Quality Assurance Manual
Quality Assurance Manual
Table of Contents
Introduction
Purpose
Statement of Authority
Company Background
Manual Issue and
Revision
Management Responsibilities
Documentation Control
Scope
Policy
Control of Quality
Records
Scope
Policy
Control of Consignment
or Turnkey Material
Scope
Policy
Assembly
Scope
Policy
Inspection
Scope
Policy
Control of
Nonconforming Material
Scope
Policy
Document, Records, Forms
Scope
Policy
Product Identification
and Traceability
Scope
Policy
Control of Handling,
Packaging, and Delivery
Scope
Policy
Policy
Scope
Purpose
Responsibility
11.0 Administrative Procedures
11.1 Receiving/Incoming Inspection
Purpose
Scope
Procedure
Definitions
Caution
11.2 Component Preparation
Purpose
Scope
Procedure
Definition.
Caution
11.3 assembly
Purpose
Scope
Procedure
Caution
11.4 Wave
Purpose
Scope
Procedure
Caution
11.5 Secondary Assembly
Purpose
Scope
Procedure
Caution
11.6 Quality Control
Purpose
Scope
Procedure
Caution
11.7 Packaging
Purpose
Scope
Procedure
11.8 Electrostatic
Discharge Prevention
Policy
Purpose
Scope
Responsibility
Definitions
Associated Documents
Instructions
Descriptions
Procedures
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.
· 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.
· To provide for a system of documented instructions and records for all aspects of quality assurance
· The system is detailed through the administrative procedures.
· 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.
The responsibility for complying with administrative procedures will lie with the leader of each department.
The outline of this report is taken from Document Quality for ISO 9000 and Other Industry Standards, by Gary E. MacLean.
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.
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.
· 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.
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
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
· 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.
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.
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.
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.
· 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.
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 Mendh