Purpose :

To specify the procedure for the training and development of personnel at a GMP site.

Scope :

This procedure applies to the training and development of all personnel within a GMP site including the documentation and retention of training records.

Responsibilities :

Department Managers (DM) are responsible for the identification of training needs and the maintenance of training files.

The DM is responsible for creating job descriptions, and for ensuring that:

• Their employees are sufficiently trained to carry out their duties, prior to commencing work.
• Training identified is carried out.
• Appropriate training records are made and supplied to the HR department.

DMs are responsible for evaluating the effectiveness of training activities undertaken.

Human Resources Manager is responsible for secure storage of employees personnel files.

Procedure Originator is responsible for determining who requires training on Document Change Notification (DCN).

Procedure :

General Training Requirements :

All new employees must be trained to perform their assigned jobs. On-the-job training must be closely monitored by the DM.

All employees must receive training in the Quality Management System (QMS), Quality Policy, relevant procedures and have a basic understanding of GMP regulatory requirements.

Whenever a QMS training deficiency is discovered, the employee shall receive re-training immediately. In the event that multiple retraining is required for the same issue, the SOP will be reviewed for change. When it is determined that an SOP should be reviewed for change, the review will occur within two weeks or at the next monthly management review meeting, whichever is first.

All employees must receive training and assessment in the Good Manufacturing Practices applicable to the GMP site. Annual refresher training shall be documented.

Customer Complaints :

All employees must be trained in what constitutes a customer complaint and in the complaint handling procedure of the site. This must include the importance of forwarding of complaints to the Regulatory Department within one business day of receipt from the customer.

Documentation :

All training shall be documented by the manager or trainer of the employee on the site training Record or the DCN training record. The training records will be maintained by Human Resources.

Training Materials :

All training materials must be retained in a retrievable format with an appropriate reference or attached to the training files.

Recruitment, Induction and Review of Training requirements :

The education, background, training and experience of prospective employees shall be considered with respect to the requirements of the position to be filled and the job description.

DMs are responsible for ensuring that the employees assigned to them are trained or otherwise qualified for the assigned position. Before employees are assigned new jobs/tasks, the DM shall check the QMS Training Matrix to verify that the employee has the required training/skills to perform the newly assigned job.

All employees shall be recruited against a job description. Job descriptions shall be date controlled and acknowledged by the employee.

All relevant qualifications will be verified, with a copy of the original certificate taken and held in the personnel file.

Controlled Environment :

Personnel required to work within a controlled environment or who perform special processes shall receive training in accordance with specified procedures.

Performance Appraisals :

Employees shall have an annual performance appraisal, where training and development needs will be identified, agreed and communicated to the employee. The performance appraisal shall be kept in the employees personnel file. Effectiveness of previous training shall be reviewed during the annual performance appraisal.

During the performance appraisal, it will be determined if any retraining or refresher training will be required and will be documented on the appropriate paper-based or on-line form depending on the position.

All training and development that require external training shall be approved by the DM and HR.

The Training Record will be completed in conjunction with the DM to indicate training requirements and method of validation and will be forwarded to the HR department

Training Methods :

Training methods include online training (STT – Self Training Tool), Coaching (On the Job), observation, self-training, self-evaluation and external training. Other methods may also be used and will be documented.

Online Training, computer training through the STT will be used for web based training i.e. Oracle or Trackwise Training.

Coaching (On the Job) may be done in an inpidual or group session. The trainer must ensure the training is logged on the employees Training Record. If training is done in a group, the group training form may be copied to the inpiduals training file.

Self-training/evaluation shall be documented on a form. It is the employees responsibility to ensure they understand and follow the applicable documents.

Training may be validated by a paper test/questionnaire or observation.

Where verification is by observation, this must be added to the Training Record upon a time frame valid to observe the appropriate training.

External Training, where appropriate, training courses may be identified by inpiduals/managers. These courses will be provided by recognized training organizations. The inpidual/manager will obtain authorization by DM (if applicable), HR and Management. A copy of the document/letter showing successful completion will be added to the employees training file.

Training records and documents will be maintained per the Documentation Retention Matrix.