2 Page 2 of 25 DOCUMENT INTRODUCTION PURPOSE OF THIS MANUAL This describes the quality management system at ABC Company Ltd, Buffalo, USA described as the Organization, and addresses the specific requirements of the standard. The document states our quality policy and quality objectives and publicly expresses our management commitment to quality excellence. APPOINTMENT ON THE QUALITY MANAGEMENT REPRESENTATIVE (QMR) To ensure implementation and full compliance with the quality management system, the Organization has appointed a Quality Management Representative, who regardless of other duties shall remain the focal point for quality management system activities. The Quality Management Representative reports directly to the President. (See Appendix 1 Organization Chart) Appointment The Organization has appointed Al Brown, Quality Manager, as the Quality Management Representative. President Date
3 Page 3 of 25 TABLE OF CONTENTS Description Page i. Document Introduction 2 ii. Table of Contents Company Profile Quality Policy QMS Scope and Organization Structure ISO 9001:2002 Quality Management System Policies Quality Management System General Requirements Documentation Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication Management Review Resource Management Provision of Resources Human Resources Infrastructure Work Environment Product Realization Planning of Product Realization Customer-related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Devices Measurement, Analysis and Improvement General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement 22 Revision Log & Distribution List 23 Appendix 1 Organization Chart 24
4 Page 4 of 25 PREFACE With increasing market awareness of the need for quality standardization, the Organization s facilities in Buffalo has aligned its Quality Management System (QMS) policies with the requirements. This (QM) demonstrates our dedication to excellence and our continuing commitment to supply quality products and services that satisfy customer requirements. 1.0 COMPANY PROFILE ABC Company Limited was founded in 1981 and is a diversified hardware fixture company providing a complete range of product and services to the industrial trade that include planning, designing, prototyping, manufacture and installation of quality products. In addition to its core business which is the manufacture and distribution of general hardware fixtures and industrial accessories, the Organization, manufactures and distributes specialized industrial hardware for the mining and petrochemical industries. Our extensive product line consists of the following major product groups: zzzzzzzzzzz sssssssss wwwwwwwwww ggggggggg yyyyyyyyyy ddddddddd We are the exclusive distributor in North America for As such, we have been instrumental in assisting many large hardware chains with their programs for converting to the... We are also a stocking distributor and retail service centre for.. USA. We can be reached at: Main Street Buffalo, New York Tel: XXX-XXX-XXXX 888-XXX-XXXX Fax: XXX-XXX-XXXX Web site:
5 Page 5 of QUALITY POLICY ABC COMPANY LIMITED and its associated companies herein described as the Organization is committed to meeting or exceeding our customers expectations and applicable regulatory requirements with regard to product quality, cost, delivery and customer service. Our motto is A business built on quality and service. Our objective is to be a leading supplier of custom-designed and manufactured hardware fixtures, xxxxx and related accessories. We achieve this by maintaining an effective QUALITY MANAGEMENT SYSTEM in conformity with ISO 9001:2000 and regulatory requirements as well as continually improving our products and processes to enhance customer satisfaction. Our QUALITY MANAGEMENT SYSTEM policies, controls and documentation are developed, reviewed and updated through the active participation of our employees. We are continually learning, improving and implementing new ideas, skills and knowledge for the mutual benefit of our customers, employees and the Company. Eric Pelletier President 3.0 QMS Scope and Organization Structure 3.1 Scope Location: The scope of our QMS covers all processes, functions and activities related to the quality of our products manufactured and distributed from our facilities at Main Street, Buffalo, New York. 3.2 Products and services: Sale, design, manufacturing, installation and distribution of hardware fixtures and accessories. 3.4 Applicable Standard: All requirements of the Quality management standards are applicable to these facilities. 3.5 QMS Processes: The Organization s QMS includes the following processes, departments and functions: Customer Oriented Processes (COP s) 1. Sales and marketing (Project bid/tender (RFQ); custom & catalogue orders) 2. Customer service (catalogue orders/requests; customer complaints and concerns) 3. Product design & development (CADD & hand drawings) 4. Production (Production Planning; manufacturing drawings; quotation input; cutting; cabinet-making) 5. Warehouse (receiving; storing; inventory management; packaging & shipping) 6. Project Management 7. Installation
6 Page 6 of Customer Satisfaction feedback Support Processes 1. Business planning 2. Management review 3. Purchasing 4. Information technology 5. Human resources 6. Facilities and equipment management 7. Tooling, jigs, fixtures and maintenance management Quality Management Processes 1. QMS & product realization planning 2. Corrective & preventive actions 3. Control of documents 4. Control of records 5. Continual improvement 6. Control of nonconforming product 7. Calibration 8. Internal audits These processes are summarized on the Process Matrix see QP Organization Structure (Appendix 1 - Organization Chart) This section of the defines the interrelationships and authorities of the various departments and its personnel Note: Titles may be abbreviated thorough this manual. Example: Quality Manager Representative may be expressed as QMR. Titles may also be referred to in common terms i.e.: Materials Department may be referred to as the purchasing function. 3.7 Business Process Work Flow Manufactured product//custom Projects/Jobs Concept to Customer Commitment Marketing/Sales Estimating - Quoting Design to make Design/CADD Store Layout & Fixtures Order Processing to Cash Sales Order Deposit - Project Management Invoicing - Collections Materials Procurement to Payment Requirement Planning Sourcing Expediting - Receiving - Payables Production Planning to Execution Resources Planning/Scheduling Manufacture Assemble Ship - Install
7 Page 7 of 25 Concurrent Timeline Business Process Work Flow Distributor Product Order Processing to Cash Marketing/Sales/Customer Service Sales Order Shipping - Invoicing - Collections Procurement to Payment Inventory Management Sourcing Expediting- Receiving - Payables - Operational Process Flows - Process Matrices - Quality Procedures 4.0 QMS Policies This section describes our policies related to compliance with the specific requirements of the standard. 4 Quality Management System 4.1 General requirements We have documented and implemented a quality management system (QMS) and strive to continually improve its effectiveness in accordance with the requirements of this standard. We have identified all the processes needed for the QMS (see section 3 above; QP 11 & 12) and determined their sequence and interaction. We have developed the criteria and methods for effective operation and control of these processes and ensured the availability of adequate resources and information necessary to support theses processes. We have established methods to monitor, measure and analyze these processes, to achieve planned results and continual improvement of these processes. Control of outsourced processes does not absolve us of the responsibility for conforming to all customer requirements. The Quality Manager is responsible for developing the Processes Matrix for each department. Each department is responsible for the effective implementation of all controls, policies, objectives, procedures, work instructions and documents pertaining to their processes and functions. The President or authorized delegate is responsible for the approval of all the processes; providing resources and reviewing the performance of all processes. References
8 Page 8 of 25 Section 3 - scope section of this quality manual provides a listing of our processes. QP 12 Processes Matrix QP 11 - Process Flowcharts 4.2 Documentation requirements General Our QMS documentation is structured in four levels: The top level is the and contains the Organization Quality Policy and QMS policies specific to the standard. The second level contains the Quality Management System Procedures, referred to as QP s. QP12 - Process Matrix includes the objectives or performance indicators for each QMS process. The third level includes documents that describe the planning, operation and control of our QMS processes. These include QP 11 Process flowcharts and QP12 Process Matrix, customer-specific Project Plans, work orders, sales orders, work instructions, forms, checklists, drawings and specifications, etc. The fourth level covers records (See QP 03 Control of QMS records) required by the standard, our customers, regulatory bodies and ABC Co business processes and these records demonstrate our conformity with requirements We maintain a quality manual that includes the scope of the quality management system (see section 3), including details of and justification for any exclusions; reference to documented procedures (QP s) established for the QMS and the Processes Matrix and process flowcharts that document the interaction between QMS processes Control of documents We have a documented procedure (QP-02) to control all QMS documents described in section (including drawings, specs and software data) that affect product and QMS conformity. The procedure includes controls to approve documents prior to issue; to review and update as necessary and re-approve document changes; a master list identifying changes and the current revision status of documents; to ensure that relevant versions of applicable documents are available at points of use; to ensure that documents remain legible and readily identifiable; to ensure that documents of external origin are identified and their distribution controlled; to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose Control of records We have a documented procedure (QP-03) to define controls to identify, store, protect, retrieve, retain and dispose of quality records. Records are legible, readily identifiable, retrievable and satisfy regulatory and customer requirements. We keep records (such as records, reports, charts, and electronic data) to show evidence of conformity to requirements and effective operation of the QMS. The QMR is responsible for establishing, documenting, and maintaining the QMS quality manual, Process Matrices, documented procedures, instructions and other operational documentation. Each department is responsible for the day-to-day conformity to policies, procedures, work instructions and documents pertaining to their departments. The Design department for controlling and maintaining all company and customer drawings and specifications.
9 Page 9 of 25 The President is responsible for the control of the Business Plan. All department managers are responsible for ensuring quality records pertaining to their departments are properly identified, stored, and maintained. Document Reference: Located on Company Intranet QP 01 QMS Planning QP 02 Control of Documents QP 03 Control of Records QP 04 Management Responsibility QP 05 Human Resources QP 06 Control of Measuring Devices QP 07 Internal Audits QP 08 Control of non-conformances QP 09 Corrective and Preventive action QP 10 Continual Improvement QP 11 Business Process Flowcharts QP 12 Process Matrix Lower Level Documentation located on company Intranet - Forms and checklists, spreadsheets, etc - Client Floor Plan and fixture drawings on Auto-Cad - Production drawings on Auto-Cad - Sales, Purchasing, Inventory Management - Business Vision QMS Records On Intranet 5 Management responsibility 5.1 Management commitment Our top management (see Appendix 1 - Organization Chart) is committed to develop, implement and continually improve QMS effectiveness by: communicating to all levels of the organization, the importance of meeting customer, as well as statutory and regulatory requirements; establishing the quality policy and objectives; conducting management reviews and ensuring the availability of resources. (See QP 04 Management Responsibility).
10 Page 10 of Customer focus Our top management ensures that customer requirements are determined and met, with the aim of enhancing customer satisfaction through the customer-oriented processes. (See QP11- Process Flowcharts and QP12 Process Matrix). 5.3 Quality Policy Our top management ensures that the quality policy (see section 2.0 of this manual) is appropriate to the purpose of the organization; includes a commitment to comply with requirements and to continually improve the QMS; provides a framework for establishing and reviewing quality objectives (see QP12 Process Matrix); is communicated and understood within the organization and is reviewed for continuing suitability at business planning and management reviews. 5.4 Planning Quality objectives Our top management ensures that quality objectives, including those needed to meet requirements of product are established for all processes within the facility. The organization s quality objectives are measurable, consistent with the quality policy, are included in the business plan and used by top management to deploy the quality policy. Quality objectives address customer expectations and are established to be achieved within a defined time period. Objectives are documented on QP12 Process Matrix, approved by top management and are regularly reviewed at management review meetings Quality management system planning Our top management ensures that planning of the QMS is carried out in order to meet the requirements given in clause 4.1 as well as the quality objectives, and the integrity of the QMS is maintained when changes to the QMS are planned and implemented. This is done through QP11- Process Flowcharts and QP12 Process Matrix. The process matrix identify the inputs, outputs, resources, documentation, responsibility, controls and performance measurable and objectives of each process included in the scope. The Process flowcharts show the flow and details of each process. Our top management is responsible for all policies listed in clauses 5.1 through 5.4. The Quality Manager and process owners are responsible for the achievement of these requirements. References QP11 Process Flowcharts QP12 Processes Matrix QP04 - Management Responsibility QP 01 Quality Planning Section 2 The organization Quality Policy 5.5 Responsibility, authority and communication Responsibility and authority Our top management ensures that functional responsibilities and authorities are defined and communicated within the facility through the organizational chart, job descriptions, procedures and work instructions.
11 Page 11 of Management representative Our top management has appointed the Quality Manager (a member of management) as the Quality Management Representative (QMR). The QMR s responsibilities include: ensuring that processes needed for the QMS are established, implemented and maintained; reporting to top management on the performance of the QMS and any need for improvement; ensuring the promotion of awareness of customer requirements throughout the organization Internal communication Our top management has ensured that appropriate communication processes exist within the facility and that appropriate communication is provided to employees regarding the effectiveness of the QMS. See QF-02 for lines of authority and reporting relationships of all functions identified on the organization chart. References QP12 - Processes Matrix Appendix 1- The Organization Chart QP 04 Management responsibility All QP s and work instructions Bulletin Board 5.6 Management review of the QMS General Our top management reviews the QMS semi-annually, to ensure its continuing suitability, adequacy and effectiveness. These reviews include assessing opportunities for improvement and the need for changes to the QMS, including quality policy and objectives. Minutes are kept of all management reviews Review Input The inputs to management review (meeting agenda) include: a) Results of internal and external audits, b) Customer feedback; c) Process performance and product conformity; d) Status of preventive and corrective actions; e) Follow-up actions from previous management reviews; f) Changes that could affect the quality management system g) Recommendations for improvement Review output The outputs from the management review include decisions and actions related to: a) Improvement of the effectiveness of the QMS and its processes b) Improvement of product related to customer requirements c) Resource needs. These decisions and actions are recorded in the minutes to each meeting (QF-88B) Our management team is responsible for holding annual management review meetings. References QP12 Process Matrix QP 04 Management Responsibility Minutes of management review meeting
12 Page 12 of 25 6 Resource management 6.1 Provision of resources We have determined and provided adequate resources needed: to implement and maintain the QMS and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirements. We accomplish this through our business plan and Processes Matrix. 6.2 Human resources General We ensure that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience Competence, awareness and training We have established and maintained a documented procedure for identifying training needs and achieving competence of all personnel performing activities affecting product quality. We have determined the necessary competency for personnel performing work affecting product quality; provided training or taken actions to satisfy these needs; evaluated the effectiveness of the actions taken; ensured that our personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives and we have maintained appropriate records of education, skills, experience and training. Human resources activities are addressed through the Business Plan, budgets, Human resources department initiatives, personnel developments reviews, etc. The department managers, Human resources representative and QMR are jointly responsible for addressing these requirements. All department managers are responsible for ensuring job descriptions and responsibilities are maintained for all staff. They are also responsible for ensuring all the skills required to perform the job are acquired, and documented. The Quality department is responsible for providing QMS awareness training to all personnel. QP 04 Management Responsibility QP 06 Human Resources Business Plan 6.3 Infrastructure We determine, provide and maintain the infrastructure to achieve conformity to product requirements. Infrastructure includes buildings, workspace and associated utilities, process equipment (both hardware and software) and supporting services. 6.4 Work environment Our work environment is managed and controlled to achieve conformity to product requirements and safety of our employees. Responsibility
13 Page 13 of 25 Our top management is responsible for the provision of adequate resources and a suitable environment work environment The President and Executive Vice President are responsible for determining the needs for all the production processes. Building Maintenance is responsible for maintaining the facility and ensuring preventative maintenance is carried out on production equipment. The Production manager is responsible for coordinating the production process and the Quality Manager/department is responsible for assuring product quality and ensuring adequate product and process quality controls are in place, where applicable. Business Plan QP 04 Management responsibility 7 Product realization 7.1 Planning of product realization We use process matrices to plan and develop the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the QMS. Our planning for product, project or contract realization includes the following as appropriate: Quality objectives and requirements for the product, project or contract; Processes, documents and resources specific to the product, project or contract; Required verification, validation, monitoring, inspection and test activities and the criteria of product acceptance; Records to show evidence that the realization processes and resulting product meet requirements. The output of this planning is documented on work orders, checklists, specifications, work instructions, etc. Customer requirements and references to their technical specifications are included in the planning of product realization. The management team is responsible for the development of appropriate plans for each product, project or contract. Input from all disciplines is considered in such planning. QP 11 Process Flowcharts QP 06 Control of Measuring Devices 7.2 Customer-related processes Determination of requirements related to the product We determine requirements specified by the customer, including the requirements for delivery and postdelivery activities; requirements not stated by the customer, but necessary for specified or intended use, where known; statutory and regulatory requirements related to the product and any additional requirements determined by our company.
14 Page 14 of Review of requirements related to the product We document and review all contract requirements determined as per section 7.2.1, prior to our commitment to supply product to the customer and ensure that: product requirements are defined; contract or order requirements differing from those previously expressed are resolved and that we have the ability to meet defined requirements. We keep records of these reviews and actions arising from them. Where product requirements are changed, we ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. We obtain customer authorization, in any situation where a formal review of contract requirements is not done Customer communication We have effective arrangements for communicating with customers relating to product information; enquiries, contracts, or order handling, including amendments and customer feedback, including customer complaints. We have the ability to communicate necessary information including data in a customer specified language and format. The Sales department in conjunction with a multidiscipline team (as appropriate) is responsible for the quote/contract activities and related reviews as required. The Project coordinator takes over the project upon completion of contract review. The Project coordinator will monitor the project and track its progress; communicate with the customer and ensure that our commitments are being met. The Purchasing department is responsible for determining material and supplier requirements. The Sales department is responsible for ensuring that the requirements of all existing product orders can be met. QP 11 Process Flowcharts 7.3 Design and development Product design and development is included and is covered by the following policies: Design and development planning We plan and control product design and development by determining the: design and/or development stages; review, verification and validation that are appropriate to each stage; the responsibilities and authorities for design and development. We update our plans as the design and development progresses. We manage the interfaces between different functions/processes involved in design and development to ensure effective communication and clear assignment of responsibilities Design and development - inputs We identify, document and review the product design input requirements, including: Functional and performance requirements specified by the customer, Applicable statutory and regulatory requirements, Where applicable, information derived from previous similar designs, and
15 Page 15 of 25 Other requirements essential for design and development. These inputs are reviewed for adequacy. We ensure that requirements are complete, unambiguous and not in conflict with each other Design and development outputs Our product design output is expressed as drawings, specifications, material requirements, work instructions, etc., that can be verified against design input requirements and approved prior to release for production. These design and development outputs: Meet the input requirements for design and development, Provide appropriate information for purchasing, production and service provision, Contain or reference product acceptance criteria and Specify the characteristics of the product that are essential for its safe and proper use Design and development review We perform systematic reviews of product design and development at suitable stages as defined in our plans. Our review includes an evaluation of the product design to meet requirements and identify any problems and propose necessary actions. These reviews are conducted by multi-disciplinary teams and appropriate records are kept of these reviews Design and development verification We perform verification in accordance with our plans to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions are maintained Design and development validation We perform validation in accordance with our plans to ensure that the resulting product is capable of meeting requirements for the specified application or intended use. Validation is completed prior to the delivery or the installation of the product. Records of the results of validation and any necessary actions are maintained Control of design and development changes We identify and keep records of product design and development changes. We also review, verify, and approve changes as appropriate, before implementation. The review includes the impact on the product, project or contract. We keep records of the results of the review of changes and any necessary actions The Design/CADD/Graphics functions in conjunction with cross-functional reviews are responsible for product design and development activities. QP 11 Process Flowcharts 7.4 Purchasing Purchasing process We ensure that all purchased product affecting quality of end product conforms to specified purchase requirements. The type and extent of control applied to suppliers and to the purchased product varies based on criticality, impact on end product and on our production process.
16 Page 16 of 25 We have a procedure to evaluate and select suppliers based on their ability to supply product in accordance with our requirements. We have defined the criteria for their selection, evaluation and re-evaluation and appropriate records are kept of these activities Purchasing information Purchasing documents contain data clearly describing the product ordered, referencing specifications, drawings, qualification of personnel, QMS & process requirements, procedures, inspection instructions, due dates, or other relevant data, as appropriate. We ensure the adequacy of specified purchase requirements, prior to transmittal to the supplier Verification of purchased product We perform inspection and other activities necessary to ensure that purchased product meets our purchase requirements. Where we, or our customers, intend to perform verification at our supplier s premises, we specify the intended verification arrangements and method of product release in our purchasing documents. The Quality Manager and the Purchasing Manager are both jointly responsible for evaluating, approving and removing vendors; determining the criteria for monitoring incoming product quality and supplier development and performance. The Purchasing Manager is responsible for maintaining the approved supplier list (ASL) and ensuring that products are purchased from approved suppliers. The Purchasing Manager is responsible for providing schedules or forecasts to suppliers of ABC Company top running jobs. The Purchasing department is responsible for reviewing PO prior to issue (other than Trion products. Customer Service is responsible for reviewing and approving PO s to Trion. The Purchasing Manager and Quality Manager are responsible for determining material specifications and establishing inspection and test requirements and ensuring that they are carried out. QP 11 Process Flowcharts QP 06 Control of Measuring Devices 7.5 Production and service provision Control of production and service provision We plan and carry out production and service provision under controlled conditions that include, as applicable: providing information that describes product characteristics (Bill of materials and drawings; providing work instructions, as necessary; the use of suitable equipment and monitoring and measuring devices; the implementation of monitoring and measuring and the implementation of release, delivery and post-delivery (where applicable) activities.
17 Page 17 of Validation of processes for production and service provision We validate any production and service processes where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. As applicable, these processes are validated by: defining criteria for review and approval of the processes; approval of equipment and qualification of personnel; use of specific methods and procedures; requirements for records; revalidation. At this time all our products are verified by subsequent verification or monitoring. The Production, Quality and Purchasing departments are responsible for planning and ensuring processes are carried out under controlled conditions. The Production Manager is responsible for ensuring work instructions are available for all processes where the lack of instruction would have a detrimental effect on quality. The Quality Manager is responsible for establishing the requirements of process monitoring (where applicable), inspection / testing instructions and the control plan. All department managers are responsible to maintain their area in a clean reasonable organized manner. The Program Manager and the Production Manager are responsible for determining the production process needs for the manufacture, assembly and packaging operations. The Building Maintenance function is responsible for ensuring maintenance for the facility and production equipment. QP 11 Process Flowcharts QP 06 Control of Measuring Devices Identification and Traceability We identify product (supplier and ABC part numbers and project numbers) and product quality status by suitable means (work order sign off) throughout all stages of product realization. Where traceability is a requirement, we control and record the unique identification (Sales Order, Work Order) of the product. The Purchasing Manager, Production Manager and Quality Managers are responsible for ensuring all materials and products are identified and traceable from receipt and through all stages of production, storage to delivery. The personnel involved in the production from receiving throughout delivery are responsible for performing specified inspections and measurements and providing product inspection and test status. QP 11 Process Flowcharts QP 06 Control of Measuring Devices
18 Page 18 of Customer Property We exercise care with customer property while it is under our control or being used by us. We identify, verify, protect, track (inventory control) and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, we report it to the customer and maintain records. The Shipping/Receiving personnel are responsible for control; verification, storage and communicating any damage of any customers supplied product or materials, to the customer. Quality department is responsible, where applicable, for assisting Shipping/Receiving for the incoming inspection and issue of Supplier NCR s if required. QP 11 Process Flowcharts QP 06 Control of Measuring Devices Preservation of product We preserve the conformity of product during internal processing and delivery to the intended destination. This preservation controls include identification, handling, packaging, storage and protection. Preservation controls also apply to components and subassemblies. The Production and Shipping/Receiving departments are responsible for ensuring product handling, storage, packaging, preservation, and delivery requirements are met. All staff is responsible for handling and storing goods in a safe effective manner to prevent damage or deterioration. Shipping / Production are responsible for packaging, preservation and protection of product during delivery. Quality is responsible for random auditing of the shipment prior to being released. Various departments are responsible for auditing stock. QP 11 Process Flowcharts QP 06 Control of Measuring Devices 7.6 Control of measuring and monitoring devices We have a procedure to determine the monitoring and measurement to be done and the measuring and monitoring devices needed to provide evidence of conformity of product to requirements. We have processes to ensure that monitoring and measurement are carried out in a manner consistent with monitoring and measurement requirements. Where necessary, to ensure valid measurement results, we use measuring devices that are:
19 Page 19 of 25 a) Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, we record the basis used for calibration or verification; b) Adjusted or readjusted as necessary, c) Identified to determine calibration status d) Safeguarded from adjustments that would invalidate the measurement result, e) Protected from damage and deterioration during handling, maintenance and storage; In addition, we assess and record the validity of the previous measuring results when equipment is found out of calibration. We take appropriate action on the equipment and any affected product and keep records of the results of calibration and verification. The organization contracts out the calibrations of all gauges to an approved source. The Quality department is responsible for the selection of measuring devices required in the control plan and recall of all the inspection, measuring and test equipment. The Quality Department is responsible for measuring devices maintenance and outsourcing for calibration. QP 11 Process Flowcharts QP 06 Control of Measuring Devices 8 Measurement, analysis and improvement 8.1 General We plan and implement appropriate methods to monitor, measure, analyze and improve our processes in order to demonstrate product and QMS conformity and to continually improve the effectiveness of the QMS. The Quality department is responsible for ensuring all the requirements for statistical techniques are met. 8.2 Monitoring and measurement Customer satisfaction As a measure of QMS performance, we monitor our customer s perception as to whether we have met their requirements and have defined the methods for obtaining and using this information. Sales, customer service and the QMR are responsible for conducting the survey, analyzing, tabulating and presenting this data at the next management review meeting, on an annually basis. All managers are responsible to evaluate the results and trends and to respond (if required) to the President. QP 04 - Management Responsibility
20 Page 20 of Internal audit We conduct internal audits to determine whether the QMS: conforms to planned arrangements (see 7.1) and to and our QMS and requirements; and is effectively implemented and maintained. We have a documented procedure that defines the responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records. Our audit program is planned to audit all QMS processes at a minimum of once a year. More frequent audits of some processes may take place based on the status and importance of the processes and areas to be audited, the results of previous audits or where internal/external nonconformities or customer complaints occur. The audit criteria, scope, frequency and use of audit methods are defined. Our auditors conduct audits exercising objectivity and impartiality in the audit process and do not audit their own work or department. The management responsible for the area audited ensure that timely corrective actions are taken to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and reporting of verification results (see clause 8.5.2). The President is responsible for approving the audit program and ensuring that adequate resources are provided. The Quality Manager is responsible for audit scheduling, planning, and for organizing auditor training. The Quality department is responsible for establishing and maintaining audit procedures, schedules, and checklists. The Quality Manager is responsible for reviewing all Non-Conformances and Audit Reports, and for presentation of all audit results for Management Review. Auditors are responsible for conducting audits, and generating Audit Reports in conjunction with the audit schedule. Internal Auditors cannot audit activities they are responsible for, or the department they work in. Internal auditors are selected, trained and assigned based on their availability, independence and objectivity in performing audits and reporting results. Auditors and or the Quality Manager are responsible for audit corrective action follow- up. QP 07 Internal Audits Monitoring and measurement of processes We apply suitable methods to monitor and measure our QMS processes, to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, we perform correction and corrective action, as appropriate, to ensure product and process conformity. All process owners and departmental managers are responsible for the effective implementation of specific QMS processes.
21 Page 21 of Monitoring and measurement of product We monitor and measure if product characteristics requirements have been met. We do this at appropriate stages of the product realization process in accordance with our product, project or contract Quality Plans. (See 7.2.1). We do not release product or provide service until all planned (process checks) arrangements (see product realization planning) have been satisfactorily completed, unless otherwise approved by a relevant organization authority and, where applicable, by the customer. These checks are done at regular intervals to allow products to flow efficiently thorough our process. Final inspection is performed in accordance with documented instructions prior to product being shipped to the customer. Products are not released until all verification activities are completed. Our records show evidence of conformity with the acceptance criteria and person(s) authorizing product release. Where products fail to pass any inspection or test criteria, they are dealt with in accordance with QP 17 - Control of nonconforming material. The Quality Manager is responsible for defining the inspection and test requirements for all products as per product quality planning requirements. Receiving personnel is responsible for inspection and testing of all incoming goods to the requirements of the Purchase Order (P.O.). The supervisors and operators are responsible for inspection and testing of all in-process products (including related assemblies). Quality function is responsible for all the final inspection activities. 8.3 Control of nonconforming product We ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure. We deal with nonconforming product in one or more of the following ways: by taking action to eliminate the detected nonconformity; by authorizing its use, release or acceptance under concession by a relevant authority and where applicable, by the customer; return to the vendor; and by taking action to preclude its original intended use or application We maintain records of the nature of the nonconformities and any subsequent actions taken, including concessions obtained. Where nonconforming product is repaired or reworked, we re-verify it to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, we take action appropriate to the effects, or potential effects, of the nonconformity.
22 Page 22 of 25 The Quality department is responsible for ensuring proper control of nonconforming product, and for generating / distributing a non-conformance report. The Quality department is responsible for review of nonconformances, and has the authority to disposition the non-conformance. Significant problems may require the team assigned for the nonconformity to evaluate, determine root cause and appropriate corrective action, disposition, and determine effectiveness of the corrective action. Department Managers or delegates are responsible for identifying the cause and for correction of problems occurring in their respective departments. Managers must obtain concurrence from Quality department for disposition of nonconforming goods. All staff is responsible for stopping any condition adverse to quality, identifying the suspect goods with HOLD tags, and notifying supervisors and Quality. All personnel are responsible for notifying Quality department of any non-conformance. QP 09 Corrective and Preventive Actions 8.4 Analysis of data We determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS 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: customer satisfaction (see 8.2.1); conformity to product requirements: characteristics and trends of processes and products including opportunities for preventive actions; supplier performance. Each department must report on set management review measurable, as well as any specific requests of the President, or management group. QP 09 Corrective and Preventive Actions 8.5 Improvement Continual Improvement We have a process to continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews. Satisfaction surveys covering Quality, Service, Price, Delivery, Quoting, are utilized to help us better understand the market, and our customer s feedback. This enables goal setting and continual improvement. Product / Process s are continually monitored / considered for quality and productivity gains. Situations that lead us to candidates for improvement are: audit results, analysis of data, nonconformities, satisfaction surveys, scrap / rework costs, employee suggestions, or difficulties Corrective action We take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of nonconformities encountered.
23 Page 23 of 25 We have a documented procedure that defines requirements for: a) Reviewing nonconformities (including customer complaints and warranty returns) b) Determining the causes of 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 action taken (see 4.2.4) f) Reviewing corrective action taken Preventive action We take 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. We have a documented procedure that defines requirements for: a) Determining potential nonconformities and their causes; We use of information such as statistical data, audit results, customer complaints, etc., to detect, analyze and eliminate potential causes of nonconformances b) Evaluating the need for action to prevent occurrence of nonconformities c) Determining and implementing action needed d) Records of results of action taken (see 4.2.4) e) Reviewing preventive action taken The Quality department is responsible for establishing and maintaining procedures for corrective and preventive action. The Department Managers are responsible for problem solving, and ensuring effective corrective and preventive actions are taken. The QMR is responsible for providing responses to customer s complaints. Specific customer documentation may be used upon request. Significant problems may require the team responsible for the nonconformity to evaluate, determine root cause and appropriate corrective action, disposition, and determine effectiveness of the corrective action. The President is responsible for reviewing preventive actions to ensure suitability, and effectiveness (as required). QP 09 Corrective and Preventive Actions Revision Log The Quality Management Representative (QMR) will update any changes and ensure all obsolete versions pages are removed from use or availability. Each section on the quality manual is reviewed on an annual basis.
24 Page 24 of 25 Revision Date: Pages effected: Details: New Issue Number: 09/30/2006 Entire Manual Original issue of the in compliance with the Standard 0 DISTRIBUTION The is available as a controlled document on the Company Intranet as well as on its website as a read-only document. Printouts of the is discouraged and must be treated as uncontrolled by the reader. Need Training or Consultancy help? askartsolutions.com has significant expertise in all of the implementation steps and can help you fast track your way to an effective and profitable QMS. If you need help in developing or implementing your QMS, please call us at for a no obligation review of your needs.
25 Page 1 of 25 Prepared by: John Brown Revision: 0 Approved by: Eric Pelletier Rev. Date: 09/29/2006 Appendix 1
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