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

INTRODUCTION
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.
EQUIPMENT GMP CONTROLS
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)].
Maintenance
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:

have a written schedule for performing these activities;

where adjustment is necessary to maintain proper operation, post the inherent limitations and allowable
tolerances of the equipment or make these readily available to personnel responsible for making the
adjustments;

document the maintenance activities including the date and individual(s) performing the maintenance
activity and the date and individual(s) conducting the inspections;

have procedures for conducting periodic inspections to assure adherence to maintenance schedules;
and,

audit the activities and document the inspection.

Records
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.
MANUFACTURING MATERIALS

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.
Analyze Use
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.

The adverse material may be measured directly and compared to the process specification.

If feasible, the component, in-process device, or finished device may be tested against its specification.
If the item passes, it follows that the residue is not affecting the performance. The test specification
should be appropriate for this method of evaluating residues and may need to include tests for toxicity,
pyrogens, material compatibility, etc.

Control Use
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:

provide written procedures for the use and removal of materials; and
remove the material or limit it to a safe amount;
document the removal.

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.
AUTOMATED PRODUCTION AND QA SYSTEMS
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.
Software Validation Guidances
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-S
52779A and the Institute of Electrical and Electronic Engineers (IEEE) "Standard for Software Quality
Assurance Plan" (IEEE Std 730 1984) 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.
Employee Responsibility and Training
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.
Formal Development of Software
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:

structured, documented and verified as it is developed;

checked to make sure that it meets specifications;
adequately tested with the assigned hardware systems; and

operated under varied conditions by the intended operators or persons of like training to assure that it
will perform consistently and correctly.

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.
Commercial Software and Equipment
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.
Validation of Automated Equipment and Processes
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:

assuring the adequacy of automated equipment and software;

verifying that all intended functions will be correctly and reliably performed; and
maintaining appropriate records.

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.
Automated Data Collection and Processing
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.
Equipment Controls and Audits
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.
MEASURING EQUIPMENT CALIBRATION
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:

suitable for the intended use in the design, manufacture, and testing of components, in-process devices
and finished devices;

capable of producing valid results;

operated by trained employees; and

properly calibrated versus a suitable standard.

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, inprocess 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.
Calibration Requirements
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.

Figure 5.1 Bias, Precision and Accuracy

Proper and periodic calibration will assure that the selected equipment continues to have the desired accuracy.
GMP calibration requirements are:

routine calibration according to written procedures;

documentation of the calibration of each piece of equipment requiring calibration;

specification of accuracy and precision limits;

training of calibration personnel;

use of standards traceable to the National Institute of Standards and Technology (NIST), other
recognizable standards, or when necessary, in-house standards; and

provisions for remedial action to evaluate whether there was any adverse effect on the device's quality.

Remedial action includes recalibration and evaluation of the impact of out-of-tolerance measurements:

on the device design or process validation parameters or data;

on the quality of existing components, in-process, or finished devices; and
appropriate corrective action.

Equipment Selection
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.
Procedures
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:

purpose and scope;

frequency of calibration;
equipment and standards required;
limits for accuracy and precision;
preliminary examinations and operations;
calibration process description;
remedial action for product; and
documentation requirements.

Management of Metrology
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:

technical education and experience in the area of job assignment;

basic knowledge of metrology and calibration concepts;

an understanding of basic principles of measurement disciplines, data processing steps, and

acceptance requirements;

knowledge of the overall calibration program;

ability to follow instructions regarding the maintenance and use of measurement equipment and
standards; and

mental attitude which results in safe, careful, and exacting execution of his or her duties.

Calibration Records
Calibration of each piece of equipment shall be documented to include:

equipment identification,
the calibration date,
the calibrator, and
the date the next calibration is due.

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.

Schedules
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.

Standards
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:

NIST calibration of standards or instruments: When this method is used, private standards are
physically sent to NIST for calibration and returned.

Standard Reference Materials (SRM's): NIST provides reference materials to be used in a user's
calibration program. These SRM's are widely used in the chemical, biological, medical, and
environmental fields.

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.
Calibration Environment
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.

AUDIT OF CALIBRATION SYSTEM

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:

requiring and receiving certification that the equipment was calibrated under controlled conditions using
traceable standards;

maintaining an adequate calibration schedule;

maintaining records of calibration; or

periodically auditing the contractor to assure appropriate and adequate GMP procedures are being
followed. For example, the contractor should have:

written calibration procedures;

records of calibration;
trained calibration personnel; and
standards traceable to NIST or other independent reproducible standards.

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.
INTEGRATING MEASUREMENTS INTO THE QA SYSTEM
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.

EXHIBITS
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.
P.C. Board Cleaning
This procedure covers the cleaning of printed circuit boards by using an automatic washer. The procedure
covers operation, shut down, cleaning, and routine maintenance.
Calibration Procedures for Mechanical Measuring Tools
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 1/1/1997