Pharmaceutical industry has great expectations and opportunities because medicines play an important role in everyone’s life. The pharmaceutical manufacturing process is complex and time taking. A lot of equipments are required to manufacture a batch of drug products.
About 65% of manufacturing operators reported that they had experienced unplanned downtime due to equipment failures at least once in a month. It indicates that a lot of machine breakdowns happen in manufacturing area because of continuous running of machines without any rest. In this article, we shall understand how to handle this and improve the situation.
Q1. Why did the compression machine stop working? – it was because the motor of the machine overheated.
Q2. Why did the motor of the machine overheat? – it was because the cooling fan was not working.
Q3. Why was the cooling fan not working? – it was because the power supply was interrupted.
Q4. Why was there a power interruption? – it was because of poor electrical maintenance.
Q5. Why is electrical maintenance poor? – it is because there is no preventive maintenance schedule.
The above example shows that the problem was not just in the working of the compression machine but it was bigger than it and finally found that there was no preventive maintenance schedule for the equipment.
1. Training of operators and other workers handling the equipment plays an important role in preventing equipment failure.
2. Create and use checklists and formats for usage and maintenance activities.
3. Create a calendar and schedule of preventive maintenance for all manufacturing equipment.
4. Do not skip any documentation.
By using the above tips, you can identify the equipment failure in the early stage. It will help the firms to get more efficient usage of manufacturing equipment without any hassle. If you have any questions, feel free to contact us.
The efficient working of equipment plays a crucial role during manufacturing process. Equipment malfunction or any failure may lead to compromise with the product quality or production loss.
About 65% of manufacturing operators reported that they had experienced unplanned downtime due to equipment failures at least once in a month. It indicates that a lot of machine breakdowns happen in manufacturing area because of continuous running of machines without any rest. In this article, we shall understand how to handle this and improve the situation.
Understanding the Equipment Failure
In simple words, the equipment failure is a situation when equipment does not work as it should. It may be due to equipment breakdown, any malfunction, any operator error or a calibration issue. In pharmaceutical manufacturing, it can be a serious issue including sub-standard product manufacturing, production delay, deviation or in worst case batch rejection. Regulatory authorities may take any action against the company due to non-compliance in the manufacturing process.Early Detection of Equipment Failure
It is important to find the equipment failure in the early stages before it creates big problems. Routine inspection, preventive maintenance and automatic monitoring of equipments play an important in the early detection of equipment failure. Any abnormal noise or any abnormal vibration can early detect the failure. In such conditions, operators should stop the machine and investigate the issue properly.Finding the Root Cause
If equipment failure occurs then the first step is to identify the root codes. We should not only try to fix the problem but also find out why it occurred. There are many root cause analysis tools are there but “5Why” is the simplest one. Using the “5Why” tool, we can find the root cause of the problem easily. For example, a compression machine stopped working suddenly. We can apply the 5Why tool as following.Q1. Why did the compression machine stop working? – it was because the motor of the machine overheated.
Q2. Why did the motor of the machine overheat? – it was because the cooling fan was not working.
Q3. Why was the cooling fan not working? – it was because the power supply was interrupted.
Q4. Why was there a power interruption? – it was because of poor electrical maintenance.
Q5. Why is electrical maintenance poor? – it is because there is no preventive maintenance schedule.
The above example shows that the problem was not just in the working of the compression machine but it was bigger than it and finally found that there was no preventive maintenance schedule for the equipment.
Implementing CAPA for the Problem
When we find the root cause of the program, the next step is to implement corrective and preventive action (CAPA). Corrective actions help to fix the problem with immediate effect means it is the direct solution to the root cause while preventive actions are taken to manage the root cause that prevents the occurrence of problem in the future. For example, in above equipment failure, the fixing of electrical problem in the fan is a corrective action while the implementation of preventive maintenance schedule is a preventative action.Tips to Handle the Equipment Failure
Following are some useful tips to handle equipment failure effectively.1. Training of operators and other workers handling the equipment plays an important role in preventing equipment failure.
2. Create and use checklists and formats for usage and maintenance activities.
3. Create a calendar and schedule of preventive maintenance for all manufacturing equipment.
4. Do not skip any documentation.
By using the above tips, you can identify the equipment failure in the early stage. It will help the firms to get more efficient usage of manufacturing equipment without any hassle. If you have any questions, feel free to contact us.
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