I would like to ask opinions and suggestions based on our existing training SOP for improvement.
We have the following outline:
For Newly Hired personnel, it was subdivided to Two Phases of Training
1.1 Conducted by HR - History of the Company, Organizational Chart, Introduction to Facilities (Outside Premises)
and Staff , Company Policies and Standard Practices, General Safety and Security Training)
1.2 Conducted by Supervisors - (Tour of employee’s work location, Characteristics of work flow, Job Description,
Product Knowledge, GMP Topics, SOP’s Required, Basic Documentation, Safety Measures)
Ongoing Training - training to update, reinforce and refresh the knowledge and skill of employees.
Granted also to employees whose activities could have impact on the quality of the product
Remedial Training – training given to employee when there is evidence that the training received was not adequate
resulting in an employee who cannot correctly, safely, effectively or efficiently perform the task assigned.
On –Job- Training – training given to any employee when, New Method is introduce (when there are changes)
New Procedure is use (when there are changes), Employees under lateral transfer of new job description,
Employees for promotion, Employees assigned to a newly created position)
What was Im looking for are the templates for Training Checklist, Programs and Other forms that we should include/attach in our SOP.
Looking forward for your kind recommendations and attachments.
Training is the biggest source to plug in mistakes in Industry and biggest source of errors too.
Try to avoid specific type of checklists. Main reason for that is the expert or individual who is responsible would like to write or give a checklist as per his or her knowledge. There is every chance of missing some important points.
Training these days based on the specific challenges that the professionals encounter at the work place to take key decision during the processing of a product.
The best way to train is based on the frequent observations you will get from your Internal/External and Regulatory authorities.
You can make them into specific sections based on the observations made and frequency of such observations found.
This can be done every quarterly (3 MONTHS) by looking into various observations found from your SOPs, BMR-BPR, Release and Testing records, Maintenance, Validation-Calibration status and Procedures, Monitoring-Cleaning procedures, Sampling-Storing procedures, Stability-Retrieval procedures etc…
Every part of training which includes Quality as main focus based on Departmental observation frequencies and associated movement of such documented procedures and evidence into other departments.
This will plug in flow of erroneous results from one department to other vise-verse and which kills most of your quality working time.
You need to formulate a Training working group which is represented by all departmental heads, Quality and External auditor.
The push by regulators / inspectors / auditors now is not just evidence that training occurred but that it was effective. Consider how you can demonstrate that training was effective. In some cases, an informal Q/A (“quiz”) session is sufficient (if documented). In others, maybe a demonstration of the application of the training may be relevant. In one case I’ve seen, the company would review performance over a defined period (e.g., 6 months) to assess effectiveness (and then document the conclusion). The point is to think beyond just documenting that training occurred.
If i am not wrong you are looking for this enclosed formats. You can elaborate Induction training with more points which should be necessary for an employee at that time of joining by each and every department.
You can make different topics as training modules like responsibilities, GMP topics,Quality Topics, Safety Topics, and Personnel and administrative topics according to your company systems. These training modules shall be finish before going to work place and evaluation shall be done with Questionnaire / Demonstration.
You can make Training feed back for each and every training season. For instance here i have enclosed for your ready reference.
Identify the Trainers according to their educational Qualifications and expertise in particular tasks. Make a List of qualified trainers on which topics they can explain more clearly.
You can make a study material like books or pamphlets with suitable cartoons and pictures for each and every topic.
For better training imparting, you shall make a Questionnaire for each and every SOP or other following documents.
You can use this formats and can modify according to your flexibility. If you have any better idea kindly share with us and greatly appreciate you. We shall be learn from you. I hope you can…
Thank you. I have finalized now the GMP Training System in our company with the hepl of your training formats and recommendations.
[quote=Pulla Reddy]Dear,
If i am not wrong you are looking for this enclosed formats. You can elaborate Induction training with more points which should be necessary for an employee at that time of joining by each and every department.
You can make different topics as training modules like responsibilities, GMP topics,Quality Topics, Safety Topics, and Personnel and administrative topics according to your company systems. These training modules shall be finish before going to work place and evaluation shall be done with Questionnaire / Demonstration.
You can make Training feed back for each and every training season. For instance here i have enclosed for your ready reference.
Identify the Trainers according to their educational Qualifications and expertise in particular tasks. Make a List of qualified trainers on which topics they can explain more clearly.
You can make a study material like books or pamphlets with suitable cartoons and pictures for each and every topic.
For better training imparting, you shall make a Questionnaire for each and every SOP or other following documents.
You can use this formats and can modify according to your flexibility. If you have any better idea kindly share with us and greatly appreciate you. We shall be learn from you. I hope you can…