supplier quality assurance manual¾›应商品质保证要领书（英）2017...this quality...

NSK (China) Investment Co., Ltd. (CHQ) NSK Q001

Supplier Quality Assurance Manual

January 2015 First Edition

NSK（China）Investment Co., Ltd.

Quality Assurance Headquarters


Table of Contents

Page

1 Basic Requirements for Quality Assurance ......................................................... 1

2 Quality Management Procedures

Procedure 1 Registration of Person in Charge of Quality Assurance ......................... 7

Procedure 2 Production Preparation and Management Procedure .......................... 8

Procedure 3 Preparation of PFMEA .......................................................................... 11

Procedure 4 Preparation of Control Plan ................................................................. 16

Procedure 5 Preparation of Inspection Standard ..................................................... 17

Procedure 6 Application for Subcontractor Utilization ............................................ 18

Procedure 7 Application for Approval of Limited Sample ........................................ 20

Procedure 8 Initial Product Management Procedure .............................................. 22

Procedure 9 Process Capability Investigation .......................................................... 25

Procedure 10 Submission of All Characteristics Inspection Results ............................ 27

Procedure 11 Submission of Inspection Record .......................................................... 29

Procedure 12 Process Change Procedure .................................................................... 30

Procedure 13 Disposition When Defects Occur .......................................................... 32

Procedure 14 Application for Concession .................................................................... 33

Procedure 15 Gauge R&R Investigation....................................................................... 34

Procedure 16 Management for Critical Control Process ............................................. 36

Procedure 17 Supplier Evaluation and Continual Improvement ................................. 37

Procedure 18 Management of Substances of Concern (SOC) ..................................... 39

3 Management Outline of Basic Requirements

Outline 1 Lot Management .......................................................................................... 41

Outline 2 NSK Property Management ......................................................................... 42

Outline 3 Product Identification at Delivery to NSK .................................................... 44

Outline 4 Management of Important Designated Products ........................................ 45


1 Basic Requirement for Quality Assurance

1. Scope

This quality assurance manual provides basic requirements for quality assurance that are

applied to parts suppliers and outsourcing manufacturers (hereinafter referred to as supplier)

dealing with NSK (China) Investment Co., Ltd. and its affiliates (hereinafter referred to as NSK

China).

This quality assurance manual is based on NSK's basic guideline of quality assurance and is

quality-oriented. To establish a quality assurance system that covers quality, costs and delivery

period throughout the company and assure 100% conforming delivery, ISO9001 and TS16949

shall be followed, and systematic management is required. With this manual, quality

management is used as a means for the purpose of quality assurance.

2. Basic Requirements for Quality Assurance

2.1 Responsibility for Quality Assurance

Supplier shall be fully responsible for quality assurance of its products and parts supplied to

NSK as a result of manufacturing process. To assure quality of purchased products and parts,

supplier shall assign a person to be in charge of quality assurance and report to NSK China plant

(see Procedure 1 for details).

The quality assurance officer shall prepare the quality policy and follow up and keep a record

of its implementation.

2.2 Establishing of Quality Assurance System (Organization and Function)

Supplier shall establish a quality assurance system in accordance with the whole

manufacturing process to ensure conformance with NSK’s drawings and purchasing

specifications (PS), and shall actively maintain and improve quality.

2.3 SOC Management

Supplier shall abide by the “NSK Green Procurement Standard” (see Procedure 18) in SOC

management of products delivered to NSK China and parts, materials, accessories, auxiliary

materials for production and packaging materials used for its production processes.

Besides, supplier, as responsible person for promotion of SOC management, shall select an

environmental management officer and apply to NSK China’s Plant (see Procedure 1).

2.4 Quality Management Instruction

Supplier shall prepare and implement quality management instructions for the following

points.

(1) Management of Specifications and Drawings

A management record shall be established for NSK China’s drawings and procurement

specifications and supplier’s drawings and specifications with regard to manufacturing and

inspection. The latest editions thereof shall be kept where they are used, and their correction

and abolishment shall be reliably managed.


Besides, old editions of the drawings and procurement specifications provided by NSK

China shall be immediately returned back.

(2) Management of Equipment and Instruments

① During manufacturing and inspection, all equipment, machines and instruments required

for quality assurance shall be prepared and be always kept in good condition. Besides,

environmental conditions (dust, temperature, humidity, noise, vibration, etc.) at the site

shall be managed. For calibration, correction and inspection, contents and valid period

shall be properly specified and a record thereof shall be kept.

② When an external testing laboratory is used, it shall be compliant with ISO/IEC17025 or

recognized by equivalent organizations in China.

③ Used instruments must be traceable to international or national measurement standards.

④ Replacement procedure and design and manufacturing management tracking system for

ageing tools shall be available. ⑤ Preventive maintenance: Equipment shall be classified by importance of manufacturing

process, operating systems and safety considerations, important equipment shall be identified, and a preventive maintenance system shall be established.

The preventive maintenance system shall contain at least the following items. Other instructions of NSK’s plant, if any, shall be applied.

· Maintenance plan · Maintenance activity manual/instruction

· Part replacement of main equipment · Tool and gauge storage instruction · Regular function confirmation system for inspection tools · Preventive maintenance mode (replacement frequency of cutters, life management of

molds, etc.) Besides, for inspection tools and other tools provided by NSK China, the “Outline 2 NSK

Property Management” shall be applied.

(3) Technical capability Management of Operator and Inspectors During manufacturing and inspection of products and parts, operators and inspectors

with relevant technical capability shall be allocated and provided with necessary education and training as planned, and their skills qualification shall be checked. Any operators or inspectors who resume his post after leaving for a long time (including those who are transferred to another post / take other’s place) shall be provided with necessary education and training.

(4) Management of Subcontractor

To assure quality of external processing manufacturers of materials and parts used for

manufacturing of products, necessary management measures, such as quality confirmation,

shall be taken for selection of the contractors (see Procedure 6).

Quality shall be identified by:

① Checking and supervising subcontractor;

② Managing process change of subcontractor (report or declare to NSK China);

③ Incoming inspecting or testing;


④ Other instructions (special requirements from NSK plant).

(5) Management of Materials, Parts and Products

Used materials, parts and products shall be properly stored to prevent defective quality.

Besides, materials and parts supplied by NSK China shall be separated from others in storage

in accordance with the Outline 2 “NSK Property Management”.

(6) Management of Manufacturing Process

① To assure product quality, specified management points in manufacturing process shall

be inspected and tested in accordance with drawings, control plan (Procedure 4) and

inspection standard (Procedure 5). Statistical process management, such as control

chart, shall be used for important characteristics.

② Process capability shall be investigated from time to time to promote process

improvement. If process capability required by NSK China’s plant is not achieved or

target process capability cannot be achieved, corrective measures shall be taken. When

process capability required by NSK China’s plant or target process capability is achieved,

further continual improvements shall be taken (Procedure 9).

③ Critical control process shall be highlighted as key process and specially managed in

accordance with the Procedure 16 “Management for Critical control process”. Special

process, such as heat treatment and welding, for manufacturing of important designated

products (see Item (13) below) must be audited by NSK China’s plant.

④ Inspections in the inspection standard may be only important items, but all indicated

points in design drawings and control plan shall be assured.

⑤ Definite normative documents, such as process instruction and condition management

standard, shall be prepared.

⑥ In addition to 4S (seiri,seiton,seiso,seiketsu), 3T (teii,teiryou,teihin) management shall be

implemented.

⑦ Additional inspections and tests shall be conducted for products if required by NSK

China’s plant.

(7) Management of Process Change

Rules for process change shall be established. Such change shall not affect the department

concerned and shall be checked with other departments beforehand. It shall be verified by

comparing data of new project with that of old projects to check if there is any difference

between new and old products rather than if new product is within the specifications. When

the change is implemented, application shall be made to NSK China’s plant in accordance

with the Procedure 12 “Process Change Procedure” to obtain recognition.

(8) Management of Initial Products

When newly designed product is put into operation or when design or process is changed, it

shall be discussed beforehand, preparations for production shall be made, and processes

shall be managed in the initial stage of mass production to assure proper quality and


stabilize the processes in the early stage. Release standard shall be otherwise specified. The

management shall be based on the Procedure 8 “Initial Product Management Procedure”.

(9) Lot Management

To stabilize quality and identify nonconforming products in the early stage, focus shall be

put on main processes, such as material、heat treatment and processing, in principle, FIFO

management and lot management shall be used, and quality record of each lot shall be

retained.

In case any products or parts are nonconforming, they can be quickly distinguished from

others without missing, and proper measures for identifying the nonconforming lot shall be

taken. The management shall be based on the Outline 1 “Lot Management”.

(10) Management of Defective Products

Defective products shall be marked, and their storage place shall be defined to prevent

such products from escape. For reprocessed products and dropped products, their marks

shall be managed.

(11) Handling of Abnormality

When an abnormality occurs, it shall be handled as follows. The Procedure 13 “Disposition

When Defects Occur” shall be followed.

① When any abnormality is found in manufacturing process, its handling procedure shall be

specified (Including identification and disposal of nonconforming products).

② When nonconforming products have been delivered to NSK China or it is suspected,

it must be immediately reported to NSK China's plant.

③ Handling of quality abnormalities shall be recorded, and such records shall be stored.

Nonconforming products shall be reprocessed by a qualified operator in accordance with

appropriate instructions, and all reprocessed products shall be inspected.

④ Potential causes of nonconformities shall be analyzed, and preventive fool-proofing

measures against them shall be taken when necessary.

The products returned by NSK China’s plant shall be investigated and analyzed to prevent

recurrence. Besides, other similar projects shall be horizontally expanded to prevent

recurrence.

When an abnormality occurs, the production line shall be stopped and emergency measures

shall be taken to separate and isolate the abnormal lot of products from the line.

This concept of quality assurance must be thoroughly carried out.

(12) Management of Prevention against Entry of Abnormal Materials and Products (Similar

Products) and Rough Materials

When more than 2 materials are used in manufacturing process for processing, they must

be thoroughly distinguished and marked by all means to prevent abnormal materials from

mixing.

The same measures shall be taken to prevent abnormal products (similar products) and


unprocessed products from mixing.

(13) Management of Important Designated Products

Important designated products (important designated products for security and as stated in

appropriate laws and regulations) shall be specially managed in accordance with the

management standard (see the “Outline 4 Management of Important Designated Products”

for details).

(14) Management of Quality Evidence

Quality evidence, lot management record and quality data shall be sorted and easy to

search, and shall be submitted at the request of NSK China (Procedure 11). Important

designated products shall be stored for over 15 years, and general products shall be stored

for over 10 years. Besides, special instructions of NSK China’s plant for storage period, if any, shall be followed.

(15) Package

Packaging materials that may cause quality deteriorations, such as rust, defects and

damage, shall not be used, and defined form of package shall be thoroughly implemented.

Besides, dust-proof and anti-static package must be used for electronic parts.

(16) Delivery

① A system that ensures 100% delivery as scheduled by NSK China’s plant shall be established.

② At delivery, after required items, such as part name, number and quantity, are confirmed,

existing product label filled with required items and specified documentation shall be

attached to the deliverables.

③ To prevent mixing of wrong lots, lots shall be definitely distinguished, and existing product

label shall be attached to each package (see the Outline 3).

3. Quality Management Procedures

When a supplier deals with NSK China, the following procedures shall be used.

Procedure 1 Registration of Person in charge of Quality Assurance

Procedure 2 Production Preparation and Management Procedure

Procedure 3 Preparation of FMEA (TS Object Product*1

)

Procedure 4 Preparation of Control Plan

Procedure 5 Preparation of Inspection Standard

Procedure 6 Application for Subcontractor Utilization

Procedure 7 Application for Approval of limited Sample

Procedure 8 Initial Product Management Procedure

Procedure 9 Process Capability Investigation

Procedure 10 Submission of all Characteristics Inspection Results (TS Object Product*1

)

Procedure 11 Submission of Inspection Record

Procedure 12 Process Change Procedure


Procedure 13 Disposition When Defects Occur

Procedure 14 Application for Concession

Procedure 15 Gauge R&R Investigation (TS Object Product*1

)

Procedure 16 Management of Critical Control Process

Procedure 17 Supplier Evaluation and Continual Improvement

Procedure 18 Management of Substances of Concern (SOC)

*1) TS object product: It must be implemented for TS object products. For products other than TS

object, each supplier shall communicate with NSK’s plant to decide if it shall be implemented

through discussion. It is the same hereinafter.

Besides, each document shall be submitted in accordance with Table 1 “List of Supplier’s

Submissions”. Please use the forms of procedures herein. (But specified form shall be used if

otherwise required by NSK China’s plant.)

4. Process Audit and on-Site Inspection and Confirmation

NSK China’s plant shall make on-site inspections at regular intervals or audit the process

when it is deemed necessary by NSK China’s plant.


Table 1: List of Supplier’s Submissions

No. Submission Form No.Beginning of

Business

Try

ProductionPreproduction

Initial Product

Delivery

Mass

ProductionReceived Dept.* Comments

1 Notice on (Selection·Change）Quality Assurance Manager Form-1 O Quality Assurance When Changed

2 Request for Production Preparation Form-2 —

3 Production Preparation Plan Form-3 Production PreparationImmediately submitted after receiving the

Request of production preparation

4 Production Preparation Plan Follow Up Table Form-4 —

5 Process Setting·Internal or External Manufacturing·Production Capacity Form-5 Production PreparationImmediately submitted after receiving the

Request of production preparation

6 Preproduction（Mass Production) Report and VA/VE Proposal Form-6 O O O Purchasing

7 Package Specifications Form-7 O(Note 1) Production Management

8 Initial Product Management Plan Form-8 O Quality Assurance

9 Initial Product Management Table Form-9 O Quality Assurance

10 PSW Form-10 O Quality Assurance TS object Product

11 FMEA Form-11 O(Note 1) O(Note 2) Quality Assurance TS object Product

12 Control Plan Form-12 O O(Note 1) O(Note 2) Quality Assurance

13 Inspection Standard Form-13 O(Note 1) O(Note 2) Quality Assurance

14 Application for Approval of Subcontractor Utilization Form-14 O Purchasing

15 Application for Approval of Limited Sample and Reply Form-15 Quality Assurance When necessary

16 Limited Sample Management Card Form-16 Quality Assurance When necessary

17 Quality Control Status Report for Critical Control Process Form-17 O Quality Assurance

18 Initial Product Delivery （Advance）Notice Form-18 O O O Quality Assurance

19 Initial Product（ include TP）Inspection Report Form-19 O O O Quality Assurance

20 All Characteristics Inspection Result Outline O O O Quality Assurance TS object Product

21 Process Capability Investigation & Improvement Report Form-20 O(Note 1) O Quality Assurance

22 Process Change Plan & Application（DRBFM） Form-21.34 O Purchasing 90 Days before change

23 Notice of Incoming･Line Defects & Countermeasure Report Form-22 Quality Assurance When necessary

24 Recurrence-Prevention Countermeasure sheet of Supplier Quality Issue Form-23 Quality Assurance When necessary

25 Application for Concession and Reply Form-24Production

ManagementWhen necessary

26 Gage R&R Report Form-25 O O Quality Assurance TS object Product

27 GRR Plan and Management Record Form-26 O O Quality Assurance TS object Product

28 Application for Lot Management Rules of Delivered Part Form-27 O O Quality Assurance

29 Notice of Unqualified Customer Property･Investigation Report Form-28 Quality Assurance When happened

30 Steel Material Acceptance Record Form-29 — When necessary

31 Relevant Document of SOC Management

See Green

Procurement

Standard

O O(Note 2) Purchasing

32 Product Label Form-30 O O O O Attached to product

33 Initial Product Label Form-31 O O O O(Note 2) Attached to product

34 Concessived Part Label、Improved Part Label Form-32.33 O Attached to product

(Note 1) Submitted before delivery of preproduction product. (Note 2) Submitted when design change or process change.

* Received Dept.: Based on actual organization structure of each NSK plant, Submitted to the functional department.



Procedure 1 Registration of Person in charge of Quality Assurance

and Environment Management

1. Scope

It provides the procedure of registration of person in charge of quality assurance and

environment management by a supplier to NSK China.

2. Purpose

Supplier shall register the person in charge of quality assurance and the environment

management with NSK China in order to ensure compliance with delivery quality and

environmental management requirements and actively promote each activity to ensure

successful performance of quality assurance activities and environmental management

activities of the supplier and NSK China.

3. Responsibility and Appointment of the person incharge of Quality Assurance

The person in charge of Quality assurance shall bear the responsibility of the supplier’s top

responsible person for quality assurance. The person to be registered is the top manager of

quality assurance.

4. Appointment of Assistant Manager of Quality Assurance

(1) Assistant manager of quality assurance (head of quality assurance department) shall take

substantive action for different plants or different products.

(2) In the case of a consortium, the responsible person for manufacturer quality assurance shall

act as assistant manager of quality assurance.

5. Responsibility and Appointment of Environmental Management Manager

Environmental management manager shall bear the responsibility of the supplier’s top

responsible person for environmental management. The environmental management manager

to be registered is the top manager of environmental management.

6. Outline of Submission of Application

Supplier shall fill company name, official seal and title, name, telephone and date of

appointment of quality assurance manager, assistant quality assurance manager and

environmental management manager in the “Form-1 Notice on (Selection and Change )

Quality Assurance Manager” and submit it to the quality assurance department of NSK

China’s plant.

Assistant quality assurance manager shall fill name of the factory or manufacturer in the

charge of the officer.


7. Outline of Change of Application

If quality assurance manager, assistant quality assurance manager or environmental

management manager changes due to change of supplier’s organization or personnel, the

change shall be marked with ○ in the “Form-1 Notice on (Selection and Change) Quality

Assurance manager”, and it shall be submitted to the quality assurance department of NSK

China’s plant as stated in the Point 6 above.



Procedure 2 Production Preparation and Management Procedure

1. Scope

It provides the procedure required for producton preparation of new products, products

with process change and products with design change.

2. Purpose

It is intended to prevent problems caused by improper preparation for production in

advance by correctly preparing for production of new products, products with process

change and products with design change in order to assure stable quality in the early stage.

3. Preparations for Production

Supplier shall prepare for production in accordance with the Form-2 “Request for

Production (Mass Production) Preparation” issued by NSK China’s plant, and shall make full

preparations for the project before initial products are delivered as required by NSK China’s

plant.

(1) Preparations for Production

1) Production Preparation Plan

2) Drawings DR (Manufacturing Difficulty and Design Intent Validation)

3) Preparation for Process

4) FMEA (TS Object)

5) Control Plan

6) Inspection Standard

7) Preparation of Standard Documents for Process

8) Preparation of Equipment, Tools and Instruments (including daily inspection and

equipment maintenance plan)

9) Delivery Packing Specifications

10) Process Capability Investigation

11) Personnel Allocation, Education and Training

12) Evaluation of Production Preparation (Project Preparation)

13) Initial Product Management

14) Product Safety (including environmentally harmful substances)

15) Gauge R&R Investigation (TS Object)

(2) Outline of Preparation

In accordance with the production preparation plan, prior performance management

is required for preparation progress of each item to avoid missing. The outline and

documentation of preparations for main items are as follows. (See the next page)


Preparations for Production Outline of Preparation Documentation

(1) Production Preparation Plan

(1) During production preparation, appoint a promotion officer and prepare a plan for prior performance management.

(2) Specify objectives (equipment, personnel, process capability, etc.) in the plan and promote production as planned.

・Form-3 Production Preparation Plan

(2) Preparation for Process

(1) Make the drawings DR (manufacturing difficulty, and design intent validation).

(2) Prepare the drawings of purchased products (material drawings, processing drawings, etc.).

(3) Establish the project preparation plan to define differentiation between internal and external manufacturing (subcontractor) and

details of the preparation plan. (4) Prepare the P-FMEA as prevention against

quality issues to define previous and predictable nonconformities and make improvements (TS object).

(5) Arrange defective points on samples, including result of pilot production, and present them to NSK China’s plant with the “Preproduction (Mass Production Report and VA/VE Proposal”.

(6) Know the specific production capacity to the production plan.

・Drawings of purchased products (material、 processing drawings, etc.) ・Form-5 Process Setting. Internal or External Manufacturing. Production Capacity ・Form-11 P-FMEA ・Form-6 Preproduction (Mass) Production Report and VA/VE Proposal ・Form-5 Process Setting, Internal or External manufacturing, Production Capacity

(3) Inspection Standard

Abide by the Procedure 5 “Preparation of Inspection Standard”.

・Form-13 Inspection Standard

(4) Control Plan Abide by the Procedure 4 “Preparation of Control Plan”.

・Form-12 Control Plan

(5) Preparation of Standard Documents for Process

Prepare and issue processing standards and relevant records.

――

(6) Preparation of Equipment, Tools and Instruments

(1) Check preparation of equipment, tools and instruments with regard to quality and production capacity.

(2) Actively discuss, completely confirm and use fool-proofing devices especially for the sake of 100% assurance.

(3) Prepare equipment, molds, tools, instruments and techniques for mass production to meet the production plan in the production (mass production) preparation instruction.

(4) Prepare the daily inspection and maintenance plan for equipment to maintain and manage the manufacturing conditions.

(5) Prepare the daily inspection and maintenance plan for inspection tools, including fool-proofing measures.

――


Preparation for Production

Outline of Preparation Documentation

(7) Delivery Package Specify packing method, rust protection, product/part packing specifications, packed quantity and weight to prevent quality deteriorations, such as rust, damage and impression.

・Form-7 Package Specifications

(8) Process Capability Investigation

Abide by the Procedure 9 “Implementation of Process Capability Investigation”.

・Form-20 Process Capability Investigation & Improvement Report

(9) Personnel Allocation, Education and Training

Establish an education and training program for processers and develop training.

――

(10) Evaluation of Production Preparation

(1) Check completion of established plans to avoid missing, and take precautions against nonconformities. Make pilot production (continuous production of specified quantity) to verify stability of process setup.

(2) Prepare and implement the initial product management plan.

(3) Submit the PSW (TS Object). (4) Other relevant documents required for PPAP.

・Form-4 Production Preparation Plan Follow-up Table ・Form-8 Initial Product Management Plan ・Form-9 Initial Product Management Form ・Form-10 PSW

(11) Initial Product Management

(1) Abide by the Procedure 8 “Initial Product Management Plan”.

(2) Abide by the Procedure 10 “Submission of All Characteristics Inspection Results” (TS Object).

Specify the evaluation items and cancellation standard. Make evaluation (quality confirmation by final inspector and the equivalent) in the initial stage of management (general products: over 1 month, important designated products: over 3 months) to prevent nonconforming products in the initial stage from escape. (Requirements of NSK China’s customer, if any, shall prevail)

・Form-31 Initial Product Label ・Form-18 Initial Product

Delivery (Advance) Notice

・Form-19 Initial Product (including TP) Inspection Result

・All Characteristics Inspection Results

(12) Product Safety (1) Check personal injury caused by burrs and safety of rust preventive oil and other products that contain harmful ingredients.

(2) Investigate the content of SOC in parts, materials, accessories and manufacturing process and report such investigation.

・Form 1-9 of NSK Green Procurement Standard

(13) Gauge R&R Investigation

(1) Abide by the Procedure 15 “Implementation of Gauge R&R Investigation” (TS Object).

・Form-25 Gauge R&R Report ・Form-26 Gauge R&R Plan and Management Record


2 Quality Management Procedures Procedure 3 Preparation of FMEA (TS Object)

1. Purpose

Possible problems that may occur during process design shall be predicted beforehand,

and qualitative evaluation shall be made to identify the cause of failure mode, minimize

such risks, and improve reliability of the product or process by reducing probability of

the failure.

2. Outline of Preparation and Application

This outline is based on the “Process FMEA” in the “Potential Failure Mode and Effects

Analysis Manual” Rev. 4 (hereinafter referred to as FMEA).

2.1 The departments involved in the planning are manufacturing department, quality assurance

department, production technology department and design department. Participants shall

have the required capacity for production preparation, and their qualification shall be

checked.

2.2 Materials required for the preparation: ① manufacturing drawings, processing drawings

and acceptance drawings; ② list of previous nonconformities; ③ flowcharts (standard

process permit, process schedule, etc.); ④ layout; ⑤ FMEA of design (if stated by NSK

China); ⑥ FMEA of similar products; ⑦ physical object part.

2.3 FMEA shall be prepared by product names in principle and may be prepared by types (similar

products).

2.4 Process FMEA shall be led by the manufacturing department and prepared by members of

the lateral coordination team. It shall be submitted by the responsible person for the

quality assurance department to NSK’s plant after confirmed by the design department and

the quality assurance department. During preparation and revision, relevant process

instructions shall be selected as required and developed in the project.

2.5 Only the marks of which security characteristics, functional characteristics and normative

characteristics can be identified, i.e.: ○S , ○F , ○SR , shall be used in process FMEA.

2.6 Corrections and revisions shall be included in the revision history and record.

2.7 In any of the following cases, process FMEA shall be revised as required and submitted to

NSK China’s plant again.

Product change--- instability of process --- Process change --- insufficient process capability

--- inclusion of nonconformities --- occurrence of nonconformities in the market

2.8 Measures taken in accordance with the process FMEA refer to the further measures against

risks that shall be decided after severity, occurrence rate, detection level and failure mode,

effects, cause and control are identified.

For failure modes with severity level 9 or 10, it shall be ensured that they have been

handled by existing design control or recommended measures.

Besides, for failure modes with severity level 8 or below, only the modes with the highest


occurrence rate or detection level shall be handled.

2.9 Special requirements of NSK China’s plant, if any, shall be followed.

2.10 Storage of originals: Originals shall be stored and managed by supplier’s manufacturing

department and shall be retained for over 15 years like manufacturing quality documents

of manufactured parts (or assemblies).

2.11 Use: Process FMEA shall not only be submitted to NSK China but also be managed as

confidential information that is only for internal use. Besides, every time process FMEA is

revised or corrected, such revision or correction shall be made in its original and shall be

submitted to each department concerned for confirmation.

3. Form

See the Form-11. The supplier's own form may be used if it is compliant with NSK China's

requirements.

4. Outline of Preparation of FMEA

4.1 Process Function

Enter the process function of each analyzed process step or/and operation, including repair

and reprocess.

Process function describes the purpose of operation. Risk analysis is suggested to limit the

number of steps to the ones of which increase seems to have a negative effect on products.

4.2 Potential Failure Mode

Potential failure mode refers to the condition that may potentially not suffice process

requirements (including purpose of design).

Potential failure modes of specific operation shall be listed in accordance with process

requirements (such as record in process flowchart).

4.3 Potential Effects Analysis

Potential effects analysis is defined by consequences of a failure mode detected by customer.

The consequences shall be described by the situations that may be noticed or experienced by

customer. The customer may be an internal customer or a final user (such as post process,

dealer, vehicle owner, etc.). If the failure mode may affect safety or cause incompliance with

regulations, it shall be clearly described in PFMEA.

4.4 Severity

Severity level refers to the rating level of the most severe effect of a specific failure mode.

It is a relative level in a single range of FMEA.


Effect Standard:

Severity of Effect on Product Level Effect

Standard: Severity of effect on Process

Failure to Meet Safety and/or Regulatory Requirements

Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning.

10

Failure to Meet Safety and/or Regulatory Requirements

May endanger operator (manufactured/assembled) without warning

Potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning.

9

May endanger operator (manufactured/assembled) with warning

Loss or Degradation of Primary Function

Loss of primary function (vehicle inoperable,does not affect safe vehicle operation)

8

Major Disruption

100% of products may have to be discarded, line shutdown or stop ship

Deterioration of primary function (vehicle operabl, but at reduced level of performance) 7

Signficant Disruption

A portion of the production run may have to be scrapped. Deviation from primary process including decreased line speed or added manpower.

Loss or Degradation of Secondary Function

Loss of secondary function (vehicle operable, but comfort / convenience functions inoperable

6

Moderate Disruption

100% of production run may have to be reworked off line and accepted.

Deterioration of secondary function (vehicle operable, but comfort / convenience functions at reduced level of performance).

5

A portion of the production run may have to be reworked off line and accepted.

Annoyance Appearance or Audible Noise, vehicle operable, item does not conform and noticed by most customers (>75%)

4

General Disruption

100% of products must be reprocessed on the line before processing

Appearance or Audible Noise, vehicle operable, item does not conform and noticed by many customers (>50%)

3

A portion of the production run may have to be reworked in-station before it is processed.

Appearance or Audible Noise, vehicle operable, item does not conform and noticed by discriminating customers (<25%)

2

Minor Disruption

Slight inconvenience to process, operation, or operator.

No effect No discernible effect 1 No effect No discernible effect


4.5 Classification

Fill in special product characteristics, such as ○S , ○F and ○SR .

4.6 Potential Cause/Mechanism of Failure

Potential cause of failure describes the process of how a failure occurs. It shall be

described as a problem that can be corrected and controlled. Each potential cause of each

failure mode shall be identified and recorded if possible. The record shall be as detailed,

concise and complete as possible.

Specific mistakes or mistaken operations (for example, seal is not installed or installed

incorrectly) shall be listed. Ambiguous words (such as mistake of operator or poor

installation of seal) shall not be used.

4.7 Occurrence

Occurrence rate refers to the probability of occurrence of a cause of failure. It is a relative

level in a single range of FMEA rather than an absolute level. “Incidents per Vehicle”

describes the estimated number of failures in the process.

Likelihood of Failure

Standard: Occurrence of Cause and Effect of PFMEA

(Incidents per items/vehicles) Level

Very high: persistent occurrence

≧100 per thousand 10

High: frequent occurrence

50 per thousand 9

20 per thousand 8

10 per thousand 7

Moderate: occasional occurrence

2 per thousand 6

0.5 per thousand 5

0.1 per thousand 4

Low: infrequent occurrence

0.01 per thousand 3

0.001 per thousand 2

Very low: no occurrence

Failure is eliminated through preventive control 1

4.8 Current Process Control Method

It is intended to prevent occurrence of failure modes or failure causes/mechanisms to the

full extent. If possible, preventive control shall be preferred. The initial level of occurrence

rate will be affected by preventive control measures that are a part of processes.

Prevention: Eliminate (prevent) or reduce occurrence of failure causes or failure modes.

Detection: Identify (detect) failure causes or failure modes, and cause development of

proper corrective measures or solutions.

4.9 Detection

Detection level is in conformity with the optimum detection control listed in the detection


control column and is relative sequencing in a single range of FMEA. To obtain a lower level,

planned detection control shall generally be improved.

When more than one control is identified, it is suggested that detection level of each

control should be included as a part of control description. Lower sequencing value shall be

recorded in the detection level column.

Opportunity of Detection

Evaluation Criteria: Likelihood of Detection by Process Control

Level Likelihood of Detection

No detection opportunity

No current process control: Cannot detect or is not analyzed

10 Almost Impossible

Not likely to detect at any stage

Failure Modes and/or Errors (cause) is not easily detected (e.g., random audits)

9 Very Remote

Problem Detection Post Processing

Failure Mode detection post-processing by operator through visual/tactile/audible means

8 Remote

Problem Defection at Source

Failure Mode detection in-station by operator through visual/tactile/audible means or post-processing through use of attribute gauging (go/no-go, manual torque check/clicker wrench, etc.).

7 Very low


Failure Mode detection post-processing by operator through use of variable gauging or in-station by operator through use of attribute gauging (go/no-go, manual torque check/clicker wrench, etc).

6 Low


Failure Mode or Error (Cause) detection in-station by operator through use of variable gauging or by automated controls in-station that will detect discrepant part and notify operator (light, buzzer, etc.). Gauging performed on setup and first-piece check (for set-up causes only).

5 Moderate


Failure Mode detection post-processing by automated controls that will detect discrepant part and lock part to prevent further processing.

4 Moderately High


Failure Mode detection in-station by automated controls that will detect discrepant part and automatically lock part in station to prevent further processing.

3 High

Error Detection and/or Problem Prevention

Error (Cause) detection in-station by automated controls that will detect error and prevent discrepant part from being made.

2 Very High

Detection not applicable; Error Prevention

Error (Cause) prevention as a result of fixture design, machine design or part design. Discrepant parts cannot be made because item has been error-proofed by process/product design.

1 Almost Certain


4.10 Risk Evaluation Risk priority number (RPN= Severity (S) × Occurrence Rate (O) × Detection Level (D)) is always used for risk evaluation, but it is not suggested to decide the priority level of measures with RPN. Limits of the RPN shall be understood. Priority level of measures shall be based on the failure mode with the highest severity level. When severity is Level 9 or 10, it must be ensured that the risk has been handled by existing design control or recommended measures. For failure modes with severity level 8 or below, cause of the highest occurrence rate or detection level shall be considered. Check information, process out a solution through discussion, and determine how to optimize the sequencing of risk mitigation measures to give the organization and customers the best service.

4.11 Recommended Action In general, preventive measures (for reduction of occurrence rate) are preferred to detection measures. Recommended measures are intended to reduce the severity level, occurrence rate and detection level by their sequencing.

(1) Reduction of Severity Level: Reduce the severity level by process change.

Besides, product and process design shall be changed in the early stage of development process.

(2) Reduction of Occurrence Rate: Reduction of occurrence rate requires change of process and design. Causes of one or more several modes are eliminated and controlled by change of product or process design. Sources of process change may be deduced and researched by statistical method. Occurrence rate may be reduced by measures arising out of the research.

(3) Reduction of Detection Level: It is preferred to use fail-safe/fool-proofing method. Redesign of detection method will reduce the detection level. In some cases, change of process steps may require increase of detection possibility (i.e. reduction of detection level). In most cases, increase of inspection frequency is not an effective measure.

If no measure is recommended after evaluation of a failure mode/cause/control, the column shall be filled with “None”.

When “None” is entered, the cause shall be indicated, which is very useful, especially in the case of high severity level.

4.12 Responsibility and Target Date of Completion Enter the name of the person who is responsible for finishing the recommended measures,

including target date of completion. 4.13 Action result After measures are taken, brief description of the measures that have been taken and

date of completion shall be entered. Severity level, occurrence rate and detection level shall be defined again, and RPN shall be calculated. All revised levels must be evaluated. If further corrective measures are required, analysis and validation shall be made after the measures are taken.



Procedure 4 Preparation of Control Plan

1. Scope

It provides the procedure of preparation and submission of the control plan for products

and parts delivered by a supplier to NSK China.

2. Purpose

Supplier shall prepare a control plan for products and parts supplied to NSK China in

accordance with the sequence of manufacturing processes. The plan shall contain the

condition management and quality assurance methods of the manufacturing department

and the inspection department in order to know all quality assurance and SOC management

activities of the manufacturing process.

3. Preparation

The control plan shall be prepared by parts in principle and may be prepared by types.

4. Forms and Records

The “Form-12 Control Plan” is used for the control plan. The supplier's own form may be

used if it is compliant with the reference form. The control plan shall contain the condition

management items in regard to cause and quality characteristics in regard to result. The

contents shall give a comprehensive knowledge of the process, and management of the

process shall be based on the concept of 100% assurance to assure the quality of delivery.

5. Submission and Confirmation

5.1 Submission

Supplier must prepare a control plan for newly ordered products and parts, and shall

submit 2 copies of the control plan to the quality assurance department of NSK China’s

plant before delivery. Other requirements of NSK China’s plant, if any, shall be submitted in

the specified period.

5.2 Confirmation

The head of the quality assurance department of NSK China’s plant shall, after checking

the control plan, affix a seal for confirmation to the plan and return one of the copies back

to the supplier.

The supplier shall fully assure NSK China that the control plan is kept confidential.

6. Re-submission after Change

If contents of the control plan are changed, the plan shall be immediately submitted again.

To handle process change, please refer to the Procedure 12 “Process Change Procedure”.



Procedure 5 Preparation of Inspection Standard

1. Scope

It provides the procedure of preparation, confirmation and submission of the inspection

standard by a supplier for products and parts purchased by NSK China.

2. Purpose

It is intended to describe the outline of quality inspection for products and parts delivered

by a supplier.

3. Outline of Preparation

The inspection standard shall be prepared by part numbers in principle and may be

prepared by types. 3.1 Inspection Items

Important items shall be mainly presented provided that all indicated items for design drawings and control plan are ensured. Measuring position and measuring method may be determined through joint discussion. Management items shall, if involving SOC of products, parts and manufacturing process, be added.

3.2 Inspection Method/Frequency Inspection method shall be defined in accordance with the following requirements

provided that 100% lots are ensured: (1) In principle, operating inspection and visual inspection of important security parts shall be

100% inspection; (2) In the following cases, sampling inspection is allowed. But it is required that each lot can

be definitely identified, and allowed number of nonconformities shall be 0 without exception.

① The project is stable, required process capability is fully met (see the Procedure 9), and level of quality assurance is the same as that of 100% inspection;

② Destructive tests are conducted; ③ Material composition analysis (including SOC);

3.3 Recording Method Records kept as required (checklist, record sheet, etc.) shall be retained and managed in

such a way that they can be duly submitted at the request of NSK’s plant.

4. Form

The “Form-13 Inspection Standard” shall be used for the inspection standard. The supplier's

own form may be used if it is compliant with the reference form.

5. Submission and Confirmation

5.1 Submission

When the first edition of the inspection standard is finished, supplier shall submit 2

copies of the standard to the quality assurance department of NSK China’s plant before the

pilot products of mass production are delivered (other requirements of NSK China's plant, if

any, shall be attached thereto).


5.2 Confirmation

The head of the quality assurance department of NSK China’s plant shall, after checking

the inspection standard, affix a seal for confirmation to the plan and return one of the copies

back to the supplier.


If contents of the inspection standard are changed, the standard shall be immediately

submitted again. To handle process change, please refer to the Procedure 12 “Process

Change Procedure”.



Procedure 6 Application for Subcontractor Utilization

1. Scope It provides the procedure of application by a supplier for use of materials and parts of

another supplier and an outsoucing contractor (hereinafter referred to as subcontractor) in products and parts delivered by the supplier to NSK China.

2. Purpose

Supplier shall, when subcontracting purchase and processing of products and parts, in whole

or in part, to a subcontractor（Incloud Tier N suppliers）, submit an application to NSK China’s

plant beforehand. NSK China’s plant shall, as required, give helpful advice on the supplier’s

use of the subcontractor（Tier N） and give support to the supplier’s quality assurance system.

3. Standard for Use of Subcontractor（Tier N）

3.1 Classification

(Contracted out

by Sub-supplier)

3.2 Standard for Utilization

(1) For general parts, subcontractor may be used. Subcontractor shall be evaluated and

selected only if its capability is compliant with the requirements stated in the subcontract,

including quality assurance requirements.

Besides, subcontractors of “electrical products” and “important designated products”

shall be recognized by NSK China’s plant.

(2) Subcontractors of important designated products with important characteristics shall be

used only after they pass the prior examination of NSK China’s plant.

(3) Any Subcontractor that takes advantage of or is taken advantaged of by a supplier dealing

with NSK China shall not be used.

(4) In principle, subcontracting by a sub-supplier is not allowed unless management capability

of the supplier and the subcontractor is recognized and the supplier holds the ultimate

liability for quality of the subcontractor（Tier N）.

(5) To assure and maintain subcontractor（Tier N） quality, the supplier shall apply the Q001 of

NSK China to and equally manage its subcontractor.

Tertiary Supplier Subcontractor Supplier

NSK China

Consortium External

Processing

Manufacturer

External

Processing

Manufacturer

External

Processing

Manufacturer

Supplier

External

Processing

Manufacturer


4. Outline of Application

If the supplier wants to use a sub-supplier（Tier N）, the Form-14 “Application for Approval of Subcontractor Utilization” shall be filled with relevant information of the subcontractor

（Tier N） and submitted to the quality assurance department of NSK China’s plant before processing instruction.

5. Management of Subcontractor（Tier N）

Supplier shall document the requirements for subcontractor（Tier N） (such as product name, product no., drawing no., specifications, inspection standard, control plan, etc.) for management, and shall be responsible for regular review, quality confirmation and guidance and make every effort to maintain and improve quality. The following points shall be specially checked:

① 4M management of 100% conforming products

② Guarantee of process capability (checked at any time/at regular intervals)

③ 4S management

④ Preparation of processing standard

⑤ Preparation of quality records, such as control chart and checklist

(Retention of quality records)

⑥ Change management

⑦ Lot management

⑧ Inspection and regular inspection before operation of equipment and molds

If special process, such as heat treatment, welding and electroplating, is used,

condition management items shall be managed as inspection items before operation.

⑨ Preparation of gauges and precision inspection before operation and regular precision

inspection

⑩ Specific identification of conforming products, nonconforming products, pilot products

and commissioning products for distinguishing

⑪ Preparation of disposal flow for nonconformities

⑫ Existence of SOC in relevant parts, materials and manufacturing process

NSK China’s plant may investigate the sub-supplier（Tier N）by checking conformity of its products. But such investigation shall not relieve the supplier of its responsibility for quality assurance. NSK China’s plant may disqualify the supplier afterward.


If any subcontractor（Tier N） is changed, the supplier shall submit an application for subcontractor again in accordance with the Procedure 12 “Process Change Procedure”.



Procedure 7 Application for Approval of Limited Sample

1. Scope

It provides the procedure of use of limited samples by a supplier and NSK China to define the

criteria for functional inspection.

2. Purpose

It is used as a standard for checking if functional characteristics of the products delivered to

NSK China are satisfactory.

3. Definition of Limited Sample

Limited sample is a reference selected for qualification or disqualification or for limitation.

4. Outline of Completion of Application for Approval

4.1 Application for Approval of Limited Sample and Reply

Supplier shall complete the contents in bold boxes in the Form-15 “Application for

Approval of Limited Sample and Reply”.

4.2 Limited Sample Management Label

Supplier shall complete the necessary contents in the Form-16 “Limited Sample

Management Card”.

5. Outline of Submission

5.1 Time of Submission

Before mass production is delivered and when it is deemed necessary by supplier or NSK

China’s plant.

5.2 Quantity of Submissions

Quantity of Submission

Application for approval of limited sample and reply

1 original copy

Limited sample management card

2 cards with the same contents

Limited sample 2 samples with the same level

5.3 Receiving Department

Quality assurance department of NSK China’s plant

6. Notice on Check Result

The check result shall be notified with the “Application for Approval of Limited Sample and

Reply” and the “Limited Sample Management Card”.


7. Management of Limited Sample

Storage that is protected from damage and contamination and changes over time shall be

used.

Besides, for limited samples, a record thereof shall be kept for management (name,

approval plant, date of approval, date of passing inspection, effective period, etc.).

8. Update of Limited Sample

If limited samples become ineffective due to damage or contamination or over time, or if

NSK China’s plant gives a notice on regular inspection of limited samples, the samples shall be

sent to NSK China’s plant for inspection. When they pass the inspection, the “Limited Sample

Management Card” shall be updated. When they fail the inspection, the Card shall be remade

and submitted to NSK China’s plant for approval.

9. Appointment of Management Officer

To properly manage the limited samples, the supplier shall appoint a management officer.

10. Marking

To prevent limited samples from mixing with conforming products, parts outside the

requested position shall be completely marked with color paint and shall be stored together

with the limited sample management card.



Procedure 8 Initial Product Management Procedure

1. Scope It provides the procedure of special management of initial products and delivery to NSK China

by a supplier. 2. Purpose It is intended for special management of initial products to assure product quality. 3. Definition of Initial Product It refers to a product or a set of parts as described below and produced in the specified

period of the initial stage of production. (1) Newly designed product: produced in accordance with new drawings (2) Design changed product: produced in accordance with changed drawings (3) Process changed product: produced from the process that is changed after the process

change procedure is approved (4) Improved product: produced after improvements are made

4. Management of Initial Products 4.1 It refers to special management that is intended to assure proper quality, stabilize

manufacturing process in the early stage and prevent causes of cost increase in advance. 4.2 Management period of initial products is as shown below in principle:

Classification Type Management Period

Important designated products

Important Safety products - Safety parts

- Functional parts Over 3 months or 3 lots in the initial stage of continuous production Products specified in

appropriate laws and regulations

General products

/ Over 1 month or 1 lot in the initial stage of production

Initial products shall be managed for the aforesaid period after new processing drawings, changed processing drawings or reply to process change is received or after report of process change is implemented.

4.3 Planning of Initial Product Management Supplier shall plan items, period and cancellation condition of initial product management,

fill them in the Form-8 “Initial Product Management Plan” and submit the plan to NSK China’s plant. The objectives of quality management of products delivered to NSK China (purchase, outsourced product, etc.) shall be discussed with NSK China’s plant and reflected in the initial product management plan.

4.4 Cancellation of Initial Product Management 4.4.1 Conformity with specifications and stability of process (checked in accordance with the

process capability, see the Procedure 9) must be identified by quality confirmation in the initial product management period. If the quality assurance officer checks that the quality assurance system is sufficient, management of initial products may be cancelled after the aforesaid period.


4.4.2 To cancel the initial product management, the Form-9 “Initial Product Management Form” shall be properly completed and submitted to NSK China's plant for confirmation. If NSK China’s plant requires submission of the PSW (Form-10), the management shall be cancelled after the PSW is recognized.

4.4.3 Besides, NSK China’s plant may request extension of the period in accordance with the quality of delivery (complaint of NSK China’s plant against purchase and quality).

5. Delivery Procedure for Initial Products

At delivery of initial products, the “Initial Product Delivery (Advance) Notice” (Form-18)

shall be provided, and initial products (newly designed products、products with process

change、products with process change、improved products) shall be marked in the spot delivery order and inspection sheet (Form-19 “Initial Product (including TP) Inspection Report”).

5.1 “Initial Product Delivery (Advance) Notice” and Submission

Classification Initial Product Delivery

advance Notice Initial Product Delivery

Notice

New designed product _________ Submitted when the first lot is delivered

Design changed product Process changed product

Improved product

Submitted 3 days before the first lot is delivered

Ditto

Note: If the first lot is deemed nonconforming at the place of purchase inspection, the next lot shall be treated as the first lot.

5.2 Labelling of Initial Products and Submission of Inspection Sheet

Classification Labelling Submission of Inspection

Sheet

New Designed product

Pre production

· Label the whole lot · Attach the label to each

container (package) (White label in Form-31)

· Label the whole lot · Submit the initial product

inspection report

Mass production

· Mark 3 successive lots · Attach the label to each

container (package) (White label in Form-31)

· Mark 3 successive lots (*1) · Submit the initial product

inspection report · All Characteristics

Inspection Result (the first lot)


Design changed product Process changed product Improved product

-

· Mark 3 successive lots · Attach the label to each

container (package) (Yellow label in Form-31; please

use the green label in Form-33 for improved products)

· Design change instruction or Process change application shall be recorded together with changed contents.

Ditto

5.3 Sampling Quantity for Inspection of Initial Products

Characteristic Delivered Quantity

Sampling Quantity

New designed product

· All characteristics stated in the approved inspection standard (*2)

· Characteristics other than the ones stated in drawings (*3)

· Other characteristics internally specified by NSK's plant

1~10 11 and above

All 10 (*4)

Design changed product Process Changed Product Improved product

· All characteristics related to process change, process change and improved products (including all characteristics among changed

characteristics if otherwise stated)

① Characteristics that vary with mold precision (Rubber, plastic, etc.)

② Characteristics that require destructive inspection -

3 per mold cavity

2

(*1) The 4th and subsequent lots shall be submitted if necessary. (*2) If no inspection standard is approved, characteristics stated in the inspection standard for

similar parts shall be applied. (*3) All characteristics other than the ones stated in drawings refer to total characteristics with

dimensional tolerances stated. (Except where general tolerances in JIS are applicable) (*4) Special instructions of NSK China’s plant, if any, shall be followed.



Procedure 9 Process Capability Investigation

1. Scope

It provides the outline of process capability investigation in manufacturing process of newly

designed parts and changed parts.

2. Purpose To assure stable quality, supplier shall investigate process capability and check if it is allowed

to start mass production before mass production. Besides, process capability investigation shall be made during initial product management or daily management to promote stability of the project.

3. Definition of Process Capability Process capability refers to evaluation of the deviation of product quality in the project from

specifications. Generally, it is expressed by process capability indexes (Cp, Cpk) and performance indexes (Pp, Ppk).

4. Outline of Implementation

4.1 Characteristic Investigation and Period of Investigation

Characteristic investigation and period: The investigation shall be regularly made during

initial product management and daily management. For initial product management, see

the Procedure 8. For process capability in the daily management stage, please decide it

with NSK’s plant through discussion (by Cpk/Ppk investigation, X-R control chart, etc.).

4.2 Quantity of Samples (Sampling Method)

(1) Samples shall be taken from over 300Pcs at pilot production before mass production.

Variable: over 50Pcs

(Over 100 object parts stated in ISO/TS16949)

Attribute: over 250Pcs

(2) Data of the control charts of over 10 lots shall be directly used during initial product

management or daily management.

Special requirements of NSK China’s plant, if any, shall be followed.

(Generally, over 10 groups are required, and quantity of samples per group shall be

5Pcs.)

(3) Random sampling

5. Calculation of Process Capability Index

Process capability index shall be calculated with the following formulas.


(1) Side Specification

・Process Capability Index T: Width (tolerance)

K: Straggling parameter

σc: Standard deviation in subunit

σc=R/d2(d2=1.693 when n=3) R: Mean range

But M: Central value of specification

Ｘ: Mean value

Ｃpk＝0 when K≧1

・Performance Index

Ppk = （1-k） σ: Standard deviation of total variation

(2) Upper Limit of Specification

Su: Upper limit of specification

(3) Lower Limit of Specification

SL: Lower limit of specification

6. Criteria of Judgment

The criteria of judgment on whether mass production can be started are as follows. Special

requirements of NSK China’s plant, if any, shall be followed.

6.1 Variable

Process Capability Index

Important Designated Characteristic

General Characteristic

Both sides Specification

Cpk≧1.33 Upper (Lower) Limit of Specification

Cp≧1.33

Process capability is sufficient for production of important designated products. Mass production can be started.

Process capability is sufficient. Simplification of management can be considered.


1.0≦Cpk＜1.33 Upper (Lower) Limit

of Specification

1.0≦Cp＜1.33

Process capability is slightly insufficient. Improvement is required. 100% inspection is made.

Process capability is sufficient. Mass production can be started, but much attention is required.


Cpk＜1.0 Upper (Lower) Limit

of Specification

Cp＜1.0

Process capability is insufficient. Immediate improvement is required. 100% inspection is made.

Process capability is insufficient. Improvement is required. 100% inspection is made.

Ｍ－Ｘ

Ｔ／2

2（Ｍ－Ｘ）

Ｔ＝ K＝

Ｃp＝

Ｃp＝Ｘ－ＳＬ

3σc

Ｓu－Ｘ

3σc

Ｃpk＝（1－K）Ｔ

6σc

Ｔ

6σ

Pp＝Ｓu－Ｘ

3σ

Pp＝Ｘ－ＳＬ

3σ


When there are TS requirements, solutions are as follows:

Process Capability Index Solution

Cpk and Cp＞1.67 This project is fully satisfactory, and production can be started after approval by NSK China’s plant.

1.33≦Cpk≦1.67 This project is satisfactory. Up to Cpk>1.67, production is made with much attention to characteristics.

Cpk＜1.33

This project deviates from NSK China’s requirements. The improvement plan shall be documented. Inspections and tests shall be strengthened to achieve Cpk>1.33.

6.2 Count value

If no nonconformity is found in randomly inspected samples, it shall be deemed that

process capability is sufficient.

Even if only 1 nonconforming sample is found, 100% inspection is required and process

improvements shall be made.

7. Submission of Process Capability Investigation & Improvement Report

The Form-20 shall be used in principle. The supplier's own form may be used if it is

compliant with the reference form.

8. Number of Submitted Copies

1 copy shall be submitted to the quality assurance department of NSK China’s plant.



Procedure 10 Submission of All Characteristics Inspection Results

1. Scope

It provides the outline of preparation of the total characteristics inspection results of

drawings submitted by a supplier when it delivers initial products (TS object) to NSK China’s

plant.

2. Purpose

As a means of identifying characteristics of initial products and prevent nonconformity after

mass production is started, it is a part of the quality assurance system.


3.1 Object Parts

All initial products (TS object). For total characteristics inspection of products from pilot

production and mass production, instructions of NSK’s plant shall be applied.

3.2 Contents of Inspection

All characteristics stated in the drawings (NSK China’s part drawings or supplier’s

acceptance drawings) issued by NSK China.

(But changed product shall be deemed a part)

(1) Appearance

(2) Shape (including C or R chamfer)

(3) Dimensions

(4) Material certificate

(5) Strength

(6) Surface treatment

(7) Others (heat treatment characteristics, rubber property, etc.)

(8) Existence of SOC

3.3 Quantity of Inspected Parts

n=more than 1 (each mold and cavity of mold parts shall be inspected).

3.4 Outline of Submission

(1) Submitted Form

Copy the drawing, fill the measured value in the [ ] box next to characteristics with a

red ball pen, and mark the [Inspection Drawing] in the copy.

(2) Deadline of Submission

It shall be submitted when the first lot of initial products from mass production is

delivered. For data that cannot be submitted at delivery of the first lot, such as data of

endurance tests, estimated date of submission shall be specified. The results of total

characteristics inspection of products other than initial products shall be submitted as

stated by NSK China’s plant.

(3) Outline of Completion

An example is given below [outline of completion of all characteristics inspection].

If the requirements stated in 3.2 are met, other forms may be used.


△ ・・涂装・防锈承認審査検図設計製図

△ ・・表面处理规格客先Ｐ・ＮＯ

△ ・・ SURFACE

TREATMENT

名

ＨＥＸ．ＮＵＴ：ＣＡＵＬＫ．

△ ・・ EP-Fe/Zn 5/CM2B

(３価)

材

料Ｓ３３Ｃ

称

△ ・・尺

度２：１数

量

名

番 8108-037

符

号日付変更№ 記事変更者

日

付

．．図

番４

Lot：

判定：全项目ＯＫ

△△制作(股份)品质保证课

年月日

责任者担当

备注

１．无毛刺 [OK]

２．如左图 3处铆接后第一次的回转力矩是

1700～6900mN･m

[5700]

３．硬度 HB170 以上 [HB183]

[8μｍ]

［参照添付的材质证明书。 OK]

[24 OK]

记录要领

Rz 25

30°

12 ±0.2 0

-0.25

[6H 通止规 OK] [29.5°] [+0.1] [－0.12]

[11.2]

[-0.2]

[9.2]

0

-0.5

120°

[ 121°]

φ11

MIN

（φ9.3）

13.9

[46°]

45°

M8×1.25 6.5

铆接（３处）

[3处 OK]

检查图

本品应遵守、NES W0210･0221

或最新的 NSK 绿色采购基准书。

THIS PRODUCT TO BE MANUFACTURED IN

ACCORDANCE WITH “NESW0210 & 0221”,

OR THE LATEST EDITION OF

“NSK GREEN PROCUREMENT STANDARD”

［参照添付的分析结果。 OK]

NSK (China) Investment Co., Ltd.(CHQ) NSK Q001

< ３０ >


Procedure 11 Submission of Inspection Record

1. Scope It provides the procedure of submission of characteristics inspection record by a supplier

when it delivers designed parts to NSK China’s plant.

2. Purpose

It is intended to regularly check supplier’s quality change.

3. Scope and Outline of Submission

3.1 Scope of Submission

(1) Components and all inspected characteristics (such as rubber, plastic, casting and

die casting) indicated by the quality assurance department of NSK China's process in the

quality assurance agreement (procurement specification, inspection standard).

(2) For examples of inspected characteristics of thermally treated products and welded parts,

see the following table (for details, please discuss with NSK China’s plant).

○･･･object △･･･as stated in the quality assurance agreement

Characteristic

Classification

Sur

face

Har

dnes

s

Cor

e H

ardn

ess

Dep

th o

f Que

nchi

ng

Sco

pe o

f Que

nchi

ng

Mic

rost

ruct

ure

Mat

eria

l

Dep

th o

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HT Part

Normalizing, annealing ○ ○ －－ ○ ○ －－－－－

Quenching, tempering ○ ○ －－ ○ ○ －－－－－

Carburizing and quenching,

nitriding ○ ○ ○ ○ ○ ○ －－－－－

High frequency quenching ○ － ○ ○ ○ ○ －－－－－

Welded part

Sweating and quenching －－－－－－ ○ △ ○ －－

Resistance welding －－－－－－－－ ○ △ ○

3.2 Outline of Submission

(1) Form of Inspection Sheet

① Supplier’s form is allowed (including depth of penetration and spot welding diameter

of welded parts).


(2) Time of Submission

① For thermally treated products and welded parts, the inspection sheet and the T.P of

each manufactured lot shall be submitted together with the delivery. The T.P shall be

returned back after confirmed by NSK China’s plant, and supplier shall retain it for

more than 6 months.

② If specially stated by NSK’s plant for other parts, the inspection sheet shall be

submitted once a month before the 10th day of the next month.

* The maximum period of a lot is 1 day. In the case of 2 days, it shall be treated as a

different lot.

(3) Number of Submitted Copies and Receiving Department

1 copy, submitted to the quality assurance department of NSK China’s plant.

3.3 Storage of Inspection Record

In principle, supplier shall retain the inspection record for more than 10 years. But the

inspection record of important designated products shall be retained for more than 15

years.



Procedure 12 Process Change Procedure

1. Scope

It provides the procedure that shall be applied to NSK when a supplier changes process.

2. Purpose

It is intended to prevent quality issues caused by change of sequence and operating

condition of manufacturing process and inspection process for the purpose of rationalization

and cost reduction.

3. Process Change to be Approved

The following table lists the process change for which supplier shall apply for approval to

NSK China’s plant.

No Change content

1 Important change related to materials (change of material manufacturer and procurement of raw materials)

2

Change of sequence, operating condition and equipment of important management process of casting, forging, heat treatment, welding, gold plating, rubber vulcanization, locking and surface treatment; Change of inspection process of soldering, adhesion, riveting and fatal defects; Change of auxiliary materials (welding wire, protective gas, etc.) for production that may affect product quality.

3 Change of manufacturing place, supplier and external processing manufacturer (subcontractor)

4 Important change of sequence, operating condition and equipment (including molds and tools) of processing process (machining, assembly, etc.)

5 Change of quality inspection method

6 Change of personnel due to addition of production lines and addition of shifts

4. Procedure of Process Change

(1) When process change is planned, supplier shall fill in the necessary items in the Form-21A

“Process Change Plan” in accordance with the process change stated in Point 3 above, and

shall submit the plan to the quality assurance department of NSK China’s plant together

with relevant documents. The time of such submission shall, in principle, be 90 days before

the application for approval is made＊1.

(2) The quality assurance department of NSK China’s plant shall, after confirming the process

change plan, record necessary items and return the original back.

(3) Supplier shall fully sample the change points and verify their effects in accordance with the

change plan to prevent quality issues.


(Supplier also can use the Form-34 DRBFM to sample the change points and verify their effects,

and please follow the instructions of NSK's plant)

(4) Supplier shall fill in the necessary items in the Form-21B “Process Change Application”, and

shall submit it to the quality assurance department of NSK China’s plant together with

relevant documents. The time of such submission shall, in principle, be 45 days before the

defined date of process change.

*1: In principle, the forms shall be submitted in the aforesaid period. If the period has to be

extended as required by customer or as required for sample evaluation, please follow the

instructions of NSK's plant.

5. Implementation of Process Change

The quality assurance department of NSK China’s plant shall, after checking as required,

give a reply whether process change is allowed in the “Reply to Process Change” of the

Form-21B “Process Change Application”. Supplier shall, only after receiving a positive reply,

implement the approved change.

After process change, initial products shall be properly managed (see the Procedure 8) to

prevent nonconformity in the initial stage of such change.

6. Submission of Quality Assurance Documents

When inspection standard, control plan and application for sub-contractor have to be

changed as a result of process change, they shall be immediately submitted to NSK China

again. (Refer to the submission method of various documents.)

7. Delivery of Products with Process Change

When supplier delivers products with process change to NSK China, special management of

processing conditions and inspection results shall be recorded. At the delivery, the

Procedure 8 “Initial Product Management Procedure” shall be followed.



Procedure 13 Disposition When Defect Occur

1. Scope

It provides the solution to abnormality that occurs in products and parts delivered by a

supplier to NSK China.

2. Purpose

It is intended to prevent nonconforming products from reaching customers and prevent

reoccurrence of nonconformities in advance.

3. Reporting and Handling when defect occur

If supplier’s quality assurance officer identifies any nonconformity in the project and the

abnormal lot has been or may have been delivered to NSK China, the officer shall notify NSK

China’s plant thereof by telephone as soon as possible and give a written notice to NSK

China’s plant afterward. If information of abnormality occurrence is received from NSK

China’s plant, the officer shall immediately report the following matters to the ordering

department and the quality assurance department of NSK China’s plant and wait for their

instructions. For form of the report, see the “Form-22 Notice of Incoming·Line Defects &

Countermeasure Report”. The supplier's own form may be used if it is compliant with NSK's

requirements.

(1) Occurrence and cause of the nonconformity.

(2) Date of delivery to NSK China, delivered quantity, part No., lot No., etc.

(3) Emergency disposal of supplier’s products, and disposal of delivered products.

4. Reporting of Solution to Nonconformity

While the aforesaid items are handled, supplier shall identify the cause of the

nonconformity and process out a temporary solution. The solution to the nonconforming

part and similar parts and measures against recurrence shall be filled in the Form-22, and

the form shall be submitted to the quality assurance department of NSK China’s plant in

10 days after occurrence (or at the date otherwise specified by NSK China’s plant). If NSK

China’s plant specifies the date of such submission, the Form-23 “Recurrence-Prevention

Countermeasure sheet of Supplier Quality Issues” shall be used for reporting.

Besides, if the form cannot be submitted as scheduled, it shall be communicated to the

quality assurance department of NSK China’s plant beforehand to obtain its approval.

4. Delivery of Improved Products

4.1 Labeling

In the first lot of improved products, the “Form-33 Improved Product Label” shall be

attached to each container or package for delivery.


Besides, the notice on initial product delivery shall be submitted (unless otherwise

stated by NSK China’s plant).

4.2 Submission of Quality Confirmation Result

At delivery of the first lot of improved products, the “Initial Product Inspection Sheet”

shall be submitted to the quality assurance department of NSK China’s plant.

For delivery of the improved products, the Procedure 8 “Initial Product Management

Procedure” shall be followed.



Procedure 14 Application for Concession

1. Scope

It provides the procedure of application for special adoption by a supplier to NSK China.

2. Purpose

It is intended to specify the standard of application for special adoption in order to control

the loss of delivery period and economic loss caused by processing of replacement of

nonconforming products.

3. Basic Principle of Special Adoption

If supplier has to apply for special adoption of products and parts (nonconforming products)

that are incompliant with the quality specifications stated in our drawings and inspection

standard, degree of defect, quantity, cause and solution shall be clarified before the

application.

Special adoption shall meet the following requirements and shall be limited to the products

that are deemed still usable.

(1) Function and commercial value of the products are not impaired.

(2) It is proved by technical data that function, performance and endurance of the products

are not affected.

(3) Subsequent process (including customers) will not be hindered by the products.

(4) There are measures against recurrence.

Besides, in principle, special adoption is not allowed if the same nonconformity reoccurs.

4. Application

(1) After the specified items in the Form-24 “Application for Concession and Reply” are completed,

the application shall be submitted to the ordering department of NSK China’s plant and

forwarded to the quality assurance department.

(2) If location and degree of the nonconformity are indefinite, a sample shall be attached.

(3) As other relevant documents, control plan and processing standard shall be attached when

necessary.

5. Decision

NSK China’s plant shall check the application and fill the result thereof in the reply. The

reply shall be issued by the receiving department of NSK China’s plant to the supplier.

6. Delivery

Before specially adopted products are delivered, the delivery note and the products shall

be definitely marked.


The “Form-32 Concession Part Label” shall be attached to each container (package). Besides,

the “Form-33 Improved Product Label” stated in the “Procedure 13 Disposition When Defects

Occur” shall be attached before delivery of improved initial products (Serial number of the

application for and reply to special adoption must be marked on the label).



Procedure 15 Gauge R&R Investigation (TS Object)

1. Scope

It provides the outline of gauge R&R investigation (investigation of measurement variation)

by a supplier (TS object).

2. Purpose

It is intended to investigate measurement errors caused by human elements and improve

deficiencies if any in order to maintain and improve quality.

3. R&R Explanations

(1) Repeatability (error of repeated measurement)

Variation that occurs when one measurer uses one gauge to measure some characteristic of

one part several times.

(2) Reproducibility (measurer’s measurement variation)

Variation of mean measured value that occurs when several measurers use the same gauge

to measure some characteristic of one part several times.

To investigate the aforesaid two errors, the selected gauge shall be at least as precise as 1/10

of the tolerance range of the measured characteristic.


4.1 Investigation Object

If stated in the “Request for Production Preparation”, object quality characteristics shall

be all of the quality characteristics that are stated in the “Inspection Standard” and can

be measured with variables.

4.2 Investigation Method

(1) Investigation plan Record the investigation plan for object gauge in the Form-26 “GRR

Plan and Management Record”.

(2) Implementation of investigation

Use the “Average-Range Method” for gauge R&R investigation.

3 measurers, A, B and C, measure the same 10 products (with the same characteristic)

three times.

(3) Analysis of measurement results Record the measurement results in the Form-25

“Gauge R&R Report” and calculate repeatability and reproducibility of the gauge.


4.3 Judgment and Response

(1) Judgment of and response to total variation of measurement (%GRR) are as follows:

Total Variation of Measurement

(%GRR) Judgment Response

Variation below 10% Acceptable measurement system

Not required

Variation above 10% and below 30%

Measurement system that shall be improved and is conditionally acceptable

Depending on importance, cost of measuring installation, cost of repair, etc.

Variation above 30%

Unacceptable measurement system that has to be improved

Recheck and improve the error of repeated measurement or the error artificially caused by measurer.

(2) Judgment of and response to NDC are as follows:

NDC Judgment Response

NDC above 5 Acceptable measurement system

Not required

NDC below 5 Unacceptable measurement system that has to be improved

Recheck and improve the error of repeated measurement or the error artificially caused by measurer.

4.4 Re-evaluation

When NDC is below 5 or %GRR is above 30%, the error of repeated measurement or the

error artificially caused by measurer shall be rechecked, improved and re-evaluated.

4.5 Investigation Result Statistics

Judgment of and response to gauge investigation shall be recorded in the “Gauge R&R

Report” and the “GRR Plan and Management Record” as investigation result statistics.

5. Submission and Storage of Gauge R&R Record

For parts for which the production preparation instruction provides the requirements,

supplier shall submit the copies of the “Gauge R&R Report” and the “GRR Plan and

Management Record” to the quality assurance department of NSK China’s plant and retain the

originals thereof.

Reference: Considering accuracy of GR&R, please take samples dispersively where is in the tolerance range if

possible.



Procedure 16 Management of Critical Control Process

1. Scope

It provides the procedure of special management by a supplier for cirtical control process

and submission of management status report to NSK China.

2. Purpose

For manufacturing process of which product and part quality is difficult to assure with

general inspection method, such as welding, heat treatment and gold plating, and special

inspection process, such as magnetic particle inspection, ultrasonic inspection, eddy current

inspection and radiographic inspection (hereinafter referred to as cirtical control process),

supplier shall implement special management and submit the information of equipment,

process, processers and inspectors of such process to NSK. When necessary, NSK shall give

helpful advice on the items of special management process and give support to the supplier’s

quality assurance system.

3. Management of Cirtical Control Process

For cirtical control process, supplier shall implement special management, at least including:

‧ Education, evaluation and examination of personnel

‧ Inspection, maintenance and recording of equipment

‧ Supervision of condition management items and quality characteristics

‧ Documentation of process and management highlights

‧ Retention of all quality records (special data records)

4. Submission of Management Status Report of Cirtical Control Process

Supplier shall submit the management status report of cirtical control process and other

process specified by NSK. Necessary items shall be filled in the report in accordance with the

“Form-17 Management Form of Cirtical Control Process”, and the report shall be submitted to

the quality assurance department of NSK China’s plant.

5. Management of Special Process of Important Designated Products

Special process for manufacturing the important designated security products and legally

specified products, such as heat treatment and welding, must be checked and supervised by

NSK China’s plant in addition to the aforesaid management.


If management of cirtical control process changes, supplier shall make the change in

accordance with the Procedure 12 “Process Change Procedure” and present the management

status report of important management process again.


Reference

“Special process” is one of “cirtical control process”. As important process, it must be

highlighted and must be specially managed. Special process, such as welding, heat treatment,

electroplating and coating, may be managed in accordance with CQI and other appropriate

standards.

For example: CQI-9 heat treatment, CQI-11 plating, CQI-12 coating, CQI-15 welding, etc.

Other special process, such as cleaning, riveting and other “condition management process”

of which nonconformities are difficult to identify in the inspection, must be specially managed in

the same way. These requirements apply to NSK's designated process.



Procedure 17 Supplier Evaluation and Continual Improvement

1. Scope

It provides NSK China’s regular evaluation system for overall quality of suppliers of NSK

China’s purchased products and outsourced products (hereinafter referred to as purchased

products).

2. Purpose

In order to assure quality of NSK products, it is indispensable to maintain and improve

purchase quality and ensure stable supply. For uniform quality evaluation of NSK China,

unified supplier evaluation is required. Supplier’s system shall be improved, and purchase

quality shall be maintained and improved.

3. Supplier Evaluation and Continual Improvement

3.1 Evaluation Object

Object purchase refers to the products purchased by the plant (excluding accessories).

3.2 Statistical Method and Evaluation Method

(1) The quality assurance department of NSK China shall regularly collect the information

(supplier name, qualified rate of parts, abnormal part name, unqualified content, identified

process, quantity of nonconformities, re-delivery, degree of defect, submission of solution

report, etc.) of quality performance of each supplier. The quality assurance department of

NSK China shall evaluate and rank its suppliers in accordance with evaluation contents and

criteria in 3.4. Each plant of NSK China shall evaluate its suppliers respectively in

accordance with the plant’s evaluation requirements.

(2) NSK’s plant shall require the top worst suppliers to make improvements and submit

improvement plans in accordance with the result of evaluation. When necessary, the plant

may give instructions in such improvement together with other departments concerned of

NSK China.

3.3 Continual Improvement

(1) The quality assurance department of the plant shall be responsible for checking and

following up the improvements submitted by the supplier.

(2) The quality assurance department of each plant shall make different inspections

(confirmation of solution to nonconformity, process inspection, field inspection for quality

assurance system, etc.) for suppliers in accordance with their quality condition data

counted by the plant and the result of overall evaluation of NSK China's quality assurance

department.

(3) When necessary, each plant may contact the quality assurance department or other

departments concerned of NSK China to inspect suppliers together.


3.4 Items and Criteria of Evaluation

3.4.1 For items and criteria of evaluation, see Table 1 below:

No Item of Evaluation Rating Standard of Evaluation Score

① Qualified rate of products 15

(1-number of unqualified products / total accepted products) X 100%

Qualified rate

X 15%

②

Number of Quality complaints issues

(Zo*1+Z+Y+X) 75

Zo1=10 points, Zo2=8, Z=5 points, Y=3 points, X=1 point / case; Recurrence=double points

75-points

③

Submission of Countermeasure report (rate)

10

1-(required submitted report - actually submitted report)/required submitted report × 100%

Submission rate X 10%

Final score 100 ①+②+③

*1: Zo1--- customer’s complaint – cannot discovered by NSK and escape; Zo2--- customer’s complaint – can discovered by NSK but escape;

A) Number of unqualified products in unqualified rate of products = Number of unqualified products in incoming inspection + number of unqualified products in post process

B) X.Y.Z: For classification of severity of unqualification (contents, number and location), see Table 2 below. Degree of defect: X-minor defect, Y-major defect, Z-fatal defect;

C) Recurrence unqualification: The same quality issue recurs after measures against the same cause of the same model or the same type are taken.

3.4.2 For classification of XYZ, see Table 2 below:

Identified Process Incoming Inspection

(Number of Products) Post Process

(Number of Products)

No Defects Z Y X Z Y X

1 Skipped product ≧1 ≧1

2 Different product ≧1 ≧1

3 Different material ≧1 ≧1

4 Crack ≧1 ≧1

5 Size &Precision defect ≧1 ＞10 2~10 1

6 Rust

Yellow rust stain (floating)

≧10/box

＜10/box

Rust pitting ≧

10/box ＜

10/box ≧1

Black rust stain ≧

10/box ≧2 1

7

Visible defect: length*width*depth > 3*1*0.5

≧1 ＞10 2~10 1

8

Poor appearance: crust (invisible or poor precision at acceptance)

＞10 2~10 1


9 Marking (Double mark.fuzzy mark.

wrong mark) ≧1 ＞10 2~10 1

10 Defornation ≧1 ＞10 2~10 1

11 Incorrect lable ≧1 box

≧1 box

12 Incorrect weight ≧1 box

13 Character defect ＞10 2~10 1

14 Foreign matter ≧1 ＞10 2~10 1

4. Periodic Feedback of Evaluation Result to Supplier

The quality assurance department of NSK China shall collect the information of supplier

quality performance submitted by each plant, and regularly evaluate overall condition of NSK

China and notify suppliers thereof. The suppliers shall be rewarded in accordance with the

result of their annual evaluation.



Procedure 18 Management of Substances of Concern (SOC)

1. Scope

It provides the procedure of SOC management of products delivered by a supplier (*) to

NSK China. Besides, this procedure shall be applied in combination with the “NSK Green

Procurement Standard”.

*: Supplier refers to a manufacturer from which parts, materials, accessories, auxiliary

materials and packaging materials for production are purchased or an external

contractor of assembly and processing of such parts and materials.

2. Purpose

It provides necessary items of management in accordance with the supplier’s SOC

management rules.

3. Definitions (See the “NSK Green Procurement Standard” for details)

(3.1) Green Procurement Standard

It is a procurement standard prepared for parts, materials and assets to abide by

appropriate environmental laws and regulations and NSK's own requirements.

(3.2) Substance of Concern (SOC)

It refers to any substance that has or may have an adverse effect on environmental

protection and human and animal health.

(3.3) Auxiliary Material for Production

It refers to anything that is used in the manufacturing process, directly comes into

contact with and is attached to products and will not be left over, such as heat

treatment oil, processing oil, detergent, solvent, inter-process rust preventive oil and

grinding wheel.

(3.4) Accessory

It refers to anything that is attached to delivered products, such as rust preventive oil,

adhesive, coating, solder, tape, ink, ink pen and operating instruction. But packaging

material is excluded.

4. Classification and Criteria of SOC Management

Products that contain SOC shall be effectively managed by prohibition, reduction and

management, and criteria of such management shall be prepared. Besides, the prohibition,

reduction and control shall be based on the “List of NSK's Controlled Substances” attached to

the Green Procurement Standard.


5. Boundary Value/Threshold of SOC

(1) Intentional: It means to continue using and containing SOC in order to maintain stable

physical property, quality and appearance of materials.

(2) Unintentional: It is used for other purposes than intentional use.

1) Including raw materials, as an occasion that industrial materials cannot be

technologically removed in the refining process;

2) Occasion that by-products in the manufacturing process cannot be technologically

removed.

(3) Allowable Concentration (Boundary Value)

Unintentional content shall, if the content value is below the boundary value, not be

deemed as an object of prohibition and reduction.

● Concentration can be “deemed as weight of homogeneous material” and is calculated as a

denominator.

● On the occasion of intentional content, even if allowed concentration is below the

boundary value, it shall be deemed as the object of NSK’s prohibition, reduction and

control.

6. SOC Management

6.1 Establishment of SOC Management System

Supplier shall manage NSK's prohibited substances in design/development and

manufacturing stages. For details, see the “NSK Green Procurement Standard”.

6.2 Check of Supplier’s SOC Management System

Check if the supplier abides by the requirements stated in the Green Procurement

Standard. Besides, check management of the change of the supplier’s materials, process

and sub-suppliers. Such check shall be self-check (check by the supplier) or field check

(check by NSK China) as required by NSK China.

6.3 Reply to NSK’s Investigation Instruction

For NSK’s investigation on the following items, duly and quick response shall be given:

1) Composition;

2) Customer’s specific chemical substances.

6.4 Record Management

Supplier shall retain the SOC record for at least 15 years.

7. Submissions Stated in Green Procurement Standard

・Form 1 Approval for Environmental Protection Activities

・Form 2 Company Information Register

・Form 3 Questionnaire for Environmental Protection Activities

・Form 4 Questionnaire for Product SOC Reduction Project

・Form 5 SOC Questionnaire


・Form 6 Questionnaire for Composition of Delivered Product (100msaa% Open in Principle)

・Form 7 Analytic Results of Lead, Cadmium, Hexavalent Chrome, Mercury, Specific Bromic

Fire Retardants

・Form 8 Proof of No Existence

・Form 9 Checklist of NSK’s SOC Management System

Form 1, 2, 3 must be submitted. For details, see the instructions of NSK China’s plant.



Outline 1 Lot Management

1. Scope

It provides the outline of “Lot Management” that has to be specially stated in the Basic

Requirements for Quality Assurance.

2. Lot Management

Lot management is intended to track and search the history of each manufacturing process by

lot number, identify the cause, take proper measures and detect the nonconforming products

when nonconformity occurs.

(1) Object Part

The object is all products delivered to NSK China’s plant (including supply of NSK China’s plant).

(2) Lot Marking

1) When each part is marked

Marked by stamping and corrosive stamping, and marking position shall be recorded in

acceptance drawings or manufacturing drawings, processing drawings and procurement

specifications. When necessary, it may be discussed with the ordering department of NSK

China’s plant for adjustment and decision.

2) When it is impossible to mark each part

Shipping tag and label of each container shall be marked.

(3) Lot Formation

1) Lots shall be managed for important process throughout materials, heat treatment,

processing, assembly and delivery in accordance with part characteristics to facilitate tracing

of the result of important characteristics.

2) For unit parts (part assemblies), each lot of assembled parts can be searched by lot no.

3) Lot size shall, in principle, not exceed daily output.

(4) Notes of Lot Management

1) Thoroughly implement FIFO management;

2) Manage remaining products;

3) Manage reprocessed and retained products if any;

4) Prevent lots from mixing.

(5) Lot Management Record

To facilitate searching, lot management record (each lot of product and part materials can

be recalled by lot No. from the history delivered to NSK China) shall be established and shall be

submitted at the request of NSK China’s plant.


(6) Composition of Lot No. and Marking of Delivery to NSK China

Composition of lot No. and marking of delivery to NSK China shall be determined by each

supplier and shall be submitted to the quality assurance department of NSK’s plant via its

ordering department.

・Paper of submitted application

……… Form-27 Application for Lot Management Rules for Delivered Parts

・ Example of Lot No. ……… Lot No.：4Z01

Meaning:

2004 年 12 月 1 日

01～31

1～9・X・Y・Z

Last digit of calendar year



Outline 2 NSK China Property Management

1. Scope

It provides the outline of “NSK China Property Management” that has to be specially stated

in the Basic Requirements for Quality Assurance.

2. NSK China Property Management

2.1 Definition of NSK China Property

NSK China property refers to materials, raw materials, parts and tools that are directly

delivered by NSK China or its suppliers for processing or assembly of the products

delivered to NSK China.

2.2 Management Outline of NSK China Property

NSK China property shall be managed from delivery of materials from supplier to delivery

of products in accordance with the following outline.

(1) Delivery of Materials

1) Confirmation (Inspection) of Supplier

Each delivered lot of supplies shall be confirmed (inspected) in accordance with the

following items.

Item Content

Existing product label The content of existing product label shall be consistent with that of delivery documents, such as delivery label and delivery note.

Appearance Check for damage and other nonconformities.

Quantity No inconsistency with delivery documents, such as delivery label and delivery note.

Only for bar

steel

label End face (above φ30)

Check if steel grade in the delivery label is the same as that in the end face label.

color End face (below φ30)

All supplies shall be painted.

2) Judgment and Response

① Qualified

Accepted as “conforming” when all of the inspection items listed in 1) are met.

② Unqualified

Deemed “Unqualified” when one or more of the items listed in 1) are not met.

Proper measures shall be taken against the lot to identify, isolate and store the

“Unqualified” products (if possible).

③ Notice of Unqualified Product


Complete the Form-28 “Notice of Customer Property·Investigation Report” and

submit it to the quality assurance department of NSK's plant.

④ The quality assurance department of NSK China’s plant shall give the issuer a reply

to disposal of existing products in one week after receiving the “Notice of

Customer Property·Investigation Report”.

3) Confirmation (Inspection) Record and Retention

Confirmation (inspection) record and storage of the property shall be subject to the

following table, and the record shall be submitted at the request of NSK China’s

plant.

Classification of Property

Recording Period of Retention

Directly delivered

steel material

Recording as decided by the supplier at its own discretion in accordance with the Form-29 “Steel Material Acceptance Record” or this table, and the record shall be retained and confirmed.

The records of important designated products shall be retained for over 15 years , Others shall be retained for over 10 years.

Others

Recording as stated in the delivery label or as decided by the supplier at its own discretion, and the record shall be retained and confirmed.

The records of important designated products shall be retained for over 15 years, Others shall be retained for over 10 years.

(2) Storage

Storage place shall be specified to prevent damage, deterioration, loss and entry of

abnormal products.

(3) Use

① While used, lots shall be managed on the FIFO principle.

(Refer to Outline 1 “Lot Management” herein).

② If any unqualified is found in use, processing or assembly of the lot shall be immediately

stopped, and NSK China’s plant shall be informed thereof. When instructions of disposal

are received, Form-28 “Notice of Customer Property·Investigation Report” shall be

issued for notification.

2.3 Management Outline of Inspection Tools and Manufacturing Tools

(1) Inspection of incoming materials

To inspect the incoming materials and retain the records of such inspection.

(2) Marking of existing products


To specify ID no. for owners and permanently mark the name of NSK China’s plant

(For example: electroprobe, sign, etc.).

(3) Record registration

Register in the record for management.

(4) Periodic inspection

Specific the effective period and make periodic inspection.

If any Unqualified occurs, NSK China’s plant shall be informed thereof in the form of

unqualified occurrence notice.



Outline 3 Product Identification at Delivery to NSK

1. Scope

It provides the outline of “Product Identification at Delivery to NSK” that has to be specially

stated in the Basic Requirements for Quality Assurance.

2. Product Identification at Delivery to NSK

(1) Product Label

At delivery to NSK China, all necessary items shall be stated in NSK’s product label and the

label shall be attached to each delivered lot as evidence of conforming products that have

passed your final inspection.

Product Label ------ Refer to the Form-30

(Note) The supplier's own form may be used if it is compliant with NSK's requirements.

For detailed contents, please follow the instructions of NSK China’s plant.

(2) Identification

To prevent entry of wrong lots by classification, a product label (auxiliary label) shall be

attached to each container.

Besides, information such as product no. and lot no. shall be stated in the product label.



Outline 4 Management of Important Designated Products

1. Scope

It provides the management outline of “Important Designated Products” that has to be

specially stated in the Basic Requirements for Quality Assurance.

2. Management of Important Designated Products

2.1 Definition of Important Designated Product

Important designated product is a collective term of the following designated products.

1) Important Designated Safety Product

Safety part: Parts marked with ○S in drawings refer to the products that may cause a

major accident, such as personal casualty and vehicle burning, if they are

defective, faulty or improperly operated. Special important quality

characteristics of the products are also called ○S characteristics.

Functional part: Parts with important functional characteristics (○F characteristics)

refer to ① the quality characteristics against which the user may make

a complaint due to function deterioration in the early stage; ② the

quality characteristics that may cause disorder to the customer’s

production line due to obstruction in installation and assembly of other

parts

2) Legally Designated Product

It refers to an assembled product that consists of legally designed parts and a part

with legally designated characteristics (○SR characteristics).

○SR characteristics refer to the quality characteristics that may cause nonconformity

with national and international safety laws and regulations.

2.2 Management Officer and Duties

A management officer (head of the quality assurance department) shall be appointed

for special management of important designated products and planned self-check of its

implementation in order to achieve comprehensive management.

2.3 Implementation of Special Management

1) Discussion about Prevention against Nonconformities

At preparation for production, solutions to defective points of quality assurance shall

be processed out, the project shall be guarantee with P-FMEA, and quality issues in mass

production shall be prevented.

2) Guarantee and Maintenance of Process Capability

For ○S , ○F and ○SR characteristics, quality condition shall be regularly checked, and

quality level shall be managed in accordance with the following criteria.


Type General Requirement TS Requirement

Variable characteristic Cpk≧1.33 Ppk≧1.67

Attribute characteristic P≦0.01% P≦0.0001%

3) Identificationg of Important Designated Products

Important designated products and their characteristics shall be marked in their

process and labels to indicate importance of parts and improve quality awareness.

4) Education and Training of Operator

Operator of special process (heat treatment, welding, electroplating, etc.) of important

characteristic manufacturing of important designated products shall be educated and

qualified to maintain and improve their skills.

5) Management of Initial Products

Follow the “Procedure 8 Initial Product Management Procedure”.

6) Management of Lot No.

When important designated products and parts are handed over between process,

they shall be managed by lots, and a quality history shall be prepared.

7) Management of Repaired Products

When important designated products are repaired, both repaired characteristics and all

affected characteristics shall be inspected.

Lots shall be specified and a quality record shall be kept. Every time important

characteristics are repaired, approval of NSK China’s plant shall be obtained beforehand.

8) Retention of Quality Record

The quality records of important designated products shall be retained for over 15 years.


[Explanations]:

① This Manual was prepared by the following WG (Working Group) members in 2014.

WG members who prepared the [Supplier Quality Assurance Manual]:

CHQ Quality Assurance Headquarters Han Chao, Zhou Guorong

SNBC Quality Assurance Section Liu Jing, Zhang Xinping

NNBC Quality Assurance Department Chen Ying, Zhang Xiaojun

NSSC Quality Assurance Dep. Section 2 Zhu Weitao

WG members who prepared the [Supplier Evaluation and Continual Improvement]:

CHQ Quality Assurance Headquarters Wei Huling, Fan Qiang

SNBC Quality Assurance Section Zhang Xinping

KS Quality Assurance Department Xu Yinhua

NWSS Quality Assurance Department Qiu Jinbao

SY Quality Assurance Section Jin Chuanlin

② For preparation of the “Q001 Supplier Quality Assurance Manual” of NSK China, NSK China

must improve the entire supply chain rapidly and continually in accordance with the market,

environmental and customer requirements that are getting stricter year by year.

Particularly, to realize the relevant customer requirements and objectives of QCDS,

evaluation, solution and effect shall be checked during product preparation, and a stable

production system must be established for the whole process from initial stage of mass

production to supply chain.

Therefore, each supplier shall truly understand NSK China’s quality assurance requirements

and must improve business quality and business efficiency between NSK’s departments.

As a result hereof, a comprehensive version has been prepared by sorting and studying the

[Q001 Supplier Quality Assurance Manual] prepared and issued by NSK China’s each plant.

On the basis of standardization, popularization and generalization, NSK expects the persons

concerned to effectively, flexibly apply this manual as a part of global activities in order to

ensure safety, quality and abidance by disciplines and laws.

After this manual is implemented, the quality assurance department, CPD and CQA of each

plant of NSK China shall keep monitoring its operation.

It is planned to amend and modify this manual once 2 years.

③ According to the feedback from each plant,revised in February 2017.

Main revised, added form-34(DRBFM) and cancel the bottom mark of form-24(Application for

Concession and Reply) for NSSC.And corrected the input miss etc.