GMP Training Primer: Complaint Management

February 18, 2015

Complaint management is one area of manufacturing that has the potential to impact every person in the company. FDA regulations make it clear that all employees bear the responsibility for reporting complaints about products, so it’s important that all staff have at least a rudimentary understanding of how complaints are handled. Use the following outline to develop an introductory course that ensures everyone in your organization is ready to respond to complaints.

Part One: Overview

Start by explaining the What, Where, Why and Who of complaint management.

What is a complaint?  Trainees first must understand that not all customer complaints are actionable – a complaint must indicate that a real or perceived problem exists – but all must be reported to the proper department to make the determination.

Where do complaints come from? Complaints don’t have to be formal statements made through official channels; they can be as simple as an off-hand comment to a field representative or even something overheard at a social gathering. Regardless of the source and method of communication, they must be reported.

Why is complaint management important? Beyond complying with regulations, trainees should learn the objectives and benefits of complaint management, such as improving product quality and enhancing customer relationships.

Who is involved in complaint management? The quality assurance unit may drive the process, but other departments may be involved, depending on the nature of the complaint. These may include marketing, production, finance, regulatory and legal affairs, and others.

Part Two: Regulations

Introduce trainees to the FDA’s good manufacturing practices regulations and guidance documents on the subject. If your company does business outside the U.S., you should also inform trainees about other regulatory authorities and their requirements for complaint management.

Part Three: The Process

An explanation of complaint management can be broken into six parts.

  1. Receiving Complaints – Discuss the possible sources of complaints and what to do with them when they are received.
  2. Assessing Complaints – Explain how complaints are evaluated in terms of risk to consumer safety and what types of complaints must be reported to regulatory authorities, such as the FDA.
  3. Investigation – Introduce the concept of root cause analysis, the importance of documenting all phases of the investigation and tools that can be used to determine cause and effect.
  4. Correction – Explain the corrective and preventive action (CAPA) system, its objectives and outcomes.
  5. Close Out – Discuss the complaint file and the documentation it must contain to show how the problem was addressed and justify closing the file.
  6. Trend Monitoring – Show how looking at complaint trends can help evaluate the effectiveness of CAPA actions and identify/prevent potential future problems.

Once training is complete, employees should know, at a minimum, how to identify a complaint, where to send it and how it will be handled.
In next week’s issue, we’ll look at basic root cause analysis training.

The complete Product Complaint Overview training package, including slides, leader’s script and knowledge assessment, is available as part of the FDAnews Customizable Training Series for drug manufacturers and devicemakers.

Special Offer for Quality Training Advisor Subscribers: Register for the Medical Device Complaint Management Workshop, Feb. 25-26, and save 15%.  Use code QTA15 at checkout to take advantage of this offer.