrication activities, the team determined that Orrvilon personnel were trained, certified, or qualified to perform those fabrication activities based upon review of each individuals training records or certifications.
The team focused on the procedures and drawings that addressed basket panel gaps as Orrvilon had issues with these gaps in the past. The current procedures for inspecting panel Page 10 of 12
gaps were adequate and the team assessed after reviewing recent gap inspection documentation that excessive panel gaps were no longer a significant panel fabrication or basket assembly concern.
The team determined that Orrvilons testing and inspections were structured, controlled, verifiable, well documented, and retrievable from the beginning of the metal Metamic-HT manufacturing phase through final fabrication. The team assessed that test and inspection activities were acceptable with no concerns identified.
4.3.4 Tools and Equipment The team reviewed Holtec quality procedure HSP-101201, Control of Measuring and Test Equipment, Revision 4, to verify that it was being properly implemented on the Orrvilon MPC and transportation packaging basket projects. HSP-101201 states that M&TE calibration may be performed by Orrvilon or an approved outside service vendor.
HSP-101201 further states that all tools to be calibrated are scheduled for calibration through the Orrvilon Tool and Equipment computer Calibration Database. All Orrvilon M&TE is in a computer database which tracks all M&TE information and can print a calibration due schedule; which will include the M&TE identification description, serial numbers, calibration due date, and department assigned location. HSP-101201 also states a calibration sticker shall be attached to each M&TE or its container listing the identification number, date calibrated, and due date for re-calibration. Each QC inspector is required to document the Orrvilon calibration serial number of the measuring and test equipment used for an item acceptance inspection on a fabrication traveler.
When a M&TE device is found discrepant during calibration, all items checked using that particular M&TE shall be considered unacceptable and an evaluation of the impact of the out of calibration condition shall be completed. The evaluation shall be documented and when it is determined that no adverse impact on items exists, the evaluation shall be attached to the calibration record or documented on a Condition Report. Condition Reports are used to document conditions that are not CAQs at Orrvilon.
When an M&TE is found unacceptable during a periodic check, all items measured since the last periodic check shall be re-inspected or a Condition or Nonconformance Report shall be issued to evaluate the impact on previously inspected items. All items inspected with the unacceptable M&TE are placed on hold until resolution is completed.
The team interviewed the Quality Control individual responsible for administrating the Orrvilon M&TE program and maintaining the M&TE database through the Orrvilon computer software.
The QC individual demonstrated using the database on a computer screen a listing of all the M&TE requiring near term calibration. The list included the devices description, department assigned to, its serial number, and next calibration due date. For some of the generic M&TE devices in the database, for example a gage, there were several units and models listed with unique serial numbers. The QC individual demonstrated how calibration documentation from outside vendors could be scanned into the computer database system and associated with an M&TE device. The QC individual also demonstrated how queries could be made from the database for various M&TE information. The team reviewed the certification records for the QC individual that administers the M&TE program and found them acceptable.
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The team reviewed Holtec/Orrvilon procedure HSP-101202, Calibration of Measure and Test Equipment, Revision 7, which provided instructions to Orrvilon QA/QC personnel on how to perform all generic M&TE calibrations performed in-house The team reviewed the current calibration documentation/records for the following nine M&TE devices that were actually used on MPC and transportation packaging basket assembly projects:
Caliper Serial Number 1121107 Friction Stir Welding Machine Serial Number 52505 Dial Micrometer Serial Number 66588655 Tape Measure Serial Number Orr T-475 Vacuum Furnace #4 Serial Number EAT-Furnace #4 Mixing Scale Serial Number FM84638 Lab Scale Serial Number AE4383322 Weld Wire Storage Room Temperature & Serial Number HOH190511811 Humidity Measuring Device Coating Thickness Measuring Device Serial Number HOH3393962 The team visually inspected the nine M&TE devices to verify that calibration stickers were attached showing component identification information and calibration dates. The team found the stickers to be in compliance with HSP-101201 requirements. For the weld wire storage room temperature and humidity measuring device and the coating thickness measuring device, the latest calibration and calibration documentation was provided by an outside vender that the team verified to be on the Holtec/Orrvilon AVL. The team noted that lab temperature and relative humidity were recorded by the calibration vendor on the certificate of calibration for these two items.
Overall, the team found the Holtec/Orrvilon M&TE program to be adequate with no concerns identified.
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