Fluid Components International Quality Assurance User Manual

DOCUMENT NUMBER

Uncontrolled Copy

This document is current on the FCI Website or the FCI intranet Quality Document Control program.

SUBJECT

Quality Manual

PREPARED BY:

allp7

CAGE CODE

64818

LTI

DATE

10-8-2012

QUALITY MANUAL

SECTION

.11

07QA070003

PAGE

CURRENT REVISION

Burt Tanaka Quality Assurance Manager

Ronald E. Ogle Director of Administr n & Quality

APPROVED BY:

Signature on File President

DOCUMENT NUMBER

07QA070003

SUBJECT

Quality Manual

CAGE CODE

64818

DATE

10-8-2012

SECTION

PAGE

CURRENT REVISION

COMMITMENT TO QUALITY

FLUID COMPONENTS INTERNATIONAL LLC will hire experienced personnel, continually train them, and clearly define their responsibilities in order to provide the highest level of quality products and services to the wide variety of markets and industries that we support. All employees will be responsible for quality and are expected to participate in continuous quality improvement functions so that industry standards will be met or exceeded. Employees will also be expected to take initiative in continuously improving processes and in their own selfdevelopment skills. Employees will be provided the tools, instructions, and authority to act in the best interest of the company with regard to the quality of our products and or service. The Quality Assurance and Quality Control organizations will function as a catalyst to establish informational quality needs, compliance standards, mutual improvement targets, process changes, and overall quality focus. These organizations will demonstrate continuous communications and collaboration with all operational departments.

The Quality Assurance organization is chartered with defining and enforcing the standards that are specific to the various industries that we service. Quality Assurance shall either integrate or isolate those requirements so that we efficiently meet all industry specific quality expectations.

The Quality Manual that follows shall be used as an internal baseline for quality processes. The Manual will serve as a standard for which we will compare our performance. The Manual will be a living document and will be regularly updated with improvements and changes that are necessary to meet the evolving business environment. The Manual will additionally reflect our commitment of quality to our customer base and will be readily available for review and recommendations.

The President

DOCUMENT NUMBER

07QA070003

SUBJECT

Quality Manual

CAGE CODE

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DATE

10-8-2012

SECTION

PAGE

iii

CURRENT REVISION

TABLE OF CONTENTS

DESCRIPTION

SECTION

PAGE

Title Page

Commitment to Quality Statement

Table of Contents

iii

Revision Page

iv, v,

Quality Management System

vi-viii

Appendix A

Appendix B

x-xii

Appendix C

xiii

Appendix D

xiv-xviii

Section One

1 – 19

Section Two

1 – 32

Section Three

1 -- 21

DOCUMENT NUMBER

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CURRENT REVISION

REVISION PAGE

Location

REV

DESCRIPTION

APPROVALS

DATE

CO.MGMT.

N/A A COMPLETELY REVISED from QA Manual 8003 Rev. K. Changed to new numbering system. Initial release at new number is Rev. A

7-1-97 SM

DMQ DMF

B Revised to incorporate process changes required as a result of installing a new business system

2-03-98 SM

DMQ DF

C Completely revised to incorporate AS9100 and ISO9001

requirements. Made changes to what is now “Section Three”, (previous “Control Manual in its entirety).

8-24-00 REO

DMQ REO

2 of Section 2

Added the second paragraph in “1.0 Scope” 10-9-00 REO

DMQ REO

All, (four places)

Changed “AS9100” to include “AS9000”, i.e., “AS9000/AS9100”.

2-03-98

DMQ DF

28 of Section 2

Added “customers and” (regulatory authorities …) to the last

sentence in 4.16.

8-24-00

REO

DMQ REO

All E Renumbered pages as necessary

7-31-02

REO

DMQ REO

v Added (customer and Field Services)

viii Added and corrected “NQA-1” references

ix Updated Org Chart

x Reformatted, deleted 04QA704027, added several procedures.

2 Added second paragraph to 1.0

17 of Section 1

Added “Notification” paragraph to 4.14.3

12 of Section 3

Changed the reference from 04QA704027 to 01DM000064 in paragraphs 5.3 & 5.4

14 of Section 3

Deleted sentence pertaining to superscript on Op –Sheet and changed reference from 04QA704027 to 01DM000064 in paragraph 5.9.

16 of Section 3

Added sentence pertaining to ASME Certificate to paragraph 7.1.1

17 of Section 3

Added reference to Quality Assurance Procedure 04QA704032 to paragraph 7.3

Completely revised

8-19-03

REO

DMQ

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CURRENT REVISION

Location

REV

DESCRIPTION

APPROVALS

DATE

CO.MGMT.

vi, x, xi, section 2 pages 2, 10, 15, 16, 20, 22, & 23

Made references to 8100.7 in Appendix B and where applicable in Section 2 of the manual per FAA request.

09/30/05

REO

DMQ REO

ii Updated company‟s name vi

Added “Industrial” to Controlled projects paragraph

Change “ATEX” to “EX” in Appendix A

Deleted QAP 04QA704025, procedure was inactivated.

Corrected procedure # “07QA04044” to “04QA704044” Corrected procedure # “04QA404062” to “04QA704062”

Renumbered index

Corrected manual # “007QA070003” to “07QA070003”

Deleted “20” from the 8100.7 reference column for procedure

04QA704091. (No such paragraph exists) Renumbered index Updated company‟s name

xii

Updated procedure number reference to correlate to renumbering of index on pages xi and xii Added note to explain the number references

Sect 1;2

Revised the end of the first paragraph in 1.0 – Scope from “quality

system as it relates to all projects not identified as Controlled” to “minimum quality system requirements”

09/30/05

REO

DMQ REO

Sect 1;2

Included reference to “Ex” representative in paragraph 1.0 – Scope

Sect 1; 18 & 19

Included reference to “Ex” representative and 10 year record

retention requirement in 8.3 – Notification

Sect 3;2

Included the “B” in “Appendix B” in paragraph 1.1 Corrected “Appendix B of the manual” to Appendix D of the manual” in paragraph 1.1 Corrected “Appendix B of the manual” to “Appendix A of the manual” in paragraph 1.1

Sect 3;2

Updated company‟s name in paragraphs 1.1, 2.1 and 2.2

Sect 3;3

Updated company‟s name in paragraph 2.2

Sect 3; 4

Updated company‟s name in paragraphs 2.6 and 3.1

Sect 3;5

Updated company‟s name in paragraph 3.5

Sect 3;6

Updated company‟s name in paragraph 4.1

Sect 3;12

Updated company‟s name in paragraph 5.1

Sect 3;14

Updated company‟s name in paragraph 9.1 Sect 3;21

Updated company‟s name in paragraph 18.3

Sect. 7.1.

revised the end of paragraphs “(a)” & (b) to add “Planning”

APX B

Made references in Appendix B and where applicable per UL AS9100/ISO Audit request 2006

9/11/06

REO

Sec 3

7.1.1

EDITED 7.1.1 APPROVED VENDORS LIST requirements of ANSI/ISO/ISE 17025

DOCUMENT NUMBER

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SUBJECT

Quality Manual

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Location

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APPROVALS

DATE

CO.MGMT.

APXD

updated table of contents, added new revision page, added “EX Representative” to Appendix D, deleted “pr” , Sec. 2 8.3 and “DQS100” from 8.3, Changed all ISO9000 references from Rev. A to “current rev.” Section 2, 3.0 added “Note” Removed “Conformal Coat” from section 9.1(section 3) as a special

process. Removed personnel qualifications for Conformal Coat from section 9.2 Revised Section 1 and 2 to ISO9001 2008 and AS9100C respectively. Added new FAA regulations 21.137, etc. to Section

2. Revised the org chart Appendix A and updated Appendix B. Updated Appendix C. Revised pages vi, vii, xv, and xviii

11/10/10

REO

Header

vii

APNX A

APNX B

APNX C

APNX D

Section 1

8.3

Section 2

8.2.3c

Section 2

8.2.4

Section 3

1.1

Section 3

2.2

Section 3

2.3

Changed Date of Origin to Date

Updated to current specification list. Removed reference to MILI-45208.

Organization Chart Revised.

Added Risk Management & Return to Service

Revised “Validation of Processes for Production and Service

Provision/ Special Procedure” to “Special Processes”

Revised Interrelationship Diagram per 2011 AS9100 Findings

Revised President responsibility for acting as QA Manager. Added Director of Administration & Quality Added Administering the ESD material to QA Staff. Added Identifying Critical… to Nuclear Qualification Engineer Added DMIR and Return-to-Service. Removed Quality Engineer/Supervisory position Corrected Production Test to Test and reporting to Engineering.

Changed 8.3 for EN13980:2002 Section 8.3 b & c

Duplicate information removed “c) Identify and control the

nonconforming product” and 8.2.3.e.

Revised “reorganized” to “recognized”, typographical error.

Removed reference to a specific revision 2000 for ISO and NQA-

Removed reference to Rev A & B of the Manual.

Changed Yearly to Annual.

10/8/12

REO

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SUBJECT

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APPROVALS

DATE

CO.MGMT.

Section 3

2.4

Section 3

2.6

Section 3

3.4

Section 3

3.5

Section 3

4.1

Section 3

5.1

Section 3

5.2

Section

5.3

Section 3

5.4

Section 3

6.3.1

Section 3

6.3.2

Section 3

7.1

Section 3

7.1.1

Section 3

7.1.2

Section 3

7.2

Added “as required by contract.”

Aded “Manual Section 3.”

Added reference to procedure 04QA704091

Removed sentence “The same individual…verification and analysis.”

Replaced “Fluid Components International LLC”, with “the Company‟s.”

Revised first three sentences. Removed requirement to send drawings and certified shippers.

Reworded redirection to paragraph 5.2

Removed the word “some”.

Added “A Process Sheet…the Operation Sheet.”

Removed reference to Process Manual.

Removed Process Manuals Replaced with the document control system.

Replaced reference to “FCI” to “the Company”

Revised Document Change Notice to Engineering Change Notice and DCN to ECN.

Replaced DCN with ECN. Corrected reference to QR, Test Reports…

Replaced The Quality Department… Added “Audits”

Complete revision.

Added “& Approved Vendor List(AVL)” Added “Vendor performance…” and reference to listing

08QA080002. Corrected procedure 04QA704046.

Removed “items as described in” Replaced „purchased on “Commercial” Purchase Order‟ Replaced “transferred to “re-evaluated”

10/8/12

REO

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SUBJECT

Quality Manual

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DATE

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Location

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DESCRIPTION

APPROVALS

DATE

CO.MGMT.

Section 3

7.3

Section 3

7.4

Section 3

8.1

Section 3

8.2

Section 3

9.1

Section 3

10.2

Section 3

12.2

Section 3

16.2

Section 3

16.4

Section 3 17

Section 3

18.3

Removed third paragraph on Certified Shipper.

Replaced reference the obsolete table to the current database.

Removed See QAP 04QA704025 for more details on Parts List. Removed explanation of Limited Life…

Corrected the Serialization system to show the current Business System generated

Removed “utilized by FCI…” Corrected the “When additional processes…”

Corrected “Currently Welding and Soldering…”

Corrected “according” to “accordance”

Corrected wording in the first sentence.

Added the option for a CPAR.

Removed DR are mostly…

Replaced 04QA704013 with Quality system Database; Quality Records.

Added Critical Safety Characteristics Evaluation.

10/8/12

REO

Date of effectivity for Revision L is April 8th, 2014

Burt Tanaka

2014.04.29 16:43:54 -07'00'

DOCUMENT NUMBER

07QA070003

SUBJECT

Quality Manual

CAGE CODE

64818

DATE

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SECTION

PAGE

CURRENT REVISION

Scope of Work

FCI manufactures Flow, Liquid Level, Temperature and Pressure Instrumentation, and Flow Conditioners.

Quality Management System

This Quality Manual provides an overview of FCI‟s quality system and identifies the processes

used to ensure that our products and servicing (customer and Field Services) meet specified requirements. The processes described in this Manual are aimed at achieving customer satisfaction by preventing nonconformities at all stages of design, product realization, service, and delivery.

The Quality Manual shall be in English and is available in the database system. FCI has developed and implemented a quality management system, based on the ISO 9001 and

AS9100 (current revision), the Quality System Requirements of 10CFR50 Appendix B, 14CFR Part 21.137 (a)-(n) and the basic Quality System Requirements of ANSI NQA-1-2000 to support our quality policy. This Manual defines the quality management system. Procedures and work instructions provide additional detail. Procedures address the “what, when and where” and include responsibilities, objectives, and activities for each applicable function in the company. Those procedures referring to particular revisions of the above standards shall be viewed as complying with the current standards and not limited to the revisions that are referenced. Work instructions provide step-by-step details on performing specific tasks, and include criteria for determining compliance.

Customer specific requirements, which are not addressed by the current quality system, are considered on an individual project/contract/order basis, and communicated throughout FCI as required.

The Quality Management system at FCI has been developed to accommodate three levels of quality management. The level of quality management to be applied to a specific project/contract/order is set at Contract Review and is suitably identified thereafter. The three levels are defined as follows:

Industrial “Controlled” Projects: These projects include (but are not limited to) Nuclear Safety. These types of projects/contracts/orders adhere to all the requirements of ISO 9001as defined in Section One of this manual, the Quality System Requirements of 10CFR50 Appendix B, and the basic Quality System Requirements of ANSI NQA-1as defined in Section Three of this manual. These projects/contracts/orders and all associated data and documentation have the unique identification of “Controlled”.

Aerospace Projects: These projects include all Aerospace identified projects. These types of projects/contracts/orders adhere to all the requirements of ISO 9001, AS9100, and the Quality System Requirements of 14CFR Part 21.137 (a)-(n) as defined in Section Two of this manual.

DOCUMENT NUMBER

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Quality Manual

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SECTION

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CURRENT REVISION

These projects/contracts/orders and all associated data and documentation are also identified as “Controlled”.

All Other Projects:These projects include (but are not limited to) Commercial projects. These types of projects/contracts/orders adhere to all the requirements of ISO 9001 as defined in section one of this manual. Any and all projects/contracts/orders, data, and/or documentation not identified as “Controlled” is deemed to fall within this level of quality management.

Hierarchy of Quality System Documents

 Quality Manual: Level 1 document that provides a general overview of the quality

system and defines the quality policy.

 Quality System Procedures: Level 2 documents that provide more detailed

explanation of the quality system elements and describe the structure of the quality system.

 Work Instructions: Level 3 documents that provide step-by-step instructions for

executing activities.

 Quality Records: Level 4 documents or data that contain the data, charts, checklists,

or other records which demonstrate conformance to specified requirements and the effective operation of the quality system.

DOCUMENT NUMBER

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SUBJECT

Quality Manual

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64818

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CURRENT REVISION

Level 1

Level 2

Level 3

Level 4

Management definition of POLICIES that support its quality system

Processes that define WHAT is done to meet quality system requirements

Documents that describe HOW processes are performed (more detail than Level 2)

Forms, reports or data that demonstrate compliance to quality system requirements

Quality Manual

Work

Instructions Procedures

Quality Records

Quality System Documentation Structure

DOCUMENT NUMBER

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SUBJECT

Quality Manual

CAGE CODE

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DATE

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SECTION

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xii

CURRENT REVISION

Appendix A: FCI Organization Chart

President & CEO

Executive Assistant

General Manager

Aerospace Division

Manager

Marketing

Director

Human

Resources

Director

Manufacturing

Aero Production

Aero Engineering

Aero Sales & Service

Industrial Production

Manager

OEM Business

Development

Director

Engineering

Director

Administration

Quality

Director

Finance

Director

Sales & Customer

Service

Document Management

Engineering

Test

Vortab Engineer

Nuclear Qualification Engineering

Quality Control

Information Systems

Legal

Facilities

Sales

Contract Mgmt

Cust. Service

Order Entry

Metrology

EX Representative

Management Rep

Planning

Material Control Mgr

Purchasing

Assembly Circuit Board

Fabrication Welding

Manufacturing Engr

DMIR

Return to

Service

QA Manager

Machining

Material Control

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xiii

CURRENT REVISION

Appendix B: Interrelation of Quality System and ISO 9001/AS9100; FAR Clauses; and NQA-1.

Manual Sections

Level 1 & 2 Documents

Section 1 ISO9001

Section 2 AS9100

Section 3 NQA-1

AS / ISO

FAR Clauses

NQA-1 & 10CFR50

Appendix B

Quality Manual

Quality Management System

4.1

Quality Manual

Documentation Requirements

4.2.1

07QA070003, Quality Manual

Quality Manual

4.2.2 1

01DM000064/01DM000025, Engineering Document Control

Control of Documents

4.2.3

21.137(b)

04QA704007, 04QA704102, Quality System

Control of Documents

4.2.3 6.2

04QA704013, Control of Quality Records

Control of Records

4.2.4

21.137(k)

04QA704052, Project Notebooks

Control of Records

4.2.4 17

04QA704078, Back-Up Procedure

Control of Records

4.2.4 17

Quality Manual

Management Responsibility

5.1 - 5.5.3

04QA704062, Management Review

Management Review

5.6.1 - 5.6.3

2.2

Quality Manual

Resource Management

6.1

04QA704034,Competence, Awareness, and Training

Human Resources

6.2.1- 6.2.2

2.6

04QA704097, Preventive Maintenance of the Building

Infrastructure

6.3 --

04QA704086, Preventive Maintenance of Process

Infrastructure

6.3 --

Quality Manual

Work Environment

6.4

Quality Manual

Planning

7.1-7.1.4

04QA704103, Risk Management

Risk Management

7.1.2,8.5. 3

04QA704002, Order Entry Procedure

Customer - Related Processes Identification of Product Related

7.2.1 3.1

04QA704005, Contract Review

Review of Product Requirements

7.2.2 3.1

Quality Manual

Customer Communication

7.2.3

04QA704091, Design and/Or Development

Design / Development

7.3.1 - 7.3.6

01DM000010, Design & Development Changes / ECO

Design and Development Changes

7.3.7

21.137(a)

3.5

04QA704044, Vendor Surveys

Purchasing Process

7.4.1

21.137(c)

7.1

04QA704077, Evaluation of Subcontractors

Purchasing Process

7.4.1 7.1.2

04QA704077, 04QA704046, Evaluation of

Purchasing Process

7.4.1 7.1

04QA704003, Purchasing Information

Purchasing Information

7.4.2 4

04QA704094, Signature Authorization

Purchasing Information

7.4.2 4

04QA704058, Plastic Coated Sensor Head Testing

Verification of Purchased Product

7.4.3

04QA704032, Testing Wetted Surfaces

Verification of Purchased Product

7.4.3 7.3

04QA704064, Hardness Testing

Verification of Purchased Product

7.4.3 7.3

04QA704001, Receiving Inspection

Verification of Purchased Product

7.4.3 8.1, 10

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SUBJECT

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CAGE CODE

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DATE

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SECTION

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xiv

CURRENT REVISION

Manual Sections

Level 1 & 2 Documents

Section 1 ISO9001

Section 2 AS9100 Section 3 NQ-A-1

AS / ISO

FAR 21.137

NQA-1

04QA704026, In-Process Inspection

Verification of Purchased Product/Processing

7.4.3 8.1, 10

04QA704020, Job Orders

Production – Control

7.5.1

21.137(d)

5.2

04QA704048, Foreign Object Prevention

Production – Control

7.5.1 --

04QA704050, Return of Controlled Items for Repair/Rework

Production – Control

7.5.1 10

04QA704074, Aerospace Return Items

Production – Control

7.5.1 --

04QA704079, Field Service/Installation Procedure

Production – Control

7.5.1 --

04QA704080, Repair Procedure Commercial/Non-Safety

Production – Control

7.5.1 --

04QA704082, Production and Service Provision / Process Control Procedure: Non-Controlled Jobs

Production – Control

7.5.1 --

04QA704084, Tooling Procedure

Production – Control

7.5.1 --

04QA704049, First Article

Production Validation

7.5.1,8.2.4

04QA704026, In-Process Inspection

Production - Validation

7.5.2 10

04QA704039, Welder Qualification

Production - Validation

7.5.2 9.2

04QA704057, Workmanship Standard

Production - Validation

7.5.2 9.2

04QA704088, Special Processes

Production - Validation

7.5.2 9.1

04QA704024, Issuing Stamps

Id & Traceability

7.5.3

45.15

14.3

04QA704067, Issuing Serial Numbers to Mil/Aero Units

Id & Traceability

7.5.3 --

04QA704085, Product Id

Id & Traceability

7.5.3 --

04QA704055, Customer Property

Customer Property

7.5.4 7.6

04QA704018, Standard Handling, Packaging & Shipping

Product Preservation

7.5.5

21.137(j)

13.3

04QA704019, Final Cleaning

Product Preservation

7.5.5 13.2

04QA704048, Foreign Object Prevention

Product Preservation

7.5.5 --

04QA704053, Dated Coded Materials

Product Preservation

7.5.5 7.4, 8.1

04QA704081, Storage

Product Preservation

7.5.5 13.1

04QA704010, Special Handling, Storage & Shipping

Product Preservation

7.5.5 13.3.1

04QA704006, Calibration Program

Control of Monitoring / Measuring

7.6 12.1

04QA704029, Evaluation of Measuring & Test

Control of Monitoring / Measuring

7.6

21.137(f)

12.3

04QA704063, Inspection History

Measurement, Analysis & Improvement

8.1 --

04QA704076, On Time Delivery

Measurement, Analysis & Improvement

8.1 --

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SUBJECT

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CAGE CODE

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DATE

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CURRENT REVISION

Manual Sections

Level 1 & 2 Documents

Section 1 ISO9001

Section 2 AS9100 Section 3 NQ-A-1

AS / ISO

FAR 21.137

NQA-1

04QA704098, Customer Satisfaction

Customer Satisfaction

8.2.1 --

04QA704008, Audits

Audits

8.2.2

21.137(l)

18.1, 18.2

04QA704054, Auditor Qualification

Audits

8.2.2 303 & /2S-3

Quality Manual

Monitoring & Measurement Processes

8.2.3

04QA704026, In-Process Inspection

Monitoring & Measurement Product

8.2.4

21.137(g)

21.137(n) &

21.137(e)

8.1, 10.1

04QA704038, Final Inspection

Monitoring & Measurement Product

8.2.4 8.1, 10.1

04QA704058, Plastic Coated Sensor Head Testing

Monitoring & Measurement Product

8.2.4 8.1, 10.1

04QA704105, Return to Service Aero PMA Parts

Monitor & Measurement of Product

8.2.4 --

04QA704004, Control of Nonconforming Product

Control of Nonconforming Product

8.3

21.137(h)

04QA704011, 10 CFR 21.3 Reporting

Control of Nonconforming Product

8.3 15.3

04QA704075, Reporting to the FAA

Control of Nonconforming Product

8.3

21.137(n)

Quality Manual

Analysis of Data

8.4 & 8.1

21.137(n)

Quality Manual

Continual Improvement

8.5.1

04QA704070, Vendor Corrective Action

Corrective Action

8.5.2 16.1

04QA704083, Corrective and Preventive Action

Corrective Action

8.5.2 - 8.5.3

21.137(i),

21.137(m) and

21.137(n)

04QA704070, Vendor Corrective Action

Preventive Action

8.5.3

04QA704093, Customer Response

Preventive Action

8.5.3 16

04QA704071, Commercial Grade Item Testing

-- 7.5

06QA020013, Qualification Verification Analysis

-- 3.4

06QA020014, Nuclear Item Dedication Plan

-- 7.5

*Paragraphs 425 & 612 are met by the procedures referenced, no cross-reference to the manual

paragraphs. Paragraph 612 is also met by manual paragraph 7.4.

Note: all “04QA” number sequences listed in this manual reflect Fluid Components International LLC‟s current

numbering system. The core number of the document is 704xxx, which remains the same regardless of the prefix added. Some of the quality assurance procedures listed in this manual have not been revised since the implementation of the 04QA system; therefore this note serves as notice that the document with the core number 704xxx, regardless of the prefix represents the same document.

DOCUMENT NUMBER

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CAGE CODE

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SECTION

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CURRENT REVISION

Appendix C: Interrelationships Diagram

Management

Responsibility

(23)

QMS Continuous Improvement

(10, 23, 30)

Continuous Improvement

Process Improvement

Teams

Risk Analysis 04QA704103

Resource Management

QM 07QA070003 Sec

6.1

Management

Responsibility

QM 07QA070003 Sec

5.5

Measurement,

Analysis,

& Improvement

QM 07QA070003 8.1,

8.4

Product

Realization

QM 07QA070003

Sec 7 & 8

Customers

Order

Acknowledgement

Contract Review

Customers

Product

Delivery Reports

CPARs

Customer

Reports

Satisfaction

Management Review

04QA704062 &

QM 07QA070003 Sec 5.6

Discrepancy Reports

Supplier Reports

Reports to Management Review

Reports to

Improvement Teams

Improvement Requests

Objectives & Policies

Improvements to the Process

Quotatio

Contrac

A description of the interaction between the processes of the quality management system:

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CURRENT REVISION

Appendix D: Structure, Responsibility, and Authority of the Quality Management System

President

The President is responsible, through the Director of Administration & Quality and the Quality Assurance Manager, for the authorization and implementation of the Quality Management System throughout the company, including:

 The overall responsibility for the definition of, and adherence to, the quality policy.  Establishing quality goals and monitoring progress to ensure continued suitability and

effectiveness of the quality management system.

 Providing the necessary resources to maintain the quality management system.  Conducting management reviews of the quality management system.  Monitor the audit team for timely completion of the annual Internal Quality Assurance

Program audit.

The President shall resolve matters regarding quality that the Director of Administration & Quality and the Quality Assurance Manager determines necessary to bring to the attention of executive management or cannot be resolved to the satisfaction of the Quality Assurance Manager by any other means.

Director of Administration & Quality

In support of the President, the Director of Administration & Quality is responsible for:

 Overseeing the Quality, Maintenance and Information Technology departments.  Providing counsel to the President when requested, and in support of the Company.  The Director of Administration & Quality shall act as the Quality Assurance Manager in

the Quality Assurance Manager‟s absence.

Quality Assurance Manager

In support of the President and Director of Administration & Quality, the Quality Assurance Manager is responsible for:

 Administering the Quality Management System and defining, measuring, and

maintaining the overall effectiveness and enforcement of the Program.

 Identifying resources to maintain the quality management system.  Reporting to the President on a yearly basis as to the effectiveness of the Quality

Management System.

 Reviewing organizational requirements and providing recommendations for changes.  Directing and auditing quality-related activities; and, reporting to and advising the

President and executive staff on quality matters.

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 Ensuring the quality management system is maintained through appropriate audits, tests,

inspections, and surveys.

 Leading and initiating actions to prevent the occurrence of any nonconformities relating

to product, process, and quality management system.

 Reporting quality and nonconformance data and trends. The Quality Assurance Manager delegates quality responsibilities to persons and

organizations within the company. (References to the Quality Assurance Manager throughout this manual and the supplementary Quality Assurance Procedures shall mean the Quality Assurance Manager or the Quality Assurance Manager's Representative.)

 To liaise with the notified body responsible for the assessment of the quality system in case of changes to the quality system, together with the EX representative

Managers and Supervisors

Actively support those responsible for implementing and improving the quality management system.

Ensure the quality policy is fully supported, understood, implemented, and maintained at appropriate levels of their organizations.

Ensure appropriate supporting procedures are documented and followed throughout their respective departments.

Ensure adequate resources and prioritization; assign trained personnel to perform work and verification activities including internal audits, and work affecting product quality.

When appointing a designee to act on their behalf for the purposes of any element of this quality system, ensure the person appointed is adequately trained and given sufficient organizational freedom and authority to execute the responsibility.

Initiate “stop shipment” as appropriate to prevent nonconformance, and then, Initiate a documented corrective action procedure.

Maintain the “stop” until receipt of authorization and associated data and documentation to

release the “stop”.

Employees

Understand and support the quality policy and the appropriate elements of the quality management system for their areas of work

Dedicate their efforts to the reduction, elimination, and prevention of quality deficiencies Initiate action to prevent the occurrence of nonconformities related to product, process, and

quality system.

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Specific Task performed throughout the organization

Quality Assurance Staff (Reports directly to the Quality Assurance Manager) has responsibility for the following:

 Reviewing, approving, and generating instructions, procedures, & forms,  Reviewing, approving internal and customer Purchase Orders,  Compiling project record notebooks,  Administering the Discrepancy Report program,  Auditing, and  Training and certifying personnel performing activities affecting quality.  Administering the ESD program.

Metrology Department (Reports to the Inspection Supervisor)

All in-house calibration of Measuring and Test Equipment shall be performed under the direction of the Metrology Department. The Metrology Department is responsible for all Measuring and Test Equipment and shall assure that the equipment is maintained in

accordance with Quality Assurance Procedure 04QA704006, “Calibration program”.

The Metrology Department is also responsible for generating calibration procedures for Measuring and Test Equipment calibrated in house.

Contract Manager has authority and responsibility for the following:  Assuring that all contractual items, terms, and conditions are identified complied with

and/or met.

 Participating as a Material Review Board member,  Acting as a drawing checker, and reviewing and approving Operation Sheets, Test

Procedures, and Test Reports for conformance with contractual requirements and FCI practices.

 Act as the primary liaison between the customer and FCI once a contract has been

accepted and obtaining customer response on all documents and drawings sent to the customer for approval.

Director Of Engineering/Engineering Manager Staff

 Ultimately responsible for design control.  Responsible for incorporating customer specifications, codes, standards, and

requirements into all approval and sub-assembly drawings to be used by the Production and Quality Assurance/Control Departments.

 Responsible for the generation of Operations Sheets, Process Sheets, Process Manuals,

and other such instructions and procedures required by the Production Department to

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consistently build quality products.

 Has the responsibility of controlling copies of the above referenced documents and

ensuring only current or specified revisions are used during the manufacturing process. Engineering shall also ensure that obsolete or expired documents have been removed from the factory floor.

 Has the authority to participate as a member of the Material Review Board Committee.  Under the direction of Quality Control Metrology and Engineering, the Engineering Test

Group may be responsible for the calibration and maintenance of Flow Stands and Measuring & Test Equipment used to calibrate product.

Nuclear Qualification Engineering (QE)  Responsible for maintaining qualification of Safety-Related Class 1E product through the

use of Similarity Analyses, Testing, and other appropriate methods.

 Responsible for overseeing qualification test programs.  Participating in drawing reviews and the Material Review Board to address qualification

related issues.

 Identifying critical characteristics for Commercial Grade Dedication of Components and

services.

Directors Of Manufacturing/Manufacturing Manager

Operations Management is responsible for the activities of the Planning, Purchasing, Material Control, and Production.

Planning

Planners have the responsibility to schedule projects through the factory areas, obtain controlled documents, requisition items, and issue Job Orders needed for each contract.

Purchasing

Purchasing is responsible for purchasing items, services, and equipment in accordance with specific instructions and requirements.

Material Control

Material Control is responsible for all inventories; for providing items as required to fill orders and maintaining lot control of items so identified. Material Control also has the responsibility for receiving parts and outside processed goods as well as all aspects of shipping product.

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Production

The Production groups perform the fabrication and assembly of shippable product in accordance with applicable instructions, procedures, and drawings. Production is also responsible to record the work and processing performed as required by these documents.

Test

Test shall perform all calibrations of instruments supplied to the customer. All calibrations and tests shall be in accordance with the applicable contract requirements and approved procedures. Test shall also perform such other tests as requested by the Engineering, Production, or Quality Assurance Departments.

EX Representative

The EX Representative shall have the following responsibilities and authority:  Effective monitoring, dissemination, review and implementation of the latest applicable

technical knowledge  Effective coordination of activities with respect to products intended for use in

potentially explosive atmospheres  To liaise with the notified bodies in case of changes to the design in the EC-Type

Examination Certificate and the technical documentation  To liaise with the notified body responsible for the assessment of the quality system in

case of changes to the quality system, together with the Quality Assurance representative.

 Authorize the initial approval and changes to related drawings  Authorize concessions if it does not take the product outside the design as defined in

the EC-Type Examination Certificate

 Communicate information to the customer of special conditions or limitations  Participate in the Management Review Meeting

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Designated Manufacturing Inspection Representative (DMIR)

The DMIR shall be responsible to verify conformity by inspecting parts to be released per the Production Approval Holder (FCI). The release is to conform to various sections of 14 CFR 183.31 as authorized and limited to the Official Certificate of Authority. The authorization is limited to the Function Codes 01, 03, 05, 06, and 07.

Return-to-Service Inspector

The Return-to-Service Inspector shall be responsible for returning Aerospace PMA parts used for aircraft and has been rebuilt or altered under the FAA Part 43, section 43.3(j). Authorization is based on FCI‟s Production Certificate and FAA-Parts Manufacturing Approval. Return-to-Service Aerospace PMA parts follow the procedure 04QA704105. Personnel authorized to Return-to-Service under this provision are limited to the “Personnel Authorized for Return –to-Service” attached to this manual.

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SECTION ONE

DESCRIPTION

PAGE

1.0 Scope

2.0 Reference Documents

3.0 References

4.0 Quality Management System

5.0 Management Responsibility

6.0 Resource Management

7.0 Product Realization

8.0 Measurement, Analysis, and Improvement

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1.0 SCOPE

The requirements described in this section, Section One, of the Quality Manual provide an overview of FCI‟s minimum quality system requirements.

Issuance and changes to the manual shall be performed in accordance with

“Document and Data Control, paragraph 4.2.3 of this section of the manual.

Changes to this Manual that substantially effect the Quality System e.g. Change of Quality Assurance Manger or EX Representative (ATEX, IECEx, etc.), Certifications i.e. ISO, etc., shall be submitted to a Notified Body (ATEX, IECEx, etc.) by the appropriate Representative (EX Representative, Management Representative, Quality Assurance Manager, etc.) if required by the standard.

In addition, FCI shall know and understand the monitoring requirements and applicable performance criteria for AMS and the impact of these requirements on instrument design, manufacturing and certification pursuant to EN15267.

2.0 REFERENCED DOCUMENTS

This manual is supplemented by numerous procedures as identified in Appendix

“B” and referenced throughout this manual. Procedures other than those

referenced may also be used to implement the Quality Management system.

3.0 REFERENCES

ISO 9001 (current revision), Quality management systems - Requirements

4.0 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL

FCI has established, documented, implemented, and maintains and continually improves a quality management system in accordance with the requirements of ISO 9001.

To implement the quality management system FCI will: a) Determine the processes needed for the quality management system and their

application throughout the organization,

b) Determine the sequence and interaction of these processes, c) Determine criteria and methods needed to ensure that both the operation and

control of these processes are effective,

d) Ensure the availability of resources and information necessary to support the

operation and monitoring of these processes,

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e) Measure, monitor and analyze these processes, and f) Implement action necessary to achieve planned results and continual

improvement of these processes.

FCI manages these processes in accordance with the requirements of the ISO 9001International Standard.

Where FCI chooses to outsource any process that affects product conformity with requirements, the organization ensures control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

Documentation for the quality management system includes: a) Documented statements of a quality policy and quality objectives, b) A quality manual, c) Documented procedures and records required by ISO 9001, d) Documents including records determined by FCI to be necessary to ensure

the effective planning, operation and control of its processes.

4.2.2 QUALITY MANUAL

A quality manual is established and maintained that includes the following: a) The scope of the quality management system, including details of, and

justification for, any exclusions,

b) The documented procedures established for the quality management system,

or reference to them (See Appendix B), and

c) A description of the interaction between the processes of the quality

management system (See Appendix C).

4.2.3 CONTROL OF DOCUMENTS

Documents required for the quality management system are controlled. A documented procedure is established to define the controls needed: a) To approve documents for adequacy prior to issue, b) To review, update as necessary, and re-approve documents,

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c) To ensure that changes and the current revision status of documents are

identified,

d) To ensure that relevant versions of applicable documents are available at

points of use,

e) To ensure that documents remain legible and readily identifiable, f) To ensure that documents of external origin determined by FCI to be

necessary for the planning and operation of the Quality Management System are identified and their distribution controlled,

g) To prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose.

4.2.4 CONTROL OF QUALITY RECORDS

Records are established to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records will remain legible, readily identifiable, and retrievable. FCI shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records.

5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

Top management provides evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:

a) Communicating to the organization via email, presentations, postings,

and/or a newsletter the importance of meeting customer as well as statutory, and regulatory requirements,

b) Establishing the quality policy, c) Ensuring that quality objectives are established, d) Conducting management reviews, and e) Ensuring the availability of resources.

5.2 CUSTOMER FOCUS

Top management ensures that customer requirements are determined and are met

with the aim of enhancing customer satisfaction. (See section 7.2.1, and 8.2.1)

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5.3 QUALITY POLICY

Top management ensures that the quality policy: a) Is appropriate to the purpose of the organization, b) Includes a commitment to meeting requirements and to continually improve

the effectiveness of the quality management system,

c) Provides a framework for establishing and reviewing quality objectives, d) Is communicated and understood within the organization, and e) Is reviewed for continuing suitability. FCI‟s quality policy is as follows:

“To continually meet and exceed customer expectations and requirements for

products and services and to continually improve the effectiveness of the quality

management system.”

5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

Top management ensures that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy.

5.4.2 QUALITY PLANNING

Top management ensures that:

a) The planning of the quality management system is carried out in order to

meet the requirements given in 4.1, as well as the quality objectives, and

b) The integrity of the quality management system is maintained when changes

to the quality management system are planned and implemented.

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5.5 RESPONSIBILITIES, AUTHORITY, AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

Top Management ensures that responsibilities and authorities are defined and communicated within the organization through this Quality Manual (also see Appendix A and D) and individual organizational charts at the departmental level.

5.5.2 MANAGEMENT RESPONSIBILITY

Top Management has appointed (by virtue of this document) the Quality Assurance Manager as the Management Representative. This individual is a member of the management structure of FCI. Irrespective of other responsibilities the Management Representative has the responsibility and authority that includes:

a) Ensuring that processes needed for the quality management system are

established, implemented and maintained,

b) Reporting to top management on the performance of the quality

management system and any need for improvement, and

c) Ensuring the promotion of awareness of customer requirements throughout

the organization.

5.5.3 INTERNAL COMMUNICATION

Top management ensures that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. This includes the posting of Quality Objective data to communicate information to the employee population regarding the effectiveness of the quality management system.

5.6 MANAGEMENT REVIEW

5.6.1 GENERAL

Top management reviews the quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews are maintained.

5.6.2 REVIEW INPUT

The input to management review includes information on:

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a) Results of audits, b) Customer feedback, c) Process performance and product conformity, d) Status of preventive and corrective actions, e) Follow-up actions from previous management reviews, f) Changes that could affect the quality management system, and g) Recommendations for improvement.

5.6.3 REVIEW OUTPUT

The outputs from the management review include any decisions and actions related to:

a) Improvement of the effectiveness of the quality management system and its

processes,

b) Improvement of product related to customer requirements, and c) Resource needs.

6.0 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES

FCI determines and provides the resources needed; a) To implement and maintain the quality management system and continually

improve its effectiveness, and

b) To enhance customer satisfaction by meeting customer requirements. On an annual basis, the Directors submit all proposed resource needs for the

upcoming fiscal year to the Chief Financial Officer (CFO). These proposed resource needs include, the infrastructure and resources needed to:

a. Achieve conformity to product requirements, b. Implement and maintain the quality management system and continually

improve its effectiveness, and

c. Enhance customer satisfaction by meeting customer requirements.

The President, with input from other corporate entities, determines the

departmental budgets. The approved departmental budgets document the determination of the infrastructure and resources needed.

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