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NRC Inspection Notice and Inspection ReportMay 3, 1996 Mr. Michael L. Bussler, President and Chief Executive Officer SUBJECT: NRC INSPECTION REPORT NO. 99901294/96-01 Dear Mr. Bussler: This letter transmits the report of the U.S. Nuclear Regulatory Commission (NRC) inspection of Algor, Inc., conducted by Robert L. Pettis, Jr. and Billy Rogers, of this office, on February 20 through 22, 1996. The NRC inspection team conducted an evaluation of the Algor quality assurance (QA) program and the implementation of that program as it relates to safety-related software supplied to the nuclear industry. The NRC inspection team reviewed documentation, procedures, and representative records, conducted interviews and held discussions with members of your staff. On the basis of this inspection, the inspection team determined that the implementation of the Algor QA program failed to meet certain requirements of Appendix B to Part 50 of Title 10 of the Code of Federal Regulations and 10 CFR Part 21. The enclosed inspection report contains a detailed discussion of the areas examined. In accordance with 10 CFR 2.790(a) of the NRC "Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC Public Document Room. Should you have any questions concerning this report, we will be pleased to discuss them with you. Thank you for your cooperation. Sincerely, Gregory C. Cwalina, Acting Chief Docket No.: 99901294 Enclosures: Notice of Violation Inspection Report No. 99901294/96-01 NOTICE OF VIOLATION Algor, Inc. Docket No. 99901294 During an NRC inspection conducted at Algor, Inc., on February 20 through 23, 1996, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below: Title 10 of the Code of Federal Regulations Part 21.21(b) states if the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to 21.21(a). Contrary to the above, Algor, Inc., did not inform NRC licensees of deviations within five working days of discovery when informing licensees of the deviations identified by the Algor, Inc., Quality Assurance Bulletins Nos. 68, 69, 71, 84, 100, 101, and 102. This is a Severity Level IV violation (Supplement VII). Pursuant to the provisions of 10 CFR 2.201, Algor, Inc., is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Chief, Special Inspection Branch, Division of Technical Support, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. Where good cause is shown, consideration will be given to extending the response time. Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public. Dated at Rockville, Maryland Enclosure 1 U.S. NUCLEAR REGULATORY COMMISSION REPORT NO.: 99901294/96-01 ORGANIZATION: Michael L. Bussler, President and Chief Executive Officer Algor, Inc. ORGANIZATIONAL NUCLEAR INDUSTRY: Suppliers of safety-related finite-element computer programs. INSPECTION DATES: February 20 through 22, 1996
Enclosure 2 1 SUMMARY OF INSPECTION FINDINGS During this inspection, the NRC inspection team evaluated the implementation of the Algor, Inc., quality assurance (QA) program related to the supply of the safety-related finite-element computer programs to the nuclear industry. The inspection was conducted to determine Algor’s compliance with the requirements of Appendix B to Part 50 of Title 10 of the Code of Federal Regulations (Appendix B) and the provisions of 10 CFR Part 21 (Part 21). The inspection team reviewed technical information, procedures and representative records, conducted interview [sic] and held discussions with members of Algor’s staff. 1.1 Violations 1.1.1 Contrary to 10 CFR 21.21(b) which requires that if a deviation is discovered by a supplier of basic components and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation, Algor, Inc., (Algor) did not inform NRC licensees of deviations with five working days of discovery. (Violation 96-01-01) 1.1.2 Contrary to 10 CFR 21.6 which requires that entities subject to the regulations post 10 CFR Part 21, Section 206 of the Energy Reorganization Act of 1974, and the procedures adopted pursuant to 10 CFR Part 21, Algor had not posted Section 206 or the Algor 10 CFR Part 21 Procedure, QAPM Section 8, and the copy of 10 CFR Part 21 that Algor had posted was dated January 1988 which did not contain the numerous subsequent revisions contained in the later editions. (Non-Cited Violation) 2 STATUS OF PREVIOUS INSPECTION FINDINGS This was the first inspection of Algor. 3 INSPECTION FINDINGS AND OTHER COMMENTS 3.1 Background Algor, Incorporated, is a designer of various engineering finite-element analysis software programs used both in nuclear and commercial applications. Algor’s product line includes both linear and nonlinear stress analysis programs designed to analyze various applications including dynamic, vibration, heat transfer and piping analysis. 3.2 Entrance and Exit Meetings During the entrance meeting, held on February 20, 1996, the NRC inspection team met with members of Algor management and staff, discussed the scope of the inspection, and established organizational contacts. During the exit meeting, held on February 22, 1996, the inspection team summarized its findings with Algor management. Section 4 of this report lists the persons contacted during this inspection. 3.3 10 CFR Part 21 Procedures and Implementation Section 10 CRF 21.6, "Posting Requirements," requires that entities subject to the regulations post 10 CFR Part 21, Section 206 of the Energy Reorganization Act of 1974, and the procedures adopted pursuant to 10 CFR Part 21. The Quality Assurance Procedures Manual (QAPM) Section 8, "10CFR21 – Error Reporting," Revision 4, dated February 21, 1995, Paragraph 8.6 "Posting," stated that 10 CFR Part 21 shall be prominently displayed on the employee bulletin board but did not address Section 206 or the Algor 10 CFR Part 21 procedure, QAPM Section 8. The inspectors reviewed Algor’s posting and determined that Section 206 was absent and Algor’s 10 CFR Part 21 Procedure was absent. In addition, the copy of 10 CFR Part 21 that was posted was dated January 1988 and did not contain the numerous subsequent revisions contained in the later editions. The inspectors provided Algor with current copies of 10 CFR Part 21 and Section 206 and Algor indicated that they would correct their posting. The failure to meet the posting requirements specified in 10 CFR 21.6 constitutes a violation of minor significance and is being treated as a Non-Cited violation, consistent with Section IV of the NRC Enforcement policy (NUREG-1600). The inspectors reviewed the implementation of Algor’s 10 CFR Part 21 program to determine compliance with 10 CFR Part 21. Discussion of Algor products provided to NRC licensees indicated that deviations would occur as errors in the computer software. Algor had defined four error types in QAPM Section 7, "Qalipak Quality Assurance Package," Revision 4, dated February 21, 1995; Class A errors, Class B errors, Class C errors, and Class H errors. Class C errors, defined as errors which produce results that may appear reasonable and correct, but are in fact erroneous; were difficult for the end user to detect because the program did not provide any clear indication that the results may be invalid; and provided no warning messages, error messages or other abnormalities despite responsible operation of the Algor product, relative to the error itself, which indicated that the results may be invalid. The inspectors concluded that Class C errors would constitute deviations, as defined by 10 CFR Part 21, and would therefore require evaluation by the supplier (Algor) or the user (NRC licensee). Algor had determined that it would not evaluate Class C errors but would inform the user such that the user could perform the evaluation to determine whether the deviation was a defect or a failure to comply. Algor had notified customers of Class C errors by providing them with Quality Assurance Bulletins (QAB) which described the error and provided customers with applicable information on software revisions which corrected the error or methods that users could follow to work around the error. The inspectors review of the QABs included a block of twenty, which were issued during 1995 and early 1996. The review determined that seven of the Class C error reports were provided to NRC licensees with greater than five working days between error classification (identification of the deviation) and providing the QAB to the licensee (informing the customer of the deviation). The length of time between error classification (identification of the deviation) and providing the QAB to the licensee (informing the customer of the deviation) ranged from twenty-three to seventy-one days. The error classification dates and QAB issuance dates are listed as follows:
The provisions of 10 CFR 21.21(b) required that if a deviation or failure to comply is discovered by a supplier of basic components and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers of affected licensees may evaluate the deviation or failure to comply, pursuant to 21.21. Contrary to the requirements of 10 CFR 21.21(b), Algor did not notify NRC licensee within five working days of identifying the deviations. This was identified a Violation No. 96-01-01. 3.4 Review of Qalipak Quality Assurance Package The inspectors reviewed QAPM Section 7, "Qalipak Quality Assurance Package," Revision 4, dated February 21, 1995, which established the service to which Algor customers could subscribe to receive notification of errors which could produce significant, erroneous output data despite responsible operation of an Algor product. Algor offered two levels of Qalipak Subscription: (1) Basic – a service which was available free, upon request, to all Algor customers. The customer would receive a Qalipak Summary Report (QSR) which would provide a brief description of Class C errors and was to be issued monthly; and (2) Qalifax – a service in which Quality Assurance Bulletins (QAB) are issued to customers by telefax as soon as the QAB is completed. The Basic Qalipak Quality Assurance Package was discussed in QAPM Section 7, which stated that the Quality Summary Report would be provided to customers monthly, on request. Algor indicated that although QAPM Section 7 required the monthly issuance of the Qalipak Summary Report none had yet been issued. Algor indicated that they were in the process of developing the first issue of the Qalipak Summary Report, to be issued in the near future, and monthly thereafter. The Qalifax Quality Assurance Package was the method by which Algor notified NRC licensees of deviations (Class C errors) through the issuance of QABs. Algor provided Qalifax as a service sold in conjunction with the purchase of safety-related software. A Qalifax subscription was required to be in place (previously purchased and current) or purchased concurrently with safety-related software purchases. A customer was only required to have one Qalifax subscription in place which could support numerous safety-related software purchases. All QABs related to different software packages were provided to all Qalifax subscribers regardless of the software that the customer had purchased. The inspectors reviewed Algor’s Qalifax subscribers records and Qalifax distribution records to verify that Algor had been providing notification of all Class C errors to all Qalifax subscribers including NRC licensees. Section 7, Paragraph 7.3, of the QAPM, "Qalipak Distribution" states that a Qalipak Transmittal Sheet would be included with each transmittal of a QAB. The Qalipak Transmittal Sheet was provided so that the customer could acknowledge receipt of the QAB. If the first Qalipak Transmittal Sheet was not received Algor would send a Second Notice and, if necessary, a Final Notice in conjunction with telephone calls. The inspectors reviewed the records for QABs Nos. 33 through 47, Class C errors, issued in September of 1993. Algor’s records showed that all Qalifax subscribers, current in September 1993, had been notified and the records contained documentation of positive receipt acknowledgment from all Qalifax subscribers (Qalifax Transmittal Sheets signed by the customer and returned to Algor). The inspectors concluded that Algor had taken adequate measures to ensure that licensees had received notification of Class C errors. The inspectors noted that QAPM Section 7.1 stated that Qalifax subscribers would only receive QABs if the error was in purchased software while Section 7.3 stated that any QAB for Class C errors would be immediately distributed to all current subscribers of the Qalifax subscription program. Algor indicated that although the procedure was contradictory the practice was to distribute QABs for all Class C errors to all Qalifax customers. The inspectors verified that QABs had been distributed to all Qalifax customers, regardless of software purchases. In addition, Algor indicated that, if a customer did not renew the yearly license for a piece of software and also did not renew the Qalifax subscription, all licensees would still be notified of all Class C errors which were applicable to the version of software that they had initially purchased as safety-related with a corresponding Qalifax subscription. The inspectors concluded that although there was an inconsistency in the Algor procedures, Algor had indicated an adequate position on the licensee notification of Class C errors. 3.5 Purchase Order Review The NRC inspectors reviewed purchase orders (POs) to Algor from nuclear customers to determine the extent to which Appendix B and Part 21 requirements were imposed. The review determined that almost all the POs reviewed imposed such nuclear quality assurance requirements for software and related Qalifax technical support. The following is a list of POs which were selected for review during the inspection: Carolina Power & Light Company PO No. 597206M-CR, dated December 9, 1993, ordered various finite-element analysis manuals including a Qalifax subscription. The PO was marked "Safety-Related" and imposed the requirements of Appendix B and Part 21. The corresponding Algor invoice for this order was Invoice No. 038558, dated December 23, 1993. PO No. 599637M-CR, dated March 31, 1994, ordered numerous unix [sic] platform stress and heat transfer software, including technical support. The PO was marked "Safety-Related" and imposed requirements of Appendix B and Part 21. The corresponding Algor invoice for this order was Invoice No. 040374, dated March 31, 1994. Florida Power & Light Company PO No. B91536 01071, dated December 16, 1991, ordered various finite-element analysis software including a Qalipak subscription. The PO was marked "Nuclear Safety-Related QL-1" and imposed the requirements of Appendix B and Part 21. The corresponding Algor invoice for this order was Invoice No. 033730, dated February 26, 1993. Entergy Operations Contract No. C-6135, dated November 30, 1994, ordered various finite-element analysis software, including a Qalifax subscription, for Arkansas Nuclear One, River Bend Station, Grand Gulf Nuclear Station and the Waterford Steam Electric Station, Unit 3, and imposed the requirements of Appendix B and Part 21. The corresponding Algor invoice for this order was Invoice No. 044404, dated November 30, 1994. Public Service Electric and Gas Company (PSE&G) PO P1-431641, dated October 4, 1993; PO P3-0751638-1250-0000, dated October 28, 1994, and PO P3-0826805-1240-0000, dated October 31, 1995. All three POs were for various software modules including a Qalifax subscription. All POs reviewed were for non safety-related material. The above PO review identified an extremely low level of nuclear safety-related activity processed by Algor over the past several years. Wolf Creek Nuclear Operating Corporation Algor Invoice No. 053195, dated December 28, 1995, referenced customer PO No. 566898 for various finite-element software including a Qalifax subscription. The Wolf Creek PO could not be located during the inspection but their quality Program Requirements Document No. AD17, Revision 00, dated December 27, 1995, identified in Section 3.1 that the reporting requirements of Part 21 applied. A review of revenue reports from Algor’s nuclear customers identified only nine nuclear customers out of several thousand total customers purchasing Algor software and related services. However, not all nuclear customers may have purchased safety-related products and services from Algor pursuant to Appendix B and Part 21 requirements, as in the case of PSE&G. Algor’s nuclear customers included Bechtel, Carolina Power & Light (CP&L), Crosby Valve, Entergy, EQE Engineering, Florida Power & Light (FP&L), Lockheed Idaho, Northern States Power, Proto-Power, PSE&G and Wolfcreek Nuclear. A review of all of the available audit reports of Algor from these customers only produced audit reports from FP&L, CP&L and Entergy. The review of the CP&L audit report, performed at Algor in September 1993, identified that it was a Nuclear Procurement Issues Council (NUPIC) based audit and as such other NUPIC member licensees could use the report for implementation purposes if it adequately covers their respective scope of supply. However, for most of the nuclear customers, purchasing activity preceded the CP&L inspection thereby making it impossible for them to take credit for the CP&L audit of Algor. The NRC inspectors concluded from its review that not all licensees purchasing Appendix B and Part 21 software and technical services had audited Algor for quality program implementation compliance. This issue will be addressed in a future NRC inspection at these licensees. 4 PERSONS CONTACTED The following persons were contacted during the inspection and except as noted, attended both the entrance and exit meetings. Algor, Incorporated: * M. Bussler President and Chief Executive Officer U.S. Nuclear Regulatory Commission: R. Pettis Team Leader * Did not attend exit meeting. Forward to: Algor Reply to NRC Inspection Notice | |||||||||||||||||||||||||||||||||||||||||||
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