Applies To Product(s): AutoPIPE Version(s): 2004, XM, & V8i Environment: N/A Area: QA&R Subarea: Original Author: Bentley Technical Support Group Problem: What is Quality Assurance and Reporting (QA&R)? Prepared by Gary Philippi PE Answer: Bentley Systems, Inc. maintains a quality assurance program that controls the development and maintenance of Bentley Structural Group applications software products for the approved design of nuclear piping and structural systems. This quality program is documented in our Quality Assurance Policy Manual, and has been developed to comply with applicable portions of 10 CFR 50, Appendix B; 10 CFR 21; ASME NQA-1-2000; ANSI/ASME N45.2-1977; and international standards such as CSA N28~.7-99 . Bentley Structural Group also maintains reviewed and approved test plans for verification of modifications and new features to applications software as well as integration testing for features implemented in previous versions. Records of validation testing are maintained for all commercially released software versions. In addition, all users with current QA&R subscriptions can access published error reports (at our website) that classify errors based on severity, and affected versions. Full descriptions of each error, and known workarounds or avoidances are also included. Our 'QA & Reporting' subscription (STAAD.PRO and AutoPIPE® only) are available to SELECT customers who use Bentley Structural Group software in safety-related applications or who desire to verify the implementation of Bentley Structural Group's QA program. This subscription provides customers with the prompt notification of critical software errors and the right of access for QA audits and surveillance. The Bentley QA program has been routinely audited by our nuclear customers including Nuclear Procurement Issues Committee (NUPIC) and Nuclear Industry Assessment Committee (NIAC). Deliverables: Consistent with the applicable federal regulations and industry codes, Bentley provides a "QA and Reporting" (QA&R) subscription for AutoPIPE which consists of the below listed activities. It should be noted that the provision of"QA&R subscription requires that each AutoPIPE License be covered by a Select Program Agreement. 1. A "Certificate of Compliance" is provided for each AutoPIPE version shipped to the "QA&R" subscriber. 2. One (I) controlled copy of Bentley Quality Assurance Policy Manual is provided to the designated recipient of the "QA&R" subscription. 3. Notification of any confirmed "Critical" software error is promptly provided in sufficient details to assess the potential impact on the Safety-Related systems designed with the affected software version in accordance with the requirements of 10CFR21. 4. A right of access to Bentley facility and documents is granted for the purpose of QA audits or inspections to verity the implementation of our quality assurance program. 5. Notification is provided of our intent to destroy or otherwise dispose of AutoPIPE software verification and validation records which has exceeded the designated retention period. 6. One (I) controlled copy of AutoPIPE Acceptance Test Set is provided. This document includes all referenced test system input files required to execute user "validation tests". It also includes the verified benchmark comparison files for each test system. 7. Access to the most recently compiled "Open Error Report" is provided via our website. This report describes all errors known to exist in the software version released. These reports are being updated on a monthly basis. 8. Access to summary error reports is provided via our website. These reports describe the nature, classification, severity, and status of all confined errors in the current version of the released software during the last calendar month. 9. Notification of the error rep01ts posting is provided via email to the designated recipient with a QA&R subscription. 10. Automatic updates of all controlled documents are provided to current subscribers when revisions thereto are published. As mentioned above, one of the privileges extended to Quality Assurance and Reporting (QA&R) subscribers is a right of access to Bentley facilities and documents, for the purpose of QA audits or inspections, to verify the implementation of our quality assurance program. The reason we allow this is to assure the client that our QA Program is in accordance with the codes and standards required for the performance of work related to nuclear facilities, Department of Energy (DOE) facilities, and other highly regulated facilities. This includes, but is not limited to, power plants, enrichment facilities, nuclear repositories, and their subcontractors who must satisfy the requirements of the Code of Federal Regulations 10CFR50 Appendix B, 10CFR21, ASME NQA-1, ASME NQA-N45.2, and other standards. This is the same reason they audit us, to assure themselves that we are living up to our obligations as a supplier of safety related software. The distribution of our QA Manual, the software, and acceptance criteria to validate the program functionality is controlled and documented in accordance with these federal regulations. QA&R Questions: Q1. Who can I contact if I am interested in the QA&R program? Answer: 1. Tony C. Chen, PE, QA Manager, email : tony.chen@bentley.com 2. Joanie Mayberry, Regional Subscription Specialist, email: Joanie.Mayberry@bentley.com 3. Yaser Sohaib, Senior Software Quality Manager, Yaser.Sohaib@bentley.com Q2, What quality standards/bodies comply? Answer: Primary Ref Standards. U.S .. Code of Federal Regulations, Title 10, Part 50 (10CFR50), Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. U.S .. Code of Federal Regulations, Title 10, Part 21 ( 10CFR21) , Reporting of Defects and Noncompliance. ASME NQA-1-1994, including 1995 Addenda and NQA- I - 2004, Quality Assurance Program Requirements for Nuclear Facilities. ANSI / ASME N45.2-1977, Quality Assurance Program Requirements for Nuclear Facilities. Canadian nuclear CSA N286.7-99 Software Qality Assurance Ref Standard NUREG / CR 4640 August 1987 ~ Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry. Bruce P. and S M Pederson 1982. The Soft Development Project - Planning and Management J. Wiley and Sons, Inc.. Note: NRC rejected NQA-1 :2008 ISO 9001 is not recognized by the NRC as an acceptable QA system. Search internet for comparing ISO 9001 vs. NQA-1 ( example 1 click here , example 2 click here ) NQA-1 :2009 addenda expected to be approved by NRC (similar to NQA-1 :1994) Quality Assurance Manual and Procedures updated periodically to comply with NQA-1 See the following generic letter about AutoPIPE's QA certification that can be downloaded here . Q3: What parts of the regulatory standards do we comply with and audited by NUPIC & NRC? Answer: Our QAP manuals are broken down into sections (refer to the TOC in the beginning). Columns 3-6 to the left show the appropriate chapters/sections that map to our QA manual for each regulatory standard we conform to. Q4: What is the difference between the NRC and NUPIC and what do they have to do with our QA? Do they actually audit us? Answer : The Nuclear Regulatory Commission as a collegial body formulates policies, develops regulations governing nuclear reactor and nuclear material safety, issues orders to licensees, and adjudicates legal matters. The Nuclear Procurement Issues Committee is represented by all Domestic and several International nuclear utilities operating nuclear power plants. NUPIC provides a cost and quality effective program for the evaluation of suppliers furnishing safety related items and services to the Industry. NUPIC Joint Audits and Surveys are performed utilizing an industry-wide standardized approach. Q5: What is NIAC and what do they have to do with our QA and NUPIC? Do they audit us? Answer: Organized in 1994 as a result of an industry initiative to share audits among members, the Nuclear Industry Assessment Committee (NIAC) has fulfilled its charter by performing supplier qualification activities at the highest industry performance standards while eliminating the redundancy and costs associated with duplicate audits. NIAC has grown to 86 member companies. Membership to NIAC is open to suppliers having a 10CFR50 Appendix B or equivalent DOE quality program. If a company joins NIAC, they can save money by leveraging the audits done by other companies in NIAC. They are basically maintaining a database of audits and interfacing with NUPIC to make sure those audits follow proper guidelines set by 10CFR50, ASME NQA-1, etc. For more info, please visit http://www.niacusa.org/ The NUPIC membership is limited to utility companies who own or operate nuclear power plant(s) while NIAC is open to anyone in the nuclear business who is willing to pay the membership fee and follows 10CFR50 Appendix B Q6: Is there such a thing as NRC, NUPIC or NIAC “certified”? Is there a website I can point my customers to and see products like STAAD.Pro and AutoPIPE listed? Ans wer: Companies like BENTLEY are listed as a nuclear supplier whose QA Programs have been verified by NUPIC audits. Hence, all nuclear utilities can procure these products without a supplier qualification process, i.e. audit. There is no such website. Q7. Can AutoPIPE be installed, run, and licensed on a shared server? Answer: What does a shared server mean in this context? Program installed on a server and users connect to it through remote desktop or some other mechanism? Would there be 1 particular user using the software installed on the server at one time or multiple concurrent users? Normally AutoPIPE does not have a server part – and is a desktop program. One option would be to install on the server and users connect to it using remote desktop. There is a limitation with installing on a server machine – that at one time only one user should be connected. There are conflicts on writing configuration files – if multiple users use the program from same server in different sessions at the same time. With regards about licensing, refer to the EULA for details about licensing AutoPIPE installation on a server location with one or more user(s) access. The intent is when 1 person using 1 installation of AutoPIPE, where Bentley's Select Serve logs 1 usage of that license for the duration of usage. Another words, if multiple people use the application at the same time and only 1 license usage is logged then that configuration is direct violation of the licensing agreement. Q8. What is the method for Bentley to communicate AutoPIPE errors to QA&R users? Answer: All errors discovered through each month are communicated through a Monthly Error Report email. The same information is published to our error reports page on SELECT website .(press AutoPIPE & STAAD.Pro Error reports link in the "Support" column). Remember only those people that are signed up with QA&R program have access to this web site. If you are part of the program and are having troubles with accessing this web site, please contact the Bentley Response Center (BRC) about your Logon credentials are associated with a contract that has QA&R entitlement in good standings. The user does not need any special Web Permission or Web Entitlements, belonging to he proper Site ID is the only requirement for access. Example: a company that is part of QA&R, but have more than one Site ID (I.e. 5001505014, 5001650385, and 8010274) where only Site ID = 8010274 has QA&R entitlement. All user of that company who want access to the QA&R Error reports must belong to the correct Site ID that has QA&R Entitlement, i.e. 8010274 . All user who belong to the other Site Id's will not be able to access the error reports. Furthermore, per our QA&R manual, Bentley is mandated to inform all QA&R designated informants by email wi thin 5 working days of when any Critical errors have been discovered. Q9. What is the method for QA&R user to communicate potential AutoPIPE errors to Bentley ? Answer: All communications including Potential errors should be referenced or reported to Bentley though service requests. Q10. What are the details of the installation testing package that Bentley provides for AutoPIPE in regards to how would QA&R users determine receipt inspection by testing that after AutoPIPE installation that AutoPIPE was working properly. Does Bentley provide acceptance criteria for the installation test results? Answer: Bentley provides an “Acceptance Test Set” of models with pre-verified results. An automatic utility executes this set of test models through AutoPIPE and compares the results against included benchmark values. Users can also compare their results manually against those provided through a pdf document. This confirms that AutoPIPE is working as expected. Q11. Is there any issue with storing the AutoPIPE user’s manual with the executable on the share drive? Answer: No, there is no problem. See Also Bentley AutoPIPE External Links Bentley Technical Support KnowledgeBase Bentley LEARN Server Comments or Corrections? Bentley's Technical Support Group requests that you please submit any comments you have on this Wiki article to the "Comments" area below. THANK YOU! )
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