Information & Training. | Quality Assurance. Quality Management.
Training Records
Training records are essential to ensure a clear status can be confirmed on the suitability of an individual to perform a task, they facilitate the ongoing development and implementation of a training schedule and they can be utilized to demonstrate the existence and suitability of the training process to external auditors and regulatory bodies.Every organization will develop its own specific form of training record, however, certain generic information will be detailed into all records.
The following information will normally be recorded (at a minimum):
– A brief description of the objective or area of training.
– Reference to relevant internally approved documents (standard operating procedures, bills of material, batch records, etc..)
– Reference to relevant external standards, regulations, specifications.
– The date of the training or the duration of the training provided.
– Verification that the training was effective. The outcome of the training may be that the training was successfully completed, partially completed or maybe there was a failure by the trainee to successfully complete.
– Recommendations for follow-on action where appropriate. Further training may be necessary or maybe a recommendation to retrain (in say) one month’s time.
– Signature of trainer and trainee.
Training records will need to be retained for a defined period of time. This retention period will be determined by relevant regulatory requirements or will be determined by organizational needs. For example where an individual is involved in processing medical product, then training records will need to be retained for the life-time of the product, plus the expected time of product patient impact. This may well span many years if not decades.
For records which extensive retention periods, there will be a need for defined storage conditions and strict record access controls in order to ensure record integrity.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>