Quality Manual Power Engineering & Manufacturing Inc 1463 94th Lane NE Blaine Minnesota MN 55449 COVER PAGE PD 0002 rev. 3
Section QM 01 Page 1 of 17 This document is approved for use Manual Contents Section Title Page QM 01 Manual Contents 1 QM 02 Distribution 2 QM 03 Scope and Copy Holder 3 QM 04 Amendments - Procedure and Table 4-5 QM 05 Corporation Profile and Process Diagram 6-7 QM 06 Quality Policy 8 QM 07 Organization 9 QM 08 Elements & Requirements - ISO 9001:2008 10-17
Distribution Section QM 02 Page 2 of 17 Quality Manual Copy Number 1 - Quality Manager Copy Number 2 - Computer network (Quality Manager)
Scope and Copy Holder Section QM 03 Page 3 of 17 Copy Holder: Computer network (Quality Manager) Copy Number: 2 This Quality Manual covers the activities and functions performed by the operating areas included in the scope definition: - The design, engineering and manufacture of specialized products for the Military, Medical, Industrial and Commercial sectors. The Quality Management System is designed to meet the requirements of ISO 9001: 2008 Certificate Number: A2556US
Amendments Section QM 04 Page 4 of 17 All copies of this Quality Manual must be kept under strict control to prevent the System from becoming unreliable. The following procedures will ensure that the System remains current and valid. 1) All copies of the Manual will be clearly numbered and the holder recorded. 2) Each page in the Manual will carry its own number. 3) The Quality Representative will be responsible for all revisions and additions being recorded. 4) Changes can be suggested by any employee but they must receive signed approval before being entered into the Manual. 5) All changes must be recorded in the Table of Amendments and the pages in the Manual updated to the proper revision level.
Section QM 04 Page 5 of 17 Table of Amendments Quality Manual Section Number Page Number All All 2 January 14 th Rev. Date Description of Change Authorization 2009 All All 3 January 28, 2010 Updated to ISO 9001:2008 Per Audit of January 13, 2009 Updated per Audit of January 21, 2010, See Annual Audit Non- Conformance Report CA2556US Thomas Kerrick Thomas Kerrick
Corporation Profile Section QM 05 Page 6 of 17 Power Engineering & Manufacturing, Inc. (PEM) is a design and manufacturing Corporation established in 1994 by the merger of Power Engineering, a five-year-old mechanical design company and System Design Engineering, a two-year-old electronic design company. The combination of these two companies yielded a new entity with capabilities for design of rugged, remote, low maintenance electromechanical products for military, industrial, medical and commercial markets. Currently, PEM is located within a 16,000-Sq Ft facility located in Blaine, MN. Continual partnering with customers to provide a full range of product solutions has led PEM into the manufacturing of mission kits used throughout the US Army, hydraulic controls used in oil wells and actuators for heating, ventilation and valve control. Since 1994 PEM has established its design and manufacturing capabilities in its target markets and has a leading reputation with its US and international customers The Corporation has a wide-ranging portfolio including: Biological Sampling and Detection Equipment Fluid Consumables and Packaging Field Consumables for Military use Industrial Control Equipment Medical Products Automated Manufacturing Systems
Process Diagram Section QM 05 Page 7 of 17 Customer Sales and Marketing Main work process (Summary) Customer enquiry/order Company Management Planning Policy and objectives Regulations and standards Resources and training Plan work/order goods & materials Verify purchased goods &materials Sub-contractors and suppliers Manufacturing and Inspection Packing and Shipping Full details shown in the Process Control and other procedures Performance measurement Internal audit Non-conformance Corrective and preventive action Collection and analysis of data Process performance Customer Customer satisfaction Management review
Quality Policy Section QM 06 Page 8 of 17 Power Engineering & Manufacturing Inc recognizes that the disciplines of Quality, Health and Safety and Environmental management are integral parts of its management function. The Corporation views these as a primary responsibility and to be the key to good business in adopting appropriate Quality standards. The Corporation Quality Policy calls for continuous improvement in its Quality Management activities and business will be conducted according to the following principles: We will: - Comply with all applicable laws and regulations. Follow a concept of continuous improvement and make best use of our management resources in all Quality matters. Communicate our Quality objectives and our performance against these objectives throughout the Corporation and to interested parties. Take due care to ensure that activities are safe for employees, associates, subcontractors and others who come into contact with our work. Work closely with our customers and suppliers to establish the highest Quality standards. Adopt a forward-looking view on future business decisions, which may have Quality impacts. Train our staff in the needs and responsibilities of Quality Management. Signed: - Date: -
Organization Structure Section QM 07 Page 9 of 17 President & CEO Product Design Sales - New Products Purchasing VP of Engineering Product Design Sales - New Products, Purchasing Office Administrator Administration, Accounting, Customer Service Purchasing Internal Auditor Project Manager Purchasing Project Management Engineering Department Maintenance Product Design and Test Internal Auditor Production Manager Manufacture Inspection Purchasing Quality Manager Quality Representative Quality Control, Internal Auditor Manufacturing Team Receiving Manufacture Shipping
Section QM 08 Page 10 of 17 4 Quality Management System 4.1 General QMS Requirements Power Engineering & Manufacturing Inc is an independent design and manufacturing organization and, through the offices of the President and Vice President, is committed to maintaining an effective Quality Management System. This Manual has been prepared to satisfy the requirements of ISO 9001:2008 for Quality Management Systems for the activities carried out at the Blaine, MN site. Wherever possible, Quality controls have been integrated into existing systems (Environment, Health and Safety) and cross-referenced for ease of interpretation. The effective implementation of the Quality Management System will be verified by regular inspections, reviews and audits, which will compare management practice against the requirements of the written procedures, based on the Quality Management System standards. Corrective action will be taken where necessary and will be subsequently reviewed for effectiveness. 4.2 Documentation (Refer to Procedure Manual PRM01) The Corporation has written it s Quality Policy, Quality Manual, procedures and work instructions as appropriate to its size, type and complexity and they are available to all employees. All records are stored in conditions to ensure they are legible, identifiable and retrievable 5 Management Responsibility 5.1 Commitment Top management of the Corporation ensures that all employees are aware of the need to meet customer and regulatory requirements and that the necessary resources are available. The currency of the Quality Policy and objectives are maintained by regular management review.
Section QM 08 Page 11 of 17 QMS Requirements 5.2 Customer Focus Customer needs and expectations are determined, and fulfilled to meet customer satisfaction. Due consideration is given to product, service, regulatory and legal requirements. 5.3 Policy The Corporation has established, through its Quality Policy, the need to meet requirements and continually improve its products and services. Quality objectives are reviewed for continuing suitability and communicated as appropriate throughout the organization. 5.4 Planning The Corporation has established that all relevant functions and levels within the organization have clear, measurable quality objectives that are consistent with the Corporation Quality Policy and product requirements. Adequate resources are available and output is planned in a controlled manner as is required by its Quality Management System, being mindful of the processes and the need for continual improvement. 5.5 Administration 5.5.1 Details of the Corporation Quality Management System are documented. 5.5.2 Elements of the Quality Management System have been defined and communicated wherever quality is affected. 5.5.3 A representative has been appointed from within the organization that has the authority and responsibility to ensure that the Quality Management System is established and maintained and that reports on the performance of the System and any needs for improvement are made available to the Quality Representative. The significance of meeting customer requirements is understood. 5.5.4 Communication between all levels and functions are set up to ensure the effectiveness of the processes of the Quality Management System.
Section QM 08 Page 12 of 17 5.5 Administration (continued) QMS Requirements 5.5.5 The Corporation has prepared and maintains a controlled Quality Manual that defines the scope of its activities. This is supported by referenced documented procedures, work instructions and drawings. 5.5.6 A documented procedure ensures that all relevant quality documentation is controlled and adequate and that it is reviewed, updated and approved as necessary. The status of the documents is identified and they are legible, retrievable and located where they are required within the organization 5.5.7 Where documents originate from outside the organization they are identified and their distribution controlled. 5.5.8 Obsolete documents are clearly identified as such to prevent unintended use. 5.5.9 Procedures are in place for the identification, storage, retrieval, protection, retention time and disposal of quality records. 5.6 Management Review (Refer to Procedure Manual PRM02) 5.6.1 The complete Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness to evaluate the need for change. 5.6.2 The review includes the evaluation of current performance and improvement opportunities related to audits, customer feedback, process and product performance, follow up from previous meetings, and any changes that could affect product or service quality. 5.6.3 The results of the activity arising from review meetings are an essential part of the review process. These include resources, the Quality Management System and its processes, and improvements to products, related to customer requirements. The results of management review activity are recorded.
Section QM 08 Page 13 of 17 6 Resource Management QMS Requirements 6.1 Provision of Resources (Refer to Procedure Manual PRM03) The Corporation has ensured that the necessary resources needed to implement and improve the Quality Management System and to address customer satisfaction, are available. 6.2 Human Resources 6.2.1 Where personnel are assigned responsibilities affecting product conformity, the Corporation has ensured that they are competent on the basis of applicable education, training, skills and experience. 6.2.2 The Corporation has identified the training needs for quality related activities and provides training to fulfill and meet these needs. Performance is evaluated and appropriate training records are maintained. 6.3 Facilities 6.3.1 Suitably equipped workplaces with appropriate hardware, software and supporting services are provided. 6.3.2 The Corporation maintains an ISO Class 6 Clean Room for the manufacture of fluid consumables and packaging. 6.4 Work environment All aspects of the human and physical factors of the working environment that affect conformity of product or service have been identified and are managed.
Section QM 08 Page 14 of 17 7 Product Realization QMS Requirements 7.1 Planning of the realization process (Refer to Procedure Manual PRM04) The process for the design and manufacture of the Corporation s products is planned and documented as defined in the Quality Management System. Quality objectives, resources, processes, documentation needs and acceptable criteria for verification and validation are defined. Records appropriate to the level of confidence required are maintained for the process and the product. 7.2 Customer related processes (Refer to Procedure Manual PRM04 & PRM05) 7.2.1 The needs of the customer in respect of availability, delivery and support are considered against the product s intended use. Regulatory and legal requirements are determined and implemented. 7.2.2 The Corporation reviews the customer s requirements and determines any additional requirements for each contract or order. Where no customer requirements are documented, details are confirmed in writing before acceptance. Any changes to contracts or quotations are resolved before proceeding and the Corporation s ability to meet the defined requirements is confirmed. 7.2.3 The customer is kept informed of product information, enquiries, order changes or amendments and progress on customer complaints. 7.3 Design and development (Refer to Procedure Manual PRM12) Control will be through the design/development plan, which will reduce the project into phases with defined input, output, and verification. The interrelationships between the involved parties will be established to organize the plan and to define, check and document progress as specified in the Corporation s procedures.
Section QM 08 Page 15 of 17 QMS Requirements 7.4 Purchasing (Refer to Procedure Manual PRM06) 7.4.1 The Corporation controls its purchasing function to ensure that the purchased goods and services conform to requirement. Suppliers are selected against defined criteria and are subject to planned review and evaluation. The results of these evaluations and follow-up actions are recorded. 7.4.2 Purchasing documents are reviewed before release for the adequacy of information on product, procedures, processes, equipment and personnel. 7.4.3 The Corporation verifies its purchased products and services and, where verification takes place at the supplier or customer premises, details of the arrangements and the method of release/acceptance are specified. 7.5 Production and service operations. (Refer to Procedure Manual PRM05) 7.5.1 Production and service activities are controlled through work orders, product specifications, work instructions and drawings. Release of product, delivery and post-delivery processes are defined. 7.5.2 Any processes for production/service provision where the resulting output cannot be verified by subsequent monitoring or measuring shall be validated in order to prevent deficiencies once the product is in use or the service has been delivered. 7.5.3 Where required, the product is identified throughout the production activities. Where traceability is required, the unique identification of the product is controlled and recorded. 7.5.4 When customer property comes within the Organization s control, it is identified, verified, maintained and protected, with details of adverse condition reported to the customer. 7.5.5 The Organization preserves the conformity of the product from receipt of raw material to delivery of finished goods. 7.6 Control of measuring and monitoring equipment (Refer to Procedure Manual PRM07) Measuring and monitoring equipment are identified throughout the Corporation where quality is affected and the equipment used is controlled to appropriate standards for consistency. The equipment is protected against random adjustments, damage and deterioration and the results of calibrations are recorded.
Section QM 08 Page 16 of 17 QMS Requirements 8 Measurement, analysis and improvement 8.1 Planning The Organization has planned and implemented the measurement, monitoring and analysis of the Quality System to ensure conformity and to continually improve the effectiveness of the System. 8.2 Measurement and monitoring (Refer to Procedures Manual PRM11) 8.2.1 Clear methods have been established to monitor customer satisfaction and review any failures to meet Corporation standards. 8.2.2 Suitably trained and impartial personnel conduct periodic independent internal audits on a planned basis. All aspects of internal audits are recorded and reviewed. Corrective action is taken, where necessary. 8.2.3 Processes affecting customer requirements are periodically reviewed to ensure that the intended purpose is being met. 8.2.4 Measuring and monitoring of the product throughout the realization process is designed to ensure that the product meets specification. Authorized personnel control the release of finished product. 8.3 Control of non-conformity (Refer to Procedures Manual PRM09) Documented procedures are in place to identify and isolate non-conforming products. Before reworked/repaired product is returned to the work process, it is re-checked. In the event of non-conforming product reaching the customer, appropriate corrective action is taken. 8.4 Analysis of data (Refer to Procedures Manual PRM02 & PRM11) Data referring to product quality problems is collected and analyzed and where changes to the Quality Management System offer improvements these changes are introduced. Areas for attention include customer complaints, meeting the customers needs, product characteristics and supplier performance.
Section QM 08 Page 17 of 17 QMS Requirements 8.5 Improvements 8.5.1 The Quality Management System is managed in a manner to offer continual improvement having regard to the statements in the Quality Policy, objectives, audit results, data analysis, corrective and preventive action and management review activity. (Refer to Procedure Manual PRM11) 8.5.2 Appropriate action is taken to rectify faults and prevent their recurrence and this procedure is documented. The requirement for identifying faults, determining their cause and taking appropriate corrective action is covered. Details are recorded and the results reviewed for effectiveness. (Refer to Procedure Manual PRM10) 8.5.3 The Corporation identifies preventive actions to prevent the occurrence of non-conformity. The results of such actions are recorded and reviewed for effectiveness. (Refer to Procedure Manual PRM10) END