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AeroGlobal Quality Manual Feb 2023

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0% found this document useful (0 votes)
27 views39 pages

AeroGlobal Quality Manual Feb 2023

mice with rice

Uploaded by

Chad G
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AeroGlobal Inc.

Quality Management System Manual

AeroGlobal Inc.
3450 S. St
Newtown, Connecticut 59532
SAI GLOBAL LIMITED
Document ID: AeroGlobal Inc. Quality Manual
Date of Issue: February 2023
AEROGLOBAL INC
QUALITY MANAGEMENT SYSTEM MANUAL

Introduction to the company

Established in 1989 in Newtown, Connecticut, AeroGlobal Inc. is a privately owned company backed
by the AeroGlobal Group. Our products and services are widely used throughout the commercial
aircraft industry and provide consistent reliability and satisfaction in use.

AeroGlobal Inc. is a company dedicated to the concept of customer care in all we do. From our purpose-
built facility located at 1230 S. St, Newtown, Connecticut, AeroGlobal designs and manufactures
avionics for commercial aircraft throughout the world. Additionally, AeroGlobal performs commercial
aircraft maintenance inspections, and provides repairs for commercial aircraft avionics. We are a
market leader in the services and products we provide.

Backed by the resources of the AeroGlobal Group, we are committed to maintaining our innovative
style of marketing, servicing and manufacturing in an endless pursuit of product and service excellence.

This Management Manual makes this commitment to our customers: we shall comply with all their
requirements and constantly strive for improvement in that all we do to serve them.

The company has set up an organization with systems, processes and personnel. Everyone in the
company has the responsibility to do his/her work right the first time.

Signed,

Samuel S. Takoft

CEO

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Table of Contents

INTRODUCTION TO THE COMPANY .......................................................................................... I


1. PURPOSE ............................................................................................................................ 1
2. SCOPE ................................................................................................................................. 1
3. REFERENCE DOCUMENTS ............................................................................................... 1
4. CONTEXT OF THE ORGANIZATION.................................................................................. 1
4.1 Organization and Context ......................................................................................... 1
4.2 Needs and Expectations ........................................................................................... 1
4.3 Scope of the QMS .................................................................................................... 2
4.4 QMS and Processes ................................................................................................. 2
5. LEADERSHIP ....................................................................................................................... 3
5.1 Leadership and commitment .................................................................................... 3
5.2 Quality policy ............................................................................................................ 3
5.3 Responsibility and authority ...................................................................................... 4
6. PLANNING ........................................................................................................................... 5
6.1 Risk and Opportunity Actions ................................................................................... 5
6.2 Quality Objectives ..................................................................................................... 5
6.3 AeroGlobal is constantly planning for change within the QMS. ............................... 6
7. SUPPORT............................................................................................................................. 7
7.1 Provision of Resources ............................................................................................. 7
7.2 Competence ............................................................................................................. 9
7.3 Awareness .............................................................................................................. 10
7.4 Communications ..................................................................................................... 10
7.5 Documented Information ........................................................................................ 11
8. OPERATIONS .................................................................................................................... 13
8.1 Operational Planning and Control .......................................................................... 13
8.2 Requirements for Products and Services ............................................................... 14
8.3 Design and development ........................................................................................ 15
8.4 Control of Externally Provided Processes, Products, and Services ....................... 18
8.5 Production and Servicing Provision ........................................................................ 19
8.6 Release of Products and Services ......................................................................... 27
8.7 Control of Nonconforming Product or Services ...................................................... 27
9. PERFORMANCE EVALUATION ....................................................................................... 28
9.1 Monitoring and Measurement ................................................................................. 28
9.2 Internal Audit........................................................................................................... 29
9.3 Management Review (MR) ..................................................................................... 29
10. IMPROVEMENT .............................................................................................................. 30
10.1 Planning for continual improvement ....................................................................... 30
10.2 Nonconformity and Corrective Action ..................................................................... 30
APPENDIX A: INTERACTION OF PROCESSES ..................................................................................... 31
APPENDIX B: ORGANIZATIONAL CHART ........................................................................................... 32

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AEROGLOBAL INC
QUALITY MANAGEMENT SYSTEM MANUAL

1. PURPOSE

This Management Manual defines the system that complies, at a minimum, with ISO 9001:2015
and AS9100 Revision D.

2. SCOPE

AeroGlobal designs and manufactures avionics for commercial aircraft throughout the world.
Additionally, AeroGlobal performs commercial aircraft maintenance inspections, and provides
repairs for commercial aircraft avionics. We are a market leader in the services and products we
provide.

3. REFERENCE DOCUMENTS

The following external documents contain provisions that, through reference material in this
Manual, constitute provisions of QMS:

ISO 9000:2015, Quality management systems – Fundamentals and vocabulary

ISO 9001:2015, Quality management systems – Requirements

a. Regulatory – Connecticut Department of Labor and Industry

(The required materials are posted as needed within our facility)

b. Statutory – OSHA Right To Know

(Please refer to SOP 2.0 Right To Know Training, as required)

The Document Master List (SOP), Forms (FM), and Flow Charts (FC).

4. CONTEXT OF THE ORGANIZATION

4.1 Organization and Context

AeroGlobal has investigated and identified the external and internal issues that affect our
business.

4.2 Needs and Expectations

We understand our customers and do not have any issues with their needs and expectations.

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4.3 Scope of the QMS

The Scope of AeroGlobal’s QMS is defined in Section 2 of the Manual. All AS9100
requirements are applicable to AeroGlobal’s QMS.

4.4 QMS and Processes

AeroGlobal’s QMS processes and their interaction are illustrated in Annex A. Statutory and
Regulatory requirements associated with these processes are defined and compliance
maintained.

During establishment of the QMS, the determination of processes included:

a. identification of the Processes and their inputs and outputs;

b. sequences and interactions;

c. identification of the criteria and methods needed to ensure the effective operation and
control of the processes;

d. resources requirements for implementation and maintenance;

e. responsibilities and authorities for these processes;

f. risks and opportunities specified in 6.1;

g. process evaluation and need for changes;

h. QMS process improvement.

Documentation required to support operation of the process and to be confident that the
processes are effective is identified and maintained. This information is defined within this
Quality Manual and includes:

• a general description of relevant interested parties

• the scope of the quality management system, including boundaries and applicability

• a description of the processes needed for the quality management system and their
application throughout the organization

• the sequence and interaction of these processes

• assignment of the responsibilities and authorities for these processes

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5. LEADERSHIP

5.1 Leadership and commitment

The Chief Executive Officer (CEO) and Vice Presidents (VPs) communicate to all personnel,
by various means, the importance of meeting customers’ requirements.

The CEO and VPs also establish the company’s policies and objectives, conduct management
reviews and ensure that the necessary resources are provided.

The VPs monitor the key processes to assure their effectiveness.

The Management System’s focus is on achieving consistent customer satisfaction. Product


and service conformity and on-time delivery performance are measured, and
appropriate action is taken if planned results are not, or will not be, achieved.

5.2 Quality policy

The CEO and VPs consider the suitability of the quality policy at alternate management
reviews. Quality in AeroGlobal is defined as operational, environmental, and health and safety
efficiency.

The quality policy of AeroGlobal Inc. is to design and supply our services to meet the
requirements of all customers and stakeholders and to:

a. continually improve our services and to allow every person in the company an
opportunity to take part in quality improvement

b. establish achievable objectives at company, departmental and personal levels and to


regularly review these

c. ensure that personnel at all levels in the company understand the role they play in
meeting the policy

d. always respect individuals and treat all personnel equally regardless of position, age,
gender, ethnicity or religious background (XXX add sexual orientation? Usually on EEO
enumerative lists)

Copies of the quality policy are displayed in each department and are controlled by the Quality
Assurance Department.

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5.3 Responsibility and authority

Responsibilities and authorities within the Management Systems are defined in this Manual,
within procedures, task descriptions and contracts of employment. Documents such as Design
and Development also detail responsibilities and authority, as does Appendix B.

Appropriate management personnel are notified of nonconforming products and processes. All
personnel are authorized to stop production to address quality issues. All shifts are supported
by Quality Assurance personnel.

The QA Manager is appointed as the AeroGlobal Management Representative and has


authority, organizational freedom and unrestricted access to top management to
resolve QMS issues. Additional responsibilities include:

• Ensuring that internal audits are resourced and carried out

• Maintaining Management Review minutes

• Maintaining Management Council minutes

• Providing the necessary help to managers and staff in developing and improving the
Management Systems and ensuring that the integrity of the QMS is maintained when
changes are made

• Ensuring that departments’ and sections’ annual objectives reflect both company goals
and focus on customers’ requirements

• Serving as the default customer representative in quality planning and issue decision
matters

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QUALITY MANAGEMENT SYSTEM MANUAL

6. PLANNING

6.1 Risk and Opportunity Actions

6.1.1 AeroGlobal considered and determined the risks and opportunities that need to be
addressed during QMS development. These included:

a. assurance that the Quality Management System can achieve its intended
result(s)

b. strategies to enhance desirable effects

c. ways in which to prevent or reduce undesired effects

d. potential to achieve improvement

6.1.2 AeroGlobal planning ensures that actions to address risks, and opportunities to
mitigate risk, were identified. Planning also considers how to integrate and implement
the actions into its Quality Management System processes and how to evaluate the
effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the


potential impact on the conformity of products and services.

6.2 Quality Objectives

The objectives established at company level by the CEO and VPs are considered at each
departmental and sectional level, and local objectives are set and reviewed.

AeroGlobal Inc. takes a disciplined approach:

• The strategic business plan incorporates planning on both long-term and short-term
bases and at different levels of the company.

• Objectives are set as part of 5-year, 2-year and 1-year plans. These objectives are set,
reviewed and modified if necessary at the corporate level, management level and
individual employee level.

AeroGlobal Inc. sets 5-year plans (5YP). An Annual Plan and Budget (APB) are simultaneously
carried out at the three organizational levels mentioned. The APB expands in detail on the first
two years of the 5YP, and from input from customers, suppliers and colleagues.

Work continues to align the plans with one another across the company. The CEO and VPs
develop the corporate APB.

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Key business/quality objectives are contained within the plans. VPs negotiate these broad
corporate business objectives with the CEO. VPs then negotiate with their direct reports (i.e.
the managers) as to what personal and departmental objectives each manager will have.
Managers negotiate with each supervisor/employee concerning what their objectives will be.

Objectives are agreed annually and reviewed throughout the year, at least on a quarterly basis.
The reviews may include new objectives, or amend targets depending on performance to date.
Team targets are specified through the project objectives.

Success of the process is measured by the employee survey and by Management System
audits.

The process of establishing and reviewing the plans and objectives is contained and outlined
within Procedure Series CS 0800.

6.3 AeroGlobal is constantly planning for change within the QMS.

Change consideration includes:

a. the purpose of the changes and their potential consequences

b. the integrity of the Quality Management System

c. the availability of resources

d. the allocation or reallocation of responsibilities and authorities

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7. SUPPORT

7.1 Provision of Resources

7.1.1 General

The CEO and VPs annually update the company’s strategic plans, and discuss and
determine the resources necessary to fulfill the plans.

7.1.2 People

Resources include identification and procurement of persons necessary for the


effective implementation of the QMS.

7.1.3 Infrastructure

AeroGlobal’s 5-year plans and the detailed shorter-term planning highlight the
anticipated needs for personnel and equipment, as well as the support services
necessary.

Planning is responsible for developing plant and equipment plans, and for optimizing
plant layout, material travel and floor space. Planning is also responsible for devising
and updating contingency plans to protect both customers and AeroGlobal.

Planning is responsible for inspecting and maintaining production equipment,


product-handling equipment, automated machine programming and perishable
tooling utilizing our Total Maintenance System. Equipment/tooling in storage is
periodically checked for issues of deterioration or other damage. Procedure Series
CS 1100 provides guidance on the conduct of this program.

7.1.4 Work Environment

Planning Department is responsible for ensuring that the work areas are safe, clean,
appropriate for the product or service, and operating efficiently. Factors that may be
considered include temperature, humidity, lighting, and other assumed industry
concerns.

Administration is responsible for ensuring that staff offices, walkways, rest areas,
cafeterias, parking lots, etc. are kept clean, safe and operating efficiently.

CS procedures for all departments restate the responsibility of all employees to work
in a safe manner, and to report any conditions that are not correct to their supervisor.

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7.1.5 Control of Monitoring and Measuring Equipment

Procedure Series CS 1100 covers monitoring and measuring equipment


maintenance, handling and adjustment. It provides for maintaining a register of the
monitoring and measuring equipment, and the recalling of this equipment for
calibration. It defines the process employed for the equipment’s calibration including
details of equipment type, unique identification, location, frequency of checks, check
method and acceptance criteria.

Planning Department is responsible for ensuring equipment used to measure and


monitor product is fit for use.

JCDs, SWOs and specifications define the measurements to be made.

Equipment used to carry out measurement has its extent of error checked regularly
and therefore its measurement capability against traceable national and international
Standards. The error is recorded and where unacceptable, the equipment is
adjusted, repaired or destroyed. The impact of the unacceptable error is reported to
the Planning Manager who is responsible for any investigations and decisions
needed.

Marking is used to indicate to personnel the status of measuring gauges, etc.


Equipment that is past due calibration is reported to Planning department
management.

Records are kept of the maintenance and checking of all equipment. The records
provide all details necessary for proper and effective management of our measuring
system.

Required Measurement System Analysis studies are carried out by QA, and records
are maintained.

Maintenance is responsible for ensuring that calibrations are conducted under


appropriate environmental conditions.

7.1.6 Organizational Knowledge

AeroGlobal considers its current knowledge and determines how to acquire or access
any necessary additional knowledge as required.

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QUALITY MANAGEMENT SYSTEM MANUAL

7.2 Competence

Procedure Series CS 1800 covers HR activities.

AeroGlobal’s business planning processes take a long-term view of skill requirements in terms
of:

• existing skills that must be retained

• skills to be redirected

• skills no longer required

• skills to be recruited/developed/provided

To meet future needs, AeroGlobal has its Skills Architecture (SA), which covers technical (i.e.
design, quality planning) and professional competence and encompasses all skills throughout
the organization. AeroGlobal uses the SA to analyze its 5-year business plan to identify critical
skills and the gap between current and future needs. This is fed into the annual planning
process to ensure that the gap is closed by plans.

The mixture of individual and business needs is the major input to the creation of training
programs.

People with redundant skills are retrained. Line managers sponsor all training programs so that
the training is related to business needs. On-the-job training (OJT) is utilized wherever
possible. Where required by regulatory authorities and/or managers or supervisors,
technicians, inspectors and engineers are certified against the applicable training Standard,
and recertified on an annual basis.

The effectiveness of training is measured by feedback from course attendee, comparison of


post-course achievement with pre-course needs (agreed between attendee and sponsor
manager) and employee survey twice yearly.

AeroGlobal’s People Management System focuses on core and job-related competence


attributes that provide the basis for job descriptions, the staff annual appraisal systems and
monthly/quarterly reviews.

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QUALITY MANAGEMENT SYSTEM MANUAL

Core management competence is measured against the following:

• customer focus

• commercial and business awareness

• performance and results

• leadership, motivation and people management

• teamwork

• effective communication and impact

• continual improvement and managing change

Core non-manager competence is measured against the following:

• problem-solving capability

• planning and organization

• numeracy and data handling

• communication skills

• commercial approach

• team member skills

• customer focus

7.3 Awareness

Also within Procedure Series CS 1800 is the process for managing employee morale initiatives.
Measurements are taken to determine the extent of employee awareness of their
contributions to product or service conformity, product safety, and to the maintenance
of ethical behavior.

7.4 Communications

Managers are responsible for the effective operation of procedures within their areas of
responsibility and within other departments. Where processes of work are not functioning
effectively, managers or any staff report the matter to the QA Manager for consideration with
the appropriate personnel.

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QUALITY MANAGEMENT SYSTEM MANUAL

7.5 Documented Information

7.5.1 AeroGlobal QMS

AeroGlobal Inc. has a formal documented Quality Management System. To support


that system, AeroGlobal Inc. has established and maintains a documented quality
policy, quality objectives, system and departmental procedures, other essential
documentation including that from applicable regulatory authorities, and records.
These documents constitute the AeroGlobal QMS, which is defined in this QMS
Manual. Within this Manual, referenced documents clearly show the relationship to
requirements established to comply with AS9100. The interaction of our processes
is provided in Appendix A and the Organizational Chart is provided in Appendix B.
This Manual provides a response to all AS9100 requirements to establish and
maintain documented information (i.e. scope, quality policy, quality objective,
description of relevant interested parties, description of processes, IOP, roles and
responsibilities).

All AeroGlobal personnel are fully aware of procedures applicable to their work and
assigned tasks. All appropriate personnel including AeroGlobal employees, customer
representatives and regulatory authority representatives are aware of this
requirement as it relates to AeroGlobal.

7.5.2 Creating and Updating Documented Information

AeroGlobal ensures that all documentation:

a. has the correct identification and description (e.g. a title, date, author, or
reference number)

b. is in the appropriate format (e.g. language, software version, graphics) and


media (e.g. paper, electronic)

c. defines the review and approval process for suitability and adequacy
requirements (XXX ensure meaning correct – original syntax rendered
meaning unclear)

7.5.3 Documented Information Control

7.5.3.1 Documented information required by the AeroGlobal QMS and by


AS9100 is controlled to ensure that:

a. it is available and suitable for use, where and when it is needed

b. it is adequately protected (e.g. from loss of confidentiality, improper


use, or loss of integrity)

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7.5.3.2 For the control of documented information, AeroGlobal addresses the


following activities, as applicable:
a. distribution, access, retrieval, and use
b. storage and preservation, including preservation of legibility
c. control of changes (e.g. version control)
d. retention and disposition
e. prevention of the unintended use of obsolete documented
information by removal or by application of suitable identification or
controls if kept for any purpose.
All users of documents are notified electronically when documents are
revised or cancelled.
Obsolete documents are either marked as ‘obsolete’ (if needed for
reference) or destroyed. This prevents unintended use.
Documents can only be changed with approval of the originating
department, and the reasons for and the nature of the change are
recorded formally.
Document changes are coordinated with customers and regulatory
authorities as appropriate. All such documents are identified and
distributed to the personnel needing to use them.
Customer engineering documents are reviewed, distributed and
implemented in a timely manner. Records are maintained to reflect dates
of implementation into production.
Electronically managed data is password-protected to ensure
adequate security (e.g. protection from loss, unauthorized changes,
unintended alteration, corruption, physical damage).
The system for maintenance of regulatory requirements such as CFRs,
ADs and ACs is addressed in CS 0500.
All the requirements in this Manual, and referred procedures and
instructions concerning both systems and products, are reconciled with
appropriate records (Procedure Series CS 0500).
The QA Manager is responsible for ensuring that each functional area
knows what records must be retained. Departmental procedures define
what records will be produced and how long they are to be retained, in
accordance with any customer and regulatory requirements. Where
established, record maintenance for AeroGlobal Inc. conducted by
AeroGlobal suppliers is procedurally addressed.
Records are available to appropriate personnel including AeroGlobal
employees, customer and regulatory authority representatives.

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QUALITY MANAGEMENT SYSTEM MANUAL

8. OPERATIONS

8.1 Operational Planning and Control

Planning of avionics manufacturing, aircraft inspection and avionics repair operations reflects
consideration of:

• criteria for processes and acceptance of products and services

• resources needed to achieve conformity

• outsourced process control

• the establishment of appropriate process controls and development of control plans


where key characteristics and critical items have been identified

• involvement of representatives of affected functions

• identification of resources to support product use and maintenance

• external provider support

• prevention of delivery of NC product

• control of work transfer

As appropriate to AeroGlobal’s customer requirements and products and services, production


and service provisions are managed in a structured and controlled manner.

Planning is responsible for scheduling production consistent with orders received through
Sales.

Planning provides a Job Control Document (JCD) for all manufacturing operations. The JCD
itemizes product quantities, equipment operating settings, descriptions of process monitoring
required, and references to relevant specifications and build documents. The JCD is required
to be readily available where work is being carried out, and must be followed at all times.
Sometimes comprising multiple documents, the JCD must always be followed exactly.

Planning provides a Service Work Order (SWO) for all aircraft inspection and repair orders.
The SWO provides essential information to ensure that all agreed upon contract requirements
are met, and that the work meets the specific requirements of CFR 145. The SWO is required
to be readily available where work is being carried out, and must be followed at all times.

Changes to SWOs and JCDs in terms of product requirements, process improvements, etc.,
are agreed upon by customers and regulatory authorities as applicable.

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8.1.1 Risk Management

A Risk Management Process (RMP) has been established, documented and is


maintained. (See Procedure Series CS 0500).

8.1.2 Configuration Management

A Configuration Management Process (CMP) has been established, documented


and implemented. Configuration management is maintained on all products and
services provided. Maintaining configuration management is everyone’s job. The
CMP is based on ISO 10007 (see Procedure Series CS 0500).

8.1.3 Product Safety

AeroGlobal plans, implements and controls the processes needed to assure product
safety during the entire product life cycle, as appropriate to AeroGlobal and the
product.

8.1.4 Prevention of Counterfeit Parts

AeroGlobal plans, implements and controls processes, as appropriate to the


organization and the product, for the prevention of counterfeit or suspected
counterfeit part use and their inclusion in product(s) delivered to the customer.

8.2 Requirements for Products and Services

8.2.1 Customer Communication

Sales and Marketing procedures are sector, commodity and geographically-based.


Thus, the same group of staff always deals with specific customers, and relationships
can be developed to aid smooth communication with customers on all issues.
Wherever possible, communications take place in the customer-prescribed manner
or method. Marketing helps to ensure the accuracy of information sent to the
customer by reviewing documents prior to document dispatch to the customer.

8.2.2 Determination of requirements related to the product

Each customer who inquires about ordering our products or development of


specifications for product design is required to provide information about all products
and characteristics to sales for preparing a quote. A customer requesting AeroGlobal
maintenance and repair service is required to provide the aircraft avionic equipment
to AeroGlobal technicians for onsite inspection and evaluation. Sales prepares the
service quote for the customer, based on the inspection report. Refer to Procedure
Series CS 0300. Specific attention is given to customer-designated key/special
characteristics. Feasibility of meeting requirements, including risk assessment, is
accomplished as part of the quotation process.

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8.2.3 Review of Requirements Related to the Product

Procedure Series CS 0300 covers the following:

a. Ensuring that when a customer places an order based on a prior quote, the order
and quote are reconciled fully before the order is acknowledged.

b. Ensuring that the details entered into the work order are adequately defined and
include any requirements not specified by the customer but required for
production.

c. Reviewing by Planning Manager of all emails, faxes (XXX obsolete technology)


and mail from customers that consist of orders or modifications to orders prior
to order acceptance; any comments necessary are added by Planning Manager.

d. Checking by Sales of credit rating and customer’s account number, and then
notifying Accounts if either does not exist before order acknowledgment.

e. Allocation of a unique AeroGlobal Inc. contract number from the sales contract
list, allowing the order’s progress thereafter to be tracked.

f. Checking by Sales Manager or Supervisor of each customer order for


completeness before it is passed over for work order distribution.

g. Statutory and Regulatory requirements.

h. Contract or order changes.

Records of the activities in 8.2.1 and 8.2 2 are maintained.

8.3 Design and development

8.3.1 General

Product Development Department is responsible for ensuring that any new products
or processes or changes to existing products or processes follow the necessary steps
in the Design/Development (DD) process. Procedure Series CS 0400 covers product
and process development, including maintenance of confidentiality of customer-
provided information and products.

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8.3.2 Design and Development Planning

Each DD project is assigned a Project Leader by the Product Development Manager.


The Project Leader is responsible for ensuring that a multidisciplinary approach is
applied in the conduct of projects.

For each project, the assigned Project Leader prepares a project plan. Applicable
tools and techniques are identified and utilized during the project. The project plan
reflects customer design, program timing, task sequence, mandatory steps,
significant stages and method of configuration control.

The Product Development Manager is responsible for identifying single or multiple


stages during DD, at which a formal design review is carried out against the design
specification originally established. The QA Manager records these reviews and
progresses all follow-up actions, including as necessary input to management
reviews. The design review team is headed by Marketing, with representatives from
Manufacturing and Quality Assurance.

8.3.3 Design and Development inputs

Inputs to the design process may come from external customers through Sales or via
an internal customer. Specific types of products and services provided by AeroGlobal
are advertised on our website. Inputs area reviewed by a design review team member
prior to acceptance. The Project Leader gathers all inputs prior to the actual
commencement of the design effort, including a review of customer specifications.

8.3.4 Design and Development Controls

AeroGlobal controls the design and development process to ensure that:

a. the results to be achieved are defined


b. reviews are conducted to evaluate the ability of the results of design and
development to meet requirements
c. verification activities are conducted to ensure that the design and development
outputs meet the input requirements
d. validation activities are conducted to ensure that the resulting products and
services meet the requirements for the specified application or intended use
e. any necessary actions are taken on problems determined during the reviews, or
verification and validation activities
f. documented information of these activities is retained
g. progression to the next stage is authorized

Participants in design and development reviews include representatives of


functions concerned with the design and development stage(s) being
reviewed.

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8.3.5 Design and Development Outputs

AeroGlobal ensures that design and development outputs:

a. meet the input requirements

b. are adequate for the subsequent processes for the provision of products and
services

c. include or reference monitoring and measuring requirements, as appropriate,


and acceptance criteria

d. specify the characteristics of products and services that are essential for their
intended purpose and their safe and proper provision

e. specify, as applicable, any critical items, including any key characteristics, and
specific actions to be taken for these items

f. are approved by authorized person(s) prior to release

The organization shall define the data required to allow the product to be
identified, manufactured, verified, used and maintained, and for records to be
maintained. A final review prior to handover to Operations is held, at which the
specifications for the design, manufacture and testing of the product or service are
examined and each signed as acceptable by the project reviewers. This may be
accomplished at the critical design review.

8.3.6 Design and Development Changes

AeroGlobal identifies, reviews and controls changes made during, or subsequent to,
the design and development of products and services, to the extent necessary to
ensure that there is no adverse impact on conformity to requirements.

Customers are identified prior to the implementation of any changes affecting


products or services.

Documentation is maintained on:

a. design and development changes

b. the results of reviews

c. the authorization of the changes

d. the actions taken to prevent adverse impacts

Design and development changes are controlled in accordance with the


configuration management process requirements.

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8.4 Control of Externally Provided Processes, Products, and Services

Procedure Series CS 0600 covers Selection of Suppliers (a) and Supplier Development (b).

Suppliers to AeroGlobal Inc. are formally assessed prior to an order being placed with them.
Consideration is given to the Management System’s capability (financial and quality {efficiency,
environmental, health and safety}). Wherever possible, AeroGlobal requires suppliers to be
registered to the latest revision of ISO 9001 with encouragement of suppliers to conform to the
requirements of the latest revision of AS9100. Where contractually designated, AeroGlobal
utilizes customer-specified suppliers and maintains responsibility for products and services
received from those suppliers. Where specified, suppliers utilize customer-approved
processes. QA has the authority to disapprove any supplier based on QA’s determination of
an inadequate Quality Management System.

Once a supplier is considered acceptable, it is placed on the AeroGlobal Inc. Supplier List
(ASL). Evaluation of critical suppliers as determined by the Purchasing Department will be
performed at least annually. In addition, any supplier having more than five supplier rejections
(NCRs) during a calendar year will be re-evaluated during the subsequent calendar year.
Suppliers not meeting AeroGlobal’s performance standard are notified that corrective action
needs to be taken at the discretion of the Purchasing Manager (or Materials Manager when
designated). Suppliers of raw materials (e.g. steel) that do not meet requirements for
traceability are required to submit corrective action. When a supplier fails to maintain
performance in any area, a SCAR is initiated.

Established suppliers with optimal performance results are invited to become strategic partners
with AeroGlobal. This involves Electronic Data Interchange (EDI) and working together on
strategic plans and goals. Joint training in Supply Chain Development (SCD) and Customer
Relationship Management (CRM) is carried out, and goals of reduced lead times and lower
costs are ongoing objectives. Suppliers with less than optimal performance are individually
counseled, and a plan for improvement is jointly developed by AeroGlobal and the supplier.

Purchase orders are prepared from Purchase Requisitions (PR) and, before issue, must be
signed by the buyer for that commodity. The buyer verifies any PR entry that is unclear before
creating the PO. PO copies are distributed as follows:

Supplier two copies

Accounts one copy

Planning one copy

Purchasing one copy

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All POs specify suppliers to provide material certification (C of C, C of A) with all shipments.
The Purchasing Manager and buyers are responsible for ensuring that certification gained for
purchased materials indicates conformance against applicable specifications, and for ensuring
that certification is retained. Purchasing notifies acceptance of received materials to Receiving
Department, who then notifies QA, Stores and Planning. Only materials found to be acceptable
may be used in Operations. All materials received into the company from suppliers are checked
on receipt against the packing slip. The packing slip is signed by receiving personnel to indicate
that no damage exists and that quantity is correct. The packing slip is sent to Purchasing with
any certificates (Certificate of Acceptance [CoA)], Certificates of Conformance [CoCs], etc.).

Purchasing arranges for movement of the material from Receiving into Stores, and alerts
Quality Assurance who examine any material requiring it and release the batch number to
Planning. Only then is the incoming material made available for manufacturing scheduling.

QA periodically validates CoAs upon request from Purchasing.

Any unacceptable material is handled in accordance with Procedure Series CS 1300, which
requires rejection, documentation of a Nonconforming Material Report (NMR) and disposition
of the material by Quality Assurance (return to vendor, scrap, use-as-is, rework, sort/sift).

Should a customer wish to visit a supplier’s facility, this can be arranged among Sales,
Purchasing and the supplier, provided the appropriate commercial arrangements can be made,
i.e. any costs incurred are paid by the customer. Where this occurs, AeroGlobal Inc. does not
use customer results to serve as evidence of Quality Management System compliance.

An electronic Purchase Requisition/Purchase Order system is being introduced. Instructions


for use are available on the ‘Help’ tab on the computer screen from the website.

8.5 Production and Servicing Provision

8.5.1 Control of Production and Servicing Provisions

The Planning department is responsible for all planning of avionics manufacturing,


aircraft inspection and avionics repair operations with respect to:

• the establishment of appropriate process controls and development of control


plans where key characteristics have been identified

• the identification of in-process verification points when adequate verification of


conformance cannot be performed at a later stage of realization

• the design, manufacture and use of tooling so that variable measurements can
be taken, particularly for key characteristics

• special processes (see 8.5.2)

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Planning is responsible for scheduling production consistent with orders received through
Sales and the development of the Job Control Document (JCD), which provides for controlled
conditions.

Assembled Altimeters, GPS units, Radios, TACAN Displays and Airspeed Indicators undergo
inspections and tests that are specified on the JCD. Results of inspections and tests are
recorded on the JCD by the technicians performing them.

Planning provides a Service Work Order (SWO) for all aircraft inspection and repair orders.
The SWO provides essential information to ensure that all agreed-upon contract requirements
are met, and that they reflect the specific requirements of CFR 145). The SWO is required to
be readily available where work is being carried out, and to be followed at all times. The SWO
is also used to record the results of inspections and tests conducted.

The JCD provides product quantities, equipment-operating settings, descriptions of process


monitoring required and references to relevant specifications and build documents. The JCDs
have space for test results to be recorded. Only product that meets customer requirements
and product specifications can be shipped, unless a waiver is granted. The JCD is required to
be readily available where work is being carried out, and must be followed at all times.
Sometimes comprised of multiple documents, the JCD must be followed exactly.

The JCD is used to ensure that production processes are controlled, and to ensure:

a. that the characteristics of the products to be produced, the services to be provided, or


the activities to be performed, and the expected results, are well defined

b. that availability and use of test resources is planned

c. that stages are defined where the implementation of monitoring and measurement
activities is required to verify that criteria for control of processes or outputs, and
acceptance criteria for products and services, have been met. This ensures that the
criteria for acceptance and rejections are clearly defined, where verification operations
are performed, measurement requirements and results, and identification of test
equipment. AeroGlobal does not use sampling for production processes

d. the use of suitable infrastructure and environment for the operation of processes

e. the appointment of competent persons, including any required qualification

f. the validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement

g. the implementation of actions to prevent human error

h. the implementation of release, delivery and post-delivery activities

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i. the establishment of criteria for workmanship

j. the accountability for all products during production

k. the control and monitoring of identified critical items, including key characteristics, in
accordance with established processes

l. the determination of methods to measure variable data

m. the identification of in-process inspection/verification points when adequate verification


of conformity cannot be performed at later stages

n. the availability of evidence that all production and inspection/verification operations have
been completed as planned, or as otherwise documented and authorized

o. the provision for the prevention, detection and removal of foreign objects

p. the control and monitoring of utilities and supplies (e.g. water, compressed air, electricity,
chemical products) to the extent that they affect conformity to product requirements

q. the identification and recording of products released for subsequent production use
pending completion of all required measuring and monitoring activities, to allow recall
and replacement if it is later found that the product does not meet requirements

During manufacture, materials and products are controlled by continually checking processes
as follows:

(a) Manufacturing

JCDs are issued on a batch-by-batch basis and must be followed at all times. The
technicians assigned to each line sign onto the process at the handover time on each shift.
This is done on the basis of the appropriate process checks being recorded on the JCD.
Thereafter, the technicians record, at the frequency specified on the JCD, all process
parameters identified as critical.

Twice within each shift, the Supervisor also checks that process parameters are being met,
and indicates the times of the checks on the JCD along with his/her initials.

At a time different from the checks by the Supervisor, Quality Assurance personnel check
the process conditions, product characteristics and the records. The times of the checks
are varied for each shift, and each line running is checked in this way at least twice during
each shift. Quality Assurance personnel also record checks on the JCD.

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For all manufacturing operations:


• parts used are accounted for
• evidence is established to support completion of all required checks
• foreign object damage (FOD) is prevented
• utilities are monitored where critical for quality
• criteria for workmanship is stipulated

The system for FOD control requires that:


• all tools in a toolbox must be numbered and all tools must be kept in a specified place
in the toolbox
• all tools must be accounted for, and a release form (Form AR-135) signed verifying
tool accountability, before an aircraft is released from any area where work or
inspection has been carried out on the aircraft
• any FOD situation is recorded as a corrective action (see section 8.5.2)
• all FOD situations are listed in the FOD register, to cross-reference FOD situations
with corrective actions taken

(b) Final Assembly

The process of assembly is outlined in the JCD.

Final inspection is carried out by Quality Assurance personnel in accordance with the quality
plans and/or procedures. Additionally, Quality Assurance carries out random patrol-
checking and a quarterly product audit of each product line.

(c) Repair

The repair process is outlined on the SWO and is performed under a JCD. The SWO refers
to the checks needed to be made by the repair technician. Results of the checks are
recorded on the SWO.

(d) Aircraft Inspection

The inspection process is outlined on the SWO and supported by a custom checklist (CC)
for each type of aircraft. Results of the checks and actions taken are recorded on the CC.

Where mandated in the contract, annual layouts and functional testing is conducted.
Appropriate records are maintained.

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Special attention is given to the checking of products with aesthetic features. Appropriate
lighting, qualified personnel and masters with which to check are provided.

Quality Assurance is responsible for providing objective evidence that the correct systems
and processes are being followed. Only personnel from Quality Assurance can release
products into the warehouse and from the warehouse to customers. Quality Assurance is
responsible for ensuring that acceptance criteria are approved by the customer, and that
these criteria reflect the principle of zero defects.

Procedure Series CS 1700 covers product audits carried out on selected products (from the
warehouse) annually. Operators serving as product auditors record on the JCD any
incomplete batches of products. They also record a list of any unacceptable material found
during final assembly.

Records of product acceptance into the warehouse and of release from the warehouse are
retained by Quality Assurance for a period of three times the duration of the warranty period
for that product.

8.5.1.1 Control of Equipment, Tools and Software Programs

Equipment, tools and software programs used to automate, control and monitor,
or to measure production processes, are validated prior to final release for
production and are maintained. Storage requirements are defined for production
equipment or tooling in storage, including any necessary periodic preservation
or condition checks.

8.5.1.2 Validation and Control of Special Processes

For processes where the resulting output cannot be verified by subsequent


monitoring or measurement, AeroGlobal establishes arrangements for these
processes including, as applicable:

a. definition of criteria for the review and approval of the processes

b. determination of conditions to maintain the approval

c. approval of facilities and equipment

d. qualification of persons

e. use of specific methods and procedures for implementation and monitoring


the processes

f. requirements for documented information to be retained

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8.5.1.3 Production Processes Validation

AeroGlobal Inc. has a 360o control philosophy throughout all its operations. The
following details are further explained in Procedure Series CS 1000.

a. All procedures followed must be those that have been shown to provide the
optimal result (approved processes).

b. All equipment used (machinery and tools) must have been shown to
provide the optimal results (approved equipment).

c. Only those personnel formally designated as fully competent in the


processes being followed can operate approved equipment within an
approved process (approved personnel).

d. Only those materials known to be acceptable for a given product may be


used (approved materials).

e. All new processes, tools equipment and machine programs and their
changes are documented, verified and validated prior to implementation.
First article verification is conducted as part of the verification and validation
process. The Manufacturing Manager has the authority to approve changes
prior to implementation.

f. Prior to temporary transfer of work to outside organizations, Planning,


Quality Assurance and Purchasing jointly ensure that control can be
accomplished.

g. Documented information shall be retained.

8.5.2 Identification and traceability

a. Purchased components

Suppliers deliver components direct to Logistics for inventory control.

Inspection status is maintained as entries by appropriate personnel into the


AeroGlobal Inventory Management System (AIMS). In order to complete
documentation that requires traceability, personnel use inspection
stamps.

Differences between actual configuration and required configuration is


documented and maintained.

Traceability is maintained through PO, supplier lot numbers, and receiving


documents. Traceability is required on all components/parts used in any
process.

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b. Work In Process (WIP)

Accomplishment of product identification, inspection status and product


traceability for WIP is through the JCD or SWO accompanying the work.

c. Final Product

Accomplishment of product identification, inspection status and product


traceability for WIP is through the JCD or SWO accompanying the work.

d. All product and repair configurations are maintained through our Configuration
Tracking and Updating System (CTUS). Included within CTUS is provision for
identification to be maintained throughout the product life, all the products
manufactured from the same batch of raw material or from the same
manufacturing batch to be traced, as well as the destination (delivery, scrap)
of all products of the same batch; for an assembly, the identity of its
components and those of the next higher assembly to be traced; for a given
product, a sequential record of its production (manufacture, assembly,
inspection) to be retrieved.

8.5.3 Customer Property

AeroGlobal Inc. exercises care with customer property while it is under our control or
in our processes. Requirements for identification, verification, protection and
safeguarding customer property are addressed in the various procedures found
throughout AeroGlobal. If any customer property is lost, damaged or otherwise found
to be unsuitable for use, it is reported to the customer and records maintained.

8.5.4 Preservation of Product

Incoming components and raw materials are held in protective containers while in
stock.

During manufacturing operations and final product assembly, components and sub-
assemblies are held in protective containers.

Procedure Series CS 1500 addresses the provisions for:

• cleaning

• prevention, detection and removal of foreign objects

• special handling for sensitive products

• marking and labeling including safety warnings

• shelf life control and stock rotation

• special handling for hazardous materials

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8.5.5 Post-delivery Activities

AeroGlobal meets requirements for post-delivery activities associated with our


products and services.

In determining the extent of post-delivery activities that are required, AeroGlobal shall
consider:

a. statutory and regulatory requirements

b. the potential undesired consequences associated with its products and services

c. the nature, use and intended lifetime of its products and services

d. customer requirements

e. customer feedback

f. collection and analysis of in-service data (e.g. performance, reliability, lessons


learned)

g. control, updating and provision of technical documentation relating to product


use, maintenance, repair and overhaul

h. controls required for work undertaken external to AeroGlobal (e.g. offsite work)

i. product/customer support (e.g. queries, training, warranties, maintenance,


replacement parts, resources, obsolescence)

When problems are detected after delivery, AeroGlobal takes appropriate


action including investigation and reporting.

8.5.6 Control of Changes

Changes to SWOs and JCD in product requirements, production process, machine


set-up, etc., must be approved by the Manufacturing Manager. New employees will
be trained on the process for implementing changes to work documents, and their
training records will be documented to reflect this training. AeroGlobal reviews and
controls changes for production or service provision, to the extent necessary to
ensure continuing conformity with requirements. This control includes the
identification of persons authorized to approve production or service provision
change, reviewing results of changes, identification of the person authorizing the
change and any necessary actions from the review.

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8.6 Release of Products and Services

AeroGlobal shall implement planned arrangements, at appropriate stages, to verify that the
product and service requirements have been met.

The release of products and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer.

AeroGlobal shall retain documented information on the release of products and services. The
documented information shall include:

a. evidence of conformity with the acceptance criteria

b. traceability to the person(s) authorizing the release

When required to demonstrate product qualification, AeroGlobal shall ensure that


retained documented information provides evidence that the products and services
meet the defined requirements.

AeroGlobal ensures that all documented information that is required to accompany the
products and services is present at delivery.

8.7 Control of Nonconforming Product or Services

Procedure Series CS 1300 defines the actions to be taken upon discovery of nonconforming
product or service.

a. During manufacturing, any assembly that does not conform is segregated in yellow
octabins and marked with yellow labels. A record is made of all nonconforming assembly
on the JCD at the time at which the problem is identified. QA examines the rejected items
and determines disposition. Final disposition decisions are recorded on the JCD by QA.
QA personnel are approved to disposition NCM based on education, experience or
training.

b. Purchased components that do not conform are segregated in red hexabins, marked with
red labels and returned to the supplier. Records of the rejects are sent to QA who takes
up any issue of significance with the parties involved (i.e. suppliers, production, etc.).

c. Customer returns are considered nonconforming until verified to be otherwise.

d. Obsolete materials and products found in storage are treated in the same manner as
nonconforming products.

e. Customers are notified immediately in cases where nonconforming or suspect products


have been inadvertently shipped.

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9. PERFORMANCE EVALUATION

9.1 Monitoring and Measurement

9.1.1 General

AeroGlobal plans and implements the monitoring, measurement, analysis and


improvement processes needed for process conformity with the Quality Management
System and to improve the effectiveness of the Quality Management System. The
performance and the effectiveness of the Quality Management System is evaluated
periodically and results maintained.

9.1.2 Customer satisfaction

Twice annually, Sales conducts a survey on a selection of AeroGlobal’s customers


and other stakeholders. The results of the survey are supplied to the Management
Council. Also see Section 9.1.3 Analysis of Data.

Internal monitoring of AeroGlobal performance is carried out. On-time delivery,


finished product quality, and customer disruptions are the primary concerns. Results
of internal monitoring are supplied to the Management Council.

Customer complaints are captured, recorded and acted upon immediately by a cross-
functional team of members from affected departments/processes.

9.1.3 Analysis of data

AeroGlobal Inc. analyzes and evaluates appropriate data and information arising
from monitoring and measurement. The results of analysis are used to evaluate:

a. conformity of products and services

b. the degree of customer satisfaction

c. the performance and effectiveness of the Quality Management System

d. whether planning has been implemented effectively

e. the effectiveness of actions taken to address risks and opportunities

f. the performance of external providers

g. the need for improvements to the Quality Management System

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9.2 Internal Audit

Procedure Series CS 1700 defines how internal audits of operations are managed and carried
out.

Internal audits are organized to audit the complete system (all processes) twice yearly.
Additional audits may take place based on nonconformities found, nonconforming product
issues and customer complaints.

Quality Assurance is responsible for organizing and managing the audits, and ensuring that
there are trained and independent auditors to undertake the scheduled audits.

Each auditor is required to prepare for an audit by producing audit trails they will follow based
on the general planning requirements outlined in 5.2 of AS9101G. In all cases, identified
corrective actions from previous audits are reviewed. All audits are reported on an Audit
Report, with any nonconformities or observations recorded on a Corrective Action Report
(CAR). All CARs reported and agreed are followed up by QA.

Results of internal audits are provided to the appropriate management. Results are also used
as an input to the management reviews.

9.3 Management Review (MR)

The CEO, VPs and the QA Manager review the company’s performance annually against the
goals identified in the strategic business plan. Other metrics reported and discussed are
customer satisfaction and dissatisfaction, external and internal audits, product returns and
warranty claims, costs of poor quality, surveys of staff morale and actions from previous review.

The QA Manager records the actions and decisions agreed to at the review, and initiates the
actions thereafter, whether it is an improvement project to be started, analytical consultancy
help by the MIS Department, or other specified actions or agenda items for the Management
Council meetings. (See Procedure Series CS 0100).

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10. IMPROVEMENT

10.1 Planning for continual improvement

The Management Council (MC) is responsible for ensuring that continual improvement of
AeroGlobal Inc.’s business occurs.

The MC comprises the CEO and VPs, Quality Assurance Manager (secretary and facilitator)
and three managers (each of whom sits on the MC for two years).

The MC meets every three months or sooner. The MC is responsible for setting improvement
goals within AeroGlobal Inc., ensuring that the appropriate resources are directed to the
projects and for determining priorities for action.

Top priority projects are directed by the MC, particularly those where responsibility covers
multiple functions. A project leader is nominated, terms of reference are prepared and
requirements for reporting of progress are specified.

Regular agenda items at these meetings include:

• Progress of existing projects

• Training of project leaders and team members so that all participants are fully trained in
problem-solving and teamwork for the continual improvement initiatives in the company
(both inter and intra-departmentally)

Procedure Series CS 1400 covers the whole process of improvement project management,
corrective action and preventive action.

10.2 Nonconformity and Corrective Action

Quality Assurance is responsible for ensuring that information acquired from field issues is
provided to manufacturing, design and other appropriate departments. In addition, QA is
responsible for organizing and ensuring that returned products are analyzed, and that the
information obtained is provided to the appropriate departments within AeroGlobal.

Customer-prescribed methods for corrective actions are utilized where specified in the
contract. The default methodology is the Universal Problem Solving method (UPS).

Error-proofing is utilized where appropriate.

All teams are encouraged to go beyond the immediate issue and consider similar processes
or situations as part of the problem-solving process.

Procedure Series CS 1400 covers the whole process of improvement project management,
corrective action and preventive action.

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Appendix A: Interaction of Processes

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Appendix B: Organizational Chart

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NOTES

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