Handling Consumer Complaints
By Eric L. Foxman, Pharm. (Ret.), AAHP Secretary
This article originally appeared in the August 2012 hardcopy-only edition of the AAHP Network News.
The importance of managing consumer complaints is underscored by the importance FDA gives this subject during inspections. The agency always asks for established complaint management systems; deficiencies in this area are a prevalent Form 483 observation made by FDA and cited in warning letters. Here are three examples:
“Failure to establish and follow written procedures describing the handling of all written and oral complaints.... Your firm does not have any procedures that describe a process for documenting and investigating complaints relating to your... product.” (March 2012)
“You failed to establish and follow written procedures… [including] a qualified person must review all product complaints to determine whether the product complaint involves a possible failure... to meet any of its specifications. However, no qualified person investigated complaints you received.... Furthermore, products returned to your firm for similar complaints... were not always designated as complaints.” (April 2012)
“Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA....” (May 2012)
The following are important fundamental requirements to build an effective complaint management system:
a. Establishing written procedure(s)
b. Opening a complaint file when a complaint is received
c. Investigation and evaluation
d. Basic product and reporting information collected and stored in a permanent record
e. Decision regarding reporting to FDA
f. Response back to the complainant
g. Corrective and preventive action pursued
h. And often overlooked, the subsequent review of the complaints with an analysis of trends or changes
Archived copies of the AAHP webinar “Managing Consumer Calls” on this topic are available on CD; AAHP members get a $200 discount off the $425 price. To request a copy, please contact info@aahp.info for details.