Quality Manual

QUALITY POLICY MANUAL
SOLITRON DEVICES, INC.

QUALITY POLICY MANUAL QPM01
REV. DATE SECTION CHANGED AUTHORIZATION
A 10/25/99 All-Initial release RFCH5991
Page 7 Quality Policy statement 4.1.3 review
B 01/14/00 RFCH6076
meeting frequency
C 01/28/00 Page 7 Quality Policy statement RFCH6089
D 04/13/00 Page 9 Management Responsibility RFCH6203
All-Added revision history & distribution index.
E 08/22/00 RFCH7051
Changed Introduction to Rev. C 4.1 to Rev. C
F 11/19/01 Page 1 of 37 Executive Staff Organization Chart RFCH7051
G 12/20/01 Management Responsibility RFCH7091
Management Responsibility
H 02/25/02
4.1 Engineering Manager & Purchasing Manager RFCH7189
I 10/10/02 Added/RMA was not referenced on Section 4.19 RFCH7453
QPM01 Quality Policy Manual re-written to comply
J 06/03/03 RFCH7692
with ISO9001:2000
QPM01 Quality Policy Manual re-written to comply
with ISO9001:2000
K 09/18/03 Added Para 4.1 Flow Charts for Continual RFCH7869
Improvement of the QMS System Process & their
interaction
Changes to Distribution List Index page 5and to
L 06/02/04 Para 1.0 Introduction deleted “and with over 100 RFCH8162
employees today” page 6 per ISO Audit request.
Deleted last sentence in Para 5.1 “The interrelation
of personnel who manage, perform and verify work
M 04/06/05 RFCH8426
affecting quality is defined on the organization chart
on Page 14” Reason of change for clarification.
Replaced Executive Organization Chart with an
N 07/07/05 RFCH8495
updated.
Changes for clarification on pages
P 07/18/06 RFCH8887
14,19,21,29,and 33
R 10/06/08 Update to AS9100 quality system RFCH9482
RFCH9584
S 12/22/08 Update to ISO9001:2008
T 06/01/09 Update to comply with AS9100 RFCH9718

U 07/13/09 Update to comply with AS9100 Audit RFCH9755
Replace 5.6.1 General with text below as per
V 10/05/09 RFCH9843
AS9100
W 06/15/11 Review and revise to AS9100C RFCH10461
X 06/16/11 Removed last two paragraphs on Page 29 RFCH10512
Y 09/09/11 Modified section 1.2 Application on page 6 RFCH10589
Rev. Y Page: 2 of 42
INDEX
1. SCOPE
1.1. General
1.2. Application
2. APPLICABILITY
3. PURPOSE
4. QUALITY MANAGEMENT SYSTEM

4.1. General Requirements
4.2. Documentation Requirements
4.2.1. General
4.2.2. Quality Manual
4.2.3. Control of Documents
4.2.4. Control of Records
5. MANAGEMENT RESPONSIBILITY
5.1. Management Commitment
5.1.1. Responsibility and Authority
5.2. Customer Focus
5.3. Quality Policy
5.4. Planning
5.4.1. Quality Objectives
5.4.2. Quality Management System Planning
5.5. Responsibility, Authority and Communication
5.5.2. Management Representative
5.5.3. Internal Communication
5.6. Management Review
5.6.1. General
5.6.2. Review Input
5.6.3. Review Output
6. RESOURCE MANAGEMENT
6.1. Provision of Resources
6.2. Human Resources
6.2.1. General
6.2.2. Competence, Training, Awareness
6.3. Infrastructure
6.4. Work Environment
7. PRODUCT REALIZATION
7.1. Planning of Product Realization
7.1.1. Project Management
7.1.2. Risk Management
7.1.3. Configuration Management
7.1.4. Control of Work Transfers
7.2. Customer Related Processes
7.2.1. Determination of Requirements Related to the Product
7.2.2. Review of Requirements Related to Product
7.2.3. Customer Communication
7.3. Design and Development
7.3.1. Design and Development Planning
7.3.2. Design and Development Inputs
7.3.3. Design and Development Outputs
7.3.4. Design and Development Review
7.3.5. Design and Development Verification
7.3.6. Design and Development Validation
7.3.7. Control of Design and Development Changes
7.4. Purchasing
7.4.1. Purchasing Process
7.4.2. Purchasing Information
7.4.3. Verification of Purchased Product
7.5. Production
7.5.1. Control of Production
7.5.1.1. Production Process Verification
7.5.1.2. Control of Production Process Changes
7.5.1.3. Control of Production Equipment, Tools, and Programs
7.5.1.4. Control of Service Operation
7.5.2. Validation of Processes for Production
7.5.3. Identification and Traceability
7.5.4. Customer Property
7.5.5. Preservation of Product
7.6. Control of Monitoring and Measuring Equipment
8. MEASUREMENT ANALYSIS AND IMPROVEMENT

8.1. General
8.2. Monitoring and Measurement
8.2.1. Customer Satisfaction
8.2.2. Internal Audit
8.2.3. Monitoring and Measurement of Processes
8.2.4. Monitoring and Measurement of Product
8.2.4.1. Inspection Documentation
8.3. Control of Nonconforming Product
8.4. Analysis of Data
8.5. Improvement
8.5.1. Continual Improvement
8.5.2. Corrective Action
8.5.3. Preventative Action
DISTRIBUTION LIST
BOOK
NUMBER
LOCATION
1 President/CEO
2 QA Manager
3 Finance Director
4 Sales/Marketing
5 Engineering
6 QA Engineer
7 Purchasing
8 Machine Shop
9 TDE
10 Hybrid Production
11 Audit Team (A)
12 Data Review
13 Audit Team (B)
14 Document Control
15 Production Control
16 Discrete Test
17 Audit Team (C)
18 Environmental
1. SCOPE
1.1. General
Solitron Devices, Inc., a public company based in West Palm Beach, FL., Designs,
Develops and Manufactures High Quality, High Reliability Power Semiconductors
and Hybrids. Established in 1959, Solitron Devices, Inc. is a recognized Leader and
Pioneer in the Innovative Design and Manufacturing of State-of-the Art Power
Semiconductor products. Solitron Devices, Inc. is well known for producing
custom and standard power solid-state components for the Aerospace, Defense,
Industrial, Medical, and Commercial Industries. Solitron Devices, Inc.’s advanced
semiconductor device and packaging technology has contributed to the success of
virtually every U.S. and European Aerospace and Defense program.
Solitron Devices, Inc. pioneered the combining of small signal circuitry with power
semiconductors to create hybrid circuits for high-end industrial, aviation, space and
defense applications. Our unique capability as a vertically integrated semiconductor
manufacturer providing its own in-house fabrication of semiconductor die, printed
substrates and packages is a major cost and time saving benefit for our customers.
Solitron Devices, Inc. has a firm commitment to Quality and Excellence as well as
strict adherence to the stringent requirements of Industrial, Aviation, Space and
Defense Specifications. Solitron Devices, Inc. supports its products and services
with a comprehensive Service/Quality program that is second to none.
We achieve this through:

 A management philosophy of Continual Improvement in all aspects of
company performance.
 Well engineered and validated new product design processes.
 Vendor selection process based on long term relationships.
 Responsive assistance to customers, with on-site support when needed.
Solitron Devices, Inc. has implemented a Quality Management System that

complies with AS9100/ ISO9001 to better satisfy the needs of our Customers.
1.2. Application
Solitron Devices, Inc. has determined that the following requirements are not
applicable to the operations and are documented as exclusions:
 Section 7.3.6 Design and Development Validation; 7.3.6.1 Design and

Development Verification and Validation Testing; 7.3.6.2 Design and
Development Verification and Validation Documentation.
Justification: Our Customer normally does design validation of our product,
however, where the contract specifies, we can support our Customer’s effort
where possible.
 Service Provision sections 7.5.1.4 a, c, d, e.
Justification: Solitron Devices, Inc. does not provide Service.
2. APPLICABILITY
This Quality Manual covers the five major clauses of AS9100/ISO9001.
 Quality Management System
 Management Responsibility
 Resource Management
 Product Realization
 Measurement, Analysis, and Improvement
Each clause consists of elements followed by a policy statement defining the principles
and Solitron Devices, Inc.’s commitment to implement processes to ensure conformance
to each AS9100/ISO 9001 clause/element. The final paragraph in each section refers to
the Standard Operating Procedures that describe in more detail how the activities are to
be carried out. In some cases, these Standard Operating Procedures refer to Work
Instructions, Test, and Assembly Procedures. All levels of Quality System
Documentation are issued and authorized through Document Control.
3. PURPOSE
The purpose of this manual is:
 To document Solitron Devices, Inc.’s Quality system.
 To inform Solitron Devices, Inc.’s Customers of Process Controls
that ensure Conformance to Requirements.
 To provide Guidance and Instruction to Solitron Devices, Inc.’s
personnel whose work Impacts Quality.
Signed: ___________________________________Date: _______

President/CEO
Signed: ___________________________________Date: _______

Management Representative
4. QUALITY MANAGEMENT SYSTEM
4.1. General Requirements

Solitron established a Quality Management System that complies with the
AS9100/ISO9001 requirements and supports the Solitron Quality Policy and
objectives. Quality at Solitron Devices, Inc. is based on the philosophy that all
individuals and therefore their departments are responsible for Quality.
This system identifies all of the processes necessary to enable a directed process
approach that will
 Determine system processes and their application within Solitron Devices.

 Provide for development of sequential processes and interaction of the
processes within the system.
 Define criteria and methods ensuring that Operation and Control of Processes
are communicated throughout Solitron and are effective.
 Ensure that the necessary resources and information to support operation and
monitoring of processes are in place.
 Monitor measure where applicable, and analyze the processes.
 Implement actions necessary to achieve planned results and continual
improvement of processes.
 Ensure compliance with customer and applicable statutory and regulatory QMS
Requirements.
Solitron ensures Control of outsourced processes using Inspection, Measurement

and Analysis.
Continual improvement of the QMS
A P
Act Plan
Information Management C D
Flow
Responsibility Check Do
Customers
Customers
Requirements
Satisfaction
Measurement,
Resource Info.
analysis & Flow
Management
improvement
Value added
activity
Input Product
Realization
Output Product
SOLITRON QMS PROCESS INTERACTIONS
CUSTOMER
REQUIREMENTS
INQUIRY
ENGINEERING QUOTE
&
DESIGN CUSTOMER
REVIEW ORDER
DOCUMENT
ORDER REVIEW
CONTROL
PRODUCTION
CREATE WORK CONTROL STOCK
ORDER ORDER
GENERATE TRAVELER
PULL PRODUCT FROM

STOCK
TO KITTING
ASSEMBLY DATA REVIEW
OUTSIDE
SERVICES
PACKING AND
SHIPPING
FINAL VISUAL
INSPECTION
TEST DELIVERY
BILLING AND PAYMENT CUSTOMER

PROCESSING SATISFACTION
SUPPLIER
SELECTION
APPROVED VENDOR
LIST
SUPPLIER
QUALIFICATION
RECEIVING
Piece PARTS INSPECTION
RAW MATERIALS
PRODUCT ID STATUS
CONTROL OF MEASURING
DEVICES
4.2. Documentation Requirements
The Solitron Quality System documentation is structured as follows:
 Quality Policy Manual -
The first level document that provides a general overview of the Quality
System and specifies the Quality Policy. This document describes the purpose
for Solitron Devices, Inc. and "why" it is desired.
 Quality Operating Procedures -
The second level documents that provide more detailed explanation of the
Quality System Elements. These documents explain how the Policies described
in the Quality Policy are to be implemented - the "Who, What, Where and
When". These are called Quality Operating Procedures (QOP's).
 Work Instructions -
The third level documents provide the "How to" follow the process or
procedures, and do the work at the key company functional work centers. Work
Instructions are best documented using flowcharts.
 Other Instructions -
The fourth level documents provide the "How to" do specific tasks. These
documents include: Forms, Product Specifications, Task Instructions, Product
Specific Drawings, Industry Standards, etc.
4.2.1. General
The Solitron Quality Management System documentation includes the
following documented procedures as required by AS9100/ISO9001.
 Quality Manual (QPM 01)

 Document Control (QOP-05-01)
 Corrective and Preventative Action (QOP-14-01)
 Quality Records (QOP-16-01)
 Internal Auditing (QOP-17-01)
 Non-Conforming Product (QOP-13-01)
 Solitron Devices ensures that personnel have access to the Quality
Management System documentation and are aware of relevant
procedures and changes.
4.2.2. Quality Manual

Solitron Devices, Inc.’s Quality system is documented in the Quality
Manual, the Associated Operating Procedures, and Work Instructions. The
documents collectively define a quality system that complies with the
AS9100/ISO9001 standard.
This Quality Policy Manual is approved by management, as shown on page
7, and is issued by the Quality Manager/Management Representative under
the authority of the President/CEO. Implementation of the Quality System
is regularly audited and reviewed.
4.2.3. Control of Documents
4.2.3.1. General
Solitron Devices, Inc. has established and maintains documented
procedures to control all documents and data that relate to the
requirements of AS9100/ISO9001, including documents of external
origin such as standards and customer drawings. The Document
Control Department that reports to the QA Manager is responsible for
coordination; enforcing and auditing the Document Control related
activities. Quality System Documentation comprises the following
types of documents:
 Quality Policy Manual

 Quality Operating Procedures
 Work Instructions, Test, Assembly, and Process Procedures
 Standards, Safety Agency, Compliance, and other Reference
Material
 Product Drawings and Specifications
The purpose, scope, and responsibility for controlling each type of

document are defined in QOP-02-01, "Quality System".
4.2.3.2. Document Approval and Issue

Documents and document changes may be initiated by anyone at
Solitron Devices, Inc., but may only be issued by an authorized
department described in procedures "Quality System", QOP-02-01, and
"Document Control", QOP-05-01. All documents are reviewed and
approved for adequacy prior to issue. A master list identifies the current
revision status of documents and is available to all personnel to avoid
the use of obsolete or invalid documents.
4.2.3.3. Control Documents

Documents are distributed to personnel and locations where they are
used and invalid/obsolete documents are promptly removed to assure
against unintended use. Obsolete documents retained for history
purposes are identified as such by an "Obsolete" or “History” stamp.
When appropriate and relevant, documents display a distribution list.
Document placement is regulated and described in procedure
"Document Control", QOP-05-01.
4.2.3.4. Document Changes

Document changes are reviewed and authorized by the same
function/department that issued the original document. The nature of
the change is identified in the document. Revised portions of documents
are distributed with a RFC form (Request for Change form) and
obsolete documents are removed.
4.2.4. Control of Records
procedures for Control, Identification, Collection, Indexing, Access, Filing,
Storage, Maintenance, and Disposition of Quality Records. Quality
Records are maintained to demonstrate conformance to specified
requirements and the effective operation of the Quality System. Pertinent
sub-contractor Quality Records are also maintained. A Records Matrix is
maintained by Document Control.
All Quality Records are legible and stored in designated filing cabinets by
the departments responsible for their establishment, such that they are
readily retrievable. The environment is controlled to minimize
deterioration or damage and to prevent loss. Retention times of Quality
Records are established and recorded. When agreed contractually, Quality
Records are made available for evaluation by the customer for an agreed
period.
The activities of Identification, Collection, Indexing, Access, Filing,

Storage, Maintenance, and Disposition of Quality Records are described in
procedure. The records are maintained according to procedure “Quality
Records", QOP-16-01. The procedure defines the location and the
departments responsible for keeping these records.
5. MANAGEMENT RESPONSIBILITY
5.1. Management Commitment
Solitron Devices, Inc.’s policy is that executive management is responsible for
establishing and maintaining the quality system to support the Quality Policy. This
includes:
 Defining the organization.
 Assigning authority and responsibility.
 Reviewing the Quality System.
 Providing the resources necessary to maintain the Quality System.
 Continually improve the effectiveness of the Quality Management System.
 Communicate to all Solitron personnel the importance of meeting Customer,
Regulatory and Legal Requirements.
Solitron Devices, Inc. appoints the QA Manager as the Management Representative,

with the authority and responsibility to ensure that the Quality Management System
complies with the requirements of AS9100/ISO 9001. The management
representative is assigned as the POC (point of contact) with the preparing activity
(military or federal agency) with the authority and responsibility to coordinate all
specification issues.
PRESIDENT AND CHIEF EXECUTIVE OFFICER (CEO) –
Has the overall responsibility for the definition of, and adherence to, the
Solitron Devices, Inc. Quality Policy. The President/CEO are responsible,
through the QA Manager, for the authorization and the implementation of
the Quality System throughout all areas of Sales & Marketing, Engineering,
Operations and Finance. Specifically:
 Formulates the Quality Policy,
 Initiates and supervises the Quality System,
 Provides resources necessary to maintain the Quality System,
 Conducts management reviews of the Quality System.
FINANCE DIRECTOR –
Is responsible to the President/CEO for ensuring that all Corporate Finance
activities and functions are operated according to the requirements stated in
this manual. The Finance Director is responsible for ensuring that all
Finance personnel are fully aware of the importance of product and service
quality, and that the established procedures are followed throughout their
respective departments.
ENGINEERING MANAGER –
Is responsible to the President/CEO for ensuring that the product designs,
applications, and effectivity is established and maintained in a stable and
consistent manner. The Engineering Manager oversees the design planning,
activity assessment, verification and validation. The Engineering Manager
oversees the technical interface within the company and recommends aids
and methods used in calculations, test verification, and cost effectivity.
OPERATIONS DIRECTOR –
Is responsible to the President/CEO for ensuring that planning, procurement,
verification and production activities are operated according to the
requirements stated in this manual. The Operations Director is responsible
for ensuring that Operations personnel are fully aware of the importance of
product and service quality, and that established procedures are followed
throughout their respective departments.
SALES MANAGER –
Is responsible to the President/CEO for ensuring that all sales and marketing
activities and functions are operated according to the requirements stated in
this manual. The Sales Manager is responsible for ensuring that all sales
personnel are aware of the importance of product and service quality, and
that established procedures are followed throughout their respective
departments.
Responsibility and Authority (continued)
PURCHASING MANAGER –
Is responsible to the President/CEO for ensuring that the Procurement
activities are timely, complete, and cost effective. The Purchasing Manager
provides interaction between production and outside vendors to coordinate
the timely supply of items necessary for the production goals and operation of
the factory.
QUALITY MANAGER (Management Representative) –

Is responsible to the President/CEO for directing and auditing all quality-
related activities, and for reporting to, and advising the President and
Executive Staff on all Quality matters. The Quality Manager is responsible
for ensuring that all Solitron Devices, Inc., personnel are familiar with the
company’s Quality System and have the authority to ensure that the
requirements of the system are implemented and maintained. The Quality
Manager is also responsible for ensuring that the appropriate Quality
Standards are available and that the standards are applied throughout the
organization.
5.2. Customer Focus

Solitron Devices, Inc.’s policy is that each accepted request for quote, contract and
order (statement of requirements) is reviewed by the Sales, Engineering, QA, and
Manufacturing as appropriate, to ensure that:
 The requirements are adequately defined and documented. Where no written

statement of requirement is available for an order received by verbal means,
Solitron Devices, Inc. will ensure that the order requirements are agreed before
their acceptance.
 Any contract or accepted order requirements differing from those in their
quotation are resolved.
 Solitron Devices, Inc. has the capability to meet contract or accepted order
requirements.
 Solitron Customer Satisfaction
 Top management ensures the product conformity and on-time delivery
performance are measured and that appropriate action is taken if planned results
are not, or will not be, achieved.
5.3. Quality Policy
At Solitron Devices, Inc. our Quality Policy is “Customer Satisfaction”; Solitron
measures its performance against this goal through on time delivery, customer
complaints, and returned material.
This Policy:
 Is appropriate to the purpose of Solitron Devices, Inc.
 Includes a commitment to meeting requirements and to continually improve the
effectiveness of the Quality Management System.
 Provides a framework for defining, establishing, documenting and reviewing
quality objectives.
 Is communicated and understood at the appropriate levels within the company.
 Is reviewed for continuing suitability.
5.4. Planning
5.4.1. Quality Objectives
Solitron Devices, Inc. has established corporate quality objectives, which
have been deployed throughout the organization. The Quality objectives are
consistent with the quality policy and the commitment to Continual
Improvement. Quality objectives include those needed to meet the
requirements of Solitron Devices product and processes as well as customer
requirements. These objectives are reviewed Quarterly in Quality
Management review meetings for continued suitability. Actions taken as a
result of these meetings may be in the form of corrective action, preventative
action or goal adjustments for the purpose of continuous improvement.
Objectives include:
 QA Pre-cap visual Inspection yields greater that 95%
 Resistance to Solvents yields greater than 95%
 Solderability yields greater than 97%
 Final Visual Mechanical Inspection yield greater than 98%
Solitron Devices management team provides a work environment that

develops and rewards excellence. Employees are trained and empowered
with skills and knowledge that enables them to deliver a product that is in
accordance with its customers’ expectations. This philosophy is reflected in
Solitron’s Quality Policy statement, which is communicated, understood
within the organization and tracked through performance measurement
charts, and statistics.
President/CEO ________________________________________
Operations Director ____________________________________
Management Representative_____________________________________
Solitron Devices, Inc.

Organizational Chart
Chairman, CEO
and President
National Sales
Executive Assistant
Manager
Quality
Inside Sales
Manager Director of Engineering
Controller Organization Director of Operations
Management Acting
Inside Sales Manager
Representative
Hybrids/Mosfets/BiPola Sr. Design &

AP/AR/Payroll Quality Control Engineer Inside Sales r Applications Engineer
Assembly Supervisor Hybrids
Inside Sales/ TDE Supervisor Device/ Diffusion

Document
Cost Accounting Customer J-Fets Engineer
Control Specialist
Service Supervisor BiPolar/ J-Fets Devices
Test
Buyer QC Inspection BiPolar Device Engineer
Engineer
Process Applications &

MIS Administration
Engineer Process Engineer
Data Review
Environmental
Testing
Supervisor
Drafting
Electrical
Testing
Superviso
r
Instrumentation &
Calibration
5.4.2. Quality Management System Planning

The contents of the Quality Policy Manual form the basic Quality Plan to
which Solitron Devices, Inc.’s products are designed, manufactured and
supported, unless a separate contract specific Quality Plan is required.
Specific documentation is held at department level for the control of
procedures and processes within that department. It is the responsibility of
each functional operating department to define and implement processes,
procedures, controls, and measurements that are necessary to assure that
products meet the quality requirements of their internal and external
customers. The requirements for each of the above documentation levels are
referenced in paragraph 4.2. Technical References include: equipment-
operating manuals, industry standards, purchased parts catalogs, etc.
Quality planning defines how the requirements for Quality will be met.
Information and Records - Recorded data of the Quality System and the
results of the implementation. The “proof” that the policies, procedures, and
work instructions were followed with resulting consequences that measures
performance and offer opportunity for continuous improvement.
The Quality System, its make-up, how it is audited and reviewed is

described in more detail in procedures QOP-17-01, "Internal Quality Audit",
QOP-02-01 “Quality System” and QOP-01-01, "Management Review".
5.5. Responsibility, Authority, and Communication

Departmental Managers/Supervisors are responsible to and authorized by
their respective managers for ensuring that all Solitron Devices, Inc.
activities relating to their respective functions are operated according to the
requirements stated in this manual. There is a unique job description written
for each job function. The Managers and Supervisors are responsible for
ensuring that all personnel are fully aware of the importance of product and
service quality, and that established procedures are followed throughout their
respective departments.
5.5.2. Management Representative

The QA Manager has been appointed as Management Representative and is
responsible for the establishment, implementation, maintenance, and
performance reporting of the Quality Management System to top
management. The Quality Engineer is the alternate designee for the
Management Representative. The Management Representative will
communicate and promote awareness of customer requirements throughout
the organization and has the organizational freedom and unrestricted access
to top management to resolve matters pertaining to quality.
5.5.3. Internal Communication

Quality Management System processes are communicated between various
levels within the Solitron organization as follows.
 The Quality Manual.
 Operating Procedures and Work Instructions.
 Various weekly meetings i.e. Staff, Engineering, Quality, Sales,
Production Control.
 Daily communication between Managers, Supervisors and other
Employee’s.
5.6. Management Review

5.6.1. General
On a weekly basis, Solitron Devices, Inc.’s Executive Staff conducts review
and assessment of the Quality Management System to determine its
effectiveness and continuing suitability. The review is based on the results
of internal quality audits, customer feedback, non-conformances and
corrective actions taken. The objectives of the review are to identify
whether the Quality Management System is being implemented effectively,
to identify inefficiencies or nonconformities in the system, and to suggest
possible improvements. In addition Quarterly Management Review
Meetings are attended by the President /CEO and the Quality Manager. The
Quarterly Management Review meetings will include the weekly
Management Review meeting minutes as input. The President/CEO is
responsible for scheduling and conducting the reviews. Conclusions of the
reviews are recorded. Details for scheduling, conducting and recording the
reviews are provided in QOP-01-01, "Management Review".
5.6.2. Review Input

The agenda of Solitron management reviews will include assessment of
current performance and improvement opportunities. The agenda activities
are delineated in the document Management Review (QOP-01-01) paragraph
4.2. The objectives of the reviews are to insure the suitability, adequacy and
effectiveness of the Quality Management System.
5.6.3. Review Output

The objective of the Management Review meetings is to obtain output in the
form of decisions and actions. This “output” will insure the suitability,
adequacy and effectiveness of the Quality Management System improve
customer product and expose resource needs. Reference paragraph 4.3 of
Management Review (QOP-01-01).
6. RESOURCE MANAGEMENT
6.1. Provision of Resources

Department Managers/Supervisors have the opportunity to request the resources
necessary to implement or enhance the Quality Management System or to Achieve
Customer Satisfaction.
6.2. Human Resources

6.2.1. General
All personnel who manage, perform and verify work-affecting quality are
responsible for implementing the Quality System. It is Solitron Devices,
Inc.’s policy to provide adequate resources and assign trained personnel for
all verification activities. Verification activities include inspection, test,
production, servicing, monitoring of the design process and internal quality
audits.
6.2.2. Competence, Training, Awareness

Solitron Devices, Inc. has established and maintains procedures for
identifying training needs and provide for the training of all personnel
performing activities affecting quality. Personnel performing specific
assigned tasks are qualified on the basis of appropriate education, training
and/or experience, as required. Records of personnel qualifications and
training are maintained by QA.
“Training” procedure, QOP-18-01, describes in more detail the department

Manager responsibilities, the training policy and training programs. All
personnel are assessed annually by their Managers/Supervisors to determine
if their qualifications are adequate and if additional or supplemental training
is required.
6.3. Infrastructure
Solitron Devices, Inc. has identified and planned the production, and servicing
processes (customer returns only) that directly affect quality and ensures that these
processes are carried out under controlled conditions. These controlled conditions
include:
 Documented procedures defining the manner of production and servicing, where
the absence of procedures could adversely affect quality.
 Use of suitable production, and servicing equipment, suitable working
environment.
 Compliance with reference standards/codes, Quality Plans and/or Documented
Procedures.
 Monitoring and Control of Process Parameters and Product Characteristics
during Production, and Servicing.
 The approval of processes and equipment.
 Criteria for Workmanship Standards.
 Regular maintenance of equipment to ensure continuing process capability.
 Only trained operators or operators in training and under the Supervision of a
certified operator or supervisor will perform processes.
 Process Controls and the development of Control Plans where key
characteristics have been identified.
 Identification of in Process Verification points when adequate (verification of
conformance cannot be performed at a later stage or realization).
 The Design, Manufactures, and use of tooling so that variable measurements can
be taken particularly for key characteristics and special processes (see 7.5.2).
 Accountability for all Products during Manufacture (e.g., part quantities, split
lots, nonconforming product).
 Evidence that all Manufacturing and Inspection Operations have been completed
as planned, or as otherwise documented and authorized.
 Provisions for the Prevention, Detection, and Removal of Foreign Objects.
 Monitoring and Control of Utilities and supplies such as water, compressed air,
electricity and chemical products to the extent they affect Product Quality.
 Criteria for Workmanship, which shall be stipulated in the clearest practical
manner (e.g. written procedure, representative samples or illustrations).
The MOR (Material Order Request) form generated from the MRP system is used to
start a job. A packet, consisting of a traveler, drawings, bill of materials, etc.
defines the production plan, which is under the control of production. A traveler is
generated identifying the verification and testing stages. Procedure "Process
Control", QOP-09-01, describes the work order process in more detail.
When complexity or importance of an activity warrants it, production personnel are

provided with procedures/work instructions. Production equipment, processes,
product characteristics and production environment are controlled and/or maintained
in accordance with procedure "Process Control", QOP-09-01.
Activities associated with special processes are described in the procedure "Process
Control", QOP-09-01.
6.4. Work Environment

Solitron Management has in place and maintains an infrastructure that enables
compliance to product requirements. Solitron maintains a safe and healthy work
environment that is in compliance with all applicable laws and regulations. In areas
where chemicals are used Material Safety Data Sheets are maintained to provide
guidance relative to physical and environmental issues. Solitron complies with all
applicable laws and regulations relative to hazardous materials, air emissions and
waste water disposal.
7. PRODUCT REALIZATION
7.1. Planning of Product Realization
To insure that Quality Objectives and product requirements are realized (including
support of operation and maintenance of product) Solitron Devices, Inc. has
established and maintains documented procedures for inspection and testing
activities in order to verify that the specified requirements are met. The required
Inspection, Testing, and the Records established are documented in procedures.
Inspection and Testing are conducted when:
 Purchased materials and components are received

 At significant stages of production
 And prior to dispatch of finished products
The objective of inspection and testing is to verify conformance with specified

requirements. Materials, Components and Products are prevented from use,
assembly and dispatch until the required Inspections are completed. Records of
Inspections and Testing are established and maintained as evidence that products
comply with stated requirements.
7.1.1. Project Management

Solitron has in place a documented and maintained configuration
Management Process that is appropriate to the product (QOP-02-02).
7.1.2. Risk Management
Solitron has in place a documented and maintained risk Management
Procedure (QOP-02-04).
7.1.3. Configuration Management
Solitron has in place a documented and maintained configuration
Management Process that is appropriate to the product (QOP-02-02).
7.1.4. Control of Work Transfers
When planning to temporarily transfer work to a location outside the
Solitron facilities, Solitron defines the Process to Control and validate the
Quality of the work.
7.2. Customer Related Processes

7.2.1. Determination of Requirements Related to the Product
 Contract Review ensures that Customer Requirements are adequately
defined, differences resolved and that Solitron Devices, Inc. has the
capability to meet Customer Requirements.
 Solitron Devices, Inc.’s policy is that procedures for contract review and
for the coordination of contract review activities are established and
maintained (see paragraph 5.2).
 Original documents identifying Customer device drawing, revision date,
etc. are retained in Document Control files.
7.2.2. Review of Requirements Related to Product

Solitron Devices, Inc.’s policy is that procedures for contract review and for
the coordination of contract review activities are established and maintained.
Ensuring that Solitron Devices, Inc. identifies how amendments to a contract
are made and correctly transferred to functions concerned within the
company. This includes a review of risks (e.g. new technology, short delivery
time scale) QOP –02-04 “Risk Management”.
 Requirements are adequately defined and documented.
 Adequate company resources are available to meet customer
requirements.
 Differences between the quotation and contract are addressed and
resolved prior to acceptance of the order.
 Appropriate notification provided when contract/product amendments
are required.
 The Sales Department maintains records of contract reviews.
 Special requirements are determined
 Risks are identified.
The contract review process is described in more detail in procedures

QOP-03-01, “Contract Review".
7.2.3. Customer Communication

Solitron establishes and maintains Customer Communication utilizing
letters, faxes, E-mail; telephone conversations, discussions and interaction
during customer on site meetings, customer feedback and customer
complaints.
7.3. Design and Development

7.3.1. Design and Development Planning
Solitron Devices, Inc. has established and maintains documented procedures
to control and verify the design of the product to ensure that the specified
requirements are met.
Solitron Devices, Inc. designs standard and custom products. The
Engineering Department is responsible for the design of the product.
Quality assurance in design is described in more detail in procedure QOP-
04-01, "Design Control".
Solitron Devices, Inc. prepares plans for each design and development
activity, including defined responsibility, and describes or references these
activities. The design and development activities are assigned to qualified
personnel with the required resources.
All products have a "Design Check List" which identifies the activities to be
performed and the associated responsibilities.
The Design Check List may be updated periodically to reflect actual activity
steps and their status as the design evolves. The initiation, tracking, and
completion of the Design Check List are the responsibility of the
Engineering Department.
Organizational and technical interfaces between different groups that input

to the design process are identified and information is documented,
distributed and regularly reviewed. The "Design Check List" maintained by
the Engineering Department identifies these interfaces.
The design plan includes:
Design and development stages including organization, task sequence,

mandatory steps, significant stages and method of configuration control.
 Where appropriate, Solitron shall divide the design and development
effort into distinct activities and, for each activity, define the tasks,
necessary resources, responsibilities, design content, input and output data
and planning constraints.
 Structuring the design effort into significant elements.
 For each element, analyzing the tasks and necessary resources for its
design and development. This analysis considers an identified responsible
person, design content, input data, planning constraints and performance
conditions. The input data specific to each element is reviewed to ensure
consistency with requirements.
 The different design and development tasks to be carried out shall be
based on the safety and functional objectives of the product in accordance
with customer, statutory and regulatory requirements.
7.3.2. Design and Development Inputs

Design input requirements including statutory and regulatory requirements
are identified, documented and their selection reviewed by the Engineering
Department for adequacy. The Functional Product Requirement document
identifies the initial needs to be fulfilled by the product, including applicable
information from similar designs. Design input requirements are identified,
documented and reviewed for accuracy by the Engineering Department.
Incomplete, ambiguous or conflicting requirements are resolved with the
Engineering Department and applicable Customer Representatives. The
process is described in more detail in procedure QOP-04-01, "Design
Control".
7.3.3. Design and Development Outputs

Design output specifications are documented and expressed in terms of
requirements that can be verified. The Engineering Department review
design outputs to ensure that:
 Design input requirements are met.
 Acceptance criteria are clearly stated.
 Appropriate safety and regulatory requirements are met.
 Characteristics of the design that are crucial to the safe and
proper functioning of the product are identified.
 Outputs provide necessary information for purchasing,
production and service provision.
 Key characteristics (when applicable) are identified in
accordance with design or contract requirements.
Data required to allow the product to be identified, manufactured, inspected,

used and maintained are defined:
 Drawings, parts lists, specifications.
 A list of those drawings, parts lists and specifications necessary to define
the configuration and the design feature of the product.
 Information on material, processes, type of Manufacturing and Assembly
data needed to ensure conformity of the product.
Establishment, verification and release of design output are described in

procedure QOP-04-01, "Design Control".
7.3.4. Design and Development Review

At appropriate stages of design, formal documented reviews of the design
results are planned and conducted. The participants at each design review
may include the Process Engineer, Test Engineer, Production, QA and the
customer representative if required by contract. The review will address all
aspects of design and development including quality-related requirements,
identification of possible problems and necessary follow up actions resulting
in authorization to progress to the next step. The process is described in
more detail in procedure QOP-04-01, "Design Control". Records of these
reviews are maintained by the Engineering Department as detailed in
procedure QOP-16-01, "Quality Records".
7.3.5. Design and Development Verification

Design verification is performed at appropriate stages to ensure that the
design stage output meets the design stage requirements. Verification that
design output meets design input requirements is achieved by holding and
recording design reviews, undertaking qualification testing of the first article
and performing alternative calculations. The design verification measures
are recorded by the Applications Engineers as detailed in procedure QOP-
16-01, "Quality Records". Design verification activities are described in
procedure QOP-04-01, "Design Control".
7.3.6. Design and Development Validation

Our customer normally does design validation of our product. However,
where the contract specifies, we can support our customer’s effort where
possible. Validation is the responsibility of the Engineering Department and
is described in procedure QOP-04-01, "Design Control".
7.3.7. Control of Design and Development Changes

All design changes and modifications are initiated by completing a RFC,
Request for Change form. The information provides design input for the
changes and is controlled via the change procedure, which requires
appropriate approval and review of changes and modifications.
Planning, design output, and design verification activities follow the same
rules as applied to the original design and are described in procedure QOP-
04-01, "Design Control".
Design and development changes shall be controlled in accordance with the
configuration process (see7.1.3).
Note: The Solitron change control process shall provide for customer
and/or regulatory approval of changes, when required by contract or
regulatory requirements.
7.4. Purchasing
7.4.1. Purchasing Process
to ensure that purchased product conform to specified requirements.
Solitron Devices, Inc. evaluates its suppliers and subcontractors and
purchases only from those that can satisfy the company's quality
requirements. Purchasing documents clearly and completely describes
ordered products, including quality requirements. Purchasing documents are
reviewed and approved prior to release.
Solitron Devices, Inc. evaluates and selects subcontractors on the basis of

their ability to meet subcontract requirements including quality system and
quality assurance requirements. The type and extent of the control exercised
by Solitron Devices, Inc. on our subcontractors is dependent on the type of
product/service, and where applicable the quality audit reports and/or quality
records of subcontractors' previously demonstrated capability and
performance. Solitron Devices shall be responsible for the conformity of all
products purchased from suppliers, including product from sources defined
by the customer. Solitron will also ensure (where required) that customer-
approved special process sources are used. This includes all Solitron supplier
use.
Solitron shall:
 Maintain a register of approved its suppliers that includes approval status
(e.g. approved, conditional, disapproved) and the scope of the approval
(e.g. product type process family).
 Periodically review supplier performance; the results of these reviews
shall be used as a basis for establishing the level of controls implemented.
 Define the necessary actions to take when dealing with suppliers that do
not meet requirements.
 Ensure where required that both Solitron and all suppliers use customer-
approved special process sources.
 Define the process responsibilities and authority for approval status
decision, changes of approval status and condition and conditions for a
controlled use of suppliers depending on their approval status.
 Determine and manage the risk when selecting and using suppliers.
Quality performance of all suppliers and subcontractors is monitored.

Vendors showing inadequate performance are asked to implement corrective
actions and are discontinued if there is no improvement. Quality maintains
an approved supplier/subcontractor-rating list. Orders may only be placed
with vendors that are rated as approved on the list unless specifically
approved by quality. New vendors are added to the list for evaluation at the
point of initial order. Records of acceptable subcontractors/suppliers are
maintained. Detailed instructions for assessment of sub-
contractors/suppliers are provided in procedure QOP-06-01, "Subcontractor
Evaluation".
7.4.2. Purchasing Information

The Production Control Manager prepares purchasing documents. The
documents clearly and completely describe ordered products. They include
precise identification of the products, reference applicable standards and
state quality requirements. The President/CEO approves all purchasing
requests. QA and the Controller must review/approve all P/O's to ensure the
adequacy of the requirements before the orders are placed with the supplier.
However, if over $5000, the President must also sign the P/O. Rules
applicable to preparation, review and approval of purchasing documents are
provided in procedure QOP-06-02 "Purchasing".
The purchasing information shall describe the product to be purchased,

including where appropriate.
 The identification and revision status of specifications, drawings, process
requirements, inspection/verification instructions and other relevant
technical data.
 Requirements for design, test, inspection, verification (including
production process verification), use of statistical techniques for product
acceptance, and related instructions for acceptance by Solitron, and its
applicable critical items including key characteristics.
 Requirements for test specimens (e.g., production method, number,
storage conditions) for design approval, inspection/verification,
investigation or auditing.
 Requirements regarding the need for the supplier to notify Solitron of
nonconforming product and obtain Solitron approval for nonconforming
product disposition. Notify Solitron of changes in product and/or process,
changes of suppliers, change of manufacturing facility location and where
required, obtain Solitron approval and flow down to the supply chain the
applicable requirements including customer requirements.
 Record retention requirements.
 Right of access by Solitron, their customer and regulatory authorities to
the applicable areas of all facilities, at any level of the supply chain,
involved on the order and to all applicable records.
Solitron shall ensure the adequacy of specified purchase requirements prior

to their communication to the supplier.
7.4.3. Verification of Purchased Product

Where Solitron Devices, Inc. verifies purchased product at the
subcontractor/supplier's facilities, the verification arrangements and the
method of product release are specified in the purchasing documents as
detailed in procedure QOP-06-01, "Subcontractor Evaluation" and QOP-06-
02 “Purchasing”.
Verification activities can include:

 Obtaining objective evidence of the conformity of the product from the
suppliers (e.g., accompanying documentation, certificate of conformity,
test reports, statistical records, process control records).
 Inspection and audit at the supplier’s premises.
 Review of the required documentation.
 Inspection of products upon receipt.
 Delegation of verification to the supplier, or supplier certification.
Where purchased product is released for production use pending completion

of all required verification activities, it shall be identified, recorded to allow
recall, and replacement if it is subsequently found that the product does not
meet requirements.
When Solitron utilizes test reports to verify purchased product, the data in
those reports shall be acceptable per applicable specifications. Solitron shall
periodically validate test reports for raw material.
Where Solitron delegates verification activities to the supplier, the

requirements for delegation shall be defined and a register of delegations
maintained.
When Solitron or its customer intends to perform verification at the

supplier’s premises, Solitron shall state the intended verification
arrangements and method of product release in the purchasing information.
Verification of Purchase Product (continued)
When specified in the contract, Solitron Devices, Inc.’s customers have the
right to verify at the subcontractor/supplier facilities that the product
conforms to specified requirements. This customer verification does not
absolve Solitron Devices, Inc. from the responsibility of providing
acceptable product or preclude subsequent rejection by the customer.
Solitron Devices, Inc. as evidence of effective control of quality does not use
the customer verification by the subcontractor.
Consideration is given to the amount of control exercised at the

subcontractor/supplier's premises and recorded evidence of conformance
provided. All products are inspected visually, and then are subjected to a
more detailed and technical inspection and/or testing. Nonconforming
products are handled using an IMIR (Incoming Material Inspection Report)
form. They are segregated and are prevented from use in production. The
procedure, "Receiving Inspection and Testing", QOP-10-01, describes the
activities and recording processes.
7.5. Production
7.5.1. Control of Production
for control of production (see Para. 6.3 Infrastructure) customer returned
material using the Return Material Authorization (RMA) procedures.
Solitron Devices, Inc.’s procedures for Return Material Authorization
include:
 Rejection report from customer.
 Review report to approve return or require engineering sample.
 Sales to log RMA and notify customer to return product.
 Sales enter debit/credit line item information.
 Receive product from customer, log and verify proper paperwork.
 Engineering to indicate pre-disposition instructions on RMA to verify or
refute customer complaint.
 Engineering will disposition product for replacement or rework.
 Production Control enters into WIP (Work In Process) tracking database.
 Engineering/Production carry out disposition.
 Final QA visual and data review.
 Return to customer.
 Corrective action prepared and submitted to customer if required.
Servicing Procedure QOP-19-01 describes the responsibilities and activities

of customer returns (RMA’s).
Corrective and Preventive Action QOP-14-01 describes the responsibilities
and activities of corrective action.
Rework Procedure QOP-13-03 describes the responsibilities and activities of
rework.
7.5.1.1. Production Process Verification

Production operations shall be carried out in accordance with approved
data. This data shall contain as necessary.
 Drawings, parts lists, process flow charts, procedures including
inspection operations productions documents (e.g. manufacturing
travelers, process cards) and inspection documents.
 A list of specific or non-specific tools and any specific instructions
associated with their use.
 Based on customer requirements the Solitron system shall provide a
process for the inspection, verification, and documentation of a
representative item from the first production run of a new part, or
following any subsequent change that invalidates the previous first
article inspection result.
7.5.1.2. Control of Production Process Changes: Personnel authorized to

approve changes to production processes are identified.
Solitron shall identify and obtain acceptance of changes that require
customer and/or regulatory requirements.
Changes affecting processes, production equipment, tools and programs

are being documented. Procedures are available to control their
implementation.
The results of changes to production processes are assessed to confirm

that the desired effect has been achieved without adverse effects to the
product quality.
7.5.1.3. Control of Production Equipment, Tools and Programs

Production equipment tools and programs are validated prior to use,
maintained, and inspected periodically according to documented
procedures. Where applicable validation prior to production use will
include verification of the first article produced to the design
data/specification.
Storage requirements, including periodic preservation/condition checks,

are established for production equipment or tooling in storage.
7.5.1.4. Control of Service Operations N/A (Customer returns only) see

QOP-19-01.
7.5.2. Validation of Processes for Production

identifying the inspection and test status of product through production, and
servicing to ensure that only product that has passed the required inspection
and tests is dispatched, or used. The inspection and test status of product is
identified, indicating the conformance or nonconformance of product with
regard to inspections and tests performed.
Note: These processes are often referred to as special processes.
Authority responsible for the release of conforming product is defined.
Inspection status, identification system and measures to prevent product
from being used or dispatched before it passes the prescribed
inspections are described in procedure "Inspection and Test Status",
QOP-12-01.
The Supervisor ensures that Inspection and Test Status is controlled

throughout the entire process. Products that pass the receiving inspection are
placed in stock. Products that fail at receiving inspection are identified with
a red "reject" tag and IMIR and moved to the M.R.B. (Material Review
Board) holding area.
In-process inspection and test status is identified on a traveler accompanying
the product.
Products that pass the final inspection and test are identified by a certificate
of compliance.
Products that fail in-process/final inspection and test are identified and
segregated.
The QA Manager (or designee) has the authority to release product for
shipment. The final test results and all pertinent documentation are retained
forming the data pack.
7.5.3. Identification and Traceability

for identifying the product by suitable means from receipt and during all
stages of production, delivery and servicing. Parts / materials are identified
by a part number and/or lot number / in ship number correlated to
corresponding drawings, specifications and other technical documents.
Indication of Inspection Status Procedure QOP 12-01. Acceptance authority
media “stamps” are controlled using Procedure QOP-12-02 (Inspection
Stamp Control). Rework Procedure QOP 13-03.
All purchased and in-house manufactured materials and parts are identified
with Solitron Devices, Inc.’s internal part numbers assigned by engineering
through document control. The part numbers provide for a correlation
between a part and its technical documentation. Finished products are
labeled with a lot number to allow for traceability of product configurations
including sub-assemblies where applicable.
Identification and Traceability (continued)
Quality maintains the part number lists and associated technical

documentation. The part number of a product is the key to correlation with
its parts lists, technical documentation and quality records. Procedure
"Product Identification and Traceability", QOP-08-01, describes this process
in more detail.
7.5.4. Customer Property

Solitron Devices, Inc. has established and maintains documented procedures for
verification, storage and maintenance of customer supplied product provided for
incorporation into the supplies. Customer supplied products are handled in the
same manner as other products purchased for incorporation into the supplies.
When specified by the client, special handling instructions from customers will
take precedent over Solitron Devices, Inc.’s standard procedures. Customer
property can include intellectual property and personal data.
Loss, damage, deterioration or unsuitability of customer-supplied products
are recorded, and reported to the customer. Customer supplied products are
reviewed, inspected, tested, marked and stored in the same manner as other
purchased products. Procedure "Customer Supplied Product", QOP-07-01,
contains detailed instructions.
7.5.5. Preservation of Product

procedures/and or training for:
 Handling
 Storage
 Packaging
 Preservation and delivery of product
 Marking and Labeling
 Shelf life control and stock rotation
 Hazardous material handling
The Operations Manager is responsible for preventing damage or

deterioration of products through handling, storage, packaging, preservation
and delivery. Procedure "Product Handling", QOP-15-01, describes the
processes to ensure that containers are adequate and clean, that equipment
used for internal transportation of product is well maintained and operators
are trained in use of the equipment, and that product is protected during
production, storage and delivery. All personnel handling electronic
components and sub-assemblies are trained in E.S.D. protection techniques.
The storage areas and their operation are the responsibility of Production
Control. Designated storage areas and stock rooms are used to prevent
damage or deterioration of product, pending use or delivery. Methods for
receipt and dispatch to and from these areas are stipulated and described in
more detail in procedure "Storage", QOP-15-02.
Preservation of Product (continued)
Only products that are properly identified and that have passed the
mandatory inspections are authorized to enter and leave the storage areas.
During cycle counts, the storage areas are inspected to assess the condition
of stock. Personnel storing electronic components and sub-assemblies are
trained in E.S.D. protection techniques.
Packing, packaging and marking processes are controlled to the extent

necessary to ensure conformance to specified requirements. Methods for
preservation and segregation of products are applied when under the control
of Solitron Devices, Inc. The protection of quality of products is maintained
after final inspection and test, and where contractually specified, extended to
include delivery to destination.
Packaging is specified by Engineering (or when specified in the contract)

Preservation and Delivery is under the control of the Operations Manager.
After the final inspection, products are protected and stored in protective
packages under controlled environmental conditions to prevent damage and
deterioration. If delivery is specified, it is subcontracted only to carriers on
the AVL.
The activities of Packaging, Preservation and Delivery are described in

procedure "Packaging, Preservation and Delivery", QOP-15-03.
7.6. Control of Monitoring and Measuring Equipment

Solitron Devices, Inc. has established and maintains documented procedures to
control, recall and maintain inspection, measuring and test equipment (including test
software) requiring calibration that is used to demonstrate the conformance of
product to the specified requirements.
Inspection, measuring and test equipment is used in a manner that ensures that
measurement uncertainty is known and is consistent with the required measurement
capability.
Where test software or test hardware are used as inspection/testing tools, they are
checked to prove that they are capable of verifying the acceptability of product prior
to release for use during production, and servicing. These tools are re-checked at
prescribed intervals. The extent and frequency of checks and maintenance of
records as evidence of control are defined in procedure "Inspection, Measuring and
Test Equipment", QOP-11-01. Where the availability of technical data relating to
measurement devices is a specified requirement, the data will be made available,
when required by the customer, for verification that the devices are functionally
adequate. When specified in the equipment contract, Engineering determines the
measurements to be made, the accuracy required, selects the appropriate inspection,
measuring, and test equipment that is capable of the accuracy and precision
necessary.
Control of Monitoring and Measuring Equipment (continued)
QA identifies all inspection, measuring and test equipment including measurement

devices that can affect product quality, calibrates, and adjusts them at prescribed
intervals, or prior to use, against certified equipment having traceability to national
standards. Where no such standard exists, the basis used for calibration is
documented.
QA defines the process for calibration of inspection, measuring and test equipment
including details of equipment type, identification, location, frequency of checks,
check method, acceptance criteria and the action to be taken when results are
unsatisfactory.
QA is responsible for identifying calibration status of inspection, measuring and test

equipment with calibration stickers.
QA maintains calibration records for inspection, measuring and test equipment.
QA assesses and documents the validity of previous inspection and test results when
inspection, measuring and test equipment is found to be out of calibration.
QA ensures that the environmental conditions are suitable for the calibration,
inspections, measurements and tests being performed.
QA ensures that the handling, preservation and storage of inspection measuring and
test equipment are such that the accuracy and fitness for use is maintained.
QA safeguards inspection, measuring and test facilities, including test

hardware/software, from adjustments, which would invalidate the calibration
setting.
All control of inspection, measuring and test equipment and calibration related
activities are documented in procedure "Inspection, Measuring and Test
Equipment", QOP-11-01.
8. MEASUREMENT ANALYSIS AND IMPROVEMENT

8.1. General
Solitron Devices has in place the necessary methods and procedures to facilitate the
assessment of product conformance and to achieve improvement in the areas
deemed necessary within the Quality System.
QOP-01-01 Management Review –

Primary function is to assess and enhance the Solitron Management System.
QOP-04-01 Design Control –

The purpose of this procedure is to provide for implementation and assessing
responsibilities for product design control and design verification.
QOP-13-01 Non-Conforming Product –

To provide for implementation and assignment of responsibilities for identifying
and documenting a “non-conformance”.
QOP-14-01 Corrective and Preventative Action –

To provide for implementation and assigning responsibilities for initiating,
requesting, implementing and checking the effectiveness of corrective and
preventative action.
QOP-17-01 Internal Audits –

Provides a plan for continual assessment of the Quality Management System.
QOP-20-01 Statistical Techniques –

This procedure provides for implementation and assigning responsibilities for the
use of statistical techniques. Statistical techniques may be used to support:
 Design verification (e.g., reliability, maintainability, safety)

 Inspection and Failure mode and effect criticality analysis
 Process Controls
o Selection and Inspection of Key Characteristics
o Process Capability Measurements
o Statistical Process Control
o Design of Experiment
8.2. Monitoring and Measurement

8.2.1. Customer Satisfaction
Customer satisfaction is evaluated by utilizing customer communication and
feedback (i.e. customer satisfaction survey, vendor rating, RMA’s, telephone
contacts, e-mail, faxes, on site meetings, sales visits).
8.2.2. Internal Audit

for planning and implementing internal quality audits to verify whether
quality activities and related results comply with planned arrangements and
to determine the effectiveness of the quality system.
Internal quality audits on each critical process step are performed at least
once each year. These audits are scheduled and based on the status and
importance of the activity being audited. The audits are performed by
personnel independent of those having direct responsibility for the activity
being audited.
Audit results are recorded and brought to the attention of personnel having
responsibility in the area audited. The management personnel responsible
for the area respond with a corrective action on the deficiencies within the
time frame specified on the audit noncompliance report. Follow-up audit
activities record the implementation and effectiveness of the corrective
action taken.
The QA Manager is responsible for establishing an internal audit plan and

schedule in accordance with procedure “Internal Quality Audit”, QOP-17-
01. The QA Manager leads the audit team. QA activities are audited by
Independent Auditors. Every functional area is audited at least once a year,
but more frequent audits may be scheduled if required.
8.2.3. Monitoring and Measurement of Processes

Solitron Quality system processes are monitored using the following
techniques:
 Internal Quality Audits
 Corrective and Preventative Action Trends
 Measuring and Monitoring Customer Satisfaction (see Para. 8.2.1)
 Review of Product Conformity and Quality Performance data.
In the event of process nonconformity, Solitron shall:

 Take appropriate action to correct the nonconforming process.
 Evaluate whether the process nonconformity has resulted in product non-
conformity.
 Determine if the process nonconformity is limited to a specific case or
whether it could have affected processes or products.
 Identify and control any nonconforming product in accordance with
clause 8.3.
8.2.4. Monitoring and Measurement of Product

In-process inspection and testing are specified on procedures/work
instructions. Product is held until the required inspection and test have been
completed or necessary reports have been received and verified. The
procedures/work instructions travel with the product in the traveler folder.
All activities associated with in-process inspection and testing are described
in procedure "In-process Inspection and Testing", QOP-10-02.
All finished products are subjected to final inspection and testing. This is in
accordance with documented procedures. Records of final inspection and
testing provide evidence of conformance of finished product to specified
requirements. All specified inspection and tests, including those specified
on receipts of product and in process, are performed. Only
those products/services that pass all stages, and have associated
test/verification data authorized by the QA Manager (or designee) are
admitted to finished products inventory or can be shipped. Performing and
recording final verification is described in procedure "Final Inspection and
Testing", QOP-10-03.
When critical items, including key characteristics have been identified,

Solitron ensures that they are monitored and controlled in accordance with
established processes.
When Solitron uses sampling inspection as a means of product acceptance,

the sampling plan shall be justified on the basis of recognized statistical
principles and appropriate for use (i.e. matching the sampling plan to the
criticality of the product and to the process capability).
Where product is released for production use pending completion of all

required measurement and monitoring activities, it shall be identified and
recorded to allow recall and replacement if it is subsequently found that the
product does not meet requirements.
.
All inspections and tests are recorded and signed off by the personnel
performing the inspection/testing. Controls for establishing the inspection
records are described in the Receiving/In-process/Final Inspection and
Testing procedures listed above. Records, which provide evidence that the
product has been inspected and/or tested, are maintained and controlled as
indicated in procedure "Quality Records", QOP-16-01. These records show
clearly whether the product has passed or failed the inspections and/or tests
according to defined acceptance criteria. When product fails to pass any
inspection and/or test, the procedure "Control of Nonconforming Product",
"QOP-13-01, applies.
Where required to demonstrate product qualification Solitron shall ensure
that records provide evidence that the product meets the defined
requirements
Solitron shall insure that all documents required to accompany the product
are present at delivery.
8.2.4.1. Inspection Documentation

Measurement requirements for product or acceptance shall be
documented. This documentation may be part of the production
documentation, but shall include:
 Criteria for acceptance and/or rejection.
 Where in the sequence measurement and testing are performed.
 Required records of measurement results (at a minimum indication
of acceptance or rejection).
 Any specific measurement instruments required and any specific
instructions associated with their use.
8.3. Control of Nonconforming Product

Solitron Devices, Inc. has established and maintains documented procedures to
ensure that product that does not conform to specified requirements is prevented
from inadvertent use. Control provides for identification, documentation,
evaluation, segregation (when practical), and disposition of nonconforming product
and for notification to the functions concerned.
Note: The term “nonconforming product” includes nonconforming product
returned by a customer.
Solitron procedures define the responsibility for review and authority for the review
and disposition of nonconforming product and the process for approving personnel
making these decisions.
The Material Review Board is responsible for the review and disposition of
nonconforming product. Nonconforming product is reviewed in accordance with
documented procedures and may be:
 Reworked or repaired to meet specified requirements;
 Accepted, with or without repair by concession;
 Re-graded for alternative applications;
 Rejected or scrapped.
When required by contract, the proposed use or repair of product that does not
conform to specified requirements is reported to the customer for concession. The
description of nonconformity that has been accepted, and of repairs made, are
recorded to denote the actual condition and kept as part of the quality records.
Solitron shall not use dispositions of use-as-is or repair, unless specifically

authorized by the customer, if the nonconformity results in a departure from the
contract requirements.
Unless otherwise restricted in the contract, Solitron designed product which is
controlled via a customer specification may be dispositioned by Solitron as use-as-is
or repair only after approval by an authorized Solitron engineer responsible for
design.
Control of Nonconforming Product (continued)
Product dispositioned for scrap shall be conspicuously and permanently marked or

positively controlled, until physically rendered unusable.
Repaired or reworked products are re-inspected in accordance with "Inspection and

Testing” procedures, QOP-10-01, QOP-10-02, or QOP-10-03, as applicable.
Nonconformity review, disposition and recording of these activities are described in

more detail in procedure "Control of Nonconforming Product", QOP-13-01.
In addition to any contract or regulatory authority reporting requirements, the

Solitron nonconforming product control process provides for timely reporting of
delivered nonconforming product that may affect reliability or safety. Notification
shall include a clear description of the nonconformity, which includes as necessary
parts affected, customer and/or Solitron part numbers, quantity and date(s)
Note: Parties requiring notification of nonconforming product may include

suppliers, internal organizations, customers, distributors, and regulatory
authorities.
8.4. Analysis of Data

Statistical techniques is the use of statistical tools such as Check Sheets, Process
Flow Charts, Histograms and Pareto Charts to analyze a process or its outputs so as
to take appropriate actions to achieve and maintain a state of statistical control and
improve the process capability. Solitron Devices, Inc. has established, documented
and maintained procedures to implement and control the application of statistical
techniques.
Solitron Devices, Inc. has identified the need for statistical techniques for
establishing, controlling and verifying process capability and product characteristics
within the manufacturing / operations functions. This includes Receiving
Inspection, In-Process Inspection and Testing, and Final Test activities.
Qualified personnel, using statistical methods, are provided with charts, tables and
other instructions in the use of these techniques. “Statistical Techniques” procedure,
QOP-20-01, describes the activities in more detail.
8.5. Improvement
8.5.1. Continual Improvement
Continual improvement is driven by the Solitron Quality Policy and Quality
Objectives. Continual improvement needs are identified and monitored with
the use of internal quality audits, product and process performance data,
vendor performance data, corrective and preventative action data.
8.5.2. Corrective Action

for implementing corrective and preventive action. Any corrective or
preventive action taken to eliminate the causes of actual or potential
nonconformities shall be to a degree appropriate to the magnitude of
problems and the risks encountered. Any changes resulting from corrective
and preventive actions are implemented and recorded in the appropriate
affected procedures.
Solitron Devices, Inc.’s procedures for corrective action include:

 The effective handling of customer and service complaints, and other
internal or external reports of product nonconformities.
 Investigating the cause of nonconformities relating to product,
processes and quality system, and recording the results of the
investigation.
 Determining the corrective action needed to eliminate the cause of
nonconformities.
 Based on the causes of any non-conformance determining if additional
non-conforming product exists and take action when necessary.
 Applying controls to ensure that corrective action is taken and that it is
effective.
 Flow down of the corrective action requirement to a supplier, when it is
determined that the supplier is responsible for the nonconformity.
 Specific actions where timely and/or effective corrective actions are not
achieved.
 Determining if an additional nonconforming product exists
based on the causes of the nonconformance and taking
further action when required.
8.5.3. Preventative Action

Solitron Devices, Inc.’s procedures for preventive action include:
 The use of appropriate sources of information such as processes and work

operations which affect product quality, nonconformance reports, audit
results, quality records, service reports and customer complaints to detect,
analyze and eliminate potential causes of nonconformities.
 Determining the steps needed to deal with any problems requiring
preventive action.
 Initiating preventive action and applying controls to ensure that it is
effective.
 Ensuring that relevant information on actions taken, including changes to
procedures, is submitted for management review.
 Reviewing the effectiveness of the preventative action taken.
Anyone in the company may propose initiation of a Corrective/Preventative

Action, but only the Quality Manager can authorize the
"Corrective/Preventative Action Request" form. Each action is followed up
by the Quality Manager to determine if the Corrective/Preventative Action
has been implemented and if it is effective. The process of initiating a
corrective/preventative action request, documenting the proposed action and
the follow-up are described in procedure "Corrective and Preventive
Action", QOP-14-01.

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What is the purpose of the quality policy manual?

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QUALITY POLICY MANUAL

SOLITRON DEVICES, INC.

T 06/01/09 Update to comply with AS9100 RFCH9718

X 06/16/11 Removed last two paragraphs on Page 29 RFCH10512

Y 09/09/11 Modified section 1.2 Application on page 6 RFCH10589

4. QUALITY MANAGEMENT SYSTEM

8. MEASUREMENT ANALYSIS AND IMPROVEMENT

11 Audit Team (A)

13 Audit Team (B)

17 Audit Team (C)

We achieve this through:

Solitron Devices, Inc. has implemented a Quality Management System that

 Section 7.3.6 Design and Development Validation; 7.3.6.1 Design and

Signed: ___________________________________Date: _______

Signed: ___________________________________Date: _______

4.1. General Requirements

 Determine system processes and their application within Solitron Devices.

Solitron ensures Control of outsourced processes using Inspection, Measurement

Continual improvement of the QMS

SOLITRON QMS PROCESS INTERACTIONS

PULL PRODUCT FROM

ASSEMBLY DATA REVIEW

BILLING AND PAYMENT CUSTOMER

 Quality Manual (QPM 01)

4.2.2. Quality Manual

 Quality Policy Manual

The purpose, scope, and responsibility for controlling each type of

4.2.3.2. Document Approval and Issue

4.2.3.3. Control Documents

4.2.3.4. Document Changes

The activities of Identification, Collection, Indexing, Access, Filing,

Solitron Devices, Inc. appoints the QA Manager as the Management Representative,

QUALITY MANAGER (Management Representative) –

5.2. Customer Focus

 The requirements are adequately defined and documented. Where no written

Solitron Devices management team provides a work environment that

Operations Director ____________________________________

Solitron Devices, Inc.

Hybrids/Mosfets/BiPola Sr. Design &

Inside Sales/ TDE Supervisor Device/ Diffusion

Process Applications &

5.4.2. Quality Management System Planning

The Quality System, its make-up, how it is audited and reviewed is

5.5. Responsibility, Authority, and Communication

5.5.1. Responsibility and Authority

5.5.2. Management Representative

5.5.3. Internal Communication

5.6. Management Review

5.6.2. Review Input

5.6.3. Review Output

6.1. Provision of Resources

6.2. Human Resources

6.2.2. Competence, Training, Awareness

“Training” procedure, QOP-18-01, describes in more detail the department

When complexity or importance of an activity warrants it, production personnel are

6.4. Work Environment

Signed: _____________________________Date: _

Signed: _____________________________Date: _