1991 - 2019 Evolution of Quality and Management System Expectations in Finland

Quality Assurance
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On the 20th of September,1991 the Finnish Centre for Radiation and Nuclear Safety, at that time the regulatory body overseeing Finland’s nuclear power plant license holders, published the regulatory guide Quality assurance for nuclear power plants, YVL 1.4. This was the first revision of the guidance since it was published for the first time October of 1976.

The 1991 YVL 1.4 contained three pages of text and made reference to IAEA Safety Standard 50-C-QA which provided high-level principles and objectives for establishing quality assurance programs for nuclear power plants. It covered topics like organization,document control, design control, procurement, materials, processes,inspection, testing, non-conformances, records and audits at a general level. The50-C-QA It served as a foundation that countries could build upon in developing their national requirements.

Table of Contents of YVL 1.4 1991

In the intermediate time, YVL 1.4 was renamed to YVL A.3 over the course of some revisions. Today,YVL A.3 “Leadership and management for safety” (15.03.2019) is the current regulatory guidance in Finland related to management systems, which includes quality management. The current YVL A.3 guide is 24 pages long, not including an 11 page memorandum of understanding.

View the entire YVL A.3 regulatory guide on stuklex

This proliferation of prescriptive requirements, which are not standardized between jurisdictions, is a characteristic development of the nuclear power industry since the first commercial nuclear power plants began operations. It has occurred at all levels, from the purchase order for a spare part, to regulatory guides and rules like YVL A.3.

Here are some key differences in how the requirements have expanded and changed focus over those nearly 30 years:

1.    Scope: YVL 1.4 focused mainly on requiring quality assurance programs and some regulatory control. YVL A.3 covers a much broader scope including safety culture, leadership and management, graded approach, documentation, communication, managing changes, project management,and assessment/improvement. The newer guide takes a more comprehensive,holistic view of (integrated) management systems. This evolution mirrors that of the International Atomic Energy Agency’s published requirements and guidance documents related to quality and management systems.

2.    Emphasis on safety: While safety was mentioned in the 1991 guide, the 2019 version makes safety the overarching priority threaded throughout all the requirements. There are repeated statements that"safety shall take priority in all operations." Safety culture is heavily emphasized in YVL A.3 but was not covered in YVL 1.4.

3.    Management responsibility: Today’s YVL A.3 guide places much greater responsibility on management to demonstrate commitment to safety, ensure adequate resources, promote a good safety culture, and continuously improve. YVL 1.4 did not focus as much on management's role.

4.    Risk-informed, graded approach: YVL A.3 requires a graded approach where management system requirements are applied commensurate with the safety significance of the activity or item. This risk-informed philosophy was not as apparent in the older YVL 1.4 1991 guide. For more information on graded approach in the nuclear industry see IAEA TECDOC 1740

5.    Assessment and improvement: The 2019 guide has extensive requirements for monitoring, assessment, and continuous improvement of the management system and the organization's performance. Self-assessments,independent assessments, management reviews and acting on the results are key themes. YVL 1.4 was more focused on establishing QA programs vs. ongoing evaluation and improvement.

The quality management requirements on license holders in Finland have expanded from concise QA program specifications in YVL1.4 1991, closely aligned with the 1978 IAEA QA Safety Standard, to a far more comprehensive, detailed management system guideline in YVL A.3 2019 that emphasizes safety, leadership, assessment and risk-informed graded approaches.The overall philosophy has shifted from simply establishing QA practices to building a holistic framework to continuously improve safety performance.

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