ML24306A046
| ML24306A046 | |
| Person / Time | |
|---|---|
| Site: | 07103043 |
| Issue date: | 12/04/2023 |
| From: | Shaw D Mitsubishi Nuclear Fuel Co, Ltd, Orano TN Americas |
| To: | Office of Nuclear Material Safety and Safeguards |
| Shared Package | |
| ML24306A041 | List: |
| References | |
| E-63985 | |
| Download: ML24306A046 (1) | |
Text
Enclosure 4 to E-63985
MNF Fundamental Policy of Quality Management (Non-Proprietary)
ENCLOSURE
<Appendix-2>
FUNDAMENTAL POLICY
OF
QUALITY MANAGEMENT
Submitted by:
MITSUBISHI NUCLEAR FUEL CO., LTD.
Rev. December, 2023
Contents
<Appendix-2> Fundamental Policy of Quality Management A Quality Management System 1 A.1 Quality Manual 1 A.2 Document and Data Control 4 A.3 Control of Quality Records 5
B Responsibility of Applicants 7
C Education and Training 13
D Design Control 14 D.1 Design Control for Commission to Outside Company 14 D.2 Design Control for In-House Design 15
E Production Order of Packaging 17 E.1 Evaluation of the Packaging Manufacturer 17 E.2 Requirements for quality management systems toward the packaging manufacturer 17 E.3 Verification by inspection and quality audit related to packaging fabrication 19
F Handling and Maintenance 21 F.1 Maintenance Control 21 F.2 Inspection before Shipment 21
G Measurement, Analysis and Improvement 23 G.1 Internal Quality Audits 23 G.2 Control of nonconforming products 23 G.2 Corrective Nonconformity and preventive actions 24
Contents-1 Figure Lis
<Appendix-1> Fundamental Policy of Quality Management
Fig.1 Quality System of Design, Fabrication, Procurement, Maintenance of the Packaging 11 Fig.2 Organization of MNF Packaging Quality 12
Contents-2 Fundamental Policy of Quality Management
A Quality Management System Mitsubishi Nuclear Fuel Co., Ltd (hereinafter referred to as MNF) shall establish and maintain the quality management system based on ISO9001:2015 to ensure the conformity with the customer s requirements and regulatory technical standards.
A.1 Quality Manual (1) Quality manual The quality manual is a first-tier document in the QMS documentation system that documents the requirements of ISO9001(2015). It provides for the clarification of quality policy and quality objectives, and clarifies the standards of practice for quality assurance activities required at each stage of the procurement, design, fabrication, use (including handling), maintenance, etc. of transportation containers.
The Safety and Quality Assurance Department shall prepare, issue and revise a quality manual under the quality policy decided by the president (& CEO).
(2) Quality assurance program The Safety and Quality Assurance Department and the related departments shall establish and document quality assurance programs concerning design, fabrication, procurement, use (including handling), maintenance, etc. of the packaging considering the following items properly based on the quality manual. In addition, it shall ensure that the packaging conforms to the customer s requirements, regulatory technical standards, design specification in the application for the design approval, fabrication methods in the application for the packaging approval, etc. Procedures and other documents issued by the Safety and Quality Assurance Department, the Manufacturing Department, the Procurement Department, the General Affairs Department and the Transportation and Service Department shall constitute the quality assurance programs.
(a) Each related department shall clarify respective responsibility for management of design, fabrication, procurement, use, maintenance, etc. of the packaging.
The Transportation and Service Department shall reasonably carry out part of work of design, fabrication, use, maintenance, etc. of the packaging by receiving supplies of services from professional companies with appropriate quality management systems as needed.
(b) The Transportation and Service Department shall establish and implement
1 inspection procedures concerning fabrication and performance retention of the packaging to verify fabrication and maintenance of the packaging at appropriate stages of the work. In addition, the Transportation and Service Department shall provide the requirements from MNF for the inspection to the packaging manufacturer, etc. if the inspection is conducted based on the inspection procedures prepared by the packaging manufacturer, etc., and review that the requirements from MNF are reflected appropriately in the inspection procedures prepared by the packaging manufacturer, etc., and approve the procedures. The departments shall verify that the manufacturer has conducted inspections according to the procedures.
(c) Each department shall prepare effective procedures (procedures, manuals, and instructions) according to the quality assurance programs and perform quality assurance activities according to the procedures. The extent provided in the procedures, etc. and the level of their details shall be determined depending on operation complexity, operation methods, and skill and extent of training of a worker who carries out the operation.
(d) The Safety and Quality Assurance Department shall clarify quality records affecting quality concerning design, fabrication, procurement, use, maintenance, etc. of the packaging and define procedures for documentation and storage of the quality records.
(3) Quality policy and quality objectives (a) Quality policy The president (& CEO) shall establish the following as quality policy:
Quality policy As a member of the MHI group, based on the corporate philosophy, management policies and the employees conduct guidelines, MNF and all members of group companies and partner companies understand the importance of business and will work together to prioritize safety, improve quality, fulfill corporate social responsibilities and contribute to the Japanese nuclear industry, and ensure that business operations are trusted not only by customers but also by society as a whole.
2 (1) We foster a culture which prioritizes nuclear safety by ensuring that each individual understands the impact of our product on nuclear safety and by working on quality control, proactive prevention of non-conformance and the technology transmission to ensure thorough compliance with the rules and achieve high quality..
(2) To ensure the worlds highest level of quality, we continuously improve our quality management system and respond to the societys changes in a prompt and flexible manner. In addition, to achieve sustainable growth, we create new processes with innovative ideas.
(3) We provide safe and reliable products and services that exceed expectations as a Mitsubishi Group nuclear fuel company, while creating new value, based on accurate understanding of social trends and customer preferences. In addition, we aim to raise the trust of society and improve customer satisfaction by respecting delivery dates and quality requirement and contributing to the stable supply of nuclear energy.
The president (&CEO) is responsible for assigning an executive officer as a quality control officer, distributing required resources and developing the quality management system, to ensure achievement of the above quality policy.
(b) Quality objectives Each involved department manager shall set quality objectives with an evaluable attainment level, evaluate the status of the achievement and be approved by a management representative as a process for continuous improvement of the quality management system for quality objectives in order to achieve the quality policy.
(4) Management review The president (&CEO) shall hold regular management review meeting to confirm that the quality management system meets the quality policy and quality objectives and is operated effectively, and to review the quality management system.
The management review shall be conducted for the following items.
- 1. Results of internal audit and external audit
- 2. Customer feedback
- 3. Process performance, product conformity and quality trend
- 4. Non-conformities and corrective actions
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- 5. Implementation status of activities to foster safety culture
- 6. Follow-up actions from previous management review meeting
- 7. Changes that could affect the quality management system
- 8. Others
A.2 Document control (1) Scope of documents and data control The scope of control shall be applied to documents and data concerning packaging quality.
The documents to be controlled are contract specifications, drawings, order specifications, quality assurance programs, operation procedures, inspection procedures including quality manuals. They also include external documents of official standards such as JISs.
(2) Approval and publication of documents and data
- 1. Appropriateness of documents and data shall be discussed and approved by the authorized representatives of each department who are entrusted with the discussion and the approval by each department head prior to their publication.
When the packaging structure is changed and the change has some influence on the use or the operation, the order specifications, etc. shall be reviewed by the related departments.
- 2. The current version of each document shall be controlled by a register ensuring the following:
(a) Use of appropriate documents/versions (b) Disposal of invalid and/or obsolete documents (c) Appropriate identification of obsolete document to be retained
(3) Changes of documents and data
- 1. Identification of extent affected by changes (a) Systematization of documents concerning fabrication specification of the packaging (b) When there are changes in a higher document, the presence or absence of the influence shall be confirmed sequentially on the basis of the above systematization of documents to ensure that the changes are reflected in a lower document. In case there is some influence on the fabrication specification of the packaging as a result of confirmation, a notification of
4 changes shall be submitted to the packaging owner or the packaging manufacturer to instruct them to confirm the presence or absence of the influence.
- 2. Implementation of changes (a) When a document has an influence of changes, the document shall be listed and follow-up shall be conducted to issue the revised version.
(b) Any changes of documents and data shall be implemented in accordance with the same procedure as when the documents and data are issued.
(c) Each involved department shall provide supporting evidences to checkers and approvers to change the documents and data. In addition, the details of the changes shall be identified in the document or its attachment.
(d) The revised version of the documents which require changes shall be issued as soon as possible so that the lower documents can be revised and issued sequentially as necessary. In addition, when there is some influence on a fabrication specification of the packaging, the packaging owner or the packaging manufacturer shall be instructed to revise the corresponding documents and submit the revised version.
A.3 Control of Quality Records (1) Types of quality records Each department shall identify the scope of records to be controlled by reference to the following representative documents.
Records of management review Quality documents (quality assurance programs, standards, procedures, etc.)
Review records of contract Order specifications, drawings, etc.
Inspection records (inspection during fabrication, periodical voluntary inspections, inspections before shipment)
Audit records (for internal and the suppliers)
Nonconformance reports and corrective action reports Education and training records
(2) Storage of quality records
- 1. Quality records shall be legible, and stored in an environment suitable to prevention of their deterioration, damage and loss.
- 2. Quality records shall be retained in an easily-retrievable condition.
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- 3. The storage period of quality records shall be identified.
(3) Disposal of quality records Each department in charge shall dispose of quality records after storage periods.
Quality records shall be incinerated or shredded.
6 B Responsibility of Applicants Fig.1 shows a diagram of a quality assurance system concerning design, fabrication, procurement, maintenance, etc. of the packaging. MNF submits an order for fabrication of the packaging through the packaging owner or directly to the packaging manufacturer evaluated as having sufficient supplying capacity, under MNFs responsibility. Services for a part of maintenance and maintenance control of the packaging, are outsourced to maintenance companies, that have sufficient supplying capacity, as needed.
MNFs quality assurance organization is shown in Fig 2. Work and responsibility of each department in MNF is described below. The final responsible person for the activities in each department shall be the corresponding general manager.
(a) President and CEO The president (&CEO) shall have responsibility and authority for the following items.
- 1. Establishment of organization with clear responsibility and authority of each position involved in quality assurance, and proper assignment of management resources such as budget, personnel, equipment, etc. to ensure quality meeting requirements of the customer.
- 2. Setting and documentation of quality policy.
- 3. Appointment of a management representative and assignment of his/her responsibility and authority for quality assurance activities.
(b) Quality control officer (Executive officer)
An executive officer appointed by the president (&CEO) will be a quality control officer and have responsibility and authority for the following items regardless of other responsibility.
- 1. Establishment and promotion of quality assurance programs.
- 2. Overall responsibility for quality including the following five items and assessment for validity and effectiveness of the quality assurance programs. Appropriate actions taken when any improvement is required.
(i) Implementation of actions to prevent nonconformance regarding products, processes and quality management systems.
(ii) Clarification and records of the problems related to products, processes and quality management systems.
(iii) Search, recommendation and offer of a solution in a specified manner.
(iv) Verification of implementation of the solution.
(v) Suspension of delivery of nonconformance products to the next process
7 until the nonconformance is corrected.
- 3. Reports to the president (&CEO) on the implementation for the above items in 1 and 2 and need for their improvement.
- 4. Promoting to each organization to enhance its recognition of importance of meeting requirements of the customer.
(c) Safety and Quality Assurance Department The Safety and Quality Assurance Department shall be independent of other departments in the organization and have responsibility and authority for the following items.
- 1. Planning and implementation of quality management systems.
- 2. Implementation of internal quality audits and instructions of corrective actions.
- 3. Coordination of evaluation and certification of the packaging suppliers.
- 4. Implementation of quality audits and instructions of corrective actions to the packaging suppliers.
- 5. Approval of nonconformance reports and approval of operation stop instructions, corrective and preventive actions when needed.
- 6. Implementation of education and training.
- 7. Approval of reports and corrective actions on nonconformance of a packaging observed in the process of product packing, on-site inspections, UF6 cylinder cleaning, retests, evaporation and storage (hereinafter referred to as usage step).
- 8. Confirmation of procurement management records
(d) Transportation and Service Department The Transportation and Service Department shall have responsibility and authority for the following items.
- 1. Application services for a license related to the packaging.
- 2. Inspection prior to shipment of the package (including service procurement) and application for confirmation on transportation.
- 3. Receiving of the packaging and check of its expiration date.
- 4. Maintenance control of the packaging(including service procurement).
- 5. Preparation of nonconformance reports and consideration of corrective and preventive actions.
- 6. Implementation of education and training.
- 7. Packaging control at a usage step (except for control by the Manufacturing
8 Department).
- 8. Confirmation of contract details related to the design.
- 9. Evaluation of the packaging suppliers technical capability.
- 10. Preparation of order specifications related to the packaging design.
- 11. Examination and approval of design documents such as drawings and analysis documents related to the packaging design.
- 12. Preparation of attachments for a license application related to the packaging.
- 13. Preparation of design and quality requirements and order specifications related to fabrication of the packaging.
- 14. Approval of application documents for the fabrication (drawings for fabrication, inspection procedures, etc.).
- 15. Inspections related to fabrication of the packaging.
- 16. Preparation of order specifications related to the packaging components and implementation of inspections
(e) Manufacturing Department The Manufacturing Department shall have responsibility and authority for the following items.
- 1. Cleaning of UF6 cylinders
- 2. 5-year periodic inspection (hereinafter referred to as retest) for UF6 cylinders.
- 3. UF6 cylinder control at a usage step (storage and evaporation process)
- 4. Packaging control at a usage step (product packing)
(f) General Affairs Department The General Affairs Department shall have responsibility and authority for the following items.
- 1. Management of education/training programs.
- 2. Management of personnel.
(g) Procurement Department The Procurement Department shall have responsibility and authority for the following items.
- 1. Signing contracts.
- 2. Order concerning design, fabrication and procurement of the packaging and its components.
- 3. Order concerning usage and maintenance of the packaging.
9 (h) Business Plan and Process Re-engineering Department The Business Plan and Process Re-engineering Department shall have responsibility and authority for the following items.
- 1. Confirmation of customer requirements for the packaging.
10 MNF (Applicant)
[Packaging quality final confirmation on the basis of the requirements of ISO9001 ]
Quality Offer of design and records quality requirements Packaging Owner (Note 1)
Compliance with the requirements of ISO9001 and order of the packaging
Design Contractor Packaging design conforming to design requirements
Packaging Manufacturer Fabrication of the packaging complying with the requirements of ISO9001
Maintenance Company of Packaging Supply of services for a part of inspection and maintenance of packaging
Subcontractor Offer of materials/parts complying with the requirements of the packaging manufacturer
(Note 1) Omit the box of Packaging Owner when MNF orders the packaging directly.
(Note 2) Only when new packaging is fabricated.
(Note 3) To be implemented as needed.
Fig. 1 Quality System of Design, Fabrication, Procurement, Maintenance of the Packaging
11 President and CEO
Product Quality Management Review Meeting
Quality control officer
(Executive Officer)
Safety and Quality Assurance Department
General Affairs Business Plan and Procurement Transportation and Manufacturing Department Process Re-engineering Department Service Department Department
Department
Fig. 2 Organization of MNF Packaging Quality
12 C Education and Training Necessary education and training programs shall be planned and implemented for personnel involved in services affecting quality concerning the packaging to their needs.
Similarly, it shall be confirmed that such education and training programs are implemented for the packaging manufacturer, etc.
(1) Implementation outline The followings shall be implemented for personnel involved in services affecting the packaging quality.
(a) Planning of education and training.
(b) Implementation of education and training programs and storage of their records.
(c) Requirement of implementation to the packaging manufacturer according to the quality assurance program.
13 D Design Control The following items shall be conducted to ensure that the packaging design conforms to the design requirements.
D.1 Design Control for Commission to Outside the Company (1) Design control (a) When the Transportation and Service Department concludes a contract with a packaging design contractor (hereinafter referred to as designer), the order specification shall include design specifications based on the customers requirements, regulatory technical standards, performance and functional requirements, etc. and be provided to the designer.
(b) When employing new design and technology or special materials, the Transportation and Service Department shall promote exchange of information between the designer and material suppliers on relations between safety and the specification and reasons behind the decision of the specification as needed to have the designer fully understand the design requirements.
(c) The Transportation and Service Department shall examine whether the design requirements are reflected appropriately in design documents (drawings, calculation sheets, analysis documents, etc.) prepared by the designer.
(2) Design verification The Transportation and Service Department shall examine that the designer has conducted design verification with verification tests and/or alternative calculations, etc. as needed when employing new design and technology or special materials based on the above design results.
(3) Design change The Transportation and Service Department shall provide the designer with written details of changes in the design specification. When the department asks the designer to change or the designer himself changes the design due to the changes in the design specification, it shall be examined whether the design requirements are reflected appropriately in design documents (drawings, calculation sheets, analysis documents, etc.) prepared by the designer for approval. In addition, the Transportation and Service Department shall inform the involved organizations with the written details of the design changes.
14 D.2 Design Control for In-House Design (1) Design plan The packaging shall be designed by summarizing the design requirements for the packaging based on the long-term transportation plan of packages.
(2) Input into design Details of the requirements for the packaging shall be confirmed. To design the packaging, the Transportation and Service Department shall document design input information including written design preconditions, applicable laws/rules and other requirements and confirm that the requirements are appropriate based on the confirmation results of the requirements for the packaging. The design shall be reviewed and input based on the information obtained from a previous similar design, if applicable. The input information shall be recorded.
(3) Output from the designer Output of packaging design (specifications, drawings, test/inspection procedures, etc.) shall satisfy the requirements for safety required for the packaging, interface between the packaging and its transportation methods, applicable laws/rules and safety analysis documents, which shall be approved by the Transportation and Service Department. Further, design requirements, acceptance/rejection criteria and characteristics of fabrication, handling and inspections shall be incorporated in output information.
(4) Design review Output of the packaging design shall satisfy the requirements. Problems detected as a result of the review shall be identified to take appropriate actions. A person in charge of other work shall be assigned for review in addition to the involved person in charge (the designer) as required.
(5) Design verification The Transportation and Service Department shall verify that the output from the packaging designer satisfies the requirements provided by input to the packaging design. The verification results shall be recorded.
(6) Design validation The Transportation and Service Department shall conduct the design validation to
15 ensure that the requirements according to the specified application or the intended application are achieved. The validation results shall be recorded.
(7) Management of design changes (a) Management of design changes The Transportation and Service Department shall identify and document design changes to review their details.
When the details of the design changes can affect the supplier, the Transportation and Service Department shall notify the written details of the design changes to those involved.
(b) Management of changes in specification The Transportation and Service Department shall identify the changes in the specification at the stage of packaging fabrication, and review, verify and validate the plan documents considering any effects on other specifications. The changes in the specification shall be recorded.
16 E Production Order of Packaging The following items shall be conducted to ensure that the packaging conforms to the customers requirements, regulatory technical standards, design specification in the application for the design approval, its fabrication methods in an application for the packaging approval, etc.
E.1 Evaluation of the Packaging Manufacturer The manufacturing capability of the packaging shall be evaluated considering the following items on the responsibility of the Safety and Quality Assurance Department.
(a) Technology, personnel and manufacturing facility related to manufacturing of the packaging (b) Quality policy, quality assurance programs and their implementation of the packaging owner and the packaging manufacturer (c) Supply history of the packaging or similar products (d) Usage history of the packaging or similar products and their quality records (e) Evaluation of prototypes, samples, etc. (in case of no similar products)
E.2 Requirements for quality management systems toward the packaging manufacturer When placing a fabrication order to the packaging owner or the packaging manufacturer, the Transportation and Service Department shall clearly instruct in specifications and make them fulfill the following requirements on the responsibility of the Transportation and Service Department.
(a) Scope of service for the packaging owner or the packaging manufacturer (b) Technical requirements for design, fabrication, inspections, applicable laws, etc.
(c) Requirements for submission of quality assurance programs (d) Requirements for access to sites of the packaging manufacturer for quality audits and inspections (e) Requirements for submission and storage of documents and records (f) The packaging manufacturer shall establish and implement quality control programs specifying organization and procedures for quality control of the products ordered by MNF. The quality control programs shall conform to section III. Quality management details conducted by packaging manufacturers of the Quality management guideline of packaging fabrication method (annex of the Nuclear Regulation Authoritys application procedure guide for design approval and packaging approval for nuclear fuel material transport, enacted on February 26th, 2020 as Regulation ordinance No.2002264 and amended on November 18th, 2020
17 as Regulation ordinance No.2011188).
When the packaging manufacturer places an order for part of the packaging structure with its subcontractors, the quality management system requirements toward the subcontractors shall be included in the quality control programs of the packaging manufacturer.
(g) MNF and regulatory authority staff shall conduct inspections during fabrication and quality control checks of the packaging at the sites of the packaging owner, the packaging manufacturer and their subcontractors.
(h) MNF shall examine and approve criteria for selection of the packaging manufacturer by the packaging owner.
Or, MNF shall examine and approve criteria for selection of the packaging manufacturer and its subcontractors and also check the selection criteria.
(i) The responsibility among service providers involved in fabrication of the packaging shall be identified by written agreements.
(j) Adequate understanding for values of safety important material specification provided by MNF and their meanings shall be given to the packaging owner, the packaging manufacturer and their subcontractors.
(k) Exchange of information and technical study for execution, analyses, inspection methods of manufacturing among service providers involved in fabrication of the packaging shall be promoted when employing special materials with more safety importance.
(l) Arrangements of operation instructions and delivery shall be identified to establish a close connection in the process where several providers are involved in fabrication of the packaging.
(m) When the packaging with nonconformance will be repaired, written notification shall be given to MNF to receive their instructions.
In addition, procedures for corrective actions shall be established and retained to prevent its recurrence.
(n) Conditions of special processes for the packaging manufacturer shall be established in procedures. An important change in the fabrication process and any supplier change of the packaging manufacturer and its subcontractors shall be reported to MNF immediately for approval.
(o) The packaging owner and the packaging manufacturer shall conduct the following items toward their subcontractors.
(i) Evaluate their subcontractors ability.
(ii) Instruct the subcontractors to comply with the requirements that MNF asked
18 the packaging owner and the packaging manufacturer to meet.
(iii) Verify that the MNF requirements are satisfied by conducting quality audits and inspections on the packaging manufacturer and its subcontractors by the packaging owner and on its subcontractors by the packaging manufacturer.
However, the following cases are not applied to the above requirements.
(i) Contract work that is approved to be unrelated to inspection items of the packaging license.
(ii) Work under direct control with witness inspections by the packaging manufacturer.
(iii) Permissible manufacturing according to official standards like JIS and official qualification systems.
(iv) Allowable work only with inspections at the time of acceptance because of simple and general checking items.
When procuring the packaging already fabricated as a whole or in part, the Safety and Quality Assurance Department shall confirm based on records, etc. that the packaging manufacturer conforms to section III. Quality management details conducted by packaging manufacturers of the Quality management guideline of packaging fabrication method (annex of the Nuclear Regulation Authoritys application procedure guide for design approval and packaging approval for nuclear fuel material transport, enacted on February 26th, 2020 as Regulation ordinance No.2002264 and amended on November 18th, 2020 as Regulation ordinance No.2011188), or has the quality management system (ISO9001, etc.) equivalent to it.
E.3 Verification by inspection and quality audit related to packaging fabrication The following items shall be conducted to verify that the packaging conforms to procurement requirements.
(1) The Safety and Quality Assurance Department shall conduct quality audits as follows to confirm the implementation of the system provided in the quality assurance programs.
Timing of implementation: At the time when completion inspection for the first fabrication lot becomes ready to be conducted and at the time when fabrication is conducted after three years or more passed from the previous audit Audit details: Process control, identification control, control items concerning inspections and tests, control of subcontractors, control of nonconforming
19 products, corrective actions and statistical method and so on, directly related to fabrication.
Implementation outline: To prepare an audit notification and send it to an audited organization. To conduct an audit using a check sheet in which necessary items are listed.
The Safety and Quality Assurance Department shall establish audit procedures and audit programs and conduct quality audits according to them.
The department also shall identify quality audits on the subcontractors by the packaging manufacturer and take responsibility for conducting quality audits directly on the subcontractors when the need arises.
(2) The Transportation and Service Department shall prepare inspection procedures, etc.
considering safety importance, official standards, official qualification systems, special process conditions, quality control of the packaging owner, manufacturer and their subcontractors for witnessed inspections and record check.
When procuring the packaging already fabricated as a whole or in part, the Safety and Quality Assurance Department and the Transportation and Service Department shall conduct additional inspections or re-inspections on the packaging as needed as well as the confirmation of records, etc. on the status of quality activities at the time of fabrication and inspection results to verify that the packaging was fabricated appropriately.
20 F Handling and Maintenance F.1 Maintenance Control (1) The Transportation and Service Department shall prepare procedures that clarify requirements including ones described in the safety analyses report (SAR) and perform periodical inspections and maintenance in accordance with the procedures.
As to some of periodical inspections and maintenance services concerning maintenance control of the packaging, the Transportation and Service Department outsources them to maintenance companies with sufficient supplying capacity, if needed.
(2) Results of periodical voluntary inspections and maintenance shall be retained during a specified period.
(3) If part of periodical inspection and maintenance service of the packaging is outsourced, the Transportation and Service Department shall check the records of periodical inspections and maintenance of the packaging submitted by outsourcing companies to verify their implementation status.
(4) When nonconformance products are detected by periodical voluntary inspections and maintenance of the packaging, necessary actions shall be taken according to control, corrective and preventive actions for nonconformance products.
(5) The Safety and Quality Assurance Department shall confirm the implementation status of the maintenance control of the packaging by conducting periodical internal audit for the Transportation and Service Department.
F.2 Inspection prior to Shipment (1) Before transportation, the Transportation and Service Department shall conduct inspections prior to shipment of packages in accordance with the procedures that clarify the requirements. When a witness check or safety check is conducted by the authorities at departure, the Transportation and Service Department shall be subjected to the check.
(2) Before transportation, the Transportation and Service Department shall apply for verification of package transport. In the application, it shall confirm that the packaging to be used has been approved and passed the specified periodical voluntary
21 inspections. However, in the case of transportation which does not use the packaging approved beforehand, it shall confirm that the packaging conforms to the details written in the application for verification of package transport.
(3) Inspection results prior to shipment shall be retained during a specified period.
(4) When nonconformance products are detected by inspections prior to shipment, necessary actions shall be taken according to control, corrective and preventive actions for nonconformance products.
22 G Measurement, Analysis and Improvement G.1 Internal Quality Audits Internal quality audits shall be conducted to verify the status and appropriateness of quality assurance activities with respect to MNF activities that affect the packaging quality.
Internal quality audits are conducted as follows.
(1) The Safety and Quality Assurance Department shall plan internal quality audits based on the status and importance of quality assurance activities. Auditors shall be appointed by those who have been certified in accordance with auditing guidelines.
(2) In principle, internal quality audits shall be conducted once a year for departments engaged in quality activities.
G.2 Control of nonconforming products (1) Procedures for dealing with nonconforming products When nonconforming products are found at the stage of packaging fabrication, the following procedures shall be implemented to prevent misuse of nonconforming products.
(a) The Transportation and Service Department shall have suppliers report details of the nonconforming products.
(b) The Transportation and Service Department shall communicate with a person who makes the reports and confirm the occurrence.
(c) The Transportation and Service Department, together with the Safety and Quality Assurance Department and related departments, shall review and evaluate the reports from suppliers, decide on actions and give written instructions to suppliers.
(d) The Transportation and Service Department shall conduct a witness inspection or record confirmation as necessary in the event of repair or alteration of the packaging.
(2) Holding of nonconforming products Nonconforming products shall be attached an identification label or physically isolated.
23 (3) Implementation of necessary actions and Release of Holding Nonconforming products shall be re-inspected before removing the identification label on the nonconforming products after implementation of necessary actions.
(4) Action reports The Transportation and Service Department instructs suppliers to report the following actions.
(a) Confirmation of actions and reporting to relevant internal departments (including departments in charge of quality assurance)
(b) Submission of action reports on nonconforming products to MNF Action reports of nonconforming products submitted by suppliers shall be submitted to the Safety and Quality Assurance Department via the Transportation and Service Department.
G.3 Corrective actions for Nonconformity and preventive actions (1) Corrective actions Corrective actions shall be implemented in accordance with the following procedures.
(a) Investigations of the cause of nonconformity by suppliers, planning recurrence prevention actions by suppliers, reporting to MNF and validation by MNF (i) MNF shall review and check the report from the supplier and instruct to consider the cause investigations and the recurrence prevention actions.
(ii) MNF shall review and evaluate the reports on recurrence prevention actions from suppliers and shall instruct implementation of specific recurrence prevention actions as necessary.
(b) Implementation of recurrence prevention actions by suppliers, reporting to MNF and validation by MNF
(2) Preventive actions The Safety and Quality Assurance Department shall detect potential causes of nonconformities from the results of general witness inspections, external quality audits, internal quality audits and other nonconformance reports and shall instruct suppliers to implement preventive actions through the Transportation and Service Department. In the case of internal departments, the Safety and Quality Assurance
24 Department instructs the related department to implement preventive actions.
25