How to build a complaint management system


    What’s more dreadful than receiving a customer complaint?

    Being asked by a regulatory auditor how you handled the complaint and if you effectively documented it for post-market surveillance compliance.

    If you're in charge of complaint management at your life science company, there are ways you can lessen the burden and stress of the process.

    It begins with understanding the steps for building a successful complaint management system.

    We’ll also review complaint management software and how to choose the right solution for your quality team.



    Table of Contents

    1. Regulatory definition of complaint
    2. Building complaint files and procedures
      1. General requirements
      2. Initial review & evaluation
      3. Investigation of failures
      4. Medical device reporting
      5. Records
    3. Steps for complaint management
      1. Verification
      2. Focus on customer satisfaction
      3. Document the complaint
    4. Other things to consider
      1. Make your complaint records accessible
      2. Research regulatory expectations
      3. Learn from your mistakes!
    5. Benefits of complaint management software




    Regulatory definition of complaint


    First, let's clarify the regulatory definition of a complaint.

    There are slightly different definitions by each regulatory authority (ISO, FDA, etc.) and for each class, but proposed harmonization is in the works for FDA and ISO.

    So while the regulatory landscape is ever-changing, the current definition for medical device complaints in CFR Title 21 Part 820 is a great place to start.


    What is a complaint?


    "Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a [product] after it is released for distribution." — CFR Title 21 Part 820, Section 3


    The FDA even considers comments on your public website, social media pages or live chat apps to be complaints, if a commenter is relaying issues to your staff.

    It's important that all marketing and media channels are being monitored and reviewed on a periodic basis by a qualified complaint reviewer to ensure there are no missed complaints in public customer feedback forums. 


    Building complaint files and procedures


    As with any other core quality management process, a clear set of procedures backed by consistent documents and action steps are vital for good complaint management.

    21 CFR 820.198 offers a good outline for the kind of ingredients you'll need.


    General requirements


    In a nutshell, the 'general requirements' for your complaint management system are that it should 'establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that':


    • Complaints are processed in a uniform and timely manner

    • Oral complaints are documented upon receipt

    • Evaluations can take place to determine if failure investigation and/or a medical device report (MDR) is required


    Initial review & evaluation 

    Your company should the ability to review and evaluate complaints to determine whether an investigation is necessary.

    If you determine that no investigation is needed, document both the reason why and the name of the responsible individual.


    Investigation of failures

    Any alleged complaint involving possible failure of a device or labeling/packaging to meet any of its specifications must be reviewed, evaluated and investigated.
    Recurring complaints may not require investigation under complaint file handling, but may require some corrective and preventive action (CAPA).

    Medical device reporting


    The MDR (Medical Device Reporting) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events (AE) and product problems to the FDA. 

    Complaints that are also Medical Device Reports (MDRs) must therefore be promptly reviewed, evaluated, and investigated by designated individual(s).

    They should be maintained in a separate portion of the complaint file or be otherwise clearly identified, and you should keep additional records of:

    • Whether your device failed to meet specifications

    • Whether the device was used for treatment/diagnosis

    • Relationship, if any, of device to reported incident/adverse event


    You should have a clear record of servicing reports. Your customer-facing teams should be trained to identify possible complaints, then pass servicing reports and records to your formally designated unit for review.


    Steps for complaint management


    Let’s face it, no matter how great a product is or how established the business, you're going to get complaints about something.

    When you're dealing with regulated products, your complaint management system matters because of how it influences vital health decisions for customers. Even if deemed minor by you, complaints may still end up being detrimental to your company and its reputation, if not handled expeditiously and according to protocols.

    So, you’ve received a complaint, now what?


    1. Verify that the complaint is a complaint


    It's up to you (a qualified complaint reviewer) to determine if the complaint you’ve received meets the applicable regulatory definition for your product.

    In order to determine this, you will need to gather as much information as you can from the complainant at the onset to determine A) that it is your product (request part numbers, lot numbers, photos and samples, etc), B) that it is a legitimate complaint, and C) are there any immediate regulatory requirements. 

    If you can't get your hands on samples during this investigation phase:

    • Test any reserve samples or products manufactured around the time of the manufacture of the device in question
    • Analyze your device history records
    • Analyze any related service records
    • Analyze any CAPA/nonconforming data related to the device/product in question


    And, as we've touched on above, you must also ascertain if your complaint constitutes a reportable adverse event, or falls under MDR (Medical Device Reporting) regulation per FDA guidance.


    Adverse events

    An adverse event is a broader scope, and can mean any undesirable experience associated with the use of a medical product in a patient.

    The event should be reported to FDA if the consumer issue meets any of the particular parameters: death, life-threatening situation, hospitalization, disability, or permanent damage, birth defect, required an intervention to prevent permanent impairment or damage, or any other serious medical event.


    2. Focus on customer satisfaction


    Your next step is to respond and compensate your customer while you document and investigate. Use whatever means your company allows for replacing or reimbursing for their alleged issue.

    Investigation usually happens once you receive the alleged product back, but all companies handle things differently and your protocol may look different or is executed on a case-by-case basis.

    If you determine the issue is not an official complaint or no further investigation is necessary, that must be documented as well. Documentation for non-complaints is for trend purposes, because sometimes non-issues turn into real issues once you see a trend arise. 


    3. Document the complaint


    If you determine the customer has a legitimate complaint, it must be documented to ensure the complaint is processed according to your company protocol and for tracking and trending purposes.

    You should review, evaluate and investigate any complaint involving the possible failure of a product, device, labeling or packaging to meet any of its specifications, unless such an investigation has already been performed for a similar complaint and another investigation is not necessary.

    A comprehensive complaint management process details the steps from initial customer contact through post-market surveillance procedures (tracking and trending).

    Smaller companies may try to develop an internal system of documenting complaints using something like a spreadsheet, but these tend to be rudimentary and clunky.

    You may find yourself adding more columns than are manageable. Even with a small amount of products or complaints, an internally developed system usually becomes cumbersome, especially with multiple quality team members accessing complaints. 

    An internally developed system can also give you problems during an external audit. With a spreadsheet, it can be difficult to pull down certain complaints by date, which may be requested by an auditor.

    Because FDA auditors can't pull your internal audits, they may look to your complaints to see what corrective actions you’ve done - this is an easy opportunity for weaknesses in your quality processes to be discovered.

    For these reasons and more, an automated complaint management system is usually beneficial to companies of all sizes. We’ll review more benefits below.


    Corrective action

    A majority of complaints trigger corrective action to ensure a thorough investigation of what happened and how to make corrections to avoid future issues.

    A robust complaint management system is an effective tool in ensuring corrective action. Complaints and complaint investigations are integral to an effective CAPA system as they provide a source of external data post-market. One single complaint may lead a company to take remedial action or it may require ongoing analysis of numerous complaints to identify a trend that may necessitate remedial action.

    Since we referenced FDA medical device complaint definition above, these are the minimum points from CFR Part 820 Section 198, to be documented for device complaints:

    When an investigation is made under this section, the record of investigation shall include: 

    (1) The name of the device; 

    (2) The date the complaint was received; 

    (3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used; 

    (4) The name, address, and phone number of the complainant; 

    (5) The nature and details of the complaint; 

    (6) The dates and results of the investigation; 

    (7) Any corrective action taken; and 

    (8) Any reply to the complainant

    It’s also a best practice to note corrective action record numbers (automated links to those records are ideal) and additional places to designate if there were further regulation notices (MDRs, AEs), and ways to sort these escalated complaints. 

    Having a user-friendly and efficient way to sort, track and trend for your post market surveillance is of utmost importance if your company is certified to ISO standards and needs to give detailed high-level quality reports to management periodically for continuous improvement efforts.

    Not to mention, this is beneficial during audits when off-the-cuff questions and specific detailed reports are requested!


    Three tips for your complaint responses

    1) Investigate to the root cause where possible
    2) Don't take the easy road and stop at the quick fix
    3) Make sure the proposed fix won't cause unexpected results or other adverse problems



    Other things to consider


    1. Make your complaint records accessible


    As 21 CFR 820.198 states:

    When the formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.


    And 21 CFR 820.180 lays out some good record-keeping best practice too:

    All complaint files are to be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.


    If you're an international company, you should plan for that too.

    If, for instance, your formally designated complaint unit is outside the U.S., FDA compliance would require your complaint records to be 'reasonably accessible in the U.S.' at either:

    • A location in U.S. where manufacturer's records are regularly kept
    • The location of the initial distributor


    2. Research regulatory expectations


    Planning and implementing what the FDA wants to see is the best way to build a compliant complaint management system.

    Your auditor will expect:

    • Procedures clearly defining your complaint and complaint investigation process
    • Complaints to be handled in a timely and uniform manner
    • Appropriate questions to be asked and information collected to support decision(s)


    FDA 483 observations and warning letter citations for complaints are usually related to:


    • Complaints not being properly established, defined, documented, completed or implemented

    • Complaints involving the possible failure of a device to meet any of its specifications not being evaluated and investigated where necessary

    • Classifying incoming customer calls as non-complaints without conducting and documenting further follow-up with the patients or justifying the reason why

    • Not obtaining or documenting adequate details of incoming calls

    • No internal system  for timely and effective evaluation of service events that may be subject to medical device reporting requirements


    3. Learn from your mistakes!


    Most of the time, a complaint is not a dealbreaker for a customer - it’s how your organization handles the complaint that determines overall customer satisfaction.

    Improving your complaint management system will improve all aspects of quality. Additionally, it will help you more easily satisfy regulatory requirements and help you answer auditors' questions. 

    With the right combination of planning, training and technology, you can ensure that customer complaints are properly addressed and your business is well-positioned for success.

    With the right tools and procedures in place, complaint management will become less stressful and more impactful for your organization. Clear records of what you've done wrong in the past are gold dust for continuous improvement. Use your complaint file system to learn from mistakes and make suitable improvements to your quality, design and manufacturing processes.

    Remember: your complaint files are your gateway to CAPA and post-market activities that turn your company from good to great!


    Benefits of complaint management software


    Automated complaint management software has many benefits.

    While an automated complaint management system keeps your complaints organized in an easily accessible place, it can also be beneficial in the following ways:

    • Ensures uniformity of complaint documentation
    • Allows for quicker investigation and corrective actions
    • Provides real time status for customer service to have access during customer calls
    • Reminders/actions are automatically distributed
    • Required notices ensure timely closure
    • Offers wider accessibility for transparency, communication and collaboration between employees
    • Easy access to tracking and trending reports for post market surveillance

    These benefits lead to continuous improvements in your complaint management system, higher customer satisfaction and brand loyalty for your life sciences company. 

    Of course, once you’ve selected your complaint management software, it’s imperative that employees are properly trained on how to use the system. This includes understanding how to record complaints, what information is captured by the software, and who should be notified when a complaint is received.

    Looking for an eQMS to help you launch and scale life-changing products? Check out Qualio.