Bijlage Tekstaanpassing per NVR
Genoemde paragraaf en regelnummers zijn die van de IAEA Q-serie.
Definitielijst: Item of zaak houdt in: onderdelen, materialen, samenstellingen, systemen, documentatie en programmatuur.
NVR 1.3. Hoofdregel kwaliteitsborging (IAEA C Q: Code on QA etc.)
Sectie 102: Code vs. Safety Guides:
– Add the sentence:
The guidance given in the NVR’s 2.3.1-14. shall be followed by the licensee, unless the licensee is able to justify that the methods and solutions the licensee wants to implement give at least the same level of safety and quality, or if the licensee is able to justify that the specific guidance is not applicable or possible for their installation or specific situation.
Section 104: The responsible organisation:
– Add: ‘The final responsibility is with the licensee, taken into account the requirements and guidance from the regulatory body e.g. the need to supply evidence and the timely supply of information on future activities. The organisation of the licensee shall be adequate, qualitatively and quantitatively, for the tasks and responsibilities mentioned. This should be justified’.
Section 201: Management and Quality Assurance (QA) Programme:
– Add to first sentence: ... including adequate arrangements to control any change to organizational structure or resources that could impact on safety.
Section 202: Change first sentence: Management in the entire and constituent areas of work (this includes licensees board of directors and plant management) shall provide and demonstrate support ...:
– Add to first sentence: ‘and the safety importance’.
Section 204: Grading:
In stead of grading a sufficient high generic quality level is applied in order to ensure that the relative importance to nuclear safety of each item, service or process is achieved.
Section 205: Language:
– Add: Communication with the Regulatory Body (RB) and all formal license documentation (except for the NVR series which are based upon the IAEA text), shall in principle be in the Dutch language.
Section 207: Non-conformance control:
– Add: The assessment shall include the involvement of all established properties of the pertinent items.
Section 304: Design:
– Add to section: Design changes shall be justified and subject to design control measures commensurate at least with the original design and approved by the original design organisation or a technically qualified equivalent with sufficient access to background information.
Page 13: ‘Annex’: change in: ‘Appendix’. The text becomes part of the text of the Code.
Add: ‘the text of the Annex of the Code is added to the text of the Code for information and clarification, by renaming the Annex as Appendix.’
Delete: the sentence: ‘This Annex provides ...’
Page 14, section 5: Add to: ... a graded approach: ‘is used where appropriate’.
Page 16, section 3: Change into: Independence from cost en schedule considerations should be recognized as an important factor, especially with the QA/QC personnel.
Section 8: Add in sentence: This analysis includes information performance data and may include internal and external failure costs and prevention costs.
Section 10: Add: ... and that personnel may have little or no control over eliminating these problems or improving performance.
Page 21: section 5: Add: the test process includes where appropriate bench tests, ...
NVR 2.3.1 (IAEA Q1): Establishing QA Programme Implementation and other installations
Section 309, 310, 312, 313:
– The term ‘description’ will be deleted.
– Add point ‘e’: Include procedures for final release with the necessary measures to ensure that these are being performed. (from NVR 1.3, section 301).
Section 404: Planning:
– Add: Work shall be performed under controlled conditions, using approved current instructions, procedures, drawings or other appropriate means that are periodically reviewed where appropiate to ensure adequacy and effectiveness, including procedures for final release with the necessary measures to ensure that these are being performed.
NVR 2.3.3 (IAEA SG Q3): Document Control and Records
Section 201: Document Control System:
– Exchange ‘should’ or ‘would’ for ‘shall’ .
Section 317: Correct version of documents:
– First line: the distributor shall employ an acknowledgement system (‘written’ is deleted)
NVR 2.3.4 (SG Q4): Inspection and Testing for Acceptance
Section 201, 207, 311, 308, 315, 317 first line, 319, 320, 401 (eerste zin), 508:
– Exchange ‘should’ for ‘shall’ with addition: ‘for safety relevance’
Section 319: Provision of test requirements etc.:
– Add to second sentence as follows: ‘test requirements shall cover relevant aspects and be well founded’.
Section 501: Pre-operational inspection and testing:
– Add second sentence as follows: ... plant systems or major modifications of these systems, is an essential…
Section 514: Appraisal of ISI and Testing:
– Add to last sentence: and 50-SG-O8.
NVR 2.3.5 (IAEA SG Q5): Assessment of the implementation of the Quality Assurance Programme
Section 202: Assessment activities:
– Renumber 2 in 2a and add:
‘2b: The Regulatory Body (and organisations working under responsibility of the RB), is entitled to perform assessments such as inspections, audits and evaluations (including at (sub)suppliers). The licensee shall provide all co-operation necessary’.
NVR 2.3.6 (IAEA SG SG Q6): QA in Procurement
Section 305: Technical requirements:
– Exchange ‘should’ in first sentence by ‘shall’.
– Add: ‘for safety relevant items and services’
Section 311: Timing of submissions:
– Add: ‘for safety relevant products’.
– Exchange ‘should’ by ‘shall’ in first sentence.
NVR 2.3.7 (IAEA SG Q7): QA in Manufacturing
Section 308: Clean conditions and the avoidance of incompatible materials:
– Delete last part of sentence.
NVR 2.3.11 (IAEA SG Q11): QA in Construction
Section 228: Human factors:
– Add to last point after ‘considerations’: including work permits and instructions for controlled areas.
– Add extra human factor: - accessibility of locations where work is performed, occupational health and safety, and environment.
NVR 2.3.13 (IAEA Q13): QA in Operation
Section 207, 208, 215, 219, 230, 321, 341, 356, 379, 395–398, 405:
– Exchange ‘should’ by ‘shall’ in these sections.
Section 341: Software:
– Exchange ‘periodically’ by ‘adequately’.
Section 321: Controlroom shift changeover:
– Add in first sentence: ‘... observing at least the following’:
Section 328: Objectives of emergency procedures:
– Exchange by: The mutual objective of emergency procedures and guidelines is to prevent or mitigate the negative effects of an accident or incident to the outside world and to the internal situation.
NVR 2.3.14 (IAEA SG Q14): QA in decommissioning
Section 211, 217 en 236, first three sentences:
– Exchange ‘should’ for ‘shall’.