15 COMPLAINT FILES
INTRODUCTION
Complaint Handling System
Complaint Responsibility
MDR Reportable Complaints
Complaint Records
Investigation Records
File Accessibility and Location
Non-medical Complaints
Complaint Analysis
DEVICE FAILURE ANALYSIS
FEEDBACK FOR QA SYSTEM
COMPLAINT SOURCES
MEDICAL DEVICE REPORTING
Who Must Report
When to Report
Individual Adverse Event Reports
Written MDR Procedures
MDR Event Files
How to Maintain MDR Event Files
ADDITIONAL MDR GUIDANCE
Reports of Removals and Corrections
EXHIBITS
Complaint Processing Procedure and
Forms
MedWatch Forms
Section 820.3(b) of the Quality Systems regulation defines a complaint
as "any written, electronic, or oral communication that alleges
deficiencies related to the identity, quality, durability, reliability,
safety, effectiveness, or performance of a device after it is
released for distribution." All medical device manufacturers
are subject to the complaint requirements in 21 CFR Part 820,
Quality System regulation and to the reporting requirements in
21 CFR Part 803, Medical Device Reporting (MDR) regulation. A
complaint is any indication of the failure of a device to meet
customer or user expectations for quality or to meet performance
specifications. A complaint may be lodged against any finished
device that had been released for distribution. Any complaint
involving the possible failure of a device, labeling, or packaging
to meet any of its specifications is subject to the provisions
of 21 CFR 820.198, Complaint Files.
The sources of oral and written complaints are numerous. A manufacturer
can receive this information via telephone, facsimile, written
correspondence, sales representatives, service representatives,
scientific articles, and FDA or internal analyses. Information
will also be submitted by health care professionals, lay users,
consumers, user facilities and distributors on the MedWatch Forms
FDA 3500 and FDA 3500A.
Manufacturers are required to review, evaluate, and, when appropriate,
investigate complaints, establish and maintain written procedures
describing the process used to perform these activities, and designate
a responsible individual or entity to perform these tasks. Complaints
concerning death, serious injury or malfunctions, as defined in
the MDR regulation, shall be reported to FDA as discussed later.
Manufacturers of any class of medical devices are never exempted
from the Quality System regulation complaint requirements (820.198)
nor the general record requirements (820.180) which permit FDA
review and copying of these records. Complaint file requirements
are necessary to make certain manufacturers have adequate quality
systems for investigating complaints and taking corrective action.
Access to complaint files, device-related death and injury reports,
and complaints about device defects enables FDA to determine if
a manufacturer's quality system and corrective actions are adequate.
Manufacturers can identify problems with device component, labeling
and packaging quality by several methods. To meet all GMP requirements
these identification methods should include a review and evaluation
of all complaints, failed devices, and service or repair requests.
Complaints and service or repair requests are important sources
of feedback information for a quality system. Finished devices
that are returned for service or repair may meet the complaint
requirements identified in section 820.198; therefore, these service
or repair requests shall be evaluated to determine if they are
complaints. Service or repair data shall be reviewed [820.200(b)&(e)]
to identify systematic problems and problems that may qualify
as complaints. When these problems are identified they should
be processed as complaints according to the requirements in 820.198.
Complaint data, in conjunction with product audits, QA systems
audits, operational analyses, inspection and test data, etc.,
is used by the quality assurance organization to:
Complaint Handling System
An effective complaint handling system is an extremely important
part of any quality system. Even manufacturers who have not received
complaints should be prepared to receive and process them. Manufacturers
should understand that any complaint received on a product shall
be evaluated and, if necessary, thoroughly investigated and analyzed,
and corrective actions shall be taken. The results of this evaluation
should lead to a conclusion regarding whether the complaint was
valid, what the cause of the complaint was, and what action is
necessary to prevent further occurrences. Complaints cannot be
ignored. They are an excellent indicator of problems with the
use, design, and/or manufacture of a product. A single complaint
that is thoroughly investigated may lead a company to take remedial
or corrective action. It may also take an ongoing analysis of
numerous complaints before a trend is spotted that causes a company
to initiate changes in their product, labeling, packaging or distribution.
Using written procedures for handling complaints increases confidence
that all complaints will be handled properly. Written procedures
should be provided to employees to facilitate communication, maintain
consistency, and reduce quality problems. Written procedures for
the receiving, reviewing and evaluating of complaints by a formally
designated unit shall be established and maintained in accordance
with 820.198, Complaint Files, and 820.40, Document Controls,
respectively. The procedures should include the need for complaints
to be evaluated in accordance with 820.100, Corrective and Preventive
Action.
The complaint files shall be maintained in accordance with the
general record keeping requirements of 820.180. All complaint
files are to be retained for a period of time equivalent to the
design and expected life of the device, but in no case less than
2 years from the date of release for commercial distribution bythe manufacturer. The written procedure should specify: authority;
responsibilities; and the process to follow in receiving, reviewing,
and investigating complaints. However, for very small manufacturers
where division of work is minimal, and authorities and responsibilities
are obvious, the GMP requirements as detailed in 820.198 in conjunction
with appropriate forms may be sufficient as a protocol for handling
complaints.
Although FDA does not specify a standard complaint handling system,
the GMP requirements do specify certain actions that shall be
included in any system. Manufacturers shall:
Complaint Responsibility
Manufacturers shall formally assign responsibility for maintaining
complaint files and conducting complaint investigations to individuals
or an organizational unit. Under 820.25(b) it is the manufacturer's
responsibility to ensure that personnel are properly trained to
adequately perform their duties. These employees shall have the
proper education and training to process complaints. Any difficulty
noted in employees performing required tasks for proper complaint
handling may be an indication that additional training is needed.
Training shall be documented.
The person(s) assigned to review complaints should have a thorough
knowledge of the product line in order to make an informed, reasonable
decision as to the severity and significance of a complaint and
to decide whether an investigation is necessary. If it is decided
that an investigation is not necessary, a record shall be made
of the rationale used to arrive at this decision. The record must
identify the individual responsible for making this decision.
Executive management should ensure that adequate resources are
provided, including trained personnel, to the designated complaint
handling unit within the company. The activities of the unit should
be assessed on a regular basis, and corrections made if necessary.
MDR Reportable Complaints
Section 820.198(c) specifically requires that any complaint involving
the possible failure of a device, labeling, or packaging to meet
its performance specifications shall be reviewed, evaluated, and
investigated unless such investigation has already been performed
for a similar complaint and another investigation is not necessary.
Also, section 820.198(d) further specifies that any complaint
that requires an MDR report 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 clearly identified.
However, if maintained separately a manufacturer should duplicate
these serious complaints in the regular complaint file to assure
that any analysis performed by product is inclusive of all complaints.
Analysis by appropriate statistical methodology where necessary
is a means of identifying quality problems. A single event, of
course, may also be an indicator of a quality problem.
Complaint Records
FDA does not specify a standard method for recording or retrieving
complaint information. Each manufacturer should develop a method
for maintaining records of complaints and investigations that:
is functional and economical, meets company needs, and meets requirements
of the Quality System regulation. A two sided form is suggested
when using hard copy to record complaints. One side may be used
to record complaint information such as:
The other side may be used to record:
A typical form is exhibited at the end of this chapter. The completed
form should be stored in the complaint file which may be a physical
or electronic file.
Investigation Records
The designated unit or person(s) responsible for maintaining the
complaint file(s) shall prepare a written record of any investigations.
This record shall include [820.198(e)]:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
Also, the investigation record of any complaint that is being
reported to FDA in an MDR report shall include a determination
of [820.198(e)]:
(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.
Section 820.198(e) requires the record of investigation to include
any reply to the complainant. Manufacturers should send a reply
to each complainant as a courtesy, but more important to prevent
further misuse, injury or other adverse situations from recurring.
However, because of the nature of the complaint, there may be
cases where a reply is not necessary. In such cases, the record
should state that no reply was made and the reason for not replying.
When the problem was caused by misuse, it is very important to
advise the user to help prevent further misuse. Also, the manufacturer
should determine if inadequate labeling may have lead to misuse.
File Accessibility and Location
The GMP requirement states in 820.180 that "All records required
by this part shall be maintained at the manufacturing establishment
or other location that is reasonably accessible to responsible
officials of the manufacturer and to employees of the Food and
Drug Administration designated to perform inspections." "All
records" includes complaint files and records of investigations.
For complaint processing, responsible officials are general managers,
complaint processors, QA managers, R&D and process engineers,
and others who receive, process, investigate, and correct problems
associated with complaints. Complaint files shall be reasonably
accessible to FDA for review and copying. FDA has clear authority
under Section 704(e) of the Food, Drug, and Cosmetic Act to inspect
and copy all records required under section 519 of this Act.
The GMP requirement states that complaint files must be handled
by a formally designated complaint unit. If the unit or individual(s)
designated as responsible for investigating complaints is located
away from the actual manufacturing site, the investigated complaint(s)
and the record(s) of investigation shall be reasonably accessible
to the manufacturing site. If a manufacturer's formally designated
complaint unit is located outside of the United States, records
required by this section shall be reasonably accessible in the
United States at a location in the United States where the manufacturer's
records are regularly kept or at the location of the original
distributor.
When devices are produced for a manufacturer by a contract manufacturer,
the manufacturer should forward to the contractor copies of complaints
and investigations that pertain to operations performed by the
contractor. The contractor should maintain a complaint file and
process complaints as discussed herein for the primary manufacturer.
Relabelers, importers, and others who distribute under their own
name should forward complaints to the actual manufacturers, including
foreign manufacturers, who are usually in the best position to
resolve complaints on their own products.
Non-medical Complaints
Certain manufacturers products may be used both as a medical device
and for non-medical uses, for example lasers and motors. The complaints
received from non-medical users do not necessarily have to be
included in complaint files. However, if the non-medical product
fails to meet specifications, then that report should be in the
manufacturer's complaint file. This action would help assure compliance
with 820.100, which requires identifying, recommending, or providing
solutions for quality problems and verifying implementation of
such solutions. The person receiving such complaints shall be
trained [820.25(b)] to identify complaints that also affect those
units used as medical devices.
Complaint Analysis
To facilitate detection of failure or defect trends, complaint
files should be arranged in a manner that permits correlating
present and past complaints for a particular product or product
line. Thus, files are usually organized according to product or
product lines. Manufacturers who do not organize complaint files
by product or product line may have to search several files to
find similar complaints or indications to identify problem trends.
Complaints may be maintained in a computer file so that complaint
data on a specific device or type of complaint can be readily
accessed and analyzed. As appropriate, complaint analysis or their
summaries should be included in the management review and the
quality system [820.20(c)].
Manufacturers should process and analyze failed devices per 820.100.
Section 820.100(a)(1) states that returned product is subject
to corrective action. Failure analysis must be conducted by appropriately
trained and experienced personnel [820.25(b)]. They should use
a written procedure to assure that the process of device handling
and analysis will not compromise the determination of the cause
of the device failure. The failure investigation and analysis
should determine the actual failure mechanism 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 returned with
the same symptoms.
If a failure is determined to be related to safety and effectiveness,
the deficiency should be determined, corrected and documented.
If an investigation verifies a particular device deficiency and
that this deficiency may exist in other products, the investigation
should extend to determining its effect on other medical products.
Any corrective or preventive action taken shall be done following
the requirements in 820.100.
The more comprehensive a quality system is, the lower the probability
of complaints occurring. However, in order for a quality assurance
system to be dynamic or self correcting, data on quality problems
from all sources should be fed back into the system. Complaints
are a valuable source of data that can point to corrective actions.
Feedback data should flow into all operations that could be affected
by the data and should be used to aid in device and process design
evaluation and/or redesign, and to aid in improving the overall
quality system program.
Regardless of the size of the formal quality system, the feedback
data path in any company should be the same, that is, the data
should flow into all affected operations even if some of these
are not covered by the formal quality system or by FDA regulations.
Complaints that shall be processed according to the GMP requirements
may be received from:
Complaints from any source shall be equally addressed by and be
processed according to the company complaint policy and procedure.
The company should make certain that market, sales, engineering,
manufacturing, regulatory, installation, and service personnel
are trained to properly identify and report complaints. These
employees shall be made aware of this requirement according to
section 820.25(b).
In addition to the GMP requirements covering complaint handling
and failure investigations, device manufacturers shall also comply with the Medical Device Reporting
(MDR) regulation, 21 CFR Part 803.
Who Must Report
The MDR regulation requires that all manufacturers of medical
devices notify FDA when they become aware of a death or serious
injury that may have been caused or contributed to by one of their
marketed devices and/or any malfunction of one of their devices
which, if it were to recur, would be likely to cause or contribute
to a death or serious injury. These are the same complaints that
the Quality System regulation requires a manufacturer to place
in a separate portion of the complaint file or otherwise clearly
identify [820.198(d)]. The MDR regulation is intended to supplement
the Quality System regulation -- it is not meant to replace the
GMP complaint and failure investigation requirements.
When to Report
There are specific time limits within which the MDR reports shall
be made. Any report of a device-related death, serious injury
and malfunction shall be submitted within 30 calendar days from
becoming aware of an MDR reportable event. To meet these requirements,
manufacturers shall have an information handling system to assure
that data are screened to determine what shall be reported to
FDA. This system shall also be able to follow up this information
quickly and accurately in order to comply with the MDR regulation.
Manufacturers which have a good system for processing complaint
and failure investigations such as described in this chapter will
have the organization and data processing capabilities to meet
the MDR requirements.
Manufacturers of medical devices are required to report a device
related death, serious injury or malfunction to FDA using FDA
Form 3500A, within 30 calendar days after becoming aware of the
event. However, if the event necessitates remedial action to prevent
an unreasonable risk of substantial harm to public health, then
a report shall be submitted within 5 work days. Reports shall
also be submitted when FDA notifies a manufacturer that 5-day
reports involving a particular type of medical device or type
of event are required.
The reporting process starts when an MDR reportable event is first
recognized. Manufacturers are responsible for making sure their
employees know how to recognize what may be reportable. Manufacturers
should also emphasize that any employee may learn of an adverse
event during a phone call, a sales visit, a professional conference,
from correspondence received or from service/warranty orders.
Individual Adverse Event Reports
There are two types of individual adverse event reports that may
be submitted by manufacturers. The 5 work day and 30 calendar
day reports.
The 5-day report (803.53) is for MDR reportable event(s) that
require a remedial action to prevent an unreasonable risk of substantial
harm to the public health or where FDA has specified that a 5-day
report is needed. This situation may be identified by the manufacturer
or FDA:
The 5-day period of reporting starts the day after any employee,
who is a person with management or supervisory responsibilities
over persons with regulatory, scientific, or technical responsibilities,
or a person whose duties relate to the collection and reporting
of adverse events, becomes aware that a reportable MDR event or
events, from any information, including any analysis, necessitate
remedial action to prevent an unreasonable risk of substantial
harm to the public health.
The MDR regulation defines remedial action as any action
other than routine maintenance or servicing of a device where
such action is necessary to prevent recurrence of a reportable
event.
Not all remedial actions need to be submitted as 5-day reports.
Only remedial actions that are necessary to prevent an unreasonable
risk of substantial harm to the public health shall be submitted.
If a remedial action is taken, but it is not done to prevent
an unreasonable risk of substantial harm to the public health
a 5-day report is not required. A 30-day report, however, may
be required.
The discovery that a remedial action is necessary may be a direct
result of one or more MDR reportable events occurring, or may
be discovered through the performance of internal analyses using
appropriate statistical or other acceptable methodologies for
processing data.
Actions taken to fix a single device involved in the MDR reportable
event are not remedial actions.
A 30-day report is required once a manufacturer receives or otherwise
becomes aware of information that reasonably suggests that a device
they have marketed:
(1) has or may have caused or contributed to a death or serious
injury; or
(2) has malfunctioned and such device or similar device marketed
by the manufacturer would be likely to cause or contribute to
a death or serious injury, if the malfunction were to recur.
The 30-day period for reporting starts the day after receipt by
any employee of information that reasonably suggests that
an MDR reportable event has occurred. FDA expects manufacturers
to train their employees to recognize that they have received
information on an adverse event and to know to whom in the company
to forward this information for an MDR evaluation.
A manufacturer is NOT required to file an MDR report:
For the latter instance, the regulation requires the manufacturer
to forward whatever information they have to FDA with a cover
letter explaining that they did not manufacture the device so
that FDA can send it on to the correct manufacturer. In this case,
a 3500A should not be completed. Manufacturers may also voluntarily
send a copy of this information to the manufacturer they identify
as being the actual manufacturer.
Written MDR Procedures
In addition to having general complaint handling procedures, the
MDR regulation (803.17) requires manufacturers to develop,
maintain and implement written MDR procedures that at a minimum:
A. Set up internal systems for:
B. Set up documentation and recordkeeping for:
The MDR procedures should be either incorporated in the overall
complaint handling procedure or be a companion to it. In either
case these MDR procedures shall be clearly identified. If a companion
procedure, it shall be incorporated by reference in the overall
procedure. This will assure that all complaints are properly evaluated
for MDR reporting.
Each manufacturer has certain discretion to determine the level
of detail and depth of information that their written MDR procedures
contain. FDA suggests that manufacturers provide policy and interpretation
information regarding "typical" adverse events or product
problems that may be MDR reportable. FDA also suggests that the
procedures describe the investigation protocol that will be followed,
e.g., two or three or four attempts will be made to contact the
reporter either by phone, FAX or letter before an investigation
is closed; that the complaint records will contain a concise but
thorough description of the adverse event or product problem,
that the complaint records will be legible, etc.
MDR Event Files
Each event that requires a determination regarding its MDR reportability
shall be documented in an MDR event file (MEF) (803.18). This
MEF will be one of the bases for establishing compliance with
the requirements of the MDR regulation. Files are to be accessible
to FDA personnel for review and evaluation, be as complete as
possible, and are to clearly document MDR related actions and
decisions. The following information should be in the MEF to assure
that it complies with the MDR requirements:
a) The original or a copy of the initial record complaint/event.
This record should include the available information needed to
complete the Form FDA 3500A. The record may be documentation of
a telephone call, a letter or facsimile, a service report, documents
related to a lawsuit, a voluntary FDA 3500 received from a health
care professional or consumer, or mandatory FDA 3500A received
from a User Facility and/or a Distributor, etc.
b) Copies of any records documenting the manufacturer's attempts
to follow-up and obtain missing or additional information about
the event. When information cannot be obtained an explanation
shall be made part of the file.
c) Copies of any test reports, laboratory reports, service records
and reports, records of investigation, etc.
d) Copies of all documentation involving the final assessment
of the event, any deliberations and/or decision making processes
used to determine whether an MDR report was or was not needed.
When applicable, the final assessment should indicate what action,
if any, the manufacturer has taken to assure that the cause of
the event is corrected or otherwise mitigated.
e) Copies of all FDA 3500A forms submitted to FDA, when applicable.
This includes a copy of any FDA 3500A forms received from User
Facilities and Distributors.
f) Documents verifying that the event has been evaluated in accordance
with the applicable requirements of the QS regulation, sections
820.100 and 820.198.
g) References to any other relevant documents or information used
during assessment.
How To Maintain MDR Event Files
The MEF can be written or electronic files. They may make reference
to other information that was used during the investigational
process, in lieu of copying and maintaining duplicates in the
file. Any referenced material is to be made available to FDA personnel
for review, copying and verification.
Each MEF shall be retained for a period of two (2) years from
the date of the event or a period of time equivalent to the expected
life of the device, whichever is greater. Each MEF file shall
be maintained for this period of time even if the device is no
longer sold/distributed by the manufacturer.
The MEF may be maintained as part of the complaint file required
by 21 CFR Section 820.198, however, the MEF files shall be prominently
identified.
Manufacturers should refer to the guidance document entitled,
"Medical Device Reporting for Manufacturers," for further
information on how to comply with this requirement.
There is also a Web page devoted to MDR issues.
REPORTS OF REMOVALS AND CORRECTIONS
At the time of completion of this manual, FDA has not published
a final rule implementing its authority under section 519(f) of
the Act to require reports of removals and corrections. It is
important to note, however, that the agency published a proposal
to implement this authority at 59 FR 13828 (March 23, 1994). A
final rule based on the proposed rule may require reporting different
from or in addition to that required by the Quality System and
MDR regualtions.
Exhibits are described below which follow in the order described.
Complaint Processing Procedure and Forms
This sample procedure is used to establish and help implement
a system for processing routine complaints for devices. The customer
complaint form mentioned in the sample procedure is essentially
the same as the form, "customer/device complaints,"
in the next exhibit. Nowadays the complaint log shown on sheet
3 of 5 is easily maintained on a computer.
An example of a complaint recording form follows the complaint
processing procedure.
The form titled "Customer Complaint" can be used to
record most complaints.
If it matches a manufacturer's needs, the complaint form may be
used as is. Also, it may be modified to meet specific needs. If
the form is modified or a new one is developed, a manufacturer
should make sure the resulting form is consistent with the GMP
requirements and consistent with any complaint handling policy
and/or procedures being used at the manufacturer.
MedWatch Forms
A copy of the MedWatch 3500A is included at the end of this chapter.
This form may be photocopied for submitting reports.
The MedWatch 3500A is also available from the Web page devoted to MDR issues.
*** SAMPLE PROCEDURE ***
| C O M P A N Y L O G O | Sheet 1 of 5 | ||
| Title Complaint Processing Procedure | SOP Number | ||
| Prepared by | Date Prepared | ||
| Approved by | Date | Rev | |
| ECN Notes | |||
PURPOSE: To establish and implement a procedure and forms
for recording customer complaints, analysis, response, and corrective
action.
POLICY: It is the policy of our company that all complaints
regarding safety, performance, or quality of our products or services
will be subject to management review and/or investigation and
will result in prompt response and corrective action where indicated.
SCOPE / DEFINITION: This policy is applicable to and must
be complied with by all personnel who receive a customer complaint,
including personnel in Sales and other departments.
A "complaint" is any indication of the failure of a
device to meet customer or user expectations for quality or to
meet performance specifications. Thus, any written, oral, or returned
goods expression of dissatisfaction relative to the identity,
quality, durability, reliability, safety, effectiveness, or performance
of any device manufactured by this manufacturer would be considered
a complaint.
Types of complaints intended to be covered by this policy are
as follows:
1. PRODUCT PERFORMANCE: the product in some
way does not perform to user's expectation or to any level of
performance conveyed to the customer by printed labeling or verbally
by company employees.
2. PRODUCT SAFETY: all safety complaints
are covered by this procedure.
3. PRODUCT RELIABILITY: failure rate or need for service
adjustments greater than user expectation, i.e. beyond the tolerable
level of expected wear or malfunction.
4. PRODUCT APPEARANCE: visual defects inconsistent
with the user's expectations for a medical device.
5. GENERAL COMPLAINTS: order or shipping error,
delayed or unacceptable response to problems, unfulfilled promises,
etc.
6. MDR REPORTABLE COMPLAINTS: all complaints involving
device-related deaths, serious injuries and malfunctions. (See
Policy/Procedure No. XXX for handling of MDR reports.)
FORMS USED: Customer/Device Complaint and Analysis and
Complaint Log
PROCEDURE: Upon receipt of a customer complaint, the recipient
completes side one of a CUSTOMER/DEVICE COMPLAINT form and, if
the complaint is written, attaches the complaint letter to the
form. The recipient then gives the form, with any attachments,
by the next day to the Manager of Quality Assurance.
*** SAMPLE PROCEDURE Sheet 2 of 5
IMPORTANT COMPANY POLICY: Where a complaint requires immediate
corrective action or response to a customer, the complaint recipient
must either take the required action or communicate with the proper
person to take the required action. It is the responsibility of
the recipient of any complaint to see that the customer receives
a response -- nothing in the following procedure relieves him
or her of this responsibility.
Quality Assurance:
1. Assigns a sequential complaint number and enters the complaint
into the Complaint Log.
2. Determines and notes on the complaint form the person to whom
the complaint is to be assigned for investigation and/or corrective
action and the date a response is required from the assignee.
3. Notes any specific instructions to the assignee.
4. Distributes a copy to appropriate Department(s) as checked
on side 1 of the complaint form.
5. Makes 2 copies of all sides of the inprocess form and
attachments, and distributes:
Original to the Assignee.
One copy to the "UNDER INVESTIGATION" complaint folder.
The Assignee:
1. Performs the investigation and/or corrective actions and records
the results on the form; and attaches any investigation records.
If no investigation was done the reason why must be recorded and
the name of the approving official documented.
2. Returns the original of the inprocess form to QA.
Quality Assurance:
1. Records on the Analysis side:
If no action is taken, the reason for inaction should be recorded
on the analysis form.
Any additional corrective action taken or directed by QA.
Whether an MDR report was submitted to the FDA.
The nature and date of any response made to the originator or
the customer. If this response is written, a copy of the letter
or FAX is attached to the analysis form.
The final disposition of the complaint.
QA signature and date.
2. Records the final disposition of the complaint on the complaint
log.
3. Files the completed form in the appropriate complaint file
for the type of device involved; and discards the copy previously
filed in the "UNDER INVESTIGATION" complaint folder.
*** SAMPLE RECORD ***
| COMPLAINT LOG | Sheet 3 of 5 | MONTH , 19 | ||||
| Seq.
No. | Date Rec=d. | Type Device | COMPLAINT | DISPOSITION | ||
*** SAMPLE RECORD*** Sheet 4 of 5 of
Procedure No. _________________
CUSTOMER COMPLAINT (Side
1) SEQUENTIAL NO. __________________________
Device Name _______________________________________
Model Number _____________________________
Catalog Number ____________________________________
Lot Number _______________________________
Distributor_____________________________________________________________________________________
Name of Complainant ________________________________
Phone No. ________________________________
Complainant Address ____________________________________________________________________________
Complaint Received by ___________________________________________________________________________
Title ______________________________________________
Date Received _____________________________
By: Q
Visit Q Phone
Q Letter
Q Sales Q
Credit Memo Q
Other ______________________________________
COMPLAINT ABOUT
Q Sterility _____________________________________________________________________________________
Q Particulate Matter
Type ________________ Location _______________________________________________
Q Defect _____________________________________________________________________________________
Q Packaging __________________________________________________________________________________
Q Labeling ____________________________________________________________________________________
Q Patient Death
________________________________________________________________________________
Q Patient Injury
________________________________________________________________________________
Q Product Malfunction
___________________________________________________________________________
Q Other (specify)
_______________________________________________________________________________
Comments/Description of Event ____________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
ATTACHMENTS Q
Implicated Sample Q
Associated Sample Q
Letter
Received By QA Mgr ________________________________
Date _____________________________________
Assigned To _______________________________________
Response Due _____________________________
Instructions ____________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Distribution: Q
Quality Control Q
Engineering Q
Production Q
QA Q Sales
Q Service
*** SAMPLE RECORD*** Sheet 5 of 5 of
Procedure No. _________________
CUSTOMER ANALYSIS (Side
2) SEQUENTIAL NO. __________________________
Device Name ____________________________________
Model Number _____________________________
Catalog Number __________ Lot Number
____________ Date of Complaint Report _____________________
Name of Complainant ___________________________________________________________________________
Nature of Complaint _____________________________________________________________________________
ASSIGNEE EVALUATION
Date(s) Evaluation Performed______________________________________________________________________
Evaluation Results_______________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
Q Copy of evaluation
attached
CONCLUSIONS
Q Device Defective
Q Device
Failed to Meet Specifications Q
Improper Use
Q Shipping Damage
Q Repair
Request
Q Other(specify)
_______________________________________________________________________________
_____________________________________________________________________________________________
ACTION/REPLY TO COMPLAINANT
Q Recalled. FDA
phoned on - Date ______________ Spoke to ________________________________________
Q Complaint Committee
Informed on - Date ___________________ Q
MDR Filed on - Date __________________
Q Referred to _________________________________
for Further Investigation or Correction
Q Replaced Q
Repaired Q
Credited Q
Letter Sent Q
Sales Follow Up
Q Reason for No
Reply __________________________________________________________________________
NOTES:
FINAL DISPOSITION ___________________________________________________________________________
Reviewed by: Quality Assurance _____________________________________
Date ______________________-
If requested: Engineering __________________________________________
Date ________________________
Production ______________________________________________________
Date ________________________
Updated January 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
