| qms_version | 2.2.0 |
|---|---|
| sop_version | 2.0.3 |
| Document ID | CSC PR.015 |
| Document Version | 2.0.3 |
| Author | |
| Approval | |
| QMS Version | 2.2.0 |
| Regulatory References | ISO 13485:2016, sections 6.2 and 7.1 |
This SOP provides instructions for the management of personnel interacting with this QMS. It determines the personnel necessary to operate the processes of the QMS and the personnel needed to achieve conformity of products and services, and they ensure they are trained properly.
The processes in this document must be followed by all staff interacting with this QMS.
| Acronym | Definition |
|---|---|
| QMO | Quality Management Officer |
At the start of the project the following roles must be allocated. The persons filling each role must have adequate training to fulfill the role.
| Role | Description | Responsibility |
|---|---|---|
| Team Lead/Supervisor | CSC Team Member | Responsible to ensure that the employees working in their team are trained and qualified for the tasks assigned to them. |
| HR Manager | CSC Team Member | Determines the training and qualification requirements per individual role that are outlined in the quality manual. |
The organization (Trust HR) keeps the employees' HR file. The HR files includes:
- Employee contract and contractual agreements
- Personal identification (e.g. passport scan)
- Proof of qualifications (where relevant)
The general aim of employee training is to ensure the necessary competence of employees to perform their tasks. At minimum, it must ensure that employees are aware of the relevance of their tasks and how they contribute to achieving the quality objectives of the organization (ISO 13485, para. 6.2).
Training may take different forms as deemed most suitable by the instructing employee. Training methods may entail:
- Internal or external workshop
- Media and self-study material (e.g. videos, training documents)
- Talks and interviews with coworkers or supervisors, supervised working
The QMO should be involved anytime alternative training methods are chosen, in order to ensure appropriate training evaluation is guaranteed.
Completed training is documented as part of the organization’s training documentation (both CSC internal and Trust wide). For external seminars, respective training records (e.g. certificates) are saved as part of the HR file of each employee and should include at minimum: employee name, training method and content, date and signature of one of the CSC members competent in the subject.
Completed training is evaluated to ensure effectiveness of training and that employees are qualified to perform their tasks. For effectiveness evaluation, different methods can be used:
- Test / questionnaire
- Monitoring job performance
- External testing
- Where no evaluation is included in the training, effectiveness is typically confirmed by the supervisor after completion of training and also documented by the QMO as part of the organization’s training documentation (see CSC-I-003 Authorisation Log).
Training needs may arise from specific roles within the organization.
Employees speaking to a professional community or instructing on the handling of the organization’s medical devices must receive training on their tasks and responsibilities and regulatory requirements according to the law as well as product-specific training that should be repeated regularly and based on substantial product changes. The QMO is responsible to keep a list of the organization’s trained staff including the date of their latest training.
Besides the initial on-boarding, new training need may arise from one of the following:
- Annual due date: the QMO may define annually recurring training.
- When new processes are added to the QMS
- Changes in job role: certain job roles require role-specific training
- Non-conformities: root cause analysis of CAPAs may reveal additional training needs
- Regulatory changes: QMO may determine further training need when applicable regulations are changed
| Participants | QMO Employee Team Lead / Supervisor |
| Input | Additional training need |
| Output | Updated training documentation |
At minimum once per year, supervisors schedule a Performance Development Review (PDR) with their employees to exchange feedback, to discuss the employee’s personal and professional development goals and also to identify additional training needs required to achieve development goals.
| Participants | Employee Team Lead / Supervisor |
| Input | Performance Development Review |
| Output | PDR record (stored on HR portal) |
Upon notification that an employment contract is terminated, the Trust HR Department is responsible for performing the administrative off boarding. This includes:
- Timely removal of access rights to software tools and Trust Premises.
- This will be conducted by GSTT Trust HR and IT.
- Observing data deletion periods:
- Administrative data (name, address, title, dates of employment) is deleted 3 years after termination of employment.
- The employee’s business email account is suspended and deleted 60 days after termination of employment (requested by CSC lead, performed by Trust IT)
- All other personal data is deleted immediately after termination of employment.
- Where applicable, third-party processors are notified to also delete personal data.
The following task must be conducted by a QR or the QMO within GitHub:
- Removal of user accounts from the CSC team in GitHub so code cannot be changed after the termination of employment
- Reassigning any "Process Owner" roles held in the QMS.
- Reassigning "Process Owner" status and SOP responsibility to an appropriate member of staff.
- Reassigning any roles held within CSC software development projects.
- Removal from the Authorisation Log. The staff members training records will remain in the repos history
| Participants | HR Manager |
| Input | Termination of employment |
| Output | Removal of access rights Updated documentation: deleted data |
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