Five Ways to Prevent Complaint Handling Pitfalls


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from Rob Packard
at OMTEC 2014

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The best way to avoid receiving 483s is to learn from the mistakes of others. Therefore, this article analyzes each of the five most common 483s related to 21 CFR 820.198. For each of these five inspection observations, we’ll learn what FDA inspectors typically find that results in a 483. We will also describe what FDA inspectors hope to find.

Medical Device Academy’s data analysis of FDA inspection reports for FY2013 identified that there are actually 15 individual citations related to complaint handling that FDA is using from the TURBO EIR System. In aggregate, these 15 citations represent more than ten percent of the total Form 483s issued in FY2013. The table at the bottom of the page summarizes the frequency of these 15 regulatory clauses.

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“Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically…”—21 CFR 820.198(a)

This is the most frequently issued 483 observation for the complaint handling process, because complaint handling procedures are poorly written and often missing important requirements. Complaint handling requirements are prescriptive. Anyone responsible for reviewing and approving the complaint handling procedure should be trained on the requirements for complaints, and at least one person should review each of the seven subsections (i.e., a, b, c… and g) to ensure that every requirement is addressed by the procedure. This only needs to be done for the initial release of the procedure, or when there is a major rewrite of the procedure. However, it must be done—or
you may be receiving this 483 in FY2014.

In addition to ensuring that the procedure includes all requirements from 21 CFR 820.198, you must also ensure that the procedure provides adequate detail to explain how the requirements will be implemented for your company. To ensure that a procedure does this, I recommend the following approach. First, create a two-column table. Record each requirement in the left-hand column. Then ask each person responsible for complaint handling to explain how the requirement is met. Each should provide a reference to the section of the complaint handling procedure in the right-hand column to indicate where the requirement is addressed in the procedure. If one of the rows is completed incorrectly, it could mean that this person needs retraining. If multiple people make the same mistake, your training may not be effective, or your procedure may need to be written more clearly.

If your company is considering use of a software system for complaints, you may want to perform the above exercise during the software demo. If the software was not specifically developed for medical device complaint handling, you may find that some of the requirements are not clearly met. In this case, if you select the software, you may have to provide specific instructions on how to “work around” its deficiency.

“Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically…”—21 CFR 820.198(c)

The failure of a device, labeling or packaging to meet any specification is considered serious; because product, labeling and packaging should be inspected and approved prior to distribution. If a customer complaint alleges that specifications were not met, FDA expects the company to determine when and how it happened. Was inspection performed? Were the results recorded?

In order to perform an investigation, most companies request that product be returned. However, returns seldom arrive—even when the manufacturer issues a return of materials authorization number (RMA #). In these situations, the company must still perform an investigation. (The BONEZONE article, “Seven Ways to Investigate Complaints When Devices Aren’t Returned,” explains how to perform an investigation when product is not returned.)

When training an employee to answer the question of whether there is a possible failure of the device, labeling or packaging, it is important that the person is aware of, and has access to, the specifications. If you have complaint history for a similar product, you may be able to predict what types of complaints are likely, and you can then train the complaint handling unit on which specifications are applicable to each complaint category. If a software system is in use, it may be possible to make specifications available within the software as a reference tool. It is also recommended that you evaluate the effectiveness of training by testing people in the complaint handling unit with hypothetical complaints in which different specifications are not met.

“Complaint files are not [adequately] maintained. Specifically…”—21 CFR 820.198(a)

Observations specific to the maintenance of complaint files are frequently the result of companies not creating complaint files consistently. Filling in a line on a complaint log is not enough—nor is an empty folder with the complaint number on the tab. If you have a paper-based system, information received about a complaint needs to be recorded on a complaint form and the form needs to be completed. If you have different people responsible for handling complaints and for reviewing completed complaint files, then the person(s) reviewing the complaint files can also maintain metrics for timely processing of the complaints. Changes in these metrics can be used as a proactive indicator that there is a problem with the complaint handling process.

Maintenance of complaint files should also be specifically verified during internal audits. Therefore, auditors should not sit in a conference room and allow the complaint handling unit to bring in records during an internal audit. Internal auditors should go to the location where complaint records are stored and verify that the files are being adequately maintained.

If complaint handling is outsourced to a service provider, you will need access to the complaint files remotely to avoid a 483 against 21 CFR 820.198(f). If the service uses a software system, you will need to know how to print records to ensure that all the required information is included in the exported format. Ideally, the software already has a reporting option that is designed to specifically print the record in the format expected by FDA inspectors. You will also want the ability to run reports on the performance of the service provider against your quality objectives for timeliness of complaint processing.

Case Study: Complaint Backlog Solution for an Early-stage Company
Matts Bell, Business Development Manager, Argos Global

The Challenge
The client’s complaint handling system was paper based, which made it difficult to work efficiently among its various international locations. As a result, the company was facing a large complaint backlog. Like many medical device companies in the early stages of commercialization, the company needed to improve compliance with regulatory requirements. Therefore, the company sought a partner that could provide trained clinical staff and complaint handling software. Requirements of the system included 21 CFR Part 11 (ERES) compliance, eMDR capability, iPad compatibility, cost-effectiveness and a rapid deployment. Over a dozen vendors were evaluated.

The Partner
Argos Global offered an out-of-the-box system that could easily be configured to meet the needs of the client’s complex, high-risk medical device and decentralized organizational structure. Argos Global committed to a 60-day go-live target that included complaint handling support, a hosted and fully-validated instance of Sentinel® complaint handling software, procedural updates, extensive product training, a dedicated account manager and 24/7 technical support.

Launch in 60 Days
Every Argos Global project starts with assignment of a dedicated account manager to ensure proper system configuration and to guarantee that customer concerns are quickly addressed. After simple software configurations were complete, Argos Global helped the client’s Quality team modify its standard procedures and develop a comprehensive method of trending its complaint data to ensure potential quality concerns could be properly identified. Argos Global account managers provided training to the client’s team using a “sandbox” environment matching the client’s system, which users found to be intuitive and easy-to-use. After ensuring that the client’s team was trained and ready, Argos Global executed a formal validation. The new system launched on time.

The Results
In the year following launch, the new system was audited by several national Competent Authorities and Notified Bodies with no findings. As the client’s business expanded, Argos Global’s on-demand services were ready to provide additional trained medical staff for complaint handling. The Argos Global consulting team quickly delivered customized management reports for real-time charting of complaint activity and identification of potential quality concerns. These reports enable the client’s cross-functional participants to review complaint data in order to rapidly identify and escalate any concerns. The client has improved compliance while achieving nearly a 40 percent reduction in complaint handling costs.


“Records of complaint investigations do not include required information. Specifically…”—21 CFR 820.198(e)

Inspectors issue this observation for two primary reasons: 1) the complaint form is poorly designed, or 2) the form was not completed entirely (i.e., there were blanks). There are eight specific requirements for what is required by FDA for a complaint record. Therefore, the complaint form needs to have a clearly defined field for each of these eight items. The person responsible for reviewing complaint records should also ensure that every field on the form is complete, accurate and legible. If you are using a software tool, organize the software workflow so that the person responsible for the review will not receive the record for review unless all required fields have been completed.

Internal audits of complaint records should also verify that all eight requirements are included in each record. 

“Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically…”—21 CFR 820.198(b)

When an inspector issues this observation, the inspector is typically reviewing complaint records that have a blank on the form in which the person responsible for reviewing the complaint is required to document whether a complaint investigation is necessary. Companies frequently attempt to prevent recurrence of this compliance issue by revising procedures and retraining personnel in the complaint unit. Another possible corrective action, however, is to redesign complaint forms. Complaint forms need to include places to record “the reason no investigation was made and the name of the individual responsible for the decision not to investigate.” Yes/No checkboxes are not sufficient for documenting the reason. It is also not sufficient to indicate that a similar complaint was already investigated. You need to specify how the complaint is similar, by providing traceability information to the complaint to which it is similar, and indicate what aspects of the two complaints are similar (e.g., the same lot and same failure).


Robert Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. Robert served in senior management at several medical device companies, including President and CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE Marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it..

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