i

i t

i

i

i

i

Control of non­conforming product

Individual process

i i i i i i i

I

i

Monitoring and measurement Of product

Monitoring and measurement of process

Individual

process

Control of monitoring and measuring devices

Achievement of nuclear safety

Middle process

Basic process

Small process

[Source] JEA : Exposition in JEAG 4121-2005: “Guidance on QA code of nuclear safety of NPP0EAC4111-2003)’’

Figure 10.2.2 Process diagram on npp (example)

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manual or a stand-alone document.

2. )Quality manual: This is the highest document in the QMS. It prescribes the overall operation and management of the organization.

3. Documented procedures: These complement the quality manual. Six documented procedures are needed in the QMS as common instructions for the relevant tasks: document control, record control, nonconforming product control, internal audits, corrective actions and preventive actions.

4. Other management documents and technical requirements: Management documents, other than the documented procedures above, are needed to ensure errorless implementing, sure planning, operating and controlling of the processes for unspecified but intended tasks for the organization. The technical requirements to be met on implementing the individual tasks must also be documented. Additionally, it is desirable to document the rules for controlling

The terms i )~ v) are identified as document to be included in the QMS.

Provision of quality policy and quality objectives

quality policy

quality objectives

Presentation of evidence of effective operation of qms

(Source] JEA: Exposition in JEAG4121-2005:”Guidance on QA code for safety of NPPGEAC4111-2003)

Figure 10.2.3 Summary of documentation requirements

NSRA, Japan

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and handling documents of external origin (laws, private codes and standards, instructions from the regulator, and documents on procurement).

v )Records on responses to agreed requirements; All the responses to the agreed technical requirements need to be recorded as providing evidence of the conformity to the requirements or of the effective QMS operation. These do not necessarily require that the working procedures on all items specified in JEAC4111-2003 be documented and recorded. The records to be made are those needed for the tasks themselves. The organization can select the procedures to document and record as necessary and adequate for work implementation without being bound to the JEAC4111-2003 specifications. Therefore, it is necessary to stipulate, with due consideration, in the QMS documents what records are to be taken and maintained.

Figure 10.2.4 gives an overview of the QMS documentation structure.

(2) Qualify manual

The quality manual is the highest QMS document It is necessary to clarify the contents of the QMS of the organization. Since the quality manual describes the core framework of the QMS, top management is required to be involved in its documentation and maintenance. It must include the following items and be reevaluated when the situation changes.

i /Hie quality manual must describe the scope of work to which it applies (scope of application). IS09001:2000 accepts exclusions of QMS applications when justifiable. But it must be noted that none of the processes can be excluded in the JEAC4111-2003 QMS being applied to nuclear facilities.

2. The quality manual must stipulate whether the six management documents (document control, record control, nonconforming product control, internal audits, corrective actions and preventive actions), as required by IS09001:2000 and JEAC4111-2003, are described in the quality manual itself, or, if not there, where they are described.

3. )The quality manual must show in appropriate forms (tables or figures) how the task units (processes) are correlated and interrelated (See Figure 10.2.2).

Quality manual

(including Operation and Maintenance code)

Management documents

- management procedures and job descriptions etc.

detailed working documents

-work instructions, drawings, documents of external origin and technical standards etc.

[Source] JEA: Exposition of JEAG4121-2005:"Guidance of QA code on safety of NPPQEAC4111-2003)’’

Figure 10.2.4 Documentation structure on the QMS

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