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820.200
Servicing.
(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
must be reported to FDA under part 803 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. [61 FR 52654,
Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004] Interpretation:
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 PERSONNEL 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. SERVICE REQUIREMENTS 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. INSTALLATION 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. CONTRACT SERVICE 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
SERVICE EQUIPMENT 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. SERVICE PROCEDURES 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:
ACCEPTANCE STATUS 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 REPORTS 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:
SERVICE REPORT ANALYSIS 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. COMPLAINTS 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. Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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