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TABLE OF CONTENTS 1.0 PURPOSE page 3 2.0 SCOPE page 3 3.0 QUALITY MANUAL page 3 3.1 Format 3.2 Control 3.3 References 4.0 QUALITY SYSTEM REQUIREMENTS page 4 4.1 MANAGEMENT RESPONSIBILITY page 4 4.1.1 Quality Policy 4.1.2 Organization 4.1.3 Management Review 4.2 QUALITY SYSTEM page 7 4.2.1 General 4.2.2 Quality System Procedures 4.2.3 Quality Planning 4.3 CONTRACT REVIEW page 7 4.4 DESIGN CONTROL page 8 4.5 DOCUMENT AND DATA CONTROL page 8 4.5.1 General 4.5.2 Document Approval and Issue 4.5.3 Document Changes 4.6 PURCHASING page 9 4.6.1 General 4.6.2 Evaluation of Subcontractors 4.6.3 Purchasing Data 4.6.4 Verification of Purchased Products 4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT page 10 4.8 PRODUCT IDENTIFICATION AND TRACEABILITY page 11 4.9 PROCESS CONTROL page 11 4.10 INSPECTION AND TESTING 4.11 CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT 4.12 INSPECTION AND TEST STATUS 4.13 CONTROL OF NONCONFORMING MATERIAL 4.14 CORRECTIVE AND PREVENTIVE ACTION 4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY 4.15.1 General 4.15.2 Handling 4.15.3 Storage 4.15.4 Packaging 4.15.5 Preservation 4.15.6 Delivery 4.16 control of quality records 4.17 INTERNAL QUALITY AUDITS 4.18 TRAINING 4.19 SERVICING
This quality manual was developed to describe the quality management system in use by Ameritech Die & Mold Inc, Mooresville, NC. This system has been designated to incorporate the principles included in QS / TE 9000: 1994, quality system model for quality assurance in production and installation. This quality system is designed to cover the primary business activity of Ameritech Die & Mold Inc: design, manufacture, repair and service of precision plastic molds. In addition those activities which support our efforts, such as inspection, identification, handling, storage, etc. are also included. 3.1 FORMAT This manual has been structured to follow the ISO 9002 STANDARD (listed above). If requirements other than those in ISO 9002 exist, an explanation is included within the appropriate section addressing the requirement. 3.2 CONTROL Copies of this quality manual are distributed and are available in one of two categories: controlled or uncontrolled. The purpose of a controlled copy is to identify and apprise copyholders, as necessary, of changes and/or additions/deletions to the manual, and thus the quality system. Each controlled copy is issued an identification number, which identifies location, personnel/area/position information of the copyholder, and facilitates notification to the holder. Manual distribution lists shall control manual identification numbers and assignment. Internal Quality Audits shall verify the copies location and possession. Uncontrolled copies of the manual are issued upon request representing the current revision level at the time of request. There is no distribution list of uncontrolled manuals. Uncontrolled manual holders are not apprised of any changes and/or additions/deletions. 3.3 REFERENCES Technical aspects of this quality system such as calibration, inspection, identification, certification, supplier selection, etc. Have been developed utilizing certain U. S. Government, Industry or Customer specifications as guidelines. These include: 4.0 QUALITY SYSTEM REQUIREMENTS 4.1.1 Quality Policy
The following mission statement represents Ameritech Die & Mold Inc.'s commitment to quality and successful business practices: Ameritech Die & Mold Inc is a full function mold shop providing our customers with all the necessary resources to design, manufacture, and service custom precision plastic molds: committed to quality service, customer satisfaction and employee involvement. To help accomplish this mission our Quality Policy is: "To meet our customer’s specifications 100%" Ameritech Die & Mold Inc.'s approach to quality focuses on the following: 4.1.1 Organization 4.1.2.1 Responsibility and authority The Organization chart included in this manual represents the structure of Ameritech Die & Mold Inc, Mooresville, North Carolina Quality issues needing to be addressed are done so by the President / CEO, Plant Manager, Management Representative or their designees. Such issues shall include quality staffing and assignments, supplier quality performance and audits, interdepartmental quality issues, quality training, corrective / preventive action, regular assessments of the overall quality system and changes needed. 4.1.2.2 Resources and Personnel The President is responsible for providing adequate resources and trained personnel for the management and performance of work related verification activities including internal quality audits. 4.1.3 Management Review The effectiveness of the Ameritech Die & Mold Inc.'s quality system is reviewed, verified and documented annually by the President and his staff. This review focuses on customer complaint reports, results of internal audits, non-conformance / corrective action requests, statistical data (when applicable), preventive action, and customer survey results. Records of these reviews are maintained 4.2.1 General The management and employees of Ameritech Die & Mold Inc have designed and implemented a quality system based on ISO 9002: 1994 which supports our mission statement and our quality policy of "Meeting our Customer’s Specifications 100%". The quality system and quality-related activities are governed by appropriate procedures and work instructions. 4.2.2 Quality-system Procedures The quality system is documented in this Quality Policy Manual and described in the Ameritech Die & Mold Inc Quality Procedure Manual. Additional documents are maintained which facilitate and support the effective implementation of this quality system, such as work instructions and customer specific quality procedures. Also, quality records are maintained which provide evidence of compliance to the quality system procedures and the effectiveness of the quality system. 4.2.3 Quality Planning Ameritech Die & Mold Inc has developed work instructions which serve as standard quality plans documenting the actions and equipment required to ensure that standard quality requirements are met. Incorporated in the work instructions are inspection points and standards. Review and revision of these work instructions includes the consideration of updating equipment, instrumentation, or standards. Customer specific quality plans are incorporated either in special instructions documented on the work order which is issued with each job or is maintained separately as a customer specific procedures document. There are two types of contracts covered by contract review, actual contracts and purchase orders. The first type is a contract to provide a customer service and maintenance on their plastic molds for a specified period of time (six months, yearly, etc.) Review of this type of contract is accomplished prior to signing the contract. President, Plant Manager, Management Representative, Salesperson's, Administrative assistants, or their designees may be involved in reviewing and approving these contracts. Recording of these contract reviews is accomplished through a contract review checklist. The second type of contract is a specific purchase order placed by a customer through a phone call, facsimile, mail or delivery service. Review of this type of contract is usually performed by sales, administration or their designees. A notation of order review is indicated on the confirming order if forwarded by the customer. Otherwise, review is conducted while order is being placed. Contract review of both types of contracts shall include verifying that the customer’s requirements are clearly stated, checking for conflicting requirements and verifying Ameritech Die & Mold Inc.'s ability to meet these requirements. Executive Management, Administrative Assistants, Sales Personnel and Shop Personnel may verify if Ameritech Die & Mold Inc has the needed capabilities to meet the customer’s purchase order, inquiry or contract. Ameritech Die & Mold Inc is not involved in the design of products. As necessary our customers communicate their requirements to us based on computer math data, blue prints, mold performance requirements, and applicable notes used in describing a part. This information is used to determine a mold design, which is best, suited for the individual application. This design is approved and wholly owned by the customer. Therefore, Ameritech Die & Mold Inc does not maintain procedures or a system for design control. 4.5.1 General All documents and data related to the implementation of the quality system are controlled based on documented procedures. The documents and data may be either paper or electronic media. 4.5.2 Document and Data Approval and Issue All documents and data, which affect quality, are reviewed and approved by management, management representative or their designee before issue. Controls are established to ensure the following. Master list of documents are maintained; current issues of all documents are available at the point of use; and obsolete documents are prevented from inadvertent use and those which are retained are clearly identified as obsolete. 4.5.2 Document and Data Changes Revisions to existing controlled documents and data are reviewed and approved for revision in the same manner as the original document. This review and approval are carried out by the same responsible management. The revision level and / or issue date is prominently displayed on each page of a Ameritech Die & Mold Inc issued controlled document or on the computer file. Master lists are maintained which identify the current revision level of a document. When a revised document is issued, the nature of the change is identified when practical. 4.5.4 Documents of External Origin Documents of external origin are for reference only and shall not be controlled. The Plant Manager maintains all documents of external origin. Data, tables, schedules, etc. from documents of external origin may be included in controlled procedures. 4.6.1 General Ameritech Die & Mold Inc maintains an approved supplier / subcontractor system to ensure purchased mold bases, steel, graphite, mold components, equipment, supplies and services conform to clearly stated quality requirements. This is accomplished through the use of purchasing contracts and other forms of communication with suppliers and subcontractors. 4.6.2 Evaluation of Suppliers and Subcontractors Management, the management representative or their designees select and approve suppliers / subcontractors based on their ability to meet stated Ameritech Die & Mold Inc, government, customer, or industry requirements. Suppliers and subcontractors are maintained on the Ameritech Die & Mold Inc "APPROVED SUPPLIER / SUBCONTRACTOR LIST" (ASL). This list represents suppliers / subcontractors used for the procurement of contractually deliverable materials or services. When a customer specifies a supplier / subcontractor for their work, the specified source need not be on the Ameritech Die & Mold Inc.'s (ASL) unless so stated by the customer. 4.6.3 Purchasing Data Purchasing documents contain data describing the material or service ordered. Data may include CAD files, blue prints, catalog numbers or any other relevant data used for identification for receipt and approval of the items. Appropriate special quality system standards are also identified to the supplier when applicable. All purchase orders are reviewed and approved prior to release by designated personnel. 4.6.4 Verification of Purchased Product 4.6.4.1 Self-audit surveys Self audit surveys of suppliers / subcontractors quality system is initiated. Each supplier and subcontractor shall be requested to complete a self-audit survey of their quality system and capabilities. Upon completion, the self-audit is returned for review and approval. A review of the self-audit survey is conducted by management, the management representative or their designee. Upon approval of the self-audit survey the respective supplier or subcontractor is placed on the ASL. 4.6.4.2 Verification at Supplier / Subcontractor’s Facility Should Ameritech Die & Mold Inc propose to verify, inspect or test purchased material or service at the supplier or subcontractor’s facility, Ameritech Die & Mold Inc will specify such arrangements in the purchase order. 4.6.4.3 Customer Verification of Subcontractor / Supplier When specified by contract, Ameritech Die & Mold Inc will arrange for customer representative(s) to verify at our source that purchased materials or services conform to requirements. To allow for coordination with Ameritech Die & Mold Inc.'s suppliers / subcontractors requests must be made in advance of the actual inspection date(s). Drop in visits are not permitted. Source inspections by the customer or applicable agency are not considered as evidence for effective control of quality by the supplier / subcontractor, unless Ameritech Die & Mold Inc personnel are part of the visit. 4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT Handling and storage of molds, material, instruments supplied and owned by the customer is conducted in accordance with the procedures documented in the Ameritech Die & Mold Inc Quality Procedure Manual. Documentation and special reporting required for customer property is a responsibility of sales, shop and administrative areas and is coordinated with the appropriate personnel and management. 4.8 PRODUCT IDENTIFICATION AND TRACEABILITY Ameritech Die & Mold Inc maintains a tool control program for all contracted items. This program is described in the AMERITECH DIE & MOLD INC Quality Procedure Manual. It provides for continuous identification of all molds, equipment and material during all stages of handling, processing, manufacturing and delivery. Mold, material and equipment traceability is accomplished through a computer data base control system. Ameritech Die & Mold Inc maintains a controlled list of all molds, material and equipment for which identification and customer mold / equipment / material traceability is maintained. Documented work instructions describe how each operation, which directly affects quality, is carried out. Any special criteria for manufacture and / or customer requirements are listed on the AMERITECH DIE & MOLD INC work order. Applicable process specifications, standards or engineering data supplied by the customer may also be attached. Shop personnel utilize these documents to assure compliance during all phases of processing. These documents are controlled as described in paragraph 4.5 of this manual. Environmental and safety controls are in place to provide the necessary working environment. Preventative and routine maintenance of equipment is performed by Ameritech Die & Mold Inc Personnel or outside subcontractors to ensure all machines and equipment is available to meet customer’s quality requirements. The primary business activity of Ameritech Die & Mold Inc is the manufacture of molds for plastic injection. The processing capabilities we maintain in-house are not considered special processes. Some instances of manufacture or repair of molds which we contract to qualified subcontractors can be considered as special processes. Technical requirements relating to these special processes are derived from customer supplied documents, and forwarded to the subcontractor for their review and acceptance. Any and all documentation necessary to complete these processes is forwarded and agreed upon by Ameritech Die & Mold Inc and the subcontractor. 4.11 CONTROL OF INSPECTION, MEASURING, AND TEST EQUIPMENT 4.12 INSPECTION AND TEST STATUS 4.13 CONTROL OF NONCONFORMING PRODUCT 4.14 CORRECTIVE AND PREVENTATIVE ACTION 4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION, AND DELIVERY 4.16 CONTROL OF QUALITY RECORDS 4.17 INTERNAL QUALITY AUDITS 4.18 TRAINING 4.19 SERVICING Ameritech Die & Mold Inc is not involved in the servicing of products. Therefore, Ameritech Die & Mold Inc does not maintain procedures or a system for servicing products. Revision Date Reason for Change A Initial Draft |
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