Compass Health AI SOP: Competence and Training PDF

Compass Health AI SOP: Competence and Training 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: Competence and Training 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-0005 Revision History Version Date Description 1.0 03-Jan Initial Release 2024 Document # QMS-SOP-0005 1 Introduction This procedure provides a process and assigns responsibilities for identifying employee training needs and providing the required training, for ensuring that employees are assessed as competent to perform their job, for ensuring that they are aware of the relevance and importance of how they contribute to the achievement of product quality and quality objectives, for assessment of training effectiveness, and for maintaining training records. 1.1 Scope This procedure applies to all training programs and is applicable to all Compass Health personnel; regular, full-time or part-time. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 6.2 Human Resources TG(MD)R Sch3 P1 1.4(5)(b) – Requirements of the Quality Management System 2.2 Reference Documents Document Title Document # Training Record Form QMS-FRM-0011 Document # QMS-SOP-0005  Personnel Training Matrix QMS-LOG-0006 SOP: Document Control QMS-SOP-0002 3 Acronyms and Definitions Table 1: Acronyms Acronym Description CAPA Corrective and Preventative Action HR Human Resources QMS Quality Management System Table 2: Definitions Term Meaning The overall intentions and direction of an organization with respect to Quality Policy quality, as established by management with executive responsibility. The Quality Objective is established at relevant functions and levels Quality within the organization. The quality objectives are measurable and Objective consistent with the quality policy. Document # QMS-SOP-0005  An individual or group session where a new employee or personnel is Training provided with the required knowledge and competency to satisfy their assigned duties. 4 Process Roles Role Description of Responsibilities Department Heads responsible for determining on an individual basis any additional training necessary for an employee on their Functional team. managers Also ensures that training is completed by each employee within the time frames specified in the Training Plan Verifying compliance to this procedure QA-RA Retention and storage of all documents and records Required to participate in QMS orientation training which outlines New employees the Quality Policy, Quality Objectives and provides awareness of how their individual job function affects product quality once hired Required to ensure they have the training necessary to maintain Current their qualification, experience, and competency for tasks which employees they are responsible. Document # QMS-SOP-0005 5 Process 5.1 Competence and Awareness As part of the hiring process, employees are assessed to determine if they have the required qualifications, experience, and competency for the tasks for which they will be responsible as per their job description. Objective evidence of qualifications, experience and competency are documented in the employee’s personnel file along with a copy of their job description. Employees are required to sign a contract outlining their responsibilities as per the job description as evidence that they are aware of their job functions and in particular those that affect product quality and quality objectives. All new employees are required to participate in QMS orientation training which outlines the Quality Policy, Quality Objectives and provides awareness of how their individual job function affects product quality. 5.2 Training Plans Compass Health Personnel Training Matrix (QMS-LOG-0006) shall be developed to outline mandatory QMS training for all employees, as well as job specific training required as per departmental function. QA/RA and People Managers are responsible for determining the appropriate training requirements in the Personnel Training Matrix. The Personnel Training Matrix shall be maintained and updated whenever there is a change in company organization, as well as when new QMS materials are introduced, and/or when changes are made to the QMS. All employees are assessed to ensure they have the training necessary to maintain their qualification, experience, and competency for the tasks for which they are responsible. A Training Plan shall be developed by management which identifies for each job function the minimum training requirements. The Training Plan shall also include requirements for training completion of QMS training as determined in the Compass Health Personnel Training Matrix (QMS-LOG-0006). Functional Managers are responsible for determining on an individual basis any additional training necessary for an employee on their team. Training will be assigned to all employees within a month of approving the document, as per the Personnel Training Matrix. It is the responsibility of the Functional Manager to ensure that all assigned training is completed by each employee within the time frames specified in the Training Plan. Document # QMS-SOP-0005 QA-RA shall employ training, including coverage of the Quality Manual and the mandatory SOPs for all employees within three months of the employee's start date. The Training Record Form (QMS-FRM-0011) must be completed and the training record must be logged on the Training Records Log (QMS-LOG-0006) after completion of all training. 5.3 Training Effectiveness Effectiveness of training is evaluated, at a minimum, every 18 months at the employee’s performance review. Effectiveness of training is also evaluated on an on-going basis through such means as: written assessment by the hiring manager, quiz employed at the end of training courses, Internal Audits, CAPA investigations, or any other means deemed suitable by the Functional Managers. If an employee requires subsequent re-training, it is the Functional Manager’s responsibility to ensure it is completed and documented in a timely manner. 5.4 Retraining All personnel shall be retrained in applicable procedures as necessary. In general, retraining shall occur when revisions are made to the QMS and its documentation and re- acknowledgment shall be prompted when security and privacy policies are revised. If an employee requires subsequent re-training, it is the Functional Manager’s responsibility to ensure it is completed and documented in a timely manner. If retraining is required based on the revision made, new training course outlining the changes made will be assigned to all required individuals with the due date for re-training explicitly stated. If retraining is required, it shall be recorded in the SOP Impact Assessments Log (QMS-LOG-0006) 6 Process Monitoring QA-RA or the HR personnel shall ensure that all personnel are trained on the minimum training requirements as identified in the Training Matrix and as determined by their Functional Manager. Employee’s personnel files shall be monitored to ensure all training records and forms are signed and logged into each employee’s training records as Document # QMS-SOP-0005 required. QA-RA or the HR personnel shall also check that all retraining records are updated and filed prior to the effective date of the change. Paper copies of the training records and objective evidence of qualification and competency shall be controlled as per SOP: Control of Records (QMS-SOP-0003). QA-RA/HR Personnel shall generate a Quarterly Personnel Training Report outlining the required training completed by all employees and cross-reference this report to the Personnel Training Matrix to ensure no training is missed. 7 Quality Records Record type Description Internal: A signed Training Record Form (QMS-FRM-0011) and Personal Training report are used to document the training and attendees' records. Training Records External: Written proof of completion of an external course/seminar Personnel Training Matrix Document that outlines the required training for SOPs for each job title (QMS-LOG-0006) Where a manager determines that an employee or contractor already has the required knowledge, competency, experience or training to satisfy a requirement on the training matrix, or that a mandatory training is not relevant to the employees’ duties, he/she Training Waiver may waive the requirement and document the justification in a Memo memo. This memo will serve as a quality record and must be kept with the employee’s personnel file. Note: Authors and approvers of controlled documents are not requirement complete the training, nor a waiver memo is required Document # QMS-SOP-0005 SOP Impact Log capturing SOP impact on QMS/Product and any SOP changes Assessments Log and whether re-training is required. QMS-LOG-0006) Document # QMS-SOP-0005