Training system for Aseptic and Preparation for Aseptic Operators and Support Staff
Introduction
This document discusses considerations for a site Structured On-the-Job Training system including GMP tasks and knowledge necessary to perform those tasks.
Sites must comply with GMP training requirements for training by defining the knowledge, skills and attributes colleagues require to competently perform GMP tasks. This may be accomplished through education, training, experience or a combination there of.
On-the-Job training should be part of those colleagues’ job function curriculum (JFC) who have a direct impact on product quality to ensure that colleagues can competently perform all job skills prior to working unsupervised.
Job skills refer to the acquired measurable behaviours that are required to perform a job.
Scope This document will cover the various aspects of a Structured On-the-Job Training (SOJT) system including determining when SOJT is appropriate, components of the system, components/steps in the system and the required documentation.
SOJT should be targeted to all job functions potentially impacting product integrity at production sites, laboratory sites, and logistics centers, including temporary and part-time employees. Assessing which specific job functions require this detailed approach to training can be done through a risk based approach.
Recommendation and Rationale
Structured OJT can be defined as the one-to-one process of providing and mastering knowledge and skills to perform a specific task within a job; with the following characteristics:
- Occurs in the actual or simulated workplace;
- Uses a predetermined training sequence (structure for the training should be documented and approved prior to execution);
- Requires the active presence of a trainer and trainee;
- Uses materials and guides; and
- Employs a systems approach, with practice opportunity and demonstration of competence. Structured OJT provides employees with the knowledge and skills required to perform job functions in accordance with approved SOPs, and other instructional materials. OJT includes, but is not limited to technical skills training and sequential steps to perform tasks within predetermined criteria. For example, OJT practices can be applied to task such as batch record review, environmental monitoring techniques, internal audits and other job functions that require acquiring a new skill.
Typically there are five phases to a Structured OJT System:
- Preparation of the Structured OJT Process
- Introduction
- Knowledge & Skills Training
- Practice Sessions
- Training Assessment.
Step 1 – Preparation
1. Trainer
- Select a qualified trainer, who has expertise, training or a combination of these in the specific area/topic. This may be an individual who performs training as their job function or an SME who performs training secondary to their primary job function.
- Evaluate /train this individual before identifying them as a SOJT trainer to ensure that the trainer has the appropriate skills and knowledge. For example, review of a documented resume or job profile that states experience in this type of training or attendance in a Train the trainer type program for this type of training would be sufficient.
- Training Objectives should be determined before starting the training process. These are key learning points to be discussed during the SOJT. Recommended steps to define the learning objectives are:
- Review all task steps in the SOP, Batch/Packaging Records and/or related documents.
- When selecting the steps that will be included the following criteria should be considered, not all may apply to every task that you are training on. Select those which are most applicable.
- Criticality-Select steps that if done incorrectly, could affect the colleague safety, the product integrity, equipment integrity or the environment.
- Complexity – Select the task with higher complexity
- Difficulty – Select task with higher difficulty
- Frequency –Select task done with lower frequency
- Establish the Learning Objectives based on the selected tasks.
3. Training Documents & Materials
- If an SME is not identified as the OJT trainer, identify one the area to help develop and review material.
- Identify the required training documents.
- SOPs & Batch/Packaging records are the preferred training tools when they are easily understood and clearly define the steps and outcomes for a process.
- If necessary, sites may also choose to create checklists specific for each task/SOP, defining the steps which need to be performed and the required outcome.
- When creating OJT materials it is important to look at the process and break it up into definable chunks that will be easier to train and assess. For example, instead of training on the entire packaging process split the process into small tasks such as cartoning, labeling, visual inspection etc.
- Then create SOJT materials around these smaller tasks which can be clearly defined. This also allows trainee’s to begin working on certain tasks in the process prior to completing training on the entire process which can help with scheduling and resources. For example, once the trainee has completed SOJT for labeling the can work unsupervised on that section of the packaging process while continuing training on the other areas of the packaging process.
- Identify the required materials, tools, equipment, etc.
- Identify pre-requisites or job skills required for completion prior to beginning the SOJT module.
- Identify the appropriate training area based on the task and the expected outcome
- Classroom
- Workplace
- Simulation Area
- Knowledge Based Training is necessary to give colleagues an overview of the skill and the process in which it fits into. This training should include review of any applicable SOPs. A review of the SOP should determine if the information requires a more formal approach such as classroom type training. Knowledge Based Training can be performed using one or both of the following methods:
- Read & Understand practices
- Classroom Training
- Skill Based Training
- Tell, Show & Practice (real workplace or simulation area).
Training Assessment Methodology and Acceptance Criteria should be determined before starting the training process based on the task and the expected outcome (learning objectives). The assessment should measure knowledge and/or performance on those tasks identified as the learning objectives.
Step 2 – Introduction
The Introduction section contains information that should be reviewed prior to the demonstration of the skill. Therefore the site can determine when in the sequence it is best to review this information. Some examples may include including this information the knowledge based training or reviewing the information on the shop floor prior to beginning the skills based training demonstration.
- Provide an overview of the work process. Briefly show and explain how the work is done. A flowchart of the process or other applicable documents (e.g. machine manuals, engineering drawings, etc.) may be helpful in understanding the work process.
- Indicate the safety and environmental factors on this job
- Dress code
- Personal protective equipment
- Safety precautions
- Indicate the Quality Requirements, Specifications & Expectations
- Dress code
- Specifications and review cycle times. Show examples of both, good and defective products.
- Provide a Training Process Overview
- Explain the Training Process (Introduction, Theory, Demonstration, Practice and Evaluation)
- Explain Training Objectives
- Explain Assessment Methodology and criteria
- Hand out and explain training materials to be used
Step 3 – Knowledge and Skills Training
Knowledge Based Training
Train on the applicable SOP and other documentation (e.g. machine manuals, engineering drawings, etc.). The SOP training may also be concurrent with or subsequent to the demonstration step depending on the
job task and the trainee’s needs. Emphasize tasks identified as learning objectives during the training process. This training should be documented.
Equipment/Documents/Products
- Tell the trainees the correct names of records, attachments, log sheets, equipment, equipment parts, tools, hardware, software, etc.
- Explain how they works, where are located, what they are called, and why they are important
- Explain safety precautions and/or special maintenance needs.
Materials
- Tell the trainees the correct names of materials
Explains Safety and/or Quality Precautions.
Tasks
Discuss the knowledge information from the training documents (SOPs, etc) such as: (choose that which are applicable to the task)
- What tasks need to be accomplished
- Why is the task important
- Importance of doing it right
- Consequences of doing it wrong
- Which job function can perform this task
- In what location or step in the process can the task be performed
- At what time during the process can the task be performed
- What materials are needed to accomplish the task
- What is the impact to the product quality
- Emphasize any special safety or quality points that apply to the task
Skills Based Training
1. Trainer should ensure an appropriate learning environment for this part of the training.
- If the area is too noisy it may be difficult for the trainee to hear your instructions.
- If the area is very crowded, the trainee may not get a good view of all of your actions.
- Prior to starting the demonstration, ask the trainee if they are comfortable with the environment.
- Determine if you are speaking loudly enough and if the trainee can adequately see what you are doing.
2. The trainer should demonstrate the task in the workplace or simulation area.
- Using the SOP, follow all the correct steps, showing & explaining how to perform the task.
- Go through each step of the SOP with the trainee so that they can visually see each action that is performed.
- Emphasize important steps & precautions (the identified critical tasks, learning objectives).
- Include non-routine occurrences and the appropriate actions to take when they occur.
For example, when training operators for visual inspection of labels on vials the SOJT should not only include the process for inspecting correct labels but also what steps should be taken when operators find a improperly labeled vial.
3. Repeat the demonstration, moving a little faster each time.
4. This training should be documented
Step 4 – Practice
Practice
1. Allow the trainee adequate time to practice the task, under supervision, prior to having to demonstrate competence.
- All practice sessions should occur under the supervision of an approved instructor1 .
- Instructors need to be available during the practice session to offer support and guidance to the trainee while they are still learning the task. The amount guidance should be reduced as the trainee becomes more familiar and competent in the task.
- A predetermined number of practice sessions may be set for certain tasks. The practice phase is not a one time process. The length of this phase depends upon the complexity of the task/job. Observe the performance for correctness, sequence, quality and safety.
2. Provide both positive and constructive feedback; recognize and encourage the good performance, provide coaching if the performance is not within the expectations (offer in the form of specific suggestions).
3. All practice sessions should be fully documented and records retained in the training history. The site could use their current training form to document these sessions or create some other type of documentation method as long as it is specified in the SOP.
Step 5 – Training Effectiveness Assessment
1. Trainee competence should be assessed once the trainee has voiced their confidence in performing the task, or at the end of the practice period.
2. The trainee must complete the assessment without any help or guidance from the instructor
3. Determine training effectiveness and completion based on the pre-determined acceptance criteria. These examples of criteria might be used in some types of training:
- For a given period of time
- With the required safety
- At specified level of quality
- And producing a prescribed quantity
- Wearing PPE in the area where the scale is located
- Calibrating the scale correctly
- Filling out the calibration sticker correctly and placing it on the right spot on the scale
Assessing how to use an HPLC machine, acceptance criteria may include:
- Checking the PM sticker
- How to turn on the machine
- How to prepare the samples
- How to record the results
- What type of PPE should be worn
4. Document the assessment results.
- Successful completion of the assessment must be documented and filed with the trainee’s training history.
- Unsuccessful completion of the assessment should also be documented. Comments about what steps or sections of the task the trainee failed to complete according to the criteria should be documented so that these sections can be reviewed with the trainee.
- IF someone continuously fails to achieve the defined competence required for a task
- THEN some action is necessary based on risk (to product, process, safety, environment, etc.), type of task and what supporting processes you have e.g. HR, performance management. Area/Site management should be involved in the decision as to what to do with the colleague. You may consider speaking with HR if the management feels it necessary.
Note: The assessment is not a one time process. The length of this phase depends upon the complexity of the job.
Re-qualification Requirement
Some procedures define default re-qualification requirements. Review all material related to the task and ensure that your re-qualification plan matches what is stated in the area SOP and other documentation. When re-qualification is not defined in local procedures, the site should take a risk based approach to determining if and when re-qualification may be necessary. For example when a colleague has not worked in the function for an extended period of time, if there are major changes to the skills required to perform a
job, when a new piece or equipment has been installed or when a batch record has been revised.
- Define the activities necessary for the continued qualification of the colleague/employee.
- If applicable, include timeframes of inactivity or absence that would require re-qualification on the SOTJ.
- If the process is measurable, provide a mechanism for tracking the re-qualification activity. Some examples include:
- Comprehensive proficiency quiz on an established frequency (e.g. 2 years)
- Evaluation of activity for 1 year without significant incident.
Documentation of Structured OJT Process Flow
It may be helpful to the process for creating, approving, utilizing, and updated SOJT materials formalized in an SOP or flowchart. This process flow may include detail about how the OJT process works and who is responsible for carrying out each step. All roles and responsibilities should be defined and documented to avoid confusion.