Quality Manual

Quality Management System
Management Quality System

Leadership
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
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
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
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
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.
Page 1 of 27 Revision Date: February 2007
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.
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.
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.
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.
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.
RA RA Quality Policy 900-20-01

Documentation RA QMS 900-20-02 Level 1
(900 Manual)
RA Common Quality Procedures
Level 2
RA Business Unit Procedures
Work Instructions Level 3

Business Unit
Documentation
Quality Records 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.
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.
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.
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:
• 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.
7.5.1 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.
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.
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
RA Business Units will define and implement methods to evaluate training effectiveness.
Examples of methods may include:
• Pre- and post testing

• Surveys
• Process monitoring
• Customer Feedback
• Audits
• Training program adjustments
7.8.3 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:
• 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.
7.10 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.
The procedures will ensure:
• 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.
7.11 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.
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
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.
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:
• 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
7.13 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)
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
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.
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.
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.
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.
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.
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.
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 re-
validated 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.
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.
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 non-
conforming 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.
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 non-
conformities (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 non-
conformities 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.
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
EXHIBIT
Exhibit A: Cross-reference between the sections of this document and

ISO9001: 2000 clauses
Section Description ISO 9001: 2000 Clause

7.1 General Requirements 4.1 + 4.2.2
7.2 Documentation Requirements 4.2
7.3 Quality Records 4.2.4
7.4 Quality Planning 5.4.2 + 7.1
7.5 Responsibility, Authority and Communication 5.5.1 + 5.5.2
7.6 Management Review 5.6.1 + 8.5.1
7.7 Provision of Resources 6.1 + 6.2.1
7.8 Human Resources 6.2
7.9 Planning of Product Realization 7.1
7.10 Contract Review 5.2 + 7.2
7.11 Design and Development 7.2.1 + 7.3
7.12 Product Reliability System 7.3.5 + 7.3.6
7.13 Purchasing/Supplier Quality 7.4
7.14 Process Control 6.3 + 6.4 + 7.5.1 + 7.5.2
7.15 Inspection and Test 7.1 + 7.4.3 +7.5.3 + 8.1 + 8.2.4
7.16 Servicing 7.5.1
7.17 Product Identification, Traceability, and Status 7.5.3
7.18 Customer Property 7.5.4
7.19 Handling, Storage, Packaging, Preservation, and Delivery 7.5.1 + 7.5.5
7.20 Control of Monitoring and Measuring Devices 7.6
7.2.1 Monitoring and Measurement 8.1 + 8.2
7.22 Internal Quality Audit 8.2.2 + 8.2.3
7.23 Control of Nonconforming Material 8.3
7.24 Analysis of Data 8.4
7.25 Corrective and Preventive Actions 8.5.2 + 8.5.3

Quality Manual

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Quality Manual

Uploaded by

Copyright:

Available Formats

Quality Management System

Management Quality System

Copyright by Rockwell Automation February 2007

Rockwell Automation is committed

3.0 ROLES AND RESPONSIBLITY

7.2 Documentation Requirements

7.3 Quality Records

7.4 Quality Planning

7.5 Responsibility, Authority and Communication

7.6 Management Review

7.7 Provision of Resources

7.8 Human Resources

7.10 Contract Review

7.11 Design and Development

7.12 Product Reliability System

7.13 Purchasing/ Supplier Quality

7.14 Process Control

7.15 Inspection and Test

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

7.20 Control of Monitoring and Measuring Devices

7.21 Monitoring and Measurement

7.22 Internal Quality Audit

7.23 Control of Nonconforming Material

7.25 Corrective and Preventive Actions

3.0 ROLES AND RESPONSIBLITY

3.1 RA Vice-President Continuous Improvement

3.2 RA Manager of Quality Management Programs and Conformance

3.3 RA Business Units

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

6.5 Corrective Actions

6.6 Customer Property

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

6.10 Management Representative

Is the assigned quality representative appointed by Business Unit Management.

6.11 Management Review

Data supporting existence or verification of something.

6.13 Preventive Actions

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

6.16 Product Realization

6.17 Product Reliability

6.18 Quality Documentation

6.19 Quality Management System (QMS)

6.20 Quality Objective

6.21 Quality Records

Type of action to satisfy employees competency needs.

7.1 General Requirements

7.2 Documentation Requirements

RA RA Quality Policy 900-20-01

Work Instructions Level 3

Quality Records Level 4

Figure 1: RA Quality Management System (QMS) Structure.

Documents will be reviewed, updated as necessary, and approved for adequacy by

RA Business Units may submit to HQ Quality a request for an exemption or modification

7.2.2 RA HQ Quality Document Owner