2014
QUALITY MANUAL
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Supplier Quality Requirements Manual
SwissTech Automotive GmbH 1/3/2014
Document: QD-SQRM-Rev.1.0
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SwissTech Automotive GmbH QUALITY department
SUPPLIER QUALITY REQUIREMENTS MANUAL (SQRM)
REVISION HISTORY Revision
Date
Description of Changes
Revision 0.0
October 1st, 2013
Initial Release
Revision 0.1
January 3rd, 2014
Review and design modification
Approved by:
___________________________
_______________________
Edwin B. Abbink
Christy Wei
Vice President, Global Supply Chain and Procurement
Document: QD-SQRM-Rev.1.0
Vice-President, Lean Enterprise and Quality
Copyright Š SwissTech. All right reserved.
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TABLE OF CONTENTS SwissTech Automotive GmbH CORPORATION_______________________________________ Page 4 INTRODUCTION ________________________________________________________________ Page 4 SUPPLIER CODE OF CONDUCT___________________________________________________ Page 5 1 •QUALITY SYSTEM REQUIREMENTS _____________________________________________ Page 6 1.1 Quality Manual 2 •SUPPLIER APPROVAL PROCESS________________________________________________ Page 7 2.1 Supplier Assessment 3 •GENERAL REQUIREMENTS_____________________________________________________ Page 8 3.1 Compliance to Contractual Requirements 3.2 SwissTech Designated Sources 3.3 Control of Sub-Tier Suppliers 3.4 Control and Release of SwissTech Furnished Documents 3.5 E-Business Requirements 3.6 Electronic Documents 3.7 Federal Aviation Administration Regulations 3.8 Business Continuity 4 •PRODUCT QUALIFICATION _____________________________________________________ Page 10 4.1 First Article Inspection 4.2 Production Part Approval Process 5 •PROCESS CONTROL __________________________________________________________ Page 13 5.1 Special Characteristics 5.2 Error-Proofing 5.3 Work Instructions 5.4 Control of Monitoring and Measuring Devices 5.5 Statistical Process Control 5.6 Preventive Maintenance 5.7 Source Inspection 5.8 Shelf-Life Control 5.9 Sampling Inspection 5.10 Operator Self-Verification 5.11 Raw Material Lot Control 5.12 Electrostatic Discharge Control 6 •CHANGE CONTROL ___________________________________________________________ Page 15 6.1 Change Control Process 6.2 Supplier Change Requests 7 •CONTROL OF NONCONFORMING PRODUCT______________________________________ Page 16 7.1 Supplier Request for Nonconformance Deviation 7.2 Control of Reworked Product 7.3 Supplier Containment 8 •PACKAGING, LABELING, DELIVERY & RECORD RETENTION_________________________ Page 16 8.1 Preservation 8.2 Packaging 8.3 Labeling Supplier Quality Requirement 8.4 Delivery 8.5 Record Retention 9 •CONTINUAL IMPROVEMENT ___________________________________________________ Page 18 9.1 Problem Solving Process 9.2 Corrective Action Report 10 • DOCK-TO-STOCK PROGRAM _________________________________________________ Page 20 10.1 Dock-to-Stock Requirements 10.2 Dock-to-Stock Suspension 11 •SUPPLIER PERFORMANCE ___________________________________________________ Page 21 11.1 Performance Measures 11.2 Supplier Development Program APPLICABLE DOCUMENTS_______________________________________________________ Page 23 FORMS & EXHIBITS______________________________________________________________ Page 25 - 30
Document: QD-SQRM-Rev.1.0
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Company Overview
SwissTech Automotive GmbH is a relatively young, privately owned, dynamic enterprise and has its settlements in Zürich, Switzerland and a supporting office in Shanghai, China. The company is founded based on knowledge and experience mainly accumulated in the automotive OEM & independent aftermarket as well in other non-automotive related multinationals. We as a team distinguish our strength through our ability to be a sustainable, nononsense and flexible mobility partner of a comprehensive range of commercial vehicle independent aftermarket products.
Products
Our braking solutions and related service parts for a wide range of truck, trailer, bus and offhighway applications meets the highest level of safety, finest quality of precision engineering, the most environmentally friendly and state-of-the-art manufacturing technology standard against competitive conditions to wholesalers, fleet owners, mechanics and repair shops within Switzerland and other European countries.
Our Core Competencies We as a team are focused on customer service excellence and a result & performance driven group of passionate automotive professionals, operating with the latest technology to supply commercial vehicle brake quality safety solutions throughout their lifecycle. We strive for a zero default supplier base performance and 100% on-time deliveries. Webpage
Additional information about SwissTech Automotive GmbH can be found at SwissTechAutomotive.ch
INTRODUCTION
Our Suppliers
SwissTech Automotive GmbH recognizes the very important role our Suppliers have in the value we offer our customers. As an extension of our own operations, we rely on our Suppliers to provide material, products, and services which meet all of the requirements of SwissTech contracts, applicable specifications, and the quality management requirements outlined herein.
Purpose
SwissTech serves diverse market sectors, such as industrial, automotive, aerospace, and biomedical. The purpose of this manual is to inform SwissTech Suppliers of the core expectations we have regarding the Suppliers’ quality management systems, design requirements, and manufacturing process controls required for the purpose of doing business with SwissTech. This manual describes what SwissTech expects its Suppliers to do to ensure that all SwissTech requirements and expectations are met.
Scope
This manual applies to all Suppliers providing SwissTech with materials, products, processing, and related services, including intra-company Suppliers, and when applicable, to Supplier sub-tier sources. The general requirements outlined herein do not supersede conflicting requirements in the SwissTech contract, or drawing, including applicable engineering specifications and process specifications, or applicable long term agreement(s). This manual specifies additional requirements for SwissTech Aerospace Suppliers as shown in bold italics.
Requirements
In this manual, the terms "shall" and "must" mean that the described action is mandatory; "should" means that the described action is necessary and expected with some flexibility allowed in the method of compliance; and “may” means that the described action is permissible or discretionary.
Questions
Questions concerning this manual should be directed to your respective SwissTech Buyer.
Document: QD-SQRM-Rev.1.0
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SUPPLIER CODE OF CONDUCT Suppliers shall ensure operations are being performed in a manner that is appropriate, as it applies to their ethical, legal, environmental, and social responsibilities. Below is a listing of the basic requirements:
Compliance with Local Laws and Regulations Suppliers must adhere to the laws and regulations in the locality in which they reside. This includes all local, state, and federal laws/regulations in the country of origin. Compliance with Environmental, Health, and Safety Laws The Supplier must maintain and operate its manufacturing/production facilities and processes in accordance with local, state, and federal laws/regulations in the country of origin. At no time shall any SwissTech’s person be exposed to hazardous materials or unsafe conditions as a result of Supplier shipments to a SwissTech’s location, or while visiting a Supplier’s location. For items with inherent hazards, safety notices must be clearly visible. As applicable, documented safety handling and protection information must be provided. Product Safety In all instances where a product is manufactured to a new design, for a new system, or for a new application, it is important that Supplier and SwissTech’s allocate responsibility for assuring that all performance, endurance, maintenance, safety and warning requirements are met. It is preferred that this allocation of responsibility be in writing. Non-Discrimination Suppliers shall not discriminate against race, colour, sex, religion, age, physical disability, political affiliation, or other defining characteristics as prohibited by local, state, and federal laws/regulations in the country of origin. Labour Child Labour Suppliers shall employ workers of minimum legal age in accordance with local, state, and federal laws/regulations in the country of origin. Child labour laws must be followed. Forced/Indentured Labour Suppliers shall not practice the use of forced or indentured labour. Work Hours/Days Suppliers shall not exceed the daily and weekly working hours as permitted by local, state, and federal laws/regulations in the country of origin. Wages and Benefits Suppliers shall compensate workers in accordance with local, state, and federal laws/regulations in the country of origin. This includes minimum legal wage, overtime wages, and benefits (required by law). Ethics Evidence of corruption, bribes, improper advantage, or any other form of illegal practice by the Supplier or associated operations will terminate all relations with SwissTech’s. Suppliers will conduct their business in a manner that meets the ‘Code of Ethics’ policy of the SwissTech Automotive Corporation. In addition, for those Suppliers contracting with SwissTech’s for Swiss Government contracts, SwissTech’s document ‘Policy on Contracting with the Swiss Government’ shall apply. Both of these documents may be obtained from the SwissTech’s Buyer or via SwissTech’s Supplier portal. Code of Conduct and Policy Enforcement This policy applies to Suppliers and their sub-tier sources. It is the responsibility of the Supplier to verify and monitor compliance of this code at their operations and sub-tier source operations. Confidentiality The Supplier shall ensure the confidentiality of SwissTech’s-contracted products and projects under development, and related product information, as well as intellectual property shared as a result of the working relationship.
Document: QD-SQRM-Rev.1.0
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1 • QUALITY SYSTEM REQUIREMENTS Suppliers shall maintain a Quality Management System (QMS) suitable to the products and services provided to SwissTech, which is certified by an accredited third-party certification body to the latest version of one or more of the following, as applicable:
ISO 9001 - Quality Management System Requirements1 ISO 14001 Environmental Management System VDA 6.1 Quality Management System German Automobile Industry AS/EN/JISQ9100 - Quality Management System Requirements (Aerospace)2 ISO/TS 16949 - Quality System Requirements (Automotive, Truck & Heavy Equipment) 3 QS 9000 - Quality Management Requirements (Automotive)
See the following sources for a listing of accredited certification bodies: 1The
U.S. accreditation body for management systems can be found at ANSI-ASQ National Accreditation Board, http://www.anab.org. For a list of Accreditation Boards from other countries, refer to the International Accreditation Forum at http://www.iaf.nu. 2For AS9100, see SAE OASIS database at http://www.sae.org/iaqg/ 3For ISO/TS 16949, see International Automotive Oversight Bureau at http://www.iaob.org In the absence of third-party certification, depending on the product, its application, value, and criticality, the SwissTech Buyer and Quality representative may authorize the acceptance of other evidence of compliance. This may include secondparty (SwissTech) audit or first-party (self) assessment to the applicable criteria above, or to a set of alternative basic quality requirements (such as those described in a ‘SwissTech Supplier Quality Assessment’ checklist). SwissTech Aerospace Suppliers shall comply with the following requirements: Distributors/Stockists - shall establish and maintain a QMS that is in compliance with AS9120/EN9120, AS/EN/JISQ9100 or ISO 9001-2000 Calibration Suppliers - shall establish and maintain a measurement management system that is in compliance with either: o − ANSI/NCSL Z540.1 - Calibration Laboratories and Measuring & Test Equipment Requirements, or o − ISO 10012 - Requirements for Measurement Processes and Measuring Equipment • Special Process Suppliers - shall establish and maintain a QMS that is in compliance with AS/EN/JISQ9100, AS9003 or PRI/Nadcap AC7004. Software Suppliers (Deliverable Software Only) - shall establish and maintain a QMS that is in compliance with RTCA/DO-178, AS9006 and the Software Engineering Institute (SEI) Capability Maturity Model (CMM) guidelines of Level 3, prior to SwissTech approval. Commercial-Off-The-Shelf Suppliers (COTS) - Suppliers that provide commercial products shall establish a QMS in compliance with ISO 9001-2000, or equivalent. All Other Suppliers - shall establish and maintain QMS that is in compliance with AS/EN/JISQ9100, and a measurement management system which meets the requirements of either ANSI/NCSL Z540.1 or ISO 10012. Suppliers registered in accordance with AS9104 shall be listed in the SAE OASIS database.
QUALITY MANUAL Upon request, the Supplier shall furnish SwissTech with a copy of the Supplier’s Quality Management System Manual, which is to be current and approved by the Supplier's management, including or making reference to related documents. The quality management system documentation shall include Supplier’s statements of a quality policy and quality objectives. Top management shall define quality objectives and measurements which should address customer expectations and be achievable within a defined period of time. The Supplier shall promptly notify the SwissTech Buyer of any substantive changes to the Supplier’s quality management system or personnel.
Document: QD-SQRM-Rev.1.0
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7|35 2 • SUPPLIER APPROVAL PROCESS SwissTech requires all Suppliers to be approved prior to the issuance of contracts. All Suppliers must be approved by SwissTech, regardless of approvals by customers or other entities.
2.1 SUPPLIER ASSESSMENT The Supplier Approval Process may include the following: a)
Supplier Initial Assessment SwissTech may request the Supplier to provide a copy of its quality management system certificate and/or complete a self-assessment of its business and quality management system and capabilities (i.e., quality, delivery, technology, cost, and continual improvement objectives).
b)
Documentation Audit In those cases where a Supplier’s quality management system has not been certified by an accredited certification body, SwissTech may request a copy of the Supplier’s Quality Manual and supporting procedures (and perhaps internal audit reports) to determine if the Supplier’s quality management system meets SwissTech requirements.
c)
On-Site Assessment Generally, when a Supplier is certified to a related standard by an accredited certification body, SwissTech will not conduct an on-site assessment of the Supplier’s quality management system against the same criteria. However, SwissTech and/or its customers, due to product/process complexity or criticality, may elect to conduct on-site assessments of a Supplier’s product or process capabilities. As a result, findings may be issued. These assessments could include: Quality Management System (QMS) – if necessary, as a result of (or in conjunction with) product or process capability assessments, to determine whether the Supplier’s quality management system meets one or more of the applicable standards, and is functioning effectively. Business and Manufacturing Operations – to determine whether the Supplier has the financial resources, production capacity, and other business resources needed to fulfil SwissTech volume production needs and continuity of supply. Continual Improvement Initiative – to determine if the Supplier’s culture, methods and skills are present to actively pursue continual improvement. Technology Assessment - to determine whether the Supplier has the needed technical resources, including production and inspection equipment, facilities, engineering resources, SwissTech-specified computer-aided design language/format, electronic commerce capability, etc. Sub-Tier Supplier Control – to evaluate the effectiveness of the Suppliers sub-tier management processes and ensure that products or services procured from sub-tier sources and delivered to SwissTech conform to all applicable SwissTech requirements.
d)
Pre-Selection Meeting A Pre-Selection Meeting for present and potential suppliers offering new products or services shall be required prior to Purchase Order issuance (unless formally deviated by SwissTech based upon historical evidence of successful adherence to SwissTech’s requirements). Technical, quality, manufacturing, engineering, purchasing, delivery, and business issues shall be reviewed during this meeting to provide the supplier with a thorough understanding of SwissTech requirements. Under most circumstances, Purchasing shall schedule the meeting and include cross-functional membership as appropriate. Suppliers shall meet all requirements agreed to at the Pre-Selection Meeting as a condition of business award. Agreements shall be documented in the Pre-Selection Meeting minutes and formally concurred with signature on the Supplier Pre-Selection Meeting Checklist (link). Design responsible suppliers are required to comply with SwissTech’s Engineering drafting standards, which can be obtained from the applicable Engineering group.
Document: QD-SQRM-Rev.1.0
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e)
Engineering Prototype Sample Submissions Engineering prototype parts with documentation of specification conformance shall be submitted to SwissTech by the supplier as instructed by the SwissTech C2C Project Team for engineering validation testing. Each sample or prototype must be clearly labeled as such and accompanied by a completed Dimensional Results, Material Test Results, and Performance Test Results reports as described in the AIAG PPAP manual. Specific instructions, in addition to these stated requirements, may be agreed upon and documented by SwissTech via the Pre-Selection Meeting or other formal communication.
All new SwissTech Aerospace calibration Suppliers require an on-site assessment by SwissTech or its representatives for compliance to ANSI/NCSL Z540-1 prior to approval. All new SwissTech Aerospace special process Suppliers require on-site assessment by SwissTech, including personnel approved by Materials & Processes, prior to approval. Suppliers who have established a QMS in compliance with AS9003 require a QMS audit by SwissTech prior to addition of the Supplier to the APSL. SwissTech Aerospace requires all Suppliers to be approved and listed on the SwissTech Approved Suppliers List (ASL) and/or Approved Process Suppliers List (APSL), prior to the issuance of contracts to the Supplier.
3 • GENERAL REQUIREMENTS The following set of general quality requirements applies to all Suppliers. 3.1 COMPLIANCE TO CONTRACTUAL REQUIREMENT Upon accepting a SwissTech contract, the Supplier is responsible for compliance to all contract (e.g., engineering drawing, specification, purchase order) requirements. All documents, drawings and specifications, regardless of origin, are applicable to the Supplier when specified in the contract or documents referenced in the contract, and are required to be used at all levels of the supply chain. Unless otherwise specified in the contract, the document revision in effect on the date of issue of the contract applies to the contract. Neither audit, surveillance, inspection or tests made by SwissTech, representatives of SwissTech or its customer(s), at Supplier's facilities, at any sub-tier facilities, or upon receipt at SwissTech, relieves the Supplier of the responsibility to furnish acceptable products or services that conform to all contract requirements; nor does it preclude subsequent rejection by SwissTech or its customers. 3.2 SWISSTECH DESIGNATED SOURCES Where specified by contract, the Supplier shall purchase products, materials or services from SwissTech- designated sources. However, the Supplier is responsible to ensure that items procured from such sources meet all applicable technical and quality requirements. 3.3 CONTROL OF SUB-TIER SUPPLIERS The Supplier, as the recipient of the contract, is responsible for meeting all requirements, including work performed by the Supplier's sub-tier Suppliers (also known as Sub-Suppliers or subcontract Suppliers). When the Supplier uses sub-tier sources to perform work on products and/or services scheduled for delivery to SwissTech, the Supplier shall include (flowdown) on contracts, to its sub-tier sources, all of the applicable technical and quality requirements contained in the SwissTech contract, including quality system requirements, regulatory requirements, the use of SwissTech designated sources, and the requirement to document and control 'key characteristics' and/or 'key processes,' and to furnish certifications and test reports as required. SwissTech and its customers reserve the right- of-entry to sub-tier facilities, subject to proprietary considerations. a) Special Process Suppliers For SwissTech Aerospace, unless otherwise specified by contract, the Supplier shall only use special process sources that are approved by SwissTech Aerospace and listed on the SwissTech Aerospace Approved Process Suppliers List (APSL). This requirement applies to Suppliers who perform special processing such as heat treating, plating, etc., as part of their internal operations. The Supplier shall flow-down this requirement to its sub-tier sources. Risk Management For SwissTech Aerospace, the Supplier shall establish a risk management program in accordance with the guidelines established by SAE ARP9134 (or equivalent) to effectively assess those elements from all aspects of the business that could affect the quality of the products and/or services scheduled for delivery to SwissTech Aerospace. A copy of the Supplier’s risk management program shall be furnished to the SwissTech Buyer upon request.
Document: QD-SQRM-Rev.1.0
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3.4 CONTROL AND RELEASE OF SWISSTECH FURNISHED DOCUMENTS Documents furnished by SwissTech to the Supplier are furnished solely for the purpose of doing business with SwissTech. Proprietary documents may be furnished to the Supplier in hard copy, electronic or other media. The Supplier is responsible for controlling and maintaining such documents to preclude improper use, loss, damage, alteration and/or deterioration. Unless authorized by the SwissTech Buyer in writing, the Supplier may not transmit or furnish any SwissTech furnished documents, or copies of such documents, to anyone outside the Supplier's business organization except to a sub-tier source used by the Supplier for performance of work on the SwissTech contract. The Supplier shall return to SwissTech, or purge electronic copies of, all proprietary documents with the last delivery of products or services on the contract. SwissTech may request the Supplier to furnish objective evidence or certification that proprietary documents have been purged. The Supplier shall flow down this requirement to all sub-tier sources, when such sources will be in receipt of SwissTech proprietary documents during performance of work for the Supplier. 3.5 E-BUSINESS REQUIREMENTS Many SwissTech divisions currently use and are continually expanding the use of electronic business tools to facilitate day-to-day activities using electronic linkages between SwissTech internal operations as well as with SwissTech Suppliers and customers. Contracts, delivery schedules, notification of product rejections, requests for corrective action, etc. may be transmitted to Suppliers electronically, and SwissTech expects that Suppliers will adopt these tools to reduce errors and improve efficiency. For a list of e-business requirements and opportunities contact the SwissTech Buyer. 3.6 ELECTRONIC DOCUMENTS The accuracy and authenticity of electronic documents and forms submitted to SwissTech is of highest importance. The following rules apply and may be subject to review by SwissTech at Suppliers facilities: • The issue of electronic documents and application of electronic signatures must be under the direct control of the individual whose name appears on the electronic document. • The electronic signatures may only be applied at the place where the individual is located and the individual must have direct access and responsibility for the products or services described in the electronic document • The application of the electronic signature certifies that the signature (individual) represents an authorized company official. For SwissTech Aerospace, the use of electronic forms and signatures must be described in and governed by Supplier’s documented procedures. 3.7 FEDERAL AVIATION ADMINISTRATION (FAA) REGULATIONS For SwissTech Aerospace, the following requirements apply when the contract is for products/services under the authority of regulatory agencies (reference www.faa.gov): FAA Certification When specified on the contract, the Supplier shall submit a completed FAA Form 8130-3, executed in accordance with the requirements of FAA Order 8130.21, for all work performed Parts Manufacturer Approval (PMA) Certification When the contract requires the Supplier to furnish replacement or modification parts, such parts shall be manufactured and certified in accordance with Title 14 CFR Part 21, Subpart K, §21.303. The parts shall be marked in accordance with Title 14 CFR 45, Subpart B, § 45.15 and submitted to SwissTech with FAA Form 8130-3 executed in accordance with FAA Order 8130.21 Anti-Drug and Alcohol Misuse Prevention Program All Supplier employees (including any Supplier’s sub-tier employees) performing maintenance or inspection of products scheduled for delivery to SwissTech shall be included and part of a FAA approved Anti-Drug and Alcohol Misuse Prevention Program. The requirement applies both to pre-employment and random testing of current employees in accordance with the requirements of 14 CFR Part 121, Appendix “I” and Appendix “J”. Evidence of compliance to this requirement shall be made available to SwissTech upon request. Exceptions. This anti-drug and alcohol requirement does not apply to employees performing safety sensitive functions outside the United States territory and persons contracted to perform safety sensitive functions for an employer who is located outside the United States territory. 3.8 BUSINESS CONTINUITY The Supplier should have a business continuity plan which would allow for the safeguarding, storage and recovery of engineering drawings, electronic media, and production tooling in the event of damage or loss. This plan should also contain contingency plans to satisfy SwissTech requirements in the event of significant utility interruptions, labour shortages, equipment failure and field returns.
Document: QD-SQRM-Rev.1.0
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4 • PRODUCT QUALIFICATION This section defines the generic requirements for production part qualification and approval. The purpose is to determine if all SwissTech design and specification requirements are properly understood by the Supplier and that the manufacturing processes have the capability to consistently meet these requirements. In all instances where a product is manufactured to a new design, for a new system, or for a new application, it is important that Supplier and SwissTech allocate responsibility for assuring that all performance, endurance, maintenance, safety and warning requirements are met. It is preferred that this allocation of responsibility be in writing.
4.1 FIRST ARTICLE INSPECTION As a minimum, a First Article Inspection (FAI) is required to initially qualify a part/process for Supplier approval, unless the PPAP process (below) is used instead. Furthermore, a new FAI may be requested if there is an extended gap of time since last production. The FAI requires that all features and characteristics on the design specification and control plan be inspected and verified prior to production. Actual measured values shall be recorded as opposed to general statements of conformance or other notations simply indicating acceptance. For First Article Inspection guidance, see AIAG PPAP Manual (Appendix C, D, & E) – Production Part Approval Process (available from www.aiag.org). When submitting a First Article Inspection report, the Supplier should use the form provided by the SwissTech Buyer. Otherwise, generic Form # QD-FAIR, or other convenient and equivalent may be used. In addition to an FAI, Suppliers shall, as a minimum, develop a Control Plan by identifying special product and process characteristics that are key to achieving quality. The Supplier shall also include those special characteristics designated by SwissTech in the drawing, specification, or contract. SwissTech Control Plan (Form # QD-CPLAN) or other convenient and equivalent version may be used. For SwissTech Aerospace, a new FAI is required if there is a twenty-four (24) month gap of time since last production and excess stock from last production cannot be used to satisfy the FAI requirement. A delta FAI is required when new revision of the part number is released. Unless otherwise required by contract, all FAI’s shall be documented in accordance with AS/EN/SJAC9102.
4.2 PRODUCTION PART APPROVAL PROCESS When required by the SwissTech contract, the Supplier shall submit to SwissTech a more comprehensive Production Part Approval Process (PPAP) qualification package. The Supplier is responsible for obtaining the latest revision of the applicable AIAG core tool reference manuals and forms (see Applicable Documents section for where these references may be obtained). The AIAG Core Tools Manuals are:
Quality System Requirements ISO/TS-16949 Quality System Assessment (QSA) Advanced Product Quality Planning (APQP) and Control Plan Production Part Approval Process (PPAP) Potential Failure Mode and Effects Analysis (FMEA) Measurement Systems Analysis (MSA) Statistical Process Control (SPC)
When PPAP is specified on the SwissTech contract, the Supplier shall submit a “Level 3” PPAP package to the SwissTech Buyer which consists of the following items, unless otherwise directed. See AIAG PPAP Manual, Table 4.2, for complete list of submission requirements for each level of PPAP. Also, see AIAG APQP Manual for related guidance on associated product and process design and development methodology and techniques. A)
Design Record, Change Documents, and Customer Approval The Supplier shall have the design record for the saleable product/part and components; any authorized engineering change documents for those changes not yet recorded in the design record but incorporated in the product, part or tooling; and evidence of SwissTech engineering approval. See AIAG PPAP Manual.
B)
Process Flow Diagram The Supplier shall have a visual diagram of the proposed or current process. This diagram shall clearly describe the production process steps and sequence, and meet the specified SwissTech needs, requirements and expectations. See AIAG PPAP Manual.
C)
Failure Mode and Effects Analysis Suppliers with product design responsibility shall develop a Design FMEA in accordance with, and compliant to, SwissTechspecified requirements. A single Design FMEA may be applied to a family of similar parts or materials. Suppliers shall develop a Process FMEA in accordance with, and compliant to, SwissTech-specified requirements. A single Process FMEA may be applied to a process manufacturing a family of similar parts or materials if reviewed for commonality by the Supplier. See AIAG FMEA Manual.
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D)
Measurement Systems Analysis The Supplier must develop or obtain gages and standards to control their processes and to determine product conformance to specifications. Variable gages and measurements are preferred. Alternative methods, gages or standards may be used at SwissTech to verify the Supplier’s inspection results. SwissTech may request the Supplier to participate in a correlation study to compare Supplier measurement results against results obtained by SwissTech gages and methods. The Supplier shall perform Measurement Systems Analysis (MSA) studies, e.g., gage repeatability & reproducibility, bias, linearity, stability, for all new or modified gages, measurement, and test equipment. See AIAG MSA Manual.
E)
Control Plan The Supplier shall have a Control Plan that takes into account the output from the FMEA and defines all methods used for process monitoring and control of special product/process characteristics. The control plan covers three distinct phases: prototype, prelaunch, and production. A single control plan may apply to a group or family of products that are produced by the same process at the same source. See AIAG APQP Manual.
F)
Process Capability Study Process Capability Index (Cpk) is a comparison of the inherent variability of a process output to specification limits under statistically stable conditions. Most methods for estimating capability require that the characteristic being evaluated is approximately normally distributed, and in statistical control. The distribution should be determined prior to estimating capability. If the process is not in statistical control, all assignable causes must first be identified and removed. Special techniques are available for calculating capability when inherent assignable causes, such as tool wear, are present. Definitions and calculations for Cpk and Ppk indices are found in AIAG PPAP and SPC Manuals. Unless otherwise approved by SwissTech, the Supplier shall use the following as acceptance criteria for evaluating initial process study results of special characteristics for processes that appear stable:
G)
Results
Interpretation Index
> 1.67
The process currently meets acceptance criteria.
1.33 ≤ Index ≤ 1.67
The process is marginally acceptable.
Index < 1.33
The process is not acceptable.
Certification and Test Reports The Supplier shall provide evidence that the following verifications required by the design record and control plan have been completed and that results indicate compliance with specified requirements: Dimensional Results – for each unique manufacturing process, e.g., cells, lines, moulds, patterns, a record of actual results of all characteristics. Material and Performance Test Results – for all parts and product materials with chemical, physical, metallurgical, and functional performance requirements. Qualified Laboratory Documentation – documentation showing laboratory results of the qualifications for the type of measurements or tests conducted and the standards used. Sample Product – actual samples as required by the applicable specification or SwissTech contract. Master Sample – retain a master sample, when required by the Buyer, and make available upon request. Checking Aids – if requested by the Buyer, submit part-specific assembly or component checking aids. Records of Compliance – copies of records showing compliance to all applicable SwissTech-specific requirements. See AIAG PPAP Manual for applicable forms and instructions.
H)
Part Submission Warrant Upon completion of all PPAP requirements, the Supplier shall complete the Part Submission Warrant (PSW). A separate PSW shall be completed for each SwissTech part number unless otherwise specified by the SwissTech contract. Upon receipt, SwissTech will review and either approve, reject, or provide interim approval. See AIAG PPAP Manual for forms and instructions.
5 • PROCESS CONTROL This section defines the basic necessities for Suppliers to control their manufacturing processes.
5.1 SPECIAL CHARACTERISTICS The Supplier shall demonstrate conformity to those special characteristics designated by SwissTech through means of documentation and appropriate control methods. In addition to any special characteristics identified by SwissTech, the Supplier shall also review, identify, document, and control other product and process characteristics that are key to achieving quality. For SwissTech Aerospace, the Suppliers variation management program shall be in compliance with requirements of AS/EN/SJAC9103.
Document: QD-SQRM-Rev.1.0
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12 | 3 5 5.2 ERROR-PROOFING The Supplier should use error-proofing devices and techniques as a form of process control; especially for repetitive functions, difficult tasks prone to mistakes, or where the cost of error is high.
5.3 WORK INSTRUCTIONS The Supplier shall prepare documented work instructions, as necessary, for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be maintained current and accessible for use at the work station.
5.4 CONTROL OF MONITORING AND MEASURING DEVICES The Supplier shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. As a minimum, where necessary to ensure valid results, measuring equipment shall: a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; and b) be identified to enable the calibration status to be determined. For SwissTech Aerospace, unless otherwise specified by contract, the Supplier shall establish procedures to control Measuring and Test Equipment (M&TE) that are in compliance with the requirements of ANSI/NCSL Z540-1 or ISO 10012. 5.5 STATISTICAL PROCESS CONTROL Where specified in the Control Plan, the Supplier is required to apply effective statistical process controls. Suppliers should consult the Statistical Process Control (SPC) manual published by AIAG for guidance, methods, examples, and related reference information.
5.6 PREVENTIVE MAINTENANCE The Supplier should identify key process equipment and provide resources for machine/equipment maintenance activities and develop an effective planned total preventive maintenance system.
5.7 SOURCE INSPECTION Supplier’s products or services may be subject to source inspection by SwissTech, representatives of SwissTech or applicable government or regulatory agencies. Source inspection requirement will be included on the contract and may apply to any and all operations performed by the Supplier or the Supplier’s sub-tier sources, including prior to delivery of products to SwissTech. The Supplier shall provide the necessary access, equipment and resources required to effectively accomplish the source inspection.
5.8 SHELF-LIFE CONTROL a) Materials - With each delivery of materials or products that have a limited or specified shelf life, the Supplier shall furnish data that shows (a) the cure or manufacture date, (b) expiration date or shelf life, (c) lot or batch number, and when applicable any special handling or storage requirements. Unless otherwise specified by contract, for all shelf life limited materials or products delivered to SwissTech, the remaining shelf life shall be a minimum of 75% of the total shelf life for the material. b) Elastomers and Seals - For SwissTech Aerospace, Suppliers scheduled to provide elastomeric seals or assemblies to must meet the requirements for data recording procedures, packaging, and storage of elastomeric seals and seal assemblies which includes an elastomeric element per ARP5316.
5.9 SAMPLING INSPECTION The Supplier is responsible for 100% verified quality for all items delivered to SwissTech. For SwissTech Aerospace, when the Supplier elects to use statistical methods for the acceptance of products or processes, such methods shall be in compliance with the requirements established by SAE ARP9013, 9013/1, 9013/2, 9013/3 and 9013/4 as applicable, except that in all cases the sample sizes shall be AQL 4.0 or higher (i.e., AQL 1.0, .65, etc.) and the criteria for lot acceptance as zero (i.e., C=0). A copy of Suppliers statistical process control plan shall be furnished to SwissTech upon request.
5.10 OPERATOR SELF-VERIFICATION SwissTech Aerospace Suppliers may delegate inspection authority and product/process inspection and acceptance to production operators. In such cases, the Supplier’s operator self-verification program shall comply with the requirements of SAE ARP9162. Prior to implementation of the program on products/processes scheduled for delivery to SwissTech, the Supplier shall request and obtain approval from SwissTech in writing.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
13 | 3 5 5.11 RAW MATERIAL LOT CONTROL For SwissTech Aerospace, in those cases where the Supplier elects to use more than one lot of raw material, the Supplier shall ensure, document and furnish positive traceability of each individual product to the raw material certification/test report that represents the raw material from which each of the products was manufactured. Traceability shall be provided by identifying the raw material heat, lot, batch or melt number from the certification/test report on the product and/or on packaging (when used), or the products segregated and identified.
5.12 ELECTRO-STATIC DISCHARGE (ESD) CONTROL Suppliers scheduled to provide ESD sensitive devices to SwissTech Aerospace shall, prior to processing product, establish, document and implement an Electrostatic Discharge (ESD) Control Program plan in compliance with the requirements of MIL-STD-1686 or equivalent. 6 • CHANGE CONTROL The Supplier is responsible for controlling changes and notifying the SwissTech Buyer of all changes to the approved part design, manufacturing process, or site.
6.1 CHANGE CONTROL PROCESS The Supplier shall have a process to ensure that relevant versions of applicable documents furnished by SwissTech (as well as those specified of external origin) are available at points of use. The Supplier is responsible for the timely review, distribution and implementation of all SwissTech engineering standards/specifications and changes in accordance with the schedule required by SwissTech. Timely review should be as soon as possible, and shall not exceed two working weeks. The Supplier shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.
6.2 SUPPLIER CHANGE REQUESTS Suppliers shall not make changes to their processes, location, facilities, equipment, material, product design (or any change which may affect product design or function) without written approval from the SwissTech Buyer for: Correction of a discrepancy on a previously submitted part; ƒ Product modified by an engineering change to design records, specifications, or materials; or Any planned changes by the Supplier to the design, process, or manufacturing location, such as: a) Use of other material than was used in previously approved part or product b) Production from new, additional, replacement or modified tools, dies, moulds, patterns, etc. c) Production following upgrade or rearrangement of existing tooling or equipment d) Production from tooling and equipment transferred to a different plant site or from an additional plant e) Change of sub-tier Supplier for parts, non-equivalent materials, or services (e.g. heat treating, plating, etc.) f) Product produced after tooling has been inactive for production for 12 months or more g) Change to test/inspection method – new technique (no effect on acceptance criteria) h) For bulk materials: new source of raw material from new or existing Supplier, or change in product appearance attributes, etc. i) Use of any non-conventional manufacturing methods such as electro-discharge machining (EDM), electrochemical machining (ECM), laser or abrasive water jet metal cutting, flame spray coatings, etc. Before submitting to SwissTech a request for a permanent change to a Supplier-controlled design, the Supplier shall review the FMEA and Control Plan, as applicable, to ensure that all process-related issues have been addressed and resolved. SwissTech may require the Supplier to submit an updated FMEA and Control Plan prior to approval of such permanent changes. SwissTech may also require other portions, or all, of the related qualification process to be repeated. In some cases, SwissTech may elect to review Supplier proposed permanent changes at the Supplier’s facility. To request a permanent engineering change, the Supplier shall use the Part/Process Change Notification form (# QDPPCN), or other equivalent form of notification acceptable to the SwissTech Buyer. To request a one-time or temporary deviation, Suppliers shall use SwissTech’s Supplier Deviation Request (Form # QD-SDR), or other equivalent form acceptable to the SwissTech Buyer. For SwissTech Aerospace Suppliers, unless the Supplier is specifically granted material review and disposition authority by the contract, the Supplier shall document all nonconforming conditions in accordance with the requirements of AS/EN/SJAC9131 and submit them to SwissTech Material Review Board (MRB) for disposition.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
14 | 3 5
7 • CONTROL OF NON-CONFORMING MATERIAL For nonconforming products supplied to SwissTech, including those that reach a SwissTech customer, the Supplier must cover all costs to correct the non-conformance.
7.1 SUPPLIER REQUEST FOR NONCONFORMANCE DEVIATION A Supplier shall not knowingly ship product that deviates from the drawing, specification limits, or design intent without prior written authorization from the SwissTech Buyer. If such a condition exists, the Supplier may petition the SwissTech Buyer, in writing, to allow shipment of the product under a written non-conformance deviation. The Supplier shall use SwissTech’s Supplier Deviation Request (Form # QD- SDR), or equivalent, unless otherwise directed. If requested by the SwissTech QA Buyer, the Supplier must send samples of such nonconforming items to SwissTech for evaluation. The cost of shipping, inspection, and testing to determine the potential acceptability of such product will be charged to the Supplier. SwissTech approval of a deviation is specific to the products for which it has been submitted and approved and shall not to be construed as a permanent engineering change. The Supplier must begin work immediately on corrective action. In all cases, the Supplier shall fully contain all product suspected of being nonconforming. In addition, nonconforming product may be returned to the Supplier at Supplier expense, or the Supplier may be required to sort any suspect product already shipped to SwissTech sites or be charged back for the cost of sorting by SwissTech. Any parts shipped to SwissTech that have been approved for deviation shall be clearly identified as such externally on the box, container, or other packaging and on shipping documentation. Inside of each box shall contain a copy of the SwissTech-approved deviation document. For SwissTech Aerospace Suppliers, the Supplier shall document all nonconforming conditions in accordance with the requirements of AS/EN/SJAC9131 and submit them to the SwissTech Buyer for review.
7.2 CONTROL OF REWORKED PRODUCT Rework is defined as additional operations that are not part of the basic production process flow, which will bring product in full compliance with applicable drawings and specifications. Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the Suppliers appropriate personnel. All rework shall be documented and accepted by quality. On the other hand, repair is defined as using alternative manufacturing techniques, methods, materials, or processes which may not bring product into full compliance with applicable drawings and specifications. Repairs are not allowed without written approval from SwissTech.
7.3 SUPPLIER CONTAINMENT For product quality problems reported by SwissTech to the Supplier, until formal corrective action has been taken and approved, the Supplier shall provide documented evidence with subsequent shipments that such product has been inspected for the identified non-conformances and meets all applicable requirements. 8 • PACKAGING, LABELING, DELIVERY & RECORD RETENTION Preservation, packaging, labelling, and shipping methods must comply with common industry practices and SwissTech requirements specified on the contract.
8.1 PRESERVATION In order to detect deterioration, the condition of product in stock should be assessed at appropriate planned intervals. The Supplier should use an inventory management system to optimize inventory turns over time and should assure stock rotation, such as “first-in-first-out” (FIFO).
8.2 PACKAGING The Supplier must adequately plan for packaging designed to prevent product contamination, deterioration or loss and to eliminate shipping damage. Suppliers should provide expendable packaging or returnable containers, where appropriate, that provide for sufficient density and protection from any likely damage that may occur. Expendable materials and packaging must meet local and national standards for safe disposal and/or recycling. Each container, rack, box, or pallet of material shipped to SwissTech shall be identified as instructed by the SwissTech. Unique requirements will be identified and documented by SwissTech at the Pre-Selection Meeting, Packaging instruction card or other formal communication.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
15 | 3 5
8.3 LABELLING Labelling, QR-code and bar code requirements may vary among SwissTech divisions. The SwissTech Buyer will provide the Supplier with the necessary specifications. Labelling must be done per SwissTech receiving site requirements. At a minimum, the Supplier Identification, Part Number, Engineering Level, Quantity and Batch/Lot Number must be clearly legible in both human readable and bar coded form on the part-packaging label. All bar codes must be scanned by the supplier to verify readability. Identification shall permit traceability back to the specific supplier raw materials lot numbers, as well as the manufacturing, inspection and test records. The supplier should also be able to trace where products made under similar conditions (same raw material lot, same manufacturing line/batch, etc.) were shipped. Suppliers are required to utilize and ship material on a first in first out basis. Sequence of batches must be identified on the packaging label by either a date code or batch/lot number. Safety related identification criteria shall conform to all government regulatory and SwissTech requirements. No exceptions to this requirement shall be permitted unless acknowledged in writing by SwissTech. Suppliers shall ensure their products are transported in a manner that prevents damage or deterioration to the product. Suppliers shall maintain documentation detailing proper packaging, cleanliness level, storage and shipping instructions of its products. These instructions must conform to the SwissTech receiving site requirements.
8.4 DELIVERY PERFORMANCE & EDI REQUIREMENTS The Supplier should systematically inform SwissTech of any delay in delivering product and provide a new dispatch date. The Supplier is responsible for additional transport costs due to delays. Upon request, suppliers shall submit corrective action plans for delivery non-conformances. Certificates of Conformance (CoC) A signed CoC by the Suppliers head of quality or company officer (or their authorized delegate) attesting that all products and/or services delivered are in compliance with all contract requirements shall be furnished with each shipment to SwissTech Aerospace, All CoC’s must be in the English language and may be in electronic format with electronic signatures. All signatures or signature blocks must clearly show title of the signatory. The CoC shall include: a) Supplier Name b) Part number c) Drawing/specification revision d) SwissTech contract number e) line/release number (when applicable) f) Quantity delivered g) Packing list/shipper number (when applicable) When additional certifications/test reports are required for special processing, raw material, etc. the requirements will be specified on the contract.
8.5 RECORD RETENTION The Supplier shall retain quality records for a time period specified by the SwissTech contract or related reference documents. Upon request, the Supplier shall be capable of retrieving and delivering required records to SwissTech within forty-eight hours from time of request by SwissTech. Unless otherwise specified by SwissTech Aerospace, the Supplier shall maintain all records that provide objective evidence of compliance to SwissTech contract requirements for a minimum of fifteen (15) years after the last delivery of products and/or services on the contract. Prior to discarding, transferring to another organization, or destruction of such records, the Supplier shall notify the SwissTech Buyer in writing and give SwissTech the opportunity to gain possession of the records. These requirements are applicable to records generated by Supplier’s sub-tier sources. 9 • CONTINUAL IMPROVEMENT Suppliers should define a process for continual improvement. Recommend ISO 9004, including Annex B. A copy of the Supplier’s continual improvement program shall be furnished to SwissTech upon request.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
16 | 3 5
9.1 PROBLEM SOLVING PROCESS Suppliers should use a closed-loop corrective action process whenever a problem is encountered internally or upon notification from SwissTech. For example:
1 Describe the Problem
State what the problem “Is,” and “Is Not” with respect to what, where, when, who, how, and how many. Use quantitative terms.
2 Use a Team Approach
Consult and coordinate with relevant stakeholders.
3 Apply Containment
Immediately contain any suspect product to protect SwissTech and its customers.
4 Root Cause Analysis
Identify potential causes, analyse causes for failure mode, validate root cause(s), and identify solutions.
5 Implement Permanent
Implement solution. Update applicable FMEA, control plan and work instructions.
Corrective Action
6 Verify Effectiveness of
Use check sheets, auditing, sampling, and/or control plans to monitor process
Corrective Action
performance for effectiveness and sustained improvement.
7 Implement Preventive Action
Implement changes to prevent the same type of error from occurring in similar products/processes. Update applicable documents.
8 Management Support
Review, approve, and support. Provide resources and team recognition.
For additional guidance on problem solving methods, tools, training, and related references, refer to AIAG document CQI-10.
9.2 CORRECTIVE ACTION REPORT SwissTech may issue a request for a Corrective Action Report (CAR) to the Supplier when nonconforming material, components, or assemblies are found. When a formal reply is requested (whether hard copy or electronic media), the Supplier should use Corrective Action Report (Form QD-CAR) shown in the FORMS AND EXHIBITS section of this manual, or other convenient media of equivalent content. When documenting the root cause, the Supplier shall include the underlying reasons: a) Why the specific nonconforming condition or incident occurred, b) Why it was not detected by the Suppliers quality controls, and c) Why the related process, from a systemic viewpoint, allowed the non-conformance (and potentially others like it) to occur. The Supplier should apply the following criteria to determine whether the underlying root cause has been identified: 1. It initiates and causes the event you are seeking to explain. 2. It is directly controllable. 3. The elimination of that root cause will result in the elimination or reduction of the problem. Statements from the Supplier indicating that the corrective action is to alert or retrain the operator, and/or increase inspection, alone, are NOT acceptable corrective actions. These kinds of actions would be considered insufficient and not address the real underlying root cause(s) of why the Supplier’s policy, instructions, process, procedure, and/or system allowed the problem to develop and occur and not be detected by quality controls.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
17 | 3 5
Unless otherwise requested by SwissTech when notified, the Supplier shall respond to a request for corrective action as follows:
Required Action
Timeline (from initial notification by SwissTech)
The Supplier shall promptly acknowledge receipt of notification and communicate to SwissTech
Within 24 Hours
the immediate containment actions to be taken.
Within 72 Hours
The Supplier shall provide an update of the containment plan to protect SwissTech during the interim period. This update must include:
Confirmation that the Supplier has identified all suspect product in process, in stock, in transit, and potentially at any SwissTech site by lot number, SwissTech contract number, and quantity. Additional specific containment actions needed to be taken by the Supplier and/or SwissTech. Within 10 business days
The Supplier must submit the completed Corrective Action Report (Form # QD-CAR, or equivalent) indicating the permanent actions taken, or to be taken, to prevent recurrence of the same problem, to prevent the occurrence of similar problems, and the applicable effectively dates.
10 • DOCK-TO-STOCK PROGRAM SwissTech expects to receive products from Suppliers with zero defects allowing products to move directly from dock to stock, or to the point of use, without incurring additional costs associated with receiving inspection. SwissTech may charge Suppliers for costs to sort, evaluate, and return products that do not meet requirements. Where allowed, SwissTech’s respective divisions will administer a Dock- to-Stock program on the basis of individual part numbers, product families, or overall Supplier performance. Where implemented, Dock-to-Stock applies to material and components released for production that ship to a particular SwissTech location. However, SwissTech reserves the right to inspect any product upon receipt or at any other time, due to criticality or any other factor, or cancel the program at any time. Dock-to-Stock typically does not include pre-released parts, samples, prototypes, pilot fabrication runs, first articles for new tooling or processes, and other low-volume applications.
10.1 DOCK-TO-STOCK REQUIREMENTS To be considered for Dock-to-Stock, the product must meet the following requirements: Must be from an approved SwissTech Supplier The Supplier must meet requirements for a certain number of consecutive lots of the same part number being accepted by the same SwissTech location The Supplier must not be rated as having unacceptable product quality performance No open and delinquent corrective action requests for the part number (or products from the same family)
10.2 DOCK-TO-STOCK SUSPENSION The Supplier’s Dock-to-Stock privilege can be suspended when any of the following conditions occur: A part number is detected as non-conforming The SwissTech Buyer is made aware that the Supplier has a major non-conformance related to a second or third-party quality management system audit When results or audit evidence show the Supplier is not following their approved Control Plan or related work instructions Generally, the suspension process is as follows: a. SwissTech Buyer will notify the Supplier that their Dock-to-Stock privilege has been suspended. b. SwissTech will issue a request for corrective action to the Supplier. c. The suspension should end when the Supplier satisfies the conditions outlined in the section above. If the Supplier is put on suspension repeatedly, the SwissTech Buyer may place the Supplier on new business hold and/or divert the business to an alternate Supplier.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
18 | 3 5 11 • SUPPLIER PERFORMANCE SwissTech’s evaluation system uses a number of factors, such as Quality, Delivery, and Process Continuous Improvement (PCI) to develop an overall Supplier performance rating. This rating serves as an objective measure to determine whether SwissTech expectations are being met. SwissTech’s delivery mechanism for the Supplier performance rating is “Supplier Metrics” accessible via SwissTech’s supplier website. You will find a supplier Metrics is the primary performance rating system used by SwissTech. At SwissTech’s discretion, the SwissTech Buyer may determine that to address the Suppliers performance deficiencies, a meeting with Supplier’s management is necessary and a Supplier documented corrective action and improvement plan is required.
11.1 PERFORMANCE MEASURES
QUALITY This metric defines the Rejected Parts per Million (RPPM) shipped using the following formula. The definition of “rejected parts” is the total number of parts returned to the Supplier for any valid quality reason (including those caused by shipping and administrative errors):
Number of Parts Rejected RPPM =
Number of Parts Received
x 1,000,000
Based on SwissTech’s current expectations, the following table describes the resulting actions for varying RPPM performance levels:
Premiere
Meets requirement set by SwissTech
Preferred
Satisfactory; no action required
Marginal
Systemic corrective action may be required
Unacceptable
Systemic corrective action is required and may require Supplier to meet with SwissTech management representatives.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
19 | 3 5
DELIVERY PERFORMANCE This metric defines the delivery performance rating using the following formula: “On time” is based on the contract date, or kanban signal. Number of Parts Received on time Delivery Performance =
x 100
Number of Parts Received
Based on SwissTech’s current expectations, the following table describes the resulting actions for varying delivery performance levels:
Premiere
Meets requirement set by SwissTech
Preferred
Satisfactory; no action required
Marginal
Systemic corrective action may be required
Unacceptable
Systemic corrective action is required and may require Supplier to meet with SwissTech management representatives.
CONTINUAL IMPROVEMENT This metric is the percent of savings to annual spend. Spend is defined as the dollar amount SwissTech purchased from the Supplier. The following formula defines the calculation:
Dollar Value of Ideas Submitted % Savings =
Dollar Spend x Continuous Improvement Commitment Percentage
Investigative requests will be used to initiate ideas generated by SwissTech representatives. The requests are used to cultivate ideas within the Supplier’s organization and to assist the Supplier in meeting the Process Continuous Improvement (PCI) targets. PCI objectives are the responsibility of the Supplier to meet, and are not dependent on the number of investigative requests submitted by SwissTech. Investigative requests will be executed using SwissTech Supplier Performance (SwissTech’s Web-based Supplier Portal). SwissTech Supplier Performance is the primary medium by which continuous improvement ideas are submitted. The SwissTech Procurement (Supply Chain) Department is responsible for the installation and training of the system within the Supplier’s operation. SwissTech Supplier Performance On-Line Help is the instructional reference for use of the system.
11.2 SUPPLIER DEVELOPMENT PROGRAM SwissTech’s Supplier Development Program is designed to improve the Supplier operations in all aspects of their business, which includes new product development, engineering, quality, communication, performance, delivery, and cost through the implementation of a Lean Enterprise Program in conjunction with appropriate quality tools. For further information, you may contact your SwissTech Buyer.
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
20 | 3 5
APPLICABLE DOCUMENTS The following documents are referenced within this manual and may be applicable to the extent specified by SwissTech in the contract and applicable reference documents. SwissTech has prepared a PPAP workbook where you will find the PPAP required documents & templates, which download is available at the SwissTech website.
Document
Document Title
Available From
ISO 9001
Quality Management System Requirements (General)
www.ansi.org
AS/EN/JISQ9100
Quality Management System Requirements (Aerospace)
www.sae.org www.asdstan.org
AS9003
Inspection and Test Quality System (Aerospace)
www.sae.org
ISO/TS 16949
Quality Management System Requirements (Automotive)
www.ansi.org www.aiag.org
APQP
Advanced Product Quality Planning & Control Plan Manual
www.ansi.org www.aiag.org
PPAP
Production Part Approval Process Manual
www.ansi.org www.aiag.org
SPC
Statistical Process Control Manual
www.ansi.org www.aiag.org
MSA
Measurement System Analysis Manual
www.ansi.org www.aiag.org
FMEA
Potential Failure Mode & Effects Analysis Manual
www.ansi.org www.aiag.org
CQI-10
Effective Problem Solving Guideline
www.ansi.org www.aiag.org
ISO 9004
Quality Management Systems - Guidelines for Performance
www.ansi.org
Improvements
www.iso.ch
QSA
Quality System Assessment
www.aiag.org
QSA-TE
Tooling & Equipment Assessment
www.aiag.org
TC-5
The TC-5 TREAD ACT Reporting Kit
www.aiag.org
SPC
Fundamental Statistical Process Control
www.aiag.org
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
21 | 3 5
FORMS AND EXHIBITS Most of the required forms are available in the SwissTech PPAP workbook. A detailed explanation of these documents could be found in the PPAP handbook. Certain unique SwissTech forms are exhibited herein*. Electronic versions of these unique SwissTech forms (including those considered equivalent to the AIAG forms) could be obtained by the download on the SwissTech website.
QD- PSW
Part Submission Warrant
See +T PPAP Work/Handbook
QD-ECN
Engineering Change Notification
See +T PPAP Work/Handbook
QD-SDR
Supplier Deviation Request
See +T PPAP Work/Handbook
QD-DAR
Deviation Authorization Request
See +T PPAP Work/Handbook
QD-R@R
Run@Rate Worksheet
See +T PPAP Work/Handbook
QD-PFD
Process Flow Diagram
See +T PPAP Work/Handbook
QD-PFMEA
Process Failure Mode and Effects Analysis
See +T PPAP Work/Handbook
QD-CPLAN
Control Plan
See +T PPAP Work/Handbook
QD-MSA
MSA Gage Repeatability & Reproducibility
See +T PPAP Work/Handbook
QD-FAIR
First Article Inspection Report
See +T PPAP Work/Handbook
QD-PPAMR
Production Part Approval – Material Results
See +T PPAP Work/Handbook
QD-PPAMT
Production Part Approval – Module Results
See +T PPAP Work/Handbook
QD-AAR
Appearance Approval Report
See +T PPAP Work/Handbook
QD-CAR
Corrective Action Report I/II
See +T PPAP Work/Handbook
Document: QD-SQRM-Rev.1.0
Copyright © SwissTech. All right reserved.
PART SUBMISSION WARRANT (PSW)
DOC. CODE
REV.
QD-PSW-I
01
PSW Number 10001
PRODUCT INFORMATION Part Description
Safety and/or Government Regulations
Brake Disc/Rotor
Part Number
Purchase Oder No.
123456789X
SwissTech Part Number Drawing Number
Part Weight (Kg)
+T.987654321 Drawing Revision Level
123456789Z
Additional Engineering Changes Checking Aid No.
B
No Changes 76543
ORGANISATION MANUFACTURING INFORMATION 101
Organisation Name & Supplier
Vendor code
Einbahnstrasse
12
Street address
Number Zürich
City
8702
Region
567890 2.41
Part Dimensions L x W x H (mm) Engineering Change Notification ECN/No. Checking Aid Eng. Change Level
230 x 85 x 60
ECN Issue Date E/c Issue Date
1234 N/A
No 25 August 2013 Kg Volvo FH 28 July 2013 N/A
SWISSTECH SUBMITTAL INFORMATION
Preud'homme d'Hailly de Nieuport
Zolikon
Yes PO Issue Date Unit of Measure Application
Switzerland
Postal Code
Country
RESTRICTION OF HAZARDOUS SUBSTANCE (RoHS) < Mandatory > < As Applicable > RoHS Compliant DFAR Compliant Non-Compliant Non-Compliant if Non-Compliant please specify: if Non-Compliant please specify:
John McKinsey
Purchase@SwissTech.ch
Purchase Manager
E-Mail Address
George Lycklama à Nijeholt
Quality@SwissTech.ch
Supplier Quality Manager
E-Mail Address
Louis de Charon de Saint Germain
Quality@SwissTech.ch
Quality Supervisor
E-Mail Address
INTERNATIOAL MATERIAL DATA SYSTEM (IMDS) Automotive Suppliers only Global Automotive Declarable Substance List 56789 Node Number: 54321 Mode Submittal Required No Declarable Substances
MATERIALS REPORTING Has Customer-required Substances of Concern information is been reported?
Yes
No
n/a
Yes
No
n/a
Submitted by IMDS or other Customer format: Are Polymeric parts identified with appropriate ISO making codes? REASON(S) FOR SUBMISSION (check at least one) Initial Submission (for new production parts) Engineering Change(s) Correction of Discrepancy Tooling: Transfer, Replacement, Refurbishment or additional Tooling Inactive > 1 year
Change to Optimal Construction or Material Supplier or Material Source Change Change in Part Processing Parts Products at Additional Location Other - Please Specify
REQUESTED SUBMISSION LEVEL Level 3 - Warrant with Product samples and complete supporting data submitted to SwissTech QA Department
SUBMISSION RESULTS The Results for
dimensional measurements
material and function test
These results meet all drawing and specifications requirements Mold / Cavity / Production Process
appearance criteria
Yes
No
statistical process package
(If "No" - Explanation below)
N/A
DECLARATION I hereby affirm that the samples represented by this Warrant are representative of our parts, which we meet by a process that meets all the applicable current revision Part Approval Process Manual Requirements . I further affirm that these samples were produced at the production rate of X Y Hours. / I also certify that documented evidence of such compliance is on file and applicable for review. I have noted any deviations from this declaration below. EXPLONATION / COMMENTS
Read, undestood and agreed
Is each SwissTech tool properly tagged and numbered?
Yes
No
n/a
Supplier authorized signature Name
Jacque van Nassau
Title
QA Mgr.
Phone Number +41 76 6789 001
Date:
25 August 2013
Fax No.
+41 76 6789 005
E-Mail address J.van.Nassau@HaillydeNieuport.com FOR SWISSTECH USE ONLY
Part Submission Deposition Appearance
PPAP No.:
Print name
Norman d'Audenhove
SwissTech Automotive Signature Document: QD-PSW -Rev.1.0
Document: QD-SQRM-Rev.1.0
Approved 000123
Rejected
Other (Please Specify) Part Functional
Approved
Interim Approved, Need further Tolerance improvement
Rejected
Other
SwissTech tracking Number (Optional) Jean Paul Schwartzenberg
80661
Date:
02 October 2013
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
22 | 3 5
ENGINEERING CHANGE NOTIFICATION
DOC. CODE
REV.
QD-ECN-I
01
ECN Number 1234
Complete this form, unless another form is specifically requested, and email to the SwissTech Engineering department wherever notification is required Part Description Part Number New Part Number Old Part Number
To Customer
Brake Disc/Rotor
Drawing Number
123456789X
PO No.
SwissTech Automotive GmbH
Rev. B Level Issue 28 July 2013 Date SOP 01 December 2013 Date
123456789Z
Engineering Change 1234 Notification ECN/No. Application Volvo FH
123456789 N/A
PO-00001
Organisation Manufacturing Submission Information Supplier (Name) Street Address City
Preud'homme d'Hailly de Nieuport
E-Mail Address
Einbahnstrasse
Lead Engineer
Zolikon
Postal Code Region
PO. BOX No.
8702
123
E-Mail Address Quality Supervisor
Zürich
Country
Requestor (Name)
E-Mail Address
Switzerland
Title
Jacque van Nassau J.van.Nassau@HaillydeNieuport.com Pierre Flugi van Aspermont
Phone / ext. No. Phone / ext. No.
QA Mgr. +41 76 6789 001 +41 76 6789 004
P.Flugi.van.Aspermont@HaillydeNieuport.com Phone (ext.) No.
Patrick Dumonceau
+41 76 6789 003
P.Dumonceau@HaillydeNieuport.com
Product / Process Change Affects (Check all that apply) Materials
Design Responsibility: Organisation that May Effect End Item
ct
W ho
W ha t
Dimensional
Customer Product Change
Product Safety
Af fe
Functional
Customers
Appearance
Process
Organisation New or Revised sub-component Engineering drawing change Inventory
Tooling
Pricing
.
Detailed description Consequences of Product / Process Change (If Applicable) Product Safety
Final inspection to guarantee product stability and a PPM level < 50
Customer(s) / End user N/A Inventory
N/A
Tooling
N/A
Pricing
N/A
Reason(s) of Change: (Include Customer ECN Reference Number or ECR # If Applicable) 1
E/C Ref. No.
To control our process better we will add a additional inspection by the end of the line (100% check on Safety Critical dimensions)
2
Detailed Description of Change: (Include all Affected Part Numbers) 1
Part Number(s) Affected
Final 100% measurement inspection on Critical dimension ⑧,⑬,⑲ of drawing number 123456789Z
123456789X
2
Planed Date of Implementation
25 August 2013
Comments N/A Declaration:
I hereby certify that representative samples will be manufactured using the received product and/or process and verified, where appropriate, for dimensional change, appearance change, physical property change, functionality for performance and durability. I also certify that documented evidence of such compliance is on the file and available for customer review. Explanation / Comments: Name Jacque van Nassau Business +41 76 6789 001 Phone
Title FAX No.
QA Mgr.
Sign. Date
Signature
10 August 2013
E-Mail Address J.van.Nassau@HaillydeNieuport.com
NOTE: Please submit this notification prior to the planned change implementation !!! Verified By (Name) Jean Paul Schwartzenberg Document: QD-ECN-Rev.1.0
Document: QD-SQRM-Rev.1.0
Signature
Date
02 October 2013
Copyright © SwissTech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
23 | 3 5
SUPPLIER DEVIATION REQUEST
DOC. CODE
REV.
QD-SDR-I
01
VENDOR-ZONE No. ____-__-___-__
Section I. To be completed by the supplier Supplier (Name)
Preud'homme d'Hailly Manufact. de Nieuport (Location)
Project Champion
Hugo von Hertzberg
Part Description
Brake Disc/Rotor
Purchase Order No.
PO-00001
QTY in Stock Batch No.
1251
12453
Check one of the boxes
Project Leader Part Number
Zolikon
Requestor (Name)
Jacque van Nassau
Paul Von Riedesel d'Eisenbach
E-Mail Address
P.Eisenbach@HaillydeNieu Telephone port.com No.
SOP Date QTY Tested Lot No.
Drawing No.
123456789X
01 December 2013
PSO No. QTY Affected
172
Serial No.
6543
This is a ONE-TIME deviation request
Request Date
25 August 2013
+41 76 6789 002
123456789Z
Drawing Revision
B
14431
Drawing Rev. Date
27 June 2013
E/C Date
12
28 July 2013
Other if applicable
78555789
This is a temporary deviation request
This is a permanent change request
A) Description of Non-conformance and/or proposed Deviation:
Design Responsibility SwissTech Automotive GmbH Supplier
B) Effect of Deviation: Deviation Type (Chec k all that apply) Dimensional
C) Reason for Deviation Request:
Material Functional Appearance
D) How the Delivery Schedule will be Affected:
Process Manufacture Location Suppliers Sub-supplier SwissTech Supplier Quality Requirements
E) How Cost will be Affected: Section II. To be completed by SwissTech DISPOSITION:
REJECTED APPROVED This lot only Temporally,
Special indication requirements Engineer name:
Effective until: Signature
Date
Quality Hugo von Hertzberg Engineer name: QE. Phone No.
Signature
Date
Buyer name
Signature
Norman d'Audenhove
Jack Parker de Ruyter
Buyer Phone No. Document: QD-SDR-Rev.1.0
Document: QD-SQRM-Rev.1.0
H.vonHertzberg@SwissTech.ch
27 August 2013
Fax. No. Date
J.Parker@SwissTech.ch
30 August 2013
26 August 2013
Fax. No.
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
24 | 3 5
DOC. CODE
REV.
QD-DAR-I
01
DEVIATION AUTHORIZATION REQUEST
Deviation Number ____-__-___-__
PRODUCT INFORMATION Part Description Part Number
REPORTING INFORMATION Performed By (Name) Supplier (Name) Facility Location
Brake Disc/Rotor 123456789X
SwissTech Part +T.987654321 Number Drawing Number 123456789Z
Drawing Revision Level
Verified By (SwissTech)
B
Issue Date Subm. Date PO Number Review Date (SwissTe
Jacque van Nassau Preud'homme d'Hailly de Nieuport Vendor No.
Zolikon
101
Jean Paul Schwartzenberg
OTHER PARTS INVOLVED Product Family Name
Rev. Level
Part Description
E
WP2 BD Rotor
7654897
Start Date or Serial #
30 September 2013 PO-00001 02 October 2013
Product Family Name
Air Brake Disc Rotor
Part Number Involved
23 September 2013
Part Number Involved
End Date or Serial #
02 March 2011
Rev. Level
Part Description
Qty Affected
A976252
REASON (Check one)
23,476
DISTRIBUTION (Signatures)
1. Use parts that do not meet engineering drawing specifications.
Engineering
2. Material substitution (Add Comments/Special Instructions).
Manufacturing Eng.
3. Use parts that do not meet approved appearance standards.
Supplier Quality
4. Temporarily unable to follow standard process procedures.
Purchasing
5. Other:
Incoming Quality
Pierre Flugi van Aspermont Patrick Dumonceau Paul Von Riedesel d'Eisenbach Jacque van Nassau
EHS Manager
Corrective Actions
Other Other Product / Process Change Affects (Check all that apply) What
Dimensional
Materials
Functional
Appearance
Process
Affect
Product Safety
Customers
Inventory
Tooling
Pricing
.
Detailed description Consequences of Product / Process Change (If Applicable) What New material Sub-supplier Change Conceq. Need to Approve Material Source
What Change Conceq.
BILL OF MATERIAL CHANGE (BOM) Seq #
Part Number
Description
Add
Delete
N/A
FOR SWISSTECH USE ONLY Position
Name
Signature
Lead Rudolf von Hertzberg Engineer Quality Hugo Rosenthal Manager
Date 01/10/2013 29/09/2013
Position
Name
Signature
Purchasing John McKinsey Manager Quality Louis de Charon de Saint Germain Supervisor
Date
30/09/2013 02/10/2013
NOT APPROVED, REASON NOTE: Please submit this notification prior to the planned change implementation !!! Document: QD-DAR-Rev.1.0
Document: QD-SQRM-Rev.1.0
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
25 | 3 5
Run @ Rate Worksheet
DOC. CODE
REV.
QD-R@R-I
01
Part Number 123456789X
TYPE of RUN@RATE PRODUCT INFORMATION Part Description Part Number SwissTech Part Number Drawing Number
REPORTING INFORMATION
123456789X
Performed By (Name) Supplier (Name)
+T.987654321
Facility Location
Zolikon
Verified By (SwissTech)
Jean Paul Schwartzenberg
Brake Disc/Rotor
123456789Z
Drawing Revision Level
B
Inspection Date (Org.) Vendor No.
Jacque van Nassau Preud'homme d'Hailly de Nieuport
SUPPLIER DATA
Submission Date Review Date (SwissTech)
15 September 2013 101 3 02 October 2013
SWISSTECH DATA
A. Quoted Tool Capacity (QTC) [QTY/YR]
Max Schedule Volume [QTY / YR]
500,000
B. Production Days [DAYS/YR]
Production Days [DAYS / YR]
330
C. Quoted Daily Capacity [QTY/DAY]
345,000 330
Daily Volume [QTY / DAY]
1,515
PLANNED MACHINE LOADING
1,045
SUPPLIER TOOLING INFORMATION
D. Total Shift Time [GROSS HRS / DAY]
1.5
E. Planned Allocation for this Part [ % ]
100%
F. Gross Hours / Day, for this Part [HRS / DAY]
1.5
RUN @ RATE DATA PLANNED
ACTUAL
9
9
G. Duration of RUN @ RATE [HRS]: H. Downtime During RUN @ RATE: 1. Breaks 2. Lunch 3. Maintenance 4. Changeover/Setup Time 5. Unplanned 6. Total [1 - 5] I. Net Productive Time J. Part Quantities Produced 1. Total Number of Parts [#]: 2. Total Rejected Parts [#]: 3. Net Good [#]: 4. Net Parts/Hour [# / HR]:
COMMENTS
MIN
HRS
MIN
HRS
25
0.42
30
0.50
30
0.50
45
0.75
15
0.25
10
0.17
60
1.00
60
1.00
0
0.00
30
0.50
2.17
2.92
6.83
6.08
5,500
5,234
1
2
5,473
4,951
801
814
TOOL CAPACITY / PRODUCTION LINE CAPACITY / SCHEDULE ACTUAL TC
QUOTED TC
MSV
K. Net Daily Capacity [QTY / DAY]
1,221
1,515
1,045
L. Net Annual Capacity [QTY / YR]
402,862
500,000
345,000
RUN @ RATE RESULTS ACTUAL TC > QTC and ACTUAL TC > MSV ACTUAL TC < QTC but ACTUAL TC > MSV
OPEN
X
ACTUAL TC > QTC but ACTUAL TC < MSV ACTUAL TC < QTC and ACTUAL TC < MSV CONCURRENCE Supplier Repr.
Name Pierre Flugi van Aspermont
Signature
SwissTech Repr.
Name Jean Paul Schwartzenberg
Signature
Document: QD-R@R-Rev.1.0
Document: QD-SQRM-Rev.1.0
Date
16/09/2013
Date
20/09/2013
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
26 | 3 5
PROCESS FLOW DIAGRAM
DOC. CODE
REV.
QD-PFD-I
01
PART Number 123456789X
PRODUCT INFORMATION Part Description
Brake Disc/Rotor
Part Number
123456789X
REPORTING INFORMATION Performed By (Name) Supplier (Name)
SwissTech Part Number +T.987654321
Drawing Number
Jacque van Nassau Preud'homme d'Hailly de Nieuport
Rev. Level
123456789Z
B
Issue Date Vendor No. Review Date
28/09/2013 101 02/10/2013
LEGEND (Utilizes these symbols to clearly identify each step in the process) Operations
Movement
Inspection
Storage
Begin / end of the process
Step
Operation or Event Description of the process step
Duration of the Op./ Event
Description of the Operation or Event
(Utilize Symbols) In house 3rd Party
Evaluation and Analysis Methods
1
Arrival of base material
Begin of the process
0.00
2
Incoming Inspection
Take 10 samples of the material for layout inspection
25.00 Vickers, Brinell, Rockwell
3
Move to the warehouse
By Fork lift truck the material will be moved into the warehouse
3.00
4
Move mat. To operator
By Crane
2.10
5
Drilling Holes
Using GMC 20 Multi Spindle Lathe CNC equipment
0.12
6
Move to Hardening
By truck
17.00
7
Case Hardening Process
Describe detailed the (hardening) specifications
21.70
8
Move to final inspection area
By Crane
1.30
9
Dimensional Inspection
100% Dimensional Inspection by using fixture mold
18.00
10 Final Inspection
surface roughness measuring by 1 sample / batch of 100 pcs
12.00 Mitutoyo equipment
11
End of the process
0.00
12
0.00
13
0.00
14
0.00
15
0.00
16
0.00
17
0.00
18
0.00
19
0.00
20
0.00
21
0.00
22
0.00
23
0.00
24
0.00
25
0.00
26
0.00
27
0.00
28
0.00
29
0.00
30
0.00
FOR SWISSTECH USE ONLY Verified By (Name) Jean Paul Schwartzenberg Document: QD-PFD-Rev.1.0
Document: QD-SQRM-Rev.1.0
Insp. Date
02 October 2013
Signature
1.67 Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
27 | 3 5
28 | 3 5
Document: QD-SQRM-Rev.1.0
Copyright Š SwissTech. All right reserved.
CONTROL PLAN
DOC. CODE
REV.
QD-CPLAN-I
01
Control-Plan No.
PAGE 1 / 1
29 | 3 5
____-__-___-__
Prototype
Pre-Launch
Production
Control Plan Number
Key Contact
Business Phone No.
3 Distinct Phases 3. Production – a 2. Pre-Launch – a Jacque van Nassau +41 76 6789 001 1. Prototype – a comprehensive description of the description of the documentation of Part No. Drawing Numberdimensional Latest Rev. Level Core Team dimensional product/process measurements and 123456789X 123456789Z B measurements and characteristics, process material and Part Description / Product Namematerial and SOP Date Part Approval Date controls, tests, and performance tests that performance tests measurement systems will occur after Prototype Brake Disc/Rotor 01 December 2013 30 September 2014 that will occur that will occur during and before full Supplier / Plant Location Supplier No. Other Approval Date (If Required) during . mass production Production. Preud'homme d'Hailly de Nieuport Zolikon 101
Part / Process Number
Process Name / Operation Description
Define part / process number.
Define part/process operation and description.
Document: QD-CPLAN-Rev.1.0
Document: QD-SQRM-Rev.1.0
Machine Device, Tool used for Mfg.
Performance Date (Original)
Product
Process
Machine/Tools
Characteristics
Li s t the ma chine, devi ce, jig, or tools that will be used i n the ma nufacturing process.
Define the characteristics of the product or process.
Date (Revision) 02 October 2013
Date (If Required)
Customer Quality Approval
Date (If Required)
Other Approval
Date (If Required)
Characteristics No.
Submission Date 30 September 2013
Customer Engineering Approval
Methods Spec Characteristic Class
Product / Process Specification Tolerance
Special Characteristics Define the Sa fety cri tical a nd special cha rateristics of te product or process.
Specifications / Tolerance Use this area to define upper/lower spec limits for each control element.
Sample
Evaluation Measurement Technique
Size
Control Method
Reaction Plan
Frequency
Measurement Technique
Sample Size
Frequency
For each line in the control plan, list the measurement procedure that will be used (may list R&R Gage Plan or Poka-Yoke).
What is the size of the sample you should gather data from?
Define the frequency for which the measurement will be taken.
Control Method Method that will be used to control the process.
Rection Plan Actions to be taken if controls fail. .
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
MSA GAGE REPEATABILITY & REPRODUCIBILITY
DOC. CODE
REV.
QD-MSA-I
01
Gage Number ____-__-___-__
PRODUCT INFORMATION Part Description Part Number (Key) Drawing Number Supplier (Name)
GAGE INFORMATION Performed By (Name)
Brake Disc/Rotor
Inspection Date
Gage Name
123456789X
Drawing Revision Level
123456789Z
B
Preud'homme d'Hailly de Nieuport
Gage Number
Characteristics
Gage Type
Process
Gage UOM
Gage Repeatability and Reproducibility Data Collection Section Operator 1 (Name) 1
Nominal
Operator 2 (Name)
John
1 [ + Pos. ] Tolerance
UOM
25
2.85622
3 Operator 3 (Name)
Mark [ - Neg. ]Tolerance
4
5
1 No. Of Trials >1 [ n value ]
Paul Samples size >1 [ m value ]
5
15
1.41102
SwissTech Gage Repeatability and Reproducibility Criteria Cp [σ Sigma] > 2 [σ Sigma] Cpk [σ Sigma] >1.33 5.15
2.13
1.41
Sample size Observations Trial no. 1 2 Operator 1
John
0.4299
6
7
8
9
10
11
12
Yes
13
Final Result
14
15
Rejected
Average
24.993
29.169
22.639
25.674
28.129
22.688
27.539
27.688
26.490
29.414
28.244
24.311
25.055
26.30
2
24.315
26.377
26.320
29.744
22.398
24.588
29.296
22.988
25.174
27.417
27.094
29.730
27.103
25.147
22.724
26.03
3
23.970
27.508
25.257
29.551
23.053
26.386
28.859
22.909
25.098
26.363
25.657
29.771
28.759
24.297
25.852
26.22
4
24.200
26.630
25.400
29.400
22.420
25.820
28.910
22.135
26.287
26.982
25.761
29.400
25.590
25.400
23.476
25.85
5
24.600
26.810
26.100
29.600
22.580
26.120
28.526
22.877
25.197
27.133
26.630
29.744
25.820
26.320
22.420
26.03
Average
24.47
26.91
25.61
29.49
22.62
25.72
28.74
22.72
25.86
27.12
26.33
29.61
27.10
25.09
23.91
X-bara
26.09
Range
1.32
1.13
1.33
0.57
0.66
1.80
1.17
0.85
2.44
1.33
1.44
0.37
3.17
2.02
3.43
R-Bara
1.53
3
4
5
6
7
8
9
10
11
12
13
14
15
Average
1
24.279
26.486
24.311
29.414
22.479
24.974
28.555
22.963
26.162
26.958
27.221
31.759
25.674
25.230
22.479
25.93
2
24.654
26.158
25.147
29.730
23.553
25.137
27.526
21.180
25.662
26.638
26.377
29.350
24.588
25.184
23.553
25.63
3
24.682
25.761
24.297
29.771
23.476
25.590
28.972
21.332
26.570
26.797
27.508
28.438
26.386
24.155
23.476
25.81
4
24.769
26.413
25.400
29.400
22.420
25.820
28.910
22.135
26.287
26.982
26.630
29.771
25.820
24.297
22.420
25.83
5
24.315
26.377
26.320
29.744
22.398
24.588
29.296
22.988
25.174
27.417
26.810
29.400
26.120
25.400
22.398
Average
24.54
26.24
25.09
29.61
22.86
25.22
28.65
22.12
25.97
26.96
26.91
29.74
25.72
24.85
22.86
X-barb
25.82
Range
0.49
0.72
2.02
0.37
1.15
1.23
1.77
1.81
1.40
0.78
1.13
3.32
1.80
1.24
1.15
R-Barb
1.36
3
4
5
6
7
8
9
10
11
12
13
14
15
25.92
Average
1
25.559
26.490
25.230
31.759
25.055
28.244
30.126
23.513
27.141
28.033
26.486
29.169
24.974
24.993
22.639
26.63
2
24.504
27.094
25.184
29.350
22.724
27.103
27.505
22.802
25.379
26.918
26.158
29.744
25.137
26.320
22.398
25.89
3
27.738
25.657
24.155
28.438
25.852
28.759
30.000
24.049
27.255
29.094
25.761
29.551
25.590
25.257
23.053
26.68
4
24.682
25.761
24.297
29.771
23.476
25.590
28.972
21.332
26.570
26.797
26.413
29.400
25.820
25.400
22.420
25.78
5
24.200
26.630
25.400
29.400
22.420
25.820
28.910
22.135
26.287
26.982
26.377
29.600
24.588
26.100
22.580
Average
25.34
26.33
24.85
29.74
23.91
27.10
29.10
22.77
26.53
27.56
26.24
29.49
25.22
25.61
22.62
X-barc
Range
3.54
1.44
1.24
3.32
3.43
3.17
2.62
2.72
1.88
2.30
0.72
0.57
1.23
1.33
0.66
R-Barc
2.01
X-barp
26.02
R-barp
7.08
24.78
26.49
25.19
29.62
23.13
26.01
28.83
22.53
26.12
27.21
26.49
29.62
26.01
25.19
23.13
1.78
1.10
1.53
1.42
1.75
2.07
1.85
1.79
1.90
1.47
1.10
1.42
2.07
1.53
1.75
Gage Repeatability and Reproducibility Tolerance & % Variation Study Summery Report Equipment Variation Appraiser Variation Key Values Gage R&R Part Variation [ PV ] Tot. Variation [ TV ]
Calculation Values
K2
5
Is the part Stable?
27.221
Part Average
K1
4
5
25.285
Sample size Observations Trial no. 1 2 Operator 3
Paul
3
ndc >
1
Sample size Observations Trial no. 1 2 Operator 2
Mark
GR&R up to 20.00% [Marginal]
GR&R < [Pass] 10.00%
d2
2.3260
̿x
26.024
0.5230
d*2
3.4880
x̅diff
K3
0.2815
d2 d3
2.6921
R-barp
7.0812
A2
0.5770
1/d2
0.2880
R̅
1.6352
A3
1.4270
d3
0.8640
B3
0.0000
D3
0.0000
B4
2.0890
D4
2.1140
Max Range Min Range Total Tolerance
0.3368
EV % EV % EV -TV
9.000
7.81% 33.16%
% AV % AV -TV
0.17 1.84%
[ EV σ ₓ ]
lity
% σEV
[ AV σ ₓ ]
0.14
σreproduci
1.52%
% σAV
bility
% σEV -TV 33.16% % σAV -TV
GR&R % GR&R
% GR&R 7.79% TV
Equipment Variation Appraiser Variation
3.5377 σrepeatabi 0.3714
0.70
AV
Document: QD-SQRM-Rev.1.0
8.02% 34.07%
Gage R&R [ GR&R σ ₓ ]
0.03
σGR&R
0.36%
% σGR&R
% PV % PV - TV
1.99 94.02% 94.02%
TV ndc ≈ Min % GR&R
2.12 3.9 8.0%
USL USL
StdDev
0.14
σPV
0.39
1.56%
% σPV
4.30%
σTV ndc ≈ σMin %
26.16
LSL
29.00
x̅ Bar Chart
Part Variation [ PV ] Tot. Variation [ TV ] CL [ ̿x ] [ PV σ ₓ ] [ PV σ ₓ ]
7.79% % σGR&R- 34.07% % σPV -TV 94.02% TV
Document: QD-MSA-Rev.1.0
0.72
PV
25.83
LSL
20.00
R̅ Bar Chart
0.70
StdDev
0.70
26.02
CL [ ̿x ]
1.73
0.41
UCL_xA2
30.11
UCL_rD4
3.46
3.9
LCL_xA2
21.94
LCL_rD3
0.00
1.6%
GR&R Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
30 | 3 5
FIRST ARTICLE INSPECTION REPORT
DOC. CODE
REV.
QD-FAIR-I
01
PART Number 123456789X
PRODUCT INFORMATION
Part Number
123456789X
SwissTech Part Number
123456789
Drawing Number
Drawing Revision Level
123456789Z
B
5.00
X
2.00
0.05
0.03
6.76
6.68
6.69
6.67
6.74
2.08
0.02
0.06
12.72 12.64 12.68 12.71 12.65 12.67 12.72
2.10
0.05
0.02
5.05
2.30
4.98
5.05
6.71 6.68
5.03 5.01
Autom. Autom.
8
Positive & Negative Tolerances
These Upper & Lower Autom. Autom.
Specification Limits will be Autom. Autom. automaticity generated, No input required
Autom. Autom.
9
Autom. Autom.
10
Autom. Autom.
11
Autom. Autom.
12
Autom. Autom.
13
Autom. Autom.
14
Autom. Autom.
15
Autom. Autom.
16
Autom. Autom.
17
Autom. Autom.
18
Autom. Autom.
19
Autom. Autom.
20
Autom. Autom.
21
Autom. Autom.
22
Autom. Autom.
23
Autom. Autom.
24
Autom. Autom.
25
Autom. Autom.
26
Autom. Autom.
27
Autom. Autom.
28
Autom. Autom.
29
Autom. Autom.
30
Autom. Autom.
31
Autom. Autom.
32
Autom. Autom.
33
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34
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35
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36
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37
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38
Autom. Autom.
39
Autom. Autom.
40
Autom. Autom.
Document: QD-FAIR-Rev.1.0
Document: QD-SQRM-Rev.1.0
5.04
Dimensional results for all required PPAP samples
101
Cp >
SwissTech Results Only FAI FAI Cpk ≥ Result Sample Sample Result ↓ 1 2 1.68 Fail 6.73 6.69 PASS 1.67 1.24 Fail 12.71 12.64 PASS 1.33 1.69 PASS 4.98 5.02 PASS 1.67
Cpk↑
Autom. Autom. For all SRC, Key and/or Safety Critical Dimensions mark this field with a "X". The Cpk Value will change to ≥ 1.67
4.98
Vendor No.
Inspec. Date Subm. Date Final Result Review Date
25 September 2014 30 September 2013 Impr. Required 02 October 2013
Capability Results
LSL
5
7
Supplier Inspection Results
USL
4
6
Jean Paul Schwartzenberg
Sample 5
3 Print zone No. ③
Verified By (SwissTech)
Sample 4
12.70
2 Print zone No. ②
Zolikon
Sample 1
6.71
Preud'homme d'Hailly de Nieuport
Facility Location
- Tol.
x
Supplier (Name)
+ Tol.
1 Print zone No. ①
Critical Dim. Mark with "X"
Nominal value
Item No.
Specifications
Description for print zone or special notes
Performed By (Name) Jacque van Nassau
CpK Capability Result for Non- critical dimensions requires a CpK ≥ 1.33 for all SRC Key and/or safety critical dimensions require a CpK ≥ 1.67
Sample 3
Brake Disc/Rotor
Sample 2
Part Description
REPORTING INFORMATION
Cpk↑
Autom.
Cpk↑
Autom.
-Tol. Impr. Req. on Zone ① Cpk Impr. Req. on Zone ②
Autom.
Autom.
Cp Calculations Autom. Result on allCpk↑ dimensions Autom. requires Cpk↑ >2.00
Comments / Recommendations
Autom. SwissTech will prove the measurements
Autom. Autom.
Fee space for additional comments / Recommendations
Autom.
The FAI Result Pass / Fail, will be automatically generated. Autom. Autom. Cpk↑ No input required
Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑ Cpk↑
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Autom. Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
31 | 3 5
PRODUCTION PART APPROVAL - MATERIAL RESULTS
DOC. CODE
REV.
QD-PPAMR-I
01
Part Number No.
PAGE 1 / 1
32 | 3 5
123456789X
ADMINISTRATION DETAILS Part No.
Part Description / Product Name
Drawing Number
Latest Rev. Level
Supplier (Name)
Brake Disc/Rotor
123456789Z
B
Preud'homme d'Hailly de Nieuport
123456789X
OUTSIDE
Laboratory
Location Zolikon
Laboratory (Name)
Supplier No.
Key Contact
Business Phone No.
Jacque van Nassau
101
Performed by (Name)
Performance Date (Original)
IN-HOUSE TESTING
+41 76 6789 001
Submission Date 30 September 2013
Note: When an external laboratory is used, the supplier shall submit the test results on the laboratory letterhead or the normal laboratory report format
Material Specifications No.
Type of Test
Result meet Requirements
Date
Specifications
(DD / MM / YY)
Yes
No
Material Results shall include: - The name of the laboratory that conducted the test - The type of test that was conducted - The number, date, and specification to which the part was tested - The actual test results
Jean Paul Schwartzenberg
Signature
Job Title
Date
Document: QD-PPAMR-Rev.1.0
02 October 2013 Copyright © SwissT ech. All right reserved.
PRODUCTION PART APPROVAL - MODULE TEST
DOC. CODE
REV.
QD-PPAMT-I
01
Part Number No. 123456789X
ADMINISTRATION DETAILS Part No.
Part Description / Product Name
Drawing Number
Latest Rev. Level
Supplier (Name)
Location
Brake Disc/Rotor
123456789Z
B
Preud'homme d'Hailly de Nieuport
Zolikon
123456789X
Laboratory
OUTSIDE
Laboratory (Name)
Performed by (Name)
Supplier No.
Key Contact
Business Phone No.
Jacque van Nassau
101
Performance Date (Original)
IN-HOUSE TESTING
+41 76 6789 001
Submission Date 30 September 2013
Note: When an external laboratory is used, the supplier shall submit the test results on the laboratory letterhead or the normal laboratory report format
Result meet Requirements Type of Test
Test Description
Parameters Tested
Description of Supplier Test Results
Yes
No
Module Test Results shall include: - The name of the laboratory that conducted the test - The type of test that was conducted - A description of the test - The parameters tested - The actual test results
Verified By (Name)
Jean Paul Schwartzenberg
Document: QD-PPAMT -Rev.1.0
Document: QD-SQRM-Rev.1.0
Signature
Job Title
Date
02 October 2013 Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
Verified By (Name)
APPEARANCE APPROVAL REPORT
DOC. CODE
REV.
QD-AAR-I
01
Part Number 123456789X
Section 1: Component and Supplier Information Part Description Part Number
Brake Disc/Rotor
Performed By (Name) Jacque van Nassau
Inspec. Date
123456789X
Maunfacturing (location)
Supplier No.
Supplier Sourcing & Texture Information
Application
Drawing Number
Volvo FH
Supplier (Name)
List all first surface tools, graining Source(s), grain type(s), and grain
Verified By (SwissTech)
Preud'homme d'Hailly de Nieuport
Reason For Submission
Zolikon
First Production Shipment Prototype Shipment
Rev. Level
123456789Z
27 September 2013 101 Pre-Texture Evaluation
Rev. Level Date
B
27 June 2013
To be completed by Supplier QA Engineer
Review Date
Jean Paul Schwartzenberg
02 October 2013
Other Re-submission Specify Sub-supplier Change
Engineering Change Tooling: transfer, replacement, refurbishment
Section 2: Appearance Evaluation Pre-Texture Evaluation Correct and Proceed
Supplier Sourcing and Texture Information
SwissTech Representative Signature and Date
Date (DD / MM / YY) Colour Suffix
Material Type Master Number
Alphanumeric or numeric color identification
Enter alphanumeric master identification
Color Shipping Suffix
Correct and Resubmit Date (DD / MM / YY)
Identify first surface finish and substrate (e.g. paint / ABS)
Color part number suffix or color number
Approved to Texture Date (DD / MM / YY)
Section 3. Colour Evaluation Tristimulus Data
Colour Suffix
Master Number
Master Date
Material Type
HUE
Material Source
DL* Da* Db* DE* CMC
RED
Tristimulus Data
Master Date
List numerical (colorimeter) data of submission part as compared to the customer-authorized master "X"
Enter the date on which the master was approved
YEL
GRN
Material Source Identify first surface and substrate suppliers
Value BLU
Chroma
Gloss
Metallic Brilliance
LIGHT DARK GRAY CLEAN HIGH LOW HIGH LOW
Colour Shipping Suffix
Part Disposition
Hue, Value, Chroma, Gloss, and Metallic Brilliance
Part Disposition
Visual assessment by SwissTech
To be determined by SwissTech (approved or rejected)
Comments
Supplier Signature
SwissTech Use Only Comments
Approved Verified By (Name)
Jean Paul Schwartzenberg
Document: QD-AAR-Rev.1.0
Document: QD-SQRM-Rev.1.0
Approved with Deviation Signature
Rejected E-mail
Info@SwissTech-Automotive.ch
Date
02 October 2013
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 1
33 | 3 5
CORRECTIVE ACTION REPORT I
DOC. CODE
REV.
QD-CAR-I
01
VENDOR-ZONE No. ____-__-___-__
1. Problem description - include facts (i.e. where discovered, by whom, when), specifications, references and attachments Customer:
Purchase Order No.:
Customer Location:
Customer Part No.:
Customer Contact:
Organisation Part No.:
Customer Phone Number:
Part Description:
Customer Request No.:
Application:
Date C/A Received:
Quantity Shipped:
Date C/A Due:
Quantity Rejected:
Problem Description:
(Insert Photo / Sketch)
(Insert Photo / Sketch)
2. Team Roster Organisation:
Name:
Title:
Phone:
E-Mail:
3. Containment Action - interim action to immediately isolate the effect of the problem No.: Task Description:
Assigned to:
Due Date:
Effective date: Results Achieved:
4. Root Cause Analysis - Underplaying reason why the problem occurred AND why it escaped systems control 4a. Identification of Root Cause and Priority Ranking Cause Categories:
Description:
(0 = No impact, 1= low, 2= Medium, 3= High) Rank (0 - 3)
People:
Methods / Procedure
Equipment
Environment
Measurement
Document: QD-CAR-Rev.1.0
Document: QD-SQRM-Rev.1.0
Copyright © SwissT ech. All right reserved.
Copyright © SwissTech. All right reserved.
PAGE 1 / 2
34 | 3 5
CORRECTIVE ACTION REPORT II
DOC. CODE
REV.
QD-CAR-I
01
VENDOR-ZONE No. ____-__-___-__
4b. Five-Why Analysis of Root Cause - Answer why the problem occurred AND Why it escaped system controls Cause:
Why?
Why?
Why?
Why?
Why?
5. Corrective Actions - Steps taken to eliminate root cause(s) The solution to tis problem includes a detection mechanism or error-proofing device to prevent recurrence No.: Task Description:
Assigned to:
Due Date:
Yes
No
Effective date: Results Achieved:
6a. Preventive Action - Steps taken to modify systems and procedures to prevent recurrence of a similar kind elsewhere No.: Task Description:
Assigned to:
Due Date:
Effective date: Results Achieved:
6b. Read-Across - Steps taken to implement or share preventive action within other sites of the business unit or corporation No.: Task Description:
Assigned to:
Due Date:
Effective date: Results Achieved:
7. Verification - Identify methods to verify completion and effectiveness of actions taken Verify the implementation and changes to:
Policies / Procedures
No.: Method:
Work Instructions Assigned to:
FMEA
Control Plans
Due Date:
N/A
Effective date: Results Achieved:
8. Management Review - Endorsement and support by the organisation responsible for correction Organisation's Name: Top Management:
Signature:
Approval Date:
Phone No.
Signature:
Approval Date:
Phone No.
E-mail:
E-mail:
9. Final Closure - The organisation responsible for correction acknowledge completion of all action items QA Management Representative: Document: QD-CAR-Rev.1.0
Document: QD-SQRM-Rev.1.0
Signature:
Date Closed:
Phone No. E-mail: Copyright Š SwissT ech. All right reserved.
Copyright Š SwissTech. All right reserved.
PAGE 2 / 2
35 | 3 5