216 R.I. Code R. 216-RICR-40-20-12.9

Current through December 26, 2024

Section 216-RICR-40-20-12.9 - Quality Assurance

12.9.1Quality Assurance Requirements

A. Before the use of any package for the shipment of licensed material subject to this Subchapter, each licensee shall obtain Agency approval of its quality assurance program. Each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, by submitting the description to the Agency.

B. Before the fabrication, testing, or modification of any package for the shipment of licensed material subject to this Subchapter, each certificate holder, or applicant for a Certificate of Compliance (CoC) shall obtain Agency approval of its quality assurance program. Each certificate holder or applicant for a CoC shall file a description of its quality assurance program, including a discussion of which requirements of this Subchapter are applicable and how they will be satisfied.

C. For the purpose of this Part, quality assurance requirements are defined by 10 C.F.R. §§ 71.101(a), (b), (f) and (g).

12.9.2Quality Assurance Organization

For the purpose of this Part, quality assurance organization requirements are defined by 10 C.F.R. § 71.103.

12.9.3Quality Assurance Program

For the purpose of this Part, quality assurance program requirements are defined by 10 C.F.R. § 71.105.

12.9.4Changes to Quality Assurance Program

For the purpose of this Part, requirements for changes to a quality assurance program are defined by 10 C.F.R. § 71.106.

12.9.5Handling, Storage, and Shipping Control

For the purpose of this Part, requirements for handling, storage, and shipping control are defined by 10 C.F.R. § 71.127.

12.9.6Inspection, Test, and Operating Status

For the purpose of this Part, requirements for inspection, test, and operating status are defined by 10 C.F.R. § 71.129.

12.9.7Nonconforming Materials, Parts, or Components

For the purpose of this Part, requirements for nonconforming materials, parts, or components are defined by 10 C.F.R. § 71.131.

12.9.8Corrective Action

For the purpose of this Part, corrective action requirements are defined by 10 C.F.R. § 71.133.

12.9.9Quality Assurance Records

For the purpose of this Part, requirements for quality assurance records are defined by 10 C.F.R. § 71.135.

12.9.10Audits

For the purpose of this Part, requirements for audits are defined by 10 C.F.R. § 71.137.

216 R.I. Code R. 216-RICR-40-20-12.9

Adopted effective 1/1/2019
Amended effective 5/25/2022