NATIONAL INSTITUTE of AEROSPACE
QUALITY MANAGEMENT SYSTEM MANUAL Submitted in Support of NASA LaRC Contract NNL13AA00B
UNCONTROLLED COPY Original Effective Date: March 1, 2013 Revision Number/Date: Original Issue
PROPRIETARY INFORMATION: This document is the proprietary property of the National Institute of Aerospace Associates (NIAA). It should not be distributed in whole or in part without the express written consent of an authorized representative of NIAA.
Quality Management System Manual
Table of Contents 1 Approval and Revision .........................................................................................................4 1.1 Approval ..............................................................................................................................4 1.2 Revision History ..................................................................................................................4 2 Company ................................................................................................................................5 2.1 Vision ...................................................................................................................................5 2.2 Mission.................................................................................................................................5 2.3 Company Processes .............................................................................................................5 3 Scope and Exclusions ............................................................................................................7 3.1 Scope ....................................................................................................................................7 3.2 Exclusions ............................................................................................................................7 3.3 References and Inclusions....................................................................................................7 3.4 NIA Quality Management System Documents....................................................................8 4 Quality Management System ...............................................................................................9 4.1 General Requirements ..........................................................................................................9 4.2 Documentation Requirements ..............................................................................................9 4.2.1 General ............................................................................................................................9 4.2.2 Quality Manual .............................................................................................................10 4.2.3 Control of Documents ...................................................................................................11 4.2.4 Control of Records ........................................................................................................11 5 Management Responsibility ...............................................................................................12 5.1 Management Commitment.................................................................................................12 5.2 Customer Focus .................................................................................................................13 5.3 Quality Policy ....................................................................................................................13 5.4 Planning .............................................................................................................................14 5.4.1 Quality Objectives ........................................................................................................14 5.4.2 Quality Management System Planning.........................................................................15 5.5 Responsibility, Authority and Communication .................................................................15 5.5.1 Responsibility and Authority ........................................................................................15 5.5.2 Management Representative .........................................................................................15 5.5.3 Internal Communication ...............................................................................................16 5.6 Management Review .........................................................................................................16 5.6.1 General ..........................................................................................................................16 5.6.2 Review Input .................................................................................................................16 5.6.3 Review Output ..............................................................................................................17 6 Resource Management .......................................................................................................18 6.1 Provision of Resources ......................................................................................................18 6.2 Human Resources ..............................................................................................................18 6.2.1 General ..........................................................................................................................18 6.2.2 Competence, Training, and Awareness ........................................................................18 NATIONAL INSTITUTE OF AEROSPACE Original Effective Date: March 1, 2013 Revision Number/Date: Original Issue/March 1, 2013
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6.2.3 Training of Employees ..................................................................................................19 6.3 Infrastructure ......................................................................................................................19 6.4 Work Environment.............................................................................................................19 7 Product Realization ...........................................................................................................21 7.1 Planning of Product Realization ........................................................................................21 7.1.1 Project Management .....................................................................................................22 7.1.2 Risk Management .........................................................................................................22 7.2 Customer Related Processes ..............................................................................................22 7.2.1 Determination of Requirements Related to the Product ...............................................22 7.2.2 Review of Requirements Related to the Product ..........................................................23 7.2.3 Customer Communication ............................................................................................24 7.3 Design and Development ...................................................................................................24 7.3.1 Design and Development Planning...............................................................................25 7.3.2 Design and Development Inputs ...................................................................................25 7.3.3 Design and Development Outputs ................................................................................25 7.3.4 Design and Development Review.................................................................................26 7.3.5 Design and Development Verification..........................................................................26 7.3.6 Design and Development Validation ............................................................................26 7.3.7 Control of Design and Development Changes..............................................................26 7.4 Purchasing ..........................................................................................................................27 7.4.1 Purchasing Process........................................................................................................27 7.4.2 Purchasing Information.................................................................................................28 7.4.3 Verification of Purchased Product ................................................................................28 7.4.4 Management and Maintenance of Suppliers .................................................................28 7.5 Production and Service Provision ......................................................................................29 7.5.1 Control of Production and Service Provision ...............................................................29 7.5.2 Validation of Process for Production and Service Provision ........................................29 7.5.3 Identification and Traceability ......................................................................................30 7.5.4 Customer Property ........................................................................................................30 7.5.5 Preservation of Product .................................................................................................31 7.6 Control of Monitoring and Measuring Equipment ............................................................31 8 Measurement, Analysis and Improvement .......................................................................33 8.1 General ...............................................................................................................................33 8.2 Monitoring and Measurement ............................................................................................33 8.2.1 Customer Satisfaction ...................................................................................................33 8.2.2 Internal Audit ................................................................................................................33 8.2.3 Monitoring and Measurement of Processes ..................................................................34 8.2.4 Monitoring and Measurement of Product .....................................................................34 8.3 Control of Nonconforming Product ...................................................................................35 8.3.1 General ..........................................................................................................................35 8.4 Analysis of Data .................................................................................................................36 8.5 Improvement ......................................................................................................................36 8.5.1 Continual Improvement ................................................................................................36 8.5.2 Corrective Action ..........................................................................................................37 8.5.3 Preventive Action..........................................................................................................37 NATIONAL INSTITUTE OF AEROSPACE Original Effective Date: March 1, 2013 Revision Number/Date: Original Issue/March 1, 2013
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1 Approval and Revision 1.1
Approval
This “Quality Management Systems Manual” has been approved for use throughout the National Institute of Aerospace (NIA): Date of Initial Version:
March 1, 2013
Name and Title of Approver:
Dr. Douglas O. Stanley, President and Executive Director
Date of Approval:
March 1, 2013
This “Quality Management Systems Manual” was written and published by the NIA Quality Team. Please contact Dr. Karl L. Drews at
[email protected] with questions, comments and improvement ideas. 1.2
Revision History
The following revisions have been made to this “Quality Management Systems Manual” since its initial publication: Revision Date
List of Changes
Author (Name & Date)
Approval (Name & Date)
NONE.
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2 Company The National Institute of Aerospace (NIA) is a 501(c)3 Virginia non-profit research and graduate education institute created to conduct leading-edge aerospace and atmospheric research, develop new technologies for the nation, and help inspire the next generation of scientists and engineers. NIA was formed by a consortium of leading research universities. Members include: Georgia Tech, Hampton University, North Carolina A&T State University, North Carolina State University, the University of Maryland, the University of Virginia, Virginia Tech, Old Dominion University, and The College of William & Mary. The AIAA Foundation is also a full member. NIA serves as a strategic partner with NASA Langley Research Center and the aerospace community to enable research creativity and expand technology development opportunities. The Institute integrates research and graduate education while creating new government/academia/industry partnerships to solve tomorrow's problems today. 2.1
Vision
NIA’s vision is “To be a national leader in aerospace innovation in the USA”. 2.2
Mission
The mission of NIA is to: • • • •
2.3
Foster research collaboration among national laboratories, academia and commercial partners to stimulate innovation and creativity. Provide comprehensive graduate and continuing education in science and engineering via local campus presence and distance learning technologies. Incubate and stimulate the commercialization of new intellectual property developed through NIA's research activities. Promote aerospace science and engineering and through outreach programs to the region and nation. Company Processes
NIA’s senior management leads our Quality Team. The Quality Team enables NIA to identify and meet customer requirements and continuously improve customer satisfaction. NIA has appointed Dr. Karl L. Drews, Vice President of Operations, as NIA’s Quality Management Representative. NIA’s Quality Team is responsible for reviewing and evaluating NIA’s Quality Management System (QMS) and quality objectives, planning for the continuing suitability and efficacy of
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the Quality Management System, and continually improving the Quality Management System. NIA’s management team is organized as follows:
We identified the key processes and their interaction at NIA, and we fully integrated them in our Quality Management System. The flowchart below illustrates these processes and their interaction.
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3 Scope and Exclusions 3.1 Scope This “Quality Management Systems Manual” documents NIA’s quality management system and demonstrates NIA’s commitment to consistently provide a product that meets customer and regulatory requirements. This “Quality Management Systems Manual” establishes compliance with ISO 9001:2008. It applies to all our business activities including our research and development activities, graduate education, and outreach programs encompassing production, sales, marketing, installation and servicing activities as covered by this Quality Management Systems Manual (any applicable exclusion is listed below). It is the responsibility of NIA Executives and all department managers to assist in defining, implementing, disseminating and maintaining the procedures required by this manual and to ensure all processes conform to these requirements. It is the responsibility of all NIA employees to follow procedures that implement these policies and to help strive for continuous improvement in all NIA activities and processes. 3.2 Exclusions The following requirements of ISO 9001:2008 are excluded due to the nature of our company and our products in compliance with Paragraph 1.2 of ISO 9001:2008: Chapter Title
Justification for Exclusion
NONE.
3.3 References and Inclusions ISO 9001:2008: All references to ISO 9001 in this manual refer to the requirements of ISO 9001:2008. Starting with Chapter 4 “Quality Management System”, the numbering system of this “Quality Management Systems Manual” directly corresponds to the numbering system of the requirements section of ISO 9001:2008. Quality Procedures: We documented certain key processes of our Quality Management System through more detailed quality procedures as required by ISO 9001:2008. The Quality Procedures (QP) are established, documented, implemented and maintained as part of our Quality Management System. The QPs are maintained as separate documents.
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3.4 NIA Quality Management System Documents NIA’s Quality Management System documentation consists of five levels: 1) Quality Policy: Outlines the overarching quality emphasis at NIA in support of the establishment, operation, maintenance, and continual improvement of our quality management system. Further, it provides a framework for establishing and reviewing quality objectives, firmly commits NIA to the requirements of ISO 9001:2008, commits NIA to continually improve the effectiveness of our Quality Management System. 2) Quality Management Systems Manual: Defines the overall structure and policies of the Quality Management System. The NIA Quality Team is responsible for the contents of the Quality Management Systems Manual and the Quality Management Representative is responsible for its maintenance and distribution. 3) Quality Procedures: Define the operating processes and the related responsibilities and authorities that comprise the Quality Management System. These procedures support the overall structure and policies defined in the Quality Management Systems Manual. Quality Procedures are developed by the relevant organizational authorities and approved by the Quality Team. The Quality Management Representative is responsible for their periodic review, maintenance, and distribution. 4) Supporting Documents: The Quality Procedures may refer to various manuals, guidebooks, detailed procedures, forms, or other documents relevant to the implementation of the quality procedures. 5) Quality Forms and Records: Completed forms or documents that provide proof of conformance with Quality Management System requirements. The record custodians specified in each relevant Quality Procedure are responsible for the accuracy and maintenance of completed Quality Forms and records.
Quality Policy QUALITY MANAGEMENT SYSTEMS MANUAL QUALITY PROCEDURES
SUPPORTING DOCUMENTS
QUALITY FORMS AND RECORDS
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4 Quality Management System 4.1 General Requirements NIA has established, documented, and implemented a quality management system that meets the requirements of ISO 9001:2008. NIA maintains this Quality Management System and continually improves its effectiveness through the use of the quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action and management reviews. Maintenance of this system is the responsibility of the Quality Management Representative in conjunction with all Department Managers. NIA’s Quality Management System: • • • • • •
Defines the processes needed for its operation and their application throughout NIA. These processes include processes for management activities, provision of resources, product realization, measurement, and continual improvement; summarizes the sequence and the interaction of these processes, and they are documented in Chapter 2.3 in form of a process flowchart; specifies the criteria and methods needed to ensure that both the operation and control of these processes are effective. ensures the availability of resources and information necessary to support the operation and monitoring of these processes; ensures that these processes are monitored, measured where applicable, and analyzed by NIA; and ensures that necessary actions are implemented to achieve planned results and continual improvement of these processes.
NIA manages these processes in accordance with the requirements of ISO 9001:2008. Where NIA chooses to outsource any process that affects how our products meet requirements, NIA ensures control over such processes. Our Quality Management System identifies the type and extent of control of such outsourced processes (refer to Chapter 7.4). This Quality Manual along with the associated procedures identifies the processes needed for the Quality Management System at NIA. 4.2 Documentation Requirements 4.2.1 General The documentation of our Quality Management System includes the following documents: • •
The documented Quality Policy of NIA and the documented Quality Objectives of NIA. This “NIA Quality Management System Manual”.
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• • •
The documented Quality Procedures of key processes of our Quality Management System. All such Quality Procedures are established, documented, implemented and maintained. All such documents (including records) that NIA requires to ensure the effective planning, operation and control of our processes. All records that are determined by NIA to be necessary in controlling and improving our Quality Management System.
The documentation of our Quality Management System uses different forms and media depending on its use and user(s). The extent of the documentation of our Quality Management System has been determined based on the size of NIA, the type of our business, and the complexity of our processes and their interactions. The Quality Management Representative maintains a document that identifies the sequence of these processes and, in conjunction with the appropriate department managers, defines the interactions of the processes within the procedures defining these processes. Processes for management activities, provision of resources, product realization, and measurement are included. Procedures include the methods needed to ensure the operation and control of processes is effective. These processes will be managed in accordance with the documented provisions of our Quality Management System. NIA’s Senior Management will ensure the availability of resources to support the operation and monitoring of processes through regular interaction with department managers and through review activities at Management Review meetings. Department Managers and the Management Representative will monitor measure and analyze processes and implement any actions necessary to achieve intended results and continual improvement of the processes. These results will also be monitored at Management Review meetings. Any processes that we outsource which may affect our product’s conformity to requirements shall be controlled by NIA. The Quality Management Representative and appropriate department manager(s) are responsible for defining the methods to control outsourced processes and procedures. 4.2.2 Quality Manual NIA has established this Quality Management System Manual to identify and document key processes and procedures including: • • • •
The scope of our Quality Management System in Chapter 3.1. Any exclusions including details and justifications in Chapter 3.2. Our documented Quality Procedures (see Chapter 3.3 for details). A description of the interaction between the processes of our Quality Management System in Chapter 2.3.
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4.2.3 Control of Documents NIA has a documented system level procedure for controlling new and revised documents required for the operations of the Quality Management System. Procedure QP4.2.3-01 ensures that: • • • • • •
documents are approved for adequacy prior to release; documents are reviewed, approved, updated and re-approved as necessary; the relevant versions of documents are available at locations where essential activities are performed; obsolete documents are controlled to prevent unintended use; any obsolete documents retained for knowledge preservation purposes are identified; and applicable documents of external origin are identified
4.2.4 Control of Records Quality records are documents that specifically demonstrate conformance to requirements and effective operation to the NIA Quality Management System. NIA procedure QP4.2.4-01 defines the documented process for quality record retention, identification, protection, accessing, filing, storage, retrieval and disposition. This includes applicable records delivered from suppliers to NIA.
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5.0 Management Responsibility 5.1 Management Commitment The functioning of NIA’s Quality Management System, the on-going evaluation of its suitability and effectiveness, and its continual improvement is the responsibility of NIA’s Quality Team (Chapter 2.3 Company Processes). NIA’s Quality Team meets as specified in the Management Review procedure (Chapter 5.6) to evaluate the Quality Management System, evaluate NIA’s progress toward its quality goals and objectives, make improvements to the Quality Management System, and plan for the continuing suitability and efficacy of the Quality Management System. Throughout the development, implementation, review and improvement of the Quality Management System, the Quality Team ensures that customer requirements are being identified and met consistently in order to achieve customer satisfaction. It is the responsibility of the Quality Team to ensure that:
All employees understand and implement the Quality Management System. The Quality Management System is deployed effectively throughout the organization. The Quality Management System functions effectively to support NIA’s quality and business goals. The integrity of the Quality Management System is maintained.
The Quality Management System Quality Management Representative is NIA’s Vice President of Operations. The Quality Management Representative is responsible for the day‐to‐day supervision of the Quality Management System. This responsibility and authority includes ensuring the establishment, implementation and maintenance of the Quality Management System; reviewing the Quality Management System and reporting relevant information to the Quality Team; ensuring awareness of Quality Management System policies and procedures and customer requirements throughout the organization; and communicating with external parties on issues related to NIA’s Quality Management System. It is the responsibility of all NIA managers to clearly define responsibilities and authorities and communicate them throughout their functional area. It is also the responsibility of NIA Senior Management to maintain communication processes that ensure all employees understand the Quality Management System, how well it is functioning, and their role in the Quality Management System and in meeting customer requirements. All NIA employees are responsible for understanding and effectively performing their roles in implementing NIA’s Quality Management System. Every employee who interacts with a customer or delivers products or services that contribute to deliverables to our customers has the potential to affect customer satisfaction. NIA employees thus have the responsibility to follow relevant Quality Management System procedures and represent NIA in the most professional and competent manner while meeting customer requirements and striving for continual improvement.
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Senior management at NIA has not only actively participated in developing and implementing our Quality Management System, but is also committed to continually improving its effectiveness. The senior management of NIA clearly demonstrates its commitment by:
Communicating to all employees the importance of meeting customer requirements, as well as any statutory or regulatory requirements, establishing our Quality Policy (see detailed requirements in Chapter 5.3), ensuring the Quality Objectives are established (see 5.4.1 below), conducting periodic management reviews of the Quality Management System, and ensuring the availability of resources to implement and execute the Quality Management System.
The management team consisting of the President, Vice Presidents, and all department managers is chartered with ensuring our products and services meet customer as well as statutory and regulatory requirements. 5.2 Customer Focus NIA is committed to customer satisfaction and actively seeks informal and formal customer feedback on the products and services we provide. Senior Management at NIA provides leadership to ensure that we first clearly determine customer requirements, and that we then meet those customer requirements, all with the goal of enhancing customer satisfaction (see Chapters 7.2.1 and 8.2.1). NIA’s senior management ensures the focus on improving customer satisfaction is maintained by periodically setting and reviewing objectives related to customer satisfaction. 5.3 Quality Policy Senior management at NIA has established our Quality Policy with the aim of creating a policy that is appropriate to the purpose of NIA and provides a framework for establishing and reviewing quality objectives. Our Quality Policy also firmly commits NIA to the requirements of ISO 9001:2008 to continually improving the effectiveness of our Quality Management System. Senior management continues to keep our Quality Policy active by ensuring:
that our Quality Policy is communicated and understood throughout NIA, and that our Quality Policy is reviewed for continuing suitability as part of management reviews.
To ensure our policy remains appropriate, it is reviewed at least annually at one of our Management Review meetings.
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National Institute of Aerospace (NIA) Quality Policy:
It is NIA’s policy to deliver products and services that meet or exceed our customers’ requirements and comply with all statutory and regulatory requirements. We accomplish this by adhering to our management system and operational methods that recognize customer satisfaction as a primary goal.
•
We strive to continually improve the effectiveness of our quality management system and our commitment to customer satisfaction by monitoring our performance against our established objectives and through leadership that promotes employee involvement. This concept represents NIA’s commitment to quality and the increasing need to better serve a growing and demanding customer base.
•
We monitor our performance through performance metrics in order to continually improve our processes and services.
•
We utilize our quality management system for all company processes everywhere, every time, without exception.
5.4 Planning 5.4.1 Quality Objectives Senior management at NIA ensures that quality objectives are established throughout NIA at relevant functions and levels, including: at the executive level, and at the department level for all departments that have an impact on our products. NIA establishes objectives in order to give all business units, departments and employees a common direction. Objectives are established on the highest level, and then disseminate down through our departments to the individual. All objectives support the objectives of the next higher level in order to ensure that NIA Strategic Objectives are achieved. The managers of individual departments set annual business objectives that are in support of the top-level objectives. These business objectives may be incorporated in business plans and budgets. Supervisors set specific performance objectives of their staff as part of the periodic performance review. These performance objectives also support the objectives of the department and the overall strategic objectives. NIA’s Quality Objectives: • •
On-time delivery of all deliverables. Satisfactory, or higher, cumulative score on all customer satisfaction surveys.
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These quality objectives meet the following requirements:
They include (but are not limited to) objectives regarding meeting requirements for our products (see Chapter 7.1). They are measurable. They are consistent with our Quality Policy.
5.4.2 Quality Management System Planning Our Quality Management System has been planned and implemented with the aim of meeting our quality objectives and the requirements set forth in Chapters 4.1 and 5.4.1. Whenever there are changes to our Quality Management System, senior management will ensure that the planning and implementation is accomplished in such a manner as to retain the integrity of our Quality Management System. As situations arise that demand changes to the Quality Management System either to meet objectives or because of changing business conditions, all changes will be reviewed by the management team to ensure the integrity of the quality system is maintained. Quality Procedure QP5.4.2-01/Quality Management System Planning further documents our approach. 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority Senior management at NIA ensures that responsibilities and authorities are defined and communicated throughout NIA. Responsibilities and authorities are defined and communicated through: •
Organizational charts - NIA uses organizational charts to show the overall structure, interrelation and hierarchy between individual positions. Organizational charts are communicated to all positions within the functional areas that they cover.
•
Job descriptions - Job descriptions are used to define the responsibilities and authorities of individual positions. Job descriptions are communicated and made available to those positions that are affected.
5.5.2 Management Representative NIA’s President and Executive Director has appointed a management representative who, irrespective of other responsibilities, has the authority to:
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• • • • •
Ensure that the processes needed for our Quality Management System are established, implemented and maintained. Report to senior management on the performance of our Quality Management System and any need for improvement. Ensure the promotion of awareness throughout the organization. Resolve matters pertaining to quality through the use of QP8.5.2-01/Corrective Action and QP8.5.3-01 Preventive Action. Act as liaison with external parties on matters relating to our Quality Management System.
5.5.3 Internal Communication In line with NIA’s policy of leadership through employee involvement, NIA’s personnel policies have established open communication throughout the organization. Senior management at NIA ensures that there are appropriate communication processes established throughout NIA. These communication processes include our periodic all-hands meetings, emails, and weekly senior management and department meetings. Senior management further ensures that communication takes place regarding the effectiveness of our Quality Management System, specifically Internal Audit results, Corrective and Preventive Actions, and the departmental performance measures. This includes audit closing meetings and making results of internal and external audits of our Quality Management System available throughout NIA. 5.6 Management Review 5.6.1 General The President and management team review NIA’s quality management system on an annual basis, or more frequently if needed, to ensure its continuing suitability, adequacy and effectiveness. The Quality Management Representative is responsible for maintaining records from management reviews. This review includes an assessment of opportunities for improvement and the need for changes to our Quality Management System, including our Quality Policy and the Quality Objectives. NIA maintains records of these management reviews in compliance with Chapter 4.2.4. 5.6.2 Review Input Management reviews of our Quality Management System are based on assessing certain information as the review input. The following information serves as input to the management reviews of our Quality Management System:
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• • • • • • • •
results of audits, customer feedback, process performance, product conformance to requirements, status of preventive and corrective actions, follow-up actions from previous management reviews, any changes that could affect our Quality Management System, and recommendations for improvement.
5.6.3 Review Output During NIA’s management reviews, decisions are made and actions are planned, which are considered output of such reviews. The output from the management reviews of our Quality Management System includes decisions and planned actions related to the following key issues: • • •
improving the effectiveness of the our Quality Management System and its processes, improving our processes and products relative to customer requirements through analysis and/or improvement, and resource needs.
Quality Procedure QP5.6-01/Management Review further documents our approach.
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6.0 Resource Management 6.1 Provision of Resources NIA determines and provides, in a timely manner, resources needed to establish, maintain, and improve the effectiveness of its Quality Management System. NIA has implemented our Quality Management System with senior management’s full support, commitment, and the provision of the necessary resources. NIA also determines and then provides the resources needed to meet all customer requirements in order to enhance customer satisfaction. Such resources are applied to the managing of departments, processes and projects to enhance customer satisfaction by meeting all customer requirements. 6.2 Human Resources 6.2.1 General NIA ensures that all our personnel who perform work that affects product quality are competent to perform their work and meet their responsibilities. Competence is based on: • •
appropriate skills and experience; appropriate education and training.
6.2.2 Competence, Training, and Awareness NIA does the following regarding competence, training and awareness of our employees: •
NIA determines the necessary competence for personnel performing work affecting conformity to product requirements. Job descriptions are created for all positions within the organization. A job analysis is first conducted to determine the essential requirements of the position and the minimum education, experience and skills required. Candidates are screened based on requirements outlined in the job description.
•
Where personnel lack the required competence, NIA provides the necessary training or takes other actions, such as the development of a Personnel Action Plan, in order to achieve the necessary competence. Types of training may include seminars or class room training, online training, on-the-job training or mentoring. NIA also provides employees the opportunity to further their education by offering tuition reimbursement (NIA Policy COMP108 Educational Assistance).
•
NIA evaluates the effectiveness of the training or other actions taken. Supervisors are expected to assess the effectiveness of training provided, with respect to the appropriate job description, based on the employee’s ability to perform the duties outlined in the job
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description. Appropriate action will be taken to modify the training program or provide additional training if evaluations show that training is ineffective. Effectiveness of training is also discussed during the employee’s annual performance review. NIA ensures that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. •
NIA maintains personnel files that include appropriate records of education, training, skills and experience in compliance with Chapter 4.2.4.
6.2.3 Training of Employees NIA strives to ensure that all its employees are competent, trained in the latest quality principles and techniques, and continually upgrading their knowledge and skills. NIA Quality Procedure QP6.2.3-01/Training of Employees defines NIA’s training program and resources. 6.3 Infrastructure During the annual budgeting and strategic planning processes, buildings, workspace, and associated utilities are evaluated and provided. When new personnel are added, Human Resources coordinates activities to ensure appropriate process equipment including hardware and software (if required) and supporting services such as telephones, internet connections, etc., are available. NIA does the following regarding the infrastructure necessary to achieve conformity to product requirements: • • •
determination of infrastructure needs, providing the necessary infrastructure, and maintaining the infrastructure.
This infrastructure includes, as applicable, the following: • • •
buildings and workspaces (including the associated utilities), equipment used in work processes (equipment includes both hardware and software), and supporting services (such as transportation, information systems and communications).
6.4 Work Environment NIA has established and manages a work environment that is conducive to achieving the required product quality. In case of changes, NIA determines a work environment that is necessary to achieve conformity to product requirements, and then manages it accordingly to ensure that NIA employees work in a safe and secure environment.
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The work environment encompasses conditions under which work is performed, for example lighting, temperature, ventilation, noise, vibration, exposure to weather and other environmental and physical factors. 2.4
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7 Product Realization NIA is a non-profit aerospace research, graduate education, and educational/public outreach institute: •
NIA’s research products typically include test data and/or analysis results, technical briefings, technical reports, conference papers, journal articles and, occasionally, a ‘hard’ deliverable such as a material sample or computer software.
•
NIA’s education products include courses taught by resident faculty and/or classes delivered via distance learning facilities with our member universities, and research products generated by the students as part of their MS/PhD degree requirements. In addition, NIA provides short courses for professional development and continuing education of working professionals.
•
NIA’s outreach products include educational programs, live events and conferences, design competitions, workshops, web-based programs/events, radio programs, television program content, and downloadable programming. These products are focused on STEM education for K-12 students, technical content for working professionals, and the public at large.
NIA has planned and developed the processes needed to provide our customers with products and services that meet their requirements. The results of this planning are the processes and procedures defined in our Quality Management System documentation. These processes and procedures include the quality objectives and requirements for our products, the required verification, validation, monitoring, inspection and test activities specific to our products and the criteria for product acceptance verification. The records needed to provide evidence that these processes and resulting product meet requirements are defined in the procedures. Consideration is given for the need to establish processes, documents, and obtain resources specific to new products as they are developed or during contract review. 7.1 Planning of Product Realization NIA plans and develops the processes needed for product realization. This planning of product realization is consistent with the requirements of the other processes of our Quality Management System (see Chapter 4). NIA determines the following, as appropriate, during the planning phase for product realization: • •
NIA determines the quality objectives and requirements for the product; NIA determines the need to establish: a) Special processes, b) documents, and c) provision of resources specific to the product.
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• • • •
NIA determines the extent to which the following activities are required by the specifics of the product and the criteria for product acceptance: a) verification, b) validation, c) monitoring, d) measurement, and e) inspection and test; NIA determines the records of the above activities to demonstrate product and process conformance (records are controlled in compliance with Chapter 4.2.4). NIA identifies the resources necessary to support the product. NIA determines the configuration management appropriate to the specific product. The output of this planning is in an appropriate form suitable for the specific method of operations.
7.1.1 Project Management As appropriate to the specific product, NIA plans and manages product realization in a structured and controlled manner to meet requirements at acceptable risk and within resource and schedule constraints. 7.1.2 Risk Management NIA establishes and implements, as appropriate for the product, a process for managing risk to achieve conformity to requirements. We accomplish this by: • •
Assignment of responsibilities for risk management. Identification and management of actions to mitigate any identified risks.
7.2 Customer Related Processes Customer related processes essentially encompass the contractual relationship and requirements between NIA and its customers, including initial identification of the customer’s need, proposal or quote generation, award acceptance, and communication related both to in-process changes of product requirements as well as feedback related to customer satisfaction. NIA procedure QP7.2-01 Contract Management defines our overall approach to Contract Management. 7.2.1 Determination of Requirements Related to the Product Product requirements include several aspects, including consideration for the need to establish processes, documents, and obtain resources specific to new products as they are developed or during Request for Proposal (RFP) or contract review. NIA determines the following requirements that are related to our product; these different requirements constitute our comprehensive product requirements:
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Customer specifications - NIA determines those requirements that have been specified by our customers, including any such requirements for delivery and post-delivery activities.
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Implied requirements – As appropriate for a specific project, NIA determines and documents those product requirements that have not been explicitly stated by our customers but that are necessary for the specified or intended use of our products (where the use is known).
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Regulations - NIA determines statutory and regulatory requirements that are applicable to our products.
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Other - NIA may add any additional requirements that NIA considers necessary, including requirements based on our Quality Management System or quality objectives.
7.2.2 Review of Requirements Related to the Product NIA reviews all requirements related to the product (for example, Statements of Work provided with Requests for Proposals) prior to NIA’s commitment to supply a product to the customer (e.g., prior to the submission of proposals, prior to the acceptance of contracts or orders, prior to the acceptance of changes to contracts or orders). The review covers the following issues; the purpose of the review is to ensure: •
Completeness - NIA ensures that all product requirements are clearly defined. Where the customer provides no clear written statement of work, the requirements are confirmed and recorded prior to acceptance by NIA.
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No discrepancies - NIA ensures that any differences of contract or order requirements to previously expressed contract or order requirements are resolved.
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Ability to deliver - NIA ensures that we have the ability and resources to meet defined requirements for both the product and delivery.
NIA maintains records that show the results of the review and the actions arising from the review in compliance with Chapter 4.2.4. In cases in which our customers don’t provide documented requirements, NIA confirms the customer requirements in writing before acceptance. In cases in which product requirements are changed: • •
NIA ensures that relevant documents are amended (such as task order modifications), and NIA ensures that relevant personnel are made aware of the changed requirements.
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7.2.3 Customer Communication In keeping with our commitment to customer satisfaction, NIA views effective customer communication as an essential element of customer satisfaction. Appropriate handling of communications can reduce customer dissatisfaction in situations and in many cases turn a dissatisfying scenario into a satisfying experience. NIA management is responsible for establishing communication methods to ensure enquiries, contracts, including amendments, and customer feedbacks, including customer complaints are handled expeditiously and professionally. NIA management determines and implements effective arrangements for communicating with our customers regarding the following specific items: • • •
Product information and inquiries (primarily through our Business and Program Development functions), Contracts, orders, and contract/order changes (received and coordinated internally through our Contracts Department), and Customer responses relating to performance of the product (achieved through a combination of contact with NIA Program Managers and customer surveys – refer to Chapter 8.2.1).
7.3 Design and Development NIA conducts design and development activities within our three major product areas: research, education, and educational/public outreach. Our objective is to ensure that we fully formulate and execute plans for activities resulting in meeting customer requirements. Each research, educational or outreach effort is led by a Principal Investigator (PI) or a Project Manager (PM), the titles reflecting generally accepted definitions: “PI” as a scientist or engineer leading a complex technical (research) effort while “Project Manager” applies in cases where the technical content is less complex (educational and outreach projects). The PI or PM is responsible for leading the project and ensuring it is accomplished through the plan in the proposal with any subsequent changes incorporated into the SOW by, or with, agreement of the customer. Essential elements to be addressed and monitored throughout the project include: • • • • •
Resource requirements and viability Roles and responsibilities among project participants Criteria for product acceptance by the customer and the supporting quality activities Documentation and record requirements Safety, regulatory, and usage items
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7.3.1 Design and Development Planning The NIA PI or PM plans and controls the design and development of our products for each project. The design plan includes the following: •
Design stages - NIA plans for the various stages of the design and development process.
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Design reviews - NIA plans for the reviews, verification and validation activities that are appropriate to each design and development stage (see above).
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Responsibilities and authorities - NIA determines, as part of the design plan, the responsibilities and authorities for design and development.
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Interfaces - NIA determines how the different groups that are involved in the design and development process interface with each other so that effective communication and clear assignment of responsibilities are ensured.
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Updates - NIA updates the output of design and development planning, as appropriate, as the design and development process progresses.
7.3.2 Design and Development Inputs All design and development inputs are reviewed for adequacy and to ensure that all requirements are complete, unambiguous and not in conflict with each other. The inputs include: • • • •
functional and performance requirements – technical or programmatic specifications, information derived from previous similar designs (if applicable), e.g., prior literature or reports, statutory and regulatory requirements (as they may apply), other requirements that are essential for the design and development, e.g. safety, timelines for delivery, key milestones, and legal/regulatory requirements related to the conduct of Government-funded projects.
7.3.3 Design and Development Outputs The outputs are approved by the NIA PI or PM prior to release in order to ensure that they meet the following conditions: •
Meet input requirements - The outputs meet the input requirements for design and development.
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Detail - The outputs provide appropriate information for purchasing, production and service provision.
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7.3.4 Design and Development Review Where appropriate for a specific project, NIA performs systematic reviews of the design and development at suitable stages in accordance with the design plan (see Chapter 7.3.1), and maintains records in accordance with Chapter 4.2.4. The reviews include representatives of those functions concerned with the design and development states under review. These reviews address the following: •
Meet requirements - NIA evaluate the results of design and development and determine if they are able to meet requirements.
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Problems - NIA identifies any problems or concerns and proposes necessary actions.
The NIA PI or PM ensures participants in such reviews include representatives of functions concerned with the design and development stages being reviewed. 7.3.5 Design and Development Verification In accordance with the design plan (see Chapter 7.3.1), NIA performs a design and development verification to ensure that the design and development outputs satisfy the design and development input requirements. NIA documents the results of the verification and of any necessary actions and maintains records in accordance with Chapter 4.2.4. 7.3.6 Design and Development Validation In accordance with the design plan (see Chapter 7.3.1) and prior to the delivery or implementation of the product, NIA performs a design and development validation to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use (where known). Where it is not practical to undertake full validation prior to delivery, validation of the design or development outputs are undertaken to the maximum extent practical. NIA documents the results of the validation and of any necessary actions and maintains records in accordance with Chapter 4.2.4. 7.3.7 Control of Design and Development Changes NIA identifies any design and development changes and, prior to their implementation, reviews, verifies, validates (as appropriate) and approves them. The review of design and development changes includes: • •
an evaluation on the effect of the changes on constituent parts, and an evaluation on the effect of the changes on products that have already been delivered.
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NIA documents the results of the change reviews and of any necessary actions and maintains records in accordance with Chapter 4.2.4. 7.4 Purchasing In NIA’s organizational structure, purchasing is one element of our Procurement function. Procurement at NIA involves both the purchase of commodities and services as well as subcontracting (outsourcing) for specialized services when we do not have the requisite skill sets in house, or do not have adequate resources to support a given customer’s requirements. Throughout this section, the use of the term ‘purchasing’ applies to subcontracting as well, and the term ‘products’ means both tangible products as well as the output of provided services. NIA has developed Quality Procedure QP7.4-01 Subcontracting and Purchasing, to further describe our approach to the procurement function. 7.4.1 Purchasing Process The purchasing process is an integral element in NIA’s ability to provide our customers with products that meet their requirements. NIA ensures that the products we procure conform to specified purchase requirements through controlling our vendor base and evaluating purchased products, as required. The type and extent of application of these controls is dependent on the relative impact that the purchased product has on our processes or on the final product we provide to our customer. NIA will manage the risk when selecting and using suppliers as deemed appropriate to the product requirements. •
Supplier selection - NIA evaluates and selects our suppliers based on their ability to supply products in accordance with our requirements. Suppliers may be drawn from customer recommendations, NIA’s established pool of qualified providers, or from new suppliers that meet our established criteria.
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Supplier criteria - NIA establishes criteria that we use for the selection, evaluation and re-evaluation of our suppliers including but not limited to: performance history, references or customer testimonials, business or financial standing, customer service, existence of ISO or other quality management system, and status relative to the Government’s Excluded Party List.
NIA documents the results of the evaluations and of any necessary actions and maintains records in accordance with Chapter 4.2.4.
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7.4.2 Purchasing Information Depending on the nature of the product to be procured, NIA uses purchase orders or subcontracts to fully describe the required products and / or services including the following, as appropriate: • • • • • • •
Specifications or Statements of Work (in those cases where there are customer-supplied specifications or SOWs, NIA first reviews them for adequacy and clarity before incorporating them into our procurement documents), Requirements for the acceptance or approval of the product, service or equipment being purchased, Requirements for adherence to Government regulations, Requirements for qualification of personnel, Requirements on the supplier’s quality management system, and inspection / acceptance criteria, Requirements for disclosure of any Personal or Organizational Conflict of Interest, and Customer / Government flow down requirements.
7.4.3 Verification of Purchased Product NIA applies appropriate inspection activities (or other suitable activities) that are designed to ensure that our purchased products meet the specified purchase requirements. In the case of tangible, commercial goods, this is accomplished through our Receiving Department. In instances where a custom product has been ordered, the individual at NIA requiring such product works with Receiving to determine adequacy of the product. In situations where the product is the documentation of the output of services, the appropriate NIA PI/PM reviews the product prior to it being incorporated into any deliverable to our customer. In cases in which NIA or our customers desire to perform this verification at the supplier’s premises, NIA states the intended verification arrangements and method of product release in the purchasing information. Note: Customer verification does not relieve organizational responsibility for the product. When products or services have been determined to be nonconforming with purchase requirements, the procedures described in Chapter 8.3 are followed and the vendor or subcontractor is made aware of the discrepancy. The product is segregated and NIA will determine the appropriate action required to resolve the discrepant condition. Procedure QP7.4.3-01Receiving and Inspection further documents our approach to the receipt of tangible goods. 7.4.4 Management and Maintenance of Suppliers NIA tracks deliverable requirements to ensure timely delivery, including requiring regular status reports in the case of long term services.
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Both customer and NIA-driven changes to purchase requirements are immediately communicated to suppliers and any cost or schedule impacts are identified, documented and mitigated. Substandard experiences with suppliers are recorded and such suppliers are flagged in our database. Continued use of a flagged supplier is possible only upon management directive, based on considerations such as unique skills sets and ability to meet expedited delivery schedules. 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision NIA carries out our production and service provision under controlled conditions which include the following, as applicable: • • • • • •
Work instructions: Necessary work instructions are available. Product characteristics: Information that describes the characteristics of the product is available. Suitable equipment: Suitable equipment is used. Monitoring and measuring: Monitoring and measuring activities are implemented and the proper monitoring and measurement equipment is available and used (see Chapter 7.5.2 for an exception). Product release: Product release activities are implemented. Product delivery: Product delivery and post-delivery activities are implemented.
7.5.2 Validation of Process for Production and Service Provision In special situations in which we cannot use monitoring or measurement activities to verify the output of our production and service provision, and, as a consequence, deficiencies would become apparent only after the product is in use or the service has been delivered, NIA applies special controls to the processes of such production and service provision. These controls include: •
Process validation: NIA validates the processes of such production and service provision in order to demonstrate that these processes are able to achieve the planned results.
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Process approval: NIA establishes defined criteria for review and approval of these processes.
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Equipment approval: NIA establishes criteria for the approval of equipment.
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Personnel approval: NIA establishes criteria for the qualifications of personnel.
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Defined procedures: NIA establishes the use of specific methods and procedures.
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Records: NIA defines the requirements for records (refer to Chapter 4.2.4).
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Revalidation: NIA establishes the arrangements for revalidation.
7.5.3 Identification and Traceability NIA applies the following controls: •
Product identification: NIA identifies our product, where appropriate, by suitable means throughout the product realization.
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Product traceability: NIA controls unique product identifications and maintains records in compliance with Chapter 4.2.4 in cases in which it is required to be able to trace a product back.
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Product status: NIA identifies the product status with respect to monitoring and measurement requirements throughout product realization.
Quality Procedure QP7.5.3-01 Identification and Traceability further documents our approach to identification and traceability. 7.5.4 Customer Property Whenever we use our customers’ property or whenever we have our customers’ property under our control, NIA exercises care with such customer property (which can also include intellectual property and personal data). NIA maintains all property, inclusive of customer property, in the NIA inventory system. All tangible property is recorded and maintained by NIA in accordance with NIA’s federal government approved property control procedures. All property procedures are provided in the NIA Property Control System Manual, a copy of which is available to all NIA employees on the NIA internal Intranet website. Customer property that has been provided for use or incorporation into our product is cared for as follows: •
Identification: NIA identifies customer such property.
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Verification: NIA verifies customer such property.
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Protection and safeguarding: NIA protects and safeguards customer such property.
If despite all our care any customer property is lost, damaged or otherwise found unsuitable for use, NIA reports this to the customer as soon as the discrepant condition is detected and maintains records in compliance with Chapter 4.2.4.
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Quality Procedure QP7.5.4-01 Customer Property further documents our approach to customer property. 7.5.5 Preservation of Product NIA preserves our products and their constituent parts during internal processing and during delivery to the intended destination in order to maintain conformity to product requirements. This preservation includes (as applicable): • • • • •
identification, handling, packaging, storage, and protection.
7.6 Control of Monitoring and Measuring Equipment In order to provide evidence that our products conform to determined requirements (see Chapter 7.2.1), NIA determines the monitoring and measuring activities to be undertaken, as well as the monitoring and measuring equipment needed.
Monitoring and measuring processes: NIA establishes processes that ensure that monitoring and measurement can be carried out, and that monitoring and measurement is performed in a manner that is consistent with the monitoring and measurement requirements.
Measuring equipment: NIA applies the following controls on measuring equipment where necessary to ensure valid results:
Calibration: Measuring equipment is calibrated or verified, or both, at specified intervals or prior to use. This calibration or verification is done against recognized measurement standards; where no such standards exist, the basis used for calibration or verification is recorded.
Calibration status: Measuring equipment has a form of identification that enables us to determine its calibration status.
Adjustment: Measuring equipment is adjusted or re-adjusted as necessary. When measuring equipment is found not to conform to requirements, NIA reviews and records the validity of previous measuring results. In addition, NIA takes appropriate action on the equipment and any product that is affected.
Protection: Measuring equipment is safeguarded from adjustments that would invalidate the measurement results, and protected from damage and deterioration during handling, maintenance and storage.
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Software: In cases in which we use computer software in the monitoring and measurement of specified requirements, NIA confirms the software’s ability to satisfy the intended application. This is done prior to the initial use and reconfirmed as necessary. Records: NIA maintains records of the results of calibration and verification in compliance with Chapter 4.2.4. Quality Procedures QP4.2.3-01 Document Control, QP4.2.4-01 Control of Records, QP7.5.3-01 Identification and Traceability, and QP7.5.4-01 Customer Property further document our approach to control of monitoring and measurement equipment.
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8 Measurement, Analysis, and Improvement 8.1 General NIA has defined, planned and implemented the monitoring, measurement, analysis and improvement processes needed to ensure the QMS, processes, procedures, and subsequent products conform to requirements. The type, location, timing, frequency of measurements, and the requirements for records are defined and controlled. The effectiveness of measures implemented is periodically evaluated, and the results of data analysis and improvement activities are inputs into the Management Review process (Chapter 5.6) in order to continually improve the overall effectiveness of the QMS. 8.2
Monitoring and Measurement
8.2.1
Customer Satisfaction
Customer satisfaction is one of the key indicators of the performance of our Quality Management System. NIA, therefore, monitors, and measures, information relating to our customers’ perception as to whether NIA has met the customer’s requirements according to NIA’s methods established in our Customer Satisfaction Procedure ( QP8.2.1-01). 8.2.2 Internal Audit NIA conducts internal audits at planned intervals to determine whether the Quality Management System conforms to the requirements of ISO9001:2008 and has been effectively implemented and maintained. NIA plans the audit program annually, taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit scope, frequency and methodologies are to be re-defined at that time. Audits are conducted by personnel other than those who perform the activity being audited. NIA QP8.2.2-01, Internal Audits, defines the responsibilities and requirements for planning and conducting audits, ensuring audits are conducted by personnel other than those who perform the activity being audited to ensure objectivity and impartiality of the audit process, auditing records and results to be maintained, and reporting of results to management. Management responsible for the area being audited takes timely corrective action on deficiencies found during the audit. Results of audits are recorded and maintained. Follow-up actions include the verification of the implementation of corrective action, and the reporting of verification results. The Quality Management Representative is responsible for the Internal Audit Program. The responsibilities and the requirements for planning and conducting audits, and for reporting results and maintaining records are further detailed in QP8.2.2-01 Internal Audits. The NATIONAL INSTITUTE OF AEROSPACE Original Effective Date: March 1, 2013 Revision Number/Date: Original Issue/March 1, 2013
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management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results. Quality Procedure QP8.2.2-01 Internal Audits further documents our approach to internal audits. 8.2.3 Monitoring and Measurement of Processes NIA’s Department Managers and the ISO Management Representative are responsible for monitoring the effectiveness of the processes under their control. These methods demonstrate the ability of the processes to achieve planned results. Information from process monitoring is also considered for continual improvement efforts. Correction and corrective action are to be taken, as appropriate, to ensure conformity of the product when planned results are not achieved. Information from process monitoring is also be considered for continual improvement efforts. Because each process may require different measures depending on its nature, NIA applies suitable methods for monitoring and measurement of processes necessary to meet customer requirements and to demonstrate the process’s continuing ability to satisfy its intended purpose. Measurements results are used to maintain and improve those processes. The methods used to measure and monitor processes are based on the types and frequency of data needed to adequately measure the performance of each process. Such methods include, but are not limited to the following: • • • •
Internal audits External audits Management reviews Customer Satisfaction measurement, formal/informal customer feedback, and customer complaints
In cases in which the processes of the Quality Management System are found not to achieve their planned results, NIA applies correction and appropriate corrective action (see Chapter 8.5.2) to ensure that our products conform to their requirements. 8.2.4 Monitoring and Measurement of Product NIA monitors and measures the characteristics of our products at appropriate states of the product realization process and in accordance with planned arrangements (see Chapter 7.1) in order to verify that product requirements have been met. Each project has a Principal Investigator (PI) or Project Manager (PM), and the PI/PM is responsible for monitoring their individual activities. Further, the PI/PM is also responsible for maintaining communication with the customer, other NIA personnel assigned to the project, any subcontractors or consultants supporting the project, and NIA program management and finance & accounting support personnel.
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NIA maintains records (in compliance with Chapter 4.2.4) providing evidence of conformity to acceptance criteria; these records, also indicate the person(s) authorizing the release of our products for delivery to our customer. Unless otherwise approved by a relevant authority and, where applicable, by the customer, NIA ensures that the release of our products and the delivery of services to our customer do not proceed until the planned arrangements (see Chapter 7.1) have been satisfactorily completed. Any exceptions must be approved by management and, where applicable, by the customer. 8.3 Control of Nonconforming Product NIA ensures any product that does not conform to requirements is identified and controlled to preclude unintended use and / or delivery to the customer. The controls, and related responsibilities and authorities for disposition of nonconforming products are defined and documented in Quality Procedure QP8.3-01. 8.3.1 General NIA dispositions nonconforming product by one or more of the following ways: • • •
By taking action, such as re-work to product specification, to eliminate the detected nonconformity; By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; By taking action to preclude its original intended use or application.
Responsibility and authority for reviewing and resolving nonconformities is defined and records of the nature of nonconformities, and any subsequent actions taken, including concessions obtained, are maintained. When nonconforming products are reworked to original specifications, they will be re-verified to demonstrate conformity to requirements. Should nonconforming products be detected after delivery and / or returned by the customer, NIA will take all appropriate actions to determine the effects, or potential effects on the fitness for use of the product and notify the customer immediately. Further: • • •
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained according to the Quality Records Procedure. When nonconforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, NIA will take action appropriate to the effects, or potential effects, of the nonconformity.
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8.4 Analysis of Data A process for the analysis of appropriate data is one means of determining the effectiveness of the QMS and identifying where improvements can be made. The QMS Management Representative, along with NIA’s department managers, is responsible for determining, collecting and analyzing appropriate data to demonstrate the suitability and effectiveness of the QMS and evaluating where continual improvement of the effectiveness of the quality management system can be made. This data includes information generated as a result of our monitoring and measurement activities and from other relevant sources. Examples of such data include, but are not limited to: • • • • • •
Customer feedback, both formal and informal. Financial data contained in regular monthly reporting or generated by NIA’s finance and accounting tools to address a specific problem or concern. Technical data contained in monthly technical status reports or periodic technical products such as briefings, technical reports, conference papers, and/or journal publications. Data and information originating from NIA’s contract management system. Supplier performance Conformance to customer and/or product requirements.
The analysis of data is designed to provide actionable information leading to the continual improvement of NIA’s customer satisfaction. 8.5 Improvement 8.5.1 Continual Improvement NIA is committed to continually improving the effectiveness of our Quality Management System. The primary means for evaluating the Quality Management System is through periodic internal audits, continual evaluation of our quality policy and objectives, analysis of data, and regular management review. It is the responsibility of NIA Executives, all NIA Department Managers and designees to collect, record, and report information relevant to the suitability and effectiveness of the QMS. The records and metrics form the basis for evaluating the effectiveness of Quality Management System, with a particular emphasis for assessing customer satisfaction. It is NIA’s policy to continually improve the Quality Management System to achieve greater customer satisfaction. Quality Procedure QP8.5.1Continual Improvement further documents our approach.
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8.5.2 Corrective Action The ISO Management Representative is responsible for managing the Corrective Action Program. NIA has a defined documented procedure (QP8.5.2-01) for reducing and / or eliminating the cause of nonconformities in order to prevent recurrence. Should the corrective action not be achieved in a manner deemed timely by the QMS Management Representative, it will be elevated to the NIA most senior management for resolution. The system level procedure for the corrective action process includes, but is not limited to: • • • • • • •
Identification and review of nonconformities, including customer complaints. Determination of causes for nonconformities. Evaluation of the needed actions to ensure nonconformities do not recur. Recording results of actions, if any, taken. Follow up to ensure corrective actions taken were effective. Determining if additional nonconformances exists based on information learned. Records of the results of actions taken.
Quality Procedure QP8.5.2 Corrective Action further documents our approach.
8.5.3 Preventive Action The ISO Management Representative is responsible for managing the Preventive Action Program. NIA has established a documented procedure (QP8.5.3-01) for analyzing and eliminating causes for potential nonconformities to prevent occurrence. QMS records, concerns from customers and employees, and analysis of collected data are used as inputs for Preventive Action. The Preventive Action Procedure defines requirements for: • • • • •
Determining potential nonconformities and their causes. Evaluating the need for action to prevent occurrence of nonconformities. Determining and implementing action needed. Records of results of action taken. Reviewing preventive action taken.
Quality Procedure QP8.5.3/Preventive Action further documents our approach.
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