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12
PRODUCT EVALUATION
INTRODUCTION
Evaluation Specifications
CORRECTIVE AND PREVENTIVE ACTION
REPACKER/RELABELER DEVICE EVALUATION
NONCONFORMING PRODUCT
FAILURE INVESTIGATION
EXHIBITS
Portable Defibrillator Test Procedure
Test DHR of a Printed Circuit Board Assembly
Device History Record (urine plate)
Batch Production Record (XLD)
Batch Production Record (Thayer Martin)
Batch Production Record (Blank form)
Product evaluation is performed to show
with documented evidence that a component, in-process unit, or
finished device was manufactured according to the device master
record (DMR) and meets all of the acceptance criteria/acceptance
specifications in the DMR. The blank forms for recording the data
become a part of the DMR. The emphasis in this chapter is on finished
device evaluation; however, evaluation of incoming product and
in-process units is conducted according to the same type of controls
[820.80(a), 820.80(b), 820.80(c)].
The GMP requirements for finished device
evaluation are covered in section 820.80, which requires that
the manufacturer establish and maintain procedures for finished
device acceptance, to ensure that each production run, lot, or
batch of finished devices meets acceptance criteria. Finished
devices shall be held in quarantine or otherwise adequately controlled
until released. Finished devices shall not be released for distribution
until:
Manufacturers shall also identify by suitable
means the acceptance status of product, to indicate the conformance
or nonconformance of these items with acceptance criteria. The
identification of acceptance status shall be maintained throughout
manufacturing, packaging, labeling, installation, and servicing
of the product to ensure that only products which have passed
the required acceptance activities are distributed, used, or installed
(820.86).
If a manufacturer has adequate test and
inspection procedures and these are used correctly by appropriately
trained personnel, then there is a high probability that devices
released for distribution will meet the company device specifications
for acceptable product. Further, the data collected during in-process
or finished device evaluation should be appropriate, complete,
and correct. This data shows the good and bad points about the
product and specific production activities. The data may be fed
back into the quality system to identify and solve real problems
as well as to help maintain and improve the quality system.
Evaluation Specifications
In order to be assured that a device is
fit for the intended use, a manufacturer should decide which characteristics
of a device to test and/or inspect and to what detail or extent
to test and/or inspect for conformance with the device specifications.
Decisions on what to test and how to test
are made during the product and process development phase. For
example, this decision is typically based on the:
Device test and/or inspection specifications,
and test and/or inspection procedures, shall be carefully written
and shall cover all appropriate points in the device acceptance
specifications, in order to improve communication and reduce errors.
Design controls in 820.30(f) require device
developers to verify the device design. Verification requires
each manufacturer to write a test protocol and test, to the maximum
feasible extent, all parameters of each device design against
the design input specification. (The design input requirements
become the input specifications at the verification stage of the
development.) The verification test protocol includes the tests
that will be performed on production units. Therefore, the production
test procedures and some aspects of the inspection procedures
are easily derived from the verification protocol.
Before the manufacturer is ready for full
scale production, the test and inspection decisions shall be completed,
documented as test/inspection or acceptance procedures, and approved
for use. It is a violation of the FD&C Act to place inadequately
evaluated devices into commercial distribution. It is also a violation
of the quality system regulation to allow test and inspection
procedures to evolve during production, except during a highly
controlled pilot-production phase. Further, devices that are not
adequately evaluated may not meet company written or unwritten
quality claims -- manufacturers cannot bypass their responsibility
by simply not writing quality claims. Under Section 501(c) of
the FD&C Act, a device is adulterated if its purity or quality
falls below that which it purports or is represented to possess.
By the time the manufacturer is ready for
production, the device specifications shall be supported by one
or more test and inspection procedures documentation. These procedures
are part of the DMR. To reduce drafting, filing, retrieval, and
copying costs, test and inspection procedures may appear on process
and assembly documents. Combination documents are commonly used
for the fabrication and inspection/testing of subassemblies. There
may be several test and inspection documents because evaluation
may be performed at several in-process stages and at the finished
device stage.
Although the manufacturer shall establish
and maintain procedures for finished device acceptance, there
are situations where a simple data sheet or blueprint may be referred
to as the written acceptance criteria. For example, the acceptance
of a simple molded or machined component or device may be determined
by using a checklist, blueprint, or specification which specifies
finished article dimensions, flash removal, etc. In machine-shop
operations, a blueprint or engineering drawing may be used as
acceptance criteria and used to meet the quality system written
procedure requirements.
CORRECTIVE AND PREVENTIVE ACTION
GMP section 820.100 requires an analysis
of problem data, returned product, and an investigation of non-conforming
product. Also 820.198 requires an investigation of complaints
that allege a device does not meet specifications. Section 820.100
refers to analysis of processes, work operations, concessions,
quality audit reports, quality records, service records, complaints,
returned product, and other sources of quality data to identify
existing and potential causes of nonconforming or other quality
problems. Section 820.198 also involves reviewing and evaluating
complaints to determine whether or not an investigation is necessary.
All these activities and their results shall be documented.
Some devices have a specified requirement
for servicing. If this is the case, the manufacturer shall establish
and maintain instructions and procedures for performing and verifying
this servicing (820.200). The servicing reports shall also be
analyzed using 820.100, Corrective and Preventive Action; if the
servicing involves a death or serious injury, the service report
is considered to be a complaint per section 820.198, Complaint
Files, and is reported to FDA per parts 803 and 804, Medical Device
Reporting.
The significance of the device and any hazard
the defective device presents should be taken into consideration
when determining compliance with corrective and preventive action
requirements. Analysis shall be taken to the level necessary to
determine the actual failure mechanism, e.g., defective component,
incorrect raw material, erosion, composition, etc. The cause of
failure is obvious in some cases and a formal investigation may
not be needed. A record of the investigation, follow up, and conclusions
shall be made in accordance with section 820.100.
When a systematic failure has been diagnosed,
manufacturers need not analyze every device with the same diagnosed
symptoms. However, enough devices should be analyzed to clearly
establish symptoms before any assumptions are made about the cause
of failure or about corrective actions. When an investigation
results in identification of a deficiency, such as a failed component
or a design flaw, and this deficiency may exist in other product
lines, the investigation will not be effective unless it extends
to determining the effect on other product lines.
If the failure is design related, the design
shall be corrected per the design control requirements in 820.30
in order for the devices to meet company quality claims and not
be adulterated under the FD&C Act section 501(c). When a
failure is determined to be related to documentation, assembly,
processing, labeling, testing, packaging, or other manufacturing
operations, the manufacturing deficiency shall be identified,
corrected, and documented.
REPACKER/RELABELER DEVICE EVALUATION
Finished devices received by a repacker/relabeler
typically have been inspected and conform to specifications determined
by the original manufacturer except for the final packaging and/or
labeling. In most cases a repacker/relabeler would not have to
assure that the finished device as received meets performance
and configuration specifications. Finished bulk materials, such
as dental resins, in vitro diagnostics, etc. may be accepted on
the basis of a certificate of analysis for each batch.
Before releasing devices for distribution,
repackers/relabelers should assure that devices are properly labeled
(see chapter 11) and packaged (integrity, contents, etc., also
see chapter 13). Often this can be accomplished using a list,
illustration, or a model. When the packaged product will be sterilized
or aseptically filled, written instructions and inspection/testing
are necessary. Final acceptance of repacked/relabeled devices
shall be recorded in accordance with 820.80(e). As noted, the
final acceptance data is primarily related to correct labeling,
correct packaging, and sealing of the packaging. In the case of
aseptic filling operations, validation of the filling operations
and finished device sterility testing are required.
The manufacturer shall establish and maintain
procedures to control product that does not conform to specified
requirements. These established procedures shall include identification,
documentation, evaluation, segregation, and disposition of nonconforming
product. The evaluation of product non-conformance shall include
a determination of the need for an investigation and notification
of the persons or organizations responsible for the nonconformance.
This evaluation and any investigation shall be documented (820.90).
The manufacturer shall establish procedures for identifying the
training needs of personnel who handle nonconforming products
in the course of their work. These people should be trained to
recognize product noncomformance and take appropriate action to
control nonconforming products including identifying product as
nonconforming, documenting and evaluating the nonconformance,
and segregating and disposing of nonconforming product. This training
should be documented (820.25).
To facilitate detection of failure or defect
trends, internal problem data, including service reports, and
complaints should be arranged in a way that permits correlating
present and past data for a particular product or product line.
This can usually be achieved by organizing files according to
product or product lines. Such data may be maintained in a computer
file for quick accessibility and analysis.
The manufacturer shall establish and maintain
procedures that define the responsibility for review and the authority
for the disposition of nonconforming product. Nonconformance may
occur in-house, as well as before product is distributed, along
with nonconformances of distributed product. Procedures shall
set forth the review and disposition process. Disposition of nonconforming
product shall be documented. This documentation shall include
the justification for any use of nonconforming product and the
signature of individual(s) authorizing this use [820.90(b)(1)].
The decision to use a nonconforming product is usually done by
a material review board (MRB). MRB boards should operate according
to a written procedure and be comprised of individuals having
the knowledge to determine suitability for use of nonconforming
product.
Each manufacturer shall establish and maintain
procedures for rework, including retesting and reevaluation of
the nonconforming product after rework, to ensure that the product
meets its current approved specifications. Rework and reevaluation
activities, including the determination of any adverse effects
from the product rework, shall be documented in the DHR [820.90(b)(2)].
In order for a quality system to be self
correcting, data on quality problems from all sources should be
fed back into the system. For example, complaints, service reports,
and nonconforming products can provide valuable information that
can point toward possible corrective actions. The more comprehensive
a quality system is in taking preventive action, the lower the
probability of customer dissatisfaction and the resulting need
for corrective action. A true quality system has many preventive
safeguards including GMP requirements for design, packaging, labeling,
manufacturing control, installation, repairs, and complaint and
failure analysis. A quality system that also covers the customer
needs generally results in increased overall quality and greater
customer satisfaction.
Service requests resulting from long use,
misuse or accidental damage usually do not require corrective
and/or preventive action. However, if service requests or other
customer concerns are the result of rapid wear, unusual problems,
unusual maintenance, or development of hazardous conditions, action
may be necessary.
The manufacturer shall establish and maintain
procedures for implementing corrective and preventive action.
The procedures shall include the following [820.100(a)]:
All these activities and their results shall
be documented [820.100(b)].
Several forms for recording device production
and evaluation data are briefly described below and then exhibited.
Portable Defibrillator Test Procedure
Ten pages extracted from a 31-page test
specification for a family of portable defibrillators are reprinted
below. This test procedure is long and detailed because a defibrillatoris a complex device with a benefit to risk ratio that approaches
infinity. This sample evaluation procedure covers final manufacturing,
testing, and data collection performed by the production department
to make absolutely certain that finished defibrillators comply
with DMR specifications. This test procedure was developed based
on the company approved device specifications.
To reduce errors and increase clarity, the
test number column on the data sheet contains the paragraph number
of the detailed requirements in the specifications section of
the procedure. The test equipment and schematics are not reprinted
here.
Test DHR of a Printed Circuit Board Assembly
A data or "device history record"
card for a printed circuit board is exhibited. The test procedure
for the board is not reprinted. This data card is not the complete
device history record for the finished device. When the finished
device is tested, this board is tested again as an integral part
of it.
Device History Record (urine plate)
A record sheet of the filling, labeling
sample, inspection, and sample testing of a five-media urine plate
is exhibited. Each activity is performed per procedure -- these
procedures are not exhibited. The label record is an actual label
as printed on the urine plates -- the record sheet is passed through
the printing machine. This technique reduces costs and eliminates
human copying errors.
Batch Production Record (XLD)
This exhibit is the batch production record
of the XLD component used to fill one section of the five-part
urine plate discussed above.
Batch Production Record (Thayer Martin)
This exhibit is a blank copy of the form
used to record the batch production record for the Thayer Martin
component used in the urine plate.
Batch Production Record (Blank form)
This exhibit is a form used to record the
batch production record of various growth media. It could be used
to record the production of XLD as mentioned above.
Updated 1/1/1997
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