Directorate of Nuclear Cycle and Facilities Regulation April 29, 2009 4.05.02 / 37-2-6-0 Mr. F. King Vice-President and Chief Engineer Nuclear Waste Management Ontario Power Generation 22 St. Clair Avenue East, 6th Floor Toronto, Ontario M4T 2S3 Subject: DGR Project for OPG s LILW DGR Project Quality Plan Dear Mr. King, CNSC staff has completed a review of the responses [1] provided by the NWMO to our September 11, 2008 [2] letter, including the quality plan [ L&ILW Deep Geologic Project Quality Plan, 00216N-PLAN-00120-002 R001] that was also provided. Although a number of our comments have been addressed, the enlistment of the NWMO to manage Phase 1 of the DGR project (EA and Site Preparation/Construction Licence approvals phase) under the NWMO s governance and procedures rather than OPG s requires us to ask for further information. CNSC staff s comments and requests for additional information are attached. The NWMO is requested to respond. If you have any questions, please do not hesitate to contact Dan Papaz at (613) 943-8469, or me at 613-943-8103. Sincerely, K. J. Klassen, MSc. PEng. Project Officer Wastes and Decommissioning Division c.c.: A. Khan, NWMO D. Papaz, CNSC References: [1] Letter from F. King, NWMO, to K. Klassen, CNSC, dated February 27, 2009, DGR Project for OPG s LILW DGR Project Quality Plan, E-Doc# 3285529. [2] Letter to K. Nash, OPG, from K. Klassen, CNSC, dated September 11, 2008, Deep Geologic Repository (DGR) Project Quality Pan, Revision 2, E-Doc# 3285529 E-doc 3368755
ATTACHMENT CNSC Response to the NWMO s Disposition of Comments Received on the DGR Project Quality Plan (Rev. 2) Basis of Review The main purpose of CNSC staff s review was to determine the adequacy of NWMO s Low and Intermediate Level Waste Deep Geological Repository Project Quality Plan 00216-PLAN-00120-0002-R001 [1] in addressing CNSC comments [2]. However, since the project is not performed under OPG [3] governance procedures and other changes were performed; staff has also reviewed the entire document for adequacy with the criteria requirements and clarity of the information. The criteria used to measure the proposed Project Quality Plan are the requirements of N286-05 Management System Requirements for Nuclear Power Plants. Section 2.0 of NWMO Project Quality Plan (PQP) stated that the document has been prepared to satisfy the CSA N286-05 requirements. Staff noted that the NWMO Level Waste Deep Geological Repository Project Quality Plan 00216-PLAN-00120-0002-R001 was accepted by OPG. Review A. Review of NWMO Dispositions of CNSC comments on the OPG DGR Project Quality Plan, Revision 2 [1] Disposition 1 NMWO is requested to provide Records Management NWMO-PROC-AD-0002 for review. CNSC staff will verify whether the requirements of N286-05 standard, related to the control of Records, are met. A comment related to the acceptance of NWMO disposition will be made after the review of the procedure. Disposition 2 A comment related to the acceptance of NWMO disposition will be made after the review of NWMO-PROC-AD-0002. NWMO is requested to specify what procedure defines important records. The following requirements shall be followed related to the records: a. CSA N286-05 clause 5.13 identified permanent and non-permanent records, and not important records as it is mentioned in the letter. b. General Nuclear and Control Regulations section 27, requires keeping the records of all information relating to the licence; c. Class I Nuclear Facilities Regulations section 14 requires keeping and retaining the records for effluent and environmental monitoring programs. E-doc 3368755 Page 1 of 4
Disposition 3 Disposition 4 Disposition 5 Disposition 6 NWMO is requested to provide 00216N-PDP-00120-00001 and NWMO-PROC-FN-0006 for review. A comment related to the acceptance of NWMO disposition will be made after the review of the procedures. Disposition 7 NWMO specifies that design changes must be made consistent with the requirements of ISO 9001 and NWMO governance. The independence of design verifiers (N28605 clause 5.10.2) is not a requirement of ISO 9001 and CNSC staff cannot determine whether the NWMO governance that is developed based on ISO 9001 contains this requirement. Also, the N286-05 clause 5.12 requires for persons reviewing proposed changes to have an adequate understanding of the current requirements, so as to allow assessment of the effect of the change, is not an ISO 9001 requirement. NWMO is requested to provide procedure NWMO-PROC-EN-0001 Design Management for review. Disposition 8 NWMO is requested to provide 00216N-LIST-08133-0002. A comment related to the acceptance of NWMO disposition will be made after the review of the procedure. B. Comments related to the content of 00216N-PLAN-00120-0002 1. The Department titles in paragraph 5.5 and 5.6 do not match Figure 1 Department titles. 2. The responsibilities for VP Environmental Assessment & Corporate Support are not described. 3. The Manager Environment Assessment reports, as per Figure 1, to VP Environmental Assessment & Corporate Support. However, section 5.8 states that the Manager Environmental Assessment reviews consultant/contractor work-specific Quality Plans related to environment assessment, and recommends them for approval to the Vice President and Chief Engineer. The Vice President and Chief Engineer does not have the accountabilities related to the environment assessments, as is described in section 5.3. 4. NWMO is requested to submit for review NWMO-PD-AD-0001 Governance Process Description. E-doc 3368755 Page 2 of 4
5. Paragraph 6.2.2.b (b) states that the NWMO-PROC-EN-0002 Technical Computing Software is equivalent to the software quality standard such as ISO 9001 and IAEA Safety Guide GS-G-3.4. Neither ISO nor IAEA standard are quality software standards. The previous OPG PQP 00216-PLAN-00120-0001 mentioned CSA N286.7-99 as a software standard and this approach is acceptable to CNSC staff. Other IEEE quality software standards will be also acceptable. 6. The governance in OPG PQP 00216-PLAN-00120-0001was developed to meet the intent of N286 series as appropriate. Section 6.1 Nuclear Waste Management Organization Governance of NWMO PQP states that the Governance Process description implements the ISO 9001 requirements. Some of the requirements that CNSC staff expected to be covered by the quality assurance plan, are not mentioned in section 6.1. Some of them are hidden in the plan (regulatory, oversight carried out by OPG for example). Topics that need to be included are the following, as a minimum: - health, safety, environment and quality policies; - interface arrangements between OPG and NWMO; - regulatory; - self assessments; - control change; - clearly define roles, responsibilities for organizational units; - measures to ensure the health and safety of workers and protection of the environment; - traceability of data; - configuration control (including data, environmental, meteorological, geological, geophysical, survey, hydrological, biological); - oversight carried out by OPG and NWMO; - pollution control; - field and laboratory work; - use and control of computer modelling; - calculations and analysis. NWMO needs to specify in what procedures are the above topics covered. 7. Section 6.2.2.7, the contractor/ consultant needs to assess and record the validity of the previously completed measurement results since the date of the last acceptable calibration. 8. G320-Assessing the Long Term Safety of Radioactive Waste Management is not referenced in section 8.0. 9. The ISO 9001 version is not mentioned in the PQP. Previous OPG PQP mentioned ISO 9001-2000. 11. NWMO is requested to submit NWMO-PROC-FN-0006 for review (see section 6.2.1). E-doc 3368755 Page 3 of 4
12 The roles and responsibilities of the organizations units, described in figure 1, are not specified. 13. The N292.3 Management of Low and Intermediate Level Radioactive waste is not referenced in the PQP. NWMO needs to identify the process documentation that ensures that the requirements of N292.3 Management of Low and Intermediate Level Radioactive waste are met for Phase 1. 14. NWMO is requested to specify in what documents key DGR results and conclusions are defined, as stated in 6.1.5 (d). Conclusion The Level Waste Deep Geological Repository Project Quality Plan 00216-PLAN-00120-0002-R001 [1] and the NWMO responses addressed some of the CNSC staff comments [2]. Under NWMO, the Organization Governance was shifted under ISO 9001 requirements from previous OPG PQP. CNSC staff expects additional topics that need to be covered under Organizational Governance. CNSC staff will need to verify at least to what extent the Procedures for Procurement, Design and Records meet the N286-05 requirements for this phase of the project. The review is limited to the Phase 1 of the project. CNSC staff expects that for Phase 2, Design and Construction, the quality assurance requirements in the Governance will be developed based on the N286-05 requirements. NWMO is requested to provide dispositions for the comments in this review. References [1] Letter Frank King to Kay Klassen, DGR Project for OPG LILW-DGR Project Quality Plan, February 27, 2009, E-DOCS #3345398; [2] Letter K.J. Klassen to K.E. Nash, Deep Geological Repository (DRG)-Project Quality Plan, Revision 2, September 11, 2008, E-DOCS #3285529. [3] Letter P. R. Charlebois to Mark Leblanc, January 15, 2009, Changes in Control and Management of Activities to be Licensed, E-DOCS #3327514. E-doc 3368755 Page 4 of 4