Control of Documents SOP - CMS MedTech



1. PURPOSEThis procedure describes the requirements for identifying training needs, executing training programs, evaluating the competency and maintaining records of training so as to ensure proper assignment of job functions within Manufacturer’s name.2. SCOPEThis procedure applies to all employees within Manufacturer’s name who perform work that will impact the quality of the products and/or services. Therefore, they need to be trained sufficiently to demonstrate job competency.3. RESPONSIBILITIESThe HR Manager is responsible for the implementation of this documented procedure. Each Department Head is responsible to ensure that the training required by the employees in their section is planned and carried out in a timely manner. All training records are individually documented and filed for each employee.4. REFERENCE DOCUMENTSControl of Documents SOPControl of Records SOPISO 13485: 201621 CFR 820 etc5. DEFINITIONSNIL6. PROCEDURE6.1. RecruitmentPersonnel is recruited and assigned to their respective job based on the proposed academic background, relevant job experience and skillsets as defined using the Job Description Form. The job description of a new or existing hire must clearly indicate his/her role and, necessary background and competence to perform his/her role. This description includes how their job scope supports the achievement of the quality objectives.?The hiring manager shall prepare the job description and be reviewed and approved by the management. 6.2. Training (New Employee)It is the responsibility of the hiring manager to assure that new employees are competent for their position. Using the Employee Training Form, the training required can be established from the job description for the position as well as in Appendix A: Training Matrix, where it shows the respective procedures required for each category of hires to be trained. The hiring manager may input additional scope for training the new hire if required.Hiring managers are responsible for notifying the management and QA Engineer before the new employee starts work so that any administrative and logistic issues can be done prior to that. The Organisation Chart must be updated to include the new hire.The hiring manager is responsible for ensuring the employee is familiar with all relevant procedures. Training is often conducted via a briefing of the company procedures, “hands-on” or one-on-one training, participation in-group training sessions, or other means. The hiring manager must evaluate the effectiveness of the training for the new employee, prior to starting the tasks related to the respective procedures.6.3. Training (Current Employee)A current employee performing any new procedures must be?trained prior to performing the respective tasks. This is usually done by updating their individual Employee Training Form for any new training provided. For any change in procedures (design and/or process), training is allocated as part of the document change process. The updated documents (indicating the amended procedures) can only be implemented when training is completed. This may include procedures, which an employee may perform and are not previously listed as a job function requirement in Appendix A.When there are employees that need to undergo re-training or to participate in any external courses so as to maintain their ability to perform certain tasks, the hiring manager should plan and arrange for it?to be conducted.?This is done similarly via the Employee Training Form.When an employee is reassigned to a new position, the hiring manager shall assess if additional training is required based on the Appendix A. Concurrently, the hiring manager will need to complete the Job Description Form and Employee Training Form (for the new role) and submit it to the QA Engineer.The hiring manager must evaluate the effectiveness of the re-training, prior to starting the tasks related to the respective procedures.6.4. Training MethodsClass / Group Training: Employee trained by the supervisor or other qualified trainers in a group setting or one-on-one.? A qualified trainer is one who has previously been trained to the relevant document/procedure or is the author of the procedure.?This includes any external training performed by professional trainers, either in-house or off-site. If the training is conducted by an external trainer (where he/she is not linked to Manufacturer), the superior/manager can review and sign the Employee Training Form on the trainer’s behalf.Self-Training (applicable to new, current and revised documents): Where applicable, the employee may be instructed by their manager/supervisor to undergo self-training/reading of a new or revised document. All self-training requires verification that the training was effective. In most cases, this verification is performed by the individual’s manager/supervisor verbally or written. The employee may also demonstrate training effectiveness by achieving the output that meets the requirements stated in the procedures.6.5. External Service ProvidersIn the event where an external service provider, such as a regulatory consultant or specialist who is hired to perform certain specialised activities, e.g., internal audits, training, he/she must be evaluated based on their experience, certification and track records in this field.6.6. Evaluation of Training EffectivenessBefore the year ends, as part of the employee’s appraisal and review, the effectiveness of the employee’s training must be evaluated. This is done using the Employee Training Effectiveness Form. The purpose is to evaluate if the training has been effective for the employee and determine if there is a need for re-training or new training. This will help in the employee’s performance at work as well as his/her career progression.?The intensiveness of the evaluation must?be proportional to?the risk associated?with?the employee's job scope or work involved.6.7. Training RecordsThe management of Manufacturer will work with the Head of Departments and the individual staff to discuss their relevant training needs. Any courses and seminars can be planned ahead for the next year using the Annual Training Plan Form. This helps in the allocating of resources and budgets to ensure that the training and competency of staff are maintained.6.8. Training RecordsAll job description, training records, certificates and other relevant documents shall be filed according to the QA department.7. ATTACHMENTSJob Description FormEmployee Training FormEmployee Training Effectiveness FormAnnual Training Plan FormThis is the end of the document.Author: QA Engineer representing QA department.DCR No.Version No.AuthorImplementation DateDescription of Change01HR ExecutiveInitial ReleaseAPPENDIX A: TRAINING MATRIX QM Quality ManualDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable SOP1 Control of Documents SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Control of Records SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Control of Non-Conforming Product SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Corrective and Preventive Action SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Management Review SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Internal and External Audit SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Field Safety Corrective Action (FSCA) Reporting SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Adverse Event Reporting SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Good Document Practice SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Design Control SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Verification and Validation SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Change Control SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Risk Management SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Competency and Training SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Maintenance of Infrastructure and Calibration SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Maintenance of Work Environment SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Production Control SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Process Validation SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Software Validation SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Purchasing SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Feedback and Complaint Management SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Traceability and Identification SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicable Sales Execution SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Software Design Control SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Control of Software Release and Maintenance SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableApplicable Software Configuration Management SOPDirectorManagerEngineer &?ScientistPersonnel to be trainedApplicableApplicableNote: The associated job title/function shall fall under the main job categories as listed in the table above (i.e. the senior manager title shall fall under the “Manager” column as above; assistant engineer shall fall under the “Engineer” column as above). ................
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