Case Study 1 – Regulatory Training
An employee at Tosara Pharma identified an issue regarding regulatory training. To clarify, she reported that it was time consuming, everything was hand written and needed a lot of space to store the training files.
By way of background, the company was using a paper-based approach to training. For instance, they used controlled documents that each employee was obliged to complete. This was a questionnaire which consisted of Standard Operating Procedures (SOPs), Batch Packaging Records (BPRs), Packaging Instructions (PIs) and Batch Manufacturing Records (BMRs).
8-Step Problem-Solving Process
In trying to solve a particular problem, we advise using the 8-Step Problem-Solving Process:
- Current State
- Root Cause Analysis
- Select Countermeasures
- Standardisation & Learnings
First of all, training took approximately 10 minutes to complete each questionnaire. For all employees, this meant that it took 22 hours for everyone in the company to complete the training. In addition, it took over 18 hours for the Documentation Coordinator/Trainer to check and file all questionnaires for all employees.
Consequently, Tosara Pharma used Value Stream Mapping to map the current process and assess the impact of computer-based training.
Value Stream Mapping is an essential tool in the Lean process. It is the flow of materials and information through a process to deliver a product or service to the customer. Value Stream Mapping is the technique used to describe how all the company’s activities work together to produce a product or service for the customer.
Her proposal was to move away from paper-based training system and replace it using a computer-based system. This meant using a network drive that would be locally managed and password protected. Furthermore, she proposed to construct a questionnaire consisting of questions that require simple answers (a, b, c or d). Questions would be automatically checked and corrected by computer. As a result, this would reduce the time for each employee to complete the questionnaire. It would also reduce the time taken for the Documentation Coordinator/Trainer to correct and file the questionnaires.
- Significant reduction of time in the training procedure.
- Reduction of labour effort.
- More convenient and faster procedure.
- Quicker and easier access to files and storage.
- Reduction of possible human mistakes and physical storage requirements.
- Daily backup to prevent data being lost.
- First of all, with the new computer-based training system, they reduced time by at least 70%.
- Next, they freed up space where the storage area to keep the files used to be.
- Certainly, this project simplified the procedure for all employees. This also included the Documentation Coordinator/Trainer.
- Next, the company eliminated the movement and handling of the files.
- Then, they reduced human errors/defects.
- In addition, the company reduced the over-processing (double check) of the training questionnaires.
- Finally, trial results showed 70% saving per employee training per year.
We firmly believe that the expertise to develop business process improvements already exist in every organisation. This has clearly been the case in Tosara Pharma. Through their employees’ Lean projects, the company has made significant continuous improvements to their business.
ETAC has worked with Tosara Pharma to streamline their business and improve their processes. We hope you enjoyed reading about this case study on Regulatory Training. You may be interested in reading the two other case studies featured here: Case Study 2 – Label Applicator and Case Study 3 – Operational Excellence. All our case studies are available here.