Compass Health AI Quality Systems Audit SOP (QMS-SOP-0023) PDF

Compass Health AI SOP: Quality Systems Audit 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...

Compass Health AI SOP: Quality Systems Audit 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 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 1 Introduction Internal audits are critical to the success of the Quality Management System at Compass Health. They help to determine the functionality and effectiveness of the system. Internal QMS audits aid in determining if problems have arisen because the system needs to be improved, or because the documented system is not being followed. Along with corrective actions and management review, audits supply important information to make sound business decisions, and they provide information for continuous improvement opportunities. The results of these audits form an integral part of our management system. 1.1 Scope This procedure identifies actions and responsibilities for conducting and reporting internal audits of the Compass Health Quality Management System. Internal audits take place on a planned basis over the course of a year. The internal audits will inspect actual practice against the requirements of the SOPs. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.22 Quality Audit ISO 13485:2016 Section 8.2.4 Internal Audit TG(MD)R Sch3 P1 1.4(5)(b)(iii) 2.2 Reference Documents Document Title Document # Control of Records SOP QMS-SOP-0003 Corrective and Preventative Action QMS-SOP-0031 Internal Audit Checklist QMS-FRM-0016 CAPA Form QMS-FRM-0012 3 Acronyms and Definitions Table 1: Acronyms Acronym Description QA Quality Assurance SOP Standard Operating Procedure QMS Quality Management System CAPA Corrective Action Preventive Action QAM Quality Assurance Manager Table 2: Definitions Term Definition Corrective Action The action taken to eliminate the cause of a detected non-conformance. Corrective action is taken to prevent recurrence. Corrective Action Form used to document non-conformance, the Request resulting corrective action and follow-up to determine if the corrective action has been completed in a satisfactory manner. Internal Audit / Quality A systematic and independent examination to System Audit determine the effectiveness of the quality  management system ensuring adherence to SOPs, and the applicable regulatory requirement(s). Non-conformance Failure to adhere to the Quality System, required standards, policies, procedures, regulations etc. Standard Operating The written instructions and records of procedures Procedure agreed and adopted as standard at Compass Health. 4 Process Roles Role Description of Responsibilities QA-RA The QA-RA is responsible for: Organizing internal quality audits. A person or team to carry out each audit. The lead auditor will be independent of the area being audited. Ensuring that corrective actions are closed out in a timely fashion, within determined close-out dates whenever possible, this is a joint responsibility with the representative of the area being audited. Reporting results of the audit(s) to Management. Auditor / Audit The Auditor/Audit Team is responsible for: Team Arranging a suitable time for the audit with the representative. Reviewing the SOP and from this, developing an audit checklist. Completing the audit and audit report. Shall not audit their own work and ensure objectivity and impartiality of the audit process Department The Representative of the area/activity being audited is Representative responsible for: Cooperating with the internal auditor to provide information needed to conduct the audit.  Progress corrective actions to completeness, within determined close-out dates whenever possible. Department The Department Team is responsible for: Team Cooperating, to the extent possible, with the auditor(s) in interviews and provision of information, as required by the auditor. Management Management is responsible for: Resolving and facilitating a solution if Corrective Actions cannot be agreed between auditor and auditee’s representative. CAPA The administrator is responsible for: Administrator monitoring the progression of CAPAs and to verify and close CAPAs upon completion 5 Quality System Audit Process To foster employee awareness and continuous process improvement, we perform systematic process audits, based on status and importance rather than conduct complete system audits annually. Figure 1: Quality System Audit High-Level Flow 5.1 Responsibility for Audits The Regulatory Affairs Lead shall be designated by Top Management to lead the audit effort by scheduling, conducting, reporting and managing the internal audit process. 5.2 Scheduling Audits QA-RA shall, each year, prepare an approximate audit timetable for the forthcoming year, and circulate to Compass Health staff. The timetable shall be approved by QA-RA Manager. Adherence to SOP requirements will be subject to audit at least once during a 12-month period, where possible. If required to postpone an audit beyond the 12-month period for unforeseen circumstances, such circumstances shall be documented, and the audit rescheduled for as soon as practicable. 5.3. Lead Auditor Selection QA-RA is responsible for selecting the lead auditor and notifying the appropriate auditees' Department Representative at least three working days prior to audit to make appropriate arrangements. The lead auditor shall not audit their own work to ensure objectivity and impartiality of the audit process. The lead auditor must possess a strong understanding of ISO 13485 standard under the MDSAP audit program, as well as regulatory requirements of applicable jurisdictions. Compass Health may select an external contractor (evaluated as per SOP: Supplier Evaluation and Monitoring) as the lead auditor to conduct Compass' internal audits. Additionally, the lead auditor must meet the following criteria, at minimum: Have sufficient Lead Auditor training for ISO 13485:2016 At minimum, 3 years of experience in the field of medical device regulation Have conducted effective internal audits of Quality Management Systems to assess regulatory compliance to ISO 13485:2016 under the MDSAP audit program Note: If for any reason, Compass selects an individual that does not meet at least one of these qualification/criterion, justification must be provided in the supplier evaluation form completed for the supplier to outline why the individual was selected to perform internal audits nevertheless. 5.4 Conducting the Audits Compass Health evaluates QMS processes by determining: 1. if the process is identified and appropriately defined 2. that responsibilities are assigned 3. that procedures are implemented and maintained 4. that the process is effective in achieving the desired results The QA-RA shall develop an audit plan, which includes the documentation to be audited, a checklist of items to review, and sample questions to ask. An entrance briefing will be conducted with the QA-RA and Department Representative to discuss the purpose and requirements of the audit, identify all points of contact, and discuss any other concerns. Any findings from previous audits on that area will be reviewed to follow up any observations and outstanding corrective actions. The audit shall be conducted, and findings, positive and negative, are recorded by the auditors during the audit, on the audit checklist. The audit checklist shall be dated and retained as a record according to SOP: Control of Records to ensure traceability to the audit. The audit findings will be discussed with the representative at the end of the audit to ensure the auditor and representative are in agreement with the auditors’ findings. At the conclusion of the audit, the internal audit checklist (QMS-FRM-0016) shall be completed. The audit record shall include the following: Dates of the audit and/or reaudit Non-conformances raised during the audit Follow-up on corrective actions from previous audits Any observations noted A conclusion statement summarizing the number of non-conformances raised and processes audited 5.5 Corrective action The QA-RA shall issue a Corrective/Preventative Action (CAPA) Request, per SOP: Corrective and Preventative Action, for any non-conformances identified and agreed during the audit. The Audit Team shall provide the audit report, referencing any CAPAs to the Department Representative for evaluation and action within one month of the audit. The audit report shall be circulated to the Department Representative and Team. Any CAPAs raised during the audit shall have a follow-up ‘completion’ date assigned, based on agreed actions. All necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. The agreed action date should take into account the severity of the non-conformance and the expected time needed to complete the corrective action. The non-conformances are categorized as follows: Critical – Non-conformances which constitute a serious existing failure of the QMS, resulting in poor quality product from Compass Health, or noncompliance with regulatory requirements, or which are a combination of major non-conformances, indicating a critical quality system failure. This type of deficiency must be corrected as the highest priority. Major – Non-conformances which could potentially lead to a failure of the QMS that could result in poor quality product from Compass Health, or noncompliance with regulatory requirements, or which are a combination of minor non-conformances, indicating a potential major quality system failure, or a number of repetitive minor non-conformances. Requires corrective action to be agreed as a priority. Minor – Any deficiency which cannot be classified as critical or major. Requires corrective action to be agreed, but is not a high priority. 5.6 Corrective / Preventative Action Request Follow Up Upon completion of the agreed corrective or preventative action, the CAPA Administrator shall record the status on the CAPA. The CAPA Administrator shall assess the effectiveness of the action taken, and record findings on the CAPA. If results are deemed satisfactory by the CAPA Administrator, the CAPA shall be closed, per SOP: Corrective and Preventative Actions. In the event the actions are incomplete, a new date is agreed between the CAPA Administrator and the Department Representative, and the reason for incomplete actions noted on the CAPA. If problems persist, Management shall be notified. The CAPA is closed when the CAPA Administrator is satisfied that required actions are complete. CAPAs are tracked using the CAPA Log (QMS-LOG-0007) and are reviewed on a regular basis by the CAPA Administrator, per SOP: Corrective and Preventative Actions. 6 Process Monitoring QA shall periodically review audit reports and CAPAs to ensure a pattern of timely and successful action in response to non-conformances. Results of the review shall be made available to management at the QMS Management Review. 7 Quality Records Record type Description Internal Audit Recorded findings (positive and negative) by the auditors Checklist during the audit Internal Audit Includes non-conformances raised during the audit and Report follow-up on corrective actions from previous audits, as well as any observations noted. References any CAPAs to the Department Representative for evaluation and action within one month of the audit and is circulated to the Department Representative and Team. The audit report shall also include the conclusion.