A Division of Research Products Corporation

Transcription

1 A Division of Research Products Corporation Quality Manual ISO 9001:2008

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3 Table of Contents Page Number Approvals 2 Table of Contents 3 Revision History 4 Distribution List - Controlled Copies 5 Introduction, Organization Overview, and Mission 6-7 Organization Structure 8 ISO Based Requirements 4. Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis, and Improvement 23-25

4 Revision History No. Date By Explanation JJD a) Indicated the Vice President of Engineering is open on page 2. b) Removed Jim Doll from Distribution List on page 5. c) Removed Quality Objective 1 and renumbered on page 7. d) Removed "Design and implement QA Procedure" as part of Quality Objective 4 on page JJD a) Added Steve Williams to distribution list, page 5. b) added channel to quality objective one "Customer visits" page Officers a) Prepared a new set of quality objectives Officers Revised Quality Objective One JJD Revised the procedure to be RP Quality Manual SRD a) ISO 9001:2008 compliance. b) Updated organizational chart Quality Manager reporting. c) Change to Aprilaire Division d) Quality Policy and Objectives now found in QMS Documents SRD a) updated the references to the policy now QMS-08 b) updated the org chart to include new direct reports c) updated the sign off sheet to include direct reports d) updated the controlled copy index

5 Distribution List - Controlled Copies John Bloemer Eric Brodsky Paul Graham Mike McGowan Mike Rimrodt Eric Swanson Tim Watson John Wickstrom

6 Introduction This quality manual describes the policies and company-wide controls for the quality management system of The Aprilaire Division of Research Products Corporation (Aprilaire). The Aprilaire quality system meets ISO 9001:2008 requirements. Documents associated with the quality system are found in their electronic version in GroupWise/QMS Documents. Organization Overview Fresh, pure air became the top concern of Aprilaire over 60 years ago. That is when we first began to design, develop, manufacture, and distribute quality products which improve the environment by controlling and conditioning the air in homes throughout North America. We introduced Aprilaire Humidifiers in 1954 as the first evaporative, flow-throughdesign humidifiers. Since then, we've added the Aprilaire Automatic Humidifier, Aprilaire High Efficiency Air Cleaner, Aprilaire Zone Control System, Aprilaire Electronic Thermostats and Aprilaire Energy Recovery Ventilator, the Aprilaire Dehumidifier, EZ- Kleen and KleenGard filters to continue our dedication to both quality manufacturing and more breathable, more healthful air. Our commitment includes ongoing programs of testing, engineering, research, product refinement, and practical experience. As a leader in the HVAC industry, we are able to work closely with industry associations like ARI and ASHRAE. These affiliations allow us to remain on top of industry standards and testing procedures. As a result, we are proud to give you our assurances of superior quality and selection for indoor air products that help you stay comfortable. These products are conveniently sold by local heating and air conditioning contractors throughout North America. Company Contact Information Research Products Corporation 1015 East Washington Ave. Madison, WI Research Products Corporation PO Box 1467 Madison, WI address:

7 Mission Purpose and Scope The quality management system was developed to demonstrate the capability of Research Products to develop, provide, maintain, and continually improve products and services that meet and exceed customer expectations. This manual presents the quality system to our customers and interested parties. Quality Policy Our Quality Policy can be found at QMS-07 Quality Objectives Quality objectives and targets will be reviewed and set annually by the Quality Management Review Team (Officers and Quality Manager). Quality objectives can be found at QMS-08

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9 ISO Based Requirements Quality Management System 4.1 General Requirements Aprilaire has established, documented, implemented, and is maintaining, a quality management system. The following items are defined by Aprilaire: Processes are identified that are needed for the quality management system and their applications throughout the corporation. The sequence and interaction of these processes are identified. Criteria and methods are determined as needed to ensure that the operation and control of all processes are effective. Resources and information are made available to support the operation and monitoring of these processes. These processes are monitored, measured, and analyzed. Actions are implemented as necessary to achieve planned results and continual improvement. When any process that affects product conformity is chosen to be outsourced, controls are maintained over those processes. 4.2 Documentation Requirements General It is the responsibility of all department managers and supervisors to maintain internal departmental methods and procedures outlined in the quality manual. In order to exercise the required control over each manufacturing/assembly operation and to ensure the quality and reliability of the product, a specification will be operative for each process. Documented procedures are reviewed to ensure effective planning, operation and control of applicable processes. Records are maintained to support these activities. Quality Manual Aprilaire has established, documented and maintains a formal quality system to ensure products conform to specified requirements and achieves product realization. The quality system functions and intentions are understood at all levels of the organization.

10 Policies and procedures are designed to meet the ISO 9001:2008 standard. Quality planning activities define and document how quality and reliability requirements will be met. The quality system effectively utilizes a cross-functional team approach to plan and achieve quality goals. Effective implementation of the quality system is supported and monitored by management. Control of Documents Structure of the Quality System Documents: This document - the quality manual - (Level 1) defines overall management commitment to the quality system to achieve all elements of ISO (Level 2) These procedures define the processes, who has responsibility, and when it is required. (Level 3) Work instructions are available as appropriate to describe how the procedure is implemented. (Level 4) Quality records and forms provide results of activities that are essential to the operation of the quality management system. Records are retained and controlled according to a documented procedure. A system of procedures designates the specific responsibility for quality system operation and authority for initiation, review, and approval of quality system transactions. Aprilaire maintains documented procedures to control documents and data that affect and relate to the product. Control extends from the initial concept through review, approval, issuance, and obsolescence. Up-to-date documentation required for the effective function of the quality system is available at all appropriate locations. Documents and data are reviewed and approved by authorized personnel prior to issue. A master list of documents is maintained to identify the current revisions of all controlled and approved documents. Invalid or obsolete documents are promptly removed from all points of issuance and use, or otherwise prevented from unintended use, except as required for record retention or by contractual agreement.

11 Control of Records Quality records are established and maintained as evidence of conformity to specified requirements. These records are: identified, collected, indexed, filed, accessed, stored, and maintained according to documented procedures readily retrievable maintained in a suitable environment to prevent damage or deterioration and prevent loss legible and identifiable to the product involved may be destroyed upon the expiration of the retention period

12 Processes Sequence and Interaction Customer receive order new product or OEM Type of order stocked product Marketing 7.1, 7.2.1, order request Order Entry product design request sales demand Engineering 7.1, 7.2.1, 7.3, 7.6, 5.4, 8.4 material purchase Production Planning 7.1, Purchasing Process 7.4.1, requirements and purchase orders developed production schedule Manufacturing Process 7.1, 7.5, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1, 7.6 finished product Processes for material suppliers material approved Shipping 7.5.5, 8.3 product support receive materials invoice customer Receive, inspections, verifications 7.4.3, 7.6, 8.3 Receive Payment Warranty and Service 7.2.3, 8.2.1

13 Management Responsibility 5.1 Management Commitment The QMS Team and Officers are committed to a policy of continuous improvement of the quality and reliability of the products furnished to our customers. To accomplish this: the quality policy and objectives were established management reviews are conducted to ensure that resources are available the importance of meeting customer requirements are communicated all employees are authorized to stop a process if the quality of the product is in question. Management and supervisory personnel support this activity. department heads and supervisors maintain internal department methods and procedures included in the quality management system in order to exercise the required control over each manufacturing/assembly operation and to ensure the quality and reliability of the product, a formal specification will be operative for each process. 5.2 Customer Focus Aprilaire ensures that all requirements received from the customer are fully understood and that current capability exists to meet all aspects of the customer requirements prior to the acceptance of the order. 5.3 Quality Policy The quality policy is documented and communicated, understood, implemented and maintained at all levels in the organization. The quality policy is communicated by inclusion in: quality awareness training postings in the plants and on bulletin boards new employee orientation other employee meetings

14 5.4 Planning Quality Management System Planning Quality planning is done to ensure that the quality management system is maintained and quality objectives are established, measurable, and consistent with the quality policy. Quality objectives and targets will be reviewed and set annually by the Quality Management Review Team (Officers and Quality Manager). Responsibility and authority will be communicated to all personnel through the use of job descriptions, procedures, work instructions, and direct supervision. 5.5 Responsibility, Authority, and Communication Responsibility and Authority The President and Officers: Defines roles and responsibilities that can be found in job descriptions maintained in Human Resources. Provides the resources needed for the implementation and continuous operation and control of the quality management system. Appointed a Quality Management Representative responsible for reporting on the quality management system performance to the quality management system team. Other responsibility and authority are identified in procedures. Internal Communication The quality management team ensures that communication takes place regarding the effectiveness of the quality management system. This is achieved through documented procedures, work instructions, forms, and records, departmental and company meetings, training, s, company newsletters, bulletin boards, etc.

15 5.6 Management Review General The Management Review Team complete semi-annual reviews of the quality management system. The Management Representative prepares a report to facilitate the Management Review Team's review and evaluation during the management review meeting. Review Input The management review inputs shall include: Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the quality management system Recommendations for improvement Review Output The output from the management review shall include: Improvement of the effectiveness of the quality management system and its processes Improvement of product related to customer requirements Resource needs

16 Resource Management 6.1 Provision of Resources Resources needed to implement, maintain, and improve the effectiveness of our quality management system are determined. Resources including people, availability of information, equipment, and financial resources are in place to meet customer requirements, thereby improving customer satisfaction. 6.2 Human Resources General Managers and supervisors define training needs to achieve the strategic initiatives, including on-going refresher training and the assurance that the identified training needs are satisfied. Human Resources identifies training requirements for job functions with appropriate managers or supervisors, and maintains training records associated with our quality system. Competence, Awareness and Training Personnel are qualified based on appropriate education, training, or experience. Records of training are maintained. A periodic assessment of training needs and effectiveness is conducted for each position. Trainers create awareness regarding quality and the quality management system, document that training has been conducted, and provide documentation to Human Resources for tracking the training. 6.3 Infrastructure Aprilaire defines, provides, and maintains suitable infrastructure to ensure product quality. Buildings, workspace, and associated utilities are maintained by the Maintenance Department. The Plant Engineer Manager ensures the preventive maintenance program is implemented and maintained. The Maintenance Supervisor ensures that the maintenance program established for each facility is up to date, and maintenance tasks are completed within +/- 4 weeks of their scheduled time.

17 Information Technology ensures adequate systems for information and communication are in place. 6.4 Work Environment Aprilaire is committed to provide a suitable work environment to achieve product conformity. Management ensures that this environment is healthy and safe for all employees and visitors.

18 Product Realization 7.1 Planning of Product Realization Aprilaire has planned and developed the processes needed for product realization. In planning product realization, Aprilaire has determined the following as appropriate: Quality objectives and requirements for the product The need to establish processes, documents, and provide resources specific to the product Required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria of product acceptance Records needed to provide evidence that the realization processes and resulting product meet requirements Customer requirements have been included in the planning of product realization as a component of the quality plan. Acceptance criteria has been defined and, where required, approved by the customer. 7.2 Customer-Related Processes Determination of Requirements Related to the Product Aprilaire determines the product requirements including customer requirements and requirements necessary for intended use and for compliance with laws and regulations. Review of Requirements Related to the Product The company has in place procedures for reviewing and releasing orders for products and parts. Reviews are conducted prior to committing to supply product to our customer. These reviews ensure that product requirements are defined; contract or order requirements differing from those previously expressed are resolved and verify that Aprilaire has the capability and capacity to meet product and customer requirements. Customer Communication The company has determined and implemented effective arrangements for communicating with customers. Product information and literature is the responsibility of the Sales and Marketing Departments. Handling orders, contracts, and inquiries are the responsibility of the Sales Department.

19 Customer feedback, including customer complaints, customer assistance, and troubleshooting is the responsibility of Customer Service, the Product Managers, and Product Engineers. 7.3 Design and Development Design and Development Planning Documented procedures are in place describing how products are developed by crossfunctional teams. Assigned project leaders interface with the cross functional team ensuring effective communication and clear assignment of responsibility. The procedure defines the design and development stages required, the reviews, verification, and validation appropriate to the project. The planning output is updated as the project progresses through the design and development stages. Design and Development Inputs Inputs relating to the product requirements are determined and recorded. Inputs developed for the product include functional and performance specifications, as well as statutory and regulatory requirements if appropriate. Previous similar designs are reviewed when available and any other requirements essential for a successful design and development project are considered. These inputs are reviewed for adequacy, to be certain they are complete, unambiguous and not in conflict with each other. Design and Development Outputs Outputs of design and development are provided in a form that enables verification against the design and development input. Outputs are approved prior to the release of the product. These outputs meet the input requirements, provide necessary information for purchasing, production and for service provision, contain product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use. Design and Development Review Reviews are conducted at suitable stages according to the project plan. These reviews assess the ability of the design to meet requirements, and to identify any problems and propose necessary actions. Appropriate representatives of functions concerned with the design are present for these reviews. Records of these reviews are maintained including any necessary actions identified.

20 Design and Development Verification Testing and other arrangements are performed in accordance to the project plan to ensure that the design and development outputs meet the design and development input requirements. Records of the validation work activity results and recommendations are maintained. Control of Design and Development Changes Changes to the design and development project are identified and records are maintained. The proposed changes are reviewed, verified and validated as appropriate, and approved before they are implemented. The review includes an evaluation of the effect of the change on constituent parts and product already delivered. 7.4 Purchasing Purchasing Process Aprilaire ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent processes or final product. Purchasing procedures describe the process used to evaluate and select suppliers with the ability to supply product in accordance with specified requirements. Records of the results of evaluations and necessary actions resulting from the evaluations are maintained. Purchasing Information Purchasing, based on information on purchase orders, supplier information, and standard documents and drawings where appropriate, describes the product to be purchased. Requirements for approval of product, procedures, processes, and equipment; requirements for qualification of personnel, and quality management system requirements are included in the purchasing information. Specified purchase requirements are reviewed and approved prior to their communication to the supplier.

21 Verification of Purchased Product Inspections and other activities, where appropriate, necessary for ensuring that purchased product meets specified purchase requirements are established. 7.5 Production and Service Provision Control of Production and Service Provision Aprilaire does not provide onsite service to our customers. Installation, instruction, and trouble shooting manuals are provided with delivered product. A product support network is available to provide technical assistance if needed. Aprilaire plans and carries out production under controlled conditions by providing specification drawings, work instructions, suitable equipment which is well maintained, the available and use of monitoring and measuring devices where appropriate, and the implementation of release, delivery, and post delivery activities. Validation of Processes for Production and Service Provision Aprilaire validates processes for production and service provision where resulting output cannot be verified by subsequent monitoring and measurement. This includes processes where deficiencies become apparent only after the product is in use. Validation demonstrates the ability of our processes to achieve planned results. Arrangements have been established for processes as applicable: Define criteria for review and approval of the processes Approval of equipment and qualification of personnel Use of specific method and procedures Requirements for records Revalidation Identification and Traceability Where appropriate, Aprilaire identifies the product by suitable means throughout product realization. Where traceability is a requirement, Aprilaire controls the unique identification of the product. Product status is identified with respect to monitoring and measurement requirements. Customer Property Aprilaire exercises care with customer property while it is under our control. Customer property is identified, verified, protected, and safeguarded when provided for use or

22 incorporation into product. If customer property is lost, damaged, or found to be unsuitable for use, this is reported to the customer and records are maintained. Preservation of Product Aprilaire maintains documented procedures to ensure products are controlled through handling, storage, packaging, preservation, and delivery in such a manner that product integrity is maintained. Handling methods are provided to prevent damage and deterioration. Designated storage areas are maintained. Products are protected through customer delivery, in accordance with customer requirements. Shipments are made in accordance with customer transportation specification if appropriate. Shipment and production schedules are developed to meet customer requirements. Systems are in place to support 100% on-time shipments to meet customer production and service requirements. Corrective action is taken when delivery performance is not meet. Continuous efforts to improve inventory utilization are planned and executed. 7.6 Control of Monitoring and Measuring Devices Aprilaire determines the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. A calibration procedure ensures monitoring and measurements are carried out in a manner that is consistent with requirements. To ensure valid results, measuring equipment is: Calibrated or verified at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. Where no standard exists, the basis used for calibration or verification is recorded. Adjusted or re-adjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance, and storage Validity of previous results is assessed and recorded when equipment is found not to conform to requirements. Appropriate action is taken on equipment and any product affected. Records of the results of calibration and verification are maintained.

23 Measurement, Analysis and Improvement 8.1 General Aprilaire maintains documented procedures for inspection and testing to verify that specified requirements for products are met. 8.2 Monitoring and Measurement Customer Satisfaction Aprilaire obtains information from the customer in order to monitor whether the customer feels their requirements have been met. This is accomplished by various methods such as customer survey requests and monitoring customer complaints and returns. Internal Audits Internal quality audits are planned and implemented by Aprilaire. These audits verify and assess the operation and effectiveness of the quality system. Audits are scheduled on the basis of the status and importance of the activity to be audited. Audits and follow-up actions are conducted according to documented procedures. Audits are conducted by personnel independent of the areas audited. Results of the audits are recorded and communicated to management responsible for the area audited. Timely corrective action is taken, recorded, and verified based on the results of the audit. Monitoring and Measurement of Processes Aprilaire applies suitable methods for monitoring and, where applicable, measurements of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action is taken to ensure conformity of the product. Monitoring and Measurement of Product Verification of incoming materials is planned and documented to assure conformance to specifications. Process monitoring is utilized when practical.

24 Characteristics of the product are monitored and measured to verify that product requirements have been met. Inspection and testing is carried out at appropriate stages throughout the production flow, per planned arrangements. Quality records are maintained of all inspections and tests affecting quality. Product release will not proceed until planned arrangements have been satisfactorily completed or approved by a relevant authority. Non-conforming products are identified and handled as specified. Control of Non-conforming Product Aprilaire maintains documented procedures to ensure product that does not conform to specified requirements is prevented from unintended use. Control provides for identification, documentation, evaluation, segregation (when practicable), disposition, and notification of areas affected. Non-conforming and suspect product is reviewed in accordance with documented procedures. Non-conforming product may be: o Reworked to meet specified requirements o Accepted with or without repair, provided the customer authorization is obtained o Regraded for alternative applications o Rejected or scrapped Reworked product is re-inspected. Quality records of non-conforming product activity are maintained. 8.4 Analysis of Data Aprilaire collects and analyzes applicable data that demonstrates the suitability and effectiveness of the quality system and evaluates the effectiveness of the system for continual improvement. The analysis provides information on suppliers, conformance to product requirements, characteristics, and trends of processes and products for preventive action and customer satisfaction. 8.5 Improvement Continual Improvement To improve the effectiveness of the quality management system, Research Products uses tools such as: Quality policy and objectives Department objectives

25 Audit results Analysis of product and process data Corrective and preventive action Management reviews Corrective Action/Preventive Action To eliminate the causes of actual or potential non-conformities, a documented procedure has been put in place. Corrective action includes: Effective handling of customer complaints and reports on non-conformities. Investigating the causes of non-conformities and the action needed to prevent recurrence. The analysis of processes, work operations, quality records, customer complaints, and returned product to detect and eliminate potential causes of the non-conforming product. Verification that corrective actions are taken and effective. Implementation and recording of changes in procedures resulting from corrective actions. Preventive actions at a level corresponding to the risk encountered. Preventive action includes: Maintaining and utilizing information on performance to detect, analyze, and eliminate potential causes of non-conformance. Planning the steps needed to improve; obtaining management review and approval; obtaining customer approval where needed; executing the plan and verifying the results.