FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
| FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
16 SERVICING
INTRODUCTION
Interfaces
SERVICE PERSONNEL
SERVICE REQUIREMENTS
INSTALLATION
CONTRACT SERVICE
SERVICE EQUIPMENT
SERVICE PROCEDURES
ACCEPTANCE STATUS
SERVICE REPORTS
SERVICE REPORT ANALYSIS
Parts Shipping Trends
COMPLAINTS
CORRECTIVE AND PREVENTIVE ACTION
EXHIBIT
The requirements in the Quality System (QS) regulation govern
the methods used in, and the facilities and controls used for,
the design, manufacture, packaging, labeling, storage, installation,
and servicing of all finished devices intended for human
use. Servicing covers the maintenance and repair of finished,
distributed devices.
The intent of the quality system regulation is to assure that
servicing is correctly performed and verified according to company
specified requirements such that the serviced device is suitable
for the intended use and that service information is collected
and analyzed to help correct any quality system problems and device
design, manufacturing, labeling, or packaging problems.
The basic servicing requirements are in 820.200, Servicing. However,
there are related requirements throughout the QS regulation. For
example, service procedures are documented per 820.181, Device
Master Record; and servicing activities and/or data may lead to
complaint analysis per 820.198, Complaint Files, or require corrective
and preventive action per 820.100.
When a finished device manufacturer contracts with another supplier
to perform their servicing, such service (or service contractor)
must meet the applicable purchasing and servicing requirements
in the QS regulation.
Interfaces
There are interface requirements in the QS regulation that apply
to service functions. Section 820.30(b), Design and Development
Planning, requires that each manufacturer shall establish and
maintain plans that describe or reference the design and development
activities and define responsibility for implementation. The plans
shall identify and describe the interfaces with different
groups or activities that provide, or result in, input to the
design and development process.
The preamble clarifies the fact that these requirements extend
to service functions by stating: the plan shall identify and describe
the interfaces with different groups or activities that
provide, or result in, input to the design process. Many organization
functions, both inside and outside the design group, may contribute
to the design process. For example, interfaces with marketing,
purchasing, regulatory affairs, manufacturing, service groups,
or information systems may be necessary during the design development
phase. To function effectively, the design plan should establish
the roles of these groups in the design process and describe the
information that should be received and transmitted.
Therefore, for medical devices that require servicing, during
appropriate activities such as design input and design reviews,
service requirements and ease of service should be considered;
and service managers, senior service technicians, etc., may need
to participate in these design functions. Such participation may
reduce the:
Reducing the time for repairs and the need for special tools usually
reduces production assembly time and manufacturing costs.
Service shall be conducted by appropriately trained and experienced
service personnel (820.25) in order to:
The repair diagnosis should also try to determine, and/or provide
adequate data to assist analysts in determining, the actual failure
mechanism to the objective level necessary to correct or reduce
the problem.
Thus, service personnel must be trained to adequately perform
their assigned maintenance, repair, and reporting responsibilities.
Such training shall be documented (820.25). The training is also
performed in accordance with the instructions and procedures established
under 820.200 for performing and verifying that servicing meets
the specified requirements. Because servicing must be verified,
service personnel must be made aware of defects and errors that
may be encountered as part of their job functions (820.25). This
training requirement usually does not require separate or additional
training because basic training to perform repairs emphasizes
the identification of defects and errors.
The QS regulation does not require that a manufacturer service
a device. The decision to service or have their devices serviced
is left to the manufacturer. When a manufacturer specifies that
they will perform service or contract to have service performed,
such service must meet all of the applicable QS regulation requirements.
Such a manufacturer shall establish and maintain instructions
and procedures for performing and verifying that the servicing
meets the manufacturers specified requirements. Section 820.200,
Servicing, states:
(a) Where servicing is a specified requirement, each manufacturer
shall establish and maintain instructions and procedures for performing
and verifying that the servicing meets the specified requirements.
(b) Each manufacturer shall analyze service reports with appropriate
statistical methodology in accordance with 820.100.
(c) Each manufacturer who receives a service report that represents
an event which requires reporting to FDA under part 803 or 804
of this chapter shall automatically consider the report a complaint
and shall process it in accordance with the requirements of 820.198.
(d) Service reports shall be documented and shall include:
(1) The name of the device serviced;
(2) Any device identification(s) and control number(s) used;
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspection data.
Where service and installation are required by a manufacturer,
both of these product activities are related and so are the QS
requirements for both. Section 820.170 Installation states:
(a) Each manufacturer of a device requiring installation shall
establish and maintain adequate installation and inspection instructions,
and where appropriate test procedures. Instructions and procedures
shall include directions for ensuring proper installation so that
the device will perform as intended after installation. The manufacturer
shall distribute the instructions and procedures with the device
or otherwise make them available to the person(s) installing the
device.
(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.
Some manufacturers use their service department or a service contractor
to install their medical devices. Servicing may also include re-installing
a device. As shown in Table 16.1, Comparison Of Servicing And
Installation Requirements, the QS requirements for installation
in 820.170 essentially parallel the requirements for service in
section 820.200. For example, The QS regulation includes detail
of the reporting requirements for servicing; for installation,
the manufacturer chooses the information to document. However,
from a practical viewpoint, each manufacturer would choose to
have the same information documented. Thus, as appropriate, a
manufacturer may combine most of their service and installation
QS activities.
When a finished device manufacturer contracts with another supplier
to perform their servicing, such service (or service contractor)
must be obtained per the applicable requirements in 820.50, Purchasing.
Each manufacturer shall establish and maintain procedures to ensure
that all purchased or otherwise received services conform to specified
requirements. Each manufacturer shall establish and maintain the
requirements, including quality requirements, that are to be met
by contractors. Each manufacturer shall:
(1) Evaluate and select potential contractors on the basis of
their ability to meet specified requirements, including quality
requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over
the contractors based on the evaluation results.
(3) Establish and maintain records of acceptable contractors.
Each manufacturer shall establish and maintain data that clearly
describe or reference the specified service requirements, including
quality requirements. Purchasing data shall be approved in accordance
with 820.40.
A major portion of the purchasing requirements are met when the
manufacturer meets the servicing requirements in section 820.200(a)
which states:
(a) Where servicing is a specified requirement, each manufacturer
shall establish and maintain instructions and procedures for performing
and verifying that the servicing meets the specified requirements....
That is, these specified requirements, service instructions and
procedures, and device verification procedures may be used together
with other information such as the finished device description
to help show a prospective contractor the scope and expected quality
of the servicing that is being contracted.
Table 16.1 COMPARISON OF SERVICING AND INSTALLATION REQUIREMENTS
| SERVICING | INSTALLATION |
| (a) ... establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements. | (a) ... establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. |
| (a) .... and verifying that the servicing meets the specified requirements. | (a) Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. (b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and ... |
| (b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100. | |
| (a) ... establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements. | (a) ... The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device. |
| (d) Service reports shall be documented and shall include: (1) The name of the device serviced; (2) Any device identification(s) and control number(s) used; (3) The date of service; (4) The individual(s) servicing the device; (5) The service performed; and (6) The test and inspection data. | (b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation. |
| (c) Each manufacturer who receives a service report that represents an event which requires reporting to FDA under part 803 or 804 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of 820.198. |
Section 820.20(b)(2) Resources requires each manufacturer
to provide adequate resources, including the assignment of trained
personnel, for management, performance of work, and assessment
activities to meet the requirements of this part. As appropriate,
adequate resources include service instructions, service procedures,
supporting DMR drawings, and service equipment. Service equipment
includes equipment to perform the repair and to verify the proper
performance of the serviced devices. Service equipment may include
complex apparatus; however, it also includes any simple jigs,
test cables, special hand tools, etc., as needed to meet the service
needs of specific medical devices.
Servicing and Installation both require verifying that the device
meets acceptance criteria. Therefore, appropriate and calibrated
test equipment should be used. Section 820.72, Inspection, Measuring,
and Test Equipment, requires that each manufacturer to ensure
that all inspection, measuring, and test equipment, including
mechanical, automated, or electronic inspection and test equipment,
is suitable for its intended purposes and is capable of producing
valid results. Each manufacturer shall establish and maintain
procedures to ensure that equipment is routinely calibrated, inspected,
checked, and maintained. The procedures shall include provisions
for handling, preservation, and storage of equipment, so that
its accuracy and fitness for use are maintained.
When establishing service and installation procedures, each manufacturer
needs to comply with the Inspection, Measuring, and Test Equipment
requirements, as appropriate, in order to assure that the serviced/installed
device performs as intended. For example, a manufacturer may need
to determine which service equipment, if any, needs to be calibrated
in a laboratory and which, if any, may be calibrated using the
self-contained internal calibrators. Also, the manufacturer may
need to select equipment that is capable of producing valid results
after being subjected to repetitive and demanding service.
If any are required, maintenance needs, schedules, and procedures
are developed as part of the device design program. Some preventive
maintenance tasks and their schedules may result from reliability
studies performed during design development.
Repair procedures are based in part on design verification and
finished device test and inspection procedures, production procedures,
and rework procedures. Other aspects of repair procedures are
developed by qualified technical personnel and senior repair technicians.
The development of procedures may involve inserting failures or
defects and having another person find and repair them. The problems,
discovery methods, and rework techniques are documented.
For redesigns, existing maintenance and/or repair procedures that
are known to be current and correct may be referenced in the new
service procedures or these may be renumbered and copied into
the new procedures.
Identifying defective subassemblies or modules in the device and
replacing them with good modules is a common servicing practice.
The defective assembly is discarded, sent to be investigated,
or is repaired at a designated facility with the necessary environmental
conditions and facilities; test equipment and tools; component
availability; trained rework employees; etc. This approach should
also be covered by appropriate procedures.
The development of service procedures includes the development
of appropriate service reporting forms.
Service instructions and procedures must be documented per 820.40.
They are part of the device master record (DMR). Typical DMR documents
(820.181) that are needed for service or that may be modified
for service include:
These DMR documents usually cover:
Each manufacturer shall identify by suitable means the acceptance
status of devices to indicate whether it has been service and
whether it conforms with the acceptance criteria. The conformance
is determined by the procedures established in accordance with
820.200(a).
The identification of acceptance status shall be maintained throughout
servicing of the device to ensure that only devices which
have passed the required acceptance activities are distributed,
used, or installed (820.86). Identification is usually done by
appropriate information on a decal, tag, or an attached pouch
that contains the service request and/or report.
If a decal is left on the serviced device, for the next request
and service, the decal can provide immediate information about
the last service date, etc.
Service activities shall be documented by service personnel and
sent to the manufacturer according to the manufacturer's established
procedures. As mentioned, service reports shall include:
(1) the name of the device serviced;
(2) any device identification(s) and control number(s) used;
(3) the date of service;
(4) the individual(s) servicing the device;
(5) the service performed; and
(6) the test and inspection data.
The device identification should be specific regarding the revision
level, modification version, software version, etc., of the device
in order to support analysis of the service data.
The test and inspection data should verify that the servicing
meets the manufacturer's specified requirements. That is, the
serviced device did, or did not, meet the acceptance criteria.
(See Acceptance Criteria below.)
The service reports should also include information such as:
Each manufacturer that performs servicing shall analyze service
reports with appropriate statistical methodology in accordance
with 820.100, Corrective and Preventive Action, which requires
manufacturers to establish and maintain procedures for implementing
corrective and preventive action. The procedures shall include
requirements for analyzing service records and other sources
of quality data to identify existing and potential causes of nonconforming
product or other quality problems. The primary intent is to identify
the action(s) needed to correct and prevent recurrence of nonconforming
product and other quality problems; and to verify or validate
the corrective and preventive action to ensure that such action
is effective and does not adversely affect the finished device.
Failure and service report analysis should be conducted by appropriately
trained and experienced personnel (820.25). Such personnel are
also one of the resource requirements in 820.20(b)(2).
The analysis of service reports or subsequent analysis of the
same or equivalent device(s) should be designed to determine the
actual failure mechanism or quality problem to the objective level
necessary to correct the problem.
When systematic failure has been diagnosed and corrective action
established, a manufacturer need not analyze all additional devices
that are serviced or returned with the same symptoms.
The analysis of service reports is totally dependent on the quality
of the data in the reports. Therefore, it is very important that
service training cover reporting so that the resulting reports
are correct, complete, understandable, and easy to analyze.
The service reports for routine service requests for maintenance,
adjustment, or repair of damage or failure resulting from long
use, misuse or accident, usually do not need the same level of
analysis as for other failures. However, some requests for service
may appear to be routine when, in fact, they may be for unusual
conditions that warrant attention. For example, service requests
because of rapid wear, unusual problems, unusual maintenance,
or development of hazardous conditions should receive a complete
analysis in order to determine if corrective action is needed
in the preventive maintenance procedures, design, labeling, manufacturing
processes, etc. Enough information should be obtained from the
customer to determine whether the request is for routine maintenance
or the device is to be serviced for other reasons.
Parts Shipping Trends
As appropriate manufacturers should periodically (e.g., monthly)
examine shipping records for repair parts. Any increases in shipment
of specific parts due to unknown reasons should be analyzed to
determine if a significant failure problem exists. Manufacturers
have identified quality problems by this simple, low-cost technique.
Service requests for repairing or investigating an event that
allegedly resulted in a death or serious injury shall also be
investigated as a complaint. Section 820.200(c) requires that
each manufacturer who receives a service report that represents
an event which requires reporting [Medical Device Reporting (MDR)]
to FDA under part 803 or 804 of this chapter shall automatically
consider the report a complaint and shall process it in accordance
with the requirements of 820.198.
Section 820.198(d) requires that any complaint that represents
an event which must be reported to FDA under part 803 or 804 of
this chapter shall be promptly reviewed, evaluated, and investigated
by a designated individual(s) and shall be maintained in a separate
portion of the complaint files or otherwise clearly identified.
In addition to the information required by 820.198(e), records
of investigation under this paragraph shall include a determination
of:
(1) whether the device failed to meet specifications;
(2) whether the device was being used for treatment or diagnosis; and
(3) the relationship, if any, of the device to the reported incident
or adverse event.
Because of the MDR and complaint relationship, manufacturers should
have the service personnel collect as much as is possible of the
information required to complete the records of investigation,
steps 1 - 3 listed above. Thus, the service form for some devices
may need blanks/areas to support the collection of the needed
information.
The service requirements AND complaint requirements shall be met
for such combination service/MDR/complaint events. If the death
or serious injury was caused by a design error, it may not be
possible to perform a repair.
CORRECTIVE AND PREVENTIVE ACTION
A major intent of the service requirements is to look for quality
problems during servicing and analysis of service data, and, if
problems are found that affect or could affect safety or performance,
to mandate appropriate corrective action. Thus, the collection
(820.200) and analysis (820.100) of servicing data are required
and these are part of the quality feedback system. Without the
feedback provided by the quality audit and other information sources,
such as complaints and service records, manufacturers operate
in an open loop system with no assurance that the process used
to design and produce devices is operating in a state of control.
Section 820.100, Corrective and Preventive Action, requires the
analysis of quality records, service records, complaints, returned
product, and other sources of quality data to identify existing
and potential causes of nonconforming product, or other quality
problems. Appropriate statistical methodology shall be employed
where necessary to detect recurring quality problems.
In-warranty or out-of-warranty are not factors to be considered
when collecting or analyzing data regarding servicing.
When nonconformities are found they are to be investigated to
determine the cause, such as an inadequate quality system or a
defect in the design, component(s), assembly, processing, labeling,
packaging, installation method, service technique, etc.
The collection and analysis of service data should be broad based
because the root cause may be: an inappropriate component; a bad
component; early wear out; poor maintenance; compatibility; human
factors, and safety; misuse; misuse due to inadequate labeling;
poor workmanship; incorrect assembly; etc.
The investigation and corrective actions should continue until
valid actions are identified and implemented to correct and prevent
recurrence of nonconforming product and other quality problems.
If service instructions, techniques, equipment, etc., contribute
to a quality problem, make a quality problem worse, destroy valuable
data, etc., then such items are also subject to investigation
and corrective action.
An example of a service request form is included in this chapter.
This form may be modified to match individual needs as appropriate.
*** SAMPLE *** Page 1 of 2
| CUSTOMER SERVICE REQUEST | Service Report No.: | |
| Device Name: | ||
| ID/Cat. No.: | Lot Number: | |
| Any Specific Rev/Mod. #: | Date placed in use: | |
| Manufacturer/Distributor: | ||
| Account Name: | ||
| Account Address: | ||
| Phone Number: | Fax Number: | |
| Last Service Report (optional): | Date Of Last Service: | |
| Last service comments: | ||
| Technician: | Date: | |
| Device Location: | ||
| Customer Description Of Device Problem:
| ||
| Were you told that there was a serious injury or death associated with this problem?
NO YES If yes, describe relationship to incident or event. Was device being used for treatment or diagnosis? | ||
| Describe any unusual environment: | ||
| Describe any evidence of misuse: | ||
| If a repair, device problem(s) you found: | ||
| Maintenance and/or repairs performed: | ||
| Service Completed: | Service not completed: | |
| Reason Not Completed:
| ||
*** SAMPLE *** Page 2 of 2
| CUSTOMER SERVICE REQUEST | |
| In charts below, write identification code of components replaced. Write in first letter of ID code where necessary. Be SURE to put drawing number & rev. level in top row. | |
| Drawing number that shows replaced components listed below: rev. | |||
| CAP | CAP | CAP | CAP |
| RES | RES | RES | RES |
| IC | IC | IC | IC |
| TRANSISTOR | TRANSISTOR | TRANSISTOR | TRANSISTOR |
| DIODE | DIODE | DIODE | DIODE |
| BAT | LED | COIL | COIL |
| FUSE | FUSE | LAMP | LAMP |
| CABLE | CABLE | DET | DET |
| Drawing number that shows replaced components listed below: rev. | |||
| CAP | CAP | CAP | CAP |
| RES | RES | RES | RES |
| IC | IC | IC | IC |
| TRANSISTOR | TRANSISTOR | TRANSISTOR | TRANSISTOR |
| DIODE | DIODE | DIODE | DIODE |
| BAT | LED | COIL | COIL |
| FUSE | FUSE | LAMP | LAMP |
| CABLE | CABLE | DET | DET |
| Drawing number that shows replaced components listed below: rev. | |||
| CAP | CAP | CAP | CAP |
| RES | RES | RES | RES |
| IC | IC | IC | IC |
| TRANSISTOR | TRANSISTOR | TRANSISTOR | TRANSISTOR |
| DIODE | DIODE | DIODE | DIODE |
| BAT | LED | COIL | COIL |
| FUSE | FUSE | LAMP | LAMP |
| CABLE | CABLE | DET | DET |
Updated 1/1/1997
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH