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Interesting Insights
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Only 85% of firms are screening service calls
to see if they meet the definition of a complaint.
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Only 62% routinely send an acknowledgement to
the complainant.
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Only 34% always send a letter to the
complainant following closure of complaints.
Commercial Software Applications
23% reported using a commercial software
application to process complaints.
Firms generally like the
following features in their applications:
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Easy to use
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Effective in capturing consumer and product
information, automatic response generation, tracking, and reporting
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Global system: all of the divisions can use
the same system
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Powerful search capabilities; easy to sort
types of complaints
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MDR and Vigilance Reporting forms are built
into the database
Firms generally dislike the
following features in their software applications (i.e., questions that
firms should ask when evaluating a web-based system):
- Long configuration time
- Training employees is a challenge
- Difficulty in generating reports
- Annual cost of updates and maintenance
- Difficult to modify the program to meet
firm's needs
Motivating Customers and
In-House Personnel to Report Complaints
Survey respondents use the following
tactics to motivate customers to report complaints:
- Provide easy access for communication
(toll free #, web site, receptive sales reps.)
- Build a relationship by letting
customers know you are trying to solve the problem
- Provide technical assistance to
facilitate proper device use
- Go beyond the reported complaint to
ensure total customer satisfaction
- Make it easy for the customer to obtain
a free replacement for a defective device
Survey respondents use the
following tactics to motivate in-house personnel to report complaints:
- Have top management reinforce the value
to the business of effective complaint handling
- Design a simple reporting form and
provide training on its use
- Publicize actions taken in response to
issues raised by complaints.
- Provide positive reinforcement for
reporting, analyzing and acting upon complaints
Getting the Device Back From the
Customer
65% report difficulty in this area.
Survey respondents used the following
tactics to motivate people to return the device:
- Be responsive: Have a courier or
salesperson personally pick up the product
- Provide free shipping and product
replacement or credit
- Continue to follow up with the customer
until the firm gets the product back
- Tell customers about the importance of
their feedback in improving product quality
- Provide information on corrective and
preventive actions
Not Investigating Complaints
The most popular reasons cited for not
investigating complaints include:
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Complaint is for a product not manufactured by
the firm (55%)
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An adequate investigation of the alleged
compliant failure mode has already been preformed (55%)
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Corrective action is already open for the same
failure mode (52%)
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A failure investigation is already open for
the same complaint (39%)
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Complaint does not involve a possible failure
of the device, labeling, or packaging to meet specifications (35%)
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Firm is unable to obtain the device for
analysis (21%)
(The preamble to the QS Regulation contains information regarding making a
"good faith" effort to recover devices. An investigation can include, for
example, testing similar devices (e.g., same lot), reviewing DHRs and
complaint historical data.)
Closing Complaints
Firms use the following criteria in
determining when a complaint is considered closed:
- A corrective action has been initiated
or it has been determined that no action is required (42%)
- A corrective action is reported (23%)
- A failure investigation has been
completed (20%)
- A corrective action has been completed
(1%)
- Other (14%)
Goal for Closing Complaints
Firms reported the following time frames as
a goal for closing complaints:
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Less than 30 calendar days (37%)
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31 - 45 calendar days (18%)
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40 - 60 calendar days (23%)
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More than 60 calendar days (1%) (These are
probably the firms who close complaints after the corrective
action is implemented and closed.)
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16% Other
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Medical
Device Complaint Handling Practices