Sensor Scientific, Inc.

Transcription

1 Sensor Scientific, Inc. 6 Kings Bridge Road Fairfield, New Jersey Quality Manual Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 1 of 21

2 Table of Contents Page 1. Introduction 3 2. Purpose 3 3. Scope 4 4. Quality Management System 5 5. Management Responsibility 7 6. Resource Management 9 7. Product Realization Measurement, Analysis and Improvement Change Control 20 Organization Charts Macro Process Diagram Appendix A Appendix B Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 2 of 21

3 1. Introduction Sensor Scientific, Incorporated (SSI) is a leading manufacturer of Negative Temperature Coefficient (NTC) sensors and custom probe assemblies headquartered in northeastern New Jersey. The headquarters facility of SSI is located at 6 Kings Bridge Road, Fairfield, New Jersey, where all of the sales, purchasing and engineering operations take place. Founded in May 1983, Sensor Scientifics primary markets are the Automotive, Medical Component, Telecommunications, HVAC and Controls industries. The company s key strengths are its ability to design products to solve virtually any temperature measurement problem, the short time required to make evaluation samples or production lots and the low cost and high quality of its manufactured products. The offshore assembly plant is Sensor Scientific Philippines, Inc. (SSPI) is located at Calamba Premiere Zone, DPL Technology Bldg, Blk 2 Lot 4 Bgy, Batino, Calamba City, Philippines. The Philippine plant also produces custom probe assemblies and medical device components. Strategically located in the Pacific Rim, SSPI supports the emerging Asian markets for temperature sensing products. SSPI was incorporated in July As each facility performs different functions, each facility has written and is responsible for the operation of their System-Level Procedures (SLP), work instructions, forms and records. For illustration purposes, the SLPs for the NJ facility are referenced here. The QMS documents of all facilities are bound by the contents of this quality manual. 2. Purpose The purpose of this Quality Manual is to announce the Quality Policy and Quality Objectives of Sensor Scientific. This document demonstrates the commitment of SSI management to the development, implementation and continuous improvement of its Quality Management System (QMS). It defines the responsibility for each requirement of this ISO9001: 2008 quality system and references the system level procedures created to ensure consistent performance. It is an electronically controlled document, issued in both printed and electronic versions, available to all employees. SSI management is committed to ensuring that customer requirements are determined and met with the purpose of enhancing customer satisfaction. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 3 of 21

4 SSI management believes that its business is conducted through a series of sequential and interconnected processes. These processes are managed and continually monitored to assure the highest possible level of performance. Each process is evaluated periodically so as to adjust for changes in the production environment and make improvements where possible. Refer to Appendix B for a view of the sequence and interconnectivity of the major business processes. 3. Scope This manual, with its associated Quality Management System (QMS) documentation, defines the manner in which all activities that affect product quality or reliability, customer satisfaction and the stated objectives of the Quality Policy are to be conducted. Quality Objectives Sensor Scientific s quality objectives include, but are not limited to, On-time delivery Low defective parts per million Low amount of customer complaints All objectives will be defined in form SSIF0541. These objectives will be measured either monthly or yearly. The goal to which the objective is measured against will also be reviewed. Exclusion Validation of Processes (ISO9001: 2008 Standard element 7.5.2) Sensor Scientific Philippines is excluded from element 7.3 of the ISO9001:2000 standard (Design Control). All design responsibility is located in the Sensor Scientific, Inc. facility in Fairfield, New Jersey. Subsequent monitoring or measurement all through out the process verifies products being produced. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 4 of 21

5 4. Quality Management System 4.1 General Requirements SSI has established, documented, implemented and maintained this quality management system to continually improve its effectiveness in accordance with the requirements of the International Standard. SSI has a. Determined the processes needed for the QMS and their application throughout the organization, b. Determined the sequence and interaction of these processes, c. Determined the criteria and methods needed to ensure that both the operation and control of these processes are effective, d. Ensured the availability of resources and information necessary to support the operation and monitoring of these processes, e. Monitored, measured where applicable and analyzed these processes, and f. Implemented actions necessary to achieve planned results and continual improvement of these processes. Processes performed by external parties that affect the quality of products delivered to SSI customers are controlled by SSI dependent upon a. The potential impact of the out-sourced process on SSI s ability to provide products that conform to the customer s requirements, b. The degree to which the control of the process is shared, and c. The capability of achieving the necessary control through the application of incoming inspection. 4.2 Documentation Requirements General This QMS includes a. Documented statements of a Quality Policy and Quality Objectives b. This Quality Manual c. Documented procedures and records as required by the International Standard, d. Documents and records determined by SSI to be necessary to ensure the effective planning, operation and control of its processes. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 5 of 21

6 4.2.2 Quality Manual SSI has established and maintains this quality manual that includes a. The scope of the QMS, including justifications for exclusions, b. References to documented procedures established for the QMS, and c. A description of the interaction of the processes of the QMS Control of Documents Documents required by the QMS are controlled in accordance with SSIB0423 for the NJ facility. This procedure defines the controls needed a. To approve documents for adequacy prior to issue, b. To review and update and re-approve documents, c. To ensure that changes and current revision status of documents are identified, d. To ensure that relevant versions of applicable documents are available at points of use, e. To ensure that documents remain legible and readily identifiable, f. To ensure that documents of external origin necessary for the planning and operation of the QMS are identified and their distribution is controlled, and g. To prevent the unintended use of obsolete documents and to identify them if retained for any purpose Control of Records The records established to provide evidence of conformity to requirements and the effective operation of the QMS are controlled as defined by procedure SSIB0424. Records are controlled as required by internal procedures as well as customer requirements. The storage location, custodian, retrieval, retention, protection and disposal of records are defined by SSIB0424. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 6 of 21

7 5. Management Responsibility 5.1 Management commitment Top management has provided evidence of its commitment to the development and implementation of this QMS and to continually improving its effectiveness by a. Communicating the importance of meeting customer requirements, statutory and regulatory requirements to the employees of SSI, b. Establishing the Quality Policy, c. Conducting management reviews, and d. Ensuring the availability of resources. 5.2 Customer focus Top management has ensured that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 5.3 Quality policy Top management has created a quality policy that a. Is appropriate to the organization, b. Includes a commitment to comply with requirements and continually improve the effectiveness of the QMS, c. Provides a framework for establishing and reviewing quality objectives, d. Is communicated and understood within the organization, and e. Is reviewed for continuing suitability. 5.4 Planning Quality objectives Top management has ensured that quality objectives including those involving product requirements are established at all levels and functions in SSI. The quality objectives are measureable and consistent with the quality policy Quality management system planning Top management has ensured a. That the planning of the QMS is carried out in order to meet the requirements of the International Standard as well as the quality objectives, b. The integrity of the QMS is maintained when changes to the QMS are planned and implemented. 5.5 Responsibility, authority and communication Responsibility and authority Top management has ensured that the responsibilities and authorities are defined and communicated within SSI Management representative Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 7 of 21

8 Top management has appointed a member of SSI management to have responsibility and authority that includes a. Ensuring that processes needed for the QMS are established, implemented and defined, b. Reporting to top management on the performance of the QMS and any need for improvement, and c. Ensuring the promotion of awareness of customer requirements throughout SSI. The management representative for quality is responsible for liaison with external parties regarding the QMS. 5.6 Management review General Top management reviews the QMS annually to ensure its continuing suitability, adequacy and effectiveness. The review includes assessing opportunities for improvement and the need for changes in the QMS, including the quality policy and objectives Review input Inputs to the management review include information on a. Results of audits, b. Customer feedback, c. Process performance and product conformity, d. Status of corrective and preventive actions, e. Follow-up actions from previous management reviews, f. Changes that could affect the QMS, and g. Recommendations for improvement Review output The output from the management review includes decisions and actions related to a. Improvement of the effectiveness of the QMS and its processes, b. Improvement of product related to customer requirements, and c. Resource needs. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 8 of 21

9 6. Resource management 6.1 Provision of resources SSI has determined and provided the resources needed a. To implement and maintain the QMS and continually improve its effectiveness, and b. To enhance customer satisfaction by meeting customer requirements. 6.2 Human resources General SSI employees performing work affecting conformity to product requirements are competent on the basis of education, training, skills and experience. SSI employees performing tasks indirectly affecting product conformity are aware of the importance of their activities Competence, training and awareness SSI has a. Determined the necessary competence for personnel performing work affecting conformity to product requirements, b. Provided training to achieve the necessary competence where applicable, c. Evaluated the effectiveness of the actions taken, d. Ensured that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives, and e. Skills and experience Infrastructure SSI has determined, provided and maintained the infrastructure needed to achieve conformity to product requirements. Infrastructure includes a. Buildings, workspace and associated utilities, b. Process equipment including hardware and software, and c. Supporting services such as transport, communication and information systems Work environment SSI has determined and provided the work environment needed to achieve conformity to product requirements. The work environment takes into account physical and environmental conditions such as noise, temperature, humidity, lighting and weather, as applicable. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 9 of 21

10 7. Product realization 7.1 Planning of product realization SSI has planned and developed the processes needed for product realization. This planning is consistent with the requirements of the quality management system. The following were considered: 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. The output of the planning is in a form suitable form SSI s method of operations. 7.2 Customer-related processes Determination of requirements related to product SSI has determined a. Requirements specified by the customer, including the requirements for delivery and post-delivery activities, b. Requirements not stated by the customer but necessary for the intended use, where known, c. Statutory and regulatory requirements applicable to the product, and d. Any additional requirements considered necessary. Post-delivery activities include warranty provisions Review of requirements related to product SSI performs a review of the requirements related to product. This review is performed prior to committing to supply product to customer either by submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders, to ensure that a. Product requirements are defined, b. Contract or order requirements differing from those previously expressed are resolved, and c. That SSI has the ability to meet the defined requirements. Records of requirements review are documented. Where the customer provides no documented state of requirement, the customer requirements are confirmed prior to acceptance. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 10 of 21

11 When product requirements are changed, SSI ensures that the relevant documents are amended and relevant personnel are aware of the changed requirements Customer communication SSI has determined and has implemented effective arrangements for communicating with customers in relation to a. Product information b. Enquiries, contracts or order handling, including amendments, and c. Customer feedback, including customer complaints. 7.3 Design and development Design and development planning SSI plans and controls the design and development of product. During the design planning, SSI determines a. The design and development stages, b. The review, verification and validation that are appropriate to each design and development stage, and c. The responsibilities and authorities for design and development. SSI manages the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning is updated as the design and development progresses Design and development inputs SSI maintains records relating to product requirement inputs as they are determined. These inputs include a. Functional and performance requirements, b. Applicable statutory and regulatory requirements, c. Information derived from previous designs, were applicable, and d. Other requirements essential for design and development. Product requirements are reviewed for adequacy. Requirements must be complete, unambiguous and not in conflict with each other. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 11 of 21

12 7.3.3 Design and development outputs Outputs of design and development are suitable for verification against the design and development inputs and are approved prior to release. design and development outputs a. Meet the input requirements for design and development, b. Provide appropriate information for purchasing, production and service provision, contain or reference product acceptance criteria, and c. Specify the characteristics of the product that are essential for its safe and proper use Design and development review At suitable stages, SSI performs systematic reviews of design and development in accordance with planned arrangements a. To evaluate the ability of the results of design and development to meet requirements, and b. To identify any problems and propose necessary actions. Participants in design reviews include representatives of functions concerned with the design and development stages being reviewed. Records of the reviews and any necessary actions are maintained Design and development verification Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirement. Records of the results of the verification and any necessary actions are maintained Design and development validation Design and developmentvalidation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.wherever practicable, validation is completed prior to the delivery or implementation of the product. Results of validations and any necessary actions are maintained Control of design and development changes design and development changes are identified and records are maintained. The changes are reviewed, verified, validated and approved before implementation. Thereview of design and development changes Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 12 of 21

13 includes the effect of changes on the constituent parts and product already delivered. Records on the results of review of changes and any necessary actions are maintained. 7.4 Purchasing Purchasing process SSI ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. SSI evaluates and selects suppliers based on their ability to supply product in accordance with SSI s requirements. Criteria for selection, evaluation and re-evaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained Purchasing information Purchasing information describes the product to be purchased including, as appropriate, a. Requirements for the approval of product, procedures, processes and equipment, b. Requirements for qualification of personnel, and c. Quality management system requirements. SSI ensures the adequacy of specified purchase requirements prior to communication to the supplier Verification of purchased product SSI has established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where SSI or its customer intends to perform verification at the supplier s premises, the intended verification arrangements and method of product release are stated in the purchasing information. 7.5 Production and service provision Control of production and service provision SSI has planned and carries out production under controlled conditions. Controlled conditions include, as applicable, Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 13 of 21

14 a. The availability of information that describes the characteristics of the product, b. The availability of work instructions, as necessary, c. The use of suitable equipment, d. The availability and use of monitoring equipment, e. The implementation of monitoring and measurement, and f. The implementation of product release, delivery and postdelivery activities Validation of processes for production SSI validates any processes for production where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use. Validation demonstrates the ability of these processes to achieve planned results. SSI has established arrangements for these processes including, as applicable, a. Defined criteria for review and approval of processes, b. Approval of equipment and qualification of personnel, c. Use of specific methods and procedures, d. Requirements for records, and e. Revalidation Identification and traceability Where appropriate, SSI as identified the product by suitable means throughout product realization. SSI identifies the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, SSI controls the unique identification of the products and maintains records Customer property SSI exercises care with customer property while it is under its control or being used. SSI identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer property is lost, damaged of otherwise found to be unsuitable for Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 14 of 21

15 use, SSI reports this to the customer and keeps records. Intellectual property and personal data is considered customer property Preservation of product SSI has taken steps to preserve its products during internal processing and delivery to the intended destination in order to maintain conformity to requirements. Such preservation includes identification, handling, packaging, storage and protection. Preservation also applies to constituent parts of the product. 7.6 Control of monitoring and measuring equipment SSI has determined the monitoring and measurement to be undertaken and the monitoring and measurement equipment needed to provide evidence of conformity of product to determined requirements. SSI has established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment is a. Calibrated or verified, or both, at specified intervals, or prior to use against measurement standards traceable to international or national measurement standards. Where no such standards exist, SSI records the basis used for calibration or verification; b. Is adjusted or re-adjusted as necessary; c. Has identification in order to determine its calibration status; d. Is safeguarded from adjustments that would invalidate measurement results; and e. Is protected from damage and deterioration during handling, maintenance and storage. SSI assesses and records the validity of the previous measuring results when the equipment is found to not conform to requirements. SSI takes appropriate actions on the equipment and any product affected. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is done prior to initial use and is reconfirmed as necessary. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 15 of 21

16 8.0 Measurement, analysis and improvement 8.1 General SSI has planned and implemented the monitoring, measurement, analysis and improvement processes needed a. to demonstrate conformity to product requirements, b. to ensure conformity of the quality management system, and c. to continually improve the effectiveness of the QMS. This includes the determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 Monitoring and measurement Customer satisfaction SSI monitors information relating to customer perception as to whether the customer s expectations have been met as one of the measurements of the performance of the QMS. SSI uses a Customer Complaint log, Return Material Authorization requests and occasional customer satisfaction surveys as input to this process Internal audit SSI conducts internal audits at planned intervals to determine whether the QMS a. conforms to the planned arrangements, to the requirements of the international standard and to the quality management system requirements established, and b. is effectively implemented and maintained. The audit program is 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 are defined. The selection of auditors and the conduct of the audits ensure objectivity and impartiality of the audit process. Auditors must be independent of the process and area that they audit. Documented procedure SSIB0822 defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of audits and their results are maintained as controlled records. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 16 of 21

17 The manager responsible for the area audited ensures that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformances and their causes. Follow-up activities include the verification of the actions taken and the reporting of the verification results Monitoring and measurement of processes SSI has applied suitable methods for monitoring and measurement of the quality management system processes. These methods include demonstrating the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective actions are taken as appropriate Monitoring and measurement of product SSI monitors and measures the characteristics of its products to verify that the product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with planned arrangements. Evidence of conformity with the acceptance criteria is maintained. Records indicate the personnel authorizing release of product for delivery to the customer. Products are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority or the customer. 8.3 Control of nonconforming product SSI ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. This process is documented in SSIB0830 which defines the controls and related responsibilities and authorities for dealing with nonconforming product. SSI deals with nonconforming product in one or more of the following ways: a. by taking action to eliminate the detected nonconformity; b. by authorizing its use, release or acceptance under concession by a relevant authority or the customer; c. by taking action to preclude its original intended use or application; d. by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. When nonconforming product is corrected it is inspected to the demonstrate conformity to the original requirements. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 17 of 21

18 Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. 8.4 Analysis of data SSI determined, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to a. Customer satisfaction, b. Conformity to product requirements, c. Characteristics and trends of processes and products including opportunities for preventive action, and d. Suppliers. 8.5 Continual improvement SSI attempts to continually improve the effectiveness of its quality management system through the use of its quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review Corrective action SSI takes action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effect of the nonconformities encountered. Procedure SSIB0852 defines the requirements for a. Reviewing nonconformities including customer complaints, b. Determining the causes of the nonconformities, c. Evaluating the need for action to ensure that nonconformities do not recur, d. Determining and implementing action needed, e. Records of the results of actions taken, and f. Reviewing the effectiveness of the corrective action taken. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 18 of 21

19 8.5.3 Preventive action SSI takes action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. Since the process for handling both corrective and preventive actions are very similar, procedure SSIB0852 defines the requirements for a. Determining potential nonconformities and their causes, b. Evaluating the need for action to prevent occurrence of nonconformities c. Determining and implementing action needed, d. Records of results of action taken, and e. Reviewing the effectiveness of the preventive action taken. Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 19 of 21

20 Change Control Page Date Description of Change (Changed or added text is underlined in Draft) 15 Feb 1999 Initial Issue 31 Oct 2000 Complete rewrite for QS Mar 2001 Revise Calibration Section (11) to conform to QS numbering scheme. 3 APR 2001 The following sections / paragraphs were updated due to Desk Study audit: 1.4 (Business Plans), 2.3 (Quality Planning), (Special Characteristics), (Product and Process Safety), (FMEA), (Control Plan), (Tooling Management), 4.10 (Customer Prototype Support), (Obsolete Documents), 5.4 (Engineering Documents), 6.3 (Purchasing Data), 6.4 (Purchased Products), 7.0 Customer-Supplied Material), 9.2 (Maintaining Process Control), 10.0 (Inspection and Testing), (Acceptance Criteria for Attribute Characteristics) 10.6 (Laboratory Requirements), 13.4 (Engineering Approved Product Authorization), (Inventory), 15.6 (Delivery), (Supplier Delivery Performance Monitoring), (Shipment Notification), 16.0 (Control of Quality records), 16.1 (Record Retention), 18.0 (Training). 6 Aug The following sections / paragraphs were revised as a result of the QS9000 certification audit: 1.3 (Management Review), 1.4 (Business Plans), (Feasibility Reviews), 4.8 (Design validation), 10.1 (Inspection and Testing), 132. (Review and Disposition of Nonconforming Material), 13.3 (Control of Reworked Product) and 16.0 (Control of quality records). 24 FEB 2003 Introduction reworded several sentences without changing the meaning or intent of the sections. Refer to underlined text Subcontractor Development: Clarified requirement of vendors supplying component material for automotive products must be ISO9000 certified or pass a second-party audit by SSI. 1 AUG 2003 The following sections were updated for ISO9001: 2000: - Purpose - Quality Objectives (added) Quality Policy (revised on July 23, Management Review defined input / output Quality System added annual review of QMS Preventive Action Expanded scope of Preventive Action Internal Audit Process Added audit considerations for ISO9001: DEC Page 4 Exclusion for Validation of Processes added 2. Page 7 Added 2 items to Management Review agenda 3. Page 16 Clarify Contract Review for verbal agreements 4. Page 23 Added evaluation of sub-contractors Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 20 of 21

21 5. Page 38 Clarify Preventive Action 10 SEP 2007 Page 3 Remove St. Kitts from list of companies, added Sensor Scientific Vietnam. Page 4 added Design Control Exclusion for SSPI, SSVC (Element 7.3 of ISO9001:2000 standard). Page 20 deleted St. Kitts document information, added Vietnam. 10 OCT 2011 Updated the entire manual to reflect the requirements of ISO9001: SEP 2012 Page 3 Remove Sensor Scientific Vietnam from list of companies Page 4 Expanded quality objectives, established form for quality objectives Pages Changed all instances of D&D to design and development Revised: 26 September, 2012 Authorized By: G. R. Brinley Page 21 of 21