QUALITY MANUAL. This document defines the requirements, processes, structure and documentation for the Teledyne DGO Quality Management System.

Transcription

1 Page 1 of PURPOSE This document defines the requirements, processes, structure and documentation for the Teledyne DGO Quality Management System. 2. SCOPE The Teledyne DGO Quality Management System has been designed and implemented for effective management, customer satisfaction, and continual improvement. It has been implemented to meet the requirements of ISO 9001:2008. The QMS governs the design, development and manufacture of electrical and optical connectors, cable assemblies, penetrators, and servo control devices used in hostile environments for military and commercial applications, including sales, testing and technical support functions. 3. REFERENCES ISO International Organization for Standardization 4. TABLE OF CONTENTS Section Topic ISO 9001:2008 Teledyne DGO Document 5 Definitions 6 Process Approach Quality Management 4.1 System 7 Document Control 4.2.1, SOP-QMS Records Control Legal , Current Teledyne Technologies Approved Retention Schedule 9 Management responsibility and commitment Quality Policy Management Review 5.1, 5.2, 5.3, 5.4.1, 5.4.2, 5.5, 5.5.1, 5.5.2, 5.5.3, 5.6, 5.6.1, 5.6.1, 5.6.2, Provision of Resources Human Resources Training 6.2.1, 6.2.2, 12 Infrastructure 6.3, Planning of product realization 7.1, 7.2 QP-001

2 Page 2 of Design Control 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 15 Purchasing Process 7.4, 7.4.1, 7.4.2, 7.4.3, 16 Production and Process Controls Process Validation SOP-QMS-021 SOP-QMS-020 SOP-QMS-005 SOP-SCM Identification and Traceability SOP-QMS Customer Property Preservation of Product WI-SCM-0005 or SOP-QMS Inspection, Measuring and Test equipment 8.1 SOP-QMS Customer Feedback SOP-QMS Internal Audit SOP-QMS Nonconforming Product 8.3 SOP-QMS Analysis of data Continual Improvement Corrective and Preventative action 8.5.2, SOP-QMS Revision History 5. DEFINITIONS Unless otherwise specified, all terms used in this document are defined in ISO Term TDGO TOG Concession PPM QMS SOP Definition Teledyne D G O Brien Teledyne Oil & Gas A special approval that is granted to release a nonconforming product for use or delivery Policy and Procedure Manual Quality Management System Standard Operating Procedure 6. QUALITY SYSTEM PROCESS APPROACH TDGO applies a system of processes, their interactions and their management to ensure the ongoing control over the linkage between the individual processes and within the system of processes. This approach emphasizes the importance of understanding and meeting

3 Page 3 of 13 requirements, considering processes in terms of added value, obtaining results of process performance and effectiveness, and improving processes based on objective measurement. Figure I. Diagram of Process-based QMS: 7. DOCUMENT CONTROL TDGO shall determine which documents shall be controlled and which shall be managed. The document control process shall ensure that only the correct revision of controlled documents are available for use and that obsolete documents are not available for use. To align with industry standard documentation structure, TDGO has adopted QMS SOPs as Level 2 documents and Work Instructions as Level 3 documents. During the transition from PPM s to SOP s, and PPM s to Work Instructions, all new released documents shall adopt the new document labels. All other documents with PPM labels shall be renamed at their next revision. An electronic link will be established for any PPM document that has been renamed or superseded to facilitate document user s in locating renamed or superseded documents.

4 Page 4 of 13 Figure 2: TDGO QMS Document Structure: L1 Manual Policy L2 SOP (Standard Operating Procedures) L3 PPM & WI (Work instruction) L4 Forms & Records 8. RECORDS CONTROL Records established to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled. Records shall remain legible, readily identifiable and retrievable. Where customer requirements for records retention conflict with the Teledyne Approved Retention Schedule, the longer retention requirement shall take precedence. 9. MANAGEMENT RESPONSIBILITY AND COMMITMENT Customer Focus: Top Management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. Quality Policy: TDGO management shall establish a quality policy that shall be communicated and implemented across the organization to describe management s intentions with respect to

5 Page 5 of 13 Quality. As a part of TOG, TDGO implements the TOG Quality Policy and reviews it for adequacy at each Management Review. Quality Objectives: TDGO management shall establish Quality objectives that define the specific quality goals that the organization is committed to achieving. The Quality Objectives shall be measurable and consistent with the Quality Policy. TDGO is provided annual Quality Objectives. Management Representative: TDGO shall appoint a management representative who has the responsibility and authority to: a) Ensure that processes needed for the QMS are established and maintained. b) Report on the performance of the QMS and needs for improvement. c) Ensure the promotion of awareness of customer requirements throughout the organization. Internal Communication: TDGO management shall ensure that internal communication processes are established and that communication takes place regarding the effectiveness of the quality management system. Management Review: TDGO management with executive responsibility shall review the effectiveness of the quality management system at least annually. ISO Management Representative shall: a) Schedule and conduct management reviews. b) Report on the performance of the quality management system and any need for improvement, to top management. Attendees: a) All members of the general manager s staff (top management) participate and attend management reviews. Where a member is unable to attend, advance written notice must be provided to the ISO Management representative and a delegate named to participate in the review. b) Assemble and forward all required and relevant data to the Management Representative(s) prior to the scheduled meeting for inclusion into the summary to be presented at the Management Review. c) Complete any assigned actions resulting from the Management Review.

6 Page 6 of 13 Management Review Inputs: a) Results of Audits b) Customer Feedback c) Process performance and product conformity d) Status of preventative and corrective actions e) Follow-up actions from previous management reviews f) Changes that could affect the quality management system g) Recommendations for improvement h) Review of Quality Policy and Quality Objectives Management Review Outputs: a) Attendance record b) Record of the content reviewed c) Action items and a summary of decisions pertaining to: Quality Management System improvements Product improvements Resource needs 10. PROVISION OF RESOURCES TDGO shall determine and provide the resources needed to implement, maintain and continually improve the QMS and maintain its effectiveness, and to meet regulatory and customer requirements. 11. HUMAN RESOURCES TDGO shall ensure that all personnel are competent, adequately trained and equipped to correctly perform their roles and that each employee is made aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. They shall also be made aware of how product defects may occur from improper performance of their specific jobs. Appropriate records of education, training, skills and experience shall be maintained.

7 Page 7 of INFRASTRUCTURE TDGO shall ensure that infrastructure, including buildings, workspaces, utilities, process equipment and supporting services are sufficient to ensure conformity to product requirements is consistently achieved. Equipment: TDGO shall ensure that all equipment used in the manufacturing process, including inspection and test equipment, meets specified requirements and is appropriately designed, constructed, placed and installed to facilitate maintenance, adjustment, cleaning and use. TDGO shall ensure that equipment maintenance schedules are established and maintained, periodic equipment inspections are conducted and documented, and that adjustments are made correctly as needed. 13. PLANNING OF PRODUCT REALIZATION Product Realization: TDGO determines the following, as appropriate, and the output of this planning shall be in a form suitable for the methods of the organization: a) Quality objectives and requirements for the product b) The need to establish processes and documents, and to provide resources specific to the product c) Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance d) Records needed to provide evidence that the realization processes and resulting product meet requirements Customer Related Processes: TDGO shall define product, customer, statutory and regulatory requirements and shall establish processes to review and understand these requirements. This review shall be conducted prior to the organizations commitment to supply a product to the customer and shall ensure that: a) Product requirements are defined b) Contract or order requirements differing from those previously expressed are resolved c) The organization has the ability to meet the defined requirements Records of the results of the review and actions arising from the review shall be maintained. Where product requirements are changed, the organization shall ensure that relevant document is amended and that the relevant personnel are made aware of the changed requirements. 14. DESIGN CONTROL TDGO shall plan and control the design and development of product to include design and development stages, the review, verification and validation that are appropriate to each design and development stage, and the responsibilities and authorities for design and development.

8 Page 8 of 13 Design Inputs: The organization shall plan and control the design and development of the product. These inputs shall include: a) Functional and performance requirements b) Applicable statutory and regulatory requirements c) Where applicable, information derived from previous similar designs d) Other requirements essential for design and development Design Outputs: The outputs of design and development are provided in a form that enables verification against the design and development input and shall be approved prior to release. These outputs shall: a) Meet the input requirements for design and development b) Provide appropriate information for purchasing, production and for service provision c) Contain or reference product acceptance criteria d) Specify the characteristics of the product that are essential for its safe and proper use Design Review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the review shall be maintained. Design and Development Verification: Verification shall be performed to ensure that the design and development outputs have satisfied the input requirements. Records of the verification and any necessary actions shall be maintained. Design and Development Validation: Validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. When practical, validation shall be completed prior to delivery of the product. Records of the results of the validation or any necessary actions shall be maintained. Control of Design and Development Changes: Design and development changes shall be identified and records maintained.

9 Page 9 of PURCHASING PROCESS Supplier Selection and Management: TDGO shall evaluate and select potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including Quality requirements. TDGO shall establish and maintain records of acceptable suppliers, contractors and consultants in an Approved Supplier List (ASL). Purchasing Data: TDGO shall ensure that suppliers are provided with accurate and complete requirements, including quality requirements and that changes to these requirements are delivered to the supplier in writing, and records of these changes shall be retained in accordance with Records Control requirements. Verification of Purchased Product: The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. 16. PRODUCTION AND PROCESS CONTROLS Process Controls: TDGO shall ensure that production and service provisions are conducted under controlled conditions. Production process controls shall be established where deviations from specifications could occur as a result of the manufacturing process. Production and process controls shall be defined in procedures and in product specific control plans as appropriate. Production and Process Changes: TDGO shall ensure that process changes are reviewed, approved and verified or validated, as appropriate, prior to implementation. 17. PROCESS VALIDATION Validation Documentation: Where the results of a process cannot be fully verified by subsequent inspection and test, TDGO shall ensure that the process is validated with a high degree of assurance. Process validations shall be conducted according to documented and approved procedures, validation protocols and reports and performed by qualified individuals. Process Control Data: TDGO shall ensure that validated processes are monitored and controlled to ensure requirements are consistently met on an ongoing basis. The data collected as a result of ongoing monitoring shall be documented. Revalidation: TDGO shall ensure that when changes or process deviations occur that processes are reviewed and evaluated and where appropriate, revalidation is performed and documented.

10 Page 10 of IDENTIFICATION AND TRACEABILITY Identification: TDGO shall ensure that product is identified by suitable means throughout all stages of receipt, production, distribution and installation to prevent mix-ups. Teledyne shall also ensure that product status is maintained throughout all stages to ensure that all product that has passed the required inspections and tests are accepted and released. Traceability: TDGO, directly or through its suppliers, contractors and service providers, shall establish, document, and maintain procedures for identifying each unit, lot, or batch of finished products and components, where appropriate, with a unique control number. These controls shall be used to facilitate corrective action when and if required. 19. CUSTOMER PROPERTY TDGO shall exercise care with customer property, including intellectual property, while it is under the control of the organization or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records. 20. PRESERVATION OF PRODUCT TDGO shall preserve the product (and any components) during processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include: o Identification o Handling o Packaging o Storage o Protection 21. INSPECTION, MEASURING AND TEST EQUIPMENT TDGO shall determine the monitoring and measurement to be undertaken, and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. Additionally, calibration records shall be maintained. Where necessary to ensure valid results, measuring equipment shall: o Be safeguarded from adjustments that would invalidate the measurement result o Be adjusted or readjusted as necessary o Be identified to enable calibration status to be determined o Be protected from damage and deterioration during handling, maintenance and storage o Be evaluated for impact to finished product quality where equipment is found to be out of tolerance

11 Page 11 of CUSTOMER FEEDBACK AND COMPLAINTS TDGO shall establish methods for communicating with customers in relation to: a) Product information b) Enquiries, contracts or order handling, including amendments c) Customer feedback, including customer complaints 23. INTERNAL AUDIT TDGO shall conduct internal audits to determine whether the QMS: a) Conforms to the requirements of ISO 9001 and to the established quality system and external requirements b) Is effectively implemented and maintained The audit schedule shall be defined by the designated Quality Audit Leader. The schedule shall be planned taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Audits shall be conducted by trained auditors who are independent of the work being audited. Audit Documentation: Audit reports are company confidential. Additional audit records that provide objective evidence of audit execution shall be maintained and available for outside review as needed. 24. NONCONFORMING PRODUCT Nonconforming product includes nonconforming product occurring in TDGO s own facilities, as well as nonconforming product received or delivered by the organization. TDGO shall ensure that product that is nonconforming or is suspected of being nonconforming is identified, and controlled to prevent its unintended use or delivery. TDGO shall ensure that procedures are established for review and disposition of nonconforming product and that responsibility and authority for disposition is defined within these procedures.

12 Page 12 of 13 TDGO shall also ensure that actions are taken to identify, document and eliminate the root cause of nonconforming product. 25. MEASUREMENT AND ANALYSIS TDGO shall collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS, process and product quality to evaluate if improvements are needed. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to: a) Customer satisfaction b) Conformity to product requirements c) Characteristics and trends of processes and products, including opportunities for preventive action d) Suppliers 26. CONTINUAL IMPROVEMENT TDGO shall continually improve the effectiveness of the QMS through the use of: a) Quality Policy b) Quality Objectives c) Audit results d) Analysis of data e) Corrective and Preventive Actions f) Management Review g) Quest for Excellence Teams utilizing continuous improvement tools and techniques 27. CORRECTIVE AND PREVENTIVE ACTION TDGO shall ensure that action is taken to identify, correct and ensure that nonconformities that have already occurred do not recur, and to prevent potential nonconformities. CAPA investigations shall focus on the cause of nonconformities (or potential nonconformities) relating to product, processes or the QMS. A summary of CAPA activity shall be included in Management Reviews.

13 Page 13 of REVISION HISTORY o Revision G Released 10/01/03 Per ECO Revised to meet the new requirements of ISO 9001 revision o Revision H Released 12/12/03 Per ECO Revised to change procedure numbers into PPM numbers. o Revision J Released 03/11/05 Per ECO Revised to correct administrative errors. o Revision K Released 06/06/08 Per ECO to change logo to Teledyne logo; changed job title; deleted reference to QATM. o Revision L Released 06/19/08 Per ECO Added servo control devices to scope. o Revision M Released 02/04/09 per ECO Changes per Management Review Recommendation. o Revision N Released 09/21/09 Per ECO to reflect ISO 9001:2008. o Revision P Released 04/22/11 Per ECO to reflect current titles. o Revision R Released 01/08/14 Per E3476 to reflect current titles and removal of address. o Revision T Released 04/21/14 per E4019 Total Re-Write of Manual. o Revision V Released 05/12/14 Per E4053 to Include Customer Specific Record Retention guidance. o Revision W Released 05/30/14 per E4174 Legal Requirements for DGO.com o Revision Y Released 07/15/14 Author K Peek, Per E4388 Multiple Changes to Update to new document system (references, document control and definitions) o Revision AA Released 9/24/15 Author K Peek, Per E4554 Clarification of Section 7 o Revision AB Released 10/08/15 Author K Peek, Per E6025 Updated references in Section 4 o Revision AC Released 12/15/15 Author K Peek, Per E6801 Added Figure 1 to Section 6, updated verbiage in section 9 o Revision AD Released 01/26/16 Author K Peek, Per E6954 Added dates to Section 28 Revision History o Revision AE Released 03/07/16 Author K Peek, Per E7179 Added And Quality Objectives to Management Review inputs o Revision AF Released 10/25/16 Author M Mitchell, Per ECO 8214 Clerical changes to document to tighten up and correct formatting, punctuation, and grammar, and consolidate revision history, Section 28.