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This SOP provides the processes for establishing competence, providing needed training, and ensuring awareness of personnel using the eQMS called FormlyAI.
This SOP covers all employees of the manufacturer that are required to perform their job role to ensure product quality and meet regulatory requirements for compliance. It encompasses the processes for onboarding and offboarding employees, providing initial and ongoing training, setting employee requirements, and facilitating communication between supervisors and team members. The aim is to ensure that the organization retains adequately qualified staff to uphold product and company standards.
Each employee within the organization is assigned a specific role, accompanied by corresponding tasks, responsibilities, and required qualifications. This ensures that employees are capable of performing their duties to maintain product quality and regulatory compliance. Supervisors or team leaders are responsible for verifying that their team members are adequately trained and qualified for their assigned tasks. Before assuming a new role, whether as a new hire or due to a job change, employee qualifications are assessed against predefined criteria.
The Quality Team (or equivalent role) determines the training and qualification requirements per individual role.
The organization maintains information about each employee, which may include the following documents, as needed:
The employee records and the content within them are subject to the protections and rights given to the employee based on the country and region of operation and location of the business and employee.
Every employee will be subject to training to ensure the understanding of the quality management system and company and product processes so that each employee can perform with the quality required of them. Employees must be made aware of the relevance of their tasks and how they contribute to achieving the quality objectives of the organization.
Training should be performed in a medium and form that allows the employee to understand the content and apply it to their work. Training can occur in person or virtually. Some examples of training methods are:
The Quality Team (or equivalent role) is responsible for assigning training assignments to employees. All new or updated SOPs are required to be sent to employees for which it is deemed relevant when updated for confirmation of understanding of the content or changes to the SOP.
Completed training is documented as part of the organization's training documentation. Group training records can be used in order to document training for multiple employees, as needed.
All training is verified by the supervising manager through job performance reviews. Additional verification can be performed through testing of employees or certifications that are received by employees for their training, although this is not always required and may be assigned on a case-by-case basis given the employee's role. Should a performance review by a supervisor prove that training has not been effective, the HR team will be made aware and changes to the training procedure will be considered.
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Person Responsible for Regulatory Compliance (PRRC)
A PRRC is required to have specialized training prior to assuming their role. The PRRC is intended to ensure that the supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance, who fulfills the minimum conditions of qualification for the role. According to Article 15 of Regulation (EU) 2017/745 the PRRC should meet one of the following criteria:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
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Once an employee has signed their employment contract and joined the company, adequate resources shall be provided to that employee so that they can perform their job with sufficient performance to ensure product quality. This can include providing hardware (laptop, phone, etc.) and access to other resources (company software, office space, etc.).
Then, that employee shall receive initial training as required by their role on the quality management system as well as any other company processes that are required for their work in order to perform their job to the required quality to maintain product quality, safety and performance.
Following initial training, continuous training should occur as needed based on the following:
Additionally, HR and Management should ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
Supervisors conduct performance reviews with their employees at least once a year to exchange feedback, discuss the employee's development, and identify any additional training needs. If additional training is required, the HR team is informed and decides on the appropriate resources to support the employee's development.
