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.
li
ic
SUBJECT
Quality Manual
PREPARED BY:
allp7
CAGE CODE
64818
1
1
1
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7
LTI
DATE
10-8-2012
QUALITY MANUAL
SECTION
.11
07QA070003
PAGE
CURRENT
REVISION
L
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
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ii
CURRENT
REVISION
L
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
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TABLE OF CONTENTS
DESCRIPTION
SECTION
PAGE
Title Page
-
i
Commitment to Quality Statement
-
ii
Table of Contents
-
iii
Revision Page
-
iv, v,
Quality Management System
-
vi-viii
Appendix A
-
ix
Appendix B
-
x-xii
Appendix C
-
xiii
Appendix D
-
xiv-xviii
Section One
1
1 – 19
Section Two
2
1 – 32
Section Three
3
1 -- 21
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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iv
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REVISION
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REVISION PAGE
Location
REV
DESCRIPTION
APPROVALS
DATE
QA
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
D
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
SM
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
F
Completely revised
8-19-03
REO
DMQ
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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v
CURRENT
REVISION
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Location
REV
DESCRIPTION
APPROVALS
DATE
QA
CO.MGMT.
vi, x, xi,
section 2
pages 2,
10, 15, 16,
20, 22, &
23
G
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
ix
Change “ATEX” to “EX” in Appendix A
x
Deleted QAP 04QA704025, procedure was inactivated.
Corrected procedure # “07QA04044” to “04QA704044”
Corrected procedure # “04QA404062” to “04QA704062”
Renumbered index
xi
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
H
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
J
Made references in Appendix B and where applicable
per UL AS9100/ISO Audit request 2006
9/11/06
REO
REO
Sec 3
7.1.1
EDITED 7.1.1 APPROVED VENDORS LIST
requirements of ANSI/ISO/ISE 17025
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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CURRENT
REVISION
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Location
REV
DESCRIPTION
APPROVALS
DATE
QA
CO.MGMT.
APXD
K
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
BC
REO
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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
L
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-
1.
Removed reference to Rev A & B of the Manual.
Changed Yearly to Annual.
10/8/12
BT
REO
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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REVISION
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Location
REV
DESCRIPTION
APPROVALS
DATE
QA
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
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
L
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
BT
REO
DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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Location
REV
DESCRIPTION
APPROVALS
DATE
QA
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
L
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
BT
REO
Date of effectivity for Revision L is April 8th, 2014
Burt Tanaka
2014.04.29
16:43:54 -07'00'
DOCUMENT NUMBER
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SUBJECT
Quality Manual
CAGE CODE
64818
DATE
10-8-2012
SECTION
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CURRENT
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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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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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Quality Manual
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DATE
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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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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
Of
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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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)
6
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)
17
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
3
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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DATE
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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 --
DOCUMENT NUMBER
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SUBJECT
Quality Manual
CAGE CODE
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DATE
10-8-2012
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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)
15
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)
16
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.
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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
n
Contrac
t
A description of the interaction between the processes of the quality management system:
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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
2.0 Reference Documents
2
3.0 References
2
4.0 Quality Management System
2
5.0 Management Responsibility
4
6.0 Resource Management
7
7.0 Product Realization
9
8.0 Measurement, Analysis, and Improvement
16
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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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