Chapter 10 Quality Assurance (QA)

4. checks of practice conditions in the supplier’s process including audits.

If every requirement cannot be confirmed to be satisfied at some point during such verification activities, follow-up actions and their management rules are coordinated and agreed upon with the supplier for action.

The management rules for delivering and returning of supplier’s documents according to the purchasing requirements are also prescribed for action.

10.8 Production and Service Provision (Implementation of Work)

Hie process of "Production and service provision (implementation of work)" corresponds to the part of D (Do) in the PDCA cycle for product realization.

Figure 10.8.1 shows the PDCA cycle for product realization.

1. Control of Production and Service Provision (Control of Work)

Manufacturing of products to be delivered to, services to be provided for, and the work to do at, a nuclear power plant should be planned first and then carried out according to the plan under controlled conditions. The controlled conditions include the following status, as applicable. When the work is planned based on the "Planning of

product realization" (Section 10.5), the plan must be developed by incorporating the controlled conditions shown in Table 10.8.1, and include the daily work plans as well.

2. Validation of Processes

1. If the resulting output in the middle of a process for production and service provision cannot be verified by later monitoring or measurement, the process must be validated. This includes any processes in which a deficiency becomes apparent only after the work has been performed.

The processes which need validation are of the following two kinds.

i )The output of the process for production and service provision highly depends on the process management and/or the worker skills, and the planned qualities cannot be easily judged by subsequent monitoring or measurement. Examples of these "Special processes" are welding or nondestructive inspections.

2. deficiency becomes apparent only after the work has been performed. In other words, these are cases need the process validation prior to the work. For work in nuclear facilities, cases include where a new procedure is added to revise a provided work instruction or established work procedure, or where nuclear safety is affected by a deficiency in the process.

Plan

Analysis of data and improvement (Sec.10.10)

1. Analysis of data

2. Nonconforming action / corrective action

3. Preventive action

Check

Monitoring & measurement and internal audit (Sec. 10.9)

Figure 10.8.1 PDCA cycle for product realization

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Table 10.8.1 Controlled conditions and their examples

i ) Information describing the characteristics of the products and the relation with nuclear safety is available.

The information here includes the information needed for daily work, the "output from design and development," or the information from the procured products, etc. as the following examples.

[Examples of common items]

• Nuclear reactor establishment license application document

• Operational safety program for nuclear reactor facilities and information given in the final drawings of the equipment of importance

• Plant operation information (latest inspection records, equipment inspection information, work schedules, periodic inspection schedules, isolation work schedules)

• Information on radiation in the workplace (doses, contaminated areas)

[Examples of individual work]

• For operation management: the plant operation information, etc. such as matters to be confirmed and information to be handed over at the time of patrol inspection checks or before reactor startup

• For fuel management: the information, etc. on fresh and spent fuel storage or fuel inspections

• For radioactive waste management: the information related to management of radioactive solid, liquid and gaseous wastes, management of measuring instruments for radiation release, etc.

• For radiation control: the information related to area control, radiation exposure management, management of the material movement, etc.

• For maintenance management: the information related to implementation of periodic inspections and reporting of results, maintenance and repair work, etc.

• For actions in urgency (emergency), the information related to the organizational framework in nuclear disasters, reporting and communicating, etc.

ii) Work procedures are available, as needed.

'Work procedures” refer to the "Manuals" prepared in the work planning of concern, or "Established procedures". Tile work procedures do not necessarily need to be a documented manual. It is considered effective if established procedures (or Specified ways) exist.

3. ) An appropriate facility is used.

An “Appropriate facility” means the nuclear facilities or equipment, etc., as prescribed in the work planning of concern, as in the following:

• Tools, retainers, computers, and computer software, etc. used in the work, inspections, etc.

3. ) Monitoring and measurement devices are available and in use.

The meaning of this is that the monitoring and measurement devices in use are under the control of the "Control of monitoring and measurement devices" (Section 10.8.4).

3. ) The prescribed monitoring and measurement activities are carried out.

The meaning of this is that the monitoring and measurement activities prescribed in the work planning of concern are carried out. Namely, the monitoring and measurement activities must be carried out based on the "Monitoring and measurement of products (inspections and tests)" (Section 10.9.1) or the "Monitoring and measurement of the processes" (Section 10.9.2).

vi) The release (delivery to the next process), the delivery to the customer and the post-delivery activities are implemented as prescribed.

More specifically, example cases include:

1. an operation procedure to introduce constant rated thermal power operation to the first unit of a nuclear power plant;

2. action procedure for urgency (emergency);

3. implementation of new methods;

4. maintenance and inspection work which do not have results; and

5. system isolation of nuclear facilities.

6. Validation must demonstrate the ability of these processes to achieve planned results.

7. For these processes, it is necessary to establish the arrangements including the following items, as applicable.

8. Defined criteria for process review and approval

9. Qualification confirmation such as an approval of equipment and the qualification authorization

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of personnel

1. Use of pre-planned methods and procedures

2. Requirements for records

3. Revalidation