Quality Systems Manual
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TABLE OF CONTENTS
1.0INTRODUCTION
2.0QUALITY POLICY
2.1QUALITY OBJECTIVES:
3.0ORGANIZATIONAL CHART
4.0QUALITY MANAGEMENT SYSTEM
4.1Quality System
4.2Documentation
5.0MANAGEMENT RESPONSIBILITY
5.1Management Commitment
5.2Customer Focus
5.3Quality Policy
5.4Planning
5.5Responsibility, Authority, and Communication
5.5.1Responsibility and Authority
5.5.2Management Representative
5.5.3Internal Communication
5.6Management Review
6.0RESOURCE MANAGEMENT
6.1Provision of Resources
6.2Human Resources
6.4Work Environment
7.0PRODUCT REALIZATION
7.1Planning of Product Realization
7.2Customer Related Processes
7.2.1Determination of Requirements Related to the Product
7.2.2Review of Requirements Related to the Product
7.2.3Customer Communication
7.3Design and Development
7.4Purchasing
7.5Production and Service Provision
7.5.1Control of production and service provision
7.5.2Validation of processes for production and service provision
7.5.3Identification and traceability
7.5.4Customer property
7.5.5Preservation of product
7.6Control of Monitoring and Measuring Devices
8.0MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1General
8.2Monitoring and Measurement
8.2.1Customer satisfaction
8.2.2Internal audit
8.2.3Monitoring and measurement of processes
8.2.4Monitoring and measurement of product
8.4Analysis of Data
8.5Improvement
8.5.1Continual Improvement
8.5.2Corrective / Preventive Action
8.5.3Preventive Action
1.0INTRODUCTION
Company X has reliably provided high quality electronics manufacturing solutions to its customers since 1984. Our objective at Company X is to continually improve our service to customers in every way that counts: Quality, On-Time-Delivery and Cost. This is accomplished through excellence in: people, equipment, customer service and job performance.
The quality management system at Company X encourages employee ownership and empowerment and is supported by a strong top management commitment to quality excellence.
Quality initiatives focus on continuous improvement, process control, production support, employee training and continuous monitoring of customer satisfaction. This quality manual provides the overall strategy and objectives of our quality system.
Company X’s quality system is modeled after the ISO 9001:2000 quality standard and in many cases exceeds the requirements set forth in the ISO 9001 standard.
Company X is pleased to provide the quality manual to our customers. Understandably, Company Xs processes and procedures are considered proprietary and shall be considered confidential and used solely for the purposes of evaluating Company X. Manuals provided to our customers are uncontrolled and will not be updated unless specifically requested by the customer.
2.0QUALITY POLICY
At Company X, it is our goal to:
Always:
Understand and Meet the Needs
of our Partners!
Basic Principles govern our actions:
- Process Focus - Focus on the work process, issue or behavior, not the person
- Mutual Respect - Maintain the self-confidence and self-esteem of others
3.Partnerships and Teamwork - Maintain strong partnerships with your internal and external customers and suppliers
4.Personal Initiative - Take the initiative to improve work processes and partnerships
5.Leadership by Example- Lead by example
2.1QUALITY OBJECTIVES:
Company X has many objectives that it uses to gauge the health of the company and its Quality System. To drive continuous improvement, the Executive Management committee will define goals against these objectives. The following objectives have been established for the 2002 calendar year. The review frequency is noted where periodic review is defined.
Business/Financial performance objectives
- Revenue Performance (daily, monthly)
- Fixed Cost Performance (monthly)
Manufacturing performance objectives
- First Pass Yield at QC inspection, In-circuit Test, and Functional Test (daily)
- On-time delivery percentage of products to our customers (monthly)
- Labor efficiency compared to quote standard (weekly)
- Revenue per employee (daily)
- RMA Value - Percentage of returned product value to total revenue (monthly)
Materials
- Cycle count accuracy
- Inventory turns
- On time delivery from Stockroom to Production floor (weekly)
Program Management
- Gross margin analysis (monthly)
- Customer Survey Results (yearly)
Engineering
- MRB processing time
Human Resources
- Accident lost time
Finance
- Budget performance
3.0ORGANIZATIONAL CHART
COMPANY X
4.0QUALITY MANAGEMENT SYSTEM
4.1Quality System
Company X has defined and manages the processes necessary to ensure that products conform to customer requirements. The sequence and interaction of the processes is described in the figure below. As a means of implementing and demonstrating the defined processes, Company X has established, documented, and maintains a quality management system that is continually improved. Company X has prepared quality system procedures that describe the processes and systems required to implement the quality management system. The quality manual, along with several tiers of supporting procedures and documents, define the quality management system. A matrix list of all quality system procedures is maintained and includes the procedure name and number, and the current revision. Refer to the Process Map on the next page for a graphical representation of the Company X Quality Management System.
4.2Documentation
Company X has implemented and maintains a procedure for controlling all documents and records related to process and service requirements, as well as to the quality system. This includes Company X documentation, external documentation, and customer supplied documentation.
The quality manual is maintained and updated by the Operations organization and is available to all personnel as well as customers. The manual is reviewed at least annually to ensure its compliance with the ISO 9001 standard and Company Xs continual improvement initiatives.
The creation, approval, maintenance and storage of all documents related to processes and the quality system for the purpose of delivering conforming product is carried out in accordance with documented procedures. This system also controls all documents of external origin and supplied by customers, and ensures that current applicable documents are readily available to personnel performing their jobs.
Quality records are maintained to show that the required quality levels are achieved and to verify the effectiveness of the quality system. Quality records are stored and maintained in such a way that they are protected and readily available.
Refer to procedure 212-002 Document and Record Control.
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5.0MANAGEMENT RESPONSIBILITY
5.1Management Commitment
Company Xs Executive Committee has the management responsibility at Company X. They are committed to driving the development and improvement of the quality system, which includes:
- ensuring the availability of resources
- establishment and review of the quality policy and quality objectives
- implementing a plan of improvement to the quality management system.
The Executive Committee also has the responsibility to communicate the importance of meeting customer, safety and regulatory requirements throughout the organization. This communication occurs in both the monthly all-employee meeting and the daily production status meeting.
5.2Customer Focus
The business model and systems at Company X are designed with customer needs being the core focus. The Executive Committee accurately identifies adjustments that must be made to ensure a strong alignment with customer needs. To achieve this alignment they review new customer requirements, customer surveys, and market analysis reports and perform a gap analysis to determine if the currently defined Company X process meets or exceeds the customer needs and that Company X is able to effectively translate these needs into the required formats for the product realization process. Based on this analysis the Executive Committee will decide whether the systems and resources should be changed or upgraded to accommodate the new requirements or whether the customer’s business is not a good fit for the company.
5.3Quality Policy
The Executive Committee has published the quality policy and instills Company Xs commitment to the policy. They also ensure that the policy is understood, implemented, and maintained by all personnel. The quality policy shall be periodically reviewed by the Executive Committee to ensure it is appropriate and suitable for Company X, that it includes a commitment to meeting all requirements, shows continual improvement, and provides a framework for establishing and reviewing the quality objectives. See section 2.0 Quality Policy for details.
5.4Planning
The quality management system and sustaining processes support the quality policy and objectives (refer to section 2.0). An effective quality management system will assist Company X in meeting the needs of our customers through the on time delivery of error free products. The Executive Committee maintains the strategic plan to achieve the quality objectives and other requirements. They review this plan periodically to ensure its integrity and synchronization with new requirements.
5.5Responsibility, Authority, and Communication
5.5.1Responsibility and Authority
The Operations manager is responsible for ensuring that responsibilities and authorities are defined and communicated within the organization. Job descriptions are maintained by the Human Resources department, which outlines the responsibilities for all employees. These responsibilities are communicated during the employee review process and outlined in work procedures.
All levels of personnel have the authority to halt nonconforming processes and recommend corrective or preventive responses using the proper documented procedures.
5.5.2Management Representative
The Operations Manager owns the management of the quality system and objectives. As the Quality Representative for the organization he is responsible for ensuring that the quality objectives are met and that continual improvement projects are implemented with the goal of meeting each objective.
5.5.3Internal Communication
The Executive Committee is responsible for identifying and establishing the key communication processes at Company X. These processes are designed to review the status of key production and quality objectives and to identify the corrections or resources needed to achieve the objectives. The two primary communication forums used are the monthly employee meeting and the daily production meeting.
5.6Management Review
To monitor the effectiveness of the quality system, Company X reviews its quality objectives at established intervals, which are adjusted based on the business needs, risk assessment of the objective, and stability of the metrics. The Executive Committee shall review the quality management system at least annually to ensure its suitability, adequacy and effectiveness. The review shall assess opportunities for improvement and the need for changes to the quality management system, and shall include inputs from audit results, customer feedback, process performance, product conformity, preventive and corrective actions, and any recommendations and changes that could affect the quality system. Records of reviews are maintained that include decisions and actions related to improvement of the quality management system, improvement of processes, improvement of product, and resource needs.
6.0RESOURCE MANAGEMENT
6.1Provision of Resources
Company X shall determine and provide, in a timely manner, all resources needed to implement and improve the processes of the quality management system, and to address customer satisfaction. To achieve an adequate resource model, the Operations Manager shall audit that the customer/QMS requirements can be achieved within the economic constraints of the business. Evidence that adequate resources have been provided are documented in the Resource Plan and Operations Budget maintained by the Operations Manager
6.2Human Resources
All personnel who are assigned positions defined in the quality management system shall be competent on the basis of applicable education, training, skills, and experience. Company X shall provide all necessary training to satisfy the needs of the quality system. Personnel at each relevant function and level shall be made aware of:
- the requirements of the quality system
- the importance of conformance
- the impact of their work on quality
- the benefits of improved performance
- their roles and responsibilities in achieving conformance
- the potential consequences of departure from the specified procedures
Refer to procedure 250-005 Hiring, Training and Verification for additional information.
6.3Infrastructure
Company X shall determine, provide and maintain the facilities required to achieve the product conformity, including, but not limited to, workspace and associated facilities, equipment, and supporting services.
6.4Work Environment
Company Xshall determine and manage the work environment required to achieve product conformity. As a minimum, the facilities, including workstations and equipment, shall be maintained in a state of order, cleanliness, and repair that is appropriate to the process.
7.0PRODUCT REALIZATION
7.1Planning of Product Realization
Company Xbegins to develop its plan for product realization during the Request For Quote (procedure 261-002 Quoting Process) process. It is at this time that the requirements of the new product are evaluated and it is determined whether these requirements can be incorporated into the current business and manufacturing process models. After the customer accepts the quote, the product requirements are integrated into the Company X system using the Engineering Change Notification process (per procedure 212-001 ECN Process).
7.2Customer Related Processes
7.2.1Determination of Requirements Related to the Product
The Sales and Marketing department owns establishing communication with the customer and using a sales process to identify the needs of the customer and how Company X can address these needs. If Sales determines that the customer needs are a potential match for Company Xs capabilities, they will initiate the Request For Quote process (per procedure 261-002 Quoting Process).
7.2.2Review of Requirements Related to the Product
During the Request For Quote process, key contacts from Sales, Engineering, Program Management, Materials, and Document Control review the documentation provided by the customer to ensure that all requirements can be met by the currently defined production and quality processes. This review is documented in the 261-005 Turnkey Kickoff System procedure.
7.2.3Customer Communication
Sales and marketing own determining and establishing customer communication with new customers and driving the initial RFQ process. Once the initial RFQ is secured, Sales transfers the responsibility for customer communication to the Program Management department. A single program manager is then assigned as the primary customer contact and brokers all communication between other Company X departments. Program Management uses the 261-008 Order Confirmation and 261-003 Customer Issue Management procedures
7.3Design and Development
This section does not apply to Company Xs quality system. Company Xs customers are responsible for the control and verification of the design of their product, and therefore this portion is excluded.
7.4Purchasing
Company X maintains documentation to control all purchases that are required for achieving product that conforms to customer requirements in accordance with procedure 221-002 Placing/Managing Purchase Orders. Purchases are procured from approved suppliers in accordance with procedure 221-004 Supplier Management. All purchases are verified and inspected in accordance with procedure 242-001 Incoming Quality Control.
7.5Production and Service Provision
7.5.1Control of production and service provision
To clearly define and control the build process, Company X maintains detailed work instructions called Manufacturing Process Instructions (MPI) (see procedure 212-003 Manufacturing Process Instructions), which merges the customer requirements with industry specific manufacturing standards to define the specific process that is used to accurately build, inspect, and test a given product. The Engineering department is responsible for creating the MPI documentation, which is controlled using the Engineering Change Notification (ECN) process (see procedure 212-001 ECN Process).
Once a product has been confirmed to meet the customer requirements and it falls within the shipment date window agreed upon by the customer contract it can be delivered per procedure 222-003 Shipping.
7.5.2Validation of processes for production and service provision
Company X validates its processes primarily during the introduction or First Article phase of a new product. During this pilot period a close interaction is maintained with the customer to make sure that the documented product requirements are complete and can be achieved by the defined process. An analysis of the First Article phase is performed and used to generate updated process documentation for the production release of a product. A Design for Manufacturability report can be generated to feed back critical improvement requirements and suggestions that can be implemented by the customer to ensure a high quality product. Refer to procedure 211-009 Design for Manufacturability.
7.5.3Identification and traceability
Company X uses various identifiers to track material and products through the realization process. The status of the products are also identified at applicable stages of realization. Components and assemblies have unique identification requirements, which are specified by the customer and defined in the product work instructions.
Product that has been inspected and tested and exhibit no failures are stamped according to the product work instruction, which is controlled using the procedure 241-015 Control of Quality Stamps.
7.5.4Customer property
Customer documentation is collected and controlled at Company X using procedure 212-002 Document and Data Control. Customer owned property is controlled in accordance with procedure 211-004 Customer Supplied Product
7.5.5Preservation of product
Company X has many processes for defining the preservation of materials and products. The primary documentation for defining these requirements for a given product is the Manufacturing Process Instructions (MPI) (see procedure 212-003 Manufacturing Process Instructions). The MPI defines any special identification, handling, packaging, storage and protection required during assembly and once completed as a finished product. Company X also maintains separate procedures (ESD, Moisture Sensitive Devices, Material Handling) which define the special requirements for a specific device.
7.6Control of Monitoring and Measuring Devices
Company X maintains documented procedures for controlling, calibrating, and maintaining all test and measurement equipment that affect product quality. The accuracy of test and measurement equipment is controlled to assure compliance with test, inspection, and process instructions. Refer to procedure 211-001 Calibration Procedure for additional information.
8.0MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1General
Company X uses the product work instructions, referred as Manufacturing Process Instructions (MPI) (see procedure 212-003 Manufacturing Process Instructions), to validate product conformity. The MPI specifies the requirements needed to correctly manufacture a product and what validation mechanisms (Inspection, MDA/ICT, Functional Test) are used to measure these requirements. Each of these validation mechanisms generates pass/fail and defect information for the product. Defect information is aggregated daily into a Quality database as a quality record and presented to production, engineering, and management where corrective action is determined and tracked. The defect information is also summarized in defect pareto charts and yield trends and key improvement projects are prioritized. Company X also utilizes the Internal Audit Process to measure and monitor the conformity of the quality management system, as well as continually improving its effectiveness.