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EASA-Q:2000 QUALITY MANUAL

TABLE OF CONTENTS
Introduction
Preamble
Scope
Developing Your Quality Manual
Generic EASA-Q:2000 Quality Manual
APPENDIX
EASA-Q:2000 Guidelines for Compiling Documentation
A-01:

Documentation

A-02:

Clause 5 Management Responsibility

A-03:

Clause 6 Resource Management

A-04:

Clause 7 Product Realization

A-05:

Clause 8 Measurement, Analysis and Improvement

A-06: Generic examples for the six mandatory documented procedures required by
ISO 9001:2000
A-07: Cross reference guide ISO 9001:1994 to ISO 9001:2000
A-08: Samples of useful documentation for use in your quality management system
A-09: Reference Standards
A-10: Repair, Test, and Inspection Plan for AC Squirrel Cage Motors
A-11: Repair, Test, and Inspection Plan for DC Motors
A-12: Sample Process Control Procedures

EASA-Q:2000 QUALITY MANUAL

Introduction
ISO 9000:2000 and EASA-Q
EASA-Q was designed around the 1994 version of ISO 9002. The 1994 ISO 9000 series Quality
Management Standards are now replaced by a considerably revised set of ISO 9000 standards.
Because of the significant changes, it is the authors recommendation that EASA-Q be completely
overhauled in order to remain compatible with the proposed new standards, and also to reflect
changes in evaluating quality since EASA-Q was launched.
The EASA-Q manual is a guide to developing a quality system based on currently applicable ISO
standards. It follows, therefore, that the EASA-Q guidelines should accurately reflect the new
standard requirements.
By way of introduction to this revised edition of EASA-Q, the following overview of the
International Organization for Standardization's ISO 9000 system is provided.
The revision and replacing of the current ISO 9000 standards issued in 1994 is a natural process
and part of the mandate of the ISO 9000 committee TC176 to review and revise where necessary
for continuing compatibility to user and commercial needs. This review process occurs
approximately every five years. The revision process is governed by:
The evolution of the needs of customers and organizations.
Quality management concepts and practices.
The deliverables of standardization and conformity assessment.
The revised edition of the standards is identified by the suffix 2000, i.e., ISO 9000:2000.
In place of the twenty requirement clauses contained in Section 4.0 (4.1 to 4.20) of the ISO
9001:1994 standard, the new standard comprises a total of eight sections.
The headings for each of these sections is as follows:
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
A key development will be a considerable reduction in the total number of standards. One of the
goals of the revisions is to consolidate information currently spread across 25 standards and
guidelines into a simpler structure of three new standards.
ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary (Revision
of ISO 8402:1994 and ISO 9000-1:1994)
ISO 9001:2000 Quality Management Systems - Requirements (Revision of ISO
9001:1994, ISO 9002:1994 and ISO 9003:1994)
ISO 9004:2000 Quality Management Systems - Guidelines for Performance
Improvements (Revision of ISO 9004-1:1994, ISO 9004-2:1994; ISO 9004-3:1993; ISO
9004-4:1993 and ISO 9004-4:1993/Co.1:1994)
The revised version of EASA-Q is based on the requirements set out in ISO 9001:2000 and
addresses Sections 4 (Quality System) through 8 (Measurement, Analysis and Improvement).
Brian C. Merritt
QCS International

EASA-Q:2000 QUALITY MANUAL

Preamble
The revised ISO 9000 standards are significantly different in structure to the ISO 9000:1994
edition and therefore this edition of EASA-Q:2000 is significantly different in layout.
The new guide is noticeably slimmer in volume than the last EASA-Q manual. This is mainly due
to the replacement of twenty documented procedures by six documented procedures in the new
ISO 9001:2000 upon which this guide is based. Despite the reduced volume of required
documentation, the scope of requirements of the new standard is in fact much broader.
For those who have a documented quality system based upon the EASA-Q/ISO 9002:1994
manual there is a matrix in Appendix A-07 indicating which parts of your quality documentation that
you may apply to the new requirements. Comprehensive guidelines are provided to help you
modify such documentation where appropriate, or to create documentation for those starting from
scratch.
Previous revisions to the ISO 9000 quality management system (QMS) standards have been
evolutionary insofar that the focus and structure of the documentation has remained essentially
the same for each edition.
ISO 9000:2000 represents a revolutionary change insofar that its focus is now on:
the business processes and
the measurement of those processes.
The new format is also designed to remove the perception of manufacturing bias from the
standard. This is intended to make it more compatible to non-manufacturing and non-technical
service businesses.
For the first time, there is a requirement for customer satisfaction measurement
(Section 8.2.1 of the new standard).
Because EASA-Q is now based on ISO 9001:2000, the generic quality manual is set up to address
each clause of the new standard and these are identified accordingly.
The first three requirements for the International Quality Management Standard ISO 9001:2000
are presented as follows:
1. Scope (of the actual ISO 9001:2000 standard)
2. Normative References
3. Terms and definitions
These are presented here to illustrate the strong focus on customer satisfaction and process
management of the revised standard as opposed to the focus on confidence in product
conformance and supplier capabilities contained in the ISO 9001:1994 version.
1.
1.1

Scope
General
ISO 9001:2000 specifies the requirements for a quality management system where an
organization needs:
a) To demonstrate its ability to provide consistent product that meets customer and
regulatory requirements.
b) To address customer satisfaction through the effective application of the system,
including processes for continual improvement and prevention of nonconformity.
NOTE: Monitoring of customer satisfaction as stated in (b) requires the evaluation of information
relating to customer perceptions of whether or not the organization has met the customer
requirements.

EASA-Q:2000 QUALITY MANUAL


1.2

Permissible Exclusions
The organization may only exclude quality management system requirements that neither
affect the organization's ability, nor absolve it from its responsibility, to provide product that
meets customer and applicable regulatory requirements. These exclusions are limited to
those requirements within Section 7 (Product Realization) and explained in Sub-clause
5.5.5 (Quality Manual) of the International Standard. Exclusions may be due to the
following:
a) The nature of the organization's product.
b) Customer requirements.
c) Applicable regulatory requirements.

2.

Normative Reference
ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary replaces
ISO 8402:1994 Quality Management and Quality Assurance - Vocabulary.

3.

Terms and Definitions


For the purposes of this International Standard, the terms and definitions given in
ISO 9000:2000 apply. The following terms, used to describe the supply chain, have been
changed to reflect the vocabulary currently used:
Supplier

Organization

Customer

Note 1. The term organization replaces the term supplier used in ISO 9001:1994, and
refers to the unit to which this International Standard applies. Also, the term supplier now
replaces the term subcontractor.
Note 2. Throughout the text of the International Standard, wherever the term product
occurs, it can also mean service.
4.
4.1

Quality Management System


General Requirements:
The management of an organization must define and manage the PROCESSES
necessary to ensure product and/or service conforms to customer requirements. A quality
system must be established as a means of implementing and demonstrating defined
processes.
General documentation requirements:
A documented quality management system supports the defined processes. System
procedures must be established. These will be based on the complexity of methods, skills
and training involved in performing the work. These procedures must be specific and
unique to organizational needs and objectives.
Note 1. Where the term documented procedure appears within the standard, this means
a formal, documented and controlled document is required.
Note 2. Documentation can be in any form or type of medium, e.g., flowcharts, drawings,
pictograms, hard or electronic data.

4.2.1

Documentation must include:


a) A Quality Policy and quality objectives.
b) A Quality Manual.
c) Procedures required by the International Standard 9001:2000.
d) Necessary documents for: planning, operations and control of the organization's
processes.
e) Records.

EASA-Q:2000 QUALITY MANUAL

4.2.2

Quality Manual
Organizations must have a quality manual that includes a description of the quality
management system and identification of or reference to procedures. In addition, a
description of the sequence and interaction of the processes is to be included.

4.2.3

Control of Documents
Requirements for documents and data control have changed very little with several
exceptions. Document control procedures must now define a mechanism for the periodic
review and revision of documents. Also, there are now more specific requirements for
legibility, identification and revision control for quality system documentation.

4.2.4

Control of Quality Records


The requirements for control of quality records have been simplified.

Sections 4 through 8 form the actual requirements for compliance to ISO 9001:2000.
These are reflected in this new version of EASA-Q:2000 where they are presented as
example templates addressing each of the requirements of the International Standard ISO
9001:2000.
At the end of each section document there are Document references. The term SOP is
the acronym for Standard Operating Procedure. Examples of operating procedures are
provided in the EASA-Q appendices. It is at this SOP documentation level that some of the
documented procedures contained in the old version of the EASA-Q manual can be utilized.
A cross reference matrix is provided to assist you with this (see Appendix A-07). However,
any procedure documents considered for use in this manner must be carefully reviewed for
adequacy to the new requirements.
There are a total of six documented procedures that are essential for compliance to
ISO 9001:2000. These are indicated in the EASA-Q manual requirements by an asterisk (*). The
actual descriptions and ISO 9001:2000 clause references are provided below:
Activity description
Control of documents
Control of quality records
Internal audit
Control of nonconformity
Corrective action
Preventive action

ISO 9001:2000 reference


4.2.3
4.2.4
8.2.2
8.3
8.5.2
8.5.3

Guidelines for compiling your quality documentation are contained in Appendices A-01 to A-05.
Appendix A-06 contains examples of the six mandatory documented procedures required for
compliance to ISO 9001:2000.
Appendix A-07 contains a cross reference table to identify which of the ISO 9001:1994 clauses
might be used to meet the ISO 9001:2000 requirements.
Appendix A-08 contains a selection of document formats that may help in setting up your quality
management system. The selection is based upon feedback from an EASA-Q user survey
conducted in 1999.

EASA-Q:2000 QUALITY MANUAL

Developing Your Quality Manual


Quality system documents should be designed with the following characteristics in mind:

They should be simple, concise and clearly written.


Where appropriate, they should truly reflect the way things are done.
They should be free of excessive detail.
They should fully address the quality systems requirements.

The Quality Manual


The general policies and procedures addressing the requirements of the quality system are
contained in a Quality Manual. All other quality system documents can be referenced by this
manuals contents. Small businesses such as repair centers can include these additional
documents in the manual. It is not essential, however, to have all quality system documents in
one manual.
The first four pages of your manual should address the following:
1. A Distribution List which identifies all function positions who are authorized to receive
and maintain their controlled copy of the quality manual.
2. An Index and Revision Status Record. This must be updated regularly as the manual
content is revised.
3. An Introduction which briefly describes the purpose and content of the manual. This
may also include a brief profile of your Companys history, size and product range.
4. The Organizations Quality Policy. This is a formal policy document which addresses
the Objectives and Commitment of your organization and should be signed by the
companys executive management.
Examples are provided.
Note: The quality manual can be composed entirely as electronically stored data providing
adequate control systems are in place to meet the standard's requirements.
Procedures
There are no specific rules for the style and layout of procedures, but they should include or
address the following elements as may be required:
Purpose and Scope
Responsibilities
Reference to, or a description of, procedures to meet the relevant policy statement.
Definitions (if acronyms or technical terms are used, or if differing categories are
involved).
Date of issue and revision status
Approval authority
Page number
References to related procedures. Note that reference is made only to the same or next
level of document throughout the document system. For example, quality policy
procedures may refer to other policy procedures (sometimes called Standard Operating
Procedures), Work Instructions or Operating Procedures.
The following templates are provided to illustrate the minimum, simplest format for quality
manual documentation design. They are identified identically to each of the clauses of the
ISO 9001:2000 Quality Management Standard. Examples of a manual lead page or cover and
the first four pages as described above are included.

EASA-Q:2000 QUALITY MANUAL


While all of the requirements of ISO 9001:2000 are addressed in this manual template,
exceptions are allowed under the conditions set out under Clause 1.2 of the Scope of the
Standard.

XYZ Company Quality Manual


Page x of y
Revision 00

Generic EASA-Q:2000 Quality Manual


A typical cover or lead page for your quality manual

Quality Manual
For
XYZ Inc.
000 Any Avenue
Anytown, Anywhere
Tel:xxxxxxx
Fx:xxxxxxx
EASA-Q:2000 Quality Manual
Based on ISO 9001:2000

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DISTRIBUTION
MANUAL HOLDER

MANUAL NUMBER

President

001

V.P. Marketing

002

Management Representative

003

Engineering Manager

004

Service Manager

005

Human Resources Manager

006

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Index and Revision Status Record
Ref.

4.0
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
5.0
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
5.6
5.6.2
5.6.3
6.0
6.1
6.2
6.2.1
6.2.2
6.3
6.4
7.0
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7

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Title
Distribution
Content Revision Status Record
Introduction
Quality policy
Quality management system
General requirements
Documentation requirements
General
Quality manual
Control of documents
Control of quality records
Management responsibility
Management commitment
Customer focus
Quality policy
Planning
Quality objectives
Quality management system planning
Responsibility, authority and communication
Responsibility and authority
Management representative
Internal communication
Management review
Review input
Review output
Resource management
Provision of resources
Human resources
General
Competence, awareness and training
Infrastructure
Work environment
Product realization
Planning of product realization
Customer related processes
Determination of product related requirements
Review of product related requirements
Customer communication
Design and development
Design and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes

Original issue date


Approved by:
Mgmt. Rep.

Revision
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n/a
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7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6
8.0
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3

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Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control of production and service provision
Validation of processes for production and service
provision
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring devices
Measurement, analysis and improvement
General
Monitoring and measurement
Customer satisfaction
Internal audit
Monitoring and measurement of processes
Monitoring and measurement of product
Control of nonconforming product
Analysis of data
Improvement
Continual improvement
Corrective action
Preventive action

Original issue date


Approved by:
Mgmt. Rep.

Revision date

00
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XYZ Company Quality Manual


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ORGANIZATION DESCRIPTION
XYZ Inc. has been in business since 19__ and currently operates from a __,000 sq. ft. plant and
corporate headquarters in Anytown, Anywhere.
A workforce of ____ employees provides a sales and full service facility for a range of electromechanical equipment and rotating machinery.
XYZ Inc. has developed and implemented a quality management system to better meet the
needs and expectations of its customers and to improve operational effectiveness. This quality
system complies with the international standard ISO 9001:2000.
The purpose of this manual is to define and describe the quality system, to define authorities and
responsibilities for the management of the system and reference general procedures for all
activities covered by the quality system.
President______________________________________

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4.

4.1

QUALITY MANAGEMENT SYSTEM


Distribution
President
V.P. Sales & Marketing
V.P. Finance
Plant Manager
Executive Assistant
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

General
(The organization) has established a quality management system that is documented,
implemented and maintained. The system is based upon the International Quality
Management Standard ISO 9001:2000. The system comprises:
The identification of the processes needed for the quality system and its
application throughout the organization.
A description of the sequence and interaction of these processes.
A description of the criteria and methods used to ensure that both operation and
control of these processes are effective.
A commitment to provide resources and information needed to ensure the
system's continuing suitability and effectiveness.
Methods to monitor, measure and analyze these processes.
Defined authorities and responsibilities to allow actions necessary to achieve
planned results and continual improvement of these processes.

4.2 Documentation
4.2.1 Content
The quality management system includes:
A documented quality policy and quality objectives.
Documented procedures required by the International Standard ISO 9001:2000.
Documents required by the organization to ensure the effective planning,
operation and control of its processes.
Quality records.
4.2.2 Quality Manual
The quality manual is a controlled document describing:
The scope of the quality management system.
The documented procedures necessary for the effective application of the quality
system.
Descriptions of the processes, their sequence and interaction used within the
organization.
4.2.3

Control of Documents
All documents used by the quality system are controlled. The control procedure defines:
Approval requirements prior to issue.
Methods used to review and update controlled documents as necessary
including re-approval where appropriate.
Identification of changes and current revision status.
Methods to ensure that relevant versions of documents are available at point of
use.
Identification and legibility requirements of documents.
Identification of externally provided documents and their control.
Methods to remove obsolete documents and, where stored for reference,
identified as to their intended use.

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4.2.4

Control of Quality Records


Quality records are maintained to provide evidence of conformity to requirements and to
verify the effectiveness of the quality system. The control procedure for this includes:
Requirements for legibility.
A system for clear identification and effective retrieval.

Document references
SOP QS 3.0 Control of documents (See Appendix A-06)
SOP QS 4.0 Control of quality records (See Appendix A-06)
Document end

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5.

MANAGEMENT RESPONSIBILITY
Distribution
President
V.P. Sales & Marketing
V.P. Finance
Plant Manager
Executive Assistant
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

General
(Organization's name) is committed to consistently provide products and services that
meet or exceed customer and applicable regulatory requirements and to enhance
customer satisfaction by conforming to the requirements of EASA-Q:2000. This quality
system is based on the International Quality Management Standard ISO 9001:2000.
Scope and Exclusions
Scope
This quality management system applies to all products and service processes
conducted at the following locations.
(Provide location addresses of headquarters and branch operations as applicable.)
Exclusions
The following ISO 9001:2000 requirements are excluded. These are not considered to
affect the organization's ability or responsibility to provide products and/or services that
fulfill customer and applicable regulatory requirements. The exclusions are identified by
their ISO 9001:2000 clause reference:
(Identify relevant ISO 9001:2000 clause and/or sub-clause references.)
5.1

Management Commitment
Management shall ensure that:
The importance of meeting customer, statutory and regulatory requirements is
effectively communicated to all members of the organization using the most
appropriate media.
The quality policy is established with quality objectives identified appropriate to
the organization's operations and perceived customer expectations.
Reviews of the quality system are conducted at scheduled intervals and the
results of reviews are recorded.
Management is committed to providing all resources necessary to maintain the
quality system, continually improve its effectiveness and suitability for meeting
the objectives of the organization.

5.2

Customer Focus
Customer requirements are determined and fulfilled to the complete satisfaction of the
customer.

5.3

Quality Policy
(The organization)'s policy is to meet or exceed customer requirements in a timely and
cost effective manner. To achieve this (the organization) will:
Meet the requirements of EASA-Q:2000.
Seek continual improvement in product and service quality.
Set quality objectives that are based on internal and external feedback and
review these for continuing suitability at regular intervals.
Maintain the highest levels of integrity in all relationships with customers and
suppliers.
Respect environmental and social interfaces with the local community.

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Ensure that all stakeholders are fully conversant with this policy and completely
understand their respective roles in upholding it.

This policy is communicated to all interested parties including customers, employees,


shareholders, suppliers and local communities affected by the organization.
5.4
5.4.1

Planning
Quality Objectives
Quality objectives are established for each department and/or function within the
organization. The objectives are developed from results of management reviews,
product and/or process performance results, and feedback from interested
parties.
The objectives are measurable and consistent with the organization's quality
policy.
Each department and/or function determines these objectives, their measurable
characteristics and the frequency of measurement.
The objectives are reviewed at regular intervals and the results recorded.
The objectives are revised when appropriate to meet continual improvement
requirements.
Quality objectives are communicated to all persons with defined responsibility
and translated into their individual and group activity contributions.

5.4.2

Quality Management System Planning


The organization' s processes, their sequence and interaction are determined,
and critical stages identified. Criteria and methods required to ensure effective
control are established. Appropriate measurement, monitoring and analytical
tools are provided to achieve planned results and continual improvement.
Changes to the quality system are controlled through regular reviews and
contingency planning designed to maintain the system's integrity.

5.5
5.5.1

Responsibility, Authority and Communication


Responsibility and Authority
Management defines responsibilities, authorities and their interrelation with an
organization chart and detailed job descriptions for all persons in the organization. This
information is communicated to all persons within the organization and interested parties
where appropriate.

5.5.2

Management Representative
The (Function title) has been appointed as Management representative with the following
responsibilities and authorities:
Control of the quality system to ensure that the system's requirements are
established, implemented and maintained.
Reporting to executive management on the performance of the quality system
and any need for improvement.
Promotion of awareness of customer requirements throughout the organization.
Liaison with external parties on matters relating to the quality system.

5.5.3

Internal Communication
Effective communication is maintained throughout the organization regarding the
effectiveness of the quality system.

5.6 Management Review


5.6.1 General
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Management reviews the quality system at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness. The reviews are performed according to
documented procedures and the results considered quality records and controlled
accordingly.
5.6.2

Review Input
Input to management reviews include:
Audit results.
Customer feedback.
Process records.
Corrective and preventive action records.
Records of prior reviews.
Changes that may affect the system.
Recommendations for improvement from all sources.

5.6.3

Review Output
Outputs will comprise:
Actions and decisions to improve the quality management system and business
processes.
Product improvement decisions.
Identified additional resource requirements.

Document references
SOP MR 5.0 Objectives
SOP MR 6.0 Planning
SOP MR 7.0 Responsibilities, authorities and communication
SOP MR 9.0 Management Review

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6.0

RESOURCE MANAGEMENT
Distribution
President
V.P. Finance
Executive Assistant

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

6.1

Provision of Resources
The resources needed to implement and maintain the quality system, continually improve
its effectiveness, and enhance customer satisfaction are provided by management.

6.2
6.2.1

Human Resources
General
All persons performing work affecting product and/or service quality are competent in
skills, education and experience. This is ensured through a comprehensive selection and
training process applied throughout the organization.

6.2.2

Competence, Awareness and Training


The organization provides:
Customized training where deemed necessary for product and/or service quality
assurance and customer satisfaction.
Competence assessment following training or retraining applications.
Awareness of relevance and consequences of activities and their contribution to
meeting the organization's quality objectives.
Records of all training, skills and experience that are available to employees,
management and, where appropriate, interested parties affected by the quality
system.

6.3

Infrastructure
Management is committed to the provision of:
Buildings, work areas and associated utilities.
Process and measuring/monitoring equipment.
Communication and transportation services to ensure effective workflow and
product and/or service conformity to requirements.

6.4.1

Work Environment
Workflow is organized for optimum performance and conformance to product
requirements.

Document references
SOP RM 2.0 Job descriptions
SOP RM 3.0 Training
SOP RM 4.0 Buildings and equipment maintenance

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7.

7.1

PRODUCT REALIZATION
Distribution
President
V.P. Finance
Executive Assistant

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

Planning of Product Realization


The organization has identified the processes necessary to realize products and/or
services that satisfy the requirements of customers and other interested parties. These
processes and combinations thereof are planned with the following elements
incorporated as appropriate:
The quality objectives and requirements of the product and/or service.
The processes, documentation and resources specifically required for each
product and/or service category.
The required verification, validation, monitoring, inspection and/or test activities
specific to the product and/or service including the criteria for acceptance.
The appropriate elements are documented as quality plans and take the form of either:
Hard copy documentation (work orders; sales orders; drawings).
Electronically processed documentation (disk/diskette; CD; tape).

7.2 Customer Related Processes


7.2.1 Determination of Product Related Requirements
In order to determine product related requirements, the following information is
considered:
Customer defined requirements including delivery and post delivery activities.
Requirements that are not stated but may be essential to specified product
application.
Statutory and/or regulatory requirements related to a product and/or service.
Any unique requirements as may be determined outside of the foregoing.
The organization's ability to meet these requirements.
7.2.2

Review of Product Related Requirements


A review of contractual information (contract review) is performed for all customer
inquiries prior to submission of tenders, quotations, acceptance of orders or changes to
contracts.
Note 1. Where the customer does not provide documented statements of requirements
but relies on verbal communication, drawings or samples, the requirements are
documented and confirmed prior to acceptance.
Note 2. Where differences occur between stated requirements and the organization's
capability to meet those requirements, such differences are resolved prior to acceptance
of the order. Results of the reviews are recorded and maintained as quality records and
controlled accordingly.

7.2.3

Customer Communication
Product information and/or changes to orders are effectively communicated to customers.
Customer feedback, including complaints, are recorded for Management Review input.

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7.3 Design and Development
7.3.1 Design and Development Planning
The following activities are conducted by those responsible for the activities involved in
the design and development process.
An evaluation of the organization's design and development ability to fulfill
requirements, and identification of any problem(s) and their resolution.
The necessary design and development stages are determined.
The review, verification and validation appropriate to each stage is determined.
The responsibilities and authorities for the design and development are allocated.
The resulting plans are updated as appropriate as the work progresses.
7.3.2

Design and Development Inputs


The following inputs are determined and recorded in a clear and unambiguous format:
Function and performance requirements.
Applicable statutory and regulatory requirements for the product.
Previous design information.

7.3.3

Design and Development Outputs


Design and development outputs are formatted to enable verification against design and
development inputs and are approved by (an authorized person) before release. Design
and development outputs meet the following criteria:
Meet input requirements.
Provide adequate and appropriate information for purchasing, production and
service provisions.
Include reference and/or acceptance criteria where applicable.
Specify adequate safety and operating instruction for correct product use.

7.3.4

Design and Development Review


Review includes:
An evaluation of the results of design and development for the ability to fulfill
requirements.
The identification of any problems and their resolution.
Reviews are conducted by those responsible* for the activities involved in the design and
development process.
*The person(s) or function(s) title(s) may be inserted here
The results of reviews and any necessary actions are recorded as quality records and
controlled accordingly.

7.3.5

Design and Development Verification


A verification of the design and development is performed to establish if the product
and/or service meets:
The stated functional and performance requirements.
Applicable regulatory and/or statutory requirements.

7.3.6

Design and Development Validation


The validation of designed and developed products and/or services are planned where
such activities are deemed appropriate. The results of these activities are recorded and
controlled as quality records. Where practicable, validation is completed prior to delivery
of the product or implementation of the service.

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7.3.7

Control of Design and Development Changes


Any changes to original design or development characteristics are identified, reviewed
and recorded. An impact evaluation of the changes on other components and the final
product performance is included in the review. Where appropriate, the results of changes
and any actions arising as a consequence of the changes are recorded and
communicated to interested parties. (Examples of this are service bulletins, product recall
notices, etc.)

7.4 Purchasing
7.4.1 Purchasing Process
(The organization) ensures that all purchased products and services meet the
requirements specified on the purchase order and supporting documentation. The degree
to which these controls are applied is dependent upon the effect of the purchased product
or service on final product realization. Procurement is only authorized from approved
suppliers. Special authorization is required for procurement from other sources or to
substitute for originally specified products.
(The organization) evaluates its suppliers and purchases only from those that can meet
the organization's quality requirements. Quality performance of suppliers is continuously
monitored and performance data maintained as quality records. Appropriate criteria is
established for selection, evaluation and re-evaluation of suppliers and supplied products
and/or services.
7.4.6

Purchasing Information
Purchasing documentation completely describes the product and/or service requested.
This information includes where appropriate:
Dimensional measurement, type, model, serial number or drawing reference(s).
Application in final product realization or intended use.
Requirements for approval of product, procedures, processes and equipment.
Required qualification of personnel involved in the supply process.
Quality system requirements.
Required compliance to applicable regulatory requirements.
Agreed price.
Delivery requirements.
Notification of intent to verify at supplier's location.
Where appropriate, the adequacy of the specified purchased product and/or service is
evaluated prior to placing the order.
Purchase orders are approved by (enter title or function) prior to release to a supplier.

7.4.3

Verification of Purchased Product


All purchased product is subject to inspection upon receipt. The scope of receiving
inspection is appropriate to the complexity and/or nature of the purchased product and
criticality to final product realization.
When it is determined that verification of supplier's capabilities to provide a product is to
be conducted at the supplier location, this information is contained in the purchase
document information.

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7.5 Production and Service Provision
7.5.1 Control
Manufacturing and/or the provision of service is planned and controlled. Input to the
process includes, but is not limited to:
Description of the product or service.
The availability and need for work instructions.
Availability of suitable equipment and work environment.
The need and application of measuring and monitoring equipment.
The scope and application of release, delivery and post delivery activities.
7.5.2

Validation of Processes for Production and Service Provision


Where outputs of the processes cannot be verified by subsequent measurement,
validation demonstrates the ability to achieve the planned results. Inputs to the validation
process include as appropriate:
Defined criteria for review and approval of the process.
Approval of equipment and personnel qualification.
Specific methods and/or procedures.
Records.
Re-validation need.

7.5.3

Identification and Traceability


Product or service identification is by means of unique service order number allocation.
The status of the product or service with respect to monitoring or measurement is
recorded on the service order or accompanying documents. These documents bear the
same unique number as the original service order. The service order number is used
where traceability of the product is required.

7.5.4

Customer Property
Any product, material or document owned by a customer, while under (the organization's)
control, is identified and protected. Any loss, damage or other reason to render the
customer owned item unsuitable for use by (the organization) is reported to the customer
and recorded.

7.5.5

Preservation of Product
Product integrity is preserved using appropriate methods. These include:
Identification
Handling
Packaging
Storage
Protection

7.6 Control of Measuring and Monitoring Equipment


Where evidence of product conformity requires the application of measuring and/or
monitoring equipment, this equipment is controlled to ensure valid results. The control
includes:
Calibration or verification at specified intervals, or prior to use, against
measurement standards that are traceable to international or national standards;
where no standards exist, the basis used for the calibration is recorded.
Adjustment or re-adjustment as required.
Unique identification of each item of equipment to establish calibration status.
Protection from unauthorized adjustment.
Protection from damage and deterioration during use and while in storage.
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Document references
SOP PR 2.0 Contract review
SOP PR 3.0 Design and development
SOP PR 4.0 Purchasing
SOP PR 5.0 Supplier assessment
SOP PR 7.0 Verification of purchased product
SOP PR 8.0 Production and service provision
SOP PR 9.0 Identification and traceability
SOP PR 10.0 Customer owned property
SOP PR 11.0 Preservation of product
SOP PR 12.0 Control of measuring and monitoring equipment

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8.

MEASUREMENT, ANALYSIS AND IMPROVEMENT


Distribution
President
V.P. Sales & Marketing
V.P. Finance
Plant Manager
Executive Assistant
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

8.1

General
Monitoring, measurement, analysis and improvement processes are planned to:
Demonstrate the conformity of the product or services.
Ensure conformity of the quality system.
Continually improve the effectiveness of the quality system.
Determine applicable methods, including statistical techniques, and the extent to
which they are applied.

8.2
8.2.1

Monitoring and Measurement


Customer Satisfaction
Customer satisfaction is monitored in the following categories:
External customers (recipients and/or end users of the organization's products
and/or services).
Internal customers (persons with defined activities affecting the quality system
directly employed by the organization).

8.2.2

Internal Audit
Internal audits are conducted at planned intervals to determine the effectiveness and
continuing suitability of the quality system. The audits are conducted with the following
characteristics:
Consideration for the status and importance of the areas and processes to be
audited.
Criteria, scope, frequency and methods to be used are defined and planned.
Auditors are adequately trained and do not audit their own activities.
Auditors are selected to ensure objectivity and impartiality of the audit process.

8.2.3

Monitoring of Processes
Appropriate methods, equipment and trained personnel are selected to ensure that
processes are monitored to ensure that planned results are achieved and maintained.
Where planned results are not achieved, appropriate corrective action is initiated.

8.2.4

Monitoring of Product
Products are not released until:
Key characteristics have been verified.
Records indicate authorized release.
Planned results are achieved unless specifically authorized in writing by a
customer.

8.3

Control of Nonconforming Product


Products that are found to not conform to requirements are identified, controlled and
recorded as a nonconforming item to prevent further processing and/or delivery. The
controls include, but are not limited to:
Action to eliminate the detected nonconformity.
Action to preclude the original intended use or application.

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Authorizing use, release or acceptance under concession by a defined authority,


and where appropriate, by the customer.
Re-verification of conformity following corrective action.

The nature of the nonconformity and corrective action(s) taken, including any
concessions, is recorded and maintained as a quality record.
8.4

Analysis of Data
Appropriate data is defined, collected and analyzed to ensure the effectiveness of the
quality system. This data comprises input from:
Customer satisfaction records.
Nonconformance records.
Trend analysis of processes.
Supplier performance records.

8.5 Improvement
8.5.1 Continual Improvement
The continual improvement of the effectiveness of the quality system is established
through the following activities:
Review of the quality policy and quality objectives.
Review of internal and external audit records.
Data analysis from sources identified in Clause 2.0 of this document.
Review of corrective and preventive action records.
Evaluation of employee suggestions.
Evaluation of customer needs and expectations.
8.5.2

Corrective Action
To prevent repetition of nonconformance, corrective actions are defined, developed and
applied. The corrective action taken is appropriate to the effect of the nonconformity to
which it applies. The procedure for corrective action includes:
Establishing the root cause of the nonconformity.
Determining the action necessary to correct the nonconformity.
Recording the action taken.
Reviewing the effectiveness of the action taken.

8.5.3

Preventive Action
Potential problems are identified and their occurrence prevented by acting pro-actively.
The procedure for preventive action includes:
Determining the root cause of potential nonconformity.
Developing preventive action plans.
Recording the result of actions taken.
Evaluation of the effectiveness of the preventive action taken.
Document references
SOP MA 2.0 Customer satisfaction monitoring
SOP MA 3.0 Internal auditing* (See Appendix A-06)
SOP MA 4.0 Monitoring of processes and product
SOP MA 5.0 Control of nonconforming product* (See Appendix A-06)
SOP MA 6.0 Analysis of data
SOP MA 7.0 Continual improvement
SOP MA 8.0 Corrective action* (See Appendix A-06)

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SOP MA 9.0 Preventive action* (See Appendix A-06)
NOTE: Documents identified with an asterisk (*) are required procedures for ISO
9001:2000.

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EASA-Q:2000 Guidelines for Compiling Documentation


APPENDIX A-01
This guideline is applicable to the templates contained in the generic EASA-Q:200 Quality
Manual.
General
While EASA-Q is prepared for application to typical activities of EASA member operations, many
users will note that the clause identification system adopted is that of ISO 9001:2000. This is to
facilitate an easy transition for members who wish to pursue full ISO 9001:2000 registration
beyond the EASA-Q assessment stage.
Distribution Header on Documents
Most organizations have some form of distribution list for 'who gets what information.' The quality
system documentation is part of that information package. Obviously some people will need
certain documentation to perform their work (i.e., instructions, drawings etc.) while others may
need the entire quality manual as a reference.
In order that the right documents are made available to the appropriate persons, it is handy to
have each document contain a list of recipients. In order to facilitate this where appropriate, the
EASA-Q manual templates contain a table where these recipients can be listed.
The distribution header for each requirement section template contains typical function positions
that may exist in an organization:

President
V.P. Finance
Executive Assistant

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

V.P. Engineering
Service Manager
Chief Inspector

Never lose sight of the fact that your organization's quality manual must reflect what is
appropriate to your organization. Therefore only the functions in your organization that actually
need the relevant document should appear in this distribution list. The table is optional and
provided only as a suggested format.
You should insert appropriate function titles according to the needs of your organization. You do
not have to fill every cell in the header; you can add more if required and they don't need to be
the same for all sections.
Organization
Wherever you see the term Organization in a template you must replace it with the registered
name of your business.
Page and Revision Identification
Each page should be numbered. How you number them is up to the individual organization. The
template uses the format X of Y only as an example. Each section document set should have its
own number sequence. For example:
The Quality System comprises 'page 1 of 1.'
Management Responsibility comprises pages 1, 2, 3 of 3.
The reason the template pages are not numbered is simply that the compilation of your
organization's manual may result in more or fewer pages per section.
Revision identification is a requirement of document control and is indeed essential in order to
maintain control. The templates provide this information in the header block. The footer block
supports the revision number with a date of revision. The original issue date contained in the
footer block is not an essential requirement, but can prove to be handy for reference purposes.

EASA-Q:2000 Guidelines for Compiling Documentation


Both page numbering and revision identification must be described adequately in the procedure
ref. SOP QS 3.0 Control of Documents or the appropriate document in your organization's
quality system.
Document References
SOP is the acronym for Standard Operating Procedure. It is used in EASA-Q:2000 to refer to
the documented procedures necessary for compliance and also to any other documented
procedure deemed necessary for the effective application and operation of your quality system.
If you already have documented procedures that are known and accepted in your organization by
some other title or description, you can replace the SOP references with your own identifiers.
However, care must be taken that the content of those procedures required by ISO 9001:2000
fully meet the requirements identified in the ISO 9001:2000 International Standard (the six are
identified in the preamble section of EASA-Q:2000).
All SOP category documents fall within the document control requirements of EASA-Q:2000 and
ISO 9001:2000.
With the advent of the computer, it is no longer considered essential to create a hard copy of
documentation requirements. Some organizations have their complete quality system and
operational documentation stored and utilized electronically.
While it is not the intention of this guide to address electronic document control systems, some
software allows users access to procedures, work instructions and help menus by simply calling
up the appropriate file. Screen touch display features are also sometimes a part of the process. A
number of good software systems developed specifically for ISO document control were available
for the ISO 9001:1994 standards and no doubt will become available for the new standards.

EASA-Q:2000 Guidelines for Compiling Documentation


APPENDIX A-02
This guideline is applicable to Clause 5 requirements for Management Responsibility.
Scope and Exclusions
Scope
If there are activities in your organization that you do not want included within the EASA-Q
system you must clearly identify them in this section. For example you may wish to have repairs
and service of electrical/mechanical equipment covered, but not the sale of commercial finished
products. The scope of your quality system's application should indicate this.
Exclusions
Because the three 'levels' of ISO 9001, 2 and 3 no longer exist, the new standard allows you to
have exceptions where the requirement cannot or need not be met or applied.
There are two conditions applicable, however:
1. Any exceptions selected must not reduce your organization's ability or responsibility
to meet customer and applicable regulatory requirements.
2. Exceptions are limited to only the requirements listed in Section 7, Product
Realization.
For example, if your organization does not normally design product from concept to final
production status, your organization has no need to address the requirement criteria for design
contained in the Product Realization section. You do, however, need to fully explain why, and
this explanation must be provided in the Management Responsibility section.
Management Commitment
Previous ISO standards dealt with management commitment lightly. Many ISO 9000:1994 quality
systems were accepted for registration where the senior management of such organizations paid
scant attention to visibly and consistently leading the quest for quality. In most cases that
responsibility was pushed down to a management representative who quite often wasn't
appointed from management ranks and subsequently had responsibility without the required
authority!
ISO 9001:2000 has now made that situation a thing of the past. If you want your quality system
recognized, then there must be adequate proof of consistent management leadership and
support. ISO system registrars and EASA-Q assessors will now require objective evidence that
the organization's managers are in fact leaders and not just suits in the corner office!
5.1

Management Commitment
Top Management must now demonstrate commitment to the development and
improvement of the quality management system through:
Communication of the importance of meeting customer as well as
regulatory/legal requirements.
Establishing a Quality Policy and Quality Objectives.
Conducting management reviews.
Ensuring the availability of necessary resources.
What objective evidence is expected?
Here are some examples:
Managers must exhibit a thorough understanding of:
The organization's quality system requirements.
Customer focus.
The need to provide adequate resources to allow the quality system to function
correctly.
The intended results from objective setting.
The impact on the objectives from trend analyses results.

EASA-Q:2000 Guidelines for Compiling Documentation

A familiarity with activities and processes that can lead to continual improvement
within the organization and in meeting customer expectations.

The records of Management Review are extremely critical in the assessment of


management commitment!
During a registration or surveillance audit, employees may be asked for input to
evaluating management leadership, so management must ensure that their report line
employees are made fully conversant with the goals and objectives of the organization.
5.2

Customer Focus
Top management is required to ensure that customer requirements are determined in the
form of defined requirements for use within the organization. This requirement focuses on
the means by which the organization translates customer information into readable,
understandable information on an organizational level.
Every person involved in the process of meeting customer requirements must fully
understand what the customer's needs are and how their work influences the fulfillment
of those needs.
This can best be accomplished by developing a comprehensive training plan for every
function within the organization from executive to shop floor positions.
What objective evidence is expected?
Auditors will talk to employees to establish their understanding of customer requirements
and verify that documented instructions such as specifications, dimensions etc. are
provided in clear terminology.

5.3

Quality Policy
This requirement is now more specific. Top management must ensure that the quality
policy:
Is appropriate to the purpose of the organization.
Include a commitment to comply with requirements and continually improve the
effectiveness of the quality system.
Provides a framework for establishing and reviewing quality objectives.
Is communicated and understood at all levels of the organization.
Is reviewed for continuing suitability.
The organization's quality policy must be dynamic and not something cast in stone. The
policy should link up with stated objectives and describe how these objectives are
reviewed and improved upon.
Example for a typical service facility
XYZ Inc.s policy is to meet or exceed customer requirements in a timely and cost
effective manner. To achieve this we will:
Meet the requirements of the International Standard ISO 9001:2000. If the
system is registered with an accreditation agency this will be subject to regular
compliance audits.
Seek continual improvement in service quality. (A measurable characteristic.)
Set service quality objectives that are based on internal and external
feedback and review these for continuing suitability at regular intervals.
(Can be evaluated by regular review. Were the objectives met?)
Maintain the highest levels of integrity in all relationships with customers
and suppliers. (Can be evaluated from customer and/or supplier
complaints/compliments received and recorded.)

EASA-Q:2000 Guidelines for Compiling Documentation

Respect environmental and social interfaces with the local community.


(Can be documented and evaluated.)
Ensure that all stakeholders are fully conversant with this policy and
completely understand their respective roles in upholding it. (Internally this
can be achieved by having the policy included in training plans and by having all
employees sign a read and understood agreement.)

What objective evidence is expected?


Obviously the presence of a documented policy is expected.
Examination of Management Review records should reveal that regular reviews of the
policy's suitability and stated objectives have been conducted.
Employees level of understanding of the quality policy and how it affects them will be
verified.
5.4 Planning
5.4.1 Quality Objectives
The organization must have WRITTEN quality objectives at each relevant department or
functional level that are consistent with the Quality Policy commitment to continual
improvement.
Departmental and/or function level quality objectives must be measurable and aligned to
supporting the organizations quality policy.
Example for a typical service facility
Executive management objectives:
To grow profits by x% per year.
To maintain employee turnover to less than y% per year.
Accounting Dept.
To post all receivables within x days of receipt.
To pay all accounts due to maintain zero penalties for late payment.
Maintain zero defects for payroll.
Sales Dept.
Increase sales through new business by x% per year.
Increase sales from existing customers by y% per year.
Reduce customer attrition by z% per year.
Service Dept.
Reduce warranty work by x% per year.
Reduce re-work by y% per year.
Aim for zero customer complaints.
Resolve customer dissatisfaction within z hours/days of receipt of complaint.
What objective evidence is expected?
Auditors will look for records that indicate measurement towards objectives and verify
that these are consistent with the organization's overall quality policy.
5.4.2

Quality Management System Planning


The organization must determine the resources needed to achieve quality objectives are
identified and planned. The output of this planning must be documented. Planning must
cover as a minimum:
Processes required in the Quality Management System.
Resources needed.

EASA-Q:2000 Guidelines for Compiling Documentation


Continual improvement of the Quality Management System.
Planning activities must ensure that organizational change is conducted in a controlled
manner in order to ensure that the existing quality management system effectiveness is
maintained.
An effective method of developing QMS planning is to create a comprehensive flowchart
of the organizations entire business process. This chart should form a process loop
starting with the expression of a customers need, how that need is received and
processed within the organization, and feeding back to the customer the fulfillment of
their need in a timely and cost effective manner. The stages in the process should be
identified and include the scope of resources needed for each stage.
It is also recommended that consideration be given to developing contingency plans for
handling emergency situations, relocation and/or expansion of existing facilities. These
would be considered as organizational change. Elements of such contingency planning
may address the following:
Continuity of service throughout the emergency/move/expansion phases.
Employee health and safety throughout the emergency/move/expansion.
Impacts on local resources/environment from such activities/situations.
What objective evidence is expected?
Quality system plans in whatever format adopted should be available for
inspection by an auditor.
It should be clearly indicated how the quality management system's integrity will
be preserved throughout any significant changes.
There should be records to indicate that the plans are reviewed on a regular
basis and updated/modified when appropriate.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
This clause is the abbreviated requirement of 4.1.2 in the 1994 standard. This
requirement does emphasize that responsibilities and authorities are to be defined and
communicated.
The requirement is best met with a comprehensive job description for each person in the
process (including top management) that clearly sets out:
The functional responsibilities and authority levels needed to perform the
function.
Evidence of training to a defined level of competency.
EASA member organizations range from the very small to large multi-division units. They
have much in common, however, when it comes to Management Responsibility.
Management has to be effective!
There a number of parameters where this effectiveness can be measured, such as:
Customer loyalty.
Customer satisfaction.
Employee retention.
Growth and/ or diversity of products and/or services offered.
Safety record for the organization.
Corporate citizenship role.
Profitability.*

EASA-Q:2000 Guidelines for Compiling Documentation


*Profitability of course depends greatly on how well the other parameters are
managed.
When developing management job descriptions, the foregoing parameters should be
considered in the scope.
What objective evidence is expected?
Comprehensive documented job descriptions clearly indicating each function's
scope of responsibility and authority, together with identified measurement
characteristics.
An organization chart depicting report lines.
5.5.2

Management Representative
Specific duties of the management representative have been defined. In addition to the
existing requirements of the management representative the 2000 version of the
standard requires that the management representative:
Ensures that the processes of the quality management system are established,
implemented and maintained.
Reports to top management the quality management systems performance and
needs for improvement.
Promote awareness of customer requirements throughout the organization.
It is critically important that authority levels sufficient to perform the requirements of this
function are incorporated into the job description and visibly supported by top
management.

5.5.3

Internal Communication
Organizations must ensure internal communication between levels and functions within
the organization.
All communications must be clearly stated. In addition to process related
communications, bulletin boards, newsletters, and customized screensavers for
computers are all recommended methods for effective internal communications.
What objective evidence is expected?
Where documents are used to convey information they must be clearly worded.
Evidence of posted notices on bulletin boards and/or menu driven screen
displays on computer systems.
Evidence of adequate understanding of communications by employees.

5.5.4
5.5.5

Management Review
General
The description of the purpose of the management review has not changed from the
1994 version of the standard, but the requirements of management review activity have
been more clearly defined as follows:

5.5.6

Review Inputs
A management review must consist of, as a minimum, an evaluation and comparison of
inputs such as:
Audit reports.
Customer feedback.
Process reports and production conformance analysis.
The status of corrective and preventive actions.
Follow-up actions from earlier management reviews.

EASA-Q:2000 Guidelines for Compiling Documentation

5.5.7

Changes that could affect the quality system.


Recommendations for improvement.

Review Outputs
The outputs from a management review shall include, as a minimum, any decisions and
actions related to:
Improvement of the effectiveness of the quality management system and its
processes.
Improvement of product related customer requirements.
Resource needs.
It is recommended that specific quality meetings be scheduled to address management
review activities rather than tacking on the topic to production meetings or general
meetings.
A formal record of the meeting activity and action planning resulting from the meeting
must be documented. As stated in Clause 5.3, a review of the organizations Quality
Policy and objectives shall be included in the management review meeting agenda.
Summary
The management review can be considered as the vehicle of control in the
ISO 9001:2000 QMS. Everything of significance should be evaluated by use of the review
process and records. The quality of this process and its records provides clear indication
of management effectiveness.
What objective evidence is expected?
Clear evidence of records that indicate the scheduling, content and results of the
management review process.

EASA-Q:2000 Guidelines for Compiling Documentation


APPENDIX A-03
This guideline is applicable to Clause 6 requirements for Resource Management.
6.1

Provision of Resources
Resources fall into the following categories:
Human resources.
Infrastructure (buildings, equipment, utilities, transportation, software and
hardware allied to electronic data processing).
Work environment.

6.2
6.2.1

Human Resources
General Requirements
All persons performing work within the organization's processes are expected to be
competent on the basis of appropriate education, training and experience.

6.2.2

Competence, Awareness and Training


The focus of the new standard includes a much more comprehensive requirement in the
area of training. (See Clause 6.2.2 ISO 9001:2000.) Accordingly, EASA-Q requirements
are now more specific.
The keys to achieving and maintaining effectiveness in all functions of any organization
are:
Appropriate training for each function position.
Effective demonstration of desired levels of competence.
Regular reviews to determine future training needs.
Example of a general training plan related to Customer Focus (Clause 5.2
ISO 9001:2000).
Application
All personnel.
Purpose
To ensure that all employees are aware of, and understand how, they as individuals
and/or their respective departments act and interact to meet specified customer
requirements.
Responsibility and Authority
The Executive Management has overall responsibility and authority to evaluate
and approve training plans.
The Human Resource Manager is responsible for identifying, developing and
providing all training programs.
The Human Resource Department is responsible for maintaining records of
training and evidence of demonstrated competence resulting from training
applications.
Note. Small business organizations that do not have a Human Resource Department
may identify the function title for these responsibilities and authorities.
Scope
The scope of this training shall include as a minimum, but not be limited to, the following:
Product orientation with emphasis on customer quality expectations.
Presentation of the organization's quality system.
The role of employees in maintaining the quality system and continually
improving its effectiveness.

EASA-Q:2000 Guidelines for Compiling Documentation

Appropriate interpretation of customer expectations related to specific functions


within the organization and the interactions between functions needed to meet
those expectations.
Handling complaints/nonconformance reporting or detection that may impact
upon customer satisfaction.

Verification of Competence
Each person receiving training shall be required to demonstrate the degree of
competence expected from receiving training. Evidence of demonstration may comprise,
where appropriate, written and oral examination and/or performance of specific tasks
under typical working conditions and witnessed by a suitably qualified supervisor/trainer
and the results recorded.
Acceptance standards shall be determined using a combination of input from appropriate
levels within the organization.
Where outside suppliers are utilized to provide training, the training package shall include
adequate means of establishing competence and records of both results and test
content.
A training matrix addressing all functions within the organization is a useful support tool.
This does not need to be overly detailed. The following simple matrix is provided as an
example.
Example Matrix for Training
PEOPLE

EXECUTIVE
MANAGERS

DEPARTMENT
MANAGERS

ADMINISTRATIVE
STAFF

PROCESS
EMPLOYEES

PRODUCT
ORIENTATION

QUALITY SYSTEM

AB

CB

CONTINUAL
IMPROVEMENT

AB

CB

CB

CUSTOMER
EXPECTATIONS

AB

COMPLAINTS
AND
NONCONFORMANCE

AB

CB

ROLE IN THE
QUALITY PROCESS

TOPIC

A - Comprehensive knowledge and understanding


B - Use
C - General understanding
Note: The format shown may be used for any form of training conducted within the organization.

EASA-Q:2000 Guidelines for Compiling Documentation


Employee Involvement
The management of resources addresses those items that are essential to the
implementation and achievement of your organization's quality objectives. These may
include:
Employees.
Suppliers.
Information and communication systems.
Plant buildings, equipment, tools.
Transport.
Significant emphasis is placed on the quality of human resource in the new standard.
Employee involvement is required in:
The identification of competence needs for process activities.
Career planning and selection of appropriate training.
The definition of responsibilities and authorities.
The establishment of departmental and individual objectives and the evaluation
of performance results.
Recognition of contributory process improvement.
Investigation of employee attrition.
Where appropriate, involvement of subcontracted and/or temporary employees
should also be considered.
Competence and Training
The new standard amplifies the importance of training by requiring demonstrated
competence of personnel and a continual evaluation of the effectiveness of the training
provided.
How do you do this? Consider the following examples:
1. Training in the form of a seminar where an audio-visual presentation is made to the
attendees. This is supported with handout materials containing essential
information covered.
In this form of training there is no direct indication that the attendees have
absorbed the necessary information/skills presented unless some form of testing or
evaluation is applied.
2.Training in the form of instruction followed by practical or written testing.
This format allows both the trainer and trainee to establish the effectiveness of the
training provided. The follow-up evaluation can be as simple as an attendee report
describing the training and reviewed by a manager, or it can be more structured, as
in the form of a written test.
No organization can function effectively with inadequately trained employees and
yet in many organizations training is considered to be an expense to be limited to
essentials only. Often training is limited to management and sales personnel.
To obtain maximum benefit from any training investment (note the term investment
- not cost!), an organization must first identify where training is needed and then the
type of training that will produce desired results.
Appropriate performance standards for individual tasks must be established. These
are essential to the accurate measurement of the effectiveness of the training
application.

EASA-Q:2000 Guidelines for Compiling Documentation


Wherever possible, performance standards should be established in cooperation
between the worker and his/her supervisor. The standards should also relate
directly to the departmental and organizational quality objectives.
Summary
The organization must:
Determine the level of expertise required to consistently meet product
requirements.
Provide appropriate training.
Evaluate the training effectiveness.
Make the trainee aware of the importance of their work performance relative to
objectives (departmental and organizational).
Maintain records to provide objective evidence of the foregoing.
What objective evidence is expected?
Evidence of training must include:
A record of training, its scope and methodology.
Proof of effectiveness of the training (a test paper or record of skill test signed by
an authorized person).
Records of performance reviews.
6.3

Infrastructure
The term 'infrastructure' refers to all resources other than 'human resources' required to
achieve and maintain product conformity to requirements. These may include:
Buildings (offices, workshops, test bays, shipping and warehouse spaces) and
their utilities.
Process equipment such as shop equipment, machine tools, lifting and
transporting equipment, software and hardware for logistic support.
Supporting services such as transport and communication services.
These infrastructure elements must be determined, managed and planned to provide
optimum conditions for the continuous meeting of product conformity to requirements.
What objective evidence is expected?
Equipment maintenance records.
Control procedures for transportation, communication and other support services
where considered appropriate.
Procedures for the selection of equipment and where appropriate, software
applied to the process.

6.4

Work Environment
Adequate spaces, lighting, cleanliness and safety are all elements of creating a suitable
work environment. Workflow effectiveness is affected by plant and office layout. Poor
design of workflow can mean delay, safety hazards and unnecessary production costs.
It is an established fact that a clean, orderly workspace results in lower operating costs
for the organization and higher productivity from its users.
If customers see a dirty, poorly laid out facility, it is understandable that they may question
the quality of the work performed in it!
What objective evidence is expected?
Clean and orderly work areas.
Logical and effective work flows.
High safety standards observed.

EASA-Q:2000 Guidelines for Compiling Documentation

EASA-Q:2000 Guidelines for Compiling Documentation


APPENDIX A-04
This guideline is applicable to Clause 7 requirements for Product Realization.
The overall intent of a quality system that meets the requirements of ISO 9000:2000 is to
enhance business performance by continual improvement of the processes involved. One might
say that the goal is a Zero Defect condition throughout the organization. Anyone who is familiar
with Total Quality disciplines will recognize the term.
In order to facilitate this, your entire business process needs defining and set up to identify
opportunities for improvement. This definition will involve the development of flowcharts including
an overall chart showing the key stages of your business process and sub-charts addressing
individual product lines.
Product realization, as you can probably guess, is 'ISOese' for 'the individual process
flows needed to produce a finished product.'
7.1

Planning of Product Realization


Whether the product is a rewound motor, rebuilt circuit breaker, electronic control panel or
a preventive maintenance service package, there is a general process of creating the
product that comprises a number of distinct steps from start to finish.
These steps represent the logical flow of activities required to produce the final product to
the customer's satisfaction. This is the business process. (Flowchart example: ref. A-0401.) Where this starts and finishes will be unique to your organization.
This general process will incorporate discrete processes of product realization where
your organization handles more than one product. While these need to be identified and
mapped out individually, they can be identified in your organizational flowchart as one
stage, namely Product Realization (Flowchart example: ref. A-04-02).
A typical start point could be the receipt of a firm customer order. The finishing point could
be where the customer receives delivery of the finished product or service.
You may want to extend these to begin at the initial customer contact and finish only
when your customer expresses complete satisfaction with the product supplied.
Both your organization's general business process and the Product Realization
processes related to motor repair, motor sales, service contracts, refurbishing of circuit
breakers, transformers, manufacture of custom control system, etc., generally start when
the order is received from the customer. From this point the following is a typical
sequence of activities that might occur for the general business process:
Order entry.
Order evaluation.
Order approval.
Design.
Production planning.
Production.
Final testing.
Packaging and shipping.
Billing.
In addition, the activities of marketing and sales would be integral to the general process.
The product realization for individual products might have the following typical activities:
Evaluation of capacity to meet the customer's expectations (Contract Review of
the 1994 ISO/EASA-Q requirements).
Acceptance of the order as is or with mutually agreed changes.

EASA-Q:2000 Guidelines for Compiling Documentation

Design of the product (where appropriate).


Ordering parts, etc.
Planning the work into your schedule (resources, material availability etc.).
Performing verification activities during the realization process.
Packaging and shipping.

In addition, training and equipment maintenance would be integral to the product


realization processes.
The key stages of your organization's processes need to be identified based on the
foregoing and the following characteristics considered:
What are the quality objectives for the product?
What are the required 'inputs'; resources; actions; and expected 'outputs' of each
stage?
Are documented work instructions needed throughout the process?
What are the verification requirements and criteria for acceptability?
What resources are needed? (skills and equipment)
What records are required to provide evidence of conformity of the process and
resulting product?
How are changes to the process recorded and communicated to maintain
product integrity and provide a basis for improvement?
In addition, there will be customer-related expectations and maybe regulatory/legal
requirements that need to be identified and factored in to the process. This section of the
new standard expands on the Contract Review requirements of ISO 9001:1994.
The organization should also define processes needed to ensure adequate
understanding of needs and expectations of interested parties. These processes would
include identification and review of information from various sources, such as:
Market research.
Competitor analyses.
Contract requirements.
Benchmarking.
Statutory and/or regulatory requirements.
Communication with the customer and other interested parties also needs to be defined
within the documented quality system. In particular, communication related to:
Product information.
Recent technological developments available.
Rework or re-grade characteristics.
Inquiries.
Order handling, including changes to the original order.
Customer feedback, including complaints.
Process verification incorporates the Inspection and test and Inspection and test
status requirements of the old standard, but goes beyond those with requirements to
consider, where appropriate, the validation of:
Product life-cycle.
Defined methodologies and procedures.
Process equipment qualification.
End use of the finished product.
Environmental impact of the product.

EASA-Q:2000 Guidelines for Compiling Documentation

Disposal of the product after its useful life is ended.

Converting the foregoing requirements into a simple, easy-to-follow plan will entail the
following activities:
Identify the activities, resources and equipment needed for each stage. For
example:
o What is the activity? (Describe what needs to happen at this stage)
o Who performs the activity? (Title, skills)
o What resources are needed? (Documents, communication devices, facilities)
o What equipment is needed? (Computers, telephones, fax machine, machine
tooling, test equipment etc.)
o What are the required inputs needed for each stage?
o What are the expected outcomes of the activity?
o How are the outputs converted to the 'input' for the next step?
As can be seen from the foregoing, considerable effort must go into the development of
process details for your organization.
What objective evidence is expected?
An easily understood description of the business process. As stated, graphic flow
charts are suggested as the simplest and clearest depiction of your
organization's processes. These, however, should be supported with references
to:
o Appropriate procedures, work instructions, documented drawings and
any other items essential to the relevant stages of the process.
o Stated quality objectives and requirements for the product.
o Relevant verification, inspect, test, validation and monitoring points
identified for each product.
o Records of status/compliance to verification, inspection/test, validation
and monitoring criteria.
7.2
7.2.1

Customer Related Processes


Determination Requirements Related to the Product
This requires that before any commitment to supply a product is made, the customers
requirements should be determined.

7.2.2

Review of Requirements Related to the Product


Customer requirements must be carefully matched with your organization's capability to
provide the product. The 1994 version of EASA-Q and ISO 9001 contained this
requirement as Clause 4.3 Contract Review.
This entails getting a clear and adequately detailed specification of the customer's
requirements. Any applicable regulatory requirements must also be considered as should
delivery and post-delivery requirements.
Note: This process is extremely critical to Getting it right the first time. Failure to
perform an effective and comprehensive evaluation of your customer's needs at this
stage can cost a lot and may lose you a customer.
What objective evidence is expected?
Records indicating that adequate care has been taken to ensure that all aspects
of customer requirements have been evaluated and accepted prior to acceptance
of the contract to supply the required product.

7.2.3

Customer Communication

EASA-Q:2000 Guidelines for Compiling Documentation


Ensure that open communications exist to communicate product information,
amendments to contract and response to customer complaints.
What objective evidence is expected?
Records contained in customer files and non-conformance files should support
communication effectiveness.
Auditors may include direct customer input in their scope of audit data collection.
7.3
7.3.1

Design and Development


Design and Development Planning
A design plan should indicate:
The stages required for design and development.
Those responsible for design and development.
What review, verification and validation is required at each stage.
What objective evidence is expected?
A design and development planning document containing or referencing the
above requirements.

7.3.2

Design and Development Inputs


Design and development inputs should include:
The functional and performance requirements for the product.
Applicable statutory/ regulatory requirements.
Information derived from previous similar designs.
Any other pertinent requirements considered essential to the design.
What objective evidence is expected?
Records to confirm that the required inputs have been identified, reviewed and
found adequate without conflict or ambiguity.

7.3.3

Design and Development Outputs


Design and development outputs should:
Meet the input requirements.
Provide adequate information for purchasing requirements.
Provide adequate service provision criteria.
Identify the characteristics essential to safe and correct use of the product.
What objective evidence is expected?
Records to confirm that the required outputs have been established and that they
meet input requirements.

7.3.4

Design and Development Review


Systematic reviews are required throughout the design and development to:
Evaluate the ability of the results of the design and development to fulfil stated
requirements.
Identify and resolve any problems.
What objective evidence is expected?
Records to confirm that the required reviews have been conducted and adequate
proof that the design and development meets stated criteria.
Records that identify problems and their solutions related to the design and
development reviews.

EASA-Q:2000 Guidelines for Compiling Documentation


7.3.5

Design and Development Verification


Verification that design and development meet the stated input requirements is needed to
ensure that specified requirements have been fulfilled.
What objective evidence is expected?
Records of conformance such as test/inspection records, material certificates,
regulatory authority approvals.

7.3.6

Design and Development Validation


The design and development planning includes the requirement for product validation.
Validation should indicate that the product meets the stated needs of the user.
Generally validation is performed on the final (finished) product prior to delivery but may
involve on-site validation (commissioning, load testing, etc.).
What objective evidence is expected?
Records that indicate that the characteristics of the finished product meet the
needs of the user (generally the customer). These records may comprise witness
testing, load testing, environmental performance testing, etc.

7.3.7

Control of Design and Development Changes


Changes to design and development must be identified and documented. Changes must
be reviewed, verified and validated as appropriate, then approved before implementation.
This applies to changes brought about through service bulletins, product recall notices or
product failures.
What objective evidence is expected?
Records identifying the change, reason for change, authority to change and
evidence of communication to interested parties. It is suggested that each
product design incorporates a documented log containing such information.

7.4
7.4.1

Purchasing
The Purchasing Process
The quality, reliability, availability and price of essential materials and/or products required
for your organization must be monitored and controlled to maintain optimum
effectiveness in product realization and customer satisfaction. Some criteria might
include:
Logistic capability, location and resources of the supplier.
Performance references from other users of the supplier.
Financial viability of the supplier. This is of special importance when in the
process of supplier selection.
Suppliers must be selected upon their ability to consistently meet your organization's
needs in product quality, reliability, availability and price. Criteria for selection, evaluation
and re-evaluation needs to be established.
Strong relationships with carefully selected suppliers should be developed. Opportunities
to develop such relationships can include:
The establishment of effective two-way communications at appropriate levels in
both organizations to allow rapid problem solving and avoid delays or disputes.
Monitoring supplier ability to consistently meet your requirements.
Developing joint strategies and mutual understanding of purchasing needs.
Sharing knowledge and encouraging cooperation in design of products.
Evaluation and recognition of quality performance of suppliers.

EASA-Q:2000 Guidelines for Compiling Documentation


What objective evidence is expected?
Clearly stated requirements for acceptance as a supplier of products and
services to the organization. The extent of this criteria should be dependent upon
the effect of the supplied products or services on product realization.
A current list of approved suppliers.
Records of regular evaluation/re-evaluation of approved suppliers.
Records indicating that effective two-way communication exists between the
organization and suppliers.
7.4.2

Purchasing Information
Adequate information must be communicated to a supplier to enable the supplier to fully
meet requirements. Some criteria considered to be essential comprises:
All pertinent dimensional and performance related characteristics.
Quantity, delivery and packaging requirements, and where appropriate:
o approval requirements for the product and the procedures, processes
and equipment needed to produce it.
o Qualifications of personnel associated with the supply of product.
o Quality management system requirements.
What objective evidence is expected?
Copies of purchase orders (hard copy or electronically stored records).
Records of standard purchasing requirements for frequently ordered products.

7.4.3

Verification of Purchased Product


All purchased product should be subject to acceptance inspection upon receipt. There
may be a need to perform acceptance inspection at the supplier's premises before the
product is shipped. Where this is a requirement it shall be clearly stated in the purchasing
information communicated to the supplier.
What objective evidence is expected?
Records of inspection of incoming product.
Records indicating results of product inspection at the supplier's premises and
the method of release following such inspection.

7.5
7.5.1

Production and Service Provision


Control of Production and Service Provision
The effective control of product or service realization demands attention to a number of
key aspects. In order to meet the needs and expectations of the customer your
organization should review the following:
The organization's capability to meet contractual requirements.
The level and quality of available skills and training capabilities within the
organization.
Process equipment reliability and suitability.
Communication quality.
Relevant statutory/regulatory requirements.
Problem prevention capability.
Production and service provision should be planned and controlled with regard to:
The availability of information describing the product or service.
The need for work instructions.
The use of suitable equipment.
The need and availability of measuring or monitoring devices.
The need for release, delivery and post-delivery activities.

EASA-Q:2000 Guidelines for Compiling Documentation

What objective evidence is expected?


Records that indicate that effective review and evaluation of customer
requirements are matched with the organization's capacity to meet customer
requirements.
Records of regular and periodic management review of the organization's
processes, equipment and skills inventory to ensure that customer requirements
are capable of being met.
7.5.3

Identification and Traceability


It is common sense to have some form of traceability for work and documentation
sufficient to satisfy customers and internal requirements. Unique identification may be
required for:
Traceability.
Process status.
Monitoring and measurement requirements.
Contract requirements.
Hazardous materials.
Risk control.
For the majority of organizations, identification and traceability are accomplished using
unique identifiers of numerical or alpha-numerical combinations. Usually a key identifier is
linked with related references as with a work order number cross referenced to drawing
numbers, special certification of material and certain activity codes.
An effective way of checking your existing identification/traceability effectiveness is to
examine the system for potential 'black holes' where items might 'disappear. Work in
process holding areas and quarantine areas for nonconforming products are typical for
physical items, while 'in trays' throughout the office are often repositories where
documentation becomes 'lost.'
What objective evidence is expected?
A clearly understood methodology for identification and traceability.
Physical evidence of correctly applied tags, labels, signage and document
references identifying product status.

7.5.

Customer Property
Any property or asset (including intellectual property) owned by your customer must be
identified, protected and maintained as would any of the organization's property or asset.
Should any customer owned item become lost, damaged or otherwise become unsuitable
for use it must be recorded and reported to the customer.
What objective evidence is expected?
Clearly understood instructions regarding control of customer property.
Correctly identified customer property.

7.5.5.

Preservation of the Product


All aspects of handling, packaging, storage, preservation and delivery that are designed
to prevent damage, deterioration or misuse during internal processing and final delivery
must be defined and implemented. Special requirements in this regard for sensitive,
fragile of hazardous products should also be considered.
Where appropriate there should be adequate instruction to the end user of the finished
product to identify resources needed to maintain the product's effectiveness throughout

EASA-Q:2000 Guidelines for Compiling Documentation


its life cycle. Operation manuals are typical documents to contain this information. Other
forms of guidance are instructional data plates mounted at strategic places on the
finished product.
What objective evidence is expected?
Work instructions or evidence of training that addresses the important aspects of
preserving the product as required.
Nameplates, labels or labels attached to the finished product when considered a
requirement to ensure effective and safe operation.
7.6

Control of Measuring and Monitoring Devices


The various methods for measuring and monitoring the verification of products and
validation of processes must be defined.
Devices that are used to verify outputs, dimensions, physical conditions (flow, pressure,
heat, etc.) must be controlled by regular calibration to acceptable standards. Adequate
storage must be provided to protect the devices. Adequate safeguards are required to
prevent unauthorized adjustment where feasible, and a system that allows a reassessment of previous results if the device is found to be out of calibration for any
reason must be in place.
Software used to measure or monitor specified requirements shall be validated prior to
use.
Note: For those presently using a recognized quality management system such as ISO
9001/2:1994, the documented procedures for control of measuring and test equipment
(Clause 4.11) will address only the second part of the new requirements. The need to
identify methods is additional.
What objective evidence is expected?
Records of measuring, monitoring and test equipment that is required to be
calibrated to maintain accuracy.
A schedule indicating frequency of calibration required and calibration status
Supporting certification as evidence of calibration.
Procedures describing calibration methodologies, care of equipment and
prevention of unauthorized adjustment.
Procedures or work instructions addressing action required to verify/re-verify.
accuracy where equipment nonconformance has been detected and a record of
the results of such activity.
Note: The following sub-appendices provide examples of acceptable procedure layouts.
FLOWCHART EXAMPLES
Note 1: This format is simple yet effective in presenting:
The flow, interrelationship and sequence of activities involved.
The functions responsible.
The related standard operating procedures.
Note 2: SOP (acronym of Standard Operating Procedure) is used as an example only.
Relevant identification of documentation normally used in your organization can be
entered in the SOP Reference column. Typical documentation can include:
Receiving forms and inspection status tags.
Inspection/test forms.
Work orders.

EASA-Q:2000 Guidelines for Compiling Documentation

Work in progress travelers.


Drawings.
Electronic data screens.

A-04-01 General Organization


FLOW

ACTIVITY

RESPONSIBILITY

SOP REFERENCE

Order Entry

Inside Sales

SOP OE 001

Order Evaluation

Engineering

SOP EG 001

Order Approval

Accounting/Credit

SOP AC 001

Design

Engineering

SOP ED 001

Production Planning

Shop Scheduling

SOP SP 001

Production

Shop Management

Work Order

Final Testing

Shop Management

Work Order

Packaging & Shipping

Traffic/Warehouse

SOP WH 001

Billing

Accounting

SOP AR 001

EASA-Q:2000 Guidelines for Compiling Documentation


A-04-02 Product Realization
Example - Random Wound Motor Repair
FLOW

ACTIVITY

RESPONSIBILITY

SOP REFERENCE

Receive motor in shop

Shipper/Receiver

SOP SR 001

Initial inspect

Shipper/Receiver

SOP SR 002

Schedule into shop


loading

Shop Scheduler

SOP SP 002

Dismantle & inspect

Technician

Work Order

Primary core test

Technician

Work Order

Remove windings

Winder

Work Order

Secondary core test

Technician

Work Order

Rewind and connect

Winder

Work Order

Pre-assembly inspection &


test

Technician

Work Order

Assembly & Final test

Technician

Work Order

Prepare and ship

Shipper/Receiver

SOP SR 003

EASA-Q:2000 Guidelines for Compiling Documentation


APPENDIX A-05
This guideline is applicable to Clause 8, Measurement, Analysis and Improvement.
If you can't measure it, you can't manage it.
In order for any organization to effectively manage its activities and control the quality of its
products or services, it has to identify certain key characteristics in its processes and measure
them. The results need to be analyzed and then actions taken to affect improvement. This
represents a continuous cycle rather than a 'one off' activity performed on an ad hoc basis.
Measurement results can show achievement but they also reveal trends and variance from preestablished control levels. Analysis of results can involve the application of statistical techniques
that can be applied to the verification of all process operations. The results should be included as
input to the management review process.
Each step in your processes and link in your customer/supplier chain is a potential measurement
point. The danger here is that if you apply too many measures you risk drowning in information
but being starved of knowledge. What is needed is a small number of simple measures that
channel your organization's focus on areas that have the highest potential return.
8.1 General
The scope of ISO 9001:2000 in this regard is the requirement to:
Demonstrate product conformity.
Ensure conformity of the quality management system.
Continually improve the effectiveness of the quality management system.
This includes the determination of methods including statistical techniques and the extent
of their use.
8.1.1
8.2.1

Monitoring and Measurement


Customer Satisfaction Measurement
Far too often measurement is focused internally and aimed at reducing costs. It has been
said that 'cost accounting is the number one enemy of productivity.'
Effective customer satisfaction measurement can only be achieved when the
measurement is focused on the customer's needs and expectations.
Who decides what to measure?
Those directly dealing with customers (salespersons, shippers) and customers
themselves should jointly determine the strategically key measurement characteristics for
your organization!
Statistically, the five key areas for customer satisfaction measurement comprise:
Reliability - The ability to meet requirements dependably and accurately.
Assurance - The courtesy and knowledge of the organization's personnel and
their demonstrated ability to convey trust and confidence.
Empathy - The degree of care and individual attention provided to customers.
Responsiveness - The perceived willingness to help customers and provide
unique solutions to customer problems.
Tangibles - The physical appearance of facilities, equipment and personnel.
Dialogue with customers should revolve around these factors.
Here are some areas for consideration. You and your customers should select and
prioritize those that are key to your customer satisfaction goals:
Customer complaints.
Number of error-free orders processed.

EASA-Q:2000 Guidelines for Compiling Documentation

Number of on-time deliveries.


Back order volume.
Cycle time to process and ship an order.
Volume of credit notes issued and why.*
Outstanding accounts receivables.*
Volume of rework.*
Time of callers placed 'on hold.'

Internal customer satisfaction should also be monitored. Internal customers are persons
within the organization who require various 'inputs from the previous person in the
process and who subsequently provide a 'product' to the next person or stage in the
process. Inefficiencies in this aspect of the organization's 'business process' inevitably
have an adverse effect on external customer satisfaction.
*Poor quality in these areas can seriously erode profitability.
Warning!
Some potential dangers to avoid are:
Overly zealous internal measurement can also be perceived as Management
Snoopervision.

If measurement is used as a threat surveillance system by management the


benefits will be totally negative. People will falsify results to please management.

Short term measurement. Maintain methods of measuring long enough to identify


trends.

Delay can result in loss of interest. Act promptly on feedback.

Don't limit decisions on what to measure and communication of results to


executive levels. Do train and support employees to identify what to measure and
how to apply the results

Once your organization has determined what to measure and the data collection
methodologies, the procedures should be documented.
What objective evidence is expected?
Records of meaningful measurement applied to continual improvement
objectives
Evidence of active participation of personnel in determining measurable
characteristics
Records of internal customer surveys and application of their results to continual
improvement
8.2.2

Internal Audit
This form of measurement is critical in maintaining the benefits of using a quality
management system.
Auditing the new standard moves beyond simple compliance to requirements and the
Expected objective evidence passages included throughout these guidelines can be
used as a guide in compiling internal audit scope and content.
The internal audit should assess both strengths and weaknesses of the quality
management system and also evaluate the effectiveness of support activities within the
organization. In addition to documenting non-conformances, internal audit reporting

EASA-Q:2000 Guidelines for Compiling Documentation


should also indicate recommendations for improvement and identify areas of outstanding
performance.
As with the ISO 9001:1994 requirements, internal audits must be planned, implemented
and have documented follow-up. Planning, however, should remain flexible to allow
changes in emphasis based upon findings from previous audits.
Typical areas for consideration by internal auditing include objective evidence of:
Adequate documentation.
Effective implementation.
Nonconformance control and documented results.
Personnel competence.
Opportunities for improvement.
Process capability.
Application of statistical techniques.
Use of information technology.
Analysis of quality costs.
Assigned responsibilities and authorities.
Performance results and expectations.
Adequacy and accuracy of performance measurement.
Effective relationships with other interested parties including internal customers.
Follow-up activities must include:
Verification of corrective action implementation.
Timeliness and effectiveness of corrective action.
Effectiveness of the internal audit process and methodologies used.
A comprehensive documented procedure addressing all of the internal audit requirements
is required for compliance to ISO 9001:2000.
What objective evidence is expected?
A documented procedure addressing internal audits is a mandatory requirement
of ISO 9001:2000. The responsibilities, authorities, requirements for planning and
conducting the audits, reporting their results and maintaining records must be
adequately defined in this procedure.
A schedule indicating frequency and scope of internal audits.
Training records for auditors within the organization.
Records of internal audit results.
Evidence of follow-up activities resulting from corrective action and verification of
corrective action effectiveness.
8.2.3

Monitoring and Measurement of Processes


The fact that all things begin and end with some form of financial accountability is no less
a reality when operating an effective quality management system.
Communicating results in financial terms to explain organizational quality performance is
very effective (especially when talking to executive management and shareholders!).
All too often the implementation of a quality management system is viewed as a
cost rather than an investment. However, the cost of setting up and operating an
effective quality system can return many times the initial outlay and operational
costs!
Identifying, tracking and communicating financial impacts of quality activities is highly
recommended. Some examples of financial impact are:

EASA-Q:2000 Guidelines for Compiling Documentation

Prevention, appraisal and failure cost analysis.


Costs of product and/or process non-conformance.
Costs of customer dissatisfaction.

All levels of the organization will benefit from knowing and understanding the
financial impact of these and, perhaps more importantly, how all can play a role in
minimizing such costs.
Process effectiveness characteristics can include:
Timeliness (on time delivery).
Overall cycle time (production cycle time or from receipt of order to delivery are
both useful measurement areas).
Dependability (equipment unplanned downtime).
Conformance to requirements.
Production costs (see previous paragraphs).
Appropriate application of technology.
People skill levels.
What objective evidence is expected?
Records showing that the process is managed using identified measurement of
key characteristics.
Records indicating maximized 'up-time' for equipment.
Well trained personnel with high motivation to produce quality work.
8.2.4 Measurement and Monitoring of Product
8.2.4.1 General
Throughout the process of creating your product (product realization), measurements
need to be taken to ascertain that the process is working as intended and that product
conformance to requirements is maintained throughout the process.
Those of you who already have the earlier EASA-Q system or the 1994 ISO 9001 or
9002 quality system in place can adapt the inspection and test requirement activities
used in those systems to this section.
For those new to quality systems, the following considerations must be addressed:
Where in the process sequence is measurement needed to verify conformance.
What needs to be measured.(the characteristics to be measured at each point in
the process).
How measurement is applied. (what methodology and equipment is used to take
and record the measurement).
Who has the authority and responsibility to perform the measurements and
release the product to the next sequential stage in the process.
Additional considerations may include:
Which inspections and/or testing is required to be witnessed or performed by
regulatory or statutory authorities.
Where, when and how your organization intends to utilize qualified third parties to
perform:
o Testing.
o Inspections.
o Product verifications.
o Product validations.
What pre-qualification of materials, products, processes or persons is required.

EASA-Q:2000 Guidelines for Compiling Documentation

How final inspection will confirm that all previous specified inspection and testing
has been completed and accepted.
What the outcomes of the measurement process are and how they are to be
recorded.

Typical test and inspection records may include:


Test and/or inspection reports.
Mechanically and/or electronically charted data.
Material release authorizations.
Material certificates.
What objective evidence is expected?
Test and inspection records.
Material certificates.
Recorded data from electronic monitoring systems.
Work instructions where appropriate describing measuring techniques.
Note: The following sub-clause is not identified in the standard ISO 9001:2000. However
it is referred to in the Guide ISO 9004:2000 and is included here because it is considered
an important element in the measurement process.
Measurement and Monitoring of Satisfaction of Interested Parties
Interested Parties can comprise:
Management and employees of the organization.
Owners/shareholders of the organization.
Suppliers.
Society.
Note that the foregoing does not include customers. This section identifies a new
requirement not previously addressed in former versions of either EASA-Q or ISO
9001/9002:1994 and its intent is to reinforce the fact that a well run organization needs
an effective structure of well informed and motivated 'stakeholders. The following
addresses each segment:
Management and Employees
It is essential that those working for the organization consider that their expectations are
met, that they feel that management is interested in their contribution to the organization's
objectives and that those contributions are adequately recognized.
Unhappy employees are less productive, less loyal and more likely to move out of the
organization than employees who feel contented and appreciated.
So, how do you measure employee satisfaction?
Regular and open communication will allow employees to voice their concerns,
suggestions and appreciation. This can be accomplished by:
Informal meetings of groups and/or individuals with their supervisors.
Suggestion programs.
The important thing is to set up an effective recording system for capturing the inputs and
applying the results. Regardless of which methods are used, if employees sense that
management is not listening and acting upon their inputs, morale will deteriorate and
subsequently so will quality.
It is also important that employees' performance is measured in a meaningful way and is
understandable to both management and the employee. Far too many Performance

EASA-Q:2000 Guidelines for Compiling Documentation


Reviews are based upon flawed methodology and subject to personal and unquantifiable
evaluations by supervisors.
All work (including management functions) can have tangible objectives and outcomes
capable of measurement. These can be expressed in clear format. The following chart
provides a simple and effective approach to establishing measurable performance for any
task.
I PERFORM THIS TASK
(ACTIVITIES)
Format: I + transitive verb +
object

FOR THESE PURPOSES


(OBJECTIVES)
Format: In order that/to

AS EVIDENCED BY THESE
CONDITIONS
(STANDARDS)
Format: Performance is
satisfactory when.

These methods can be applied to individual or collective performance.


What objective evidence is expected?
Owners/Shareholders
The organization should be able to:
Measure its capacity to attain defined objectives.
Measure financial performance.
Communicate these effectively to interested parties.
Supplier Measurement
The organization should provide methods to:
Monitor the performance of suppliers and their compliance with your
organization's purchasing policy.
Measure the quality of purchased product.
Measure effectiveness of purchasing processes within the organization.
Society
The organization's performance as a corporate citizen is important. Part of this may be
mandated by regulatory bodies (regarding environmental requirement compliance for
example), while other aspects may include support and participation in community
activities. Your organization should determine what methods are necessary to measure
interaction with society and periodically assess the efficiencies of its actions and
perception of the results by relevant parts of that society.
Control of Nonconformance
What is nonconformance?
Nonconformance can occur when:
Material or purchased product fails to meet specification.
Product fails to meet specified inspection/test criteria.
There is a failure in the process.
Noncompliance is detected by auditing.
Those of you that have either ISO 9001:1994, ISO 9002:1994 or the EASA-Q:1994
quality systems in place can directly utilize the procedures required for Sections 4.13 of
these programs.

EASA-Q:2000 Guidelines for Compiling Documentation


For those who do not have any of the above systems in place, the control of
nonconformance requires that you have documented procedures to identify, isolate from
further use and subsequently apply a satisfactory disposition to any
product/service/process covered by the quality system.
Any person in the organization should have authority to identify and report
nonconformances. However, there should be defined personnel authorized to deal with
the nonconformance in a satisfactory manner.
Regular review of nonconformance records can discover trends or patterns that may be
considered as potential improvement opportunities.
Analysis of Data for Improvement
The application of statistical methodologies to assess performance against objectives can
help in the assessment, control and improvement of process effectiveness.
Analysis of data can help determine the root cause of problems and guide effective
corrective and preventive action.
Information from all parts of the organization should be integrated and analyzed to
provide a picture of overall performance of the organization. This should be presented in
clear terms suitable for understanding by all personnel. Some results can be used to
determine:
Financial and market-related performance.
Customer satisfaction.
Satisfaction levels of other interested parties.
Supplier contribution.
Benchmarking within the industry.
Planning for Improvement
Proactive effort towards improvement should replace the If it ain't broke - don't fix it
philosophy.
Planning process improvement using the data analysis prevents unplanned interruption
or failure and its associated costs. Many benefits have been gained in manufacturing
industries using predictive/preventive equipment maintenance programs and the
essential characteristics of these disciplines can be successfully applied to service
organizations.
Continual Improvement
A process methodology for examining the activities with a view to possible improvement
is called for. This should consist of the following activities:
Identification of areas for improvement and the reason for selecting them.
Identification of problems by compiling and analyzing relevant data (include
nonconformance records if you have an ISO 9000 quality system in place
already).
Prioritizing the problems if more than one and determining the root causes.
Proposal and evaluation of solutions.
Application of the solution(s).
Evaluation of the effects (i.e., confirm that the root cause of the problem has
been removed and the improvement target has been met).
Revision of any procedure or work instruction to reflect the improved processes.
The foregoing methodology should become an integral part of your organization's routine
and apply to all activities critical to the process of product realization.

EASA-Q:2000 Guidelines for Compiling Documentation

Corrective Action
Those of you that have either ISO 9001:1994, ISO 9002:1994 or the EASA-Q:1994
quality systems in place can directly utilize the procedures required for Sections 4.14 of
these programs.
For those who do not have any of the above systems in place, the definition of corrective
action is that which is applied to a nonconforming situation to prevent a recurrence of the
problem. A documented procedure defining the authorities, responsibilities of personnel
and the actions required to control corrective action is required.
Corrective action processes should include:
A definition of the root cause of the nonconformance(s).
Appropriate actions to avoid recurrence of the problem(s).
A record of the activity and results.
Sources of input to determining corrective action can include:
Customer complaints.
Nonconformance reports.
Management review output.
Internal audit reports.
Data analysis results.
Process measurements.
Self-assessment results.
Preventive Action
Spotting potential problems and implementing actions to prevent the problem from
happening contributes to a smooth running and efficient organization. Where feasible, a
small team of appropriate personnel should be assembled to routinely examine all
aspects of the organization's activities, analyze data and develop suitable preventive
action.
Potential sources of information may include:
Customer needs and expectations (awareness of changes in this area and
appropriate action can often result in gaining market share).
Market trend analysis.
Management review output.
Relevant quality system records.
Preventive actions with high financial impact or those with significant potential impact on
customer satisfaction should be included in the Management Review process.
Process Improvement
While small incremental improvement activities can be part of the routine operations,
breakthrough projects designed to achieve specific improvement objectives should be
planned.

EASA-Q:2000 Guidelines
APPENDIX A-06
TYPICAL OUTLINE OF A QUALITY PROCEDURE
Procedures are the second level of documentation. They describe activities typically at the
department level and their relationship to the company operations as a whole.
The ISO 9001:2000 International Standard contains six activities that need documented
procedures as a mandatory requirement:
1. Clause 4.2.3 Control of Documents
2. Clause 4.2.4 Control of Quality records
3. Clause 8.2.2 Internal Audit
4. Clause 8.3 Control of Nonconformity
5. Clause 8.5.2 Corrective Action
6. Clause 8.5.3 Preventive Action
Examples of each are contained in this guide.
As a guide, the following headers may be used

Standard Operating Procedure (SOP) is a generic term used to identify the


document. It may be identified numerically as a further aid to reference.

Purpose/Objective: Aim of the procedure.

Scope: What the procedure does and does not cover.

Definitions: Key terms and acronyms used.

Responsibilities : Who (by job function) has responsibilities for specific tasks or
action.

Documentation: What documentation is needed.

Procedures: Description(s) of the actions or tasks to be carried out, by whom and in


what sequence. Standards to be met/completion criteria. What records are kept.
What resources/equipment are needed.

References: To all documentation covered (include work instructions where


appropriate).

Write to the task, not the individual.


The purpose is to help workers perform their tasks efficiently and consistently. In certain cases,
Level 2 and work instructions can be combined.
A good test of an effective procedure is to have someone not familiar with the task follow the
procedure to perform the task. It should be easy to follow and produce the desired result.
Both procedures and work instructions are powerful training tools if correctly written.
Work instructions should only be developed where their absence may adversely affect quality.
They should be developed with full cooperation of the person(s) performing the task.
Note: Each of the following procedures are provided as examples only and will require
customizing to suit your organization's requirements and operational structure.

Operating Procedure
QS 4.0
Distribution
President
V.P. Finance
Executive Assistant

Revision: 0
Issue Date: dd/mm/yy

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

Page x of y

V.P. Engineering
Service Manager
Chief Inspector

CONTROL OF DOCUMENTS
Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for the
establishment, review, authorization, issue, distribution, and revisions of quality system
documentation.
Scope
The following document categories are covered by this procedure:
Quality manuals.
Standard operating procedures.
Work instructions.
Standards and other technical reference material.
Drawings, specifications, work orders, purchasing documents, test and
inspection forms, wiring diagrams and other documentation defining products or
services.
Quality plans.
Definitions
SOP - Standard Operating Procedure
WI - Work Instruction
HR - Historical References
Responsibilities
The Quality Manager
Has overall responsibility for the control of documents.
The Engineering Manager
Is responsible for identification and revision of all engineering drawings and specifications.
Documentation
Master list of controlled documents.
Procedure
Identification
All documents are identified by their title, code number, date of issue, revision level and issuing
authority.
Documents that originate from outside the organization are identified and their distribution is
controlled, as are internal documents.
Documents created and processed entirely electronically are identified in the same manner as
described.
Establishment of Initial Issues and Revisions
Anyone in the organization can identify a need for procedures, work instructions or additional
product related documents.
All personnel are encouraged to evaluate documents in use and suggest revisions to correct
errors or improve their effectiveness.
Originator:
Approved by
Date issued:

Operating Procedure
QS 4.0

Revision: 0
Issue Date: dd/mm/yy

Page x of y

Persons wishing to initiate a new document or revise an existing document may submit their
suggestions to their supervisor who may reject, revise or accept the draft proposal for forwarding
to the Quality Manager. The decision to approve the change and issue the new or revised
document lies with the Quality Manager.
Initial Issue
Prior to issue and release for use, documents are reviewed for accuracy, legibility, adequacy and
conformity to quality policies.
A document is considered formally issued when an authorized approval signature is placed on it
(or the master copy when multiples of the document are involved).
Electronically produced and processed documents have a hard copy approval and this copy is
filed as a 'master' document.
Revisions
Changes to documents are reviewed and approved by the same authority that approved the initial
document unless specifically designated otherwise.
Handwritten corrections are permitted only when signed and dated by an authorized person.
Revisions of documents are distributed to the same persons and locations as the original issues.
Revised documents are accompanied by a cover sheet attached, describing what has been
changed, and what has been added/deleted from the original. The cover also contains
instructions for the disposal of the superceded document. This procedure also applies where
electronically produced and processed documents are revised.
Distribution
The quality manual and operational procedures contain distribution lists. Where appropriate, other
documents may have distribution lists.
Each department has a complete set of quality documentation relevant to the function of the
department.
Pertinent documents are placed with the functions requiring their use or may accompany traveling
work orders.
Master List
A master list is maintained of all issued documents. As a minimum the list must indicate each
document's:
Title.
Identification number.
Date of issue.
Last revision level.
Distribution.
Historical/Archival documents
Obsolete documents that have been retained for reference, preservation of knowledge or legal
reasons are stamped HR - Archival - Reference only and kept separate from other documents.
Uncontrolled Distribution
Any document issued to outside parties or persons not affected by their content is stamped
Uncontrolled. This category of document is not followed up with revisions.
Originator:
Date issued:

Approved by

Operating Procedure
QS 4.0

Revision: 0
Issue Date: dd/mm/yy

Page x of y

No person who may manage, perform, or verify work directly affected by the document can
receive uncontrolled documents.
Distribution
President
V.P. Sales & Marketing
V.P. Engineering
V.P. Finance
Plant Manager
Service Manager
Executive Assistant
Purchasing Manager
Chief Inspector
CONTROL OF QUALITY RECORDS
Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for the
establishment and storage of quality records.
Scope
This procedure applies to all records required by the quality management system.
Responsibilities
The Quality Manager
Has overall responsibility for the control of quality records.
Documentation
SOP QS 3.0 Control of documents.
Procedure
Identification
Records are identified to the product, person or event to which they pertain.
Records are dated and identify the person making the record.
Records are indexed or grouped to facilitate ease of retrieval.
Storage (Hard Copy)
Records are normally stored in the department in which they are established.
Records considered confidential are stored in cabinets fitted with appropriate security devices
and control.
Records are stored in clean, dry locations. Cabinets containing records are clearly labeled as to
their contents.
No records are allowed to be kept in private desk drawers, toolboxes or workbench shelving.
Storage (Electronic)
Storage of quality records on diskette, tape or CD is accepted where appropriate. Each diskette,
tape or CD is clearly labeled as to content.
Critical records have a duplicate that is stored in a secure off-site location.
Records considered confidential are stored in cabinets fitted with appropriate security devices
and control.

Originator:
Date issued:

Approved by

62
Operating Procedure
MA 3.0
Distribution
President
V.P. Finance
Executive Assistant

Revision: 0
Issue Date: dd/mm/yy

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

Page

V.P. Engineering
Service Manager
Chief Inspector

CONTROL OF QUALITY AUDITS


Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for
planning and conducting internal quality audit records.
Scope
This procedure applies to all activities within the quality management system.
Responsibilities
The Quality Manager
Has overall responsibility for the planning and execution of internal quality audits.
Documentation
Nonconformance reports.
Corrective and preventive action requests.
Procedures:
MA 5.0 Control of nonconforming product
MA 8.0 Corrective action
MA 9.0 Preventive action
Procedure
Planning
The Quality Manager is responsible for planning and scheduling internal audits.
Each clause requirement of the international standard ISO 9001:2000 is audited at least once
each year. Certain activities may be subjected to more frequent auditing depending on their
status, importance and past history of compliance.
The audit plan identifies all requirement clauses for ISO 9001:2000, the activities associated with
them and the locations where the activities take place within the organization.
An audit date is allocated for each identified requirement.
Auditors
Personnel assigned to perform audits are independent of those having direct responsibility for the
audited activity.
Personnel assigned to perform audits are qualified through training.
An audit team leader is appointed by the quality manager for each audit.
The quality department activities are audited by the Chief Executive Officer of the organization.
Conducting the Audit
The selected audit team prepares by familiarizing themselves with the ISO
9001:2000 requirements applicable to the area(s) to be audited.
The head of the department being audited is contacted one week in advance with
a proposed audit date. A response is requested to either confirm or propose an
alternative date.
Throughout the audit, auditors look for objective evidence demonstrating
compliance to the requirements of the documented quality system.
When noncompliance is detected, the department head is notified and the
situation discussed.
Originator:
Date issued:

Approved by

63
Operating Procedure
MA 3.0

Revision: 0
Issue Date: dd/mm/yy

Page

Upon completion of the audit, each noncompliance is documented on a


Nonconformance Report form (form I.D # _______)
A summary findings report is drafted and the audit results discussed at a post
audit meeting with the department head.

Corrective Action
Upon receiving a noncompliance report, the department head investigates the root cause of the
problem, proposes a corrective action and an implementation date. The auditor team leader
reviews and approves the proposed corrective action.
On or immediately following the due date for implementation of the corrective action, the audit
team leader will verify that the action taken is effective in resolving the nonconformance. When
there is objective evidence that the action is effective, the nonconformance report is closed out
and committed to records. If more work is needed to correct the problem, a new follow-up date is
agreed upon.
Document end

Originator:
Date issued:

Approved by

64
Operating Procedure
MA 5.0
Distribution
President
V.P. Finance
Executive Assistant

Revision: 0
Issue Date: dd/mm/yy

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

Page

V.P. Engineering
Service Manager
Chief Inspector

CONTROL OF NONCONFORMITY
Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for the
identification, documentation and disposition of nonconformance.
Scope
This procedure applies to all materials, components, sub-assemblies and finished product that
are subject to inspection and/or testing.
Responsibilities
The Quality Manager
Has overall responsibility for the control nonconformance.
Documentation
SOP QS 3.0 Control of documents
Nonconformance Report Form
Nonconformance Record
Procedure
Anyone can report a nonconformance to their immediate supervisor who will then assess the
problem. If the problem warrants a nonconformance report being made out, the report will be
written up, processed and entered into the record sheet.
When a product or material nonconformance is identified, it is identified with a red
NONCONFORMANCE tag or label. Where practical the defective product or material is moved to
a clearly identified QUARANTINE area.
Review and Disposition
Nonconforming product or material can be:
Reworked to meet specified requirements.
Accepted as-is.
Regraded for alternative use.
Scrapped.
The decision is determined by the Quality Manager. Other management may jointly determine the
disposition according to the nature of the nonconformity. The disposition is documented on the
nonconformance report. Where necessary or required by contract, the customer is contacted for
concession to accept the disposition.
Re-Inspection After Rework
Reworked products are inspected for compliance to original specifications. Regraded product or
material is clearly marked to identify their different status.
Close-Out of the Nonconformance Report.
Decisions to accept as-is, regrade or scrap allows the report to be closed out and filed. Where reinspection is required, the verification result and date is entered on the nonconformance report
which is then filed.
Identification
Records are identified to the product, person or event to which they pertain. Records are dated
and identify the person making the record. Records are indexed or grouped to facilitate ease of
retrieval.
Originator:
Date issued:

Approved by

65
Operating Procedure
MA 5.0

Revision: 0
Issue Date: dd/mm/yy

Page

Storage (Hard Copy)


Records are normally stored in the department in which they are established. Records considered
confidential are stored in cabinets fitted with appropriate security devices and control. Records
are stored in clean, dry locations. Cabinets containing records are clearly labeled as to their
contents. No records are allowed to be kept in private desk drawers, toolboxes or workbench
shelving.
Storage (Electronic)
Storage of quality records on diskette, tape or CD is accepted where appropriate. Each diskette,
tape or CD is clearly labeled as to content. Critical records have a duplicate that is stored in a
secure off-site location. Records considered confidential are stored in cabinets fitted with
appropriate security devices and control

Originator:
Date issued:

Approved by

Operating Procedure
MA 8.0
Distribution
President
V.P. Finance
Executive Assistant

Revision: 0
Issue Date: dd/mm/yy

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

Page

V.P. Engineering
Service Manager
Chief Inspector

CONTROL OF CORRECTIVE ACTION


Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for
initiating, requesting, carrying out, and verifying the effectiveness of corrective actions.
Scope
This procedure applies to correcting nonconformities related to material, components, subassemblies, finished product, production and service activities, and the quality system.
Responsibilities
The Quality Manager
Has overall responsibility for the control of corrective actions.
Documentation
SOP MA 5.0 Control of nonconformity
SOP MA 3.0 Internal audit
Procedure
Application
Corrective Action Requests (CARs) are directed to:
Internal departmental heads within the organization.
Suppliers.
Initiation of a CAR can be proposed by any employee of the organization, but must be authorized
by the Quality Manager or the organization's president (Your organization's selection). CAR
requests must be in writing and contain the following minimum information:
An adequate description of the problem to be corrected.
The effect upon quality of the process, product or service.
Initiation
Corrective action may be requested in the following situations:
Identification of a major product nonconformity.
Accumulation of minor non-conformity from a common source.
Recurring problems with a process.
Noncompliance detected during internal, customer, or third party audits.
Service/commissioning problems.
Customer complaints.
Poor supplier performance.
Processing
Corrective actions are requested using the CAR form and directed to the department or person
responsible for that area of activity where the problem occurs. Upon receiving the request, the
person responsible investigates the problem, determines the root cause and proposes a
corrective action indicating a proposed implementation date. The proposed action and
implementation date are reviewed and approved by the Quality Manager or President. Verification
of corrective action is conducted by the Quality Manager on or immediately after the
implementation date. Where the action is deemed successful in resolving the problem, the CAR is
closed and filed as a quality record. If more work is needed to fully resolve the problem, a new
verification date is agreed upon.
Originator:
Date issued:

Approved by

Operating Procedure
MA 8.0

Revision: 0
Issue Date: dd/mm/yy

Page

Documentation and Record


Closed CARs are controlled as quality records. Pending CARs are kept by the party initiating the
CAR. Storage and retention periods for closed CARs are specified in SOP QS 4.0 Control of
Quality Record

Originator:
Date issued:

Approved by

Operating Procedure
MA 9.0
Distribution
President
V.P. Finance
Executive Assistant

Revision: 0
Issue Date: dd/mm/yy

V.P. Sales & Marketing


Plant Manager
Purchasing Manager

Page

V.P. Engineering
Service Manager
Chief Inspector

CONTROL OF PREVENTIVE ACTION


Purpose
To provide for a system and instructions, and to assign responsibilities and authorities for
initiating, requesting, carrying out, and verifying the effectiveness of preventive actions.
Note: Preventive action is a pro-active approach to problem resolution.
Corrective action is a reactive approach to problem resolution.
Scope
This procedure applies to the prevention of nonconformities related to material, components, subassemblies, finished product, production and service activities, and the quality system.
Responsibilities
The Quality Manager
Has overall responsibility for the control of preventive actions.
Documentation
SOP MA 5.0 Control of nonconformity
SOP MA 3.0 Internal audit
Procedure
Application
Preventive Action Requests (PARs) are directed to:
Internal departmental heads within the organization.
Suppliers.
Initiation of a PAR can be proposed by any employee of the organization, but must be authorized
by the Quality Manager or the organization's president (Your organization's selection).
PAR requests must be in writing and contain the following minimum information:
An adequate description of the problem that may occur if the action is not taken.
The suspected cause.
The potential effect upon quality of the process, product or service.
Initiation
Preventive action may be requested in the following situations:
Identification of a potential major product nonconformity.
Identification of a potential problem within the quality management system.
Identification of a potential problem with suppliers.
Processing
Preventive actions are requested using the PAR form and directed to the department or person
responsible for that area of activity where the potential problem is identified. Upon receiving the
request, the person responsible investigates the possible sources of the potential problem,
proposes a preventive action and indicates a proposed implementation date. The proposed action
and implementation date are reviewed and approved by the Quality Manager or President.
Verification of preventive action is conducted by the Quality Manager on or immediately after the
implementation date.
Where the action is deemed successful in resolving the problem, the PAR is closed and filed as a
quality record. If more work is needed to fully resolve the problem, a new verification date is
agreed upon.
Originator:
Date issued:

Approved by

Operating Procedure
MA 9.0

Revision: 0
Issue Date: dd/mm/yy

Page

Documentation and Record


Closed PARs are controlled as quality records. Pending PARs are kept by the party initiating the
PAR. Storage and retention periods for closed PARs are specified in SOP QS 4.0 Control of
Quality Records.

Originator:
Date issued:

Approved by

EASA-Q:2000 Quality Manual


APPENDIX A-07
This guideline is intended to help identify new requirements and contains a cross
reference table to indicate where requirements from the ISO 9001:1994 might be utilized in
the new ISO 9001:2000 Standard.
EASA-Q:2000
CROSS APPLICATION
OF ISO 9001:1994 REQUIREMENT CLAUSES AND ISO 9001:2000 CLAUSES
ISO 9001:2000
ISO 9001:1994
1.
Scope
1
1.1 General
1.2 Application
2.
Normative reference
2
3.
Terms and definitions
3
4
Quality management system
4
4.1 General requirements
4.2.1
4.2 Document requirements
4.2.1 General
4.2.1 + 4.5.1
4.2.2 Quality manual
4.2.1
4.2.3 Control of documents
4.5.1 + 4.5.2 + 4.5.3
4.2.4 Control of quality records
4.16
5.
Management responsibility
5.1 Management commitment
4.1 + 4.1.2.2 + 4.2.1
5.2 Customer focus
4.3.2
5.3 Quality policy
4.1.1
5.4 Planning
5.4.1 Quality objectives
4.1.1 + 4.2.1
5.4.2 Quality management system planning
4.2.3
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
4.1.2.1
5.5.2 Management representative
4.1.2.3
5.5.3 Internal communication
5.6 Management review
4.1.3
5.6.1 General
4.1.3
6.
Resource management
6.1 Provision of resources
4.1.2.2
6.2 Human resources
6.2.1 General
4.1.2.2 + 4.2.3 + 4.18
6.2.2 Competence, awareness and training
4.18
6.3 Infrastructure
4.1.2.2 + 4.9
6.4 Work environment
4.9
7.
Product realization
7.1 Planning of product realization
4.2.3 + 4.9 + 4.10.1
7.2 Customer related process
7.2.1 Determination of product related requirements
4.3.2 + 4.4.4
7.2.2 Review of product related requirements
4.3.2 + 4.3.3 + 4.3.4
7.2.3 Customer communication
4.3.2
7.3 Design and development
7.3.1 Design and development planning
4.4.2+4.4.3+4.4.6+4.4.7+4.4.8
7.3.2 Design and development inputs
4.4.4
7.3.3 Design and development outputs
4.4.5
7.3.4 Design and development review
4.4.6

EASA-Q:2000 Quality Manual

ISO 9001:2000
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of production and service provision
processes
7.5.3 identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
8. Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measuring of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

ISO 9001:1994
4.4.7
4.4.8
4.4.9
4.6.2
4.6.3
4.6.4+4.10.2+4.10.3+4.10.4
4.9+4.10.3+4.15.6+4.19
4.9
4.8+4.10.5+4.12
4.7
4.15.2+4.15.3+4.15.4+4.15.5+
4.15.6
4.11.1+4.11.2
4.10+4.17+4.20.1
4.17
4.9+4.17+4.20.1
4.10.2+4.10.3+4.10.4+4.10.5+4.2
0.1
4.13.1+4.13.2
4.14.2+4.14.3+4.20
4.1.3
4.14.1+4.14.2
4.14.1+4.14.3

EASA-Q:2000 Quality Manual


Guideline to Aid in Identifying New Requirements
New requirements are identified in italics.
ISO 9001:1994 Clause 4.2 Quality System
This clause of the 1994 standard is addressed in Clause 4 of the new standard. The 1994 version
required only that the system be established, documented, planned and maintained to ensure
product quality.
Whats new?
ISO 9001:2000 Clause 4.0 Quality Management System
The new standard is much more specific with regard to what constitutes the quality system.
Sub-clause 4.1 General requirements requires that the organizations PROCESSES shall be
defined and managed to ensure conformity to customer requirements.
Sub-clause 4.2 Documentation requirements
Specifies that an organization shall have:
A quality manual.
A quality policy and quality objectives.
Documented procedures required by ISO 9000:2000 (there are six).
Documentation necessary for planning, operations and control of the
organizations processes.
Records.
The Control of Documents (Clause 4.5 ISO 9001:1994) is essentially the same with some
exceptions. Procedures must now define a mechanism for review and revision as necessary.
There are also more specific requirements for legibility, identification and revision control for
quality system documentation.
The Quality Manual is now a requirement and must include a description of the quality system
and a reference to, or identification of procedures. A description of the sequence and interaction
of the organizations processes are also to be included.
The Control of Records (Sub-clause 4.16 ISO:1994) has been simplified.
ISO 9001:1994 Clause 4.1 Management Responsibility
The 1994 standard requirements for 4.1 Management Responsibility do not clearly indicate what
commitment is required to ensure the development and improvement of the Quality Management
System (QMS).
SECTION 5.0 MANAGEMENT RESPONSIBILITY
What's new?
ISO 9001:2000 Clause 5.0 Management Responsibility
Sub-clause 5.1 Management Commitment
Top Management is expected to demonstrate commitment to the development and improvement
of the QMS through:
Adequate communication of the importance of meeting customer, legal and
regulatory requirements.
Establishing a Quality Policy and quality objectives.
Conducting management reviews.
Ensuring the availability of necessary resources.

EASA-Q:2000 Quality Manual


Sub-clause 5.2 Customer Focus
Top management is required to ensure that customer requirements are determined and defined
as requirements for use within the organization. The focus here is on the means by which
organizations convert customer requirements into clearly written information that is
understandable throughout the organizational levels.
Sub-clause 5.3 Quality Policy
The requirements are more specific. Top management must ensure that the policy:
Is (and remains through regular review) appropriate to the purpose of the
organization.
Includes a commitment to comply with requirements of, and continually improve
the QMS.
Is effectively communicated and understood throughout all levels of the
organization.
Sub-clause 5.4 Planning
5.4.1 Quality Objectives: The organization must have documented quality objectives for each
department or functional level that are consistent with the Quality Policy commitment to
continual improvement.
5.4.2

QMS Planning: Resources needed to achieve quality objectives must be identified,


planned and documented. The scope of this planning must cover as a minimum:
Resources needed.
Processes needed within the QMS.
How continual improvement of the QMS will be achieved.
The plan must ensure that change occurs in a controlled manner to preserve the integrity
of the QMS.

Sub-clause 5.5 Responsibility, Authority and Communication


(Note the addition of communication!)
5.5.1

Responsibility and Authority: This is essentially the same as the 1994 requirement
4.1.2.
Management Representative: In addition to the requirements in the 1994 requirement
4.1.2.3, the ISO 9001:2000 requirement includes:
Report to top management on QMS performance and need for improvement.
Promote awareness of customer requirements throughout the organization.

5.5.2

Internal Communication: Organizations must ensure that effective communication


exists between levels and functions within the organization.

Sub-clause 5.6 Management Review


The requirements essentially remain the same as in the 1994 standard.
5.6.1

General: The activities are more clearly stated requiring defined inputs and outputs.

5.6.2

Review Inputs: As a minimum, the review must evaluate and compare the following
input:
Audit reports.
Customer feedback.
Process and production conformance analyses.
Corrective and preventive actions status.

EASA-Q:2000 Quality Manual

5.6.3

Follow-up from prior reviews.


Recommended changes to affect improvement.

Review Outputs: As a minimum, outputs shall document any decisions and actions
related to:
Improvement of the effectiveness of the QMS and its processes.
Improvement of product related customer requirements.
Resource needs.

SECTION 6.0 RESOURCE MANAGEMENT


The ISO 9001:1994 Standard does not directly address Resource Management as a separate
requirement.
Whats new?
ISO 9001:2000 Clause 6.0 Resource Management directly addresses resource management
and is much more specific in its requirements.
Sub-clause 6.1 Provision of Resources
Requires that resources must be provided to ensure the establishment and maintenance of the
quality system and also for the improvement of the system. Resources to address customer
satisfaction are also mandatory.
Sub-clause 6.2 Human Resources (Sub-clause 4.1.2.2 and Clause 4.18 in ISO 9001:1994)
essentially remains the same but, the terminology now focuses upon competence of those
impacting upon the quality of the product.
In addition to the training requirements, the standard now requires the organization to
demonstrate the competence of personnel after training and must evaluate the effectiveness of
training on a continual basis. Quality awareness is strongly emphasized.
In summary, the organization must now:
Provide appropriate training.
Evaluate the training.
Determine the necessary competence.
Ensure that all personnel are aware of the impact of their work on product quality.
Maintain adequate records of the above.
Sub-clause 6.3 Infrastructure (Sub-clause 4.1.2.2 and 4.9 in ISO 9001:1994)
The new standard is more specific in requiring that organizations must determine, provide and
maintain the necessary infrastructure to ensure conformity to product requirements.
Infrastructure can comprise:
Buildings and essential associated utilities.
Workspaces.
Process equipment including computer hardware and associated software.
Support services such as transportation and communications.
Sub-clause 6.4 Work Environment (Sub-clause 4.9 in ISO 9001:1994)
The new standard requires that the work environment requirements are managed to ensure
conformity to product requirements.
SECTION 7.0 PRODUCT REALIZATION
The ISO 9001:1994 Standard does not directly address Product Realization as a separate
requirement.

EASA-Q:2000 Quality Manual


Whats New?
ISO 9001:2000 Clause 7.0 Product Realization (extracts from 4.2; 4.3; 4.4; 4.6; 4.9; 4.10;
4.11; 4.15 in ISO 9001:1994) addresses the overall aspects of production related processes and
is much more specific in its requirements.
Sub-clause 7.1 Planning of Realization Processes specifies that an organization shall
consider:
Quality objectives for the product(s).
The establishment of documented processes.
The provision of specified resources and facilities for the product(s).
Verification and validation procedures and criteria for acceptability.
Records that provide evidence of process conformity and resulting product(s).
Sub-clause 7.2 Customer Related Processes now places the onus on the organization to
identify and consider fit for purpose requirements for the product(s) and also legal/regulatory
obligations. The ISO 9001:1994 Clause 4.3 Contract Review requirements remain the same in
the new standard but the capability to meet contractual requirements extends to any amendment
to contract.
Customer communications are now required to be defined. The scope includes:
Product information.
Inquiries, order processing and changes to original orders.
Customer feedback, including complaints.
Sub-clause 7.3 Design and Development maintains the ISO 9001:1994 requirements of:
Design inputs.
Design outputs.
Design verification and validation.
The new standard reinforces the design and development requirements of Clause 4.4 in
ISO 9001:1994 in the following areas:
7.3.1

Planning: Design planning documentation must now include as a MINIMUM:


Identification of design changes
Identified review, verification and validation activities
Responsibilities and authorities for design activities
Availability of design plans to all personnel who require them
Reviews and updating when necessary

7.3.4

Design Review: Results and follow up actions stemming from design reviews must
now be recorded.

7.3.7

Control of Design Changes: The impact of design changes on constituent parts and
the delivered product must now be considered before the implementation of design
changes.

Sub-clause 7.4 Purchasing generally reinforces the ISO 9001:1994 requirements of subclauses:
4.6.2 Evaluation of subcontractors (addressed in the new standard under subclause 7.4.1)
4.6.3 Purchasing data (addressed in 7.4.2) and
4.6.4 Verification of purchased products (addressed in 7.4.3)

EASA-Q:2000 Quality Manual


Sub-clause 7.5 Production and Service Operations reinforces ISO 9001:1994 Clause 4.9
(process control) and contains additional requirements in the following areas:
7.5.1

Control of Production and Service contains the requirement for identified processes
for release, delivery and, where appropriate, post-delivery activities.
The new standard elaborates the installation aspect of ISO 9001:1994.

7.5.2

Validation of Processes for Production and Service defines requirements for


special processes in greater detail.
Special processes must be validated to demonstrate their effectiveness of their control.
This may require:
Process qualification.
Equipment and/or personnel qualification.
Use of specific procedures.
Records of validated processes.
Re-validation processes.

7.5.3

Identification and Traceability reinforces the 4.8 clause requirements of the ISO
9001:1994 standard and includes the requirement to identify product status that was in
clause 4.12 of the 1994 standard.

7.5.4

Customer Property This expands the Clause 4.7 requirement of the ISO 9001:1994
standard to products and/or services provided by a customer for USE OR
INCORPORATION into the finished product. This now includes intellectual property
provided in confidence.

7.5.5

Preservation of Product reinforces and clarifies the Clause 4.15 of ISO 9001:1994.

Sub-clause 7.6 Control of Measuring and Monitoring Devices essentially reinforces Clause
4.11 of ISO 9001:1994 with the additional requirement for control of test software. Software used
for verification must be validated before use.
SECTION 8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT
Whats New?
This element gathers requirements from ISO 9001:1994 clauses 4.1; 4.9; 4.10; 4.13;
4.14; 4.17 and 4.20. The most significant change is the requirement of a process to measure
customer satisfaction.
Sub-clause 8.1 General requires that an organization defines, plans and implements
measurement and monitoring systems to assure conformity of:
The quality management system.
The product.
Improvement.
Sub-clause 8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction A process is required to obtain and monitor customer
satisfaction information and data.
8.2.2

Internal Audit Essentially these requirements remain the same as those in clause 4.17
of ISO 9001:1994.

8.2.3

Measurement and Monitoring of Processes reinforces 4.9(d)of ISO 9001:1994 by


defining the requirement for performance measurement of product realization to ensure
conformance or to apply corrective action.

EASA-Q:2000 Quality Manual

8.2.4

Measurement and Monitoring of Product replaces the inspection requirements of


Clause 4.10 of ISO 9001:1994 with a more generic scope.
Sub-clause 8.3 Control of Nonconformity reinforces the requirements of Clause 4.13.
Terminology has been introduced to apply the requirement more easily to service activities.
Sub-clause 8.4 Analysis of Data strengthens the requirement of Clause 4.20 of
ISO 9001:1994 with more specific requirements:
There must be a defined procedure for data collection and analysis as a means for identifying
opportunities for improvement in the following areas:
Customer satisfaction.
Conformance to customer requirements.
Characteristics of processes, products (and their trends.)
Supplier performance.
Sub-clause 8.5 Improvement The definitions for improvement were never really clarified in the
ISO 9001:1994 standard.
8.5.1

Planning for Continual Improvement The new standard categorically defines that
improvement of the quality management system should be continual and facilitated
through the use of:
The quality policy and objectives.
Audit results.
Data analysis.
Corrective and preventive action.
Regular management reviews.

8.5.2

Corrective Action There are now MINIMUM requirements for procedures addressing
corrective action which must now include:
Identification of nonconformity (including customer complaints).
The root cause of the nonconformity.
Evaluating action to ensure that the nonconformity does not recur.
Determining and implementing the corrective action needed.
Recording the action taken.
Reviewing the corrective action taken for effectiveness.

8.5.3

Preventive Action There are now MINIMUM requirements for procedures addressing
preventive action which must now include:
Identification of potential nonconformity and their root cause.
Determining and ensuring the implementation of preventive action needed.
Recording the actions taken.
Reviewing the actions taken for effectiveness.

EASA-Q:2000 Quality Manual


APPENDIX A-08: Samples of Useful Documents
Approved Supplier Record
Supplier Evaluation Form
Registrar Selection Table
Specimen Form Letter ISO Advisory to a Supplier
Nonconformance Record
Example Work Instruction: Application Area Warehouse
Nonconformance Report
Corrective/Preventive Action Request

APPROVED SUPPLIER RECORD

Page __ of __
Revision 00

Subcontractor

Product or Service

Quality Rating

Approved by

Quality Rating
A ISO registered
B Preferred
C Sole Supplier
D Restricted to 2nd
choice from
preferred

Originator:
Approved by:

Original issue date:


Issued by:

EASA-Q:2000
SUPPLIER EVALUATION
To be completed by SUPPLIER
NAME:

FAX:

STREET:

TEL:

CITY:
PROVINCE/STATE:

POSTAL/ZIP:

PRIMARY CONTACTS FOR:


SALES:
EXT#:

TITLE:

TECHNICAL SUPPORT:
EXT#:

TITLE:

QUALITY SYSTEM:
EXT#:

TITLE:

SUPPLIER TYPE: MANUFACTURER ( )

DISTRIBUTOR ( )

SERVICE ( )

PRODUCT(S)/SERVICE PROVIDED:
NUMBER OF YEARS IN BUSINESS:
DO YOU HAVE A QUALITY SYSTEM IN PLACE?

YES ( )

NO ( )

IF YES, TO WHICH STANDARD?


IS THE SYSTEM REGISTERED WITH AN APPROVED AGENCY?

YES ( )

NO ( )

INDICATE WHICH AGENCY:


PLEASE COMPLETE THE FOLLOWING QUESTIONNAIRE:
INSPECTION:
Are inspection procedures conducted:

upon receipt?______ -in process?______


shipping?______

-before

2. Is specific criteria applied to inspection?


3. Are inspection procedures in writing?
4. Are records kept of inspection results?
DOCUMENTATION
1. Are procedures for document control in place?

______

2. Are manufacturing, service, inspection and test procedures available at point of use?

______

3. Are records kept of warranty and customer complaints?

______

EASA-Q:2000

NONCONFORMANCE:
1. Do you have a system of reporting and recording - Nonconformance?______

- Corrective Action?______

TRAINING
1. Are training records kept for all employees?______
2. Is training focused on quality improvement in manufacture and customer service?______

Thank you for completing this brief quality survey. Please return it to:
Insert your organization's contact and postal address

EASA-Q:2000
Registrar Selection
Part 1: Questionnaire
The following questions should be considered when selecting a Quality System Registrar.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

How many firms similar to ours have been registered by you?


Can you provide references from these organizations?
What is your philosophy regarding ISO 9000 registration?
How and where do you publicize the firms that you register?
What recourse do we have if we dont agree with audit results?
How frequently do you schedule surveillance audits?
What flexibility do you have regarding scheduled audit dates?
What are your initial fees for registration?
What other fees are involved and what are they applied to?
Do you perform the initial desk audit of our documentation on site?

Part 2
Registrar Comparison Table
Did the registrar:
RATING ITEM
#1
Respond to your query promptly?
yes/no
Answer all questions to your satisfaction?
yes/no
Indicate experience in your type of business?
yes/no
Focus on your needs?
yes/no
Offer publication of your registrations?
yes/no
Quote a firm registration fee?
$
Advise you of additional costs?
$
Provide recourse if audit results challenged?
yes/no
Indicate the number of surveillance visits per year?
1 2
Demonstrate a respectful, supportive philosophy?
yes/no
Provide flexible scheduling?
yes/no

#2
yes/no
yes/no
yes/no
yes/no
yes/no
$
$
yes/no
1 2
yes/no
yes/no

#3
yes/no
yes/no
yes/no
yes/no
yes/no
$
$
yes/no
1 2
yes/no
yes/no

Summary
Once selected, your registrar and your organization will have a long term relationship (for
so long as you maintain your ISO registration).
Remember that your selected registrar becomes your Supplier of Registration Services and as
such should be treated like any other subcontractor, i.e.:
They become part of your Approved Subcontractor List.
Their performance should be measured against criteria which you decide upon.
They are subject to having nonconformances related to their performance just
like any other organization providing services or products to you, and can be
replaced if considered unsatisfactory.

EASA-Q:2000
SPECIMEN FORM LETTER ISO ADVISORY TO A SUPPLIER
Dear____________:
To further our commitment to customer satisfaction by developing an effective quality
management system for our organization, (Name your organization) has initiated a quality
process designed to meet the requirements of the International Standard Organizations
ISO 9001:2000 quality management system standard.
An ISO requirement is that our suppliers be evaluated and their performance monitored for
compliance to our defined requirements. As an initial step towards meeting our needs, we
respectfully ask you to complete the enclosed supplier evaluation form and return it to us as soon
as possible. You will be notified in due course of our specific quality requirements for the supply of
goods and/or services.
We have appointed (enter name of person and title) as our Management Representative to whom
all quality matters should be referred.
We look forward to our mutually beneficial relationship being enhanced by our decision to
implement ISO 9001:2000.
Sincerely,
NB: This letter should be addressed to the CEO of the supplier's organization and, where
applicable, to their Quality Manager.

NONCONFORMANCE RECORD

Page __ of __
Revision 00

NC #

Originator:
Approved by:

Description

Original issue date:


Issued by:

Date Open

Date Closed

CAR ref.

Approved by

EXAMPLE WORK INSTRUCTION


APPLICATION AREA - WAREHOUSE
DATE ISSUED:
REVISION #:
APPROVED BY:
Note: this level of documentation is normally a controlled document within the quality system. If
needed, you can include a distribution list for it.
STEPS ACTIVITY
RESPONSIBILITY
1

Remove all loose items from the unit to be shipped

Shipper/Receiver

Secure all items subject to damage during transportation. Use


strapping bolts as needed.

Shipper/Receiver

Install all Keepers as indicated on Bill of Materials and/or


Engineering Drawings.

Mechanic

If shipment is by open flatbed, ensure skid is protected from


weather during transit.

Shipper/Receiver

Center the item on the skid to minimize protrusion beyond skid


dimensions and support any item subject to damage during
transportation.

Shipper/Receiver

Strap or bolt the unit securely to the skid.

Shipper/Receiver

Place loose items in suitable cartons. Use suitable fill to protect


items in the carton. Secure the cartons to the skid.

Shipper/Receiver

Cover the skid contents with stretch wrap.

Shipper/Receiver

Affix cautionary labels to all sides, e.g., DO NOT STACK,


LIFT HERE ONLY, etc.

Shipper/Receiver

10

Verify shipping documentation is correctly filled out

Shipper/Receiver

DATE

NONCONFORMANCE REPORT

Part/Item
Dept./Supplier
Qty. rejected

Part #
W.O.# / P.O.#
Serial #s
DESCRIPTION OF NONCONFORMANCE

Reported by:
DISPOSITION
Comments
Use as-is
Re-grade
Rework
Scrap
Other (specify)
Approved (Quality Manager)

Approved (Inspector)

Due date:
Re-inspected
Corrective action
Approved (Quality Manager)

CLOSE OUT
Inspector.
Inspection Report #
CAR #
Approved (Inspector)

Date:
Additional notes

Date:

Report #

DATE

CORRECTIVE/ PREVENTIVE ACTION REQUEST

Dept./Supplier:
Area / operation:
Originator:

Person responsible:

NONCONFORMING CONDITION

Reported by:
CORRECTIVE/PREVENTIVE ACTION

Approved (Quality Manager)

Approved (Inspector)

Due date:
Approved
Yes
No
Approved (Quality Manager)

FOLLOW UP
New due date:
Approved
Yes
No
Approved (Inspector)

Date:
Additional notes

Date:

Request #

Appendix A-09: Reference Standards


It is recommended that current copies of reference documents and standards applicable to the
technical operations and processes of the business be kept on-hand. The following is a list of
standards that may apply to your business. It is not intended to be a complete list of all
applicable standards.
EASA Documents
EASA-Q Quality Manual
Mechanical Repair Fundamentals
Internal Connection Diagrams
Principles of Large AC Motors
Root Cause Failure Analysis
Technical Manual
EASA Reference Standards
ANSI/ABMA 7 Shaft and Housing Fits for Metric Radial Ball and Roller Bearings (Except Tapered
Roller Bearings) Conforming to Basic Boundary Plans.
ANSI S2.41 Mechanical Vibration of Large Rotating Machines With Speed Ranges From 10 to
200 RPS. Measurement And Evaluation of Vibration Severity In Situ.
ANSI/EASA AR 100 Recommended Practice for the Repair of Rotating Electrical Apparatus
ANSI/NCSL Z540-1 CalibrationCalibration Laboratories and Measuring and Test Equipment
General Requirements.
ABMA 20 Radial Bearings of Ball, Cylindrical Roller and Spherical Roller Types - Metric Design
API 541 Form-Wound Squirrel Cage Induction Motors250 Horsepower and Larger
EASA AR 200 Guide for the Repair of Power and Distribution Transformers
IEC 60034-8 Rotating Electrical Machines, Part 8: Terminal Markings and Direction of Rotation
of Rotating Machines.
IEC 60072-1 Part 1Frame Numbers 56 to 400 and Flange Numbers 55 to 1080.
IEC 60136 Dimensions of Brushes and Brush-holders for Electric Machinery.
IEEE 4 Standard Techniques for High-Voltage Testing.
IEEE 43 IEEE Recommended Practice for Testing Insulation Resistance of Rotating Machinery.
IEEE 56 Guide for Insulation Maintenance of Large AC Rotating Machinery (10,000 kVA and
Larger)
IEEE 95 IEEE Recommended Practice for Insulation Testing of Large AC Rotating Machinery
with High Direct Voltage.

IEEE 112 IEEE Standard Test Procedure for Polyphase Induction Motors and Generators.
IEEE 113 Test Procedures for DC Machines
IEEE 115 IEEE Guide: Test Procedures for Synchronous Machines.
IEEE 432 IEEE Guide for Insulation Maintenance for Rotating Electric Machinery (5 hp to less
than 10 000 hp).
IEEE 522 IEEE Guide for Testing Turn-To-Turn Insulation on Form-Wound Stator Coils for
Alternating-Current Rotating Electric Machines.
IEEE 792 IEEE Recommended Practice for the Evaluation of the Impulse Voltage Capability of
Insulation Systems for AC Electric Machinery Employing Form-Wound Stator Coils.
IEEE 841 IEEE Standard for Petroleum and Chemical IndustrySevere Duty Totally Enclosed
Fan-Cooled (TEFC) Squirrel-Cage Induction MotorsUp to and Including 370 KW (500 HP)
IEEE 1068 IEEE Recommended Practice for the Repair and Rewinding of Motors for the
Petroleum and Chemical Industry.
ISO 2953 Mechanical vibration -- Balancing machines -- Description and evaluation
ISO 10012-1 Quality assurance requirements for measuring equipment. International
Organization for Standardization. Geneva, Switzerland, 1992.
ISO 1940-1 Mechanical Vibration - Balance Quality Requirements of Rigid Rotors.
ISO 1940-2 Determination of Permissible Residual Unbalance.
ISO 10816-1 Mechanical Vibration - Evaluation of Machine Vibration by Measurements on NonRotating Parts - Part 1: General Requirements.
MIL Std 167-1 Mechanical Vibrations of Shipboard Equipment
NEMA MG 1 Motors and Generators.
NEMA MG 2 Safety Standard and Guide for Selection, Installation, and Use of Electric Motors
and Generators
NFPA 70B Recommended Practice for Electrical Equipment Maintenance
NFPA 70E Standard for Electrical Safety Requirements for Employee Workplaces.
29CFR1910.331 - .335 OSHA: Electrical Safety-Related Work Practices.

Appendix A-10
Repair, Test, and Inspection Plan for AC Squirrel Cage Motors
The procedures for AC motor repair are included as suggested and effective means of
providing a quality motor repair. They are by no means intended to cover every category of
electrical rotating machine, but rather to provide examples upon which to develop similar
process descriptions for any electrical apparatus. The procedures are, however, based on
actual and successful application of their contents. For those service centers which may have
well documented procedures already, it is acceptable to substitute those in this manual for
your own providing their content meets the ISO 9001-2000 requirements.
TEST & INSPECTION PLAN-AC
REPAIR, TEST & INSPECTION PLAN FOR
AC SQUIRREL CAGE MOTORS
INCOMING INSPECTION - PART I
UPON RECEIPT
CONTROL TASK
To establish the condition of the motor upon receipt at the service center and record its receipt.
RESPONSIBILITY
The Shipper/Receiver.
REASON FOR CONTROL
Careful examination of the motor immediately upon receipt provides safeguards for both the
service center and the customer. The inspection can reveal obvious damage, evidence of
transit damage, or missing parts such as connection box covers, lifting eyebolts, etc. Digital
photographs are an excellent, low-cost method of recording these situations.
The motor nameplate detail is recorded which, together with the customer detail, provides
positive identification and the preparation of a job card/service order set.
Recording this information prevents any potential dispute by allowing prompt detection of any
damage of which the customer may not be aware (e.g., damage in transit) and thus the
customer can be advised of this type of damage prior to repairs being started. This protects the
customer from unexpected additional repair cost.
MEASURING EQUIPMENT REQUIRED
No measuring is normally expected. A digital camera is recommended.
RECORDING DOCUMENT
(Specify document by description, form # etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
None applicable.

RECEIVING AREA PROCEDURE


1.0

All motors shall be visibly inspected upon receipt. When necessary, photographs may
be taken to serve as records of damage, missing items or ancillary fittings.* Such
photographs may be taken using a digital camera.

1.1

In all instances, details of incoming condition shall be recorded in writing on


appropriate documents.

1.2

The carrier driver and the customer shall be notified immediately of any
obvious damage noted upon receipt. The customer shall be notified of any
obviously missing parts.

Ancillary fittings are defined as attached or installed gearboxes, pulleys, couplings,


other than the items comprising the motor itself.

INCOMING INSPECTION - PART II


INITIAL INSPECTION AND TEST (Incoming Inspection cont.)
CONTROL TASK
To establish the electrical and mechanical condition of the incoming motor prior to dismantling.
RESPONSIBILITY
Dismantler/Mechanic.
REASON FOR CONTROL
A careful inspection and test of the motor's mechanical and electrical condition should reveal
whether the motor requires rewinding, a general evaluation of the bearing condition and also
the condition of the exposed shaft and keyway. This information helps reduce delay in
processing the job.
MEASURING EQUIPMENT REQUIRED
Dial indicator, megohmmeter, outside micrometer (to suit shaft size), voltmeter, ammeter,
tachometer, vibration measuring device.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

INITIAL INSPECTION & TEST (Incoming Inspection cont.)


2.0

Check motor shaft for freedom to turn, end play, shaft extension run out (see
ANSI/EASA AR100 for guidance) and damage. Record "As Found"
conditions.
2.1

Apply a megohmmeter test to the windings using a 500V


megohmmeter for machines rated up to 2400V and record the results.
For machines rated above 2400V, a 1000V megohmmeter is
recommended. (See ANSI/EASA AR100 for guidance)

2.2

Examine all leads and connections. Record condition and any special
configuration.

2.3

If the megohmmeter reading is satisfactory and the stator windings


check out for continuity, an exploratory no-load run of the motor may
be conducted.

2.4

Energize the motor momentarily to establish rotation direction and


listen for any rubbing or excessive noise. Energize the motor with a
reduced voltage and accelerate the motor by increasing the voltage
slowly. Record voltage, current per phase, R.P.M., vibration levels.
After the motor comes to rest, apply a reduced single-phase voltage
and current. Rotate the shaft slowly and note any deflection on meters
which may indicate broken bars.

2.5

Record full nameplate data.

INCOMING INSPECTION - PART III


INITIAL INSPECTION AND TEST (Incoming Inspection cont.)
CONTROL TASK
To establish the electrical and mechanical condition of all internal components of the motor.
RESPONSIBILITY
Dismantler/Mechanic.
REASON FOR CONTROL
A careful inspection and test of the motor's internal mechanical and electrical condition should
reveal any further problems and thus allow a detailed estimate to be prepared for the customer.
It also allows the service center scheduler to plan the repair with greater efficiency, order the
right amount of materials and new parts and thus reduce delay in processing the job.
MEASURING EQUIPMENT REQUIRED
Various inside and outside micrometers to suit the motor shaft and bearing sizes, feeler
gauges, core loss testing equipment, high-potential tester and surge testers, growler,
megohmmeter.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

DISMANTLE AND INSPECT PROCEDURE


3.0

Carefully examine all parts as they are removed. Record the condition of all machined
surfaces. Where applicable, record coupling/pulley/gear position on the shaft. Mark the
shaft if practical also. Check fan security.
3.1

Measure and record "As Found" condition and dimensions of bearings and
housings. Record position of spring or wave washers, thrust direction and any
spacers within the bearing assemblies. Check and record any stator/rotor
interference (rubbing/scoring caused by bearing failure).

3.2

Check shaft security to rotor. Record findings.

3.3

Check rotor for loose or broken bars (growler test). Check for damaged end
rings, etc. Record findings.

3.4

If the motor is not being rewound, all parts and windings shall be thoroughly
cleaned free of dirt, grit, grease and oil with appropriate cleaning agents. It is
important to remove all traces of cleaning agents and to ensure that all parts
are completely dry. Conduct megohmmeter, high-potential, surge and reduced
voltage three-phase balance tests on the stator.
Note: For a high-potential test, leads NOT being tested should be connected to
the motor frame.

3.5

If the motor windings are to be removed, conduct a core loss test prior to burn
out and removal of the old winding (EASA Tech Note 17 provides guidance).

3.6

If the motor windings are to be removed, carefully measure and record the coil
dimensions: inside nose-to-nose, core length and coil extensions. Cut off the
connection end of the winding and put aside for reference during connection of new
windings.

3.7

Prepare windings for removal from the core using a controlled heat oven. Do
not exceed a core temperature of 680oF

3.8

Remove old windings and clean out slots. Check for any raised, loose or
damaged laminations (EASA Tech Note 16 provides guidance).

3.9

Conduct a second Core Loss test. Record the result and compare with initial
reading. Any significant deterioration in values shall be corrected with
appropriate repair methods (EASA Tech Note 17 provides guidance).

IMPORTANT
Where new windings are required, these should be manufactured using suitable winding
equipment and using only new copper magnet wire of the correct dimension and dielectric
coating specification. Do not change the dimensions, specification or design without careful
consideration of possible effects on stray losses and winding resistance. Use a micrometer to
measure bare wire diameter, not a wire gauge.
To prevent duplicating an incorrect winding, compare the data taken to data on file (EASA
Winding Data CD for example), or calculate flux and current densities and compare with similar
machines.
EASA Tech Note 16 provides guidance on this and other related matters.
Replacement rotor bars and end rings must have the same resistance values as the originals.

PRE-ASSEMBLY INSPECTION AND TEST (In-Process inspection)


CONTROL TASK
To establish that all components have been satisfactorily serviced or repaired prior to
re-assembly of the motor.
RESPONSIBILITY
Assembler/Mechanic.
REASON FOR CONTROL
A careful inspection and test of the components after mechanical and electrical repairs have
been completed, but before final assembly, greatly reduces the need to dismantle the motor at
a later time for the purpose of making corrections. Also, careful attention to this control guards
against the possible repeating of tests already made which could cause unnecessary stress to
the windings.
MEASURING EQUIPMENT REQUIRED
Growler, megohmmeter, high-potential tester and surge testers.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

PRE-ASSEMBLY INSPECTION & TEST PROCEDURE


4.0

After completion of coil winding, wedging and connecting, but before treatment, the
following tests shall be performed and the results recorded (refer to test criteria in
ANSI/EASA AR100).
a.
b.
c.
d.

Megohmmeter test.
High-potential test.
Surge comparison test.
Reduced voltage three-phase balance test.

If the results are satisfactory, the stator can be treated.


If test failure occurs, process as nonconformance and HOLD until satisfactory
disposition is complete.
4.1

On completion of the winding treatment and bake process, visually inspect the
windings for satisfactory coating quality (even coating, no runs or drips).

4.2

Conduct a "growler test" on the rotor as a check prior to assembly.

4.3

Collect any new parts (e.g., bearings etc.). Verify that the parts are the correct
replacements by comparing with the old parts or to manufacturer's assembly
drawings or specifications. Collect all components into the assembly area.
Ensure that adequate tooling and space exists to proceed with the assembly.

4.4

Check that all fitted surfaces are clean and free of nicks and burrs, and that there
is no varnish build up on the rotor surfaces.

4.5

At this stage, windings and internal surfaces may be painted with appropriate
paints and lacquers to improve the sealing and appearance.

ASSEMBLY
CONTROL TASK
To assemble the motor and prepare for final testing prior to returning the motor to the customer.
RESPONSIBILITY
Assembler/Mechanic.
REASON FOR CONTROL
Re-assembly of a motor after repair is an important stage in the process. Control at this point is
essential to ensure that all components are correct and fully functional so that the motor will
operate correctly and reliably when returned to service with the customer. This care in turn
prevents wasted time and allows delivery as promised by removing the possibility of rework
caused by poor repair or overlooked detail, thus benefiting both customer and the service
center.
MEASURING EQUIPMENT REQUIRED
Thermometer (to establish bearing temperature for installation), feeler gauges, dial indicator
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

ASSEMBLY PROCEDURE
5.0

For motors with ball or roller bearings, gently heat the bearing inner races to a
maximum of 225oF using an approved service center method. Install the bearings with
identification numbers facing out. After the inner race has cooled, install remaining
bearing components.
5.1

Once assembled, pack the bearings with a high grade of grease to customer or
motor manufacturer specifications (generally 1/3 full).

Note: Lubricating oil for sleeve-type bearing assemblies is installed as a final step prior
to final test.
5.2

Check match marks on the motor frame and insert the rotor into the stator bore
ensuring that the drive end of the shaft is at the drive end of the motor frame.

5.3

Check end bracket and frame spigot (frame rabbet) surfaces and lightly lubricate
to facilitate installation. Check for dowel pins and align accordingly during
assembly.

5.4

Install frame bolts and tighten evenly to prevent stress on brackets.

5.5

Align inner bearing caps and install outer caps. Half fill each outer cap with the
same grease used to pack the bearings. Tighten bolts in a uniform manner to
prevent uneven stress on the bearings.

5.6

Check overall alignment by rotating the rotor by hand to ensure freedom from
rubbing or undue friction. Check and record sleeve bearing clearances.

Note: Install oil in sleeve bearings BEFORE rotating shaft.


5.7

Check and record shaft end play and run out (see ANSI/EASA AR100 for
guidance).

5.8

Make all lead connections secure and ensure that identification tags have been
attached (usually done by the winding dept.).

Note: Couplings, gears or pulleys should NOT be installed until after successful final
tests are completed on the motor. This saves time should the motor require
dismantling to correct a fault detected during the final test procedures.

FINAL TEST
CONTROL TASK
To inspect and no-load test run the repaired motor before returning the motor to the customer.
RESPONSIBILITY
Inspector/Tester.
REASON FOR CONTROL
The customer depends on the service center to provide a quality serviced motor which will
perform reliably and within the nameplate specifications. The no-load test is a key element used
to assess the motor after servicing and to determine that the above conditions are met. Careful
control of the no-load test and inspection ensures compliance to these requirements by
checking to see that the motor turns freely in its bearings without excessive friction or
overheating, that the dynamic balance is sufficient to contain vibration within acceptable limits,
that the speed is correct and that measured electrical parameters meet the given nameplate
ratings.
MEASURING EQUIPMENT REQUIRED
Megohmmeter, high-potential tester, volt/ohmmeter, ammeter, tachometer, wattmeter, vibration
measuring equipment, thermometer, dial indicator.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

FINAL TESTING PROCEDURE


6.0

Review all preceding test and inspection documentation to verify that all required test
and inspections have been completed. HOLD further testing until documents have
been cleared.
6.1

Perform and record a megohmmeter test on all windings in accordance with


customer specifications or test criteria provided in ANSI/EASA AR100. Include
RTD's, thermo-couples etc.

6.2

Perform and record a high-potential test on all windings in accordance with


customer specifications or criteria provided in ANSI/EASA AR100.

Note: All leads NOT being tested must be connected to the motor frame.
6.3

Upon successful completion of the high-potential test, conduct a second


megohmmeter test on the windings. Resistance measured should be equal to or
greater than the first megohmmeter readings.

6.4

Check continuity and resistance of space heaters, RTD's or similar devices.


Energize space heaters and check for normal current flow.

6.5

Measure and record winding resistance. Correct for temperature and compare to
commercial values or calculated values. For wound rotors, record open circuit
volts. (To run, short out rotor winding and operate as a squirrel cage motor.)

6.6

Conduct a single phase rotor test and record result.

6.7

After completing all pre-running inspection and testing, follow safe practice
standards and connect the motor to suitable power leads for a no-load running
test.

6.8

Energize the motor momentarily to establish the direction of rotation and to


determine if there are any rubbing sounds or unusual noises. To keep inrush
current to a minimum, use a reduced voltage and energize slowly. Check for any
signs of excessive vibration or higher than normal currents. If all appears in
order, bring the motor to full rated voltage. Continuously monitor the stator
current to ensure that it does not become excessive.

6.9

After reaching rated voltage, monitor bearing temperature and vibration. Verify
that shaft-mounted blowers are moving air in the correct direction. For sleeve
bearings, check that the oil rings are free and that the lubricant is reaching the
bearing surfaces.

6.10 With the motor running no-load, at its rated voltage, measure and record the
following:
a.
b.
c.
d.
e.
f.
g.

Stator line voltage;


Stator line current;
Input watts;
R.P.M.;
End play, check and mark flotation at magnetic center;
Vibration amplitude in horizontal, vertical and axial directions;
Safely accessible bearing housing temperatures (every 15 minutes).

FINAL TESTING PROCEDURE (cont'd)


Compare these results with commercial test values, customer specifications,
nameplate data or accepted service center values.
Note:

Typical running times on test should not be less than:


>
>
>

6.11

One hour for sleeve bearing motors or until temperatures are


stabilized.
15 - 30 minutes for spherical roller or ball bearing motors.
Motors with cylindrical roller bearings or bearings fitted with
cooling jackets should only be run a few minutes.

Upon completion of successful final testing, the motor shall be stopped,


disconnected from the power supply, painted and prepared for shipment.

TEST & INSPECTION FLOWCHART


FOR
AC MOTORS

1.0 RECEIPT

2.0 INITIAL INSPECTION & TEST

3.0 DISMANTLE & INSPECT

3.5 CORE TEST

3.7 BURN OUT OLD WINDINGS

3.9 CORE TEST

REWIND & CONNECT

4.0 PRE-ASSEMBLY INSPECTION & TEST

5.0 ASSEMBLY

6.0 FINAL TEST

PREPARE FOR
SHIPPING

SHIP

SYMBOLS

x
*

OPERATION STAGE
INSPECTION

OPERATION & INSPECTION


INSPECTION & TEST

DENOTES A HOLD POINT

Appendix A-11
Repair, Test, and Inspection Plan for DC Motors
Note:
The procedures for DC motor repair are included as suggested and effective means of
providing a quality motor repair. They are by no means intended to cover every category of
electrical rotating machine, but rather to provide examples upon which to develop similar
process descriptions for any electrical apparatus. The procedures are, however, based on
actual and successful application of their contents. For those service centers which may have
well documented procedures already, it is acceptable to substitute those in this manual for
your own providing their content meets the ISO 9001-2000 requirements.
TEST & INSPECTION PLAN-DC
REPAIR, TEST & INSPECTION PLAN FOR
DC MOTORS
INCOMING INSPECTION - PART I
UPON RECEIPT (Incoming Inspection for motor servicing)
CONTROL TASK
To establish the condition of the motor upon receipt at the service center and record its receipt.
RESPONSIBILITY
The Shipper/Receiver.
REASON FOR CONTROL
Careful examination of the motor immediately upon receipt provides safeguards for both the
service center and the customer. The inspection can reveal obvious damage, evidence of
transit damage, or missing parts such as connection box covers, lifting eyebolts etc. Digital
photographs are an excellent. low-cost method of recording these situations. The motor
nameplate detail is recorded which, together with the customer detail, provides positive
identification for the preparation of a job card/service order set. Recording this information
prevents any potential dispute by allowing prompt detection of any damage which the customer
may not be aware of (e.g., damage in transit) and thus the customer can be advised of this type
of damage prior to repairs being started. This protects the customer from unexpected additional
repair cost.
MEASURING EQUIPMENT REQUIRED
No measuring is normally expected. A digital camera is recommended.
RECORDING DOCUMENT
(Specify document by description, form # etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
None applicable.

RECEIVING AREA PROCEDURE


1.0

All motors shall be visibly inspected upon receipt. When necessary, photographs may
be taken to serve as records of damage, missing items or attached fittings. Such
photographs may be taken using a digital camera.
1.1 In all instances, details of incoming condition shall be recorded in writing on
appropriate documents.
1.2 The carrier driver and the customer shall be notified immediately of any obvious
damage noted upon receipt. The customer shall be notified of any obviously
missing parts.

INCOMING INSPECTION - PART II


INITIAL INSPECTION AND TEST
CONTROL TASK
To establish and record the electrical and mechanical condition of the incoming motor prior to
dismantling.
RESPONSIBILITY
Dismantler/Mechanic.
REASON FOR CONTROL
A careful inspection and test of the motor's mechanical and electrical condition should reveal
whether the motor requires rewinding, a general evaluation of the bearing condition and also
the condition of the exposed shaft and keyway. This information helps reduce delay in
processing the job.
MEASURING EQUIPMENT REQUIRED
Dial indicator, megohmmeter, outside micrometer (to suit shaft size), voltmeter, ammeter,
tachometer, vibration measuring device, feeler gauge set, digital low-resistance ohmmeter
(DLRO) or Wheatstone bridge.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

INITIAL INSPECTION & TEST PROCEDURE


2.0

Record full nameplate data.


2.1

Check motor shaft for freedom to turn, end play and damage. Record "As
Found" conditions.
Apply megohmmeter tests to the windings (e.g., winding to ground, coil to coil).
See ANSI/EASA AR100.
Record the results.
Examine leads and connections. Record condition and any special
configuration.
Inspect brush rigging for cracks or other damage and check if the neutral
position is marked. If not, mark for reference in re-assembly.
Check and record air gaps.
Inspect commutator for loose bars or other damage.
Perform a continuity test on the field windings. Record the results.
Measure and record winding resistances.

2.2

If megohmmeter readings are satisfactory, an exploratory no-load running test


may be performed. A variable DC power supply for the armature and for the
field are required to perform a running test.

2.3

Prior to running tests, check neutral setting. Record input volts at brushes and
output volts at A1 and A2.

2.4

During run test, check for sparking at the commutator; if severe, recheck
neutral and interpole polarity. Record armature voltage and current, and field
voltage and current at low speed. If safe to do so, record readings at high
speed, include tachometer reading and vibration levels.

Note:

Refer to paragraph 6.9 (Final Testing) for safe procedures.

INCOMING INSPECTION - PART III


DISMANTLE AND INSPECT
PURPOSE
To determine the condition of internal components.
RESPONSIBILITY
Assembly mechanic.
REASON FOR CONTROL
A careful inspection and test of the motor's internal mechanical and electrical condition should
reveal any further problems and thus allow a detailed estimate to be prepared for the customer.
It also allows the service center scheduler to plan the repair with greater efficiency, order the
right amount of materials and new parts, thus reducing delay in processing the job.
MEASURING EQUIPMENT REQUIRED
Various inside and outside micrometers to suit motor shaft and bearing sizes, feeler gauge set,
DLRO or Wheatstone bridge, high-potential and surge testers. DC voltmeter, DC ammeter,
megohmmeter, balancing equipment.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor received for repair or servicing.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

DISMANTLE & INSPECT PROCEDURE


3.0

Carefully examine all parts as they are removed. Record condition and any detail which
will ensure correct reassembly after repair.
3.1

Measure and record "As Found" dimensions and condition of bearings and
housings. Record positions of spring or wave washers, thrust direction and any
spacers within the bearing assembly.

3.2

Check shaft security to armature. Check fan security. Record if loose.

3.3

Check security of commutator to armature assembly.

3.4

If the motor is not being rewound, all parts and windings shall be thoroughly
cleaned free of dirt, grit, grease and oils with appropriate cleaning agents. It is
important to remove all traces of the cleaning agents and ensure that all parts
are properly dry. Volt drop test armature and DLRO test winding bar-to-bar.
Perform megohmmeter, high-potential and surge tests on the armature.
Perform megohmmeter, high-potential, surge, voltage drop test, polarity and
coil resistance on field windings. Record the results.

3.5

If no armature dismantling is involved, check armature dynamic balance.


Correct if required.

PRE-ASSEMBLY INSPECTION & TEST


IN-PROCESS INSPECTION
PURPOSE
To ensure work done on components has been satisfactorily completed prior to assembly.
RESPONSIBILITY
Assembly mechanic.
REASON FOR CONTROL
A careful inspection and test of the components after mechanical and electrical repairs have
been completed but before final assembly greatly reduces the need to dismantle the motor at a
later time for the purpose of making corrections. Also, careful attention to this control guards
against possible repeating of tests already made which could cause unnecessary stress to
windings etc.
MEASURING EQUIPMENT REQUIRED
DLRO, megohmmeter, high-potential and surge testers, voltmeter, ohmmeter, feeler gauges,
polarity test device, outside micrometer (to check shims).
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.
NOTE: Any defect or test failure noted while conducting the following tests and inspections will
be processed as nonconformances and the work placed on HOLD until a satisfactory
disposition is completed.

PRE-ASSEMBLY INSPECTION & TEST PROCEDURE


4.0

Armatures
After completion of winding/cleaning, baking, treating, turning, undercutting and
beveling processes, visually inspect the armature for cleanliness, coating quality and
commutator surface condition.
4.1

Perform the following tests and record the results.


a.
Bar-to-bar DLRO test;
b.
Megohmmeter test (see ANSI/EASA AR100);
c.
High-potential test (see ANSI/EASA AR100);
d.
High frequency surge comparison test (see ANSI/EASA AR100).

4.2

DC Field Coils
Before installation of the field poles, the field windings shall receive the
following tests:
a.
b.
c.
d.
e.

4.3

Measure coil resistance. Compare poles to check correct number


of turns;
DC drop test (max. variation +/- 5%);
AC drop test (max. variation +/- 10%);
Megohmmeter test (see ANSI/EASA AR100);
High-potential test (see ANSI/EASA AR100).

DC Field Coils - Stationary Field Poles


Remove all sharp edges from the pole piece, and install the coil. Check the
tightness of fit and shim if required. Check the mounting areas in the frame to
ensure that they are clean and free of obstruction.
It is important to match each group of shims (magnetic and non-magnetic),
springs and/or spacers to its corresponding field pole to ensure pole spacing
and air gaps are returned to the original.
Compare the location match marks of each pole piece to its corresponding
mark on the frame and install the field poles to their original location. Take care
to protect the windings from knocks etc. during installation.
After all field poles are bolted in place, perform a megohmmeter test on the
windings in accordance with ANSI/EASA AR100 and check insulation
resistance between field coils (shunt, series etc.).
Connect field pole leads, making sure to have polarity reversed for adjacent
poles of the same type. Series or interpole leads should be connected and
routed first as these are easier to form and can be used as supports to tie
shunt leads to.
AC volt drop test and surge test field coils. Note: If coil inductance makes the
AC test inconclusive, perform a DC voltage drop test.

PRE-ASSEMBLY INSPECTION & TEST PROCEDURE (contd)


4.4

Conduct a polarity test to ensure that the polarity of each pole is opposite the
polarity of the poles on either side (North - South).
Perform a megohmmeter test as per ANSI/EASA AR100.
Perform a high-potential test as per ANSI/EASA AR100.
Note: If not all coils have been rewound, be sure to
use the reduced percentage multiplier.
Perform AC volt drop test and surge test on field coils.

ASSEMBLY
CONTROL TASK
To assemble the motor and prepare for final testing.
RESPONSIBILITY
Assembly mechanic.
REASON FOR CONTROL
Re-assembly of a motor after repair is an important stage in the process. Control at this point is
essential to ensure that all components are correct and fully functional so that the motor will
operate correctly and reliably when returned to service with the customer. This care, in turn,
prevents wasted time and allows delivery as promised by removing the possibility of rework
caused by poor repair or overlooked detail, thus benefiting both customer and the service
center.
MEASURING EQUIPMENT REQUIRED
Bearing heater, thermometer, dial indicator, steel rule, feeler gauges, spring gauge.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

ASSEMBLY PROCEDURE
5.0

Collect any new parts and verify that they are the correct replacements by comparing
with the old parts or to manufacturer's assembly drawings or specifications.
Collect all components into an assembly area. Ensure that adequate tooling and space
exists to proceed with the assembly.
5.1

Check that all fitted surfaces are clean and free of nicks and burrs, and that there
is no varnish build up on the pole faces of both armature and field coils.

5.2

At this stage, windings and internal surfaces can be painted with appropriate
lacquers or paint to improve sealing and appearance where required.

5.3

Install brush holder assembly. (Where assembly is adjustable, check the match
mark for neutral before installing.) Adjust the brush holders to provide the
maximum installation clearance over the commutator.

5.4

Check match marks on the motor frame and insert the armature into the frame
bore ensuring that the drive end of the shaft is at the drive end of the frame.
Protect the commutator from damage by wrapping with heavy paper.

5.5

For motors with ball or roller bearings, gently heat the bearing inner races to a
maximum 225oF using an approved service center method such as an induction
bearing heater. Install bearings with identification numbers facing out. After the
inner race has cooled, install remaining bearing components.

5.6

Once assembled, pack the bearings with a high grade grease to customer or
motor manufacturer's specifications (usually 1/3 full).
Note: Lubricating oil for sleeve type bearing assemblies is installed as a final
step prior to final testing.

5.7

Check end bracket and frame spigot surfaces and lightly lubricate to facilitate
installation. Check for dowel pins and align accordingly during assembly.

5.8

Install frame bolts and tighten evenly to prevent stress on brackets.

5.9

Align inner bearing caps and install outer caps. Half fill each outer cap with the
same grease used to pack the bearing. (See EASA Tech Note 19 for guidance.)
Tighten bolts in a uniform manner to prevent uneven stress on the bearing.

5.10 Check and record shaft end play. Check shaft extension run out and check
commutator run out (see ANSI/EASA AR100 for guidance).
5.11 Make all lead connections secure. Attach identification tags as required.
5.12 Adjust brush holders so that they are parallel with the commutator and have a
clearance of not more than 1/8" and not less than 3/32". Install brushes, checking
snugness and freedom to slide in their holders. Note: ensure all brushes are the
same grade.

ASSEMBLY PROCEDURE (cont'd)


5.13 Adjust spring tension for uniform pressure according to the type and grade of
brushes used. Check that the brushes are centered on the commutator.
Seat the brushes using various grades of garnet paper (face to brush). Finish
with a fine grade. Vacuum out loose dust.
Note: Couplings, gears and pulleys should NOT be installed until after final tests
have been successfully completed. This saves time should the motor require
dismantling to correct a fault detected during final testing.

FINAL TEST
CONTROL TASK
To inspect and no-load test run the motor and ensure that it performs to the required
specifications before returning it to the customer.
RESPONSIBILITY
The test technician (Supervisor or Quality Control inspector).
REASON FOR CONTROL
The customer depends on the service center to provide a quality serviced motor which will
perform reliably and within nameplate specifications. The no-load test is a key element used to
assess the motor after servicing and to determine that the above conditions have been met.
Careful control of the no-load test and inspection ensures compliance to these requirements by
checking to see that the motor turns freely in its bearings without excessive friction or
overheating, that the dynamic balance is sufficient to contain vibration within acceptable limits,
that the speed is correct and that measured electrical parameters meet the given nameplate
ratings.
MEASURING EQUIPMENT REQUIRED
Feeler gauges, dial indicator, megohmmeter, high-potential tester, voltmeter, ohmmeter,
tachometer, thermometer, vibration measurement device.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
See ANSI/EASA AR100.

FINAL TEST PROCEDURE


6.0

Review all preceding test and inspection documentation to verify that all required test and
inspections have been completed. HOLD further testing until documents have been
cleared.
6.1

Megohmmeter test all windings in accordance with customer specifications or as


per criteria provided in ANSI/EASA AR100.
Record results.

6.2

High-potential test all windings in accordance with customer specifications or as


per criteria provided in ANSI/EASA AR100.
Record results.
Note: All leads NOT being tested shall be connected to the motor frame.

6.3

Upon successful completion of the high-potential test, conduct a second


megohmmeter test on the windings. Resistance measured should be equal to or
greater than the first readings.

6.4

Check continuity and resistance of space heaters, RTD's and similar devices.
Energize space heaters and check for normal current flow.

6.5

Measure and record winding resistance, correct for temperature and compare with
commercial test values or calculated values.

6.6

Visually inspect brush rigging for:


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Brush holder clearance to commutator;


Security of holder to bracket;
Brush alignment;
Equal brush spacing;
Correct spring tension;
Correct seating brush to commutator.

Check that the armature and interpoles are connected to provide correct interpole
polarity.
Check that the assembly has been set to the correct neutral position. If required,
electrically reset neutral by using the DC kick neutral method or the AC induced
voltage method.
6.7

Measure and record air gaps. The air gap length on like poles must be equal.

6.8

After completing all pre-run inspection and testing, follow safe practice standards
and connect the motor to suitable power leads for a no-load run test.
Shunt or Compound Motors
Apply rated voltage to the field circuit and then from a separate source, slowly
increase armature voltage to rated voltage. Check for any signs of excessive
vibration or higher than normal currents.

FINAL TEST PROCEDURE (cont'd)


Series Motor
Using a low-voltage, high-current source, separately excite the series field
circuit to provide for its operation as a shunt motor. When and as able,
apply full series field current (i.e. Rated load current) to simulate full load
speed. With the series field current adjusted in this manner, gradually
increase armature voltage to nameplate rating.
Caution: Care must be used when energizing an unloaded DC series
motor to prevent over-speeding.
6.9

After reaching rated speed, monitor bearing temperatures and vibration.


Verify that shaft mounted blowers are moving air in the right direction. For
motors fitted with sleeve type bearings, check that the oil rings are free and
turning, and that the lubricant is reaching the bearing surfaces.

6.10 With the motor running at its rated no-load speed, measure and record the
following:
a.
b.
c.
d.
e.
f.
g.
h.
i.

Armature voltage;
Armature current;
Field voltage;
Field current;
R.P.M.
End play;
Vibration amplitude in horizontal, vertical and axial directions;
Bearing temperature and ambient temperature;
For motors with dual speed operation (field weakening) repeat test
at maximum RPM.

Compare results with commercial test values, customer specifications,


nameplate data or accepted service center values.
Note 1:

Typical running time on test should not be less than one hour or
whatever is practical to allow bearing temperatures to settle. (See
Section 6.10 of TEST & INSPECTION PLAN-AC for more detailed
recommendations on run times.)

Note 2:

Shunt or compound motors operated at no-load with rated field and


armature voltage should typically have an armature current not
exceeding 5% of rated full-load current. For motors with large
shaft-mounted blowers, the armature current should not exceed 10% of
full-load current.

Note 3:

Series motors operated at no-load and rated speed with reduced


armature voltage should typically not have the product of the measured
armature current and voltage exceed 5% of the full load product (10%
for motors with large blowers). This test is not the same as the series
motor test described in Section 6.9.

6.11

Upon completion of successful final testing, the motor shall be stopped,


disconnected from the power supply and prepared for shipment.

TEST & INSPECTION FLOWCHART


FOR
DC MOTORS

1.0 RECEIPT

2.0 INITIAL INSPECTION & TEST

3.0 DISMANTLE & INSPECT

ARMATURE

FIELD COILS

3.4 ARMATURE COILS

INSPECT COILS

3.5 COMMUTATOR

REWIND (IF REQ'D)

REWIND (IF REQ'D)

4.1 INSPECT

4.2 TEST

4.3 TEST

REASSEMBLE

4.5 INSPECT & TEST

ASSEMBLE

6.0 FINAL TEST

PREPARE FOR SHIPPING

SHIP

Appendix A-12
Sample Process Control Procedures

PROCESS CONTROL
The main objective of having a documented process is to help eliminate the variations which can
creep into day-to-day work by providing standardized guidelines and procedures designed to
assist you in meeting customer expectations of reliability and quality. The basic intent is to identify
what is to be done, when and by whom.
The guidelines provide recommendations for procedures at each significant stage of the work
process which can help achieve the desired service quality level. While they have been compiled
from actual experience from a variety of sources, they, like anything else, can be improved upon.

TEST & INSPECTION PLAN-1


PREPARATION FOR SHIPPING
CONTROL TASK
To ensure that the motor, having successfully completed its final test and inspection, is now
suitably prepared for shipping back to the customer.
RESPONSIBILITY
Shipper/Receiver.
REASON FOR CONTROL
The customer depends on the service center to deliver a quality serviced motor to the correct
address, with correct documentation and in good condition. Proper preparation is essential to
meet these expectations. The benefits to the customer are obvious. The benefits to the service
center are: creating trust as a reliable and concerned supplier, and effective cost control by
getting the delivery "right, the first time."
MEASURING EQUIPMENT REQUIRED
None.
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every motor serviced or repaired.
TEST SPECIFICATIONS
None.

PREPARATION FOR SHIPPING PROCEDURE


1.0

Shipping personnel, under the supervision of the Service Center Foreman, shall ensure
that the items to be shipped are correctly identified, marked and recorded on the
appropriate documentation. This documentation would normally comprise as a
minimum:
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1.1
1.2

Where jurisdiction requirements apply, all necessary permits, licenses and


authorizations shall be obtained to allow proper delivery to the consignee.
Where required, or specified in the contract, protective measures and materials
shall be applied to the items for shipment sufficient to prevent damage from
environmental and normal transit damage. Protective measures may include
several or all of the following:
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1.3

Packing slip;
Carrier documentation (if subcontracted transport);
Where applicable, special instructions for installing, and/or commissioning
the repaired motor;
Prominently displayed warnings (if applicable) to be attached to the motor
(e.g., no oil in bearings).

Securing the motor to a skid or frame to allow removal by forklift should the
customer's facility not be equipped with direct lift cranes.
Securing the shaft by "blocking" to prevent possible vibration damage to
bearings, especially if the delivery is over rough road surfaces (e.g.,
delivery to a construction or mining site).
Covering the motor with weatherproof material, or sealing blower vents etc.

All shipping consignments shall be recorded on appropriate documentation.


(Specify your documents used).

TEST & INSPECTION PLAN-2


INSPECTION OF INCOMING MATERIAL
CONTROL TASK
To ensure that all products and material purchased by the service center for application to
motor repair are verified as being correct and conforming to specified requirements, are
received undamaged, and that the correct quantities have been received.
RESPONSIBILITY
Shipper/Receiver (Machinist for machined parts).
REASON FOR CONTROL
Identification of problems with products or material immediately upon receipt reduces the
possibility of wasted time and effort in the repair process by ensuring that the items received
are what was ordered and can be properly allocated to a job. If there is a problem noted upon
receipt, prompt correction will prevent possible delay. Inspection of incoming items also ensures
that any damage detected is corrected without delay. Benefit to the customer is that this
process contributes to on-time delivery. Benefit to the service center is more effective cost
control by reducing delay in the repair.
MEASURING EQUIPMENT REQUIRED
Scale (for weighing bulk items), measuring tape, micrometer (to verify magnet wire size).
RECORDING DOCUMENT
(Specify document by form #, description etc.)
FREQUENCY
Every incoming shipment of products or items used in the service process.
TEST SPECIFICATIONS
Comparison to purchase order issued, packing slip. Units of measure as applicable.

INCOMING MATERIAL INSPECTION PROCEDURE


1.0

Receiving personnel, under the supervision of the Service Center Foreman, shall
ensure that items and/or materials received are verified as matching specifications
and fitness for use. In addition, objective evidence that the material was produced to a
specific quality standard, or certification level documentation from an approved source
shall be required if the application of the received items is to a contract governed by a
recognized quality assurance standard. Where applicable, jurisdictional safety
regulatory documentation shall be required also (e.g., MSDS Material Safety Data
Sheet).
1.1

Any damage or shortages shall be promptly reported to the Service Center


Foreman who will advise purchasing department to contact the supplier and
implement effective corrective action.

1.2

Where incoming materials are destined for specific jobs, they will be clearly
marked with the appropriate job number.

1.3

Upon satisfactory inspection, materials documentation shall be approved and


signed as accepted and located to appropriate storage facilities.

1.4

Any materials not fully conforming shall be held and, where applicable, placed
in suitable quarantine storage to await satisfactory disposition. Non-conforming
items shall be processed per procedures described.

1.5

Inspection upon receipt shall be applicable to, but not limited to, the following
material:
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Magnet Wire (verify wire size, varnish coating criteria, damage, length on
spool per label);
Anti-friction bearings (correct specification, exterior packing damage,
quantity etc.);
Insulating materials, preformed (correct specifications, quantity, size,
damage etc.);
Preformed coils (correct specifications, quantity, damage etc.);
Machined items (correct specifications, quantity, damage etc.);
Varnishes, paints, resins (correct specifications, safety and conformance
to jurisdictional requirements governing this type of product, quantity).

TEST & INSPECTION PLAN-SP


SPECIAL PROCESS*
VARNISH DIPPING PROCESS
1.0

PERSONNEL
All persons performing varnish dipping shall be suitably trained and experienced in all
aspects of the process.

2.0

WORK AREAS
The dipping area shall be maintained in a clean and orderly condition at all times.
2.1

The varnish tank will be covered when not in use to prevent contamination of the
varnish.

2.2

The dipping area and tank shall be suitably equipped with approved fire equipment
and must fully comply with applicable fire regulations.

3.0

TOOLING
Suitable apparatus to lift and lower the work in and out of the varnish shall be maintained
in safe and efficient working order.

4.0

CONTROL
Preheat the stator to approximately 140oF (60oC).
Mask spigot fits and plug holes in the stator frame. Lower the stator (vertically wherever
possible) slowly into the varnish to allow varnish to displace air in the windings.
The stator should be fully immersed and allowed to stand until all signs of trapped air
escapement have ceased.
The work is then lifted clear of the varnish tank surface and allowed to drain completely.
Inspect the work for possible bare areas, poor varnish adhesion or other defects.
If required, repeat the dipping process as described, reversing stator (end to end) for
each additional dip.

* Special processes are activities such as welding, brazing, varnish dipping and VPI processes
whose results cannot be directly examined to establish full conformance. Verification of
conformance depends on evidence generated during the process.