7 Challenges Pharmaceutical Companies Face in Equipment Maintenance
Predictive maintenance of manufacturing equipment is emerging as a key area to reduce downtimes and the cost of maintenance. Globally, the predictive maintenance market is expected to grow at a Compound Annual Growth Rate (CAGR) of 25.2% from USD 4.0 billion in 2020 to USD 12.3 billion by 2025.
The pharmaceutical industry is constantly looking for ways to efficiently manage its complex processes and devise new strategies that can help it to
- Improve ongoing operations
- Meet business goals
- Enhance competitiveness
However, though supply chain, customer management, and process control may find a place in these strategies, equipment maintenance may not receive the same attention. This results in severe inefficiencies due to
- Unplanned downtime affecting productivity
- Lower quality of products caused by defects in the equipment
- Higher risk of incidents
- Higher cost of maintenance
7 Common Challenges
The seven most common problems caused by a poor equipment maintenance strategy include:
Challenge #1 – Suboptimal Challenge #1 – Suboptimal Performance of Equipment
A well-maintained system runs smoothly and produces the desired results. However, with no planning for periodic maintenance, pharma manufacturers may react to incidents rather than have a proactive approach. As a result, the equipment performance does not meet production criteria, lowering the quality and quantity of output. It may also need replacement in parts or as a whole, leading to lower RoI.Performance of Equipment
Challenge #2 – Identifying Risks
Pharmaceutical companies should understand the risks of each piece of equipment and assess the severity of the impact of each. Classification of the equipment based on its role in product quality is important. Of course, for businesses using a manual process-management system, tracking each piece of equipment and providing timely maintenance can become complex.
Challenge #3 – Inadequate Training
The user of the equipment and the maintenance staff need to have a thorough understanding of the machine, its criticality, controls, quality assurance, and compliance.
Challenge #4 – Documentation for Maintenance Activities
Auditing and compliance standards require all maintenance activities encompassing procedure, work instruction, and policies, to be documented well. With paper-based systems, this can become tedious and difficult to manage. Accessing the correct documents is also a challenge in the traditional system.
Challenge #5 – Maintenance from the Time of Purchase
Often, in the initial years after the purchase of the equipment, maintenance is not considered seriously till an event occurs. However, it is essential that along with installation and production plans, maintenance activities, schedules and responsibilities should be built-in right from the word go.
Challenge #6 – Data Security
Built-in sensors and IoT have increased access to data that can help pharma manufacturers improve their business planning. But it can also leave them vulnerable if proper security is not put in place and periodically updated to meet the ever-evolving challenges to data privacy and security.
Challenge #7 – Higher Cost of Production, Quality, Health, and Safety
Poor equipment quality leads to productivity issues as also increases waste and reduces overall efficiency. In addition to the quality issues, it can be a risk for the health and safety of the workers as well as the plant, leading to injuries and damages. This can be a drain on the resources of the company. Further, it reduces employee assurance that their safety is paramount, causing a lack of a sense of ownership and engagement, proving detrimental to the overall culture of the company.
Automating Equipment Management & Maintenance with ComplianceQuest
Manual methods are insufficient to keep pace with the growing complexity in a smart manufacturing environment. An automated equipment management system can help manufacturers manage predictive maintenance of their equipment more efficiently and reduce the risk of machine breakdowns.
The Equipment Management Software from ComplianceQuest is a cloud-based solution that helps to:
- Improve Return on Invested Capital (ROIC)
- Reduce equipment downtime
- Automate equipment management workflow to ensure that calibration and preventive maintenance schedules are on track
Some of its key features include:
Automating Equipment Lifecycle Workflow: Meet your internal requirements to test, calibrate, and validate all your equipment and instruments to correct deviations, if any. This can help to prevent nonconformance, initiate CAPA based on the severity of variations, and establish parameters for future maintenance and calibration.
Lower Costs with Preventive Maintenance: Reduce unscheduled disruptions due to downtime and repair with periodic preventive maintenance. Planned downtimes can help to improve the life of the equipment and ensure smooth operations. ComplianceQuest’s Equipment Management software automates equipment maintenance workflow by scheduling maintenance, receiving notifications, and protecting your equipment from repeat breakdowns.
Increase Return on Invested Capital (ROIC): A well-maintained and calibrated piece of equipment is an asset that can provide a good return on investment. It helps with producing quality products for a long time and meet customer requirements, regulatory standards, and internal specifications. CQ Equipment Management protects your assets and your investments as well.
Improve OEE Metrics: By automating equipment management processes, you can have access to data that helps spot trends and drive Continuous Improvements, enhancing OEE (Overall Equipment Effectiveness). The CQ solution provides an enterprise-wide view of all equipment-related data to help with overall decision-making related to equipment maintenance and replacement.
Ensure Compliance: Regulatory standards such as ISO 10012 provide guidelines for the management of measurement processes and for calibrating measuring instruments. ComplianceQuest’s Equipment Management Software streamlines and digitizes the process of helping enterprises meet these guidelines.
The Equipment Management Software is well integrated with ComplianceQuest’s solutions for management review, training management, document management and risk management.
Management Review: Using a tower of data, the management can periodically review equipment performance and maintenance. It can establish requirements, assign responsibilities, and track and monitor performance from within the system.
Training Management: Pharma companies can assess skill gaps and create and deliver specific training to the employees. It can track and assess the employees and the knowledge gained, evaluate its effectiveness, and fine-tune it based on needs.
Document Management: The companies can also integrate document management from creation to retrieval and reporting easily from within the system. By providing all relevant documents in one place, it improves access and visibility.
Risk Management: The ComplianceQuest Risk Management solution helps identify, rank, and manage risks. Businesses can prioritize based on the severity of the risk to optimize resource utilization for risk mitigation.
Apart from these, the ComplianceQuest enterprise-wide Quality Management System also offers software modules for: