Asset maintenance is often one of the single largest items included in the budget of any manufacturing business regardless of the industry — and there are reasons for that. Regular and well-executed maintenance is vital for keeping equipment, machines, and the entire plant safe and functional.
For pharmaceutical plants, asset maintenance is essential for all the above reasons and much more. The pharmaceutical industry is subject to strict regulations such as the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practice (cGMP) regulations. Apart from the stringent standards for drug production, pharmaceutical brands are also compelled to guarantee the integrity of each drug until it gets to every patient.
We have seen, time and again, the damage that poorly maintained assets can have on a company’s reputation and longevity. Among other things, poor or inadequate maintenance leads to operational inefficiency, dangerous work situations, accidents, and health problems. If a brand is associated with any of these common effects of poor maintenance, patients will likely begin to avoid those products.
Before discussing the impact of poor maintenance, it’s helpful to briefly look at the typical operational scenario in a poorly-maintained plant.
A typical poorly maintained plant
A poorly maintained pharmaceutical plant will face several challenges which can manifest in any of the following ways:
Heavy reliance on reactive maintenance
One of the common signs of poor maintenance, repair, and overhaul (MRO) operations in a plant is a continual recourse to reactive maintenance. This happens because such a system lacks a structured approach to maintenance.
From the absence of the most basic controls (like routine maintenance and inspections) to the unavailability of more advanced tracking systems (e.g condition-based monitoring and CMMS), and other resources that can provide visibility into the condition of critical assets, the chances of preempting potential equipment failure are slim to none. This lack of structure results in a distracted maintenance team that spends a large part of their workday attending to one emergency after another.
Prolonged equipment downtime
In the kind of plant described above, faulty assets are likely to remain out of use for extended periods. Imagine the result of unplanned downtime on critical equipment such as mixing vessels or homogenizers — especially the continual interruptions to production deadlines that will happen.
Over time, indifference to minor faults in the plant, machinery, and buildings will create a problem of escalating maintenance cost due to expensive and frequent repairs that could have been minimized by being more proactive.
With that in mind, for a pharmaceutical company, how can a poor asset maintenance culture affect brand reputation?
Increased risk of quality control issues
The danger of product contamination or microbial multiplication during the manufacturing process is a major concern at pharmaceutical plants. Unfortunately, there are almost endless opportunities for contamination along the production line. For instance, if an over-lubricated machine part comes in contact with the product, that has already affected product quality. Even missteps in everyday maintenance activities like cleaning can cause widespread contamination and fatalities leading to cGMP non-compliance.
In a poorly maintained plant, anything from neglected cracks and holes on the walls and ceilings, to a leaking roof and loose machine parts and fragments can contaminate the product. The loss of revenue due to a wasted batch of products or spoiled materials is often significant and can run into hundreds of thousands of dollars. But that is still secondary when compared to the negative publicity of associating that brand with contaminated products.
Manufacturing and operational inefficiencies
An indication of systemic inefficiency in a manufacturing plant is a lack of clearly-defined objectives for the maintenance unit. Or where these objectives exist, performance is not being tracked through maintenance key performance indicators (KPIs) and accompanying metrics. For manufacturers, a pattern of sustained operational inefficiency increases the risks of unplanned equipment downtime and wasted resources (e.g. labor, time and funds). When combined, these factors can jeopardize production deadlines.
For instance, let’s look at the potential effects of equipment downtime. Data from ARC Advisory Group case studies indicates that an hour of downtime could cost pharmaceutical manufacturers to lose up to $500,000/batch or approximately $8,300/minute on a scrapped batch. A typical situation where this can happen is when unplanned downtime disrupts production (due to component failure, etc.), but the issue is compounded because the maintenance technicians are waiting around for appropriate spare parts to complete the repairs.
Another issue with downtime is the ripple effect that it has on other areas of the system. When malfunctioning equipment is not detected in time, it can damage or otherwise affect other assets. Also, downtime wastes labor hours for the repair technicians as well as the machine operators. Again, other equipment problems, e.g. slow running or intermittent stoppage during production can spoil products and ruin an entire batch causing even more losses.
All these issues increase the probability that the affected plant will miss important production deadlines. If their products are not available in the market, over time, patients will definitely opt for other brands. Even worse, the products may reach the market but will have to be recalled. Product recalls in the pharmaceutical industry can have the most damaging effect on a brand because recalls tell a patient that a particular brand could put their health at risk. It is incredibly difficult to erase this stigma from a brand’s reputation.
Regulatory compliance issues
As mentioned before, this is a highly regulated industry and running short of regulatory standards is one of the most critical challenges that a pharmaceutical brand could face.
At inception, evidence of safe processes in a pharma plant is a paramount prerequisite before receiving a license to operate. A major part of safe processes is the condition of the manufacturing equipment being deployed. After a plant’s equipment have been certified fit and released for GMP use, it is the maintenance practices that occur thereafter that will ensure ongoing compliance.
In countries like the United States, poor asset maintenance practices guarantee that a brand will fail compliance audits. If the users of a drug become ill and auditors can establish that cGMP wasn’t followed during production, the company could face severe consequences. These consequences include the inevitable negative publicity that will follow criminal prosecution and heavy fines, losing its operating license, or government permanently closing down the plant.
Positioned for success
Similar to the rest of the health care industry, there is minimal tolerance for maintenance errors in pharmaceuticals. Every step of the manufacturing process requires strict monitoring. Therefore, maintenance is essential for a pharma brand’s sustainability, competitiveness, brand reputation, and value in the market.
By implementing a proactive and well-executed asset maintenance strategy supported by modern tools like computerized maintenance management systems (CMMS), and top-notch technologies like condition-based monitoring and predictive maintenance, pharmaceutical plants are better positioned to achieve the necessary levels of safety, product quality, and overall functionality required for a seamless production cycle.