7 EQUIPMENT AND CALIBRATION

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-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.

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, 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.

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