Strong regulations characterize the pharmaceutical industry. The industry must ensure its products are safe for consumers. Accuracy, precision and cost-effectiveness are very important.
A slight change in a formula, calculation, procedure or even an environmental condition could make a significant difference. A successful maintenance strategy is one of the most important steps for a production plant to reach the required level of reliability.
- A risk-based approach to maintenance isn’t applied
Treating every piece of equipment equally when it comes to maintenance is a mistake. It is better to classify equipment on the basis of its impact on production quality. For example, failure of a mixing vessel could directly affect product quality.
Failure of a temperature monitor in an autoclave could indirectly affect system performance. However, failure of the boom gate at the entrance to the site wouldn’t affect the quality of the product. Using a risk-based approach helps to prioritize and even impact the amount of work facing a maintenance department.
- CMMS software isn’t fully deployed
Using a hybrid management system usually involves a combination of spreadsheets, plans and records stored in paper files and scheduling maintenance activities with a computer system. This is an inefficient way of managing maintenance and means that records, job sheets etc. can easily go missing and schedules can be neglected.
A computerized maintenance management system prevents this from happening. It is there to gather, store and analyze data and help maintenance managers to create predictive maintenance plans. It is also there to support daily routines, issue work orders, schedule interventions and control the execution of preventative maintenance activities.
- Maintenance plans aren’t updated
Buying new high tech equipment is exciting but the fact that it has to be maintained may be forgotten in all the excitement. In the procedure covering the installation of new equipment, a plan for maintenance must be included.
- Staff isn’t trained properly
Simple maintenance activities, such as changing a filter or adding lubricant, can dramatically impact the final quality of a product. If employees are not properly trained, they don’t understand the impact of their actions on the final product. They don’t know when it’s important to involve QA or how changing a setting on a piece of production equipment can be critical.
- There’s No clarity about “who is responsible for what”
Maintaining non-production equipment such as security systems, HVAC, water and gas supplies, fire protection systems and power supplies can fall through the cracks. When things go wrong and the cracks start to show, the finger-pointing often begins. Documenting exactly who is responsible for what can prevent this from happening.
- Maintenance activities aren’t document
Policies, work procedures and instructions must exist for all maintenance activities. They provide an essential training resource as well as documentation for auditors to examine.
- Modern maintenance management techniques aren’t used
It is easy just to keep doing things the way they’ve always been done. Lean maintenance and Total Preventative Maintenance (TPM) are some modern techniques that can help to improve processes. Getting training in these techniques or calling in a consultant to help apply them can make a difference.
- Maintenance is not considered when purchasing equipment
When it comes to selecting new equipment, the maintenance department may have little input. A production engineer may base selection on criteria such as throughput but the ease of maintenance needs to be on the list too.
The choice between two products for a clean room may come down to the fact that one requires entering the room for maintenance, whereas the other can be maintained from outside the clean room so that its validated state is not threatened.