Quality System Manual
For
Maricopa Controls Inc.
ISO9001:2000
AS9100 Rev. A
Revision Status Record
REV
NC
A
B
C
D
E
F
G
H
I
J
K
L
M
DESCRIPTION
Original Issue
Complete Revision
Complete Revision
Section 4 – Design Control
Section 3 – Contract Review
Complete Revision
AS 9000 Revision
NCR 3-01a/Renumbered (1)
Added 2nd tier references.
Incorporated AS9100 Requirements
Reorganization thru downsizing and incorporated
AS9100: A requirements.
Incorporated ISO9001: 2000 Requirements
Extensive Format Change
Added References
DATE
August 23, 1998
September 7, 1998
September 24, 1998
March 22, 1999
June 7, 1999
July 7, 1999
October 13, 1999
December 10, 1999
February 17, 2000
September 24, 2001
September 27, 2002
January 24, 2003
July 28, 2003
October 22, 2003
_______________MGM_________________________
Martin G. McMurry – President
_______10/23/03____________
Date
__________________PF________________________
Paula Fouts – Management Representative
_______10/23/03_________
Date
© 2003 Maricopa Controls Inc.
www.maricopacontrols.com
Page 1 of 19
MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
TABLE OF CONTENTS
CONTENTS
PAGE
1.0 SCOPE .................................................................................................................... 3
2.0 EXCLUSIONS ........................................................................................................... 3
3.0 TERMS AND DEFINITIONS ......................................................................................... 3
4.0 QUALITY MANAGEMENT SYSTEM ................................................................................ 3
4.1 GENERAL REQUIREMENTS ......................................................................................... 3
4.2 DOCUMENTATION REQUIREMENTS ............................................................................. 4
4.2.1 General: Quality Management System Documentation ............................................ 4
4.2.2 Quality System Manual......................................................................................... 4
4.2.3 Procedure for the Control of Documents ................................................................. 4
4.2.4 Procedure for Control of Records ........................................................................... 6
4.3 CONFIGURATION MANAGEMENT ................................................................................ 7
5.0 MANAGEMENT RESPONSIBILITY ................................................................................. 8
6.0 RESOURCE MANAGEMENT ....................................................................................... 10
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT: ........................................................ 16
9.0 REFERENCE DOCUMENTS AND LOCATION: ................................................................ 19
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
1.0 Scope
This manual describes the Quality Management System in place at:
Maricopa Controls Inc.
328 S. Rockford Drive Ste. 3
Tempe Arizona 85281
Maricopa Controls Inc., designs, develops and manufactures test equipment, supervisory
controls and custom power supplies for commercial and aerospace industries. We strive to
provide our customers with products of exceptional quality and value, on time in order to meet
or exceed their expectations. This is achieved by maintaining a quality management system in
accordance with ISO9001: 2000 and AS9100A and a commitment to continually improve its
effectiveness. Our Quality System Manual encompasses the Quality Policy of Maricopa
Controls Inc. throughout this document.
2.0 Exclusions
Servicing product is not offered to the customers because our product is installed and serviced
by the customer or their representative. Maricopa Controls Inc. takes exception to section
7.5.1.5 Control of Service Operations.
3.0 Terms and definitions
The term “organization” used in this quality system manual refers to Maricopa Controls Inc.
“Supplier” refers to the external source used to acquire purchased material and or services by
the organization.
The term “Area Leaders” used in this quality manual also refers to Top Management and may
be singular or plural.
4.0 Quality Management System
4.1
General Requirements
Maricopa Controls Inc. documents, implements and maintains a quality management
system and continually improves its effectiveness in accordance with the requirements of
the ISO 9001:2000 and AS9100 Rev. A. International Standards.
Area Leaders ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the QMS.
Management Review Meetings and Training sessions are held to promote Employee
awareness, participation and input to the QMS.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
4.2
Documentation requirements
4.2.1
General: Quality Management System Documentation
The Quality Management System documentation for Maricopa Controls Inc.
includes the following:
 Documented statements of our Quality Policy and Quality Objectives,
 Our Quality System Manual (this document).
 Documented procedures required by these International Standards (are
either referenced included in this document).
 Documents needed to ensure effective planning, operation and control of
our processes.
 Records required by these International Standards (see 4.2.4).
 Quality system requirements imposed by applicable regulatory authorities.
Employees have access to QMS documentation and are aware of relevant
procedures. Customers and/or regulatory authorities representatives also have
access to QMS documentation when requested.
4.2.2
Quality System Manual
The Quality System Manual is maintained and updated by the Management
Representative. It is reviewed at minimum annually to ensure its compliance with
the ISO 9001:2000 and AS9100A standards and to the company’s continual
improvement initiatives.
The documented procedures for the control of documents (see 4.2.3) and the
control of records (see 4.2.4) are included within this Quality System Manual.
NOTE: The Management Representative may delegate matters relating to the
quality management system to other Area leaders.
4.2.3
Procedure for the Control of Documents
The purpose of this procedure is to define the controls needed to create, maintain,
approve and control Quality Management System documentation.
The Management Representative or their delegated Area Leader is responsible for
the control of QMS documentation as follows:
a) Approves QMS documentation for adequacy prior to issue.
b) Reviews, updates and re-approves QMS documentation as necessary.
c) Ensures changes and current revisions are identified.
d) Ensures QMS documentation is available at points of use with relevant versions
of applicable documentation.
e) Maintains QMS documents remain legible and readily identifiable.
f)
Maintains that QMS documents of external origin are identified and their
distribution is controlled.
g) Prevents the unintended use of obsolete documents, which are suitably
identified if they are retained for any purpose.
Evidence of review and or approval may be in the form of any one or more of the
following: revision letter, signature, date, and/or initials (hand written or typed).
Further evidence of review may be found in Management Review Meeting minutes
Training Session Records and Internal Audit Reports.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
Continued from previous page, section 4.2.3:
Red lining of documents is acceptable and are identified with an initial and date.
Red lined documents must be updated to incorporate the changes within 60 days
from the initial red lining.
Obsolete documents are identified to prevent their unintended use. This is
accomplished with either a red stamp or hand written with red ink, “OBSOLETE" or
"Reference Only".
Production documentation for product being built is listed on the Product Matrix
by specific part number, which is kept in 3-ring binders located in the stock room.
Customer supplied production documentation may be listed on the Product Matrix
and in the 3 ring binder and is controlled by its own authority. When revised or
new customer supplied production documents are issued, the product matrix is
updated with the change.
Employees are instructed how to get the current and correct production
documentation.
QMS documentation is controlled as follows:
Hard Copies are uncontrolled, or “For Reference Only”.
Originals are kept on the computer, location: \\Server\MANUFACTURING…
Revision Letter and Date identify changes to QMS documentation.
The Operational Notebook is readily available to employees to ensure their
awareness of relevant procedures and processes. It provides access to QMS
documentation or reference to them. It is located in the Quality Department and
on the computer, location: \\Server\MANUFACTURING\Operational Notebook\.
The contents of the Operational Notebook include the following:
 Maricopa Controls Inc. Quality System Manual (this document)
 Key Personnel List
 Designee List
 Source Release Representative List
 Master Index of Forms, (contains identification and location)
 Master Index of Quality Records, (contains identification, retention, and
location)
 Master Index of Controlled Documents, (contains current revisions and
locations)
 Master Index of SOP's and the referenced Standard Operating Procedures
 Master Index of QOP's and the referenced Quality Operating Procedures
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
4.2.4
Procedure for Control of Records
The purpose for this procedure is to define the controls needed for the
identification, storage, protection, retrieval, retention times and disposition of
records.
The Master Index of Quality Records contains the document description, record
location, controlled by, retention time and how it is filed. The hard copy is located
in the Quality department in the Operational Notebook and the original on the
computer, location: Server\\MANUFACTURING\Operational Notebook\.
The Master Index of Forms contains forms that may be used to create
records used by the Quality Management System. It contains the current revision,
form number, and title. The hard copy is located in the Quality department in the
Operational Notebook, and the original on the computer, location:
Server\\MANUFACTURING\Operational Notebook\.
The Management Representative or their delegated Area Leader is responsible for
the following:
 The control and maintenance of the Master Index of Records.
 Assigns record retention periods according to contract, regulatory or
company requirements.
 Coordinates the storage of records with other Area Leaders.
 Determines the method of collection, indexing and archive to be used.
Area leaders and employees are responsible for assisting in collecting and
archiving records pertaining to the Quality Management System, production,
design and development.
Employees are informed on how to use, retrieve gain access to customer supplied
and internal forms used to create quality records.
Instructions for filling out some of the forms are found in SOP 1-Manufacturing
Documentation. It is located in the Operational Notebook and on the server.
Quality Records are made available for review by customers and regulatory
authorities, when contractually agreed upon.
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4.3
Configuration Management
Maricopa Controls Inc.
Quality Management System's
Interaction and Relationship Map
Design?
5.4
YES
NO
7.3
Order Entry
Customer
Order/RFQ
7.1
Customer
Requirements
7.2
7.2.2
Human
Resources
Design and
Development
Generate
Work Order
7.3.2
7.6
6.2.1
7.3.4
7.5.3
8.2.4.1
8.2.4.2
Quality Assurance
7.2.3
Customer
Satisfaction
Purchasing
7.2.1
7.4
7.4.1
7.4.3
7.5
6.3
7.5.1.1
1.0
Quality Management
4.0
System
4.1
4.2
4.2.1
4.2.2
4.2.3
4.2.4
General Requirements
Documentation Req.
General
Quality Manual
Control of Documents
Control of Records
Product
Realization
7.3.1
7.3.3
7.3.5
7.3.6
7.3.6.1
7.3.6.2
7.3.7
7.5.1.2
7.5.1.3
7.5.1.4
8.2.4
Production Control
*Facilities
Scope
8.2.1
Receive
Material
7.4.2
7.0
7.5.1
7.5.3
7.5.2
Test
7.5.5
Accounting
8.4
7.5.4
Normative
Reference
Management
Responsibility
5.1
5.2
5.3
5.4.1
5.4.2
5.5.1
5.5.2
5.5.3
5.6
5.6.2
5.6.3
Ship
Build
Order
2.0
5.0
Terms and
Definitions
Resource
Management
3.0
6.0
6.1
Provision of Resources
Management Commitment
6.2.2 Competence, Awareness and Training
Customer Focus
6.4
Work Environment
Quality Policy
Quality Objectiives
Quality Management System Planning
Resoponsibility, Authority and Communication
Management Representative
Internal Communication
Management Review
Review Input
Review Output
Design and Development
Measurement, Analysis
Planning
8.0
and Improvement
Design and Development
Outputs
8.1
General
Design and Development
8.2.2 Internal Audit
Verification
8.2.3 Monitoring and Measurement of Processes
Design and Development
8.3
Control of Nonconforming Product
Validation
8.5
Improvement
Documentation of Design
8.5.1
Continual Improvement
and/or Development
8.5.2 Corrective Action
Verification and Validation
8.5.3
Preventive Action
Design and/or Development
Verification and ValidationTesting
Control of Design and Development Changes
Control of Production Process Changes
Control of Prod. Equip. Tools and Numerical Control Machine Programs
Control of Work Transferred, on a Temp. Basis, Outside the Organization's Facilities
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5.0 Management Responsibility
5.1
Management Commitment
Area Leaders are committed to the development and implementation of our QMS and its
continual improvement and effectiveness.
5.2
Customer Focus
Area Leaders ensure that customer requirements are determined and met with the aim of
enhancing customer satisfaction.
5.3
Quality Policy
Our Quality System Manual encompasses the Quality Policy of Maricopa Controls Inc.
throughout this document. It is appropriate to the purpose of this organization, includes
a commitment to comply with requirements and continually improve the effectiveness of
the QMS. Provides a framework for establishing and reviewing quality objectives. It is
reviewed for continuing suitability, communicated and understood within the
organization.
5.4
Planning
5.4.1
Quality Objectives
Area Leaders ensure 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

Maintain and Enhance Customer Satisfaction.

Provide on time delivery to our customers.

Monitor Supplier performance.

Monitor Internal PPM.
Quality management system planning
The quality management system and sustaining processes support the quality
policy and objectives. Area Leaders ensure that the Quality Management System
planning is carried out according to ISO9001:2000 and AS9100 standard
requirements as well as our quality objectives. The integrity of the QMS is
maintained when changes are planned and implemented.
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5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
Area leaders ensure that responsibilities and authorities are communicated within
the organization to promote effectiveness of the QMS.
An Organizational chart illustrates the responsibility and relative authority of
personnel who manage, perform, and verify the activities affecting the quality
management system.
Organizational Chart
ISO
Management
Representative
Sales
Production
Company
President
Customer
Service
Quality
Purchasing
A Management Review Team is appointed to evaluate and implement
requirements of, as well as improvement to, the Quality Management System.
The MRT is made up of representing members from departments within the
organization.
5.5.2
Management Representative
The Company President has appointed a ISO Management Representative who,
irrespective of other responsibilities, has the responsibility and authority that
includes:
 ensuring that processes needed for the quality management system are
established, implemented and maintained,
 reporting to Area Leaders on the performance of the QMS, needs for
improvement, and
 ensuring the promotion of awareness of customer requirements throughout
the organization and
 the organizational freedom to resolve matters pertaining to quality.
NOTE: The Management Representative may delegate matters relating to the
quality management system to other Area leaders.
5.5.3
Internal communication
Area Leaders ensure that appropriate communication processes are established
within the organization and that communication takes place regarding the
effectiveness of the QMS. Management Review Meetings and Training sessions
are held to promote Employee awareness, participation and input to the QMS.
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6.0 Resource Management
6.1
Provision of Resources
Maricopa Controls Inc. determines and provides the resources needed to implement and
maintain the quality management system and continually improve its effectiveness.
Enhance customer satisfaction is addressed by meeting customer requirements.
6.2
Human Resources
6.2.1
General
The personnel, performing work affecting product quality are competent based
upon appropriate education, training, skills and experience. The Quality Manager
appoints the Training Coordinator, whose responsibilities include the following:
 Maintain the Training Log Book and Schedules.
 Creates, collects and maintains Training Records for the QMS, area and
position.
 Reports on the status of training at Management Review Meetings.
 Maintains the requirements for training by area/position and the QMS.
6.2.2
Competence, Awareness and Training
The employees, at Maricopa Controls Inc. are qualified for a position by;
education, internal or external experience, and evidence of acquired skills. The
requirements for positions are on the Job Requirements/Qualifications List. It is
maintained by the Training coordinator, approved by the Quality Manager and
found in the Training Log Book. Instruction for certification of employees to
controlled specifications; Inspection and Assembly are found in SOP 9
Assembler/Inspection Certification.
The Training coordinator evaluates the effectiveness of the training provided in the
following ways where applicable:
 Successful completion of the training provided, internal or external.
 Evidence of participation, internal or external.
 Successful certification and re-certification, internal or external.
A record of required/completed training for each employee is generated.
Employee Awareness is promoted through Training Sessions and employees are
encouraged to report potential nonconformities to the Preventive Action
Coordinator.
6.3
Infrastructure
Maricopa Controls Inc. has provided for and maintains the infrastructure needed to
achieve conformity to product requirements.
6.4
Work Environment
Maricopa Controls Inc. determines and manages the work environment needed to achieve
product conformity. The employees maintain a clean orderly work environment. SOP 5
Shop Manual, SOP 7 ESD Training and Control Program, and SOP 8 Inspection
Measurement and Test Equipment provide guidance and instruction in this area.
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7.0 Product Realization
7.1
Planning of Product Realization
Maricopa Controls Inc. plans and develops the processes, (i.e. work instructions, test
procedures, inspection activities, etc…) needed for product realization. Planning of
product realization may begin with the Request For Quote process, which is carried out by
the Sales Manager. Reference the Product Realization Process.
7.2
Customer-Related Processes
7.2.1
Determination of Requirements Related to the Product
The Sales Manager reviews the requirements related to the product during the
RFQ process. Supplemental Purchase Order Conditions are verified that they can
be met. Determination of statutory and regulatory requirements related to the
product and any other requirements necessary for intended or specified use where
known.
7.2.2
Review of Requirements Related to the Product
The Customer Service Manager reviews the customers contract or order before
acceptance and submission of tender. Customer's requirements for the product
are defined. Deviations in contract or order have been addressed. The company
has the ability to meet the defined requirements and risks have been evaluated.
Customer requirements are confirmed before acceptance when there is no formal
documented statement of requirements. When product requirements are
changed, the Customer Service Manager ensures that relevant documents are
amended and that relevant personnel are made aware of the changed
requirements. Revision changes to the contract or order and/or an
initial/signature and date are evidence of a review and acts as a record. Customer
Service maintains the customer order files in accordance with 4.2.4 Procedure for
Control of Records.
7.2.3
Customer Communication
The Customer Service Manager establishes communication with the customer
regarding product information, contract amendments, order status, feedback
and complaints.
7.3
Design and Development
Reference the Design and Development Process:\\Server\MANUFACTURING\Operational
Notebook\Processes
7.4
Purchasing
Reference SOP 11 Purchasing:\\Server\MANUFACTURING\Operational Notebook\Standard
Operating Procedures.
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7.5
Production and Service Provision
7.5.1
Control of Production and Service Provision
Maricopa Controls Inc. provides a framework for the development and control of
production, installation and servicing processes, which directly affect the quality of
deliverable product and to ensure these processes, are carried out under
controlled conditions. Planning is carried out in accordance with the Product
Realization Process and with the use of Detail Inspection Reports (DIP) as
applicable.
Controlled conditions include:
 The availability of test specifications, drawings, blue prints, etc. that
describe the characteristics of the product.
 The availability of work instructions, as necessary.
 The availability and use of assembly, inspection and test equipment.
 The monitoring and control of identified process parameters and key
characteristics.
 The source release, packaging, shipping and delivery of product.
 Accountability for all products during manufacture (e.g., parts quantities,
split orders, nonconforming product).
 Objective evidence that all production, inspection and test operations have
been completed (i.e. work order steps, data sheets).
 Provision for the prevention, detection, and removal of foreign objects has
been addressed in SOP 5 Shop Manual and SOP 3 Receiving Inspection.
 Monitoring and control of utilities and supplies such as water, compressed
air, electricity and chemical products to the extent they affect product
quality.
 The criteria for workmanship is stipulated in applicable Manufacturing
Instructions, SOP 5 Shop Manual and SOP 7 ESD Training and Control
Program.
7.5.1.1
Production Documentation
Operations are carried out in accordance with approved production
documentation. The Job Packet is a collection of or reference to the
documents needed to build, and verify the acceptability of the specific
part or lot of parts is released into production; and contains as
necessary:
 Bills of Materials (BOM’s),
 Traveler,
 Detail Inspection Reports (DIP’s),
 Drawings,
 Manufacturing and Test Instructions, and
 Work Order (WO).
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7.5.1.2
Control of Production Process Changes
Personnel authorized to approve changes to production processes
controlled by Maricopa Controls Inc., are identified in SOP 1
Manufacturing Documentation and the DRM Drafting Room Manual.
Changes affecting processes, production equipment and tools are
documented as applicable according to SOP 1 Manufacturing
Documentation, DRM Drafting Room Manual and SOP 8 Control of
Inspection, Measurement and Test Equipment. Maricopa Controls Inc.
identifies and obtains acceptance of changes that require customer
and/or regulatory authority approval in accordance with contract or
regulatory requirements. The results of changes to production processes
are documented to ensure the desired effect has been achieved.
7.5.1.3
Control of Production Equipment, Tools and Numerical
Control (N.C.) Machine Programs
Maricopa Controls Inc. validates, maintains and inspects periodically
production equipment and tools. Validation occurs prior to use.
Validation prior to production use includes verification of the first article
produced to the design data/specification. Instructions for the Control of
Production Equipment are found in SOP 8 Control of Inspection,
Measurement and Test Equipment.
7.5.1.4
Control of Work Transferred, on a Temporary Basis, Outside
the Organization’s Facilities:
Maricopa Controls Inc. uses only suppliers listed on the ASL, which
includes customer-approved suppliers to control and validate the quality
of the work performed outside our facility.
7.5.2
Validation of Processes for Production and Service Provision:
Maricopa Controls Inc. validates any processes for production and service
provision where the resulting output cannot be verified by subsequent monitoring
or measurement. This includes any processes where deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation demonstrates the ability of these processes to achieve planned results.
This is achieved through the Training and Certification process of employees to the
controlled specifications. Instructions are found in SOP 9 Assembler/Inspector
Certification. The Training Coordinator maintains Training Records.
7.5.3
Identification and Traceability:
Maricopa Controls Inc. identifies the product by suitable means throughout
product realization where appropriate. The identification of the configuration of
the product is maintained in order to identify any differences between the actual
configuration and the agreed configuration. Instructions are found in SOP 3
Receiving Inspection. The product status is identified with respect to monitoring
and measurement requirements and maintained through entries made to the
applicable traveler or work order.
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Continued from 7.5.3:
Material and assemblies are issued to production by, stock number, lot number,
and customer purchase order number (when applicable).
Material being issued is to a specific job is recorded on the applicable material
usage log/report and/or Additional Parts List (Form 52).
Instructions for acceptance authority media (e.g., stamps, initials, signatures), is
found in SOP 15 Stamp Control. Records are maintained.
7.5.4
Customer Property:
Maricopa Controls Inc. exercises care with customer property while it is under our
control or being used by the company. Customer Supplied Material and Customer
Returned Product are controlled according to SOP 3 Receiving Inspection, SOP 11
Purchasing, SOP 1 Manufacturing Documentation, and DRM Drafting Room
Manual.
Lost, damaged or otherwise found to be unsuitable for use customer property is
reported to the customer in accordance to QOP 13 Control of Nonconforming
Product. Records are maintained and controlled.
7.5.5
Procedure for Preservation of Product:
Maricopa Controls Inc. preserves the conformity of product during internal
processing and delivery. This preservation includes identification, handling,
packaging, storage and protection. Preservation also applies to the constituent
parts of a product.
Employees are trained in ESD Safe Handling practices per SOP 7 ESD Training &
Control Program. ESD handling requirements are flowed down to suppliers via PO
requirement.
Employees monitor material and product preservation during the kit pulling and
are responsible for the orderly storage and handling of work in process.
Employees monitor limited shelf life material expiration dates. The storage and
control of in work in process is the responsibility of the employees.
Material and product are handled in accordance with SOP 5 Shop Manual.
The Production Manager monitors the condition of the inventory annually during
inventory counts, this includes Customer Supplied Products. Inventory is checked
for visual damage (including the detection, prevention and removal of foreign
objects), expiration dates and documentation accuracy. Preservation of product
and material is also monitored during Receiving Inspection per SOP 3 Receiving
Inspection.
Quality/Receiving Inspection monitors and maintains the list of shelf life limited
material. Shelf life limited material is identified marked with an expiration date. A
list of shelf life limited material is posted and maintained in the stock room.
This list as a minimum contains: Stock Number, Date code, Description/Part
Number, and Expiration Date.
Shipping is responsible for the storage, handling and packaging of finished
product. Customer purchase orders contain shipping instructions. Finished
product is held in the stock room until its delivery date. Then Final Inspection
packages it in accordance with customer requirements. Shipping updates the
Final Product Inspection Log (Form 113).
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Continued from 7.5.5:
In the absence of specific customer requirements product is typically packaged as
follows:
 Individual parts are placed in individual boxes or bags.
 Individual bags/boxes are labeled with applicable part number, serial
number, PO and ESD cautioning label when applicable.
 Individual containers are placed in a shipping box along with a copy of the
packing list and necessary cushioning.
 Two copies of the packing list are placed in a document pouch, which is
attached to the outside of the shipping box.
 A label with the customers name and ship to address and Maricopa Controls
name and address is attached to the shipping box.
Special instructions may be given verbally by sales for all shipments to a particular
customer, who may indicate the use of a special carrier, Certificates of origin and
Commercial invoice requirements.
The Stock Room Supervisor maintains the organization of the stock room and
identifies shelf life limited material with expiration dates. Reports findings to the
Purchasing and Quality departments as necessary.
Material and Products are handled at the facility as follows:
 External packaging is visually checked for damage.
 Products and Material are inspected for foreign objects and are removed.
 Inspected and Cleaned as necessary.
 Stored, transported and handled at ESD safe workstations and in ESD safe
containers.
 Identified with stock numbers, date codes and ESD warning labels as
necessary.
Hazardous material is defined by and handled in accordance with manufacturer’s
recommendations and local regulations as they apply.
Un-issued material and assemblies are stored in the stock room per SOP 3
Receiving Inspection and as follows:
Stock bins, material and/or product are identified by stock numbers and date
codes or lot numbers.
Questionable material is reported and processed per QOP 13 Control of
Nonconforming Product.
7.6
Control of Monitoring and Measuring Devices:
Maricopa Controls Inc. maintains documented procedures for controlling, calibrating, and
maintaining test and measurement equipment that affect product quality. SOP 8
Inspection Measurement and Test Equipment.
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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT:
8.1
General:
Maricopa Controls Inc. uses Production and Manufacturing Documentation to validate
product conformity. The Internal Audit System is used to ensure conformity of the
Quality Management System. Management Review Meetings and Training Sessions are
used to continually improve the effectiveness of the Quality Management System.
8.2
Monitoring and Measurement:
8.2.1
Customer Satisfaction:
Maricopa Controls Inc. monitors information relating to customer perception as to
whether their requirements have been met. Customer Service communicates with
the Customer to determine their requirements. Customer supplied Supplier
Profiles and Supplier Performance Reports are reviewed during MRM to determine
customer satisfaction.
8.2.2
Internal Audit:
Maricopa Controls Inc. conducts internal audits at planned intervals on the basis of
importance to the processes and areas to be audited as well as follow up audits.
Instructions for internal audits are found in QOP 17 Internal Audit.
Records are maintained and controlled by the Audit Coordinator.
Internal Audits meet contract and/or regulatory requirements.
8.2.3
Monitoring and Measurement of Processes:
Maricopa Controls has determined suitable methods for monitoring and, where
applicable, measurement of the QMS processes. MRM, ISO Registration Audits,
Internal Audits, Final Inspection and Work in Process Inspection are used to
demonstrate the ability of the processes to achieve planned results. When
planned results are not achieved, correction and corrective action may be taken,
as appropriate, to ensure conformity of the product per QOP 14 Corrective and
Preventive Action.
8.2.4
Monitoring and Measurement of Product:
Maricopa Controls Inc. monitors and measures the characteristics of the product to
verify that product requirements have been met. Manufacturing, Test
Instructions, Source Release Inspections, Receiving Inspection Reports, Detail
Inspection Reports and First Article Inspection Reports lay out appropriate stages
of the product realization’s criteria for monitoring and measurement.
SOP 3 Receiving Inspection, QOP 19 Service, QOP 13 Control of Nonconforming
Product, also gives detail instructions for monitoring and measurement activities.
Receiving inspection is performed prior to materials/product being release and/or
returned to production and documented on through entries on applicable logs and
inspection reports.
Records are maintained that indicate the person(s) authorizing release of product.
Acceptance criteria are found in SOP 15 Stamp Control.
Product release and service delivery does not proceed until the Work Order is
complete.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
8.2.4.1
Inspection Documentation: Measurement requirements for
product or service.
Measurement requirements for product or service acceptance are
documented. Receiving Inspection Reports and Detail Inspection
Reports may contain the following:
a) criteria for acceptance and/or rejection,
b) where in the sequence measurement and testing operations are
performed,
c) a record of the measurement results, and
d) type of measurement instruments required and any specific
instructions associated with their use.
Test records show actual test results data when required by specification
or acceptance test plan. Where required to demonstrate product
qualification, records provide evidence that the product meets the
defined requirements.
8.2.4.2
First Article Inspection:
SOP 12 Self Release Program provides a process for the inspection,
verification, and documentation of a first production run of a new part,
or following any subsequent change that invalidates the previous first
article inspection result. AS9102 is the form used for FAIR’s and is
maintained and controlled.
8.3
Control of Nonconforming Product:
Maricopa Controls Inc. ensures that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery. The
controls and related responsibilities and authorities for dealing with nonconforming
product are defined in QOP 13 Nonconforming Product.
Records of the nature of nonconformities and any subsequent actions taken, including
concessions obtained, are maintained and controlled.
8.4
Analysis of Data:
Maricopa Controls Inc. determines, collects and analyzes appropriate data to demonstrate
the suitability and effectiveness of the QMS and to evaluate where continual improvement
of the effectiveness of the QMS can be made. This includes data generated as a result of
monitoring and measurement and from other relevant sources.
The analysis of data provides information relating to:
a)
customer satisfaction (see 8.2.1),
b)
conformity to product requirements (see 7.2.1),
c)
characteristics and trends of processes and products including opportunities for
preventive action, and
d)
suppliers.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
8.5
Improvement:
8.5.1
Continual Improvement:
Maricopa Controls Inc. continually improves the effectiveness of the quality
management system through the use and review of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive actions and
management review meetings.
8.5.2
Corrective Action
Maricopa Controls Inc. takes action to eliminate the cause of nonconformities in
order to prevent recurrence. Corrective actions are appropriate to the effects of
the nonconformities encountered. QOP 14 Corrective and Preventive Action is
established to define requirements for:
 Reviewing nonconformities (including customer complaints).
 Determining the causes of nonconformities.
 Evaluating the need for action to ensure that nonconformities do not recur.
 Determining and implementing action needed.
 Records of the results of action taken (see 4.2.4).
 Reviewing corrective action taken.
 Flow down of the corrective action requirement to a supplier, when it is
determined that the supplier is responsible for the root cause.
 Specific actions where timely and/or effective corrective actions are not
achieved.
8.5.3
Preventive Action
Maricopa Controls Inc. determines action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions are
appropriate to the effects of the potential problems.
QOP 14 Corrective and Preventive Action procedure includes the use of
appropriate sources of information such as:
 Process and work operations, which affect product quality, Concessions,
Audit results, Quality records, and Customer complaints.
 Determination of the steps needed to deal with problems requiring
preventive action.
 Application of controls to ensure preventive action taken is effective.
 Submitting for managements review relevant information on actions taken.
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MARICOPA CONTROLS – QUALITY SYSTEM MANUAL
9.0 Reference Documents and location:
QOP 13 - Control of Nonconforming Product:\\Server\MANUFACTURING\Operational
Notebook\Quality Operating Procedures
QOP 14 – Corrective and Preventive Action:\\Server\MANUFACTURING\Operational
Notebook\Quality Operating Procedures
QOP 17 – Internal Audits:\\Server\MANUFACTURING\Operational Notebook\Quality Operating
Procedures
Management Review Process:\\Server\MANUFACTURING\Operational Notebook\Processes
Product Realization Process:\\Server\MANUFACTURING\Operational Notebook\Processes
Design and Development Process:\\Server\MANUFACTURING\Operational Notebook\Processes
Operational Notebook: Quality Department & \\Server\MANUFACTURING\Operational Notebook
SOP 1 – Manufacturing Documentation:\\Server\MANUFACTURING\Operational
Notebook\Standard Operating Procedures
SOP 3 -Receiving Inspection:\\Server\MANUFACTURING\Operational Notebook\Standard
Operating Procedures
SOP 5 – Shop Manual:\\Server\MANUFACTURING\Operational Notebook\Standard Operating
Procedures
SOP 7 -ESD Training and Control Program:\\Server\MANUFACTURING\Operational
Notebook\Standard Operating Procedures
SOP 8 – Inspection Measurement and Test Equipment:\\Server\MANUFACTURING\Operational
Notebook\Standard Operating Procedures
SOP 9 -Assembler/Inspection Certification:\\Server\MANUFACTURING\Operational
Notebook\Standard Operating Procedures
SOP 11 –Purchasing:\\Server\MANUFACTURING\Operational Notebook\Standard Operating
Procedures
SOP 12 –Self-Release Program:\\Server\MANUFACTURING\Operational Notebook\Standard
Operating Procedures
SOP 15 - Stamp Control:\\Server\MANUFACTURING\Operational Notebook\Standard
Operating Procedures
DRM - Drafting Room Manual:\\Server\MANUFACTURING\Drafting Room Manual
PS0010 – Shelf Life Extension of Flux Core Wire
Solder:\\Server\MANUFACTURING\ProcessSpecifications
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