ML22063B111
| ML22063B111 | |
| Person / Time | |
|---|---|
| Site: | 07103036 |
| Issue date: | 12/31/2021 |
| From: | Kyoto Univ |
| To: | Office of Nuclear Material Safety and Safeguards |
| Bernie White NMSS/DFM/STL 301-415-6577 | |
| Shared Package | |
| ML22063B110 | List: |
| References | |
| EPID L-2020-DOT-0000 | |
| Download: ML22063B111 (34) | |
Text
Appendix 2 Quality management methods for transport containers, etc.
(Limited to those related to design)
Basic policy for quality management The basic policy for this quality management stipulates the requirements for quality assurance activities by reference to the Guidelines for Quality Assurance on the Safety at Nuclear Power Plant Equipment (JEAC4111-2009).
A. Quality management system A.1 General requirements (1) In order to comply with the technical criteria of the relevant regulations and design specifications and manufacturing methods described in the application for confirmation regarding transport or application for transport packaging approval, Institute for Integrated Nuclear and Radiation Science, Kyoto University (hereinafter referred as KURNS) shall establish, perform and maintain the quality management system (hereinafter referred as QMS) concerning design, manufacture, handling, maintenance and transport of the transport packaging and nuclear facilities relevant to handling, maintenance and transportation of transport packaging (hereinafter referred as transport packaging, etc.). This quality assurance system shall be improved continuously through management review.
(2) KURNS shall carry out the following operations:
a) clarifying the details of the necessary processes entailed by the QMS (including the results to be achieved by said processes), be able to identify how said processes will be individually applied.
b) Determine the order of these processes and their mutual relationships.
c) Determine the criteria and methods necessary for ensuring the implementation of processes and the effectiveness of their management.
d) Ensure a system that enables the use of the resources and information necessary for the implementation of processes, as well as their monitoring and measurement.
e) Monitor, measure, and analyze processes. However, where measurement is difficult, measurement shall not be required.
f) Take the necessary measures for obtaining the results of the processes set forth in item (i) and for maintaining effectiveness.
g) Render processes and organizations pertaining to the implementation of (III)-1
quality assurance consistent with the QMS.
h) Promote safety activities based on findings from the social sciences and behavioral sciences.
A.2 Requirements for documentation A.2.1 General In order to establish a QMS pursuant to the provisions of A.1, KURNS shall prepare the following documents and implement the items prescribed in said documents.
a) A Quality Policy Statement and a Quality Objective Statement.
b) A document specifying the provisions of the QMS (Quality Assurance Plan).
c) Documents necessary for ensuring the effective and planned implementation and management of processes.
d) Procedural manuals and records as defined in the Quality Assurance Plan.
A.2.2 Document management (1) KURNS shall manage the documents specified in this document and other documents necessary for the QMS (excluding records; hereinafter referred as quality management documents").
(2) KURNS shall prepare procedural manuals stipulating the controls required for the following operations:
a) When issuing quality management documents, to review the validity of said documents and approve their release.
b) When updating quality management documents after performing the necessary reviews, to approve said updates.
c) To make it possible to identify content changes and the status of the latest revisions to quality management documents.
d) When using a revised quality management document, to ensure that systems are able to use the appropriate revised version of said document.
e) To ensure that quality management documents are easy to read and in a state such that their contents can be easily grasped.
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f) To identify quality management documents prepared by external bodies and manage their distribution.
g) To prevent the unintentional use of obsolete quality management documents. In such cases, when retaining said documents, to identify such regardless of their purpose.
A.2.3 Control of records (1) As well as clarifying the object of records specified in this document and of records demonstrating compliance with other requirements and effective implementation of the QMS, KURNS shall prepare and manage said records in a searchable format while ensuring that their contents are easy to read and can be easily grasped.
(2) KURNS shall prepare procedural manuals stipulating necessary controls relating to the identification, preservation, protection, search, retention period, and disposal of the records set forth in the previous paragraph.
(3) KURNS shall confirm the following items regarding the quality records of the transport packaging:
a) Quality records shall include quality records submitted by the manufacturer of the transport packaging, b) Retention periods of the quality records shall be determined with regards to the validity period of the packaging license and design license of the transport packaging.
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B. Responsibility of the Applicant B.1 Commitment of the management The director of KURNS (hereinafter referred as Director), as operating representative, shall demonstrate responsible leadership through his or her involvement in establishing, implementing, and maintaining the effectiveness of the QMS by conducting the following operations:
a) Establishing a quality policy.
b) Ensuring the establishment of quality objectives.
c) Promoting activities that foster a safety culture.
d) Implementation of management review.
e) Ensuring systems that are able to utilize resources.
f) Informing personnel implementing safety activities (hereinafter, Section personnel) of the importance of observing the applicable laws and regulations and otherwise ensuring the safety of nuclear energy.
B.2 Responsibility and authority B.2.1 Responsibility and authority (1) System Figure III-B.1 shows the quality assurance organization which performs the duties regarding the quality assurance plan.
(2) Responsibility and authority The Director shall ensure that the responsibilities and authorities of each Section and Section personnel (including responsibility for explaining the content of safety activities) are defined, documented, and widely understood.
B.2.2 Quality assurance representatives The director shall grant responsibility and authority for the following operations to personnel responsible for managing and supervising the QMS (III)-4
(hereinafter, quality assurance representatives).
a) Ensure that processes are established and implemented, and that their effectiveness is maintained.
b) Report to the director the implementation status of the QMS and any needed improvements.
c) In each Section, raise awareness about observing the applicable laws and regulations and otherwise ensure the safety of nuclear energy.
B.2.3 Responsibilities and authority of section heads The Director shall grant responsibility and authority for the following operations to the heads in each Section (hereinafter, Section Heads) as the parties responsible for managing and supervising these processes.
a) Ensure that processes for the individual operations managed by the Section Head are established and implemented, and that their effectiveness is maintained.
b) Raise awareness regarding individual operations requirements on the part of Section personnel engaged in individual operations managed by the Section Head.
c) Conduct evaluations regarding the performance of individual operations managed by the Section Head.
d) Promote activities that foster a safety culture.
B.2.4 Internal audit representative (1) The Director shall appoint an internal audit representative.
(2) The internal audit representative shall perform operations for planning and implementing the internal audit as the responsible personnel of the internal audit.
B.3 Management review B.3.1 General (1) The Director shall, at predefined intervals, review the QMS to confirm its (III)-5
validity and effectiveness, as well as maintain its effectiveness (including evaluation of room for improvement and the need for changes to the QMS, quality policy, or quality objectives; hereinafter, management review).
(2) KURNS shall arrange for quality assurance representatives to prepare and manage records of the results of the management review.
B.3.2 Input to management review The Director shall carry out management review based on the following inputs:
a) Audit results.
b) Feedback from parties outside KURNS (e.g., external institutions, regulatory agencies, the Kyoto University administration, local residents, and users).
c) Process implementation status.
d) The results of inspections of the transport packaging, etc.
e) Quality objective achievement status.
f) Implementation status of activities for fostering a safety culture.
g) Compliance status regarding applicable laws and regulations.
h) The status of corrective actions (hereinafter understood as remedial actions carried out to prevent the reoccurrence of nonconformities, which in turn are hereinafter understood as states that do not conform to requirements) and preventive actions (hereinafter understood as preventive measures to prevent potential nonconformities.)
i) Measures taken in response to the results of previous management reviews (follow-up measures).
j) Changes that may affect the QMS.
k) Proposals for improvements from each Section or from Section personnel.
B.3.3 Output from management review The Director shall obtain information pertaining to the following matters from the management review and take steps as necessary.
a) Improvements needed to maintain the effectiveness of the QMS and operations.
b) Improvements to safety activities associated with the planning and (III)-6
implementation of individual operations.
c) Resources necessary for ensuring maintenance of the validity and effectiveness of the QMS.
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(III)-Fig.B.1 Quality assurance organization for design of the transport packaging (III)-8
C. Education and training C.1 Securing resources KURNS shall determine and secure the necessary resources for ensuring safety.
C.2 Section personnel KURNS shall ensure that Sections are staffed with personnel who have demonstrated their abilities sufficiently to satisfy the following requirements.
a) Have appropriate education and training.
b) Have the requisite skills and experience.
C.3 Education and training, etc.
KURNS shall undertake the following operations.
a) Determine the kinds of abilities required by Section personnel.
b) Clarify the need for education and training among Section personnel.
c) Provide education and training and otherwise take steps to fulfill the need for education and training set forth in the previous item.
d) Evaluate the effectiveness of measures set forth in the previous item.
e) Ensure that Section personnel are aware of the relationship and importance of their own individual operations to achieving quality objectives, and that they recognize ways of making their own contributions.
f) Prepare and manage appropriate records regarding the education and training, as well as skills and experiences of Section personnel.
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D. Design control D.1 Planning of processes required by individual operations (1) KURNS shall formulate and establish plans for the processes required by individual operations for transport packaging etc.
(2) Plans formulated pursuant to the provisions of the previous paragraph (hereinafter referred as individual operations plans) shall be consistent with the requirements of the other processes.
(3) When formulating individual operations plans, KURNS shall appropriately determine with regard to the following items.
a) Quality objectives and individual operations requirements pertaining to individual operations and transport packaging, etc.
b) Necessary processes, and quality management documents and resources that are specific to individual operations or transport packaging, etc.
c) Necessary verification, validation, monitoring, and measurement, as well as inspection and testing specific to the individual operations or transport packaging, etc., and criteria for determining the compliance of individual operations or transport packaging, etc.
(hereinafter, compliance-determining criteria).
d) Records necessary for verifying that processes pertaining to individual operations and transport packaging, etc., and the results thereof conform to individual operations requirements.
e) KURNS shall ensure that outputs relating to the formulation of individual operations plans take forms that correspond to work methods.
D.2 Determination of individual operations requirements KURNS shall determine the following items as individual operations requirements.
a) Matters that, although not explicitly stated by outside parties, are known to be necessary requirements for individual operations or transport packaging, etc.
b) Applicable laws and regulations that concern said individual operations and transport packaging, etc.
c) Other requirements deemed necessary by KURNS.
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D.3 Review of individual operations requirements (1) Prior to implementing individual operations or utilizing transport packaging, etc., KURNS shall implement a prior review of individual operations requirements.
(2) When implementing the review set forth in the previous paragraph, KURNS shall confirm the following items.
a) That individual operations requirements have been specified for said individual operations or transport packaging, etc.
b) Where the individual operations requirements pertaining to said individual operations or transport packaging, etc. differ from individual operations requirements determined beforehand, those said differences are clarified.
c) That KURNS has the ability to comply with the predetermined requirements.
(3) KURNS shall prepare and manage records pertaining to the results of the review set forth in the first paragraph, as well as records pertaining to the steps taken based on the results of the said review.
(4) When individual operations requirements are changed, in addition to revising the relevant documents, KURNS shall ensure that the relevant Section personnel are informed of the modified individual operations requirements.
D.4 Transmission of information to external parties KURNS shall clarify and implement effective methods for the transmission of information to external parties.
D.5 Design and development planning KURNS, as well as formulating plans for design and development (Hereinafter design and development plans understood as the definition of specifications for transport packaging, etc., taking their necessary requirements into consideration.), shall also manage design and development.
(1) When formulating design and development plans, KURNS shall determine the (III)-11
following items:
a) Stages of design and development.
b) Review, verification, and validation as appropriate for each stage of design and development.
c) The responsibility and authority of Section and Section personnel involved with design and development (including the responsibility to explain the content of safety activities).
(2) In order to ensure the effective transmission of information and clear assignment of responsibility and authority, KURNS shall manage and supervise communication between the various individuals involved in design and development.
(3) KURNS shall properly update the design and development plan formulated pursuant to the provisions of the first paragraph in accordance with the progress of design and development.
D.6 Input related to design and development (1) As well as determining inputs relating to design and development as listed below with regard to the requirements pertaining to transport packaging, KURNS shall prepare and manage records relating to the pertinent information.
a) Requirements pertaining to transport packaging with regard to function or performance in accordance with intended usage.
b) Information obtained from the prior implementation of similar design and development that is applicable as input to said design and development.
c) Applicable laws and regulations.
d) Other requirements essential to design and development.
(2) KURNS shall review and approve the validity of inputs relating to design and development.
D.7 Output related to design and development (1) KURNS shall retain outputs related to design and developments in a format that enables verification relative to inputs related to design and development.
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(2) When approving progress from design and development to the next stage in the process, KURNS shall first approve the relevant outputs related to design and developments.
(3) KURNS shall ensure that outputs related to design and development meet the following conditions.
a) Compliance with requirements that constitute inputs related to design and development.
b) Provision of appropriate information for procurement, for the implementation of individual operations, and for the use of transport packaging, etc.
c) Inclusion of compliance-determining criteria.
d) Prescription of specific characteristics of transport packaging, etc..
that are indispensable for the safe and proper use of transport packaging, etc.
D.8 Design and development review (1) At the appropriate stage, KURNS shall implement a systematic review of design and development (hereinafter, design and development review) including the following items in accordance with the design and development plan.
a) Evaluate whether the results of design and development can comply with requirements.
b) Where problems with design and development exist, ensure the ability to identify the problematic content in question and propose the necessary measures.
(2) In the design and development review process, KURNS shall involve representatives of the Sections associated with the design and development stage that is the object of the review in question, as well as experts related to said design and development.
(3) Where the necessary measures have been taken based on records of the results of design and development review and the results in question, KURNS shall prepare and manage the records thereof.
D.9 Design and development verification (III)-13
(1) KURNS shall implement verification in accordance with the design and development plan in order to ensure that outputs related to design and development are in a state of conformance with requirements that are inputs related to the design and development in question. In this case, it shall ascertain conformity with the requirements when proceeding to the next stage in the process in accordance with the design and development plan.
(2) KURNS shall prepare and manage records of the results of the verification set forth in the preceding paragraph (including records of necessary measures taken based on the results of the verification in question).
(3) KURNS shall not allow any Section or Section personnel involved in the design and development in question to conduct the verification set forth in the first paragraph.
D.10 Validation of design and development (1) In order to ensure that transport packaging comply with the requirements concerning the prescribed performance, purpose of use, and intended usage method, KURNS shall implement the validation of the design and development in question in accordance with the design and development plan as it relates to the transport packaging in question (hereinafter referred to in this article as design and development validation).
(2) When using the transport packaging, KURNS shall first complete design and development validation. However, if it is not possible to carry out validation until after the installation of the transport packaging in question, then design and development validation shall be carried out prior to commencing the use of the transport packaging.
(3) Where the necessary measures have been taken based on records of the results of design and development validation and the results of the validation in question, KURNS shall prepare and manage the records thereof.
D.11 Control of design and development changes (1) When a design and development change has been made, as well as ensuring that the ability to identify the content of said changes, KURNS shall prepare and manage a record pertaining to the change in question.
(2) When implementing design and development changes, KURNS shall approve these (III)-14
after first carrying out the appropriate review, verification, and validation.
(3) KURNS shall ensure that the scope of the review of design and development changes includes evaluation of the impact of the changes in question on transport packaging (including an evaluation of impact on materials and components that constitute the transport packaging in question).
(4) KURNS shall prepare and manage records relating to the results of the review of changes under the provisions of paragraph 2 (including any records of necessary measures taken based on the results of said review).
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E. Manufacturing order of transport packaging E.1 Quality management plan KURNS shall establish a quality management plan defining the quality management operation of transport packaging manufacturing, including the quality control of manufacturer and supplier of transport packaging.
E.2 Procurement process (1) When ordering the manufacturing of the transport packaging, KURNS shall ensure that the manufacturing of the transport packaging complies with the technical criteria set by law, design specifications specified in application for transport packaging design approval or application for transport packaging approval and manufacturing process specified in application for transport packaging design approval, and shall ensure that externally procured goods and services procured (hereinafter referred as procured goods, etc.)
shall comply with its own specified requirements pertaining to procured goods, etc. (hereinafter referred as requirements for procured goods, etc.).
(2) KURNS shall ensure the items in the preceding paragraph when KURNS orders the manufacturing of the part(s) of the transport packaging and supplies the part(s) to the manufacturer of the transport packaging.
E.3 Evaluation of the Manufacturer of Transport Packaging KURNS shall perform the following items:
(1) Evaluate the ability of the manufacturer of transport packaging to manufacture the transport packaging and select the manufacturer. The following items shall be considered upon evaluating the manufacturers ability.
a) Technology and personnel regarding the transport packaging manufacturing.
b) Quality policy, quality management plan of the manufacturer and their implementation status.
c) Supply experience of transport packaging or similar products.
d) Usage experience and quality records of transport packaging or similar products.
e) Evaluation of test products and samples, etc.
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(2) Clarify the method and level of management of the manufacturer performed by KURNS.
E.4 Quality Management Requirement to the Manufacturer When ordering the manufacturing of transport packaging, KURNS shall clearly instruct the manufacturer of the transport packaging about the following requirements in a document such as a specification sheet, and ensure the manufacturer to implement the requirements:
a) The manufacturer of the transport packaging shall implement quality control that complies with "E.8 Content of Quality Management by Manufacturer of the Transport Packaging".
b) Measures shall be taken so that the personnel of KURNS and the regulatory authorities can inspect the manufacturer of the transport packaging and the supplier of the manufacturer of the transport packaging during the manufacture of the transport packaging and confirm the quality control status.
c) Measures shall be taken so that KURNS can examine and approve the selection criteria for suppliers of manufacturer of the transport packaging. Measures shall be taken so that KURNS can confirm the selection status of the manufacturer of the transport packaging's supplier.
d) Measures shall be taken to clarify the relationship of responsibilities between business operators involved in the manufacture of transport packaging through contracts.
e) Measures shall be taken to ensure that the manufacturer of the transport packaging and the supplier of the manufacturer of the transport packaging fully understand the meaning and importance of the numerical values regarding the safety-critical material specifications specified by KURNS.
f) When using special materials that are of high safety importance in the manufacture of transport packaging, information on the construction, analysis, and inspection methods related to manufacturing shall be exchanged beforehand between the business operators involved in the manufacture of transport packaging and take measures to ensure that technical studies are carried out sufficiently.
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g) In processes that involve multiple business operators regarding the manufacture of transport packaging, clarify the arrangements such as work instructions and delivery agreements and ensure close cooperation.
h) If a non-conforming product occurs and it is used by rework, etc., notify KURNS in writing and receive instructions for handling.
i) Immediate reporting and approval of any significant changes in the manufacturer of the transport packaging's manufacturing process.
E.5 Verification of manufacturing of transport packaging (1) KURNS shall conduct quality audits on the manufacturer of the transport packaging, understand the status of quality audits by the manufacturer of the transport packaging on suppliers, and directly check the quality control status with the supplier if necessary.
(2) When inspecting transport packaging, KURNS shall perform witness inspection and record inspections considering the importance of safety and other factors, while considering the existence of public standards and official qualification systems and the status of quality control of manufacturer of the transport packaging and suppliers.
(3) KURNS shall prepare and implement documents such as inspection plans, inspection procedures, and implementation procedures for quality inspections related to the production and inspections of transport packaging.
E.6 Schedule management and certification of special processes KURNS shall create and manage the manufacturing schedule and inspection schedule for manufacturing the transport packaging. KURNS shall also certify processes that cannot be sufficiently verified in the subsequent inspection as special processes, and clarify the method of certifying and managing workers and processes.
E.7 Measurement, analysis and improvement E.7.1 General KURNS shall formulate and implement a plan concerning processes related to the monitoring, measurement, analysis, and improvements necessary for the following (III)-18
operations (including applicable methods of inspection and testing [including statistical methods] and the determination of the scope of the application of the methods in question):
a) Demonstrating conformity with individual operations requirements.
b) Ensuring the conformity of the QMS and maintaining its effectiveness.
E.7.2 Opinions from outside parties (1) As part of the monitoring and measurement of the implementation status of the QMS, KURNS shall grasp the opinions of individuals external to the transport packaging, etc., for ensuring safety.
(2) KURNS shall clarify its grasp of the opinions referenced in the preceding paragraph, as well as determine methods concerning the reflection of said opinions.
E.7.3 Internal audit (1) In order to determine whether the QMS meets the following requirements, KURNS shall implement an internal audit by an Internal Audit Committee at predefined intervals. KURNS shall arrange for an Internal Audit Representative to convene and instruct the Internal Audit Committee.
a) KURNS conforms to the requirements of the individual operations plan, the provisions of this document, and the requirements related to the QMS in question.
b) Effective implementation and maintenance have been carried out.
(2) KURNS shall formulate an internal audit implementation plan that takes into consideration the status and importance of the areas and processes targeted by the internal audit, as well as the results of previous audits.
(3) KURNS shall establish the criteria, scope, frequency, and method of the internal audit.
(4) KURNS shall ensure objectivity and impartiality in its selection of internal audit committee members and in the implementation of the internal audit.
(5) KURNS shall not allow the internal audit committee to conduct an internal audit of its own individual operations.
(6) KURNS shall establish the responsibility, authority, and requirements for formulating and implementing an internal audit implementation plan, as well (III)-19
as reporting the results of the internal audit and managing the records thereof, in a procedural manual.
(7) KURNS, in addition to having managers responsible for the areas subjected to internal audit take rapid measures to eliminate any discovered nonconformities and the causes of said nonconformities, shall also arrange for the verification of said measures and the reporting of their results.
E.7.4 Process monitoring and measurement (1) When conducting the monitoring and measurement of processes, KURNS shall apply monitoring and measurement methods suited to the monitoring and measurement of said processes.
(2) Using the monitoring and measurement methods set forth in the preceding paragraph, KURNS shall demonstrate that processes are able to obtain the results prescribed in the quality management plan and individual operations plans.
(3) In the event that it is not possible to obtain the results prescribed in the quality management plan and individual operations plans, KURNS shall take appropriate remedial and corrective action to ensure conformity with individual operations requirements.
E.7.5 Inspection and test (1) KURNS shall carry out the inspection and testing of transport packaging in order to verify that the transport packaging conform to requirements.
(2) KURNS shall carry out the inspection and testing set forth in the previous paragraph at the appropriate stage of processes relating to the implementation of individual operations, according to the individual operations plan and the procedural manuals.
(3) KURNS shall prepare and manage records, etc., related to the results of inspection and testing, which constitute evidence of conformity with the compliance-determining criteria of inspection and testing.
(4) KURNS shall prepare and manage records specifying individuals who approve proceeding to the next stage in a process.
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(5) KURNS shall not approve proceeding to the next stage of a process until inspection and testing based on the individual operations plan is completed and found to be free of trouble.
(6) KURNS shall designate individuals to conduct inspection and testing in accordance with the importance of individual operations and transport packaging. In this case, the neutrality of the individuals who will conduct inspection and testing shall be taken into consideration.
E.7.6 Management of nonconformity (1) In order to prevent individual operations and transport packaging that do not conform to requirements from being neglected, KURNS shall identify the individual operations and transport packaging in question and ensure that they are managed correctly.
(2) KURNS shall set out management pertaining to the handling of nonconformities and the responsibility and authority associated with such in a procedural manual.
(3) KURNS shall handle nonconformities using one of the following methods.
a) Taking measures to eliminate any nonconformities discovered.
b) Approving the implementation of individual operations, the use of transport packaging or advancement to the next stage of a process (hereinafter, specially adopted measures).
c) Taking measures to prevent the originally intended use or application.
d) In the event that a nonconformity is discovered after the implementation of an individual operation, taking appropriate measures against the effects or potential effects of the nonconformity.
(4) KURNS shall prepare and manage records of the content of nonconformities and of measures (including specially adopted measures) taken against said nonconformities.
(5) Where a nonconformity has been modified, KURNS shall carry out a secondary verification to confirm conformity with individual operations requirements in the wake of the modification.
E.7.7 Data analysis (III)-21
(1) In order to demonstrate that the QMS is appropriate and effective and to evaluate room for improvement in terms of its effectiveness, KURNS shall determine, collect, and analyze appropriate data (including data obtained from the results of monitoring and measurement and data from other relevant information sources).
(2) By analyzing the data set forth in the preceding paragraph, KURNS shall obtain information relating to the following items.
a) Opinions from parties external to the transport packaging b) Conformity with individual operations requirements c) Characteristics and trends of processes and transport packaging (including those that will serve as the starting point for preventive action) d) The supply capacity of the suppliers of procured goods, etc.
E.7.8 Improvement As well as clarifying all items for which changes are necessary for maintaining the validity and effectiveness of the QMS through the utilization of its quality policy, quality objectives, the results of internal auditing, data analysis, corrective actions, preventive actions, and management review, KURNS shall implement the changes in question.
E.7.9 Corrective actions (1) KURNS shall take appropriate corrective action in light of the impact of the nonconformities discovered. In such cases, KURNS shall conduct an analysis for investigating the fundamental causes of matters that have arisen affecting nuclear energy safety (hereinafter, root cause analysis) after establishing procedures for doing so.
(2) KURNS shall prepare a Corrective Action Procedural Manual stipulating the following requirements.
a) Review of nonconformities.
b) Determination of the causes of nonconformities.
c) Evaluation of the necessity of measures for ensuring that nonconformities do not reoccur.
d) Determination and implementation of the necessary corrective actions (III)-22
(including document updates).
e) In the event that a survey has been carried out regarding corrective actions, recording of the results thereof and of corrective actions taken based on said results.
f) Review of the corrective actions taken and their effectiveness.
E.7.10 Preventive actions (1) KURNS shall determine and take appropriate preventive action in light of the impact of the potential problems. In such cases, KURNS shall reflect appropriately not only on findings obtained through the implementation of safety activities in its own transport packaging, etc., but also on findings obtained from other facilities.
(2) KURNS shall prepare a Preventive Action Procedural Manual stipulating the following requirements (including requirements relating to root cause analysis).
a) Determination of potential nonconformities and their causes.
b) Evaluation of the necessity for preventive action.
c) Determination and implementation of the necessary preventive actions.
d) In the event that a survey has been carried out regarding preventive actions, record of results thereof and of preventive actions taken based on said results.
e) Review of the preventive actions taken and their effectiveness.
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E.8 Content of quality management system by manufacturer of transport packaging KURNS shall require the following items related to quality management from the manufacturer of transport packaging when placing an order for manufacturing the transport packaging with the manufacturer of transport packaging.
E.8.1 Quality management system E.8.1.1 General The manufacturer of the transport packaging shall establish, document, implement and maintain a quality management system in order to implement the manufacturing in conformity with the requirements related to the manufacturing of transport packaging.
E.8.1.2 Documentation requirements E.8.1.2.1 General The quality management system documentation shall include a documented statement of quality policy and quality objectives, and E.8.1.2.2 through E.8.1.2.4 below.
E.8.1.2.2 Quality Manual The manufacturer of the transport packaging shall develop and maintain a quality manual containing a description of the scope of the quality management system, the documented procedures established for the quality management system and the interrelationships between the processes of the quality management system.
E.8.1.2.3 Document management The manufacturer of the transport packaging shall control the documentation required by the quality management system. Establish documented procedures that (III)-24
define the controls required for document approval and review and identification.
E.8.1.2.4 Quality record management The manufacturer of the transport packaging shall create and maintain readable, identifiable, and searchable quality records. The manufacturer shall establish a documented procedure that defines the controls required for the identification, storage, protection, retrieval, storage period and disposal of quality records.
The quality record shall include the quality record submitted by the supplier.
E.8.2 Responsibility of the Manufacturer of the Transport Packaging E.8.2.1 Chief Executive Commitment The chief executive of the manufacturer of the transport packaging shall show evidence of its commitment to establishing and implementing a quality management system and continually improving its effectiveness by setting quality policies, ensuring that quality objectives are set, and conducting management reviews.
E.8.2.2 Responsibility and authority E.8.2.2.1 Responsibility and authority The chief executive of the manufacturer of the transport packaging shall ensure that the responsibilities and authorities for the operations that affect the quality of the production of the transport packaging are defined and are known to the entire organization.
E.8.2.2.2 Management Representative Officer The chief executive of the manufacturer of the transport packaging shall appoint a management representative officer who has the responsibility and authority for the implementation of the quality management system from the management personnel level.
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E.8.2.3 Management review The chief of the manufacturer of the transport packaging shall regularly review the quality management system to ensure that it is effective.
E.8.3 Resource operation management E.8.3.1 Provision of personnel The manufacturer of the transport packaging shall identify and provide the personnel necessary to implement and maintain the quality management system and to continually improve its effectiveness.
E.8.3.2 Education and training (1) The manufacturer of the transport packaging shall clarify the competence required for personnel engaged in work that affects the quality of manufacturing of transport packaging, educate and train them to have the necessary competence and maintain the records.
(2) Persons engaged in the specified work shall be qualified based on appropriate education/training history and experience as necessary.
E.8.4 Manufacturing of transport packaging E.8.4.1 Quality control plan (1) The manufacturer of the transport packaging shall establish a quality control plan that defines quality management operations related to the manufacturing of transport packaging, including quality control of suppliers, and formulate a quality control plan.
(2) The manufacturer of the transport packaging shall consider the following items as appropriate in order to meet the requirements related to the manufacture of transport packaging.
a) All control measures, processes, equipment (including inspection equipment), equipment, management resources and technology that are considered necessary to achieve the requirements shall be secured.
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b) Manufacturing process, inspection procedures and documents shall be coordinated.
c) Quality control and inspection techniques shall be updated as necessary.
d) Verification method in the transport packaging manufacturing process shall be clarified.
e) Acceptance criteria shall be clarified.
f) Quality records shall be created E.8.4.2 Confirmation of Contract Details (1) The manufacturer of the transport packaging shall establish the procedure for confirming the contract content.
(2) The manufacturer of the transport packaging shall confirm the contents before submitting the quotation specification or before contracting, and confirm that he/she has the ability to meet the contract requirements.
E.8.4.3 Purchasing E.8.4.3.1 General The manufacturer of the transport packaging shall define the procedure for conforming the purchased items (including services; the same shall apply hereinafter) to the requirements. It should be noted that this does not apply to purchased goods manufactured based on JIS or other public standards, or those for which the items to be checked for inspection are simple or general-purpose products, and whose compatibility can be confirmed by inspection at the time of acceptance.
E.8.4.3.2 Evaluation of the suppliers The manufacturer of the transport packaging shall implement the following items.
a) Develop selection criteria for suppliers, evaluate whether suppliers have the ability to meet the requirements of supply contracts, and make selections.
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b) Clarify to the supplier the type and extent of controls performed by the manufacturer of the transport packaging.
E.8.4.3.3 Purchasing data The manufacturer of the transport packaging shall prepare a purchase document stating the supply requirements and instruct the supplier.
E.8.4.3.4 Purchase verification (1) The manufacturer of the transport packaging shall prepare a document such as a guideline for the inspection of purchased products.
(2) The manufacturer of the transport packaging shall verify the purchased items by performing necessary inspections or other activities.
E.8.4.4 Process control (1) The manufacturer of the transport packaging shall carry out the following items when planning and controlling the manufacturing process of transport packaging.
a) Develop a written procedure that clarifies the method of manufacturing that may affect quality.
b) In each process, use appropriate equipment and ensure an appropriate work environment.
c) Perform all processes according to quality control plans, procedures, etc.
d) To monitor the characteristic values of processes and products.
e) Appropriate maintenance of equipment to maintain continuous process capability.
f) In the event of a supplier nonconformity or significant change in the manufacturing process, prompt documentation shall be provided and appropriate action shall be taken.
(2) The manufacturer of the transport packaging shall certify the process whose results cannot be sufficiently verified by the subsequent inspection as a special process in consultation with the applicant, and clarify the method of certifying and controlling the worker and the process. Records shall be kept as appropriate for the certified processes, equipment and personnel.
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E.8.4.5 Identification and traceability (1) The manufacturer of the transport packaging shall establish a procedure for identifying the condition of the transport packaging at all stages from receiving the material to manufacturing.
(2) The manufacturer of the transport packaging shall establish procedures to enable tracking of quality records for individual transport packaging.
E.8.4.6 Managing customer supplies The manufacturer of the transport packaging shall establish procedures for verification, storage and management of the goods supplied by the applicant for incorporation into the manufactured transport packaging or for related work. For lost or damaged supplies and other supplies not suitable for use, record and report to the applicant.
E.8.4.7 Inspection E.8.4.7.1 General The manufacturer of the transport packaging shall establish the procedure for inspection work. Required inspections and records shall be specified in the quality control plan or procedure manual.
E.8.4.7.2 Acceptance inspection The manufacturer of the transport packaging shall not use or process the purchased product until it confirms that the purchased product complies with the requirements.
E.8.4.7.3 In-process inspection The manufacturer of the transport packaging shall implement the following items:
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a) Inspect the transport packaging in accordance with the provisions of the quality control plan and procedure manual.
b) Do not proceed to the next step until the prescribed inspection is completed or the required report is received and verified.
E.8.4.7.4 Final inspection The manufacturer of the transport packaging shall perform a final inspection in accordance with the quality control plan and procedure manual to confirm that the transport packaging complies with the requirements.
E.8.4.7.5 Inspection record The manufacturer of the transport packaging shall create and keep an inspection record of the transport packaging. These records shall show whether the inspection has been passed according to the criteria. If the inspection does not pass, apply the procedures for managing nonconforming products.
E.8.4.8 Control of inspection, measurement and test equipment E.8.4.8.1 General (1) The manufacturer of the transport packaging shall define procedures for controlling and calibrating inspection, measurement and test equipment (hereinafter referred to as "measuring equipment, etc."). Use the measuring device according to the measuring ability.
(2) The manufacturer of the transport packaging shall define the scope and frequency of inspection of measuring devices and keep the records.
E.8.4.8.2 Management procedure The manufacturer of the transport packaging shall implement the following items:
a) Clarify the measurement items and the required accuracy, and select appropriate measurement equipment.
b) To specify calibration of measuring devices.
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c) Calibrate and adjust measuring devices, etc. regularly or before use. If there are no international or national standards for calibration and adjustment, record the standards used for calibration.
d) Identify the calibration status of the measuring device, etc., by using an appropriate sign.
e) Keep calibration records of measuring devices.
f) If the measuring device is discovered to be out of the calibration standard, the validity of the past inspection results shall be evaluated and recorded.
g) Calibration, inspection, measurement and testing shall be performed under appropriate environmental conditions.
h) Protect the measuring device etc., from damage and deterioration during handling, maintenance and storage.
E.8.4.9 Inspection Status The manufacturer of the transport packaging shall identify the inspection status of the transport packaging in all processes of manufacturing in order to ship only the transport packaging that has passed the inspection, in accordance with the provisions of the quality control plan and the procedure manual.
E.8.5 Measurement, analysis and improvement E.8.5.1 Internal Audit (1) The manufacturer of the transport packaging shall conduct internal audits on a regular basis to clarify whether the quality management system is effectively implemented and maintained. The audit plan and its implementation shall be defined in a documented procedure. Auditors shall not audit their own work.
(2) The person in charge of the audited area shall ensure that any nonconformities found and their causes can be taken without delay. The results of the internal audit shall be input to the management review.
E.8.5.2 Management of nonconforming products (III)-31
(1) The manufacturer of the transport packaging shall ensure to identify and control transport packaging that do not meet the requirements. Controls and associated responsibilities and authorities for handling nonconforming products shall be established in documented procedures.
(2) Repaired or reworked transport packaging shall be reverified to demonstrate compliance with the requirements.
E.8.5.3 Improvement E.8.5.3.1 Corrective Action (1) The manufacturer of the transport packaging shall take measures to eliminate the cause of nonconformity in order to prevent recurrence.
(2) Documented procedure shall be established by the manufacturer to specify requirements for:
a) Applicant's complaint and confirmation of nonconforming product report contents.
b) Identification of the causes of nonconformities related to transport packaging, processes and quality management systems.
c) Assessing the need for action to ensure the prevention of nonconformity recurrence.
d) Determination and implementation of necessary measures.
e) Recording the results of the actions taken.
E.8.5.3.2 Preventive Measures (1) The manufacturer of the transport packaging shall decide the action to eliminate the cause in order to prevent the occurrence of possible nonconformity.
(2) The manufacturer shall establish a documented procedure to specify requirements for:
a) Identification of possible nonconformities and their causes.
b) Assessing the need for action to prevent the occurrence of nonconformities.
c) Determination and implementation of necessary actions.
d) Recording the results of the actions taken.
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F. Handling and Maintenance F.1 Handling Management (1) In order to prevent accidental operation and damage to the transport packaging during handling, KURNS shall establish in a document a handling management method including the following items and manage it appropriately.
a) Measures to prevent erroneous operation and damage during inspection and handling of handling equipment.
b) Handling conditions for transport packaging.
c) Conditions and methods for loading and unloading transport packaging from storage facilities.
d) Person in charge of facility management.
(2) KURNS shall clearly indicate the handling requirements to the person who handles it, and reflect it in the prevention of incorrect operation and damage of the transport packaging.
F.2 Maintenance and storage management (1) In order to maintain conformity with the requirements for transport packaging, KURNS shall establish in a document a storage management method that includes the following items and manage them appropriately.
a) Measures to prevent damage during storage.
b) Storage method and storage area setting in consideration of environmental conditions.
c) Inspection during storage.
d) Person in charge of facility management.
(2) KURNS shall clearly indicate the requirements for maintenance and storage management to those who perform maintenance and storage management, and reflect them in the prevention of erroneous operation and damage to the transport packaging.
If the quality management system is reviewed, the revised content shall be applicable.
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