Checklist for Complaint Handling Procedures

Proper management and follow-up of product complaints is one of the major stumbling blocks for FDA-regulated companies. Compare your existing Complaint Handling Procedures against this checklist of best practices:

√ Define your complaint sources

√ Decide how a complaint is evaluated initially for validity, extent and impact

√ Ensure every complaint receives such an evaluation

√ In every evaluation, decide whether a root cause investigation is required

√ Describe how and where the initial evaluation is documented (form or electronic system)

√ Describe how a complaint or complaint trend escalates to a root cause investigation or opens a CAPA

√ If you don’t do a root cause investigation, document the justification for your decision

√ Describe how root cause investigations are conducted and documented

√ Establish controls to prevent the distribution and use of nonconforming products identified by complaints

√ Link field actions and removals to complaint procedures

√ Address the need to analyze and trend complaint data

√ Compare results of analyses across data sources to determine extent of quality problems

√ Define responsibilities and time-frames; define “timely”

√ Link complaint evaluations, investigations, and data analysis to Management Reviews

For additional information and training on best practices in Complaint Management, plan to attend EduQuest’s The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.

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