Our Quality & Environmental Commitment Honeywell The Sensing and Control (S&C) Global Management System Manual Honeywell Page 1 of 37
HONEYWELL Global Management System Manual No. GMS 0001 Issue 6 Revision Date: August, 2011 The only valid copy is the master on the Global Quality web page, paper copies are uncontrolled. A copy of this manual may be accessed by entering the S&C Global Quality Intranet Website http://acsnet.honeywell.com/sites/dept199/default.aspx TABLE OF CONTENTS Approvals and Revision History 1 Introduction 2 Purpose 3 Scope 4 Global Management System Requirements 4.1 General Requirements 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality & Environmental Manual 4.2.3 Control of Documents 4.2.4 Control of Records 5 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality & Environmental Policy 5.4 Planning 5.4.1 Quality & Environmental Objectives 5.4.2. Quality & Environmental Planning 5.5 Responsibility, Authority, & Communication 5.5.1 Responsibility & Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Inputs 5.6.3 Review Outputs Honeywell Page 2 of 37
6 Resource Management 6.1 Provision of Resource 6.2 Human Resources 6.2.1 General 6.2.2. Competence, Awareness & Training 6.3 Infrastructure 6.4 Work Environment 7 Product and/or Service Realization 7.1 Planning of Realization Process 7.2 Customer Related Processes 7.2.1 and 7.2.2 Determination & Review of Requirements Relating to the Product 7.2.3 Customer Communication 7.3 Design & Development 7.3.1 Design & Development Planning 7.3.2 Design & Development Input 7.3.3 Design & Development Output 7.3.4 Design & Development Review 7.3.5 Design & Development Verification 7.3.6 Design & Development Approval 7.3.7 Control of Design & Development Changes 7.4 Supply Management 7.4.1 Supply Management Process 7.4.2 Supply Management Information 7.4.3 Verification of Purchased Product and/or Services 7.5 Production and Service Operations 7.5.1 Operations Control 7.5.2 Validation of Special Processes 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Measuring and Monitoring Devices 8 Measurement, Analysis, & Improvement 8.1. General 8.2 Measurement & Monitoring 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring & Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconformity 8.4 Analysis of Data for Improvement 8.5 Improvement 8.5.1 Continuous Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action Appendix A -- Definitions Honeywell Page 3 of 37
Approvals and Revision History This document is approved by the President, the VP of Integrated Supply Chain, and VP or Director of Quality for S&C. Tony Sugalski Dean Anderson Peter Fritsche President of S&C VP of ISC Director - Quality Changes that do not affect the content will not require either review or approval but will be recorded in the Revision History section by the technical owner. Issue 1, revision date 13 February 2003 New document covering the Global Management System. Issue 2, Updated for clarification on the purpose of the GMS, as well as the addition of environmental requirements throughout the manual. Removed references to IM&C and ECC and updated scope accordingly. Revision made to approval requirements based on this manual only applying to S&C. Updated revision references on Standards. Added references from both the AS and TS standards throughout the manual. Clarification regarding the three levels of management reviews and management representatives. Issue 3, Updated sections. 4.2.4, 5.1, 6.2.2, 7.1, 8.3 and 8.5.2 for references to the new revision of ISO 14001. Update title from VP of Operations to VP of Integrated Supply Chain. Issue 4, Section 3, added reference to support of VPP. Section 4.2.2, added sign off by VP Quality. Section 5.3, updated the Environmental Policy, also update links to external web sites for Quality and Environmental Policies. Section 5.5.2; remove reference to Global and Business Management Representatives and Figure 5.6, eliminate reference to business reviews and global as global and business levels are not required. Section 7.4.3, corrected typo. Section 8.1, added a reference to Honeywell Operating System. Section 8.2.4., added reference to cover positive recall of material released without verification. Section 8.5.1, added reference to HOS and included a NOTE: which previously appeared as part of the definition of continual improvement. Update definitions in Appendix A. Issue 5, Section 4.2.3, added clarification that that 10 days for review is from date of receipt. Section 8.5.1, added clarification that GEMBA walks may not be used at all sites. Reviewed and updated links contained in this document. Throughout the document, changed error-proofing to the current terminology used, mistake-proofing. Issue 6. Revised organization changes to reflect new leadership. Updates sections to AS9100C definitions. Updated sections to reflect movement of information from one section to the other related to AS9100C. No major changes in definition, just location of information. AS9100C increased focus on contract review, risk assessment and flow down. For Honeywell S and C, these procedures were already a focus for our business and involves no major change to approach. Honeywell Page 4 of 37
1 Introduction Honeywell is committed to quality leadership and continual improvement of its products and processes, including the Global Management System (GMS) which supports them. This document describes the elements of that framework. Additional information about Honeywell International is available on the internet at http://www.honeywell.com/ 2 Purpose Identify and document a common Quality and Environmental Management System. The GMS is designed to incorporate the needs of our customers/regulatory agencies and uses ISO 9001:2008 and ISO14001:2004 as its foundation with AS9100C, and TS 16949 requirements also being included and applicable in locations having the need to comply. AS9100C requirements are printed in italics and TS 16949 requirements are printed in bold. The document is intended to provide an umbrella Quality & Environmental system. Honeywell's vision is to use the GMS to provide a framework for sharing best practices and ensuring consistent processes. Processes that are identified which can be effectively deployed at a global level will be added to the GMS. To meet the requirements of the relevant standards and the effective operation of individual site operations, the GMS will be supported by local site supplement quality manuals, procedures and processes where appropriate. Sector specific quality standards or other relevant third party certifications not covered by this manual will be referenced in the appropriate site quality manual supplement. 3 Scope The scope of this manual covers the Sensing and Control (S&C) businesses within Honeywell Automation and Control Solutions, hereafter referred to as The Organization. It incorporates the following: Design development and manufacture of controls for Sensing and Control. These controls cover applications for sensors, switches, controls systems, actuators and instruments for measuring pressure, air flow, temperature and electrical current. The integration of the quality and environmental systems supports the idea that quality and caring for our environment should be part of our daily business. Note: All references to Environmental Management Systems in this manual apply only to sites that are ISO 14001 certified or in the process of becoming certified and in support of those sites interested in become a VPP Star Site. References to AS 9100 and TS16949 requirements only apply to those sites which require certification or compliance to these standards. Honeywell Page 5 of 37
4 Global Management System (4 ISO 14001) 4.1 General Requirements (4.1 ISO 14001) A. Introduction: Description of Key Processes (Ref GMS section 4.1) Figure 4.1 Market or Customer Needs 1 Strategic Management Process 3 Improvement Process Support Processes 2 Performance Management Process 4 Knowledge Management Process 5 Communication Process Core Processes 6 Customer Needs Identification To all Core Processes 7 Product / Process Design & Verification 8 Scheduling and Analysis 9 Customer Support (Quotes, Contracts, Order Management) 10 Supplier Selection and Management 11 Production 12 Shipping & Honeywell Warehousing To Support Processes Customer Satisfaction Honeywell Page 6 of 37
Each site must align their local management system with the Key Process map, Figure 4.1. Some sites may not have all of the processes identified on the map. Elements of this may be sub-contracted or may be carried out by other sites within the scope of the GMS. In those cases, any processes carried out by other locations should be stated in the site quality manual supplement. The organization is responsible for conforming to customer requirements, including those which may be controlled in outsourced processes. The organization s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. 4.2 Documentation Requirements 4.2.1 General (4.4.4 ISO 14001) The documentation requirements of the GMS, including those requirements imposed by the applicable regulatory authorities, and their relationships are described in the Figure 4.2.3. The organization shall ensure that personnel have access to the quality management system documentation and are aware of relevant procedures. The quality management system documentation, and change history within them, is available on-site to customers and/or regulatory authority representatives and this manual can be viewed on-line at http://sensing.honeywell.com/index.cfm/ci_id/15107/la_id/1.htm 4.2.2 Quality & Environmental Manual (4.4.4 ISO 14001) This manual describes the requirements of the GMS. Each Site is required to support the GMS and to provide direction and guidance to their relevant areas. The Quality and HSE managers constitute the interface between the requirements of the Quality and Environmental standards and the structure of the company. The GMS is established and reviewed under the responsibility of the Quality function and approved by the President Honeywell S&C, the Vice President of Integrated Supply Chain and the Vice President or Director of Quality. Cross references to Global Procedures are made in the appropriate sections of this manual which they support. A hyperlink to each procedure is included for internal usage only and is identified in a Box In addition to the GMS Manual, sites have a manual supplement. The supplement defines: a.) local processes and practices potentially including their relationship to the requirements of the applicable standards b.) scope of system including identification of support locations and exclusions (along with justification), and Honeywell Page 7 of 37
c.) the applicability and sequence of the global key processes (Ref Figure 4.1) in relation to the site. ESGP 04.02.02 Application of the EMS to Projects, Production Processes 4.2.3 Control of Documents (4.4.5 ISO 14001) Documents which maintain and improve the quality and environmental performance of our products & processes are controlled by procedure, reference QSGP 04.02.03 for the global procedure regarding document control. Sites are responsible for establishing and documenting procedures which cover the approval, legibility, periodic review, revision control, distribution, availability and disposition of obsolete documents, as might be appropriate for site specific documentation. QSGP 04.02.03 Control of Documents Figure 4.2.3 Global Management System Manual Site Processes and Procedures Who does what? Quality and Environmental Policies, Objectives, Site Supplements and Global Procedures How? Site Guidelines and Procedures Local Processes and Procedures How? Dept/Function Guidelines and Records External documents, such as engineering specifications are distributed and reviewed in a timely manner or as customers may specify (10 days for TS16949). Appropriate actions are taken and records of implementation dates are maintained. 4.2.4 Control of Records (4.5.4 ISO 14001) Records which are required to show the effective operation of the GMS and its processes are established and maintained at all appropriate levels. QSGP 04.02.04, Records Control Procedure is used at the S&C level. Sites are responsible for establishing and documenting a Records Control Procedure which controls the identification, storage, protection, retrieval, Honeywell Page 8 of 37
retention and disposition of records, as appropriate for their business in satisfying the needs of their customers and regulatory authorities. This includes any records which are created by and/or retained by Honeywell suppliers. Where identified by customers and regulatory authorities, records are available for their review. All necessary precautions for the good conservation of the filed documents are taken. Documents can be stored in computer file. Computer backup shall be executed daily or at a defined frequency per Honeywell guidelines. All documents are analyzed, evaluated, indexed, filed and maintained by the responsible department at each site. Corporate retention periods are defined in the following web link http://my.honeywell.com/rim/schedule.html?c=1 QSGP 04.02.04 Control of Records 5 Management Responsibility (4.4.1 ISO 14001) 5.1 Management Commitment (4.2, 4.4.1, 4.4.7 ISO 14001) Management at all levels is responsible for demonstrating their commitment to the GMS. This is accomplished through: conducting reviews of the QMS (otherwise known as the Management Review Process); establishing the Quality and Environmental Policies and Objectives; assuring compliance and continuous improvement to the GMS; ensuring resource availability; communicating and ensuring customer and regulatory authority needs and expectations, and conducting reviews which assure the effectiveness and efficiency of the product realization and supporting processes. Each site shall establish and maintain procedures identifying the potential for and responding to accidents and emergency situations, and for preventing and mitigating the environmental impacts that may be associated with them. Procedures covering emergency response are reviewed, revised as needed and tested periodically. ESGP 05.01 Objectives, Targets and Programs 5.2 Customer Focus (4.3.1, 4.3.2 ISO 14001) The primary goal is to focus relentlessly on satisfying customers. Management ensures that the customer and consumer needs and expectations are determined, converted into requirements and achieved, e.g. contract review/customer satisfaction surveys/field trials/quality function deployment. Honeywell Page 9 of 37
Customer feedback including any field returned products are monitored/analyzed and used to drive internal improvement. Management ensures through management review, Customer Care Organization, and communication with employees that customer satisfaction is a continuous focus of our efforts. Top management shall endure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not or will not be achieved. 5.3 Quality & Environmental Policies (4.2 ISO 14001) Management establishes, approves and maintains a Quality & Environmental Policy which is applicable throughout the organization. Communication of the Policy to employees, the public and other stakeholders is the responsibility of management. Refer to: http://sensing.honeywell.com/1/4/2/5/8/8/index1.shtml http://www.honeywell.com/sites/hser/sustainable.html These policies are reviewed for continuing suitability. Quality Policy Pursuit of Perfection in Everything We Do Be the first choice of our customers by delivering products and services of uncompromising quality. Utilize Six Sigma Plus and Digitization to become a Premier Lean Enterprise. Achieve Operational Excellence through Ensuring Ownership and accountability by all stakeholders. Implementation of best practices and global processes. A systematic review process which identifies and eliminates performance gaps Focusing on Customer data to drive change Environmental Policy The Environmental Policy is described in the Sustainable Opportunity Policy Sustainable Opportunity Policy Honeywell s Commitment to Health, Safety and Environment By integrating health, safety and environmental considerations into all aspects of our business, we protect our employees, our communities and the environment, achieve sustainable growth and accelerated productivity, drive compliance with all applicable regulations and develop technologies that expand the sustainable capacity of our world. Our health, safety and environmental management systems reflect our values and help us meet our business objectives. Honeywell Page 10 of 37
We protect the safety and health of our employees, and minimize the environmental footprint of our operations through efforts to prevent illness, injury and pollution. We actively promote and develop opportunities for expanding sustainable capacity by increasing fuel efficiency, improving security and safety, and reducing emissions of harmful pollutants. We are committed to compliance with all of our health, safety, environmental and legal requirements everywhere we operate. Our commitment to health, safety and the environment is an integral aspect of our design of products, processes and services, and of the lifecycle management of our products. Our management systems apply a global standard that provides protection of both human health and the environment during normal and emergency situations. We identify, control and endeavor to reduce emissions, waste and inefficient use of resources and energy. We are open with stakeholders and work within our communities to advance laws, regulation and practices that safeguard the public. We abide by the company s own strict standards in cases where local laws are less stringent. Our senior leadership and individual employees are accountable for their role in meeting our commitments. We measure and periodically review our progress and strive for continuous improvement These are our commitments to health, safety, and the environment, and to creating Sustainable Opportunity everywhere we operate. 5.4 Planning (4.3 ISO 14001) 5.4.1 Quality & Environmental Objectives (4.3.3 ISO 14001) Management is responsible for establishing top level quality and environmental objectives and measurements. These objectives and measurements are established during the annual strategic planning process and are cascaded throughout the organization to the relevant functions and levels. The objectives are to be measurable and consistent with the Quality and Environmental policies. Quality objectives and measures are defined in support of the Quality Policy and recorded in the Business Plan. ESGP 05.01 Objectives, Targets and Programs 5.4.2 Quality & Environmental Planning Management is responsible for the planning of resources and activities in order to achieve the Quality & Environmental objectives at all levels. The objectives in 5.4.1 are reviewed during the annual evaluation of the performance appraisal/hpd and management review processes. Honeywell Page 11 of 37
In general, our Quality and Environmental management systems are designed to ensure business objectives are not compromised when organizational changes occur. ESGP 05.01 Objectives, Targets and Programs 5.5 Responsibility, Authority & Communication (4.1 ISO 14001) 5.5.1 Responsibility & Authority (4.4.1 ISO 14001) Management ensures that functions and their interrelations are identified in the key process Figure 4.1 and ensure that responsibilities and authorities are defined and communicated within the organization through items such as lower level organizational charts, job descriptions, and Site procedures, as well as team and department meetings. President and VP of Integrated Supply Chain: Ensure Global Management System and Quality & Environmental policies are communicated and deployed, as applicable, throughout the entire organization. Operations, Technology and Business Leaders: Ensure Quality and Environmental Policies and GMS are communicated, deployed and implemented, as applicable, throughout their reporting organizations. Global Quality & Environmental Leaders: The Global Quality and Environmental Leaders are assigned the responsibility and authority for development and maintenance of the GMS and ensuring its implementation and responsible to act on the behalf of the top management to ensure: the GMS and Quality & Environmental Policies are communicated, effectively deployed and implemented; and the GMS and its core processes are measured, monitored, and continually improved. Product or process nonconformities are promptly reported to the manager who is responsible for assuring the corrective action. When action is needed to correct product quality problems, the person responsible for the quality of the product may stop production. In multiple shift operations, each shift has a shift leader who is responsible for product quality. 5.5.2 Management Representative Site Quality and HSE Management Representatives: The scope of the Site Quality and HSE Management Representatives responsibilities are defined by the Quality or Environmental certification applicable to their site. They are responsible for ensuring consistency between site specific documentation and the GMS Manual and to ensure all local documentation is compliant with ISO9001, as well as AS9100, TS 16949 and Honeywell Page 12 of 37
ISO 14001 requirements when applicable. Their responsibilities include but are not limited to: ensuring the GMS is established, implemented, and maintained at the site level; reporting to top management at the site on the performance of the GMS as a basis for continual improvement of the GMS; ensuring the promotion of awareness of customer requirements throughout the organization; and the organizational freedom and unrestricted access to top management to resolve quality management issues. Additional responsibilities include the communication of information from the Site Quality Management Reviews to Global Quality Leaders as appropriate The Management Representative is responsible for ensuring that customer requirements are reviewed and addressed. 5.5.3 Internal & External Communication (4.4.3 ISO 14001) Internal It is the responsibility of management to gather and communicate information regarding the effectiveness of the Global Management System to their organizations. External The Site Leader is responsible for the external communication in case of incidents. The HSE manager is responsible for the communication with local environmental authorities. The Site Leader will ensure that customers and/or regulatory authority representatives can obtain access to relevant documentation, when requested. The Site Leader will ensure that quality and HSE matters are included in regular communications within their sites. ESGP 05.01 Objectives, Targets and Programs and ESGP 07.02.03 Environmental Related Communications 5.6 Management Review (4.6 ISO 14001) 5.6.1 General The Management Representatives (as described in Section 5.5.2.) are responsible for conducting management reviews of the GMS at least once a year. These reviews ensure the continuing suitability, adequacy, and effectiveness of the GMS, including assessing opportunities for improvement and the need for changes. Honeywell Page 13 of 37
The HSE & Global Quality leadership are responsible for continuous improvement of the Environmental and Quality System. The complete Management Review process is described in the Figure 5.6. These quality reviews include all of the quality management system requirements and performance trends, including quality objectives, cost of poor quality measure, and customer satisfaction. QSGP 05.06 Global Management Review 5.6.2 Review Inputs There are standard inputs for the management review. Besides the standard inputs, the team can add other (system related) inputs, if required. These inputs are: review Quality and Environmental objectives, targets and Policies; results of assessments/audits; supplier selection and Quality performance; customer satisfaction feedback; process performance (reference Global Scorecard); product conformity; status of preventive and corrective actions; follow-up actions from earlier management reviews; planned changes that could affect the Quality & Environmental management system; recommendations for continual improvement; analysis of actual and potential field-failures and the impact of these failures on quality, safety and the environment; summary of results related to design and development phase measurements; incidents and accidents*; and development in techniques and legal requirements. *recommended for all sites. Required only in those sites with ISO 14001 systems. 5.6.3 Review Outputs The output from the management review includes decisions and actions related to: improvement of the effectiveness of the Quality & Environmental framework and its processes; improvement of product and processes related to customer requirements; and resource needs. Results of management reviews are to be recorded and maintained. Honeywell Page 14 of 37
Figure 5.6 - Management Review Process Input Mgmt Review Package Site Mgmt Review Site Output Audit Results Customer Feedback Process Conformity Corrective/Preventive Action Status Mgmt Rev Follow-up Actions QSM Changes Improvement Recommendations QSM Improvements Product/Process Improvements Resource Needs 6 Resource Management (4.4.1 ISO 14001) 6.1 Provision of Resources Management is responsible for planning and deploying resources to achieve the goals of the GMS. Resource requirements are defined during the business planning process and reviewed during the Management Review process. Resources include human resources and specialized skills, technological and financial resources. New employees are always instructed on Quality & Environmental related items. 6.2 Human Resources 6.2.1 General Management is responsible for identifying and assigning personnel based on appropriate education, training, skills, and experience. Ref performance development through HPD. 6.2.2 Competence, Awareness & Training (4.4.2. ISO 14001) Management uses the HPD (Honeywell Performance and Development) system or annual performance review system to assess and manage the training requirements and competency of employees. Management cascades goals throughout the organization annually using the Annual Operating Planning process which then cascades objectives down to individuals. Each site develops procedures regarding identification of training needs, implementation of training, and assessment of competence. Training includes Honeywell Page 15 of 37
assuring that individuals are aware of how they contribute to quality and environmental policies, objectives and targets. Product design personnel are skilled in the usage of the appropriate tools for achieving the design requirements. In addition to the identification of training needs, the documentation includes responsibility for conducting training, recording of the completion of training and evaluating the training provided. Both full and part time personnel, who affect the quality of products and services, are given on the job training when given new or changed work assignments. Also they are told of the consequences to customers when there is a non-conformance in quality requirements. Processes are in place to motivate achievement of quality objective, continual improvements, and an environment for innovation, with a measurement process for determining the level of employee awareness. 6.3 Infrastructure (4.4.1 ISO 14001) The organization provides and maintains the infrastructure necessary to achieve conformity of products and services (including subcontracted). Including but not limited to: buildings, workspace and associated facilities; process equipment, both hardware and software; and supporting services (e.g. transport, communications, facilities, maintenance). The organization utilizes a cross-functional team approach in developing the plans for facilities, equipment, and processes. The objective is to optimize process and material flow, floor plans, and the use of floor space. As indicated in the appropriate procedures, evaluations are made of the factors that affect our manufacturing capability, such as plant layout, work flow, automation and human factors issues, and inventory management. Plans are developed to assure that emergencies which cause work stoppage are planned for. This includes plans for utilities and equipment failures, labor shortages, and field returns. 6.4 Work Environment Functions and sites provide the appropriate work environment needed to achieve conformity of product, and to minimize any risk to the environment. In the design and development of products and manufacturing processes, consideration is given to the safety risks of employees. This includes considerations made during FMEA risk analysis, mistake proofing during design and process control, and consideration for compliance to regulations. Honeywell Page 16 of 37
The sites maintain a clean and orderly work environment appropriate to the products being produced. 7 Product and/or Service Delivery (Realization) (4.4, 4.4.6 ISO 14001 7.1 Planning & Product Delivery (Realization) (4.3.1, 4.4.6, 4.5.2, ISO 14001) Management provides the infrastructure (including needed resources) for deployment, maintenance and implementation of processes, including local and customized processes. The organization establishes and maintains controlled processes for performing and verifying all key processes shown in Figure 4.1. These processes are described in procedures (text or process map) and work instructions. Each process has its own clearly defined targets. It is the site leader s responsibility to ensure and evaluate compliance with Honeywell requirements, and environmental legislation, as well as other applicable requirements (4.5.2 ISO 41001). ESGP 07.01 Legal, Regulatory and other Requirements Environmental aspects (4.3.1 ISO 14001) are considered for each key process shown in Figure 4.1. The identification and impact assessment of the environmental aspects is documented in a global procedure (ESGP 04.02.02) These are reviewed annually at a minimum and consideration is given to new developments, activities and products, as well as those currently existing. ESGP 04.02.02 Application of the EMS to Projects, Production Processes During the development of the quality plan, consideration is given to customer specific requirements, as well as those of the current revision of the TS 16949 standard. Acceptance criteria for product is defined in test plans and approved by the customer if required. Acceptance criteria for attribute data sampling is zero defects. Confidential documents and data are controlled to ensure against possible misuse. This includes customer data and documentation. A process is in place for control and reaction to changes to both products and processes, and which looks at the effects of the changes. The need for verification and validation of changes is determined and carried out as appropriate. Consideration is given to the requirements of the customer during verification and validation. Honeywell Page 17 of 37
As appropriate, quality objectives and requirements for the product shall be determined. Aspects for consideration may include: product and personal safety reliability, availability, and maintainability producibility and inspectability suitability of parts and materials used in product selection and development of software recycling or final disposal of the product at the end of its life configuration appropriate for the product resources to support the use and maintenance of the product 7.1.1 Project Management As appropriate to the organization and the product, the organization shall plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints. 7.1.2 Risk Management The organization shall establish, implement, and maintain a process for managing risk to the achievement of applicable requirements. 7.1.3 Configuration Management A configuration management process is established, documented and maintained as appropriate to the product. 7.1.4 Control of work transfers The organization shall establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organizational facility to another, from organization to supplier, or supplier to supplier) and to verify the conformity of work to requirements. 7.2 Customer Related processes 7.2.1 and 7.2.2 Determination and Review of Requirements Relating to the Product (4.3.1, 4.3.2, 4.4.6 ISO 14001) The method of determining and reviewing product requirements is controlled at the Business and/or Site levels as appropriate for each business and customer set. The organization determines customer requirements both stated and not stated, as well as other additional requirements including statutory and regulatory requirements. Reviews are conducted prior to acceptance of a contract or order. These reviews include requirements of the product, order or contract. Needs related to special characteristics, traceability, safety, environmental requirements, produceability, and after sales support will be defined. Honeywell Page 18 of 37
Manufacturing feasibility, including risk analysis, are conducted and documented as part of these reviews. In addition, risks are evaluated to determine those which may adversely affect the ability to meet the commitment to supply product to the customer. QSGP 07.02.01 Agency Approval QSGP 07.02.02 Product Sales Contract Review Procedure 7.2.3 Customer Communication (4.4.3 ISO 14001) Customer focus and two way communication is a key element of everyone s responsibility. When designated, the customer s specified language and format for communications is followed. Feedback of the customer and regulatory agencies, related to both positive and negative experiences is used as feedback for the organization and is used for continuous improvement of the quality & environmental system. ESGP 07.02.03 Environmental Related Communications 7.3 Design & Development (4.4.6 ISO 14001) The product development processes define the inputs, outputs and review process required. The organization uses the New Product Introduction Process to manage product development. It may be customized, to meet unique operating environments. Owners of customized processes are responsible for ensuring deployment, maintenance, implementation, and monitoring of these customized processes. Input data is reviewed to verify that there is consistency with the requirements identified. 7.3.1 Design and Development Planning The development process is defined by documented procedures. Every project encounters different circumstance, conditions and constraints and has different needs and requirements which must be met. Each project development team has responsibility to determine and document the elements (both mandatory and optional deliverables/tasks) that are necessary to accomplish the project and the order in which they will be accomplished in a project plan, as well as identification of configuration management needs. In planning, consideration is given to identification of project owner and team members, design requirements including the input and output needs as it relates to each element, and for achieving the objectives for the safety and functionality of the product including those requirements identified by customers and regulatory authorities. Environmental considerations are part of the design process from early concept through to delivery. Each element s input data is reviewed to assure that they are consistent with the requirements. ESGP 04.02.02 Application of the EMS to Project and Production Processes Honeywell ESGP 07.03.01 Application of the EMS to the Page Design 19 of and 37 Development of New Products
A cross-functional approach is used in the product realization process, including the development and review of FMEA s and control plans, as well as the development and monitoring of special characteristics. 7.3.2 Design & Development Input During the requirements stage, a detailed methodology is available to assure that customer and environmental requirements are accomplished. Documents are used to identify and register the different requirements. The technology organization is responsible for completing all necessary steps needed for customer, agency and environmental requirements. The design and manufacturing process design inputs are identified, documented and reviewed, and include the identification of special characteristics. 7.3.3 Design & Development Output Quality records required by the project plan are kept in a project file (electronic or hardcopy). These are the outputs in the stage summary matrices of all elements that are mandatory as well as all other project specific elements the team has selected. The project outputs: meet the inputs requirements, provide valuable information to assure appropriate purchasing, production, and servicing, identify the acceptance criteria for the product, identify any characteristics important to the safe and proper use of the product, and specify as applicable any critical items such as key characteristics related to the design and contract requirements. The product design output is verified and validated, and includes: design FMEA, reliability results, product special characteristics and specifications, product mistake-proofing, as appropriate, product definition including drawings and mathematically based data, product design review results, and diagnostic guidelines, where applicable. The manufacturing process design outputs are verified and validated against manufacturing process design input requirements, and includes: specifications and drawings, manufacturing process flow chart/layout, manufacturing process FMEAs, control plan, Honeywell Page 20 of 37
work instructions, process approval acceptance criteria, data for quality reliability, maintainability and measurability, results of mistake-proofing activities, as appropriate and methods of rapid detection and feedback of product/manufacturing process nonconformities. A project file accessible to all team members are established and maintained by the project team. Data is provided which supports the configuration, design, manufacture, and sale of conforming product. This includes, but is not limited to, drawings, part lists, routings, product specifications, inspection and test documents, work instructions, and quality plans. 7.3.4 Design & Development Review During the stages of the Design and Development process, reviews are built in to assure the full potential of the new design/development to meet the customer/market and environmental requirements. During review, problems are identified and solutions proposed, and if warranted authorization is given to move on to the next design and development phase. Checklists are completed to keep track of the process. Measurements for specific phases of design and development are defined, and analyzed. These may focus on areas such as quality risks, costs, leadtimes, and critical paths, to name a few. Results from the analysis are summarized and provided as input into the site s Management Review. 7.3.5 Design & Development Verification The verification of the Design and Development Process is planned to assure that output of this process is consistent with inputs of the process. Records are completed as a part of the verification process. 7.3.6 Design & Development Approval The Design and Development approval process is a team based process. A project approval form is completed by the team. Upon completion of the design and development activity, records showing that the product meets the defined specifications are maintained. The planning, conducting, reviewing and documenting of tests for verification and validation are performed when required and reviewed to insure they meet the specification requirements. This provides evidence that: the plans address the product and test objectives, acceptance criteria, the conditions that the test is run under, and the resources to be utilized; the test procedures address the test methods, performance and results; the proper product configuration was provided for testing; the test plan and procedures were followed; and the criteria for acceptance were met. Honeywell Page 21 of 37
Design and development validation is performed in accordance with customer requirements (e.g. program timing). The prototype process utilizes the same suppliers, tooling, equipment and processes that are planned for use in the production of the product. Performance testing to requirements is conducted according to plans. Outsourced processes are controlled in the same manner that would be applied if they were being performed in-house, including the providing of technical support. The product and manufacturing process approval procedure applies both internally and to suppliers. QSGP 07.03.06 U.S. Military Qualification Maintenance Tests 7.3.7 Control of Design & Development Changes When changes in the design or development occur, the team reviews the impact for the customers. When the changes have a significant impact for the customers, or there are contractual requirements to do so, the changes are discussed with the customer. Design and development changes shall be controlled in accordance with defined configuration management processes. 7.4 Supply Management (4.4.6 ISO 14001) 7.4.1 Supply Management Process The organization ensures that requirements for purchased products and services are clearly defined, communicated to and understood by the supplier. This includes the need for purchased products and materials to conform to any applicable regulatory requirements. Suppliers are evaluated and selected on their ability to meet the defined requirements, the nature and criticality of the product or service being purchased and the supplier s environmental impact. Suppliers are certified to ISO 9001 and have a goal of achieving conformance to the TS 16949 standard. Exceptions require customer approval. The use of customerdesignated approved suppliers may be specified by the customer through contract; purchase orders, drawings, or specifications. Careful consideration is given prior to the usage of a customer-designated supplier to assure that the supplier is capable of providing the same quality of product and service, we require from all our suppliers. The organization maintains records of qualified suppliers. Honeywell Page 22 of 37
To ensure the quality of the supplied material meets the requirements, a supplier selection and assessment process has been established. New suppliers are selected according to criteria, including but not limited to, the following: quality; delivery time; price; service and readiness to join in a continuous quality improvement program (zero defects goal); and environmental aspects. Goods and services are purchased from suppliers that are included on our current approved suppliers list/database which identifies the supplier and scope of their approval. Supplier performance is reviewed and the level of controls to be placed on individual suppliers is identified. The extent of control exercised is dependent on the type of product being purchased, and when applicable, the supplier s previously demonstrated capability and performance. This control includes the actions which are taken on suppliers who do not meet requirements, the use of customer-approved special process suppliers, and a process for disapproving the use of suppliers. Risks shall be determined and managed for supplier selection. 7.4.2 Supply Management Information The organization s purchasing documents clearly describe the products or services being purchased. Including where appropriate: the requirements for approval of the product or service, qualified personnel, management system, identification (including revision) of drawings, procedures (processes, inspection) and other technical information, acceptance methods (test, inspection, etc.), management of test samples (production, identification and storage), handling of nonconforming product, including notification and approval; product and process changes; access of supplier facilities and records by the organization, also by our customers or their representative, and any applicable regulatory agencies when specified by contract and with prior coordination with the organization; and flow down of requirements from the supplier to its sub-tier suppliers, including any Key Characteristics. These documents are reviewed and approved for the adequacy of the specified requirements prior to release to the suppliers. Honeywell Page 23 of 37
7.4.3 Verification of Purchased Product and/or Services The organization plans for verification of purchased products and services to determine that they meet the specifications of purchase. This verification may include one or more of the following: receipt of and review of objective evidence of quality of the product supplied, including documentation such as inspection and test reports, C of C s, statistical data and process control records; inspection or audit at suppliers facilities, including those by 2 nd or 3 rd parties when supported by delivery of acceptable product quality; documentation review; incoming inspection; evaluation of material at an approved laboratory, and delegation of inspection to supplier or certification by supplier. When specifically agreed to by the customer, other verification methods may be utilized. Incoming material released without verification is recorded to allow for recall and replacement. The organization may delegate the verification activities to the supplier. Records of delegation are maintained. Methods, acceptance and reporting criteria for these verification activities are documented in appropriate procedures, quality plans or other instructions. Test reports for raw materials are periodically validated by the organization. Where specified on the purchasing documents, verification at the supplier s premises may be carried out by the organization and by customer s representative or regulatory agencies when the contract specifies. Verification by the customer is not evidence of quality control and does not relieve the organization of its responsibility to provide product which meets requirements, nor does it prevent rejection by the customer later. Supplier performance is monitored based on the following: product quality; customer interruption including those involving field returns; delivery performance (including incidents of premium freight); and quality or delivery issues identify by customer. Suppliers are encouraged to monitor the performance of their own production processes. 7.5 Production & Service Operations (4.4.6 ISO 14001) 7.5.1 Operations Planning and Control Operations Planning includes establishing of process controls and the development of control plans, when key characteristics are identified; establishing in-process verification method, when conformance cannot be Honeywell Page 24 of 37
verified at later phases of production; provision of tooling to take variable measurements, include those for key characteristics; and consideration of special processes (see 7.5.2). The organization establishes and maintains controlled conditions for performing and verifying production and service processes. These controlled conditions include: information describing the product characteristics; monitoring and controlling suitable process and product characteristics during production, with emphasis on those characteristics designated as key by the organization, or the customer; documented procedures and/or work instructions for production; generation and retention of quality records as evidence of the completion of planned manufacturing and inspection operations. identification of activities related to process monitoring and measurement; to release, delivery and post-delivery; and to Foreign Object Detection; use of suitable equipment and working environment (including documented compliance with government safety, environmental, and hazardous material related regulation as appropriate) planning and performing of regular scheduled maintenance of production equipment as necessary, to ensure process capability and reduce downtime, criteria for workmanship are either written or expressed by means of representative samples; identifying and accounting for all product during production; and monitoring and controlling utilities (such electricity, gas and water) and supplies (such chemicals) as it relates to their effect on product quality. These processes are described in detail at the Business or Site level and include quality and environmental controls. Control plans are developed for the pre-launch and production phases and are updated when changes affect the product realization. Processes that affect the quality of the products are documented in procedures or work instructions and support the quality plan, control plan and product realization process. This documentation is available to the employees responsible for these processes. Verification of job set-ups is preformed when setting up the initial run, and after change over. Set up personnel have access to the work instructions as well. Statistical techniques are utilized where appropriate. Preventive and predictive maintenance methods are applied to key equipment, tooling and gauging. In conjunction with outside resources, tooling and gauging is designed, produced, and verified. Production scheduling is driven by customer requirements. Field claims are managed through the corrective action process and involve manufacturing, engineering and quality. When a service agreement is in place by customer contract, action will be taken to assess the effectiveness of the service centre equipment, tools including software and training of personnel. Honeywell Page 25 of 37