Quality Manual
This Quality Manual complies with the Requirements of ISO 9001-2000. Prepared By:
Rick Douglas
Release Date:
3/9/05
DET NORSKE VERITAS MANAGEMENT SYSTEM CERTIFICATE Certificate No. CERT-08776-2006-AQ-HOU-ANAB This is to certify that
ALABAMA SPECIALTY PRODUCTS, INC. at
152 Metal Samples Road, Munford, AL 36268 USA Has been found to conform to Management System Standard:
ISO 9001:2000 This Certificate is valid for the following products/service ranges: DESIGN AND MANUFACTURE OF CORROSION MONITORING EQUIPMENT, INSTRUMENTATION AND SUPPLIES, AND SPECIALTY MANUFACTURED PRODUCTS. Place and date:
This certificate is valid until:
Houston, Texas; 25 September 2006
11 September 2009
for the Accredited Unit: DET NORSKE VERITAS CERTIFICATION, INC.
Houston, TX USA
Initial Certification Date:
11 June 1997
Robert Keys
Len Williford
Management Representative Det Norske Veritas Certification, Inc.
Lead Auditor
DET NORSKE VERITAS CERTIFICATION, INC., 16340 Park Ten Place, Suite 100, Houston, TX 77084 TEL: (281) 721-6600 FAX: (281) 721-6903
Alabama Specialty Products, Inc. Quality Manual Page: 1 of 25 Revision: -1-
Table of Contents ISO 9001-2000
TABLE OF CONTENTS POLICY
1.0 2.0 3.0 4.0 4.1 4.2 5.0 5.1 5.2 5.3 5.4 5.5 5.6 6.0 6.1 6.2 6.3 6.4 7.0 7.1 7.2 7.3. 7.4 7.5 7.6 8.0 8.1 8.2 8.3 8.4 8.5
CONTENTS Table of contents Manual distribution Page revision status Introduction Activities, scope and permissible exclusions Normative reference Terms and definitions Quality management system General requirements Documentation requirements Management responsibility Management commitment Customer Focus Quality Policy Planning Responsibility, authority and communication Management review Resource management Provision of resources Human resources Infrastructure Work environment Product realization Planning of product realization Customer-related processes Design and development Purchasing Production and service provision Control of monitoring and measuring devices Measurement, analysis and improvement General Monitoring and measurement 23 Control of non-conforming Product Analysis of data Improvement
PAGE
PROCEDURE
PROCESS
QP 4.2-1
FC 4.1-1 FC 4.2-1
1 2 3 4 5 6 7 8 8, 9, 10 11 11 11, 12 13
PC 5.4-1
13, 14, 15 16
PC 5.6-1
17 17 17 17
PC 6.1-1 PC 6.1-1 PC 6.1-1 PC 6.1-1
18 18 19, 20 20 21
PC 7.1-1 PC 7.2-1 QP 7.3-1 QP 7.5-1
22
FC 7.4-2 PC 7.5-1
PC 7.6-1
23
QP 8.1-1 QP 8.1-1
24 24 24, 25
QP 8.3-1 QP 8.3-1 QP 8.3-1
Alabama Specialty Products, Inc. Quality Manual Distribution ISO 9001-2000
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MANUAL DISTRIBUTION ISSUE NO.
DATE OF ISSUE
ISSUED TO
Master Hard Copy File Hard Copy Electronic Copy
10 March 03 10 March 03 11 March 03
Management Representative QA Administrative Assistant Management Rep / Acrobat
Master Hard Copy File Hard Copy Electronic Copy
09 March 05 09 March 05 09 March 05
Management Representative QA Administrative Assistant Management Rep / Acrobat
Alabama Specialty Products, Inc. Quality Manual Page Revision Status ISO 9001-2000
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PAGE REVISION STATUS PAGE
1 – 25 11 16 1 - 25
REVISION
-NEW-1-1-1-
DETAILS OF CHANGE
Initial Release Added Quality Objectives following 5.3 Added minimum number of attendees to Paragraph 5.6.1. Revisions listed above plus new “Release Date: 03/09/05”
DATE
APPROVED BY
1/16/03 8/25/03
Don Johnson Rick Douglas
05/17/05
Rick Douglas
03/09/05
Rick Douglas
Alabama Specialty Products, Inc. Quality Manual Introduction ISO 9001-2000
Page: 4 of 25 Revision: -1-
INTRODUCTION International Standard ISO 9001-2000 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of the quality management system, to enhance customer satisfaction by meeting customer requirements. To function effectively Alabama Specialty Products, Inc. has identified and manages numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process. Often the output from one process directly forms the input into the next. The application of a system of processes within the organisation, together with the identification and interactions of these processes, and their management, are referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within the quality management system, such an approach emphasizes the importance of:
• • • •
Understanding and meeting requirements The need to consider processes in terms of added value Obtaining results of process performance and effectiveness Continual improvement of processes based on objective measurement.
The methodology known as “Plan-Do-Check-Act” can be applied to all processes and can be briefly described as follows: Plan:
establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organisation’s policies,
Do:
implement the processes,
Check:
monitor and measure processes and service against policies, objectives and requirements for the service, report the results, and
Act:
take actions to continually improve process performance.
Alabama Specialty Products, Inc. Quality Manual Section 1
SCOPE ISO 9001-2000 Element 1
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1 ACTIVITIES, SCOPE AND PERMISSIBLE EXCLUSIONS Alabama Specialty Products, Inc. is comprised of Metal Samples Co., Alabama Research and Development, and Alabama Laser, and is located in Munford, Alabama, USA. The success and reputation of the company may be measured by the high standing maintained with our customers. A policy of continuous self-appraisal and attention to detail has ensured the expansion of our customer base. The company has implemented a quality management system to demonstrate its ability to provide a consistent product and service that meets customer and applicable statutory and regulatory requirements. This enables the company to address and achieve customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of nonconformity. The scope of the quality management system applies to: • • •
•
a complete line of corrosion engineering and monitoring equipment and supplies; medical laboratory equipment, and engineering, research and development services; industrial laser beam delivery components, and industrial laser cutting and welding equipment, and; complete custom product manufacturing/fabrication capabilities.
At this time, ASPI is not taking any exclusions to the ISO 9001-2000 Standard.
Alabama Specialty Products, Inc. Quality Manual Section 2
Normative Reference ISO 9001-2000 Element 2
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2 NORMATIVE REFERENCE This quality manual defines the policies and principles applied against each of the requirements of ISO 9001-2000 and relates to all activities carried out in the company that determine quality, and lays down guidelines within which the company can operate. Each section of the manual is related to an identified element of ISO 9001-2000.
Distribution The ISO 9000 Management Representative (Management Representative) is responsible for the controlled internal distribution of this manual, and changes thereto. Outside organizations, and personnel have access to the latest revision of our Quality Manual through the company web site: www.alspi.com.
Uncontrolled Manuals Any uncontrolled hard copy manuals are up-to-date at issue and are only issued to outside organizations, customers, etc. Such uncontrolled manuals will be clearly marked “For information only, not subject to automatic update�.
Alabama Specialty Products, Inc. Quality Manual Section 3
Terms and Definitions ISO 9001-2000 Element 3
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3 TERMS AND DEFINITIONS The following terms and definitions are provided to assure a uniform understanding of selected terms as they are used in these requirements. COMPANY
means Alabama Specialty Products, Inc. and its Divisions
SUPPLIER
means the party to whom an order has been placed by the company for the purchase of raw materials, equipment, supplies, or the performance of outside services for a particular order.
CUSTOMER
means firm or person having a contractual agreement with, or the recipient of a product or service from the company.
PRODUCT
means the result of a process, or series of processes, which is the combination of some, or all of the four generic product categories, hardware, software, services and processed materials.
SERVICE
means product installation and prove-out, or maintenance/repair other than routine preventive maintenance, routine replacement of consumables, or replacement of out of warranty broken and/or worn components of our products.
Alabama Specialty Products, Inc. Quality Manual Section 4
Quality Management System Requirements ISO 9001-2000 Element 4
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4 QUALITY MANAGEMENT SYSTEM 4.1
General Requirements
See Process Flow Chart FC 4.1-1
The company has established, documented and implemented a quality management system which will be maintained and continually improved in accordance with the requirements of this International Standard ISO 9001-2000.To implement the quality management system, the company has:
• • • • • • • 4.2
Identified the processes needed for the quality management system and their application throughout the company. Determined the sequence and interaction of these processes. Determined criteria and methods required to ensure the effective operation and control of these processes. Ensured the availability of information necessary to support the operation and monitoring of these processes. Put procedures in place to manage, monitor, measure, and analyse these processes. Implemented action necessary to achieve planned results and continual improvement. Ensured any outside services, are identified and controlled. Control of such outside services is identified within the quality management system. (See Process Flow Chart FC 7.4-2)
Documentation Requirements
4.2.1
General
The quality management system based on the requirements of ISO 9001-2000 describes how the company’s program is designed to ensure that customer’s quality requirements are recognized and that consistent and uniform control of these requirements are adequately maintained. This manual describes how effective control is established by the use of formal written procedures, and also as required by contract. The quality management system documentation includes:
• • • • • •
Documented procedures and records required in this International Standard including a quality manual, quality policy and quality objectives; documents required by the company to ensure the effective planning, operation and control of its processes in the form of written or visual reference standards of acceptability and verification methods at various stages of the process which may arise from: Contractual requirements from the customer or other interested parties; acceptance of international, national, regional and industry sector standards; relevant standards, statutory and regulatory requirements, and; decisions by the company.
Alabama Specialty Products, Inc. Quality Manual Section 4 4.2.2
Quality Management System Requirements ISO 9001-2000 Element 4
Quality Manual
Page: 9 of 25 Revision: -1See Process Flow Chart FC 4.2-1
A quality manual has been established which includes the scope of the quality management system, including details of and justification for any exclusions, with documented procedures describing the sequence and interaction of the processes (see Process Flow Chart FC 4.1-1) included in the quality management system. Executive Management has defined the documentation needed to support the needs of the company and the quality management system. The defined documentation provides for implementation, maintenance and improvement of the system and includes:
• • • • •
Policy documentation Documentation for control of processes Work instructions where required for defined tasks Standard formats for collection and reporting of data Quality records.
The primary purpose of quality documentation is to express the quality policy and to describe the quality management system. This documentation serves as a basis for the implementation, effective operation and maintenance of the system. The quality manual is under the control of the Management Representative.
4.2.3
Control of Documents
See Quality Procedure QP 4.2-1
Sufficient records are maintained to demonstrate conformance to requirements and verify effective operation and provide knowledge for maintenance and improvement of the quality management system. Documentation control has been defined and implemented to ensure that correct documents are used. All obsolete documents are promptly removed from all points of issue, therefore prevented from unintended use. Documents to be retained, are controlled, maintained and protected. Controls are imposed to ensure that the latest copies of all documentation relevant to the accomplishment of work are available at the time and place of work to ensure effective functioning of the company’s quality management system. Documentation may be in any form or type of medium suitable for the needs of the company. A documented procedure for Control of Documents has been established to: • Approve documents for adequacy prior to use • To review, update as necessary and re-approve documents • Identify the current revision status of documents • Ensure that relevant revisions of applicable documents are available at point of use • Ensure that documents remain legible, readily identifiable and retrievable • Ensure that documents of external origin, are identified and their distribution controlled • Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. All quality system documentation stored on the intranet server is controlled by the Management Representative through use of Adobe Acrobat software.
Alabama Specialty Products, Inc. Quality Manual Section 4 4.2.4
Quality Management System Requirements ISO 9001-2000 Element 4
Control of Quality Records
Page: 10 of 25 Revision: -1See Quality Procedure QP 4.2-1
Records required for the quality management system are controlled, maintained, and protected to provide evidence of conformance to requirements and of effective operation of the quality management system. Quality records are analysed to provide inputs for corrective and preventive action, improvements to process control and the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure has been established to define the controls needed for identification, storage, protection, retrieval, retention time and disposition of records. Quality Records may be in any form or type of medium suitable for the needs of the company. Any Quality Records retained on computer are controlled by means of revision level.
Alabama Specialty Products, Inc. Quality Manual Section 5
Management Responsibility ISO 9001-2000 Element 5
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5 MANAGEMENT RESPONSIBILITY 5.1
Management Commitment
We the undersigned Executive Management of Alabama Specialty Products, Inc. (ASPI), fully support the Quality System defined in this Quality Manual and the foregoing statements of policy, objectives, responsibilities, and authority. All personnel are hereby instructed to fully comply with this system and to cooperate with the Management Team in a unified effort to ensure that the products we provide meet or exceed our Customers’ Requirements, as well as Regulatory and Legal Requirements, and the Quality Management System described in this manual. We are committed to Management Reviews of performance to the Quality Policy and Quality Objectives, we have established to ensure the availability of necessary resources, and continuous improvement of processes and products. The Management Team, upon identifying or otherwise being made aware of a Quality Management System Process, or Product conformance problem, shall exhaust any and all means deemed necessary in the attempt to remedy the problem. In the event any problem concerning Quality System or product conformance cannot be resolved by the Management Team, the problem shall be brought to one of the undersigned for complete and final resolution without compromise of Customer Requirements, regulatory and legal requirements, or this Quality Management System. The CEO and Executive Management have provided evidence of this commitment to the development and improvement of the quality management system by: Communicating to the staff the importance of meeting customer as well as statutory and regulatory requirements. Establishing the quality policy and quality objectives. Conducting management reviews. Ensuring the availability of necessary resources.
5.2
Customer Focus
The CEO and Executive Management have ensured that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction. Obligations related to service including statutory and regulatory requirements are considered when determining these needs and expectations.
5.3
Quality Policy
It is the policy of the company to provide a range of products, and services, which meet the requirements of its customers and quality standard parameters, and that products and/or services are shipped on schedule at the agreed price. All work is carried out in a cost effective and timely manner, and in accordance with the highest professional standards aiming for continual improvement and customer satisfaction through the involvement and participation of all levels of management, staff and other interested parties. This Quality Policy is supported by the following Quality Objectives. These objectives are: • • • •
To fully understand and communicate customer requirements. To continually meet or exceed requirements. To ship quality products on schedule. To continually improve our products and processes to guarantee customer satisfaction.
Alabama Specialty Products, Inc. Quality Manual Section 5
Management Responsibility ISO 9001-2000 Element 5
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A policy for quality conforming to the requirements of ISO 9001:2000 has been established to ensure that it:
• • • • •
Is appropriate to the purpose of the company, the expected level of customer satisfaction and the needs of other interested parties Includes a commitment to meeting requirements and to continual improvement Has the resources needed and the contribution of suppliers and partners Provides a framework for establishing and reviewing quality objectives Demonstrates Executive Management commitment and ensures the quality objectives are communicated, understood and implemented at appropriate levels of the company is regularly reviewed at the management review meeting for suitability and effectiveness, addressing continual improvement and customer satisfaction.
Due to our size, a number of personnel have dual roles to carry out within its many aspects and functions. It is, however, company policy that this dual role shall not deter, in any manner, personnel from their prime objective of providing quality product and/or service through an adequately controlled quality management system. The initial function of all management and employees shall be the maintenance of this objective. Executive Management is ultimately responsible for making balanced judgements, assessing the significance of variations in our processes and making decisions. In arriving at such decisions, the quality and personal integrity of staff are of fundamental importance. In this context, every effort is made to ensure that each person in the company understands that quality assurance is important to their future, that they know how they can assist in the achievement of adequate quality and that they are encouraged to do so. This policy is approved by the undersigned and is supported by all the levels of management within the company. All personnel shall be guided by the contents of the quality management system and no deviation from the methods and procedures set down shall be permitted.
Signed: Signature on Master File Donald G. Johnson Chief Executive Officer
01/16/03 Date
Signature on Master File James P. Gray President Metal Samples Co.
10/16/02 Date
Signature on Master File Kirk Johnson President ASPI
01/14/03 Date
Signature on Master File Sai Mudiam President Alabama Research & Development
11/07/02 Date
Signature on Master File Matthew Johnson President, Alabama Laser Technologies
12/26/02 Date
Signature on Master File Ronnie Smith Vice President Manufacturing
10/02/03 Date
Alabama Specialty Products, Inc. Quality Manual Section 5
5.4 5.4.1
Management Responsibility ISO 9001-2000 Element 5
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Planning Quality Objectives
See Process Chart PC 5.4-1
The CEO and Executive Management have ensured that quality objectives needed to meet requirements for product, service, and customer satisfaction which are measurable and consistent with the quality policy including the commitment to continual improvement have been established and maintained at relevant functions and levels within the company. The quality management system is described in a series of Quality Procedures, Process Flow Charts, and Work Instructions that specify the management objectives, policies and processes that have been developed to ensure compliance with ISO 9001-2000. When any inconsistency exists between the requirements any particular customer specified in a contract/order and those called for in the above standard, the higher standard will prevail. The quality manual provides a general outline of the quality management system with respect to the requirements of ISO 9001-2000. Detailed responsibilities of management and organization have been set out in this manual. This manual is controlled and the current version is always available for reference to all employees. The quality system is detailed and targeted to achieve organization, quality policy, and quality objectives documented in this manual. The quality system is maintained to provide assurance to our customers that the company has the ability and resources to provide consistent product and service to a defined standard of quality.
5.4.2
Quality Management System Planning
See Process Chart PC 5.4-1
Quality planning is an integral part of the quality management system and the CEO and executive management have identified, planned and provided the resources needed to achieve the quality objectives and ensure continual improvement of the system. Process Flow Chart FC 4.1-1 represents an overview of the ASPI Quality Plan. The company applies quality planning to all their work resources and considers the implementation of the contents of this quality manual to meet ISO 9001-2000 to be their primary quality plan. Quality Plans for individual jobs is documented through individual job routings and Inspection and Test Reports, QF 8.2.4-A.
5.5
Responsibility, Authority and Communication
5.5.1
Responsibility and Authority
The responsibilities, authority and the interrelation of all personnel who manage, perform and verify work affecting quality are defined and communicated in order to facilitate effective quality management. All people have been given authorities and responsibilities to enable them to assist in the achievement of the quality objectives. This assignment of authority and responsibility helps to establish involvement and commitment of people throughout the organisation. The responsibility of personnel is assigned via job descriptions, procedures and work instructions. An individual may be assigned with dual roles, in such cases he/she will be responsible for fulfilling the tasks assigned to both roles.
Alabama Specialty Products, Inc. Quality Manual Section 5
Management Responsibility ISO 9001-2000 Element 5
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Chief Executive Officer (CEO) The CEO is responsible to the Board of Directors for identifying and providing all the necessary resources to meet the requirements of the quality system and the company’s customers. These resources include trained personnel for the management and performance of work, including system audits and verification activities. The CEO has responsibility for the overall performance and operation of the company, developing the strategy in the medium and long term, ensuring resources are available for the successful implementation of the strategy. His duties include the future direction of the company, maintaining customer, supplier and interested party liaison as required. He has responsibility for determining the criteria for recruitment against each of the categories of staff employed and thus ensuring adequate resources are available. He is responsible for the selection of all staff.
President, ASPI Is responsible to the CEO for the day to day control of all operations ensuring customer requirements are met. Regular meetings are held either individually or collectively to brief staff on performance, customer requirements, any recurring problems and obtaining feedback as necessary. He will ensure that annual evaluations of all staff are performed, and arrange for the preparation of any training plans and implementation. He is responsible for ensuring that the company’s performance can be adequately measured to meet the requirements of its customers and has assigned a Management Representative with the authority and responsibility for ensuring that the requirements of the latest issue of ISO 9001-2000 are implemented and maintained by internal quality audits. He will chair the Management Review Meetings.
Chief Financial Officer (CFO) Is responsible to the CEO for all legal and accounting functions, including the preparation of financial information and control of accounts, personnel and administration.
Receivable, Payable, and Benefits Accounts Personnel Are responsible to the CFO for all day to day accounting functions.
Human Resources Manager Is responsible to the CEO, and the President, ASPI, for all personnel and administration ensuring all records and filing is kept up to date.
Marketing Is responsible to the CEO, for development and distribution of advertising and catalogues, and development and maintenance of industrial show display media.
Presidents: ASPI, Metal Samples, Alabama Research & Development, and Alabama Laser Are responsible to the CEO for day to day operation of their respective divisions.
Alabama Specialty Products, Inc. Quality Manual Management Responsibility ISO 9001-2000 Element 5
Section 5
Page: 15 of 25 Revision: -1-
Vice President, Manufacturing Is responsible to the President, ASPI, for the operation of plant and processes.
Compliance Director Is responsible to the President, ASPI, for all inspection, measurement, analysis, and improvement functions.
Salespeople Are responsible to their respective Division President, for all sales functions, including customer contact, feedback and records.
Materials Manager Is responsible to the President, ASPI, for the day to day control of all purchasing, receipt, inventory control, storage, distribution, and delivery of materials.
Maintenance Manager Is responsible to the CEO, and the President, ASPI, for the maintenance of all equipment and facilities.
ORGANIZATION CHART CEO, ASPI
ISO 9000 Management Representative
CFO
Compliance Director
Accounts
President, ASPI
Marketing
Maintenance Manager
Division Presidents
Salespeople
Human Resources Manager
5.5.2
Vice President Manufacturing
Materials Manager
Management Representative
The CEO has appointed the Compliance Director as the Management Representative with the authority and responsibility for the development, overall implementation and maintenance of the quality management system together with the control and issue of all quality documentation.
Alabama Specialty Products, Inc. Quality Manual Section 5
Management Responsibility ISO 9001-2000 Element 5
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The Management Representative is responsible for monitoring the system, and in particular for advising and training other personnel in the system, continually looking for improvements. Ensuring that internal quality audits are carried out as detailed on the schedule, and that all corrective and preventive actions arising from audits are closed out, reporting to the management review on the performance, including needs for improvement and the awareness of customer needs and requirements throughout the organization.
5.5.3
Internal Communication
The CEO and Executive Management have defined and implemented processes for the communication of quality requirements, objectives and accomplishments. The providing of this information becomes a resource for improvement and the involvement of people in achieving quality objectives including one to one, and team briefings, in-house memos, information on notice boards, audio-visual and electronic media as necessary.
5.6
Management Review
5.6.1
General
See Process Chart PC 5.6-1
The President, ASPI, in conjunction with Executive Management (CEO, President ASPI, President MSC, President ALT, President AR&D, Shop Superintendent, Management Rep, QA Administrative Assistant), and other staff deemed appropriate, review the quality management system at intervals of at least once a year to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the system and to verify that quality policy and objectives are being satisfied. The meeting is arranged by the Management Representative and is chaired by the President, ASPI. Attendees shall be Executive Management, and shall include a minimum of six of those listed above. Other personnel may attend where necessary to provide relevant input at the discretion and invitation of the Executive Management team.
5.6.2
Review Input
The Management Review inputs include: • • • • • • •
5.6.3
audit results, customer feedback, process performance, and product conformity, status of corrective and preventive actions, follow-up actions from previous reviews, changes that could affect the quality management system, and recommendations for improvement.
Review Output
Management review outputs include any decisions and actions related to: • • •
Improvement of the quality management system, and its processes, Improvement of product related to customer requirements, and Resource needs.
Alabama Specialty Products, Inc. Quality Manual Section 6
Resource Management ISO 9001-2000 Element 6
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The Management Representative is responsible for minutes including observations, conclusions and recommendations issued as a result of such review. Minutes of the meeting are signed as approved by the attendees and retained as a quality record with all agreed actions monitored and results recorded and maintained.
6 RESOURCE MANAGEMENT 6.1
Provision of Resources
See Process Chart PC 6.1-1
The resources needed to develop, implement and continually improve the processes of the quality management system and to address and enhance customer satisfaction have been determined and provided in a timely manner to ensure requirements are met.
6.2 6.2.1
Human Resources
See Process Chart PC 6.1-1
General
Personnel who are assigned responsibilities defined in the quality management system are competent on the basis of applicable education, training, skills and experience.
6.2.2
Competence, Awareness and Training
It is company policy to identify and determine competency needs for personnel performing activities affecting quality, provide training to satisfy those needs, and evaluate the effectiveness of the training provided. A procedure exists for the introduction of new employees to the mandatory quality system elements and for the training needs of existing staff in order to achieve its objectives. Employees are given job descriptions and made aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives. Records are maintained of education, training and experience.
6.3
Infrastructure
See Process Chart PC 7.1-1
The CEO has determined, provided and arranged maintenance for the infrastructure needed to achieve the conformity of the service requirements, including buildings, workspace and associated facilities, process equipment, computer hardware and software, communication media, transport and supporting services. A maintenance program specifies the type and frequency of needed maintenance, the methods for maintenance and the verification of its completion.
6.4
Work Environment
It is ensured that the working environment in the factory, offices, and site areas is suitable at all times to achieve conformity to specified requirements.
Alabama Specialty Products, Inc. Quality Manual Section 7
Product Realization ISO 9001-2000 Element 7
Page: 18 of 25 Revision: -1-
7 PRODUCT REALIZATION 7.1
Planning of Product Realization
See Process Chart PC 7.1-1
Planning of product realization is that sequence of processes and sub-processes required to achieve the required end product. Planning of the realization processes is outlined in Process Flow Chart FC 4.1-1, and is consistent with the other requirements of the company’s quality management system. Documentation has been put in place to support and manage the processes including:
• • • • 7.2 7.2.1
Quality objectives and requirements for the product, Activities within the processes, including documents and the provision of resources, Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for acceptance of the product. Records are to provide evidence that the realization processes and resulting product meet specified requirements.
Customer-related Processes Determination of Requirements Related to the Product
See Flow Chart FC 7.2-2
Requirements including product requirements specified by the customer are determined. Particular consideration is given to:
• • • • • 7.2.2
The extent to which customers have specified the requirements of the product, Customer requirements, including requirements for delivery and post-delivery activities, Requirements not specified by the customer but necessary for fitness and purpose, Obligations related to product, including statutory and legal requirements, and Any additional requirements determined by the company.
Review of Requirements Related to the Product
See Flow Chart FC 7.2-2
In order to establish and maintain customer satisfaction, a formal system is in place and maintained to ensure that each commitment to supply a product is formally reviewed and controlled. This review is conducted prior to the commitment to supply and shall ensure that:
• • • •
The requirements are adequately defined, documented and planned. Where the customer provides no written statement of requirement, the order Requirements are confirmed verbally before acceptance. The requirements comply with the quote and any differing requirements are satisfactorily resolved. The company has the ability to meet those defined requirements.
The results of the review and subsequent follow-up actions are recorded. Where product requirements are changed, and agreed with the customer or their representative the documentation is amended, and all relevant personnel made aware of the changed requirements.
7.2.3
Customer Communication
See Process Chart PC 7.2-1
Methods and procedures have been identified and implemented to communicate with customers on information about the product and service, to deal with enquiries, contracts or order handling, including amendments, customer feedback and complaints.
Alabama Specialty Products, Inc. Quality Manual Section 7
7.3
Product Realization ISO 9001-2000 Element 7
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Design and Development
7.3.1
Design and Development Planning
See Quality Procedure QP 7.3-1
The company plans and controls the process of planning. During the design and development process the assigned Project Leader determines: • • •
Design and development stages Reviews, verification and validation of the design and development at appropriate stages Design and development responsibilities and authorities.
The Project Leader also ensures effective management of communications between the different groups involved in the design and development as well as a clear assignment of responsibility.
7.3.2
Design and Development Inputs
See Quality Procedure QP 7.3-1
Inputs relating to product requirements are determined and include;
• • • •
Functional and performance requirements. Statutory and regulatory requirements where ever applicable. Information derived from similar historical designs if applicable. Any additional requirements essential for that design and development.
These inputs are reviewed for adequacy and are complete, unambiguous and do not conflict with each other and their records are maintained.
7.3.3
Design and Development Outputs
See Quality Procedure QP 7.3-1
Any output from the design and development is provided in a form that enables the output to be verified against the design and development input and is approved prior to release. Design and development outputs: • • • •
7.3.4
meet the input requirements for design and development, provide adequate information for purchasing, production and service provision, contain product acceptance criteria, and specify product characteristics essential for its safe and proper use.
Design and Development Review
See Quality Procedure QP 7.3-1
The Project Teams review design and development in accordance with its planning, ref 7.3.1, and evaluate the resulting design and development's ability to meet the requirements and to identify problems and propose any necessary actions. Relevant individuals or groups that are concerned in the design and development are present at such reviews and the results of the reviews and their actions are recorded.
7.3.5
Design and Development Verification
See Quality Procedure QP 7.3-1
All verification of the design and development are carried out as per the planned arrangements, ref. 7.3.1, ensuring that that the output meets the requirements of the input. Records of the verification are maintained.
Alabama Specialty Products, Inc. Quality Manual Section 7 7.3.6
Product Realization ISO 9001-2000 Element 7
Design and Development Validation
Page: 20 of 25 Revision: -1See Quality Procedure QP 7.3-1
The design and development validation is carried out using and in accordance with the planned arrangements. Ref. 7.3.1. The validation is completed where practicable prior to the delivery or implementation of the product. Records of the validation are maintained.
7.3.7
Control of Design and Development Changes
See Quality Procedure QP 7.3-1
Any changes to the design and development are identified and recorded. Any such changes are reviewed, verified and validated where appropriate and approved before implementation. Any review of design and development changes include an evaluation on the effect of the changes to parts or product already delivered. Records are maintained of the result of the review of changes.
7.4 7.4.1
Purchasing Purchasing Process
See Process Chart FC 7.4-2
All purchasing processes are controlled to ensure purchased product or services conform to requirements. The type and extent of control will be dependent upon the effect on subsequent realization processes and their output. A system for the evaluation and selection of suppliers is implemented, and is based on their ability to supply a product or service in accordance with the company’s requirements. Evaluation and selection criteria for suppliers is based on either:
• •
A supplier’s previous and continuous record of providing product and/or services to satisfactory standards. An evaluation of a suppliers quality management system, to determine their ability to satisfy the purchase requirements.
An “Approved List” of those suppliers affecting the final product or service is maintained to show they have been evaluated and successfully selected.
7.4.2
Purchasing Information
See Process Chart FC 7.4-2
Purchasing documents contain information clearly describing the product or service ordered, including where appropriate:
• •
Requirements for approval or qualification of product, procedures, processes, service, equipment and personnel Quality management system requirements.
The individual requesting the purchase reviews and approves purchasing documents for adequacy of the specified requirements prior to release.
7.4.3
Verification of Purchased Product
See Process Chart FC 7.4-2
The activities necessary for verification of purchased product or service are identified and implemented. Where the company or its customer proposes to perform verification activities at the supplier’s premises, the intended verification arrangements, and the method of product or service release are specified in the purchasing documentation. Verification by the customer neither absolves the company of responsibility to provide product or service, which are acceptable to the customer, nor does it preclude subsequent rejection by the customer.
Alabama Specialty Products, Inc. Quality Manual Section 7
7.5 7.5.1
Product Realization ISO 9001-2000 Element 7
Page: 21 of 25 Revision: -1-
Production and Service Provision Control of Production and Service Provision
See Process Chart PC 7.5-1
The company performs production, and provides services under controlled conditions. The conditions are controlled through implementation of documented procedures, processes and work instructions where necessary. See Work Instruction WI 7.5.1-1 These controls include:
• • • • • • •
The availability of information that specifies the characteristics of the product or service The provision of suitable working environment The availability of work instructions, as necessary The use of suitable equipment The availability and use of suitable monitoring and measuring devices The implementation of monitoring and measuring activities Suitable methods for release, delivery and applicable post-delivery or on-site activities.
7.5.2 Validation of Processes for Production and Service Provision
See Process Chart PC 7.5-1
Any production processes where the resulting output cannot be verified by subsequent measuring or monitoring, including those where deficiencies may become apparent only after the product is in use or has been delivered is validated. Validation demonstrates the ability of the processes to achieve planned results and include the following arrangements: Also see Quality Procedure QP 7.5-2
• • • • • 7.5.3
Defined criteria for review and approval of processes Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Revalidation.
Identification and Traceability
See Process Chart PC 7.5-1
The company identifies product by suitable means throughout all phases of product realization, identifying the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the company controls and records the unique identification of the product.
7.5.4
Customer Property
See Work Instruction WI 7.5.4-1
The company exercises care with customer property while it is under our control or being used by us. We identify, verify, protect and safeguard customer property provided for use or incorporation into the product. (See WI 7.5.4-4, Processing Customer Supplied Material.) The customer is notified and records are maintained of any lost damaged or unsuitable customer property. See Work Instruction WI 7.5.4-3
7.5.5
Preservation of Product
See Process Chart PC 7.5-1
The company preserves conformity of product with customer requirements during all phases of internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. This preservation also includes constituent parts of the product.
Alabama Specialty Products, Inc. Quality Manual Section 7
7.6
Product Realization ISO 9001-2000 Element 7
Control of Monitoring and Measuring Devices
Page: 22 of 25 Revision: -1See Process Chart PC 7.6-1
Monitoring and measurements to be made are identified and the monitoring and measuring devices required to ensure conformity of product to specified requirements are determined. Measuring and monitoring equipment is used and controlled to ensure that measurement capability is consistent with the monitoring and measurement requirements.
Measuring and monitoring equipment is:
• • • • •
Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration is recorded; adjusted or re-adjusted as necessary; identified to enable the calibration status to be determined; safeguarded from adjustments that would invalidate the measurement result, and; protected from damage and deterioration during handling, maintenance and storage.
Calibration / verification results are recorded and maintained. When equipment is found not to meet requirements, the validity of previous measurement results is assessed, and appropriate action is taken on equipment and any affected product. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed, prior to initial use and reconfirmed as necessary.
Alabama Specialty Products, Inc. Quality Manual Section 8
Measurement Analysis and Improvement ISO 9001-2000 Element 8
Page: 23 of 25 Revision: -1-
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1
General
See Quality Procedure QP 8.1-1
The company plans and implements the monitoring, measurement, analysis and improvement processes needed to:
• • •
demonstrate conformity of the product; ensure conformity of the quality management system, and; continually improve the effectiveness of the quality management system.
This includes determination of applicable methods, including statistical techniques, and the extent of their use.
8.2 8.2.1
Monitoring and Measurement Customer Satisfaction
See Quality Procedure QP 8.1-1
As one of the measurements of the performance of the quality management system, information relating to customer perception as to whether the company has met customer requirements is monitored. The method’s for obtaining and using this information are determined, and include review of Customer Return Reports, repeat customer order volume, and a customer satisfaction survey that is posted on our web site.
8.2.2
Internal Audit
See Quality Procedure QP 8.1-1
An internal audit system is established for performing periodic internal audits of the quality management system and related processes. The purpose of the internal audit is to determine whether:
• •
The quality management system conforms to the requirements of ISO 9001-2000. The quality management system has been effectively implemented and maintained.
An internal quality audit program has been put in place. The annual audit schedule is determined taking into consideration the status and importance of the activities and areas to be audited as well as the results from previous audits. The audit scope, frequency and methodologies are defined. Audits are conducted by personnel other than those who perform the activity being audited. The documented procedure includes the responsibilities and requirements for conducting audits, ensuring their independence, recording results and reporting to management. Management responsible for the area being audited shall ensure that timely corrective action is taken on deficiencies found during the audit. Follow up action includes the verification of the implementation of corrective action, and the reporting of verification results.
8.2.3
Monitoring and Measurement of Processes
See Quality Procedure QP 8.1-1
The company applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product.
Alabama Specialty Products, Inc. Quality Manual Section 8 8.2.4
Measurement Analysis and Improvement ISO 9001-2000 Element 8
Monitoring and Measurement of Product
Page: 24 of 25 Revision: -1See Quality Procedure QP 8.1-1
Documented procedures have been established and maintained to monitor and measure the characteristics of the product to verify that requirements for the product are met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria is maintained and records indicate the person(s) authorizing release of the product. Release and product delivery does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
8.3
Control of Nonconforming Product
See Quality Procedure QP 8.3-1
A documented procedure is in place to ensure that product which does not conform to requirements is identified and controlled to prevent Its unintended use or delivery. Non-conforming product is dealt with in one of the following ways:
• • •
By taking action to eliminate the detected nonconformity By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer By taking action to preclude its original use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. When nonconforming product is corrected it is subject to re-verification to demonstrate conformity to the requirements When nonconforming product detected after delivery, or use has started, the company takes action appropriate to the effects, or potential affects, of the nonconformity.
8.4
Analysis of Data
See Quality Procedure QP 8.3-1
All data is effectively collected and analysed to determine the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. Data is analysed to provide information on customer satisfaction, conformity to product requirements, characteristics and trends of processes and products, including opportunities for preventive action, and suppliers.
8.5 8.5.1
Improvement Continual Improvement
See Quality Procedure QP 8.3-1
The processes necessary for the continual improvement of the quality management system are planned and organized. Continual improvement of the quality management system is facilitated through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Alabama Specialty Products, Inc. Quality Manual Section 8 8.5.2
Measurement Analysis and Improvement ISO 9001-2000 Element 8
Corrective Action
Page: 25 of 25 Revision: -1See Quality Procedure QP 8.3-1
A corrective action program is established and maintained to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action appropriate to the impact of the problems encountered is carried out. The documented procedure for corrective action defines requirements for: • Identifying and reviewing nonconformities including customer complaints • Determining the causes for nonconformities • Evaluating the need for actions to ensure that nonconformities do no recur • Determining and implementing the corrective action needed • Recording results of action taken • Reviewing of corrective action taken.
8.5.3
Preventive Action
See Quality Procedure QP 8.3-1
Documented procedures have been established and are maintained for implementing preventive action to eliminate the causes of potential nonconformities in order to prevent occurrence. Preventive actions are appropriate to the effects of potential problems. The documented procedure for preventive action defines requirements for: • Identifying potential non-conformities and their causes • Evaluating the need for action to prevent occurrence of non-conformities • Determining and ensuring the implementation of action needed • Recording results of action taken • Reviewing preventive action taken.