Compass Health AI SOP: Complaint Handling PDF

Compass Health AI SOP: Complaint Handling Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin...

Compass Health AI SOP: Complaint Handling Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document# QMS-SOP-0026 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-0026 1 Introduction The purpose of this procedure is to provide for instructions and a system for handling, initiating, receiving, resolving and maintaining records of customer complaints and other customer feedback relating to the quality of Compass Health products. Complaints can provide valuable feedback on the effectiveness of an organization and can be used to improve Compass Health’s products with the customer in mind while allowing Compass to provide customers with access to an open and responsive complaints-handling process 2 Scope This procedure incorporates all internal and external customer complaints concerning Compass Health Inc. inclusive of investigational devices. 3 Applicable and Reference Documents The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 8.2.2 Complaint Handling Canadian Medical Device Regulation (CMDR-(SOR/98-282) Section 57 & 58 Complaint Handling FDA QSR § 820.198 Complaint Files, § 803 Medical Device Reporting Document# QMS-SOP-0026  TG(MD)R Sch1 P1 2 – Design and construction of devices to conform with safety principles, Sch3 P1 1.4(3)- Post market requirements, 1.4(5)(b)(iii) &1.4(5)(f) – documentation of post-market experience 3.1 Reference Documents The following documents, templates and forms are referenced within this procedure and are related to the Product Development Process: Document Title Document # SOP: Control of Records QMS-SOP-0003 SOP: Management Review QMS-SOP-0004 SOP: Control of Nonconforming product QMS-SOP-0024 SOP: Device Recall and Advisory Notices QMS-SOP-0028 SOP: Medical Device Reporting and QMS-SOP-0029 Mandatory Problem Reporting SOP: Corrective and Preventive Action QMS-SOP-0031 4 Definitions and Acronyms Table 1: Acronyms Acronyms Term Document# QMS-SOP-0026  NC Non-Conformance CA Corrective Action Table 2: Definitions Term Meaning Action to eliminate the cause of a potential nonconformity or other undesirable situation. Corrective Action NOTE 1: There can be more than one cause of non-conformity. NOTE 2: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, Incident might lead—or might have led—to the death of a patient, or USER or of other persons or to serious deterioration in their state of health. A person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for Manufacturer designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. Device Complaint A complaint that is communicated in a written, oral or electronic method alleging deficiencies in: Identity, quality, durability, Document# QMS-SOP-0026  reliability, safety, effectiveness or performance of a medical device after its release for distribution. The use for which the device is intended according to the data Intended Purpose supplied by the MANUFACTURER on the labeling, in the instructions and/or promotional materials. Act or omission of an act, that has a different result to that User Error intended by the MANUFACTURER or expected by the OPERATOR of the MEDICAL DEVICE. The health care institution, professional, care giver or patient User using or maintaining MEDICAL DEVICES A general complaint constitutes all other complaint types that are not device complaints as stated above. General complaints can General Complaint be about: Advertising, availability, lost or error in product delivered, errors in billing, pricing etc. MDR Reportable A complaint that is mandatory to report to FDA as per 21 CFR Part Complaint 803. The individual or facility that initially reports the complaint to Complainant Compass Health Inc. A malfunction is said to occur when there is a failure of such device to meet its performance specifications or not to perform Malfunction as intended. Performance specifications include all claims made in the device labelling. Mandatory Problem Reporting (MPR) - A mandatory problem report is required under section 59 (1) of Health Canada the Medical Devices Regulations of Canada for any incident Document# QMS-SOP-0026  involving a medical device that is sold in Canada when the incident occurs either within or outside Canada; i) relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labeling or in its directions for use (section 59 (1)(a)); ii) and has led to death or a serious deterioration in the state of health of a patient, user or other person or could do so if it were to recur (section 59 (1)(b)). The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action or unless the regulatory agency has required the manufacturer to take corrective action A MDR is mandatory to report to FDA when one of the following occur: When Compass Health Inc. receive information or become Medical Device aware of such information that reasonably suggests that one of Reporting (MDR) - its marketed devices (1) may have contributed or caused a death FDA or serious injury or (2) that a device malfunction occurred and is likely to cause a death or serious injury if such malfunction were to recur. The following classifications are: Defect, not-a defect, Complaint enhancement, and change requests, CARs, product Classifications nonconformity record (PNR), general complaints and/or feedback. Comes usually from a user or product group that suggests a Change Request modification of device features behaviour as per the device specifications. Document# QMS-SOP-0026  A user or product group requests an extension of device features Enhancement or a new feature to satisfy a new requirement or from a wish list of requirements. Request to take action to eliminate the causes of an existing non- Corrective Action conformity, defect or other undesirable situations in order to Request (CAR) prevent recurrence. TABLE 1: SEVERITY CLASSIFICATIONS An issue that a) causes a total system failure, causes defects that corrupt images or cause loss of images or misrepresentation of data, Critical Issue and b) could cause serious injury to a person, and c) there is no workaround at the application level, and d) reports of incidents alleging adverse events, with respect to any MDR/MPR applicability An issue which potentially hinders clinical use of the product, and Serious Issue results in a degradation of productivity which is an inconvenience to the user. A workaround is available. Moderate An issue which may be considered an annoyance or inconvenience to Issue the user. Cosmetic issues that do not impact the functionality or performance of Minor Issue the product Document# QMS-SOP-0026 5 Process Roles Role Description of Responsibilities Engineering Assist in processing all complaints when required Maintains records of all formal complaint investigations. Informs top management of all pertinent information (MDR, CARs, Recall and Advisory Notices). Review complaint tickets in liaison with the Customer Success and Engineering QA Team and coordinate all MDR complaints. RA Planning verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance specific to vigilance activities Reviewing complaint trends Responsible for all communication/notification between relevant parties (ie. US FDA Agent) Product Size and schedule fix to resolve complaints Receives, defines, classifies, logs and closes out all complaints with the help of Engineering, if necessary Maintains general and device complaint logs Customer Success Maintains general support web interface Participates in complaint review meetings and monitors complaint trends All Employees Report complaints to Customer Success Document# QMS-SOP-0026 6 Receiving and Recording Complaints Complaints originate from both internal and external sources. Internal complaints are typically received from Quality Assurance, Management, Marketing, Engineering and/or Engineering QA Teams; whereas, external complaints are received from partner companies/user sites and/or clinical beta sites. Complaints may be received via Compass Health’s support web interface (managed by Customer Success), verbally or via email from the Complainant. Upon receiving a complaint, Customer Success verifies the complaint and will request for more information if necessary. All complaints are recorded electronically and is maintained by Customer Success. 6.1 Complaint Classification Complaints are classified into “General” complaints and “Device” complaints General Complaints include: Inaccurate quantity or product shipped Customer receives late delivery Issues of communication and responsiveness Disputed or invoice errors Complaints of business practices, publicity practices etc. Customer Feedback (not product-related) Device complaints include, but are not limited to: Failure to meet labeling and packaging specification Failure to meet quality specification Durability Reliability Safety Breaches of privacy and Security Effectiveness Performance Product, process and/or quality system regulatory nonconformity Document# QMS-SOP-0026 6.2 Customer complaint logs Complaints will be stored as electronic records. Complaints received from channel partners and /or users will be recorded and tracked through Compass’s Complaint Handling Software. The following details shall be recorded Complaint Handling Log, as part of the support ticket description, if applicable, in each complaint record: Reference id or Ticket ID s (e.g. Support ticket number, defect tracking number) Full identification of the originator including contact information or reference to customer contact information. Name, number and identification of medical device (may not be applicable to general complaints); Description of complaint; Determination of Reportable complaint (refer to Section 8); Risk Assessment; Returned or soon to be returned medical devices; Complaint response; Decision of whether a formal investigation is required and justify if not as well as the responsible party making this determination; Any corrective and/or preventive actions taken and reference such actions Status Affected Software version Date & Time Created NOTE: External representatives who learn of any complaint are responsible for reporting such complaints to the Product Team even if they are dealt with on-site. 7 Device Complaint Processing 7.1 Complaint Assessment Upon receipt of the complaint, all device complaints are evaluated by the Customer Success team (with input from Engineering/Product as needed). Complaints shall be classified based on the severity classifications listed in Section 4 – Table 2. Document# QMS-SOP-0026 7.2 MDR/MPR/Device Recall Assessment Customer Success team shall alert the Regulatory Affairs (RA) team as soon as possible following the report of an incident alleging an adverse event, with respect to any MDR/MPR and Vigilance applicability. All reportable complaints must be marked as critical issues. However, not all critical issues are reportable complaints. Once alerted, the Regulatory team shall investigate to validate whether the complaint in question is indeed a reportable complaint. If deemed as a reportable incident, the complaint is followed up per SOP Medical Device Reporting/Mandatory Problem Reporting. Executive Management or Regulatory Affairs will determine if a recall is necessary in accordance with SOP: Device Recall and Advisory Notices. In the following circumstances, RA will lead the formal investigation: When a complaint in question is deemed a mandatory reportable event under FDA 21 CFR Part 803 or under SOR/ 98-282 section 59 (1) of the Medical Devices Regulations of Canada; When the complaint involves the potential failure of not meeting any specifications of the device, labeling and packaging NOTE: If a similar complaint has already been received and fed into the complaint handling system, there is no need to repeat the complaint handling procedure with the new complaint. Customer success shall also alert the Regulatory Team and/or the Risk Management Team if they determine that there are potential risks to consider. 7.3 Complaint Investigations All complaints shall be reviewed and evaluated to determine whether an investigation is required. If it is determined that an investigation is not required, the decision must be recorded, including the reasoning as to why an investigation is not necessary, as well as the name of the individual responsible for the decision not to investigate. o When it is deemed that an investigation is required, an engineering ticket shall be opened and linked to the compliant ticket. If a fix is required, the fix number shall be identified and included in the engineering ticket to allow for full traceability. o All fix shall go through the product development process as per SOP: Product Development Process (QMS-SOP-0016) and SOP: Software Development Process (QMS-SOP-0017) for softwares. Document# QMS-SOP-0026  For critical issues, Compass Health shall provide an initial response to the complaint originator within 1 hour during primary support hours. Compass Health shall initiate a complaint investigation and continuously provide updates regarding the status of the investigation (e.g. proposed resolution path if known, target timeline for resolution) to the customer. Compass Health will use commercially reasonable efforts to resolve the complaint within 2-3 business days for critical issues. All actions taken in response to the complaints shall be recorded. Critical issues deemed to be reportable complaints will be reported to regulatory bodies as per SOP: Medical Device Reporting and Mandatory Problem Reporting (QMS-SOP- 0038). For serious issues, Compass Health shall provide an initial response to the complaint originator within 2 hours during primary support hours. Compass Health will initiate a complaint investigation and continuously provide updates regarding the status of the investigation (e.g. proposed resolution path if known, target timeline for resolution) to the customer. Compass Health will use commercially reasonable efforts to resolve the complaint within 10 business days for serious issues. Moderate and Minor issues may be resolved in the next product update or release, at the discretion of Compass Health. Quality Assurance maintains records of all formal investigations including: The device name Date of complaint received Device number or identification used (if applicable) Name and contact information of complainant Details and nature of such complaint The investigation dates and result findings Corrective and/or preventive action taken and reference to such actions Correspondence with the complainant If an investigation determines activities outside the organization contributed to the company, relevant information shall be exchanged between the organization and the external party involved. 7.3.1 Non-conforming Product Non-conforming product is handled per the SOP: Control of Non-Conforming Product. Document# QMS-SOP-0026 7.3.2 CAPAs The necessity of carrying out a corrective action to deal with underlying causality is determined by RA. Such action will be in accordance with SOP: Corrective and Preventive Action. If RA determines that some third party or external organization contributed to such complaints, they are duly informed by RA and if required, must comply with corrective and preventive actions. 8 Reportable Complaints The complaint is marked as “REPORTABLE” when an event meets the device reporting criteria under FDA 21 CFR Part 803; under SOR/ 98-282 section 59 (1) of the Medical Devices Regulations of Canada. For Reportable complaints, a complaint form (QMS-FRM-0110) is opened and a formal investigation is initiated. Over and above the required conditions for recording non-reportable complaints, reportable complaints must assess the following items: Was there a failure to meet specifications; Was the device utilized for treatment or diagnosis; and Was the reported incident or adverse effect in any way related to the device NOTE: Complaints that allege injury or a malfunction that may lead to injury will be reported to Compass Health's Management Team within one business day of screening the complaint. Complaints within this category shall be stored and monitored separately from all other complaints. 9 General Complaints Processing Customer Success reviews and processes all general complaints. Customer Success may assign a person from another department to follow up on a general complaint if appropriate. General complaints are logged in Compass’s Complaint Handling Software. The responsible personnel and all communication relating to the complaint will be recorded within the Complaint Handling Software. Customer Success evaluates the following: What personnel should be informed concerning the complaint Document# QMS-SOP-0026  Information sent to the complainant Does the underlying causes of such complaint justify a corrective and/or preventive action General complaints are tracked and followed up by the appropriate department. General complaints are reported on per SOP: Management Review, and SOP: Analysis of Data. 10 Complaint Closure General complaints are closed by the person assigned to follow-up on the general complaint. The date and individual closing the report is recorded in the Complaint Log. Device complaints are closed per the following: For Defects, per the WI: Defect Handling For non-conforming product, per the SOP: Control of Non-Conforming Product For CARs, per the SOP: Corrective and Preventive Action. In the event that the customer fails to respond within 10 business days to a request from Compass for more information, Compass may close the ticket with the following response text: “Due to inactivity, this issue will be closed. Please don’t hesitate to contact us to re-open this ticket.” The Complaint Log shall record the name of the individual closing the complaint, and the date. 11 Complaint Trending Device complaints shall be periodically reviewed, as needed, by RA/Operations/Customer Success to identify adverse trends in product quality and customer satisfaction. Complaint trends that have been determined to exhibit an adverse trend shall be reviewed for Corrective and Preventive Action (CAPA) Document# QMS-SOP-0026 12 Quality Records Record type Description An electronic log QMS-REC-2654_A that all customer complaints Customer are documented on. Supporting documentation of such Complaints Log complaints is filed and correlated with the complaint number. When complaints are required to be reportable to FDA or Health Reportable Canada, the complaint log entry and file are marked as, Complaint files “REPORTABLE”, and the complaint file is stored separately from other complaints. Document# QMS-SOP-0026