DETHMERS MANUFACTURING CO. Demco 4010 320th Street Boyden IA 51234 Phone 712-725-2311 Fax 712-725-2380
ISO 9001:2000 Quality Manual Approved by:
Date
Approved by:
Date
Approved by:
Date
Revision: 0
05/07
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL
Introduction For over 40 years Dethmer’s Manufacturing Company has been turning ideas into products that help people do things better. Our goals have always been to produce quality products that fully satisfy customer needs. We have been asked to help solve many problems. The results can be seen in a product line that represents many solutions. Answers to questions as diverse as the best way to tow your car, spray crops, move a refrigerator, enjoy a weekend at the lake, or print a full color brochure. Demco's Production facility is located in Boyden, Iowa and covers over 300,000 square feet. As a result of this physical investment, we benefit from increased productivity and more efficient use of time and materials. These investments help us to build new and more advanced products at a competitive price. Demco is recognized as the national leader among manufacturers of automotive towing equipment. Our Kar-Kaddy™ and Tow-It™ have earned a reputation as the undisputed leaders in the auto transport world. Today there are more Demco tow dollies on the road than all others combined. The Demco line of Agricultural Sprayers are built for today's demanding crop management systems. We use the highest quality materials to ensure long life and serviceability. Demco's progressive designs reflect what we know best in the heartland. Demco's Gravity Flow Wagons and Grain Carts are tough and reliable. They possess every feature you'll need to transport your payload safely and securely. We gain our expertise in design and quality from direct input from our customers.
1. Scope DETHMERS MANUFACTURING COMPANY has implemented a quality management system to enhance customer satisfaction and to improve management of the company. The quality system complies with the ISO 9001:2000 International Standard. Demco Printing and Demco Transportation are not included in the implementation of ISO9001:2000 at this time.
2. Quality Policy DETHMERS MANUFACTURING COMPANY Quality Policy: “To meet or exceed our external and internal customer’s requirements and expectations. We are committed to the quality and continual improvement of our products, processes, and quality management system.” DETHMERS MANUFACTURING COMPANY ensures that this policy is communicated and understood at all levels of the organization via postings and training. This policy and other quality objectives are regularly reviewed for continued suitability during planned management reviews. (5.6) Page 2 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL
DETHMERS MANUFACTURING COMPANY Mission Statement: “Dethmer’s Manufacturing Company determines specific customer needs then designs, develops, tests, and markets products to meet those specific needs. We then strive to efficiently deliver those products using the latest technology and manufacturing procedures. Our team provides these products for Agriculture, the National Rental Industry, the Hydraulic Brakes Market, the RV Market, and our Printing Customer Clientele.”(mission statement is currently under review) DETHMERS MANUFACTURING COMPANY Vision Statement: “To become profitable, innovative leaders in our chosen markets, to provide secure, exciting, rewarding employment to our co-workers, and to foster dependable partnerships with our customers, suppliers, and community.”(vision statement is currently under review) DETHMERS MANUFACTURING COMPANY Core Values: (STRIVE) SERVICE: Providing professional, friendly solutions to achieve total customer satisfaction TEAMWORK: Working together we can accomplish the impossible RESPECT: Listen with sincerity to develop an understanding to appreciate each other INTEGRITY: Honestly maintaining a position based on values that you will not compromise VISION: Through our strong determination we strive to achieve our goals for today while creating opportunities for tomorrow EXCELLENCE: Continuously reaching for the highest standard of quality
DETHMERS MANUFACTURING COMPANY Core Purpose Statement: "A living, breathing entity that is passionate about it's resources and providing "Solutions to Situations" today and tomorrow, for our customers, coworkers, and community, while holding ourselves to the highest standards."
3. Management Responsibilities and Key Processes
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DETHMERS MANUFACTURING COMPANY QUALITY MANUAL Jim Koerselman Chairman of the Board
Robert Koerselman President
Jason Terhark Controller
Ken Streff (VP) Sales & Marketing
Kevin Ten Haken Executive Vice President & Cost Accounting
Ted Riepma Credit & Office Manager
Ron Damstra (VP) Purchasing
Del Towne Quality Assurance
Terry Bielfelt Engineering
Dave Cain (VP) Operations HR Manager
Maintenance
Ron Berg Ag Sales/Manager
Joel Rosenboom Scheduling
Dave Damstra Purchasing
Ardell Niemeyer Shipping
Galen Kroese Welding
Doug DeWeerdt Staff Member/Sales Freight Scheduling
Steve Wandersheid Inform. Technology
Joel Heidebrink Purchasing
Dave Sipma Fab
Tadd Gerloff West Assembly
Bob Netten Product Coordinator
Aaron Wiekamp & Paint
Les Hanson Machining
Daryl Grooters Product Coordinator
Roger DeKruyf Shear
Henry Van Voorst Night Shift
Scott Johnson Product Coordinator
Russ Perkins Robot Welding East Assembly
Brent Dokter Gage Control Tool Crib
Pat Harms Product Coordinator
Jerry Sandbulte Customer Service
Ken Kruse Customer Service
Chairman of the Board - Provides leadership and direction, oversees the operation of the company, promotes the quality management system. President - Provides leadership and direction, formulates quality policy and quality objectives, supervises the quality system. Executive Vice President & Cost Accounting – Determines production scheduling, costs, and pricing of our products. VP Finance & Trans. – Provides any resources necessary to maintain the quality system. Sales - Conducts proposal, order, and contract reviews, provides customer interface, and addresses customer complaints. Engineering – Prepares product specifications from customer specified requirements and conducts design reviews. Purchasing – Purchases materials, and determines who our suppliers will be. Page 4 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL Quality Assurance - Maintains the quality management system and manages all quality related activities including inspection and auditing. VP Operations – Determines production processes, personnel, and equipment requirements to make our products. Every Employee - Is responsible for the quality of the products and/or services they provide to internal and external customers.
DETHMERS MANUFACTURING COMPANY’s key processes: Purchasing & Receiving
Sales & Engineering
QA Analysis & Monitoring
Assembly & Shipping
Planning & Production
4. Quality Management System 4.1 General Requirements DETHMERS MANUFACTURING COMPANY has established, documented, implemented, and maintains a quality management system and continually improves its effectiveness in accordance with the requirements of the ISO 9001:2000 Standard. DETHMERS MANUFACTURING COMPANY: a) Has identified the key processes of the quality management system and their application throughout the organization b) Has determined the sequence and interaction of these processes c) Has determined the criteria and methods needed to ensure that both the operation and control of these processes are effective Page 5 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL d) Through management, ensures the availability of resources and information necessary to support the operation and monitoring of these processes e) Using inspection, testing, and internal audits, monitors, measures and analyzes these processes f) Through management review and corrective/preventive action, implements continual improvement to achieve the planned results of these processes. When DETHMERS MANUFACTURING COMPANY chooses to outsource any processes that affect product conformity with requirements, DETHMERS MANUFACTURING COMPANY will ensure control over such processes. Control of such outsourced processes will be identified within the quality management system. 4.2 Documentation Requirements 4.2.1 General The documented system includes: a) Documented statements of a quality policy and quality objectives b) A quality manual c) Documented procedures required by ISO 9001:2000 d) Documents needed by the organization to ensure the effective planning, operation and control of its processes e) Quality records required by this International Standard and others deemed necessary DETHMERS MANUFACTURING COMPANY has documented and maintains a quality system as a means of ensuring that products conform to specified requirements. Changes to the quality system will be coordinated with customers where contractually required. The documented system consists of: Level I Quality Manual - Defines the quality management system and contains the Quality Policy that provides the direction and intent to meet the ISO 9001 standard. Level II Procedures - For each of the ISO 9001 requirements and other activities, as necessary, that define who, what, when, and where throughout the organization. Level III Work Instructions and Forms - Describe how major tasks will be accomplished. Instructions, standards, specifications, product routing, forms, etc. may be included. Level IV Other documentation - Records as defined in the procedures, internal audit check sheets, and customer supplied documentation, etc. may be included. This accomplished by: • This Quality Manual • Quality Policy and Objectives • Procedures, Work Instructions, Records 4.2.2 Quality Manual Page 6 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL DETHMERS MANUFACTURING COMPANY has developed and maintains a quality manual that includes: a) The scope of the quality management system b) Reference to documented procedures established for the quality management system c) A description of the interaction between processes of the quality management system This is accomplished by: • This Quality Manual • Organization chart 4.2.3 Control of Documents DETHMERS MANUFACTURING COMPANY has controlled documents that explain the quality management system. A procedure is established for defining document controls: a) To approve documents for adequacy prior to issue b) To review and update as necessary and re-approve documents c) To ensure that changes and the current revision status of documents are identified d) To ensure that relevant versions of applicable documents are available at points of use e) To ensure that documents remain legible and readily identifiable f) To ensure that external documents are identified and their distribution controlled g) To prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose This is accomplished by: • Document Control Procedure QP00001 4.2.4 Control Of Quality Records DETHMERS MANUFACTURING COMPANY has established and maintains quality records providing objective evidence of conformity to requirements, and of the effective operation of the quality management system. There is a documented procedure stating records will be legible, identifiable and retrievable, have defined storage, protection, retention time and disposition. This is accomplished by: • Record Control Procedure QP00002
5. Management Responsibility
5.1 Management Commitment Top management, through various documents and meetings, will provide commitment to the development, implementation, and continual improvement of the quality management system including: a) Communicating importance of meeting customer, statutory, and legal requirements b) The established quality policy c) The established quality objectives d) Management reviews e) Availability of necessary resources Page 7 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL This is accomplished by: • Communication and training of personnel on customer, regulatory, and legal requirements • Quality Policy • Quality Objectives • Continual improvement and resource discussions during Management Reviews 5.2 Customer Focus Top management ensures that customer needs and expectations are: a) Determined b) Converted into requirements c) Addressed with the aim of enhancing customer satisfaction This is accomplished by: • Various activities within the quality management system, including: 1. Customer Focus (5.2) 2. Management Representative promoting customer requirements (5.5.2 c) 3. Management Review output (5.6.3 b) 4. Provision of Resources enhancement of customer satisfaction (6.1 b) 5. Determination of Requirements Related to the Product (7.2.1) 6. Customer Communication (7.2.3) 7. Customer Satisfaction (8.2.1) 8. Analysis of Data customer satisfaction (8.4 a) 5.3 Quality Policy Top management established and assures that the Quality Policy is: a) Appropriate for DETHMERS MANUFACTURING COMPANY b) A commitment to complying with requirements and continual improvement of the effectiveness of the quality management system c) A framework for the establishment and review of quality objectives d) Communicated and understood within the organization e) Reviewed by management for continuing suitability This is accomplished by: • Quality Policy as stated in this Quality Manual 5.4 Planning 5.4.1 Quality Objectives Quality objectives have been established to improve DETHMERS MANUFACTURING COMPANY’s performance including: a) Those needed to meet product requirements b) Established at relevant functions and levels c) They are measurable d) Consistent with the Quality Policy This is accomplished by: Page 8 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL •
Documented quality objectives (see Management Review Minutes)
5.4.2 Quality Management System Planning Top management provides continued assurance that: a) The planning for quality is carried out to meet the requirement of the quality management system and quality objectives b) Integrity in the quality management system is maintained during change to the system This is accomplished by: • Quality management system documentation • Production planning • Quality records 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority Functions and interrelationships including responsibilities and authorities are defined and communicated. This accomplished by: • Management Responsibility section of this Quality Manual • Job descriptions • Organizational Charts 5.5.2 Management Representative Top management has appointed Demco Vice President of Operations as the Management Representative, with responsibility and authority to: a) Ensure processes needed for the quality management system are established, implemented and maintained b) Report to top management on the performance and need for improvement of the quality management system c) Promote awareness of customer requirements throughout DETHMERS MANUFACTURING COMPANY This is accomplished by: • Quality management system documentation • Reports • Customer awareness training plans 5.5.3 Internal Communication Top management ensures appropriate communications between the various levels and functions of The DETHMERS MANUFACTURING COMPANY regarding the effectiveness of the quality management system. This is accomplished by: • Quality management system documentation • Formal channels of information distribution Page 9 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL • •
Meetings and minutes, where appropriate Information postings
5.6 Management Review 5.6.1 General Top Management reviews the quality management system a minimum of quarterly to: a) b) c) d) e)
Ensure its continuing suitability Adequacy Effectiveness Assessing opportunities for improvement Evaluate need for changes including quality policy and objectives
Records of Management Review meetings are maintained. This is accomplished by: • Management Review meetings • Management Review Minutes • Management Review procedure 5.6.2 Review Input Management Review inputs include current performance and information on: a) Audit results b) Customer feedback c) Process performance and product conformance d) Status of corrective and preventive actions e) Follow-up action from previous management review f) Changes that could effect the quality management system g) Recommendations for improvement This is accomplished by: • Quality records 5.6.3 Review Output Management Review outputs shall include the following actions: a) Improvement of the effectiveness of the quality management system and its processes b) Improvement of product related to customer requirements c) Resource needs This is accomplished by: • Minutes of Management Review meetings
6. Resource Management Page 10 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL
6.1 Provision of Resources DETHMERS MANUFACTURING COMPANY has determined and provides resources needed to: a) Implement and maintain the quality management system b) Continually improve effectiveness of quality management system c) Enhance customer satisfaction This is accomplished by: • Management Reviews • Quality Objectives • Training records • Customer feed-back
6.2 Human Resources 6.2.1 General DETHMERS MANUFACTURING COMPANY assigns competent personnel to perform functions of the quality management system. Competency is determined by appropriate education, training, skills and experience. This is accomplished by: • Human Resource activities • Responsible management/supervision • Performance reviews • Resumes and training records 6.2.2 Competence, Awareness and Training The DETHMERS MANUFACTURING COMPANY’s management determines the necessary competences for all personnel performing work affecting product quality, determines the training or other activities needed, and provides the training and evaluates its effectiveness. Personnel understand the relevance and importance of activities and how they contribute to specific quality objective for their activities. DETHMERS MANUFACTURING COMPANY will maintain appropriate records of education, training, skills and experience. This is accomplished by: • Job descriptions • Instruction and training plans • Training records • Skills matrices • Applicable education and experience Page 11 of 23
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Quality Objectives
6.3 Infrastructure DETHMERS MANUFACTURING COMPANY determines, provides and maintains infrastructure needed to achieve product conformity, including: a) Buildings, workspace and associated utilities b) Equipment, hardware and software c) Supporting services This is accomplished by: • Business plan • Annual budgets • Machinery and equipment plans • Management Review resource needs output 6.4 Work Environment DETHMERS MANUFACTURING COMPANY manages the human and physical factors of the work environment to achieve product conformity. This is accomplished by the following activities: • Health and safety awareness • Analysis of workplace hazards and ergonomic studies • Health and safety records • Employee surveys • Management Review resource needs output
7. Product Realization 7.1 Planning of Product Realization DETHMERS MANUFACTURING COMPANY has planned and developed, consistent with the quality management system, the processes needed to produce and deliver its products and services that meet customer requirements. Consideration was given to: a) Quality objectives and requirements for the product b) The establishment of processes, documentation, resources and facilities specific to the product c) Verification, validation, monitoring, inspection and test activities and criteria for product acceptability d) Records necessary to provide objective evidence that the processes and products meet requirements This is accomplished by: • Quality objectives • Quality management system documentation Page 12 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL •
Quality records
7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product DETHMERS MANUFACTURING COMPANY determines customer requirements including: a) Customer specified product, delivery and support requirements b) Product requirements other than specified by the customer that are necessary for intended or specified use c) Regulatory and statutory requirements related to product d) Any additional requirements determined by The DETHMERS MANUFACTURING COMPANY This is accomplished by: • Customer information • Market research • Customer feed-back 7.2.2 Review of Requirements Related to the Product DETHMERS MANUFACTURING COMPANY reviews customer requirements and orders prior to committing to supply products to ensure that: a) Product requirements are adequately defined b) Differences between customer requirements and what The DETHMERS MANUFACTURING COMPANY has offered are resolved c) The DETHMERS MANUFACTURING COMPANY has the ability to meet the customer requirements When the customer provides no documented requirements, the customer requirements shall be confirmed before acceptance of the order. When product requirements are changed, relevant documents will be amended and relevant personnel will be made aware of the changes. Records of the review of customer requirements and orders will be maintained in the order entry department. This is accomplished by: • Quality management system documentation • Records of orders, changes and follow-up actions 7.2.3 Customer Communication DETHMERS MANUFACTURING COMPANY has identified and implemented effective processes for customer communications relating to: a) Product information b) Inquiries, contracts or order handling, including amendments c) Customer feedback and customer complaints Page 13 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL This is accomplished by: • Contact with customers • Promotional materials • Customer satisfaction surveys and analysis • Appropriate action plans to address customer feedback
7.3 Design and Development 7.3.1 Design and Development Planning DETHMERS MANUFACTURING COMPANY plans and controls the design and development of products by determining: a) The design and development stages b) The review, verification and validation that is appropriate at each stage of the design and development c) The responsibility and authority for design and development To ensure effective communication and clear assignment of responsibility, the interfaces between the different design and development groups will be managed. Planning output will be updated as appropriate to the design and development progress. This is accomplished by: • Product design and development procedure QP00010 • Product plans • Project management • Cross functional teams 7.3.2 Design and Development Inputs Inputs relating to product requirements are reviewed and resolved for adequacy, completeness, ambiguity and conflicting requirements. The inputs will include: a) Functional and performance requirements b) Applicable statutory and regulatory requirements c) Where applicable, information derived from similar designs d) Other requirements essential for design and development This is accomplished by: • Project team meetings • Product specifications • Analysis of customer needs • Regulatory and legal specifications • Feasibility and budget studies Page 14 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL 7.3.3 Design and Development Outputs Outputs from the design and development process will be approved and in a format that enables verification against the inputs, which includes: a) Meeting the input requirements b) Providing appropriate information for purchasing, production, and servicing c) Having or referencing product acceptance criteria d) Specifying the characteristics of the product that are essential for safe and proper use This is accomplished by: • Quality management system documentation • Design drawings • Output information • Inspection and test plans 7.3.4 Design and Development Review Planned and systematic design reviews, including representatives of functions concerned with the design, are conducted at suitable stages to: a) Evaluate the ability of the design results to meet the requirements b) Identify any problems and propose necessary actions c) Ensure records of the results and actions to be taken will be maintained
This is accomplished by: • Samples and prototypes • Design drawings • Quality management system documentation • Records of reviews and actions taken 7.3.5 Design and Development Verification DETHMERS MANUFACTURING COMPANY will perform design and development verification to ensure the output of design and development meets the input requirements. Records are maintained. This is accomplished by: • Pilot Production • Comparison with similar designs • Inspection, testing and sampling records • Records of design and development verification 7.3.6 Design and Development Validation Validation will be performed to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. When practical, the validation will be completed prior to product delivery. Records are maintained. This is accomplished by: Page 15 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL • • • • •
Validation plans Records of design and field tests Agreements with customers related to validation Performance records Records of design and development validation
7.3.7 Control of Design and Development Changes Design and development changes are identified and recorded, reviewed, verified, validated, as appropriate, and approved prior to implementation. Review includes the evaluation of the effect the change may have on “where-used” applications, as well as already delivered product. Records of the reviews and actions taken are maintained. This is accomplished by: • Quality management system documentation • Engineering change Notices • Procedure and process updates • Customer notification • Inspection, testing and sampling records • Records of design and development changes and actions taken 7.4 Purchasing 7.4.1 Purchasing Process DETHMERS MANUFACTURING COMPANY controls its purchasing processes to ensure: a) Purchased products and services conform to requirements b) The controls are sufficient depending upon the effect the purchased products or services have on subsequent processes or the final product c) Suppliers are evaluated and selected based on their ability to supply products and services that meet DETHMERS MANUFACTURING COMPANY’s requirements d) Defined criteria are used for selection, evaluation and re-evaluation of suppliers e) Records of evaluations and follow-up actions are maintained This is accomplished by: • Quality management system documentation • Product specifications • Supplier reports and ratings • Approved supplier listing • Records of supplier evaluations 7.4.2 Purchasing Information Purchasing documentation is determined for adequacy and describes the product or service being purchased, including where appropriate: a) Requirements for approval of product, procedures, processes, and equipment b) Qualifications of personnel c) Quality management system requirements Page 16 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL This will be completed prior to communication with the supplier This is accomplished by: • Quality management system documentation • Purchase orders • Product certifications 7.4.3 Verification of Purchased Product DETHMERS MANUFACTURING COMPANY has identified and implement inspection and other activities necessary to ensure purchased products meet specified requirements. When inspection or other activities are to be performed at the supplier, they are to be specified along with methods of product release in the purchasing information. This is accomplished by: • Quality management system documentation • Quality control plans • Receiving inspection records • Purchase orders 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision DETHMERS MANUFACTURING COMPANY plans and conducts production and service operations under controlled conditions, as applicable, through: a) Availability of information that specifies the characteristics of the product b) Availability of work instructions, as necessary c) Use of suitable equipment d) Availability and use of measuring and monitoring devices e) Implementation of monitoring and measurement f) Implementation of release, delivery and post-delivery activities This is accomplished by: • Quality management system documentation • Quality control plans • Preventive maintenance records
7.5.2 Validation of Processes for Production and Service Provision DETHMERS MANUFACTURING COMPANY ensures that there is objective evidence that the requirements have been fulfilled for any special processes for products and services where monitoring or measurement cannot verify the output. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Page 17 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL Validation will demonstrate the ability of these processes to achieve planned results including, as applicable: a) Defined criteria for review and approval of the processes b) Approval of equipment and qualification of personnel c) Use of specific methods and procedures d) Validation records e) Revalidation This is accomplished by: • Quality management system documentation • Process and equipment capability studies • Education, training, skills and experience records
7.5.3 Identification and Traceability DETHMERS MANUFACTURING COMPANY will, using appropriate means, identify the parts and product throughout production and identify the status with respect to measurement and monitoring requirements. When traceability is a requirement, the product will be controlled and records of the unique identification will be maintained. This is accomplished by: • Quality management system documentation • Inspection and test records • Product identification 7.5.4 Customer Property Care will be exercised with material and property provided by the customer while it is under DETHMERS MANUFACTURING COMPANY’s control. This includes identification, verification, protection, and maintenance of customer property. Customer property that is lost, damaged, or otherwise found to be unsuitable for use will be recorded and reported to the customer. This is accomplished by: • Quality management system documentation • Safeguarding customer tooling, equipment, and intellectual property 7.5.5 Preservation of Product DETHMERS MANUFACTURING COMPANY will ensure parts and product conformity during internal processing and delivery to the intended destination by preservation including: identification, handling, packaging, storage, protection, and preservation. This is accomplished by: Page 18 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL • • • •
Quality management system documentation Inventory information Product shelf-life information Packaging specification
7.6 Control of Measuring and Monitoring Devices DETHMERS MANUFACTURING COMPANY has identified the measurements to be made and measuring and monitoring devices required to assure product conformity. These devices are to be used and controlled to ensure that measurement capability is consistent with measurement requirements. Measuring and monitoring devices, where applicable: a) Are calibrated or verified and adjusted periodically, or prior to use, against devices traceable to international or national standards; where no such standards exist, the basis used for calibration is recorded b) Are safeguarded from adjustments that would invalidate the calibration c) Are protected from damage & deterioration during handling, maintenance, and storage d) Are identified to enable the calibration status to be determined e) Are adjusted or re-adjusted as necessary f) Have results of their calibration recorded When devices are found to be out of calibration, DETHMERS MANUFACTURING COMPANY will: a) Assess the validity previous measuring results b) Record the validity c) Take appropriate action on equipment and any product affected When used in the monitoring and measurement of requirements, the ability of computer software to satisfy the application will be confirmed prior to use and as necessary. This is accomplished by: • Quality management system documentation • Measuring and monitoring device listing • Measurement standards • Calibration records
8. Measurement, Analysis and Improvement 8.1 General DETHMERS MANUFACTURING COMPANY has defined, planned, and implemented measurement, monitoring, analysis and improvement processes needed to: a) Demonstrate product conformity b) Ensure conformity of the quality management system c) Continually improve the effectiveness of the quality management system
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DETHMERS MANUFACTURING COMPANY QUALITY MANUAL This includes determination of applicable methods, including statistical techniques, and the extent of their use. This is accomplished by: • Quality management system documentation • Quality control plans • Quality records 8.2. Monitoring and Measurement 8.2.1 Customer Satisfaction DETHMERS MANUFACTURING COMPANY has determines methods for monitoring information on customer perception as to meeting customer requirements. This is one measure of quality management system performance. This is accomplished by: • Quality management system documentation • Customer Surveys/Contacts • Customer recognition and awards • Customer Complaints • Returned Materials • Industry benchmarking 8.2.2 Internal Audit DETHMERS MANUFACTURING COMPANY conducts internal audits at planned intervals to determine whether the quality management system: a) Conforms to the requirements of ISO 9001:2000 and the quality management system defined in this manual b) Has been effectively implemented and maintained The internal audits are planned, taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. Personnel who are independent of the activity being audited conduct audits to ensure objectivity and impartiality. DETHMERS MANUFACTURING COMPANY has a documented procedure that includes: a) Responsibilities and requirements for planning and conducting audits b) Recording results c) Reporting to management d) Maintaining records Management responsible for the areas audited ensure: Page 20 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL a) Actions are taken without undue delay to eliminate detected nonconformances and their causes. (Actions taken will be appropriate to the impact of the problem) b) Follow-up activities to verify actions taken c) Reporting of verification results This is accomplished by: • Internal Auditing Procedure QP00003 • Internal Audit Record QR00003 • Audit reports • Qualified Internal Auditors
8.2.3 Monitoring and Measurement of Processes DETHMERS MANUFACTURING COMPANY applies suitable methods for monitoring, and where applicable, measuring the quality management system processes. These methods: a) Demonstrate ability of processes to achieve planned results b) Ensure when results are not achieved, appropriate correction or corrective action are taken This is accomplished by: • Quality management system documentation • Process failure mode and effects analysis (PFMEA) • Process capability studies • Corrective action records 8.2.4 Monitoring and Measurement of Product DETHMERS MANUFACTURING COMPANY, at appropriate stages within the processes needed to produce and deliver its products, inspects and tests the key characteristics to verify that requirements for the product are met. The evidence of product conformity includes: a) Documented acceptance criteria b) Records that indicate the authority responsible for release of product Product release and service delivery do not proceed until all specified activities have been satisfactorily completed or otherwise approved by relevant authority or by the customer. This is accomplished by: • Quality management system documentation • Inspection and test records • Customer deviations 8.3 Control of Nonconforming Product DETHMERS MANUFACTURING COMPANY has a documented procedure for controlling nonconforming product that includes: a) Identifying product which does not conform to requirements b) Controlling nonconforming product to prevent unintended use or delivery Page 21 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL Nonconforming product is controlled by: a) Taking action to eliminate the detected noncomformances b) Authorizing its use, release, or acceptance under concession by relevant authority and where applicable by the customer c) Taking action to preclude its original intended use or application d) Re-verification to demonstrate conformity to requirements Records are maintained that include the nature of nonconformities, subsequent actions taken, and concession obtained. When nonconforming product is detected after delivery or use has started, DETHMERS MANUFACTURING COMPANY will take action appropriate to the effects, or potential effects, of the nonconformity. This is accomplished by: • Control of Nonconforming Product Procedure QP00004 • Inspection and test records • Nonconforming product records including disposition and information to the customer 8.4 Analysis of Data DETHMERS MANUFACTURING COMPANY shall determine the suitability and effectiveness of the quality management system and identify continual improvement opportunities that can be made by collecting and analyzing appropriate data to provide information relating to: a) Customer satisfaction b) Product conformity to requirements c) Characteristics &trends of processes/product including preventive action opportunities d) Suppliers Analysis shall include data from results of monitoring and measurement and from other relevant sources. This is accomplished by: • Quality management system documentation • Customer satisfaction reports • Audit, inspection and test records • Supplier evaluations • Corrective / Preventive action records 8.5 Improvement 8.5.1 Continual Improvement DETHMERS MANUFACTURING COMPANY shall continually improve the effectiveness of the quality management system through the use of: a) The Quality Policy b) Quality objectives c) Audit results Page 22 of 23
DETHMERS MANUFACTURING COMPANY QUALITY MANUAL d) Analysis of data e) Corrective and preventive actions f) Management review This is accomplished by: • Quality management system documentation • Quality records • Management review outputs 8.5.2 Corrective Action DETHMERS MANUFACTURING COMPANY takes corrective action to eliminate the cause of nonconformities and to prevent recurrence. Corrective action taken will be appropriate to the impact of the problems encountered. There is a documented procedure for corrective action that includes: a) Review of nonconformities (including customer complaints) b) Determining the causes of nonconformities c) Evaluating the need for actions to ensure the nonconformities do not reoccur d) Determining and implementing the action needed e) Recording results of action taken f) Reviewing of corrective action taken This is accomplished by: • Corrective Action Procedure QP00005 • Monitoring the effectiveness of corrective actions • Quality records 8.5.3 Preventive Action DETHMERS MANUFACTURING COMPANY takes preventive action to eliminate the causes of potential nonconformities and to prevent occurrences of problems. Preventive action taken will be appropriate to the impact of potential problems identified. There is a documented procedure for preventive action that includes: a) Identifying potential nonconformities and their causes b) Evaluate the need for action to prevent occurrence of nonconformities c) Determining and implementation action needed d) Recording results of action taken e) Reviewing of preventive action taken This is accomplished by: • Preventive Action Procedure QP00006 • Analysis of data (8.4) • Risk analysis • Management Review Outputs
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