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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
      • Templates
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
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  • GP-014 Feedback and complaints

GP-014 Feedback and complaints

Procedure flowchart​

Purpose​

To describe the methodology used to collect, monitor and analyze the information coming from customers using our device.

Scope​

All the communication coming from the customers of the company.

Responsibilities​

JD-001​

To approve the procedure and provide the required resources to comply with the requirements set out in this procedure.

JD-004​

To ensure compliance with this procedure and to supervise or directly establish the documentation, analysis and resolution of customer complaints.

JD-005​

To analyze the communication and determine whether or not it is classified as a customer complaint. In case of customer complaint, to classify whether it is an incident. To assign categories to customer complaints according to their criticality. To perform the investigation and follow up of the customer complaints.

JD-016​

To send customer surveys and to collect, analyze and share the results coming from the surveys.

Inputs​

  • Any communication coming from customers.

Outputs​

  • T-006-002 List of non-conformities, claims and communications
  • T-014-001 Customer satisfaction survey
  • T-006-003 CAPA
  • Input to the GP-004 Vigilance system and the GP-007 Post-market surveillance

Definitions​

  • Customer complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device or related to a service that affects the performance of such medical devices

  • Incident: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

Development​

Information coming from customers​

This procedure aims to collect post-market data in relation to our medical device and the experience of users, customers, distributors or any other agent involved in the commercialization of our products.

We can divide the information received from customers into two main categories:

  • proactive customer's feedback gathered by means of surveys (T-014-001 Customer satisfaction surveys) sent to the customers to collect data about safety, performance and general satisfaction with the device
  • communications received from customers: all general communications received from clients or other commercial operators will be registered in the tickets management tool Hubspot. Clients can create their own tickets through the contact form from the webpage, or the employees, receiving the client feedback through a different channel (for example by phone), will create them.

Customers management tool​

We have a special tool for customers management ruled by Hubspot platform, with access control and different permissions depending on the user profile. In adition to managing customer deals, it allows to receive direct communication from clients that complete the contact form at the website or the application, and to register the other tickets communicated to us through other channel.

Communications management​

We evaluate all the communications received from customers to treat them properly. The person receiving the communication will assign it to the employee required to follow it up and to solve it.

The first question to answer in order to categorize and treat accordingly the customer communication is Is it a customer complaint?

  • If the communication is not related to the product (disappointment about the service or about the relationship with the client, or other communication not related to the safety and performance of the product), the communication is not a customer complaint and it is noted down in the "Notes" section of each client and the sales team will be leading the follow up.
  • If the communication expresses deficiencies directly related to the identification (printed material, labelling, etc.), quality, durability, reliability, safety, effectiveness or operation of the final product after it is placed in the market, the communication is a customer complaint and it will be registered as a ticket and assigned to the JD-005 to perform the complaint evaluation and defined the required steps to solve the issue.

Among the communications received from customers, we identify another category that is technical assistance service communications. If the communication is considered a technical assistance service requirement, it is noted down as a ticket and assigned to the technical responsible to solve it, according to the GP-017 Technical Assistance Service procedure. This type of communications are first screened to understand the type of technical assistance: request for support, request for new features, and bug. In the last case (bug), the communication is considered a customer claim and it will be treated as such.

Customer complaint management​

Customer complaint treatment starts when any employee receives notifications of a claim. The customer compliant will be immediately communicated to the JD-005, the JD-004 or JD-003 and any other relevant employee required for its management.

The follow up of the customer complaint is performed and documented through the tickets tool Hubspot. The complaint record includes:

  • Ticket title
  • Description
  • Owner
  • Status
  • Creation date
  • Closure date
  • If it is a customer complaint
  • Investigation performed, that will include the information compiled during the investigation.
  • If it is needed to open a CAPA and the corresponding code
  • If it is needed to report it to the NCA (National Competent Authorities) and NBs (Notified Bodies)
  • Customer complaint classification based on its effect on safety and performance.

The maximum response time is established in 3 weeks.

Customer complaint investigation and evaluation​

Based on the information received, the JD-005 investigates the registered complaints. The investigation and evaluation bases its analysis on the determination of whether the compliant is appropriate in relation to the product, its safety and/or its performance or it is not:

  • Appropriate complaint: It is a complaint based on a real cause that suggests that there has been an issue that interferes with the product or service safety or performance.

  • Non-appropriate Complaint: It is a complaint that does not come from a real cause but a subjective dissatisfaction or related to other aspects not directly related to the product and its quality (comments regarding customer service, prices or other similar). In this case the communication will be followed up and managed as previously explained.

The complaints evaluation and its results are recorded in the corresponding field within the complaint ticket in Hubspot.

In case the complaint is evaluated as appropriate complaint, the JD-005 shall classify the complaint based on its criticality in terms of safety and performance. The criticality categories are the following:

  • High: complaints categorized as high impact represent the most critical failures in terms of safety and performance. These issues may result in misdiagnosis, delays in treatment and worsening of the patient's health status, impairment of the overall functionality of the software. High impact complaint could include failures that lead to incorrect diagnosis or treatment recommendations, compromised patient data security.
  • Medium: complaints categorized as medium impact represent failures that have a notable but not immediate impact on safety and performance. While they may not pose an immediate risk of severe harm, they still require attention to prevent potential complications or adverse effects on patient outcomes. Medium impact complaints could include software bugs that result in inaccurate or incomplete information provided to the users.
  • Low: complaints categorized as low impact represent minor failures that have minimal impact on safety and performance. While these issues may be undesirable and require correction, they are unlikely to cause significant harm to patients or impair the overall functionality of the software to a critical extent. Low impact complaints could include cosmetic issues, minor usability issues, or non-critical errors that do not affect the core functionality of the software or its ability to provide accurate diagnostic information.

The evaluation of the complaints' criticality is recorded in the field called Priority within the complaint ticket in Hubspot.

By categorizing customer complaints related to the product (appropriate complaints) into these classes based on their impact on safety and performance, we can prioritize resources and efforts more effectively, ensuring that critical issues are addressed without undue delay.

The JD-005 will also determine if the customer complaint is an incident (according to the definition in GP-004 Vigilance system) and, in case of incident classified as serious, the process explained in GP-004 Vigilance system will be followed to notified Regulatory Authorities.

In the event of a product defect that requires the recall of the device from the market, we will follow the process explained in GP-004 Vigilance system.

note

According to the nature of our product, we did not specified the "Handling of complaint-related product" as the only "handling" of the product we can perform is to block the access to it to the customer, that will be properly indicated at the investigation of the complaint or in the associated CAPA (T-006-003 CAPA report).

Customer complaint resolution​

If the evaluation of the complaint concludes that it is required to apply a corrective or preventive action, the complaint will be managed according to GP-006 Non conformities. Corrective and preventive actions. The owner of the complaint will open the corresponding CAPA and register the CAPA code at the Hubspot complaint ticket to allow its traceability. The follow up of the complaint will be then performed in the T-006-003 CAPA report created.

Additionally, the JD-005 determines its possible impact on the product risk management to update the T-013-002 Risk Management Record and to establish the measures required in each case.

Proactive customer's feedback collection​

Proactive customer's feedback is collected through different channels:

  • Regular meetings with clients scheduled before and during the contract agreement.
  • Phone calls: The sales team contact monthly each client to ensure they have no problems, incidences or doubts regarding the product and its use, and to receive any possible suggestion they want to communicate. A brief summary of the phone call is noted down at the client section within Hubspot.
  • Periodic customer satisfaction surveys:
    • We perform this surveys quarterly, as it is registered at the R-002-005 Quality calendar.
    • The surveys are defined in the T-014-001 Customer Satisfaction Survey.
    • Surveys are provided to the customers using the tool Google forms to be completed.
    • The sales team keeps the files with the surveys answers and analyzes them.
    • The most important metric we consider is the NPS (Net Promoter Score). We have assigned a 1 to 10 range, being 1 to 6 a negative result, 7 to 8 a null result and 9 to 10 a positive result.
    • We analyze the results of the survey by the following sectors: Customers, practitioners and patients.
    • We review the score obtain each period and share it with the team at the quartely business meeting update in order to establish new actions if the target defined it is not achieved (the target is established on a yearly basis).

In the event that the analysis and evaluation of the T-014-001 Customer Satisfaction Survey recommends taking actions to improve the QMS or the product, these will be evaluated during the annual management review to plan and establish the actions required to achieve the improvements approved by the top management.

Associated documents​

  • T-002-004 Annual management review report
  • R-002-005 Quality calendar
  • GP-004 Vigilance system
  • GP-006 Non-conformity. Corrective and preventive actions
  • T-006-003 CAPA report
  • T-006-002 List of non-conformities, claims and communications
  • GP-007 Post-market surveillance
  • T-013-002 Risk Management Record
  • T-014-001 Customer Satisfaction Survey
  • GP-017 Technical Assistance Service

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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T-013-003 Risk management report
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Templates
  • Procedure flowchart
  • Purpose
  • Scope
  • Responsibilities
    • JD-001
    • JD-004
    • JD-005
    • JD-016
  • Inputs
  • Outputs
  • Definitions
  • Development
    • Information coming from customers
      • Customers management tool
    • Communications management
    • Customer complaint management
      • Customer complaint investigation and evaluation
      • Customer complaint resolution
    • Proactive customer's feedback collection
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)