Quality Manual

Quality Management System

Management Leadership

Quality System

People Customer Focus Information & Analysis

Copyright by Rockwell Automation February 2007

Our Quality Policy Rockwell Automation is committed to a global quality system focused on customer solutions. We achieve this through superior products and services, rapid customer support, technical expertise, supplier partnerships, and industry leadership. Our quality and business objectives are designed to challenge the organization through continual improvement, innovation, and a passion for results.

This document is the property of Rockwell Automation, Inc., and may not be copied, used or disclosed for any purpose except as authorized in writing by Rockwell Automation, Inc. Revision Date: February 2007

Quality Management System TABLE OF CONTENTS: 1.0 PURPOSE 2.0

SCOPE

3.0

ROLES AND RESPONSIBLITY 3.1 Vice-President Continuous Improvement 3.2 Manager Quality Management Programs and Conformance 3.3 RA Business Units 3.4 RA Functions/Departments

4.0

EXHIBITS

5.0

FORMS

6.0

DEFINITIONS

7.0

POLICIES 7.1 General Requirements 7.2

Documentation Requirements 7.2.1 General 7.2.2 RA HQ Quality Document Owner 7.2.3 Business Unit Document Owner 7.2.4 Business Unit

7.3

Quality Records

7.4

Quality Planning

7.5

Responsibility, Authority and Communication 7.5.1 Responsibility and Authority 7.5.2 Internal Communication

7.6

Management Review

7.7

Provision of Resources

7.8

Human Resources 7.8.1 Awareness Competency and Training 7.8.2 Evaluation

This document is the property of Rockwell Automation, Inc., and may not be copied, used or disclosed for any purpose except as authorized in writing by Rockwell Automation, Inc. Revision Date: February 2007

7.9

Planning of Product Realization

7.10

Contract Review

7.11

Design and Development 7.11.1 Design Control 7.11.2 Design Input 7.11.3 Design Output 7.11.4 Design Reviews 7.11.5 Design Verification 7.11.6 Design Validation 7.11.7 Design Changes 7.11.8 Control Elements

7.12

Product Reliability System

7.13

Purchasing/ Supplier Quality 7.13.1 Supplier Evaluation and Selection 7.13.2 Purchasing Documents 7.13.3 Control of Purchased Material, Product and/or Services

7.14

Process Control

7.15

Inspection and Test 7.15.1 Received Products/Materials 7.15.2 In-Process Verification 7.15.3 Final Verification 7.15.4 Inspection and Test Records

7.16

Customer Support and Service

7.17

Product Identification, Traceability and Status

7.18

Customer Property

7.19

Handling, Storage, Packaging, Preservation and Delivery 7.19.1 Handling 7.19.2 Storage 7.19.3 Packaging 7.19.4 Preservation and Delivery

7.20

Control of Monitoring and Measuring Devices 7.20.1 Inspection, Measuring and Testing Devices 7.20.2 Calibration Records

7.21

Monitoring and Measurement

7.22

Internal Quality Audit

7.23

Control of Nonconforming Material

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7.24

Analysis of Data

7.25

Corrective and Preventive Actions 7.25.1 Corrective Actions 7.25.2 Preventive Actions

8.0

RECORDS

9.0

REFERENCES

This document is the property of Rockwell Automation, Inc., and may not be copied, used or disclosed for any purpose except as authorized in writing by Rockwell Automation, Inc. Revision Date: February 2007

Quality Management System

1.0

PURPOSE To document the top level Rockwell Automation (RA) Quality Management System in support of RA Quality Policy 900-20-01.

2.0

SCOPE This policy is intended for use at Rockwell Automation (RA) facilities worldwide.

3.0

ROLES AND RESPONSIBLITY 3.1

RA Vice-President Continuous Improvement Has the defined authority and responsibility for ensuring that all policy requirements are documented, implemented and maintained.

3.2

RA Manager of Quality Management Programs and Conformance Has the delegated responsibility and authority for implementing this policy.

3.3

RA Business Units Have the responsibility for developing and implementing processes and procedures to support this policy.

3.4

RA Functions/Departments Have the responsibility for completion of duties specified in support of this policy.

4.0

EXHIBITS Exhibit A- Cross-reference between the sections of this document and the ISO 9001:2000 clauses (For ISO 9001:2000 certified Business Units).

5.0

FORMS Not Applicable

6.0

DEFINITIONS 6.1

Auditor A competent individual (qualified on the basis of appropriate education, training, experience, and demonstrated skills) who actively participates in conducting the audit process. This participation may include responsibilities as the Audit Team Leader, technical specialist, and/or management representative.

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Quality Management System

6.2

Business Unit A group, business, facility, function or other organizational structure within RA.

6.3

Business Unit Management Is the functional leadership of the RA Business Unit.

6.4

Continual Improvement Is the process of enhancing the Quality Management System to achieve improvements in overall quality performance in support of RA Policy.

6.5

Corrective Actions Actions taken to eliminate the root cause of an existing nonconformance and to prevent its reoccurrence.

6.6

Customer Property Is customer owned or supplied material parts, product returns, and intellectual property.

6.7

Effectiveness Extent to which planned results are realized and achieved.

6.8

Impact Assessment Is an evaluation that is performed by individual(s)/organization(s) utilizing equipment that was found to be unsatisfactory during calibration. The purpose of such evaluation is to assess the situation and if appropriate drive corrective actions after determining that the use of the equipment may have affected the quality or accuracy of past measurements/tests.

6.9

Infrastructure Buildings, workspace, associated utilities, process equipment (both hardware and software), and other supporting services such as transport or communications.

6.10

Management Representative Is the assigned quality representative appointed by Business Unit Management.

6.11

Management Review Is the formal evaluation by the Business Unit Management of the continuing suitability, adequacy and effectiveness of the Quality Management System in relation to RA Quality Policy, internal business process results, business objectives and customer feedback. Opportunity for improvement and the need for changes to the Quality Management System including the Quality Policy and objectives are considered during the review.

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Quality Management System

6.12

Objective Evidence Data supporting existence or verification of something.

6.13

Preventive Actions Actions taken to eliminate a potential root cause of a potential problem that has not occurred.

6.14

Process A set of interrelated resources and activities that transforms inputs into outputs. The process will be suitable and documented for the Business Unit’s plan for product realization.

6.15

Product Result of a process including service, software, hardware or processed materials.

6.16

Product Realization Is the set of processes used to bring a product into being from an idea to a final product.

6.17

Product Reliability Is the ability of products to perform their intended design functions consistently over time.

6.18

Quality Documentation Is any document or data that could affect the safety, reliability and/or quality of RA products and services. Quality documentation includes documents of external origin such as customer drawings and standards, when applicable.

6.19

Quality Management System (QMS) Is the part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining RA Quality Policy.

6.20

Quality Objective A strategic goal arising from RA Quality Policy that the Business Unit sets to achieve and is quantified.

6.21

Quality Records Are records that demonstrate the achievement of the required quality or substantiate operation of the Quality Management System.

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Quality Management System

6.21

Training Type of action to satisfy employees competency needs.

7.0

POLICIES 7.1

General Requirements This document defines the Rockwell Automation (RA) Quality Management System in support of RA Quality Policy.

7.2

Documentation Requirements 7.2.1

General This document establishes RA requirements for the Quality Management System. Each Business Unit is responsible for meeting all requirements of this policy and will establish and maintain a method for referencing their Business Unit procedures to the applicable RA Quality Management System policy. Form 48-10F, RA Quality Policies and Procedures Applicability Matrix, or equivalent, will be used to establish the cross-reference. Each Business Unit will identify procedures, referenced forms, and work instructions. Documents may be maintained either in hard copy or electronic form. Figure 1 below shows the structure of the RA Quality Management System.

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Quality Management System

RA Quality Policy 900-20-01 RA QMS 900-20-02

RA Documentation (900 Manual)

Level 1

RA Common Quality Procedures RA Business Unit Procedures

Work Instructions

Business Unit Documentation

Quality Records

Level 2

Level 3

Level 4

Figure 1: RA Quality Management System (QMS) Structure. Each RA Business Unit will establish and maintain documented procedures to identify and control documents (including data and documents of external origin) that relate to the requirements of the RA Quality Management System. Documents will be reviewed, updated as necessary, and approved for adequacy by authorized personnel prior to issue. RA Business Units may submit to HQ Quality a request for an exemption or modification from applicable quality polices or procedures. 7.2.2

RA HQ Quality Document Owner The document “owner” will review, of planned intervals, and reissue approved RA Quality Management System Documentation (900 manual policy/common procedures) to reflect current quality strategies or as a result of management review. The issue, recall and control of documents will be under the jurisdiction of authorized personnel.

7.2.3

Business Unit Document Owner The document “owner” will review and reissue approved Business Unit Documentation (policy/procedures) in accordance with the Business Unit documented procedure, to reflect current quality practices or as a result of management review. The issue, recall and control of documents will be under the jurisdiction of authorized personnel.

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Quality Management System

7.2.4

Business Units Business Units will: • Develop written procedures and instructions to control the development, approval and issuance of quality documents and changes. • Develop procedures, and instructions that describe significant activities required to design, manufacture, test, inspect and service RA products. • Develop and control specifications, drawings and/or standards necessary to design, manufacture, test, inspect and/or service RA products. • Develop a system of documentation control that will ensure essential documents required by the Quality Management System are available at the point of use. • Assure that documents will remain legible and readily identifiable. • Assure that reviews, approvals and changes are performed by qualified personnel with access to pertinent information. • Define standard methods for adding and identifying revisions. The same authority that approved the original document, unless otherwise designated, will approve revisions. • Identify, where practical, the nature of changes in the document or appropriate attachments. • Make provisions for obsolete documents to be removed or recalled from points of issue and activity locations to assure against unintended use. • Obsolete documents required for legal and/or knowledge preservation purposes will be retained and suitably identified. • Assure that product safety considerations are taken when writing advertisements, product promotional publications and instructional publications. For Product Safety policies and procedures, please reference Section 50, Product Safety, of the 900-Series Manual.

7.3

Quality Records Quality records will be maintained to demonstrate achievement of the required quality objectives and effective operation of the Quality Management System. Pertinent quality records from suppliers will be an element of these records. Each Business Unit will develop procedures for identification, access, storage, maintenance and disposition of quality records to be reviewed at their level. Quality records will be legible, readily identifiable and retrievable to the product/process involved. Quality records will be utilized in compiling trend analysis, when necessary. Associated records will demonstrate the use of the data for corrective/preventive action. Quality records will be kept active as identified in applicable procedures. Records will be made available upon request to representatives of a customer or other agency. A formal system for the disposal of records will be established. Quality records will be stored in a suitable environment to minimize deterioration or damage and to prevent loss.

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Quality Management System

Quality records will be kept according to an established and documented schedule as defined by the Business Unit or RA procedure (RA procedure takes precedence). Quality Records can be in the form of hard copy media, electronic or other. Quality records will be traceable as appropriate to the activity product or service involved. As applicable to the Business Unit, the following records types will be maintained: • • • • • • • • • • • • • • • • • • •

Management Review Records and Actions (ISO Clause 5.6) Training/Competence (ISO Clause 6.2.2e) Planning of Product Realizations (ISO Clause 7.1) Review of Product Requirements (ISO Clause 7.2.2) Design Inputs (ISO Clause 7.3.2) Design Reviews (ISO Clause 7.3.4) Design Verification (ISO Clause 7.3.5) Design Validation (ISO Clause 7.3.6) Design Changes (ISO Clause 7.3.7) Supplier Assessment (ISO Clause 7.4.1) Process Validation (ISO Clause 7.5.2) Unique ID of product (ISO Clause 7.5.3) Property Loss Report to Customer (ISO Clause 7.5.4) Instrument Calibrations (ISO Clause 7.6) Internal Audits (ISO Clause 8.2.2) Product Conformity (i.e. Inspection & Test) (ISO Clause 8.2.4) Non-Conforming Material Reports and Actions (ISO Clause 8.3) Corrective Action (ISO Clause 8.5.2) Preventive Action (ISO Clause 8.5.3)

Disposal or destruction of records will be done in a manner that will properly maintain the security of the information. Records will be made available for evaluation by the customer or the customer’s representative for an agreed upon period when contractually specified. For additional records retention and maintenance requirements, reference Policy B-11, Rockwell Automation Records and Information Management, and the Corporate Records Retention Schedule. 7.4

Quality Planning Business Units will prepare quality plans and objectives and manage change to maintain the integrity of the Quality Management System with the aim of promoting continual improvement and awareness of customer requirements and improving customer satisfaction.

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Quality Management System

Quality planning will include, but not be limited to: • Continual improvement of the Quality Management System through the use of the Quality Policy, objectives, audit results, analysis of data, corrective and preventive action and management review. • Identification of controls and processes to maintain the Quality Management System when changes are required. • Identification and preparation of quality records. 7.5

Responsibility, Authority and Communication 7.5.1

Responsibility and Authority The responsibility, authority and the interrelation of personnel, who manage, perform and verify work affecting quality and/or any processes of the Quality Management System will be defined, documented and maintained. The Quality Management Representative of each RA Business Unit is responsible to the Senior Vice-President or appropriate Business Unit Management. Employees are authorized to: • • • •

Initiate action to prevent the occurrence of non-conformities relating to the product, service, process and or Quality Management System. Identify and record any problems relating to the product, service, process and or Quality Management System. Initiate, recommend or provide solutions through designated channels. Verify the implementation of solutions. Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.

The management representative will: • • •

7.5.1

Ensure that the processes needed for the Quality Management System are established, implemented and maintained. Report on the performance of the Quality Management System and any need for improvement. Ensure the promotion of awareness of customer requirements throughout the organization.

Internal Communication RA Business Unit Management will communicate the importance of meeting the Business Unit’s goals and objectives as well as customer and legal requirements. RA Business Unit Management will establish communication processes between its various levels and functions regarding the Quality Management System and its effectiveness.

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Quality Management System

7.6

Management Review Business Unit Management with responsibility and authority for the Quality Management System will review the quality results and overall effectiveness of the Quality Management System. This will be done to demonstrate the continuing suitability, adequacy and effectiveness in satisfying RA Quality Policy, objectives and the continual improvement of the Quality Management System. Inputs to the review process will include current performance and improvement opportunities related to the following: • • • • • • •

Audit results Customer feedback Product, service and process performance and conformance Status of preventive and corrective actions Follow-up actions from earlier management reviews Changes that could affect the Quality Management System Recommendations for improvement

Results and actions from Quality Management System management reviews will be documented, submitted and reviewed by the applicable Quality Management and shared across RA as deemed appropriate. Results of the management review will be used to evaluate the effectiveness of the Quality Management System and to establish improvement actions related to the following: • Improvement of the effectiveness of the Quality Management System and its processes • Improvement of products and services related to customer requirements • Resource needs At a minimum, reviews will take place on an annual basis. 7.7

Provision of Resources It is the responsibility of Business Unit Management to provide and maintain adequate resources and competent personnel to perform activities as defined in the Quality Management System. These resources include workspace, equipment, personnel, supplies and supporting services, along with any other human or physical factors that would affect the ability to comply with the procedures or quality plans. Resources must be defined to meet requirements for products and services that will enhance customer satisfaction.

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Quality Management System

7.8

Human Resources 7.8.1

Awareness, Competency and Training Competency requirements or equivalent are defined in job descriptions and procedures. Competency needs are identified using inputs and objective evidence from sources that may include the following: Safety, Project or Product Planning, Project Results, New or Changed Products, Technology Changes, Organizational Changes, Customer Feedback, Quality Data, Corrective/Preventative Action, Equipment Changes, Changed or New Processes, Engineering Changes, Deviations, Leadership Programs, Business Plans, Department Needs, Audits. RA Business Units will provide training or take other actions to satisfy competency needs. New and existing employee minimum training requirements, process and procedure will be defined. Any On-the-Job training will have supportive documentation (example: checklist for critical skills). Training will include the relevance and importance of work activities and how they contribute to achievement of product and service quality. Internally conducted training is rendered by competent trainers on the basis of experience, education, competencies and training.

7.8.2

Evaluation Personnel performing specific assigned tasks will be deemed competent on a continual basis through appropriate education, training, experience, and demonstrated skills. RA Business Units will verify competence using objective evidence. Examples include: • • • • • • • • • • • • •

Signed Applications Resume Signed Affidavit Diploma Certificates Training Records Status of Training Provision Interviews Project Results Job Experience Review and Updates to Job Descriptions Education Certifications or letters of attendance

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Quality Management System

RA Business Units will define and implement methods to evaluate training effectiveness. Examples of methods may include: • • • • • • 7.8.3

Pre- and post testing Surveys Process monitoring Customer Feedback Audits Training program adjustments

Competency and Training Records Documented evidence is required and must be readily available to demonstrate that competency requirements have been satisfied. Records of education, training, experience, skills, qualification, competence and competency needs are specified by the RA Business Units and maintained.

7.9

Planning of Product Realization Processes needed for product realization will be planned and developed. Planning of product realization will be consistent with the requirements of other processes of the Quality Management System. Planning of product realization will include, but not be limited to: • • • • • •

7.10

Identification and acquisition of controls, processes, infrastructure, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality. Compatibility of the design, production process, installation, servicing, inspection and test procedures and the applicable documentation. Updating as necessary the quality control, inspection and testing techniques, including the development of new instrumentation. Identification of measurement requirements involving capability that exceed the known state of the art, with sufficient time to develop the needed capacity. Identification of suitable verification and validation at appropriate product development stages. Clarification of standards of acceptability for features and requirements, including those which contain a subjective element.

Contract Review RA Business Units will provide methods for initial review and subsequent changes of customer specifications and contracts for control of special quality, reliability, product safety, service and process requirements, to provide a documented record of these requirements and to communicate these requirements to all appropriate departments/functions and customers. RA Business Units will develop, implement and maintain procedures to ensure an adequate understanding of the needs and expectations of the customer or other interested parties. For additional contracts review and approval requirements, reference 700-01-13, Sales Contracts Review and Approval Policy.

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Quality Management System

The procedures will ensure: •

• • • • • •

7.11

Product and service requirements specified by the customer are adequately defined and reviewed, and include availability, delivery and support. The review of requirements will be performed and documented before any commitment to supply product and/or service is made (e.g. submission of tender or acceptance of a contract). Product and/or service requirements not specified by the customer, but necessary for intended use, are defined. These requirements are to be confirmed by the customer. Product safety, reliability and legal requirements are identified and can be met. Adequate and suitable resources necessary to fulfill the contract requirements are available. Requirements differing from the quotation are resolved with the customer. Before the submission of a tender, or the acceptance of a contract or order (statement or requirement), it will be reviewed by the appropriate RA personnel. Incomplete or ambiguous information is clarified with the customer before production is started.

Design and Development RA Business Units will implement the design control requirements necessary to develop and maintain a product throughout its life cycle. These requirements will assure that the product meets defined requirements and objectives for functionality, manufacturability, product safety, quality, reliability, serviceability, and customer satisfaction. This policy applies to RA design control activities regardless if the work is performed internally by RA personnel or externally by suppliers or contractors under the direction of RA. Required development and design records regardless of origin will be maintained or accessible within RA to demonstrate conformance. This includes records associated with work performed externally by suppliers or contractors. 7.11.1 Design Control RA Business Units will implement and maintain design control procedures that meet the following: • Responsibilities will be defined for identifying and documenting the design requirements. • The responsibilities and requirements for each design and development activity will be documented and updated as the design evolves. • Qualified personnel, equipped with adequate resources, will be assigned to the design, verification, and validation activities. • Responsibilities will be defined and documented for internal and external interfaces to ensure that necessary information is documented, transmitted, and regularly reviewed. The process will resolve questions relating to incomplete, ambiguous, or conflicting requirements.

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Quality Management System

7.11.2 Design Input Design input will be developed to clearly define requirements of the product. Inputs to the design process must be documented with records maintained. Design inputs will include: • • •

Functional and performance requirements Applicable legal requirements Requirements essential to the design

7.11.3 Design Output The design output may be expressed in terms of requirements, calculations, analysis, drawings, and/or Bills of Material. The output of the design process will be compiled in a manner that enables verification against the design input. Design output will: • • • • •

Meet design and/or development input requirements. Provide appropriate information for purchasing, production and service operations. Contain or reference product acceptance criteria. Define the characteristics of the product that are essential to its safe and proper use. Be reviewed and approved prior to product release for shipment.

7.11.4 Design Reviews Design reviews will be planned, conducted, and documented. Pertinent personnel will participate as part of the review process. Design review records will be maintained and will: • Identify participants involved in the activity. • Identify specific functions reviewed and their ability to meet the input requirements. • Identify problems and propose follow-up actions. 7.11.5 Design Verification Methods will exist to demonstrate that the product described by the design output meets the design input requirements. Design verification methods and associated records will be maintained. Add example of design verification

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Quality Management System

7.11.6 Design Validation Design validation will be performed to ensure that the resulting product conforms to the defined and documented user needs and/or intended use. Design validation follows successful design verification activities. • • • • •

Design validation will be performed under specified operation parameters. Multiple design validations may be performed if there are several intended uses of the product. Where applicable, validation will be completed prior to the delivery or implementation of the product. If it is impractical to perform full validation prior to the delivery or implementation, partial validation will be performed to the extent possible. The results of the validation and subsequent follow-up actions will be recorded.

Add example of design validation 7.11.7 Design Changes Design and development changes are identified, documented, and controlled. The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions are maintained. 7.11.8 Control Elements Control Elements needed to control the product processes are as follows: • • • • • • • • • • •

Establish a system for the control and verification of hardware, firmware and software development. Identify product characteristics that will be monitored to ensure conformity and ensure that such information is communicated to responsible parties. Establish a system to control the revision of products and associated documentation. Establish a system to control the retention and storage of design documents. Define the design plan, review, verification and validation requirements. Establish a system to control purchased (Factored) products. Establish a system to control product obsolescence. Establish requirements to assure that safety and reliability is considered during the development process. Establish a system to control third-party certification (e.g., UL/CSA), if required. Establish a system to handle special commitments (e.g., Beta Site Testing). Define the use of statistical methods through the product development process, where applicable.

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Quality Management System

7.12

Product Reliability System RA Business Units that produce hardware and/or software products will establish and implement a product reliability program that complements the design and development verification and validation processes. The product reliability program may include but is not limited to: • Developing and maintaining reliability operation procedures, design standards, and technical guidelines. • Establishing product reliability qualification methodology. • Participating in design reviews. • Coordinating product reliability training programs. • Developing and implementing production reliability monitoring and screening practices. • Defining requirements for collecting, reporting and releasing reliability data. Typical life cycle reliability activities which may include: • • • • • • • • • • •

7.13

Establishing a reliability and maintainability specification. Performing reliability feasibility studies. Qualifying new components/materials. Performing thermal evaluation. Performing circuit and software stress analysis. Performing environmental qualification testing. Conducting design reliability reviews at specified stages of development. Performing reliability margin/life tests. Reviewing product field performance. Component de-rating analysis. Product Safety Assessments

Purchasing/ Supplier Quality RA Business Units will establish a system to ensure that materials, products and services purchased by RA Business Units conform to specified requirements. 7.13.1 Supplier Evaluation and Selection • Suppliers will be based on their ability to meet specified requirements. These specifications will be documented. • Selection and maintenance of a supplier will be primarily dependent upon: • Type of material, product or service • Impact of the purchased item with relation to the final product or service • Material, product or service evaluation results • Records of previous capabilities and performance • Quality Management System control (survey results)

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Quality Management System

Selected and approved suppliers will be included on an approved supplier list which will be maintained by the Business Unit. Performance of suppliers will be monitored to ensure their quality level is maintained. Supplier performance data will be used as the basis for removing suppliers from the approved list, when required. Materials, products and/or services that affect the quality, product safety, reliability or customer satisfaction of RA products and services will be purchased from approved suppliers. Exceptions to this will be approved by the Quality function of the Business Unit or by customer request. For additional requirements, reference procedure 900-20-25, Supplier Evaluation and Qualification. 7.13.2 Purchasing Documents Purchase orders will be reviewed and approved prior to release to ensure that pertinent drawings, specifications, and other necessary information are listed and the sources of supply have the data required. This data will define appropriate quality requirements (if required), including the title number and issue of the appropriate standards. Revisions to purchasing documents will be controlled in the same manner as the original document. Revisions will be fully documented by the purchasing department/function. Purchase orders and associated reference data required by contract will be available for review by the customer or requester. If RA Business Unit proposes to verify purchased product and/or services at the supplier’s site, the verification arrangements and the method of product/service release will be documented in the purchasing documents. 7.13.3 Control of Purchased Material, Product and/or Services Purchased material, products and/or services for use in RA products and/or services will be controlled to ensure compliance to the purchase order requirements or customer requirements, as applicable. One or more of the following criteria will be used in establishing adequate control procedures: • • • • • •

Sample approval and qualification testing Documented evidence of compliance provided by the supplier Examination and acceptance of the items upon delivery Inspections and audits at the suppliers’ facilities Procedures for the disposition of non-conforming items Procedures for re-evaluation and updating of approved suppliers

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Quality Management System

When required by customer contract, a customer will be afforded the right to verify at the source or after receipt that purchased material, equipment or services conform to specified requirements. The right of access will extend to a supplier’s facility to permit verification at the source. A system for handling non-conforming material, product and/or services that adversely affect quality, reliability and safety, and for requesting corrective action by a supplier will be established. Procedures will be documented that ensure customer supplied materials are handled, stored, maintained, verified upon delivery that material is not damaged, and quantity is correct, etc. Procedures will ensure that material is identified to prevent inadvertent misuse, and for disposition of unused material. When customer supplied material is lost, damaged or otherwise unsuitable for use, it will be documented and the customer notified. 7.14

Process Control The Business Unit will identify the quality system processes and controls needed for product and/or service realization. The Business Unit will determine, provide and maintain the infrastructure needed to support the process controls necessary to achieve conformity to product and/or service requirements. Processes that have a direct affect on product and/or service quality will be carried out under controlled conditions. There will be written procedures covering the planning and control of manufacturing quality including applicable reference standards/codes and quality plans. Documented work specific procedures that define the methods of production, test and installation will be prepared for processes where the absence of such instruction would adversely affect quality. The characteristics of processes, products and services will be identified, monitored and controlled to ensure compliance with specified requirements. The results obtained from the monitoring activity will be subject to analysis using valid statistical methods for identifying opportunities for improvement. Documented procedures will exist that specify the qualification requirements for new and revised processes, products, services and equipment. Workmanship standards will exist and apply to RA products and services, except as required by contract or documented exception. Acceptance standards for workmanship and product characteristics will be defined in written standards, representative samples, or by other means. Production equipment that directly affects product conformance will be controlled, maintained, and calibrated in accordance with an established control and maintenance system, to ensure continuing process capability. When processes are used in the monitoring and measurement of specified requirements, the ability of computer software to achieve the intended application will be verified.

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Quality Management System

7.15

Inspection and Test Each RA business unit will establish a system to ensure that various verification activities are performed as required by plans, documented procedures, or contractual agreements. 7.15.1 Received Products/Materials Received product or materials will not be used or processed (except when released for urgent production purposes as outlined below) until such products/materials have been verified as conforming to specified requirements. Verification will be in accordance with Quality Plans, documented procedures and contractual requirements. Received product or materials released for urgent production purposes will be positively identified and recorded in order to permit immediate recall in the event of a rejection of the received product/material. A documented process for authorization and release of received products or materials prior to verification is needed and may require customer approval, if required by contract. When determining the amount and type of receiving inspection, consideration will be given to the amount of control exercised at the supplier’s premises, and the recorded evidence of conformance provided. Received product/material in compliance with requirements will be released to designated areas. Documentation received in support of received product/material will be reviewed and retained as required. Received product/material that is not in compliance with requirements will be segregated and placed on hold, awaiting authorized disposition. 7.15.2 In-Process Verification Products passing through the manufacturing process will be inspected, tested, and identified at pre-determined points as defined by the Quality Plan, documented procedures and contractual requirements. Product conformance to specified requirements will be established by means of process monitoring and control. Products in process will be held at pre-determined points until the required inspections and tests have been completed and/or the necessary reports have been received and verified. Non-conforming products will be identified to prevent unintended use or delivery.

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Quality Management System

7.15.3 Final Verification The Quality Plan or other documented procedures for final inspection and testing will require that specified inspections and tests have been carried out including those specified either on receipt of product or in process. Evidence of conformity with the acceptance criteria will be documented. Records will indicate the authority responsible for release of product. Final inspection and testing will be carried out in accordance with the Quality Plan or other documented procedures, and evidence will be retained to demonstrate conformance of the finished product to the specified requirements. Records will identify the inspection authority responsible for the release of product. Records of verification will be retained when specified in the Quality Plan. No product will be released until activities specified in the Quality Plan and other documented procedures have been satisfactorily completed. Associated data and documentation will be available, completed and authorized. Note: Product may be released prior to meeting the above requirements if specifically approved by the customer. 7.15.4 Inspection and Test Records Inspection and test records will be maintained to provide evidence of product conformity and that elements of the quality plan or documented procedures have been completed. Product that does not meet the criteria will be considered non-conforming and dispositioned accordingly. 7.16

Customer Support and Service RA Business Units will establish and maintain processes to ensure that customer support and service requirements are defined and implemented if such services are specified, implied, or required by contract. Methods will be established to ensure that customer support and services provided meet specified requirements.

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Quality Management System

7.17

Product Identification, Traceability and Status RA Business Units will establish systems to positively identify materials and product at all stages of production, packaging, installation, repair, modification, and use when required by customer and/or contract. When traceability is required by contract, codes, or regulations, items will be traceable to a specified source and have a unique identifier. RA Business Units will also establish, implement, and maintain systems to identify the status of product throughout the production, installation and servicing of that product. Other requirements may include: • Separate lots or batches of identical product will be assigned a unique identification. • The unique identification will be recorded on documents, such as process, inspection and test records. • The Business Unit will identify the status of the product with respect to measurement and monitoring requirements. • The inspection and test status of product will be identified by using suitable means, to indicate the conformance or nonconformance of product. • The identification of inspection and test status will be maintained, as necessary, throughout production and installation of the product to ensure that only product that has passed the required inspections and tests is shipped, used, or installed. • The authority for application or removal of any inspection and test status indicators will be clearly documented. • Methods for distinguishing new products from customer returns, exchanges, or remanufactured units will be established.

7.18

Customer Property Customer property including intellectual property used or incorporated into a product and under RA Business Unit control or used by RA Business Unit will be identified, verified, protected and safeguarded. If any customer property is lost, damaged or otherwise found to be unsuitable for use, it will be reported to the customer and documented.

7.19

Handling, Storage, Packaging, Preservation and Delivery RA Business Units responsible for manufacturing, material control, stockrooms, warehouses, and any other function that handles, stores, packages or delivers products (including Customer Supplied Material and materials being received and awaiting assembly or being transferred to another facility) will be responsible for ensuring that documented systems exist to control the handling, packaging, preservation, shipping, and storage of material to prevent damage, deterioration during manufacturing and transit, and the safety of the handlers and users. 7.19.1 Handling RA Business Units will provide methods of handling product to prevent damage or deterioration. Requirements will be identified during pre-production planning for handling, marking, labeling, packaging, shipping, and storage of products and materials, and provide for the safety of the handlers and users. Necessary requirements for critical, sensitive or perishable items will be specified.

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Quality Management System

7.19.2 Storage Storage areas or stockrooms will be provided to prevent damage or deterioration of the product or materials. Appropriate methods for authorizing receipt and dispatch to and from storage areas will be documented. Stock will be assessed at appropriate intervals in order to detect any deterioration of the condition of product. 7.19.3 Packaging Packing, packaging and marking processes will be controlled to ensure conformance to specified requirements. 7.19.4 Preservation and Delivery The RA Business Unit will implement appropriate methods to preserve conformity of product during processing stages and until delivery to the intended destination. 7.20

Control of Monitoring and Measuring Devices The RA Business Units will establish effective systems to maintain accuracy of measuring and process equipment and tooling and to control the selection, maintenance, and calibration of equipment used to verify that products, services, and/or processes conform to specifications. The RA Business Units will determine the monitoring and measurements to be made and select equipment capable to ensure that products, processes, and/or services conform to specification. 7.20.1 Inspection, Measuring and Testing Devices Measuring and test equipment and devices (hardware and software) used in verification activities will be identified and calibrated (validated/re-validated where software is concerned) in accordance with established calibration and maintenance schedules, processes and as appropriate to maintain suitability. The calibration will be traceable to National, International and/or Industry Standards. Where no standards exist or alternative specifications are required, the basis used for calibration will be documented, approved by appropriate authority, and communicated to the personnel performing the calibration. Procedures will be developed for scheduling, calibrating and recalling equipment including a list of equipment due/overdue for calibration and the identification of “lost” equipment.

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Quality Management System

Original Equipment Manufacturers (OEM) recommended calibration and preventive maintenance techniques and schedules are to be reviewed and taken into account when establishing process and procedure. Calibration, preventive maintenance, and software validation will be performed according to defined process and/or appropriate time frames to maintain suitability of measuring, monitoring, tooling, and process equipment and minimize the effect on the manufacturing process, product, and/or service quality. New measuring and testing equipment will require a certificate of calibration, capability or accuracy prior to purchase: otherwise it will be calibrated prior to installation or use. Equipment and devices will be designed in such a way to avoid unauthorized adjustments. This includes both hardware and software when used in inspection, measuring and testing facilities. Where test hardware (e.g., jigs, fixtures, templates, patterns) or test software is used as suitable forms of inspection, they will be checked to prove that they are capable of verifying the acceptability of product. This will be done prior to release for use during production and installation and will be rechecked at prescribed intervals, or for software revalidated as appropriate to ensure suitability. Users of test equipment will ensure that the equipment has current and valid calibration. Steps to safeguard the equipment will ensure that the equipment has current and valid calibration: • • • •

Calibrate and use it in a suitable environment. Calibrate it as part of the repair or adjustment process. The inspection, measuring and test facilities, including both test hardware and test software, will be safeguarded from adjustments that would invalidate the calibration setting. Take care during both handling and use of equipment and devices, to ensure that damage is not sustained and calibration affected.

When measuring, monitoring, tooling, or process equipment is found not to conform to a requirement, appropriate action will be taken on the equipment and any product effected. An Impact Assessment will be performed to determine if remedial or corrective actions are required. Rationale for action or inaction will be documented and records maintained. 7.20.2 Calibration Records Calibration records for devices will be maintained. Records will include details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the actions taken, which include Impact Assessment, when results are unsatisfactory. Technical data pertaining to the inspection measuring and test equipment will be made available when there is a specified requirement.

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Quality Management System

7.21

Monitoring and Measurement Monitoring, measuring, analysis, verification activities, and improvement processes will be performed to demonstrate conformity of the product and/or service, ensure conformity and effectiveness of the Quality Management System, and drive continual improvement. Business Units will secure input from customers to ensure customer needs and expectations are determined and met.

7.22

Internal Quality Audit Each RA Business Unit will develop, document and implement an Internal Quality Audit program that defines: • Programs, systems and procedures to be audited, scope of the audits and schedules (every 12 months minimum). • Personnel qualified to perform audits by virtue of their training and independence of the area being audited. • Corrective action process approval, implementation, and verification. • Method of reporting findings and observations to RA Business Unit and Management through the management review process. Internal quality audits will include an evaluation of: • Activities, processes and programs performed by the business unit within their respective facilities. • Documented quality practices, systems, procedures and instructions that each Business Unit has developed and implemented in support of these programs and any supporting documents and records. Internal quality audits will be performed in accordance with internal audit procedures and/or checklists. Each Function/Department being audited will review, agree upon and correct deficiencies revealed in the audit report within a time period mutually agreed upon with the auditors and the function being audited. Corrective Actions will be initiated and implemented based on audit results. Actions taken to correct deficiencies will be re-evaluated and documented to verify effectiveness. Internal quality audit/reports will be used by management to review the continued effectiveness of the Quality Management System.

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Quality Management System

7.23

Control of Nonconforming Material RA Business Units will establish systems to identify basic activities required for controlling the identification, documentation, segregation, disposition and notification to affected parties of nonconforming materials. • Materials/products which do not conform to RA Business Unit requirements will be identified and segregated to prevent further processing, delivery, installation or inadvertent use from receiving through shipping until proper disposition has occurred. • The responsibility for review and authority for the disposition of non-conforming product will be defined. • All non-conforming material/product will be evaluated and dispositioned as: rework/repair, use-as-is, accept on deviation or waiver, scrap, return to supplier, or re-graded for alternative application, in accordance with documented procedures. • Product that has been repaired and/or reworked will be re-verified to ensure conformance with documented procedures or quality plans.

7.24

Analysis of Data Data collection systems will exist to provide data to the function/department responsible for analyzing and reporting issues related to the effectiveness of the Quality Management System and overall quality improvement. The system will include methods for analyzing the information collected and extracting specific details for monitoring and performing corrective and preventive actions. Appropriate sources of information, such as product and/or service quality, concessions, audit results, quality records, service reports and customer complaints will be used to detect, analyze and eliminate potential causes of non-conformities. RA Business Units will establish systems and document the requirements for collecting, analyzing and reporting internal/external data relative to products, services, and associated processes within RA Business Units. This data will be used to apply corrective and preventive actions and enable continuous improvement of product and service quality. Data generated as a result of monitoring and measurement and from other relevant sources will provide information relating to: • Customer satisfaction • Conformity to product or service requirements • Characteristics and trends of processes and products including opportunities for preventive action • Suppliers Collection systems will exist to provide data to the department/function responsible for analyzing and reporting issues related to quality. Appropriate sources of information, such as processes and work operations that affect product quality, concessions, audit results, quality records, service reports and customer complaints, will be used to detect, analyze and eliminate potential causes of nonconformities.

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Quality Management System

Data analysis will be used to: • Determinate issues requiring preventive actions. • Initiation of preventive actions and application of controls to ensure that it is effective Implementation of Statistical Techniques: • Analysis of the results will be used to determine the suitability of processes associated controls, process capabilities and product characteristics. 7.2.5

Corrective and Preventive Actions 7.25.1 Corrective Actions Each Business Unit will establish, document and maintain systems for identifying nonconformities (including customer complaints) and initiating corrective actions. The level of management involved in a given corrective action will be determined by the magnitude of the problem and the risks encountered. A documented procedure will be established to define requirements for: • • • • • •

Investigating the cause of non-conforming products, processes or services. Initiating corrective actions in a reasonable time period to eliminate the nonconformities root cause and to ensure non-conformities do no recur. Applying controls to ensure that the corrective actions have been implemented and reviewed for effectiveness. Implementing and recording changes to the documented procedures resulting from the corrective actions. Communicating corrective actions to other Business Units for evaluation as appropriate. Maintaining records of the cause of the non-conformities and the actions taken.

7.25.2 Preventive Actions RA Business Units will take actions to eliminate causes of potential nonconformities in order to prevent their occurrence. A documented procedure will be established to define the requirements for: • • • •

Determining potential nonconformities and their causes. Determining, evaluating, implementing actions necessary to prevent occurrence of nonconformities. Reviewing preventive action results after implementation for effectiveness. Maintaining records of the results of actions taken to eliminate the causes of potential nonconformities.

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Quality Management System

8.0

RECORDS Not Applicable

9.0

REFERENCES RA Quality Policy 900-20-01 900-Series Manual, Section 50, Product Safety Policies and Procedures B11 Rockwell Automation Records and Information Management Policy Corporate Records Retention Schedule 700-01-13 Sales Contracts Review and Approval Policy

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Quality Management System

EXHIBIT Exhibit A: Cross-reference between the sections of this document and ISO9001: 2000 clauses Section 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14 7.15 7.16 7.17 7.18 7.19 7.20 7.2.1 7.22 7.23 7.24 7.25

Description General Requirements Documentation Requirements Quality Records Quality Planning Responsibility, Authority and Communication Management Review Provision of Resources Human Resources Planning of Product Realization Contract Review Design and Development Product Reliability System Purchasing/Supplier Quality Process Control Inspection and Test Servicing Product Identification, Traceability, and Status Customer Property Handling, Storage, Packaging, Preservation, and Delivery Control of Monitoring and Measuring Devices Monitoring and Measurement Internal Quality Audit Control of Nonconforming Material Analysis of Data Corrective and Preventive Actions

ISO 9001: 2000 Clause 4.1 + 4.2.2 4.2 4.2.4 5.4.2 + 7.1 5.5.1 + 5.5.2 5.6.1 + 8.5.1 6.1 + 6.2.1 6.2 7.1 5.2 + 7.2 7.2.1 + 7.3 7.3.5 + 7.3.6 7.4 6.3 + 6.4 + 7.5.1 + 7.5.2 7.1 + 7.4.3 +7.5.3 + 8.1 + 8.2.4 7.5.1 7.5.3 7.5.4 7.5.1 + 7.5.5 7.6 8.1 + 8.2 8.2.2 + 8.2.3 8.3 8.4 8.5.2 + 8.5.3

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