1 Quality approach

 

1.1 Background

Quality standards' evolution

1.1

The evolution of the quality concept and the standards of quality management systems (Quality Management System = QMS) in industrial countries in the 20th century can be summarized as:

The technical committee "Management and quality assurance" (ISO/TC 176) within the ISO (International Organization for Standardization) was created in 1980. ISO itself was created in 1947. ISO comes from the Greek "isos" (equal).

The ISO 9000 standards (see figure 1-1) have appeared in:

revisions
Figure 1-1. Revisions of ISO 9000 family

The fourth edition (revision, version) of ISO 9001 was published in 2015. 

The standard “ISO 19443 - Quality management systems — Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS)” was published in 2018.

Some historical points (standards and references) related with the creation of the ISO 19443 standard, of French initiative, are shown in figure 1-2:

history iso 19443

Figure 1-2. History of ISO 19443

Atomic Energy Act, US Congress, 1946

N45.2 Quality Assurance Program Requirements for Nuclear Facilities, ANSI, 1971

GS-R-3 IAEA, The management system for facilities and activities, Safety requirements, IAEA, 2006

NQA – 1, Nuclear Quality Assurance - Quality Assurance Requirements for Nuclear Facility Applications, ASME, 2008

NSQ-100, Nuclear Safety and Quality Management System Requirements, NQSA, 2010   

DOE O 450.2, Integrated Safety Management, US Department of Energy, 2011

Decree of 7 February 2012, Order of February 7, 2012 establishing the general rules relating to basic nuclear installations (BNI), French laws, 2012

GSR Part 2, General Safety Requirements for Leadership and Management for Safety, IAEA, 2016

AS9100 - Quality Management Systems – Requirements for Aviation, Space and Defense Organizations, IAQG, 2016

The requirements of ISO 19443 are not intended to replace customer, statutory and regulatory requirements, but are complementary.

In addition to ISO 9001, the ISO 19443 requirements mainly focus on:

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1.2 Scope

Scope of the QMS, when certain requirements cannot be applied 

1.2

The ISO 9001 standard (Quality management systems - Requirements) is generic as it can be applied to the management system of any company, without limitations on size, activity or type. It is a voluntary international standard which allows certification by accredited bodies.

The scope of ISO 19443 applies to any organization supplying ITNS (important to nuclear safety) products or services.

Nevertheless, certain requirements cannot be applied in particular cases. This is possible when:

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1.3 Principles and steps

Quality management principles, preparation and implementation, Deming cycle

1.3 

Quality is anything that can be improved. Masaaki Imai

The quality approach is a state of mind which starts with top management as a priority strategic decision and extends to all employees. Top management develops a quality policy which determines the quality objectives, themselves applicable to all activities. The tool used to achieve the objectives is the quality system. Prevention is a key concept of quality management systems.

Quality management systems include three distinct and interrelated steps:

The purpose of a quality management system is to increase the satisfaction of customers (both external and internal) by meeting their needs and expectations through continual improvement of the effectiveness of the processes.

Quality is almost free when customers are satisfied: they remain loyal to us. It’s only when the customer is not fully satisfied that quality becomes very expensive to us: sooner or later the customer will go to a competitor.

Quality remains long after the price has been forgotten

The seven quality management principles (cf. figure 1-2) will help us achieve sustained success (cf. ISO 9000: 2015, sub-clause 2.3). Previously there were eight but now the system approach is integrated into the process approach.

principles
Figure 1-2. The 7 quality management principles

A well-prepared approach is half successful

The approach to implementing a quality and safety management system starts with the preparation. An example is shown in figure 1-3.

prep
Figure 1-3. QMS preparation

Step 1 involves identifying the needs and expectations (requirements) of stakeholders

The involvement of top management at its highest level is truly indispensable. The advice of a consultant is often solicited. Determining the current status of the management system (whole or partial) would be welcome at this stage. An external certification body is chosen.

One of the key questions that comes up quickly (step 2) is the need for this decision. If this is not really necessary or if the estimated costs of the certification approach exceed the available resources, it is better to reject this idea immediately.

The ISO 9000 family of standards will stop you making promises you can't fulfil and help you keep those you can. David Hoyle

The benefits of implementing a management system are often:

The benefits of ISO 19443 certification are often:

True story 

Mirion Technologies (France & Germany), a supplier of radiation measurement solutions, sought to ensure maximum quality and safety in a highly sensitive field.

Several Mirion sites obtained ISO 19443 accreditation (certification). The audits highlighted effective collaboration between their departments and their methodical approach to projects.

The benefit: the accreditation validates the robustness of their quality management system, their unwavering commitment to nuclear safety and their ability to provide reliable products and services for the nuclear environment.

The internalization of the spirit of the principles and requirements of an ISO standard significantly improves the overall performance of your business, especially when it is not considered as a constraint.

The third step shall determine whether this approach receives the approval of the staff. A communication campaign is launched in-house on the objectives of a quality and safety management system (QSMS). The staff is aware and understands that, without their participation, the project cannot succeed.

Have confidence: success will come with the involvement and effort of all!

The vision (what we want to be), the mission (why we exist) and the business plan of the company are determined. The following step (4) includes the establishment of an outline of the quality policy and quality objectives. If you do not have a copy of the ISO 19443 standard, now is the time to get it (see sub-clause 2.1 of the present course).

Planning is the last step (5) of the project preparation for obtaining ISO 19443 certification. A reasonable period is between 5 to 8 months (each company is unique and specific). The financial resources and staff are confirmed by top management. A management representative is appointed as project leader. Top management commitment is formalized in a document communicated to all staff. A person is appointed project leader for obtaining ISO 19443 certification.

The establishment and implementation of an ISO 19443 quality and safety management system are shown in figure 1-4.

1-4
Figure 1-4. QSMS implementation

Step 1 aims to identify and determine the processes, interactions, owners, responsibilities and drafts of certain documents. The first versions of process sheets, job descriptions and work instructions are written with the participation of the maximum number of available persons.

The necessary resources to achieve the quality objectives are determined in step 2. Planning tasks, responsibilities and time frames are established. Training of internal auditors is taken into account.

Step 3 allows you to set and implement methods for measuring the effectiveness and efficiency of each process (indicators). Internal audits help to evaluate the degree of implementation of the system.

Nonconformities of all kinds are listed in step 4. A first draft for dealing with waste is established. Corrective actions are implemented and documented. A sorting out of correctve actions is introduced.

A first encounter with the tools and application areas of continual improvement is made in step 5. A table with the main costs of obtaining quality (COQ) is filled by people with the information at hand. Risks are determined, actions are planned and improvement opportunities are found. An approach to preventing nonconformities and eliminating causes is established. The internal and external communication is established and formalized.

To conduct the pre-audit of the QSMS (step 6), documentation is checked and approved by the appropriate people. A management review allows evaluation of compliance with applicable requirements. The quality policy and objectives are finalized. A quality manager from another company or a consultant can provide valuable feedback, suggestions and recommendations.

When the system is accurately implemented and followed, the certification of the QSMS is a breeze, a formality (step 7).

An example of a certification project plan with 26 steps is shown in annex 01. record

An appropriate method for evaluating the performance of your quality and safety management system is the RADAR logic model of excellence EFQM (European Foundation for Quality Management) with its nine criteria and overall score of 1000 points.

The Deming cycle (figure 1-5) is applied to control any process. The PDCA cycles (Plan, Do, Check, Act) are a universal base for continual improvement.



Figure 1-5. Deming cycle

For more information on the Deming cycle and his 14 points of management theory you can consult the classic book "Out of the crisis",  W. Edwards Deming, MIT press, 1982.

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