Complaint Management for FDA and ISO Compliance

Complaint Management for FDA and ISO Compliance
October 9, 2018 seouser
complaint management

For any company that follows International Organization for Standardization (ISO) standards or is regulated by the Food and Drug Administration (FDA), having a system to manage and track complaints is a compliance requirement.

Overview of relevant FDA and ISO standards

The FDA requires that manufacturers establish and adhere to quality management systems to ensure their products are consistent and meet required specifications.

The quality systems for FDA-regulated products, be they food, drugs, biologics or medical devices, are known as current good manufacturing practices (CGMPs).

FDA 21 CFR Part 820 outlines requirements specifically for medical device manufacturers.

The ISO 9000 family of standards provides guidelines and principles for quality management systems. ISO 9001 outlines requirements organizations must meet to comply with these standards. Worldwide, over a million organizations have ISO 9001 certification.

A number of other ISO standards also address complaints management. For example, ISO 10003 provides guidelines for resolving disputes regarding product- or service-related complaints that couldn’t be satisfactorily resolved internally.

ISO 10002:2004 provides guidelines for complaint handling as it relates to products.

ISO 13485 sets quality management system requirements for the design and manufacture of medical devices.

ISO and FDA requirements for complaint management

To comply with ISO or FDA requirements, a company must have a formal complaints handling process that includes a complaints management system.

If your company is inspected by the FDA or audited by an ISO registrar, your complaints management system is one of the things they will look at.

FDA requirements

FDA-regulated companies are required to record details of complaints, including those they receive orally, electronically, and in writing.

Information that must be recorded about each complaint includes:

  • the complainant’s name and contact details
  • the product giving rise to the complaint and its model and serial number (if applicable)
  • the nature of the product defect or failure
  • circumstances surrounding the product failure
  • the warranty period
  • the product history – for example, to establish time to failure.

An FDA-regulated business must also have a system for evaluating complaints to determine whether it should proceed with an investigation and whether a complaint must be reported to the FDA.

Where the decision is taken not to conduct an investigation, FDA 820.198 specifies that a record must be kept of the reason for this decision and the name of the person responsible for making it.

If an investigation is conducted, FDA 820.198 says a record must be kept of the dates and results of the investigation, any corrective action taken, and any reply made to the complainant.

ISO requirements

As part of a quality management system, an ISO 9001-compliant company is required to keep meticulous and permanent records of all complaints. It must also have clear procedures for receiving, reviewing, and evaluating these complaints.

All complaints must be recorded by a formally designated department or person. Causes of issues should be assessed, and each complaint should be investigated and resolved in a uniform and timely manner.

For medical device manufacturers, ISO 13485 defines complaints broadly, as any “written, electronic, or oral communication that alleges deficiencies” in a medical device’s identity, quality, durability, reliability, usability, or safety or performance. Clause 8.2.2 of ISO 13485 defines rigorous requirements for a complaint handling procedure.

Compliance challenges

Companies may face a number of challenges in implementing fully compliant complaints management systems.

Outdated systems

If the system used to manage complaints is inflexible and lacks integration, your business won’t be able to resolve these issues quickly because the customer and complaint information will be less accessible. The flow of information between customer complaint agents and management will be stymied, resulting in unnecessary delays.

Lack of information

Systems and procedures that don’t allow for the proper and thorough recording of customer information or complaint details can cause these issues to never be properly resolved. This can result in customer service issues and product flaws going undetected for longer than necessary. Incomplete information in complaint reports is also a compliance violation.

Poorly defined procedures

Procedures that aren’t properly defined or explained to customer complaint agents can result in ineffective communication between agents, management and customers. Agents may be left to their own judgement to try and interpret these insufficient procedures. This makes the complaint management system inconsistent and ineffective.

Overcoming these challenges

Fortunately, with the correct complaints management software, you can easily overcome these challenges. Complaints management software allows for negative customer feedback to be centrally recorded, stored and tracked which results in better investigation and eventual resolution.

You can also create comprehensive workflows to make sure nothing is overlooked. You are able to automate certain aspects of the complaints handling procedure, such as task notifications and reminders. The system also allows you to track Corrective Action (CAPA) requests, so you know when they have been completed.

Complaints management software from isoTracker

At isoTracker, we offer modular, cloud-based quality management software, including complaints management software.

Our complaints management module is specifically designed to enable easy compliance with both ISO and FDA standards. It provides a comprehensive system for recording, assigning, and investigating complaints – and non-conformances and root causes can be recorded and then resolved using built-in corrective and preventive action (CAPA) features.

Contact us to find out more or to discuss your company’s complaint management needs.


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