Table of Contents
Introduction
Quality
assurance is a process that assures assemblies and/or
systems are built and inspected properly and that they
retain their quality and performance during operation.
Quality assurance ensures us that systems are
developed and maintained according to plans and requirements.
Quality requirements will be considered to have
been fulfilled only when the customer receives a highly
reliable product, which fully conforms to all applicable
specifications.
1.0
Policy
·
All positions relating to quality specific activities
are stated in the quality manual.
·
All activities of the company related to quality assurance
will be defined by a group of documented administrative
procedures.
·
This series of administrative procedures will be standardized
and consistent in format structure and presentation.
·
All administrative procedures will consist of the same
series of systematic discussions or components.
·
Documents, forms, and records will be maintained which
form a means of communication and record of events.
1.1
Purpose
·
To provide for a system of documented instructions and
records for all aspects of quality assurance
·
The system is detailed through the administrative procedures.
1.2
Scope
·
These administrative procedures will apply to all departments
of the corporation.
·
These administrative procedures will be acknowledged
and adhered to by all employees of the corporation.
2.0
Responsibility
The
responsibility for complying with administrative procedures
will lie with the leader of each department.
3.0
Associated documents
The outline
of this report is taken from Document Quality for
ISO 9000 and Other Industry Standards, by Gary E. MacLean.
4.0
Vision Statement
Micron Corporation's
vision is to be recognized as a leader in contract manufacturing. With a friendly atmosphere, employee discipline, and management's
commitment to excellence, we will continue to strive
for improvement, growth, and expansion of our manufacturing
line while maintaining high business and ethical standards
for the benefit of our customers and employees.
5.0
Mission Statement
Micron Corporation
is committed to providing unsurpassed service to our
customers for their assembly needs. We will do our best to provide 100% customer
satisfaction in every area of the assembly process by
using state of the art equipment and careful attention
to detail.
6.0 Quality Policy
·
Management is committed to excellence.
·
Employee discipline towards unsurpassed quality.
·
We are committed to delivering quality products on a
timely basis.
·
We aggressively pursue higher quality through employee
involvement and teamwork.
7.0 Quality System
The quality
system describes the policies and operations of Micron.
This provides an accurate description of the
organization. The practices adopted in order to consistently
satisfy the customer requirements Micron's quality system
consists of a number of levels of documentation:
·
Quality Manual
·
Administrative Procedures
·
Documents, Forms, and Records
The quality
manual defines the positions of the company on its quality
management system. The systems defined in this quality assurance
manual are designed to meet the requirements of MIL-STD-2000. It also satisfies the requirements of
ISO-9001. It
is mandatory that the organizational controls as described
in the quality assurance manual are adhered to by all
personnel at Micron Corporation.
The Quality
Control Manager is authorized to prepare, implement,
and maintain the Quality Assurance Program described
in this manual.
Micron Corporation
was incorporated in Massachusetts in 1982.
It is an electronics contract manufacturer servicing
medical, industrial, military, and instrumentation industries.
Although Micron's
beginnings were in through-hole technology, it has expanded
into surface mount technology. This recent expansion gives Micron the
ability to fully serve its customer's needs. The goal at Micron is to excel at customer service while maintaining
a superlative level of quality.
It is the
policy of Micron Corporation that all internal copies
will be controlled copies. All external copies will be uncontrolled.
The Quality Control Manager will maintain the
Master copy of the manual. The Quality Assurance Manual is periodically reviewed to ensure
its conformance to current standards, customer and company
requirements.
The frequency of review is at least once a year.
Revisions
to the quality manual are by revision numbers.
Each revision replaces the previous issue within
the manual. The quality control manager prior to their issue will approve
all revisions.
Revisions to the Quality Assurance Manual are
sent to all registered copyholders: A revision Record
Sheet must be returned to the Quality Control Manager
after the revised pages are incorporated into the copy
holders manual. The obsolete pages must be returned together
with the Revision Record Sheet, to the Quality Control
Manager. The Quality Control Manager in the Quality
record control revision log keeps an updated record
of the revisions.
The Quality
Assurance Manual will be revised and reissued after
a practical number of changes are made.
The quality
policy of the company is to provide customers with quality
products at the highest level of service.
Company personnel at all levels of the organization
have the mandate to implement and maintain this program
and work within its guidelines to conform to the requirements
of the appropriate quality standard.
The Quality
Control Manager has the necessary authority to resolve
all quality matters within the company and to act as
liaison with the customers on all quality matters.
In case a
quality matter can not be resolved mutually by various
functions of Micron Corp., final authority will be resolved
by the Material Review Board within the dictates of
the applicable quality standard.
The organizational
chart shown below reflects the organizational structure
and reporting relationships within the organization.
Those positions in bold are members of the Quality
Review Board.
A system will
be established to ensure all documentation that relates
to the manufacturing of the products are controlled,
revised, and maintained.
All documents
at Micron Corporation will be current.
A record of all revisions will be kept in the
revision record sheet attached to each document folder.
Obsolete documents will be discarded unless they
are needed for reference. Such referential materials will be marked "Obsolete, for
reference use only".
All documents
will be filed in the document control area.
They will be filed by the company name and by
assembly number.
To establish
and maintain a documented system that will ensure safe
and orderly identification, collection storage and dispensation
of quality records.
The quality
records are stored and maintained in such a way as to
ensure easy retrieval. Quality records are filed by company and by assembly number.
The retention time for quality records will be
as follows:
·
Commercial Products - 1 year
·
Military Products - 5 years
Upon the expiration
of the retention period, the quality control manager (or
delegate) will dispose of all expired records.
To establish
and maintain a system for verification and processing
of all material.
Incoming inspection
bears the responsibility for verifying and ascertaining
that all material (whether consignment or turnkey) conform
to the specifications per the supplied documents.
Any shortages, damages, or nonconforming materials
will be reported in writing to the customer or the origin
of purchase.
To establish
and maintain a system for the assembly of the product
to customers specifications.
The Production
Manager bears the responsibility to ensure the products
are built in accordance with the latest documents and
company standards. The
proper process control documents follow the product through
its assembly cycle (see AP).
To establish
and maintain a system for all necessary inspections throughout
the entire process, from receiving to final acceptance.
The quality
control department bears the responsibility of performing
inspection through the various phases of assembly and
verifying the product is built in accordance with the
latest documentation and in compliance with MIL-STD-2000.
To establish
and maintain a system for the disposition of nonconforming
material.
The quality
control inspectors bear the responsibility of dispositioning
nonconforming material. Such material will be identified and segregated.
The originator will establish the nature of nonconformity
and all functions concerned will be notified.
Corrective action will be initiated to correct
nonconformity. Nonconformity
material will be rejected.
To define the
forms required for inspection of the product.
The Quality
Manager bears the responsibility of generating, maintaining,
and reviewing the forms, records, and documents, which
form a means of communication and a record of events. During the inspection of the product.
To establish
and maintain a system for identifying the product from
applicable documents during all stages of production.
Quality Control
Procedures on product identification and traceablility
will be followed during all stages of the production cycle,
which includes production and delivery. Identification is made to the date of production,
customer name, job order number, and assembly number. A traceability system will be used either lot-by-lot
or unit-by-unit as detailed in the administrative procedure,
or per customer requirements.
To establish
and maintain a system for handling, packaging and delivery
of finished goods.
The Production
Manager bears the responsibility to produce appropriate
methods and instruction for handling material to prevent
damage (see AP)
Protection against electrostatic discharge
(ESD) is provided throughout the production process - including
handling, storing, and transporting.
All employees and visitors on the shop
floor are bound by the requirements of this section.
·
All personnel handling assembled printed circuits or electrostatic
sensitive components will utilize ESD protection devices. This information is recorded in the Ground Strap Check Log.
·
Stations will be created, labeled, and maintained to track
the use of ESD protective devices.
·
Every station in the manufacturing process will maintain
ESD protection.
·
ESD protected areas will be tested every six months to ensure
continuity and specified resistance of ESD protective devices. This testing is documented in the Work Station Check Log.
·
ESD protective materials are used for transporting components
or printed circuit boards.
·
Materials used for static shielding and other ESD protection
are listed in the ESD Materials List.
All personnel are responsible for following
ESD protective procedures while on the production floor.
·
All personnel handling ESD sensitive devices will sign out
and check a wrist-strap (or other ESD protective device)
each day from the Ground Strap Check Log.
·
The Production Manager is responsible for ensuring that
the Ground Strap Check Log is filled out.
·
The Quality Control Manager is responsible for maintaining
the Work Station Check Log.
·
The Production Manager is responsible for entering new protective
packaging materials and ESD protective devices into the
ESD Materials List.
Handling -
manipulation (directly or indirectly) with the hands that
occurs at a station
Protection -
any material, device, or condition, which deters or prevents
ESD
Protective devices -
devices designed (or altered) to deter or prevent ESD
Protective packaging -
packaging which guards against the admittance of ESD
Static shielding -
material, which prevents a static discharge from penetrating
through the package and onto a board or components
Storing -
the long terms or short terms placement of production materials
Transporting -
movement of material from one station to another
11.0 Administrative Procedures
The chart below indicates the sequence
of component workflow through the manufacturing cycle.

The
purpose of this administrative procedure is to list the
steps required for receiving a kit.
The scope of this AP covers all incoming kits
Procedure
·
Inspect all components and verify that they have the correct
value per parts list. Note
any substitutions.
·
Verify that quantities are correct and agree with Bill of
Material.
·
Each component should be packaged separately, and with proper
identification: e.g. part number and value.
·
All axial components should be grouped together. All radial components should be grouped together.
·
Generate a shortage list when required and send a copy of
the shorts to customers.
·
Generate History Log
·
For every new kit, enter into the computer the job number,
assembly number, company name, quantity, date in, due date,
and revision number. When
all of this information has been entered, generate a manufacturing
kit release (MKR) form.
·
Secure the latest revision of assembly prints and include
in kit.
·
Include picking list of material supplied (consignment)
·
Include purchase list with all receipts of material for
the assembly (Turnkey)
·
Sign MKR form and send kit to preparation area.
·
SMT components sent to assembly.
Kit - A kit consists of all the material and documents required
for assembly.
All active components
such as IC's, diodes, and LED's should be handled with care. Proper anti-static hand straps should be worn. Straps should be tested on a daily basis.
The purpose of this AP is to specify the steps required
in component preparation.
The
scope of this AP covers all components for through-hole
kits. Axial components should be prepared per MIL-STD-2000.
·
Refer to assembly prints and comply with any unique requirements
relating to preparation of components.
·
Components, which display their value, should be bent with
the value showing on the top of the component.
·
Bend resistors, axial caps, and diodes per QA-309 Workmanship
Standards utilizing the Hepco or APS Resistor Bending machines,
making sure the body of the component is centered between
bends, and have proper strain relief (cut leads to 3/16
length).
·
Pre-cut leads to 3/16 length on such components as radial
caps, transistors, and pots, utilizing the Hepco cutting
unit.
·
Place all prepared components in the appropriate package.
·
Prepare board for assembly by masking holes that will be
used for secondary assembly, mounting holes and cover gold
fingers of the board. This
information should be marked on the print.
·
Sign MKR form and send kit to assembly.
QA-309
Workmanship Standard: Provides standards for MIL-STD-2000,
WS-6536E, WS-6536D, MIL-STD 4574E, and MIL-STD 454K.
All
active components such as IC's, diodes, and LED's should
be handled with care. Proper
anti-static hand straps should be worn.
Hand straps should be tested on a daily basis.
11.3 Assembly
The
purpose for this AP is to outline the steps required for
the assembly of the boards.
This
scope is for all through-hole assemblies.
Assemblies are built to MIL-STD-2000 reference document
QA-309.
·
Obtain documentation and study assembly prints for unique
requirements associated with assembly. Comply with the requirements.
·
The following requirements should be observed. All axial components should have proper strain
relief and lie flush with the PC board.
·
Capacitors should have proper spacing off the board to accommodate
proper wetting of leads on component side of board. Whether teardrop, radial lead, or ceramic,
they must be mounted perpendicular and parallel to the board,
respectively.
·
Power resistors and diodes (1 watt and up) must have a small
amount of lift off the board to facilitate air movement
and prevent scorching of the board.
·
DIP packages must be mounted parallel to the surface of
the PCB.
·
Utilizing the documentation, start the assembly procedure.
·
For each component refer to parts list. Verify value and location on board.
·
Place component on its proper location on board, making
sure polarized components are oriented correctly.
·
For each component placed on the board check off the parts
list indicating component has being placed on the board
·
Secure small components (e.g. resistors, diodes) to the
board by placing a drop of solder mask on top of components.
·
Upon completion of placement of all components, assembly
supervisor should check the parts list and board and verify
all components have being placed to the board. Sign MKR
form and send kit for wave.
All
active components such as IC's, diodes, and LED's should
be handled with care. Proper
anti-static hand straps should be worn.
Hand straps should be tested on a daily basis.
11.4 Wave
The purpose of
this AP is to list the steps required for waving of through
hole boards.
The scope of this
AP is for boards with through holes.
Commit the following
steps for preparation of the wave:
·
Turn on the solder pot and set solder temperature at 500
degrees Fahrenheit. The pot will take five hours for solder
to reach temperature.
·
Set flux container in place. Fill it with flux read the
specific gravity of the flux and add thinner accordingly
to attain the proper specific gravity per manufacturers
specification.
·
Set the air pressure for the flux stone until tiny flux
bubbles appear throughout the surface of the flux.
·
Adjust the height of the conveyor relevant to the solder
by sending a sample glass board through making sure solder
height covers the bottom of the board and hits the front
face of the board by 50%.
·
Turn on pre-heaters and set the temperature of pre-heaters
to about 600 Fahrenheit.
·
Adjust speed of conveyor to 2 feet per minute.
·
Send a board through and monitor the temperature on the
top surface of the board.
It should reach 225 degrees Fahrenheit. Adjust pre-heater
temperature accordingly.
·
Once ideal heater conditions have been established send
a board through and examine all solder points (top and bottom
of board) and verify that ideal solder connections are evident
throughout the board. Once this is accomplished proceed
to solder the boards.
·
Upon completion of each job sign MKR.
·
Upon completion of soldering the boards, clean solder pot,
put flux back into its container, clean all around the unit
and shut down the unit.
·
Every six months take a sample of the solder and send for
solder analysis. Check results and verify the weight of
each element in the solder is within maximum allowable limits
per MIL-STD 6536.
Caution
Anti-static foot
strapping should be worn all the times.
The purpose of
this AP is to list the steps required for the secondary
operations.
The scope of this
AP is for through hole assemblies.Procedure
·
Boards should be cleaned of residues from solder mask and
or capton tape that has been placed on the board.
·
Checks boards and verify that all components are sitting
flat on the board, rework if required. Sign the MKR and
send boards for leads to be cut.
·
Utilizing the lead-trimmer machine Q2G cut leads 1/32 above
solder connection. Sign the MKR and sent boards to the floor.
·
Check all solder connections top and bottom of the board
and ensure they are acceptable to MIL-STD-2000.Rework as
necessary.
·
Check the prints and install any secondary components per
documentation. Sign MKR and sent assembly to QC for inspection.
All active components
such as IC's, diodes, and LED's should be handled with care. Proper anti-static hand straps should be worn. Hand straps should be tested on a daily basis.
The purpose of
this AP is to list the requirements for inspecting boards.
The scope of this
AP is for boards with through hole components.
Board inspection
will be done according to MIL-STD-2000. Reference document
QA-309.
QC to ensure product
complies fully with customer’s requirements; it is built
properly and retains their quality and performance during
operation.
·
Obtain documentation make sure documents are to the latest
rev. Study the assembly print for unique requirements
associated with the assembly, make sure assembly meets those
requirements
·
Boards should comply to the following general requirements:
·
All boards are inspected 100% for components and solder.
·
All axial components should have proper strain relief and
seated flat on board.
·
All radial components should be mounted vertically and horizontally
to the board with the proper spacing off the board.
·
All IC's should be seated flatly on the board.
·
Power resistor and diodes must be lifted of the board for
air circulation.
·
Check all components for damages.
·
Inspect the boards per documentation verifying all components
are in the right location and polarized components have
correct polarity.
·
Inspect boards for proper solder connection on each point.
·
Fill a QC report denoting the following:
·
Accept boards if they pass all above listed requirements
·
If any boards do not pass above requirements note failure
in the report and sent board back to assembly for correction.
Re-inspect boards after correction.
·
Sign MKR and send boards for final wash.
·
After boards have being final washed, verify that boards
are clean.
·
According to customer specification the following should
be done.
·
Mark boards with assembly number, rev, serial number, and
date of manufacturing.
·
On military assemblies fill a production traveler and a
certificate of compliance.
·
For commercial products fill out a QC report.
Send yellow copy of QC Report to customer. Keep original copy of QC report and the Manufacturing Kit Release
for one year.
·
For military products fill out a QC report.
Send yellow copy of QC Report to customer. Keep original copy of QC report and the Manufacturing Kit Release
for five years.
·
Sign MKR and send boards to packaging, include the yellow
copy of the QC report.
·
All documents referring to traceability should be placed
in a Manela folder. The folder should be marked with Assembly
# and date of manufacturing. Records should be kept according
to industry requirements.
Commercial Products - One Year
Military Products - Five Years
Medical Products - Seven Years
·
Traceability Records:
1.
Picking List from customer with quantities issued (Consignment)
2.
Purchase List with quantities and receipts of components
(Turnkey)
3.
Shortage list
4.
History Log
5.
Manufacturing Kit Release Form
6.
QC Report
7.
Final assembly and QC check list
Boards contain
static sensitive components. Anti-static hand strapping
should be worn at all times.
11.7 Packaging
The purpose of
this administrative procedure is to specify the steps for
packaging.
Preparation of
product for packaging.
·
Boards contain static sensitive components. Anti-static
hand and or foot strapping should be worn all the times.
·
Each board should be wrap in anti-static packaging.
·
Place each wrapped board in a box, caution should be exercised
to insulate adjacent boards so they don't get damaged.
·
Include in the box QC report and seal the box.
·
Place a copy of the invoice in a packaging envelope and
attach envelope to the box.
·
Ship product to customer via UPS, or to local vendors deliver
with the company van.
·
ESD protection will be available wherever ESD sensitive
components will be stored or handled.
·
All employees will utilize ESD protection when handling
or transporting ESD sensitive components.
·
All ESD sensitive components will be stored in ESD protective
packaging or on protective holders.
·
The use of ESD protection will be documented.
·
The resistivity and continuity of workstations will be checked
and recorded.
·
New materials and devices utilized for ESD protection will
be listed.
·
To provide for the creation and labeling of stations.
·
To provide instructions for documenting ESD protection in
the Ground Strap Check Log.
·
To provide instructions for documenting workstations in
the Work Station Check Log.
·
To define the different forms of ESD protection available
on the production floor using the ESD Materials List.
·
This AP will apply to all stations on the production floor.
·
All employees (and visitors) will adhere to this AP while
on the production floor.
·
All employees will follow the directions of this AP.
·
The Production Manager will verify that all employees are
in accordance with the directions relating to the Ground
Strap Check Log in this AP.
·
The Quality Control Manager will ensure that the directions
relating to the Work Station Check Log are carried out.
·
The Production Manager will be responsible for maintaining
the ESD Materials List as specified in this AP.
Antistatic -
A material, which resists charging upon contact and separation
with another material.
Surface resistivity of less than 1014
Ohms/sq. (MIL-M-38510, Section 3.1.3.21)
Antistatic packaging -
Material used to help prevent the buildup of a charge. Used as inexpensive cushioning material inside
of static shielding.
Conductive -
Surface resistivity less than 105 Ohms/sq. (MIL-M-38510,
Section 3.1.3.22).
Continuity -
an indication of the flow of electricity through a defined
circuit
ESD -
electrostatic discharge
Insulating -
Surface resistivity of greater than 1014 Ohms/sq. (MIL-M-38510, Section 3.1.3.23)
Protection -
any material, device, or condition, which deters or prevents
ESD
Protective devices -
devices designed (or altered) to deter or prevent ESD
Protective holders -
conductive devices designed to hold components or printed
circuit boards
Protective packaging -
packaging which guards against the admittance of ESD
Resistivity -
a measure of the resistance (ohms) provided by a component
or circuit
Sensitive components -
components and devices that may be damaged by ESD
Static shielding -
material, which prevents a static discharge from penetrating
through the package and onto a board or components
Station -
a defined area on the production floor
Storing -
the long terms or short terms placement of production materials
Transporting -
movement of material from one station to another
EN 100015-1, European Standard for protection
of electrostatic sensitive devices (1992).
Protecting ICS from Electrostatic Discharge,
Robert C. Kerns, and Jeffrey R. Riskin, Analog Devices Inc.
(1984).
Electrostatic Discharge Sensitivity Training
Manual, Ortho Diagnostics Systems Inc. (1982).
Integrating Quality Standards to Help Combat
ESD, Nick Mendham, 3M Electrical Specialties EBU (1995).
Labeling Stations
The physical locations on the shop floor
where ESD protection is to be provided are referred to as
stations. Each station is to be labeled clearly with a 1
inch by 4 inch piece of durable black plastic with large
white lettering: the colors of the letters and the plastic
should contrast each other enough to provide for easy viewing
of the label. Labels should be fastened onto a permanent
part of the station. If
a work station table is available at the station then the
label should be fastened to the table.
Signing the Ground Strap Check Log
At the beginning of each day, each employee
checks his or her ground strap with a strap continuity test
device. If the ground strap is OK, then the employee
initials the Ground Strap Check Log. If the ground strap is not OK, then the ground strap should be delivered
to the Production Manager.
The Production Manager evaluates the Ground
Strap Check Log at the end of every week and maintains a
supply of functioning ground straps.
Verifying Work Station Functionality
The Quality Control Manager will visually
check the continuity of each workstation every six months. Information on the workstation is entered into the Work Station
Check Log. The Quality
Control Manager maintains the ESD protection of all workstations.
Compiling New Protections
The Production Manager maintains a current
list of materials and devices used for the purpose of ESD
protection. All packaging materials, conductive mats, wrist straps, heel straps,
ground connectors, tray tables, and any other materials
or devices are included in the ESD Materials List.
Ground Strap Check Log
This document, when completed, is a day-by-day
record. It contains a list of employees and their initials
for each day that they sign-out a functioning ground strap. All employees handling ESD sensitive components
fill the document out each day.
At the bottom of the Ground Strap Check
Log is a place for the Production Manager’s signature.
At the end of each week, the Production Manager looks
over the completed Ground Strap Check Log.
He ensures that the employees handling components
have been consistently signing-out ground straps.
Work Station Check Log
This is a list of all the ESD protected
stations on the production floor.
Every six months the Quality Control Manager visually
checks the continuity of the workstations.
If the station checks out, then the Quality Control
Manager enters her initials next to the corresponding station
on the Log. If the
station does not pass the tests then the Quality Control
Manager enters an X in the corresponding location.
ESD Materials List
This is a list of all materials and devices
used by the company to protect against ESD.
It includes the name of the material or device and
the producer of said material or device.
It can also include information about the resistivity
(or other properties) of the material when available.
At the very least it includes a classification of
the material (or device) as either a conductor, an anti-static,
or an insulator.
Ground Strap Check Log
Each day, each employee will check his
or her wrist strap or heel straps.
1.
Plug the end of the protective strap into the SIMCO strap
tester.
2.
If the light does not turn the ground strap is defective: Deliver the defective ground strap to the Production
Manager: obtain another ground strap and check it.
3.
If the light comes on then the ground strap is OK: Initialize
the Ground Strap Check Log for that day.
4.
At the end of every month the Production Manager must place
the start and end date at the bottom of the Log, sign it,
and then start a new Log.
Work Station Check Log
Once every six months the Quality Control
Manager (or someone appointed by her) will perform the following
test on each station.
1.
Visually check to see that all of the connections required
for grounding are actually connected.
2.
Check to see that there is continuity between a functioning
wrist strap and the ground connection.
3.
If the station has passed these tests then fill out the
WorkStation Check Log.
4.
If the station hasn’t passed both these tests then identify
the problems and remedy the situation immediately.
5.
If the station cannot be fixed it should be marked as defective
and not used.
ESD Material List
Every time a new item or material is acquired
for the purpose of ESD protection, its information must
be entered in the ESD Material List by the Production Manager.
1.
Place the date of entry in the left hand column
2.
Enter the name of the material.
3.
Enter the name of the manufacturer.
4.
If the item is a material (and not a device) then categorize
the material as either a conductor, antistatic, or insulator.
5.
Lookup (or estimate) the surface resistivity of the material
(Ohm/sq.) and enter it onto the form.
12.0
TRAINING
A major component
in attaining quality objectives is the education and training
of personnel. Training needs will be identified and training
provided according to established procedures.
All Personnel
performing functions that effect quality of the product
shall receive training for quality improvement. Specific
functions, regarding inspections, will require a level of
education and experience. Training schedules, records and
attendance shall be maintained and coordinated by the Quality
Assurance.
13.0
INTERNAL QUALITY AUDITS
Policy
A strategic
system of planned and periodic audits shall be implemented
to verify compliance with all aspects of the quality assurance
system.
Procedure
All quality
related functions shall be audited at least once each calendar
year or more frequently as required by the importance or
the need of the activity. Internal audits, when documented,
shall serve to supplement information to management for
overall quality system and product performance.
Audits shall
be performed in accordance with written procedures and checklists
by personnel not directly accountable to the function or
area being audited. Follow –up corrective action shall be
instituted by management in deficient areas within a specified
time frame.
Documented objective
evidence shall be part of the audit results. Concerns, findings
and corrective action for audit items shall be reviewed.
Recommendations will be made to the management having direct
responsibility for the area being audited.
Quality assurance
management shall be responsible for the audit program. Audit
personnel shall be qualified by education and experience.
Each auditor shall receive on- the – job training to assure
proficiency
A listing of various
documents, forms, and reports used during the manufacturing
cycle is given below.
DOCUMENT
REV LEVEL
1.
Reference document QA-309 (not included)
2.
Manufacturing Kit Release
REV-1
3.
Component Shortage
REV-1
4.
Inspection Report
REV-1
5.
Certificate of Compliance
REV-1
6.
DMR Report
REV-1
7.
ECN Log
REV-1
8.
Special Requirement Log
REV-1
9.
Traceability Report
REV-1
10.
Final Assembly and
QC Check List
REV-1
11.
Disposition Sheet
for Waveroom
REV-1
12.
Assembly Kit log
by Date
REV-1
13.
Quality Improvement
Program
REV-1
14.
Training Record
REV-1
15.
Annual Audit Schedule
REV-1
16.
Ground Strap Check
Log
REV-1
17.
Mat Work Station
Check Log
REV-1
18.
Maintenance Log
My Data
REV-1