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Complaints: A Second Chance to "Make it Right"

Complaint Handling Process is Under Control

By using written procedures for handling complaints this will increase 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, depending upon the risk(s).

Although FDA does not specify a standard complaint handling system, the cGMP-QSR requirements do specify certain actions that shall be included in any system. All manufacturers shall: 1) document, review, evaluate, and file all complaints, 2) formally designate a unit or individual to perform these activities, 3) determine if an investigation is necessary, 4) record the reason if no investigation is made, 5) assign responsibility for deciding when not to investigate, 6) determine if the complaint requires an MDR report, and 7) determine if an MDV report should (also) be filed with your company's authorized representative in Europe.

Complaints are important for several reasons:

    • You don't know how to improve your medical device or service if you don't know what's wrong
    • Customer complaints can supply ideas for new products and services.
    • Complaints give you valuable information about what's important to health care professionals and what they're willing to spend money on.
    •  They are truly a "heads-up" gift


Complaints also tell you that the customer still wants to do business with you..... The customer still cares about the relationship they have with your company. They want you to fix the problem so they can continue to do business with you. Many health care professionals don't complain—they just take their business elsewhere, because they've given up hope of getting what they need from you.

Complaint Responsibility

The person assigned to review complaints should have a thorough knowledge of the orthopaedic 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.


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