Policy and Procedures Headers Template

NSK Americas IQMS Document.

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NSK AMERICAS POLICY AND PROCEDURE

KEY PROCESS CONTROL POLICY NUMBER: AQM-013 ORIGINAL ISSUE DATE: 8/5/2004

REV. IMPLEMENTATION DATE: 2/11/2013 WRITTEN BY: David Jones APPROVED BY: Darcy Cooper PAGE NO: 1 of 7

1. SCOPE

1.1. This procedure applies to all Δ NSK Americas production locations and to suppliers of direct material or components utilized in the final products produced and/or sold by NSK Δ Americas.

2. PURPOSE

2.1. The purpose of this procedure is to ensure NSK Americas understands and manages issues related to key processes at our production locations and at suppliers. This will assist NSK and NSK suppliers in improving their quality assurance systems for those processes that are difficult to detect in the processes that follow Δ or are critical processes such as those processes related to safety characteristics.

3. ASSOCIATED DOCUMENTS

3.1. NSK Quality and Environmental Manual (AQM-001) 3.2. NSSH Q3391 – Control of Special Processes (reference)

4. DEFINITIONS

4.1. Δ Key Process: Key process is defined as a process that can produce defects, which cannot be detected readily. It is also any process that may produce defects which lead to a serious quality problem when the bearing is in service or result in a safety related process. It is noted that any process related to a safety feature is a key process, however, not all key processes are safety critical processes 4.2. Safety Critical Process: Any process that is associated with the processing of a feature that is indicated as safety critical by NSIK or NSK’s customer. 4.3. Swaging: Displacing material using force to roll form. Generally, this refers to the process of roll forming the B2 spindle material to retain the B1 ring in the production of hub bearing. NSK AMERICAS POLICY AND PROCEDURE

Key Process Control POLICY NO: AQM-013 REVISION DATE: 2/11/2013 PAGE NO: 2 OF 7

4.4. Staking: The process of using an impact force to deform of deflect material to prevent two components from separating. This generally refers to the processes utilized for retaining joint cover plates or for column tubes to assure the slider shaft / tube do not separate.

5. RESPONSIBILITIES 5.1. Δ QA Manager: Responsibility to assure that the appropriate work instructions and supporting documentation are written, approved, and maintained to support this requirement. 5.2. Supplier Development Engineer: Responsibility to assure that the appropriate work instructions and supporting documentation are written, approved, and maintained to support this requirement at their defined supplier. . 5.3. The Quality Engineering Group has the responsibility to verify audit results and assure follow-up on finding resulting from the audits. 5.4. The auditors have the responsibility to conduct the applicable audits, verify conditions with evidence of actual current state conditions, accurately document the audit results, and communicate results to the Quality Manager, applicable Quality Engineer, and production management. .

6. PROCEDURE 6.1. What is a key process: 6.1.1. Processes related to Δ safety critical characteristics indicated on NSK Δ or customer drawings. 6.1.2. Process that may produce defects which are difficult to detect in subsequent processes, 6.1.3. Processes that may produce defects which lead to a serious quality problem when the product is in service. 6.1.4. Δ The following processes are considered Key Processes: heat treatment, welding, soldering, casting, and forging. greasing, swaging (Hub Bearings), staking (steering components), magnetic particle inspection, and eddy current testing. 6.1.5. Processes that can lead to cracks, mixed material, material voids/inclusions or other material related defects. 6.1.6. Processes that NSK may specify for additional countermeasures due to significant defects.

6.2. Requirements for the key processes and safety critical processes 6.2.1. Indication of key process on the process machines. Δ This can be marked with the word “Key Process” or other representative symbol as defined by the locations.

6.2.2. Δ Safety Critical Process Symbol: If the process is a safety critical process, the symbol shall defined as S or [S] in place of the Key Process Symbol. The safety symbol shall be used to identify all process, NSK AMERICAS POLICY AND PROCEDURE

machines, test equipment, and measurement devices that are used in relation to safety critical characteristics.

6.2.3. Δ Identification of Safety Critical Characteristics on Quality Documentation. The following documentation shall have the safety related characteristics identified: 6.2.3.1. Process Flow Chart 6.2.3.2. pFMEA 6.2.3.3. Control Plan (CP 6.2.3.4. Standard operating procedure (SOP) 6.2.3.5. Work Instructions 6.2.3.6. Training matrix (safety related processes) 6.2.3.7. Process Check-sheets

6.3. Certification/ training program 6.3.1. Δ Defined minimum training requirements 6.3.2. Identification of approved operators and inspectors (machine, shift) 6.3.3. Identified process leader(s). 6.3.4. Classification of personnel within the key process flow: trainees, operators, trainers and experts, with definition of each classification. 6.3.5. Δ On the job training of the safety related process against pre-determined criteria. 6.3.6. Δ One month of operating the process under increased supervision. 6.3.7. Δ Following one month of supervised operation, the operator’s skill level shall be judged by use of a pre-determined checklist. 6.3.8. Certification of each key process team members 6.3.9. Training record shall be maintained

6.4. SOP (Standard Operating Procedure) and Checksheet 6.4.1. Definition of abnormalities within the products, processes and machines. 6.4.2. Procedure addressing disposition of abnormalities 6.4.3. Identification of key points of operation 6.4.4. Identification of control items for the process and machines 6.4.5. Identification of key process on the quality documentation such as SOP’s, Δ control plans, etc.

6.5. Process Capability Requirements for Key Processes 6.5.1. If the process capability is below 1.67 Cpk for key processes, Δ additional quality checks shall be required until the process capability can be improved to be above 1.67. 6.5.2. Δ If process capability is below 1.33 Cpk for a key process, 100% verification shall be required to assure quality. Exception would be for characteristics that require destructive testing to evaluate. The Quality NSK AMERICAS POLICY AND PROCEDURE

Manager would then be responsible for determining the appropriate evaluation methods, quantity, and frequency.

6.5.3. Δ If the process capability is below Cpk of 1.67, the characteristic is not currently evalauted 100% and a quality problems occurs at the location’s customer, the location will be required to improve the process capability, implement 100% error proofing device(s), or implement a 100% automatic quality assurance check. This would generally apply to those processes between a Cpk of 1.33 and 1.67. Exception would be for characteristics that require destructive testing to evaluate. The Quality Manager would then be responsible for determining the appropriate evaluation methods, quantity, and frequency.

6.6. Δ Poke-yoke devices shall be confirmed each shift at a minimum.

6.7. Traceability of products 6.7.1. Δ Lot control shall be traceable to processes, supplied components, and raw materials shall be established and maintained. 6.7.2. Indication of products throughout manufacturing process Δ shall be maintained 6.7.3. Δ All safety related products shall be traceable with the following information, as a minimum, being available: 6.7.3.1. The date of production 6.7.3.2. The shift of production 6.7.3.3. The specific machine (in the event of multi-machines used for the same product). 6.7.3.4. The lot/batch number of sub-assemblies and components with safety characteristics.

 Note (1) – for sub-assembled product, the same requirements apply.  Note (2) – When possible, identification/lot marks should be permanent (stamped, labeled, etched, or other means). The QA Manager will determine marking if the product will not have a permanent identifier.

6.8. Δ If a defect related to a key process is discovered at any point of the process or during quality checks, the production process shall be stopped. The group leader/manager and QA shall be notified immediately to start investigation of the defect and root cause. QA must provide approval prior to line restart.

6.9. Δ Process parameters and operational controls shall be verified each shift

6.10. Storage of quality and production records Δ shall be maintained per the site document storage requirements. NSK AMERICAS POLICY AND PROCEDURE

6.11. Site shall document the process capability. The site should complete a periodic capability study of quality items and parameter controls as determined by the site Quality Manager.

6.12. The preventative maintenance plans should be reviewed and updated periodically as determined by the site QA Manager. .

6.13. A periodic Key Process Audit should be completed for all processes related to safety critical characteristics as determined by the site Quality Manager. The attached Key Process Audit, Form AQM-013A shall be used for the audits. It is encouraged that all Key Processes be audited on an annual basis.

7. Key Process Rework 7.1. In the event that a non-conforming condition is established on a feature related to a Key Process, the affected parts shall be considered for rework by adhering to the following standard: 7.1.1. Population established and tracked 7.1.2. The affected parts are judged as acceptable for rework by related departments (minimum requirements are QA Mgr, ME, Manufacturing, Plant Mgr). The design/engineering department should be consulted as appropriate. 7.1.3. The rework standards are documented and approved by use of a Rework TPD, Work Instruction, or SOP. 7.1.4. Any rework/repair process shall ensure the product is subjected to all quality standards defined as part of the normal process control. 7.1.5. The personnel carrying out the rework are qualified.

7.2. Safety Related Welded Components 7.2.1. In the event that a non-conforming weld condition is identified on a welded joint deemed as safety critical, the affected parts shall be scrapped. In no circumstances shall a rework operation be considered for a safety critical welded joint.

8. Specific Individual Steering Component / Assembly Key Process Controls

8.1. Welding Process: The following regulations shall be applied, as a minimum requirement, for all welding processes:

8.1.1. All welds shall be 200% overchecked, by an independent operator, with paint mark applied to the overlap of the weld. 8.1.2. The quality acceptance criteria shall be clearly defined and approve d, including the use of master samples for ease of understanding, w here applicable and beneficial. NSK AMERICAS POLICY AND PROCEDURE

8.1.3. Machine confirmation setting masters shall be utilized where applic able. Includes the following: 8.1.3.1. Press force poke-yoke confirmation. (Circular welding machin e). (Possibly fulfilled by “dry” run without work-piece.) 8.1.3.2. Torch setting/aiming position. (All machines). 8.1.4. As appropriate (e.g. circular welding machines), the load cell setting for press force setting shall be confirmed on a daily basis and the re sult recorded on the machine condition check sheet. The machine shall include tamper-proof devices to prevent inadvertent adjustme nts to the load cell settings. 8.1.5. In the event of a poke-yoke device detecting an abnormal condition during the machine cycle, the part shall not be ejected or presented to the operator in the same mode as a conforming part. 8.1.6. All weld wire barrels shall have wire detection sensors installed to p revent a wire shortage during a weld cycle. 8.1.7. Daily weld penetration check results, including changeovers and ch ecks following maintenance activities, shall be plotted on a control c hart. 8.1.8. All scrap parts shall be positively identified with red paint. 8.1.9. The reject bin shall be in the form of a chute connected to a locked box, with a sensor linked to the machine controller, to ensure a part is scrapped before the process proceeds.

8.2. Bolt Fastening Process: The following regulations shall be applied, as a mi nimum requirement, for all bolt fastening processes:

8.2.1. All bolts shall be hand-started (minimum of 2 turns) before applying the tightening wrench. This method shall be documented and stand ardized by use of the SOP document. 8.2.2. For a pinch-bolt application, a 100% pull-check or poke-yoke device shall be used to ensure the pinch-bolt is located in the shaft groove. This method shall be documented and standardized by use of the S OP document. 8.2.3. An operator independent of the original tightening process shall sub ject all fastenings to a 200% torque wrench over-check, (where pos sible). 8.2.4. Suitable controls shall be implemented to avoid oil and grease cont amination of the fastenings surfaces (threads, spot face etc). 8.2.5. A product audit shall be carried out, at a defined frequency (each 2 hours minimum); to confirm the fastening torque meets specificatio n. All results shall be recorded on a control chart. The inspection to rque for the described controls is often different to the manufacturin g setting torque. The inspection torque shall be calculated and docu mented per site standard and related control charts. NSK AMERICAS POLICY AND PROCEDURE

8.3. Joint Assembly and Bearing Staking Process: The following regulations shall be applied, as a minimum requirement, for all joint assembly and b

earing staking processes: 8.3.1. Sample checks, as documented in the process control documentati on, shall be plotted on a control chart. 8.3.2. The quality acceptance criteria for bearing/joint staking shall be cle arly defined and approved, including the use of master samples for ease of understanding. 8.3.3. Red paint shall be applied to parts deemed as scrap. 8.3.4. The reject bin shall be in the form of a chute connected to a locked box, with a sensor linked to the machine controller, to ensure a part is scrapped before the process proceeds. 8.3.5. A 200% inspection, by an independent operator, or a poke-yoke de vice shall be installed to confirm no bearings are missed from the jo int assembly. This shall be documented and standardized on the S OP. 8.3.6. Note – In the case of a 200% inspection, each bearing shall be iden tified with a paint mark.

9. Documentation

9.1. Δ Locations are to maintain the quality records related to this procedure as defined within their quality management system.

10. Record Retention

10.1. Electronic documents will be original documents in their respective files and will be retained per the local NSK quality procedure timelines.

Name of Attachment / Exhibit List the Name / number of attachment or list “NONE” Key Process Audit, Form AQM-013A