ML23038A075
| ML23038A075 | |
| Person / Time | |
|---|---|
| Site: | 07100970 |
| Issue date: | 02/14/2023 |
| From: | Aida Rivera-Varona NRC/NMSS/DFM/IOB |
| To: | Jones P Perma-Fix Environmental Services |
| Shared Package | |
| ML23038A073 | List: |
| References | |
| PF-Q-1, Rev 8 | |
| Download: ML23038A075 (1) | |
Text
Enclosure Request for Additional Information Perma-Fix Environmental Services, Inc.
Docket No. 71-0970 Perma-Fix Quality Management System, PF-Q-1, Rev. 10 By a submittal dated April 28, 2022, Perma-Fix Environmental Services, Inc. (Perma-Fix) requested approval of Perma-Fix Quality Management System (QMS), PF-Q-1, Rev. 8.
Following a review of the initial request for approval, the U.S. Nuclear Regulatory Commission (NRC) responded with a request for additional information (RAI) dated September 1, 2022 (Agencywide Documents Access and Management System {ADAMS} Accession No. ML22242A267).
Perma-Fix responded to this initial RAI from the NRC in a letter dated September 20th, 2022 (ADAMS Accession No. ML22273A047). Perma-Fix Quality Management System (QMS),
PF-Q-1, Rev. 9 (ADAMS Accession No. ML22273A108). Following an initial NRC review of this RAI response, a clarification call was held on November 1, 2022, between the NRC staff and Perma-Fix personnel. As an outcome of this clarification call, Perma-Fix chose to provide a supplement to their initial response. The NRC received the Perma-Fix supplement in a letter dated December 2, 2022. Perma-Fix Quality Management System (QMS), PF-Q-1, Rev. 10 (ADAMS Accession No. ML22342A243) was included as an enclosure to this letter. This RAI has been prepared following the review of this most recent revision of the Perma-Fix quality assurance program description. These RAIs identify information needed by the NRC staff in connection with its review of the Perma-Fix QMS. The requested information is listed by chapter number and title in the applicants QMS. NUREG 2216, Standard Review Plan for Transportation Packages for Spent Fuel and Radioactive Material, was used by the staff in its review of the application.
Each RAI describes the information needed by the staff for it to complete its review of the submittal and to determine whether the applicant has demonstrated compliance with the regulatory requirements.
2 Section 4.18 Quality Assurance Records 4-11 State the nuclear industry experience requirements that will be applied to ensure that Perma-Fix NQA-1 lead auditors possess sufficient nuclear industry experience.
NRC Regulatory Guide 1.28, Revision 5 (ADAMS Accession Number No.
ML17207A293) provides clarification of necessary lead auditor qualifications as stated in NQA-1-2015.
Prospective lead auditors, with comparable industry experience, may satisfy the lead auditor qualification requirement of participating in a minimum of five quality assurance (QA) audits within a period of 3 years prior to the date of qualification by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results and participate in at least one nuclear audit within the year preceding the date of qualification, subject to review and acceptance by the responsible QA organization.
Title 10 of the Code of Federal Regulations (10 CFR), Section #71.105(d) states, The licensee, certificate holder, and applicant for a Certificate of Compliance shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained.
This information is needed to determine compliance with 10 CFR 71.105(d) and 71.137.
Section 4.18 Quality Assurance Records 4-16 Provide detailed information on the controls or state the recognized industry standards Perma-Fix will apply with regards to the storage and protection of electronic records related to 10 CFR 71 activities.
NRC Regulatory Guide 1.28, Revision 5 (ADAMS Accession Number No.
ML17207A293) provides clarifying guidance on the management of records in electronic media that is specified in NQA-1:2015 and some relevant industry technical guides that have already been approved for use.
This is needed to ensure compliance with 10 CFR 71.135.
ML23038A073; ML23038A075 OFFICE NMSS/DFM/IOB NSIR/DPR NMSS/DFM/IOB NAME AThomlinson JGoodridge ARivera-Varona DATE Feb 7, 2023 Feb 10, 2023 Feb 14, 2023