7 EQUIPMENT AND CALIBRATION
INTRODUCTION
EQUIPMENT GMP CONTROLS
Maintenance
Records
MANUFACTURING MATERIALS
Analyze Use
Control Use
AUTOMATED PRODUCTION AND QA SYSTEMS
Software Validation Guidances
Employee Responsibility and Training
Formal Development of Software
Commercial Software and Equipment
Validation of Automated Equipment
and Processes
Automated Data Collection and Processing
Equipment Controls and Audits
MEASURING EQUIPMENT CALIBRATION
Calibration Requirements Equipment
Selection
Procedures
Management of Metrology
Calibration Recordsv Schedules
Standards
Calibration Environment
AUDIT OF CALIBRATION SYSTEM
INTEGRATING MEASUREMENTS INTO THE QA SYSTEM
EXHIBITS
P.C. Board Cleaning
Calibration Procedures for Mechanical
Measuring Tools
The Quality System (QS) regulation requires that each manufacturer
develop, conduct, control, and monitor production processes to
ensure that the end device conforms to its specifications [820.70].
All equipment used to manufacture a device shall be appropriately
designed, constructed, placed, and installed to facilitate maintenance,
adjustment, cleaning, and use [820.70(g)]. The degree of maintenance
on equipment and the frequency of calibration of measuring equipment
will depend upon the type of equipment, frequency of use, and
importance in the manufacturing process. Where deviations from
device specifications could occur as the result of manufacturing
processes, the manufacturer shall establish and maintain process
control procedures. This chapter addresses the steps necessary
to ensure that manufacturing equipment continuously operates within
the parameters necessary to produce a product that meets specifications.
The selection, purchase, and installation of the most appropriate
manufacturing equipment is important to successfully manufacture
a medical device to specifications. After this manufacturing equipment
has been installed and placed in operation, it shall be maintained.
This includes the periodic inspection, adjustment, cleaning, and
other maintenance of this equipment to insure that product specifications
continue to be met [820.70(g)(1), (2) and (3)]. If the manufacturing
equipment used in production includes computers or an automated
data processing system, the manufacturer shall validate the software
for its intended use and the software changes using an established
protocol [820.70(i)]. In addition the manufacturer is responsible
for ensuring the establishment of routine calibration [820.72],
inspection, and maintenance on all of their inspection, measuring,
and test equipment so this equipment will be suitable for its
intended use(s).
Equally important to the purchasing and maintenance of manufacturing
equipment is the adequate training of personnel so they are able
to operate the equipment correctly [820.25(b) and 820.70(d)].
This training shall be documented. Included in adequate personnel
training is the establishment and maintenance of requirements
for health, cleanliness, personal practices, and clothing of employees
when contact between these people and the product or the environment
could reasonably be expected to adversely effect the finished
product quality [820.70(d)].
Device manufacturers shall establish schedules to maintain, clean,
and adjust equipment used in the manufacture of medical devices
where failure to do so could have an adverse effect on the equipment's
operation and hence the device. For example, failure to maintain,
clean, and adjust a sealing and/or packaging machine used for
primary packaging of sterile devices will eventually result in
defective packages and thus nonsterile products.
A manufacturer should determine if the equipment requires maintenance
and apply the appropriate parts of the GMP requirements for equipment.
The user usually can determine if specific equipment requires
maintenance by reviewing the equipment operations and maintenance
manuals usually supplied by the equipment manufacturer. Typically,
a manufacturer will maintain equipment simply because it prolongs
equipment life and minimizes the need for major service.
If it is necessary to maintain, clean, or adjust equipment, the
manufacturer should:
Manufacturers may find it helpful to establish and maintain maintenance
procedures for manufacturing equipment in order to ensure meeting
the manufacturing specifications. These procedures should include
adjustment and cleaning, as well as other equipment maintenance.
Documentation should be kept on maintenance activities including:
the activity performed, the date, and the individual providing
the maintenance [820.70(g)(1)]. An example of an operation and
maintenance procedure, "P.C. Board Cleaning," is exhibited
at the end of this chapter. Maintenance records and schedules
are not needed for equipment such as lathes, presses, grinders,
etc., that are used in a machine shop and maintained by skilled
employees on a daily basis. Automated machining equipment will
require maintenance schedules.
The proper or optimum operation of manufacturing equipment often
requires the use of lubricants and other manufacturing materials.
The QS regulation defines "manufacturing material" as
any material or substance used in or used to facilitate the manufacturing
process, a concomitant constituent, or a byproduct constituent
produced during the manufacturing process, which is present in
or on the finished device as a residue or impurity not by design
or intent of the manufacturer [820.3(p)]. Manufacturing materials
are often used with equipment. Manufacturing materials include,
but are not limited to: mold release compounds; cleaning agents;
lubricating oils; and other substances used to facilitate manufacturing.
If any of these materials has an adverse effect on the finished
device, procedures shall be established and maintained for the
removal or at least the reduction of these manufacturing materials
to an amount that will not adversely affect the device's quality.
Manufacturing materials are specified, procured, inspected/tested,
etc., the same as components [820.3(r), 820.50, and 820.80]. For
details see Purchasing and Acceptance Activities, Chapter 10 of
this manual.
The use of manufacturing materials that may adversely affect the
finished device should be carefully analyzed. Each process should
be designed to use a minimum amount of adverse materials so as
to reduce costs, reduce removal efforts, and increase the intrinsic
safety of the device. Whether or not a manufacturing material
has been removed or adequately limited may be determined by using
either of the two general approaches below.
Section 820.70(h) requires a written procedure for the use and
removal of manufacturing materials that can have an adverse effect
on devices. Usually, the procedure used for routine cleaning of
the device and its assemblies can be used for this purpose. If
so, a special procedure is not necessary. However, when residues
from agents such as ethylene oxide should be reduced, special
instructions usually are necessary.
When manufacturing materials such as oils, mold-release compounds,
gases, cleaning agents, etc., are used on or in equipment, manufacturers
should:
Where a manufacturing material residue is not or cannot be made
safe for everyone such as for sensitized individuals, the manufacture
should meet limits set by regulation, standards, guidance, etc.
When appropriate, a caution label should be used to advise sensitized
or atopic individuals about the residue.
A sample procedure, "P.C. Board Cleaning", covering
equipment used for removing adverse manufacturing materials (flux
and debris) is exhibited at the end of this chapter. This procedure
covers the removal of flux, finger oils, debris, etc., from printed
circuit (PC) boards. In some cases, flux is an adverse manufacturing
material.
The hardware system, software program, and general quality assurance
system controls discussed below are essential in the automated
manufacture of medical devices. The systematic validation of software
and associated equipment will assure compliance with the QS regulation;
and reduce confusion, increase employee morale, reduce costs,
and improve quality. Further, proper validation will smooth the
integration of automated production and quality assurance equipment
into manufacturing operations.
Medical devices and the manufacturing processes used to produce
them vary from the simple to the very complex. Thus, the QS regulation
needs to be and is a flexible quality system. This flexibility
is valuable as more device manufacturers move to automated production,
test/inspection, and record-keeping systems.
The QS regulation requires in 820.70(i) that software programs
be validated for their intended use according to an established
protocol when computers are used as part of an automated production
or a part of the quality system. Software used in automated production
and quality systems consists of programs or codes that cause computerized
equipment to perform desired tasks, plus operator manuals and
instructions. FDA has drafted an information document, "Application
of the Medical Device GMPs to Computerized Devices and Manufacturing
Processes," which is reprinted in the Appendix. Also, a document
entitled, "Reviewer Guidance For Computer Controlled Medical
Devices Undergoing 510(k) Review," is available from DSMA.
Both of these documents can be used with the QS regulation to
help establish a software QA and validation program.
There are also standards, books, and articles that can be used
for guidance. Military Specification MIL-S52779A and the
Institute of Electrical and Electronic Engineers (IEEE) "Standard
for Software Quality Assurance Plan" (IEEE Std 7301984)
are examples. Manufacturers, however, should not rely completely
on such documents, but should examine their software needs and
develop whatever controls are necessary to assure software is
adequate for its intended use.
The device manufacturer should identify individuals or departments
responsible for software quality and clearly specify their responsibilities.
These individuals and/or department personnel should have sufficient
training, authority, responsibility, and freedom of action to
specify and evaluate the design and use of software and associated
equipment.
A manufacturer probably will experience problems if employees
operating the automated system or inputting data do not have adequate
background and/or training. Employees should have adequate knowledge
of the system through both formal training and on-the-job experience.
Those responsible for data input should be able to recognize data
errors (820.25). The QS regulation requires that processes be
controlled (820.70). Thus, automated systems should be designed
[820.70(a)] and employees trained (820.25) to help prevent inaccurate
data input or adjustments. This requirement can be accomplished
by the aforementioned training and by software controls. Where
practical, software programs should have built-in error controls
such as prompts, alpha-only fields, numeric only fields, length
limits, range limits, and sign (+or -) control to help eliminate
mistakes during data entry. These error-control or human-factors
requirements, as appropriate, should be part of the specifications
for software being developed or purchased.
Manufacturers that develop their own process control software
shall follow the design controls in 820.30 and document each step
of the development. The software should be appropriately structured
and documented so that any future changes can be accomplished,
even by a different programmer, with a minimum of difficulty and
maximum reliability.
To validate software, it should be:
Each module or routine of the program should be verified to make
sure it performs the specified function. The main core of the
program should be checked to make certain that all parameters
are correctly initialized and that data is correctly transferred
between the routines. The input-output routines should be checked
for proper operation with the intended peripherals to the extent
feasible at this stage of the development. The testing is performed
with real or simulated input data. The input data should accurately
represent the real data that will occur in the next phase of testing.
This input data should include data at the boundaries of acceptability,
i.e., limit testing. The test protocol, data and results should
be documented. The documentation should be made available to the
party, who will evaluate the software with the automated production
or quality assurance equipment to be used in routine manufacturing.
The testing of the software with the actual medical device production
or testing equipment should exercise program functions under expected
production conditions. The testing should include the input of
normal and abnormal (limited case) data to test program performance
and error handling. The validation should assure that the software
and associated equipment meet the company specifications. The
test protocol, testing, results, and design review should be documented
in the design history file. Procedures for use and maintenance
of the equipment and acceptance of the output product are documented
in the device master record. Any serious deficiencies should be
corrected.
When an outside contractor is engaged to develop software, the
device manufacturer should make sure that the contractor clearly
understands the software requirements and translates them into
documented specifications with sufficient objectivity that compliance
can be measured. FDA recognizes that most of the validation may
be done by the contractor, however, the device manufacturer is
still responsible for the adequacy and the validation of the software
for its intended use. Therefore, the contractor should be required
to develop the software according to a quality system plan that
includes validation.
When possible, the purchaser also should conduct pre-award audits
to verify adequacy of the contractor's quality system. Two key
elements that should be checked are the contractor's test plans
and system for controlling changes to documentation. Subsequent
audits should be conducted as needed to verify that the contractor
is complying with the quality system plan. The manufacturer who
has custom software prepared and validated by a contractor should
ensure the software program is running properly and producing
correct results before using the program to produce medical devices
for distribution.
Manufacturers who purchase commercial equipment with incorporated
software should validate the software and associated equipment
for the intended applications. If, however, the software has been
validated by the developer and proven through use, the purchaser
need not test it as comprehensively as new software. For example,
automated production and test equipment that is controlled by
software can usually be validated through use of a "dummy"
device. This "dummy" device should exercise functions
and decisions in normal and limit-case situations that may reasonably
be expected during production. In some cases, suppliers provide
test programs that may be used to assure that the equipment will
appropriately and accurately perform all intended functions before
it is used for routine production.
Validated, automated machine tools such as lathes, printed-circuit
drills, and component inserters usually can be monitored and maintained
by conducting a first and last-piece inspection of representative
product lots. The record of this activity may be noted on the
routine quality control or production records for the machine.
Validation of complex microprocessor-controlled equipment, such
as sterilizers or to verify satisfactory operation is generally
a more extensive activity than the validation of machine tools.
Typically, verification should be done by using calibrated measurement
instruments to check the actual parameters achieved during trial
runs, and comparing these measurements with the set points and
data outputs of the automated system. In all cases, under the
QS regulation the user is responsible for:
Validation records [820.70(i)] for software and automated equipment
can be maintained by the user in the design history file [820.30(j)],
the device history record [820.184], or the quality system record
[820.186], depending on what works best for the manufacturer.
Specifications for the hardware and software including directions
for their use, if any, shall be included or referenced in the
device master record [820.181]. The device master record [820.3(j)],
as explained in Chapter 8, is a compilation of records containing
procedures and specifications for a finished device. The device
master record (DMR) contains or references the records covering
the use of the equipment and the specifications of the output
product. Upon request, these records shall be made available to
FDA investigators for review and copying during their audit [820.180]
of the manufacturer's GMP system.
All changes to software programs shall be formally reviewed and
approved before implementation [820.30, 820.70 and 820.40]. Because
changes in one part of software can affect other parts of software,
adequate consideration should be given to side-effects of these
changes. Such changes are much easier to make and evaluate when
the original software is appropriately structured and thoroughly
documented.
In addition to aiding the production of devices, computers may
be used to collect and maintain quality control and production
records. These records are called the device history record in
the QS regulation. A device history record [820.3(i)] is a compilation
of records containing the production history of a finished device.
When design history files, device history records, device master
records, or quality system records are maintained by computer,
appropriate controls should be used to assure that data is entered
accurately, changes are instituted only by authorized personnel,
and records are secure. Hard copy or alternative systems such
as backups [820.180], duplicates, tapes, or microfilm should also
be used to avoid losing records as a result of inadvertent erasure
or other catastrophe. As appropriate, access to records and data
bases should be restricted to designated individuals.
The increased use of computers and related input/output peripherals
has affected FDA policy regarding GMP signature requirements.
In response to the use of electronic technology, FDA has issued
an advisory opinion stating that magnetically coded badges or
other computer-compatible identifiers may be used in lieu of signatures
as long as there are adequate controls to prevent inaccurate data
input. If coded badges and the like are not controlled (i.e.,
not restricted to designated employees), they will not meet the
applicable GMP requirements.
Manufacturers may wish to keep appropriate records such as device
master records and complaint files at central or corporate offices.
If the overall data handling system is controlled as stated above,
manufacturers may maintain appropriate quality system records
at central locations if they can transmit these records to the
manufacturing establishment by computer plus modem, or other high
speed data transfer system.
Automated equipment and any peripheral equipment requiring maintenance
and/or calibration shall be included in a formal calibration and
maintenance program [820.72]. Also, environmental factors suchas temperature, humidity, contamination, static electricity, magnetic
fields, and power-supply fluctuations can adversely affect automated
equipment and data storage equipment such as magnetic discs, tapes,
optical systems, etc. Consequently, necessary precautions, environmental
controls, and maintenance programs [820.70] shall be implemented
to prevent adverse effects on the equipment and stored data.
During the quality system audit [820.22], manufacturers shall
audit the use and control of their automated production and quality
systems. The audit should include software and equipment maintenance
procedures and records, and should evaluate the adequacy of security
measures, change controls, and other controls necessary to maintain
software quality and proper performance of associated equipment.
The audit shall be documented, important results reviewed with
management, and corrective action taken as appropriate.
The QS regulation is intended to help assure that devices will
be safe, effective, and in compliance with the FD&C Act. To
support this goal, each medical device manufacturer should develop
and implement a quality system that assures, with a high degree
of confidence, that all finished devices meet the company's device
master record specifications. These specifications should, in
turn, reflect the company quality claims. Section 501(c) of the
FD&C Act states a device shall be deemed to be adulterated
if its strength differs from, or its purity or quality falls below,
that which it purports (claims). Such assurance is obtained by
many activities including the measurement of component, device,
and process parameters during design and production. These measurements
shall be made with appropriate and calibrated equipment as required
by 820.72.
Each manufacturer should assure that production equipment and
quality assurance measurement equipment, including mechanical,
electronic, automated, chemical, or other equipment, are:
To succeed, the quality system shall include a calibration program
that is at least as stringent as that required by the QS regulation
(820.72). The intent of the GMP calibration requirements is to
assure adequate and continuous performance of measurement equipment
with respect to accuracy, precision, etc. The calibration program
implemented by a company may be as simple or as sophisticated
as required for the measurements to be made. Some instruments
need only be checked to see that their performance is within specified
limits, while others may require extensive calibration to a specification.
Manufacturers should determine which measurements are necessary
to assure that finished devices meet approved device master record
specifications, and assure these measuring instruments are included
in a calibration program. Measurement equipment should be identified
by label, tag, color code, etc., when located in the same areas
as instruments that are not part of the calibration system. Identification
can assure that proper equipment is employed to verify and determine
compliance to specification of a device component, in-process
device, or finished device.
Sometimes equipment used only for monitoring a parameter need
not be calibrated but should be identified (e.g., for monitoring).
A monitoring function might be to indicate if a voltage or other
parameter exists, but the exact value is not important.
The QS regulation requires in section 820.72(b) that equipment
be calibrated according to written procedures that include specific
directions and limits for accuracy and precision. Figure 5.1 illustrates
bias, precision, and accuracy.
Precision has no unit of measure and only indicates a relative
degree of repeatability, i.e., how closely the values within a
series of replicate measurements agree with each other. Repeatability
is the result of resolution and stability.
Bias is a measure of how closely the mean value in a series of
replicate measurements approaches the true value. The mean value
is that number attained by dividing the sum of the individual
values in a series by the total number of individual values.
Accuracy is the measure of an instrument's capability to approach
a true or absolute value. Accuracy is a function of precision
and bias. Because different manufacturers have different accuracy
requirements, each manufacturer should decide the level of accuracy
required for each measurement and provide equipment to achieve
that accuracy.
Proper and periodic calibration will assure that the selected
equipment continues to have the desired accuracy. GMP calibration
requirements are:
Remedial action includes recalibration and evaluation of the impact
of out-of-tolerance measurements:
The manufacturer should establish and maintain procedures to ensure
that purchased and otherwise received equipment and associated
supplies conform to specified requirements (820.50). The purchase
of stable and accurate measuring equipment can reduce the frequency
of calibration and increase confidence in the company's metrology
program. Where economically feasible, equipment with more accuracy
than needed for various measurements can be used longer without
recalibration than equipment that marginally meets the desired
accuracy requirements. Delicate instruments, however, that are
"pushing the state-of-the-art" should not be used for
routine measurements unless no other approach is feasible.
There are a number of sources of information from which calibration
procedures can be developed. Instrumentation manufacturers often
include calibration instructions with their instruction manuals.
Although these instructions alone are not adequate to meet the
QS requirements for a calibration procedure, they usually can
be used for the actual calibration process. In some cases, voluntary
standards exist such as those by the American Society for Testing
and Materials (ASTM), the American National Standards Institute
(ANSI), and the Institute of Electrical and Electronic Engineers
(IEEE).
Information contained in calibration procedures should be adequate
to enable qualified personnel to properly perform the calibrations.
An example of a calibration procedure for mechanical measuring
tools appears at the end of this chapter.
A typical equipment calibration procedure includes:
Managers and administrators should understand the scope, significance,
and complexity of a metrology program in order to effectively
administer it.
The selection and training of competent calibration personnel
is an important consideration in establishing an effective metrology
program. Personnel involved in calibration should ideally possess
the following qualities:
Calibration of each piece of equipment shall be documented to
include:
Many manufacturers use a system where each device has a decal
or tag which contains the date of calibration, by whom calibrated,
and date the next calibration is due. Examples of such decals
are shown below.
These decals are examples of the types commonly used to identify
the status of measuring instruments and tools. They are available
as catalog items or a manufacturer may use its own artwork to
purchase decals with specialized wording.
Calibration information is entered onto cards or forms, one for
each piece of equipment, or entered into a computerized data system.
Most data systems include the calibration date, by whom calibrated,
date recalibration is due, the reason for the calibration, comments,
address of the manufacturer and calibration laboratory, equipment
specifications, serial number, use, etc. An example of a typical
card used to record calibration information follows.
Measuring instruments should be calibrated at periodic intervals
established on the basis of stability, purpose, and degree of
usage of the equipment. Intervals between calibrations should
be shortened as required to assure prescribed accuracy as evidenced
by the results of preceding calibrations. Intervals should be
lengthened only when the results of previous calibrations indicate
that such action will not adversely affect the accuracy of the
system, i.e., the quality of the finished product.
A manufacturer should use a suitable method to remind employees
that recalibration is due. For small manufacturers, calibration
decals on the measuring equipment may be sufficient because recalibration
can be tracked by scanning the decals for the recalibration date.
For other manufacturers, a computerized system, calibration cycle
cards, tickler file, or the like may be used. Calibration cycle
cards are maintained in a 12-month (12-section) tickler file.
There is one card per item of measuring equipment. The cards in
the section of the file for the current month are pulled and all
of the equipment listed is calibrated. For example, in a 6-month
calibration cycle, when an instrument is calibrated in May, the
card is moved from the May section to the November section of
the file. When the file is checked in November, the cycle card
will be there to remind the manufacturer that calibration is due.
The process is repeated until an event such as instrument wear-out
occurs and the respective cycle card is removed from the file.
Cycle cards are used where a manufacturer has many instruments
to be calibrated. It would be rather difficult to keep track of
the calibration of a large number of instruments by reviewing
calibration record cards or scanning the decal on each instrument.
It is easier to use a cycle card file. A cycle card file or equivalent
also should be used if the calibration records are filed by type
of instrument or manufacturer rather than due date. A typical
cycle card follows. The "calibration card number" blank
refers to the calibration record card for the same item of equipment.
CALIBRATION CYCLE CARD FORM NO. 5-15
MANUFACTURER:
INSTRUMENT:
MODEL NO.SERIAL NO.
CALIBRATION INTERVAL:
LOCATION OF EQUIPMENT: CALIBRATION CARD NO. |
Where practical, the QS regulation requires that standards used
to calibrate equipment be traceable to the National Institute
of Standards and Technology (NIST), or other recognized national
or international standards. Traceability also can be achieved
through a contract calibration laboratory which in turn uses NIST
services.
The meaning of traceability to NIST is not always self-evident.
Two general methods commonly used to establish and maintain traceability
to NIST are:
Information can be obtained from the "Catalog of NIST Standard Reference Materials," available free from the National Institute of Standards and Technology, Office of Standard Reference Materials,
Gaithersburg, MD 20899, phone: (301)975-2016.
When in-house standards are used, they should be fully described
in the device master record or quality system record. Independent
or in-house standards should be given appropriate care and maintenance
and should be used according to a written procedure as is required
for other calibration activities. FDA recommends that at least
two in-house standards be maintained -- one for routine use and
one for a back up.
As appropriate, environmental controls should be established and
monitored to assure that measuring instruments are calibrated
and used in an environment that will not adversely effect the
accuracy required. Consideration should be given to the effects
of temperature, humidity, vibration, and cleanliness when purchasing,
using, calibrating, and storing instruments.
The calibration program shall be included in the quality system
audits required by the QS regulation. These audits should determine
the continuing adequacy of the calibration program and assess
compliance with the program.
Many manufacturers use contract calibration laboratories to calibrate their measurement and test equipment. If this is the case, FDA views the contract laboratory as an extension of the manufacturer's GMP program or quality system. Normally FDA does not inspect contract laboratory facilities, but it does expect the manufacturer to assess the contract lab to verify that proper procedures are being used. Generally, the manufacturer of the finished device is responsiblefor assuring the device is manufactured under an acceptable quality system.
When a medical device manufacturer uses a contract calibration
laboratory, FDA expects the manufacturer to have evidence that
the equipment was calibrated according to the GMP requirements.
The device manufacturer can do this by:
Certification notes and data should include accuracy of equipment
when received by the lab to facilitate remedial action by the
finished device manufacturer, if necessary. Certification should
also include accuracy after calibration, standards used, and environmental
conditions under which the equipment was calibrated. The certification
should be signed and dated by a responsible employee of the contract
lab.
If in-house standards are used by a contractor to calibrate device-related
measuring equipment, these standards shall be documented, used,
and maintained the same as other standards.
Proper and controlled calibration can contribute to overall quality
by assuring that device design and process parameters are accurately
measured and that unacceptable items are not accepted, and acceptable
items are not rejected as a result of measurements. If the appropriate
product-quality parameters are not checked, however, calibrated
equipment will have little impact on assuring quality.
A good quality system shall include calibration activities. However,
proper calibration will be of little use unless the applications
of the measurement equipment are properly developed and qualified
during the preproduction development of inspection test methods
and procedures. As stated, effectiveness depends on the participation
and influence of QA and production management at the preproduction
stage. Calibration of equipment cannot correct poor design of
products nor can it compensate for poor applications of equipment
and techniques. It is the continued use of a complete, integrated
quality system, which assures that safe and effective devices
are produced.
Examples of calibration cards, decals, and cycle cards were presented
above in the text. Examples of a device cleaning procedure and
a calibration procedure follow. Manufacturers may use these as
presented if they match the manufacturers operations; or may modify
them to meet specific requirements.
This procedure covers the cleaning of printed circuit boards by
using an automatic washer. The procedure covers operation, shut
down, cleaning, and routine maintenance.
This is a calibration procedure for mechanical measuring tools.
In actual use, the initial accuracy of each tool is checked using
the procedure and is recorded. Thereafter, each tool is recalibrated
(checked) versus the initial accuracy. Of course, the initial
accuracy should meet or exceed the requirements of the measurements
to be made with the tool. Precision is checked by making several
measurements at various points on the tool's measuring face (surface).
TITLE: P.C. Board Cleaning___________________ NO: ______________________________
REV: _______________________________________________________________ Sheet: 1 of 2
DRAFT: __________________________ APP: ________________________
DATE: _______
1.0 PURPOSE: The purpose of this procedure is to document production
operations performed on the XXXXXX printed circuit board washer.
2.0 SCOPE: This procedure sequentially identifies all operations
necessary to properly operate and maintain this equipment.
3.0 OPERATING PROCEDURES:
3.0.1 Switch the Exhaust Systems fan on.
3.0.2 Assure that the sump pump is on at the circuit breaker panel.
3.1 Turn the power switch to the "ON" position.
3.2 Push the main power "START" button (#21 on Control
Panel Diagram).
3.3 Visually inspect all pump compartment and screen filters for
debris - make sure they are clean before continuing.
3.4 Push the fill buttons on the rear control panel to fill the
wash and rinse sections with water. Make sure all drain lines
are closed. The incoming water will stop automatically when the
tanks are filled to the correct levels.
3.4.1 Add 4 gallons XXXXXX detergent to the wash tank.
3.5 Depress the center knob on the temperature controllers (#30
on control panel diagram) and turn clockwise until the red pointer
indicates 60°C (140°F)
for the wash tank and 60° C (140°F)
for the rinse tank.
3.6 Wait about 10 min. for water temperature to rise in the wash
and rinse tanks. Wait until the red lights on the temperature
controllers go off and the black needle aligns with the red pointer.
3.7 Push the START-STOP button (#25 on diagram) on for the conveyer.
3.7.1 Adjust the "SPEED CONTROL" (#27 on diagram) to
the correct setting for the boards to be run. See the cleaning
specifications for each family of boards for the set points.
3.8 Push the "START" button (#28 on diagram) on for
the dryer cycle. NOTE: conveyer belt MUST be moving when dryer
section is on or the equipment will be damaged.
3.9 Turn Photocell Switch (on Rear Panel) to the "Automatic"
position.
Sheet 2 of 2
4.0 SHUT DOWN PROCEDURES:
4.1 Push the dryer cycle "STOP" button for the Wash
and Rinse sections (#29 on control panel).
4.2 Turn Photocell Switch (on Rear Panel) to the "OFF"
position.
4.3 Push the conveyer "START - STOP" button (#25 on
diagram) to stop the conveyer.
4.4 Pull the DRAIN buttons on the control panel for the wash and
rinse sections. Using litmus paper, take a reading on the wash
tank before draining it. IF the wash water has a reading of "10"
or less drain it; otherwise, do not drain the wash tank. Always
drain the rinse tank.
4.5P Pull the FILL buttons on the control panel for the wash and
rinse sections to let water flush the equipment for five minutes.
Using a soft cloth, wipe off any residue remaining on the equipment.
4.6 Pull the drain buttons on the control panel for the wash and
rinse sections to let the water drain.
4.7 Remove the screen filter in the washer and remove any debris.
4.8 Wipe the exterior front section of the machine with a soft
cloth.
4.9 Push the main power "STOP" button, (#33) to shut
off the equipment.
5.0 MAINTENANCE:
5.1 Monthly
5.1.1 Lubricate the conveyer drive chain with high temperature
grease.
5.1.2 Check the wear strips on the conveyer belt frame and replace
if required. These are two white plastic strips located at the
front of the equipment.
5.1.3 Check conveyer belt tightness - using a wire cutter and
needle nose pliers, remove links to tighten if required.
5.2 Quarterly
5.2.1 Shut off power in main panel at rear of equipment.
5.2.2 Lubricate pump motor ball bearing using standard bearing
grease.
5.2.3 Lubricate flange bearings on conveyer shafts with bearing
grease.
5.2.4 Check all wiring for loose connections and tighten if necessary.
5.2.5 Check all heater contacts - replace worn contacts.
Sheet 1 of 1
TITLE: Calibration Procedures for Mechanical Measuring Tools No.________ Rev.________
ECN Notes ________________________________________________________________________ ______________________________________________________________________________
Drafted by ____________________________________ App. _______________
Date ___________
PURPOSE: This procedure establishes a standard method for
the calibration and maintenance of mechanical measuring tools
such as micrometers, calipers, etc.
SCOPE: All measuring tools used to set specifications or
measure conformance to specifications, such as micrometers, calipers,
etc., will be included in the calibration program. Each tool will
be assigned a number and checked every six months for accuracy.
If you suspect a tool is damaged or out of calibration, it should
be removed from service and brought to the Quality Control Lab
(QC) for checking. To enter a tool in the program, take it to
QC where a number will be assigned and initial accuracy checked
and recorded.
PROCEDURE:
1. Each measuring tool shall be kept clean and maintained in a
protective container. As needed, all threads and slides shall
be lubricated with a fine tool oil to assure free movement.
2. The calibration shall be done by a comparison to standard gage
blocks traceable to the National Institute of Standards and Technology
standard with an accuracy 3 to 10 times greater than that of the
measuring tool.
3. The comparisons shall be made at different points along the
measuring range of the tool. The gage blocks used shall be picked
at random to assure that the measuring tool is not checked at
the same points on each calibration cycle. When a measurement
is made, move the gage blocks from one side of the tool's measuring
face to the other on an X/Y axis to assure no wear or taper exists
on the measuring faces.
4. Measurement tools not intended for testing or manufacturing
do not require calibration in accordance with the QS regulation.
These tools should be kept out of manufacturing or labeled to
avoid inadvertent use. Otherwise, they should be entered in this
calibration program.
5. After calibration, the date of calibration and the next due
date of calibration shall be recorded on the Calibration Form
No. _______. Any adjustments and/or repairs to be recorded. The
form is placed in the tickler file according to the next calibration
date.
6. If a tool is found to be out of calibration, the QC lab will
immediately pass the out-of-calibration information to the appropriate
supervisor in the department where the tool is used. The Department
and QC management will take appropriate remedial action for affected
in-process or finished devices.
Updated January 1, 1997
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