Overall Equipment Effectiveness: An Important Aspect To Consider Before Buying An Inspection Equipment

Introduction

The world is waking up to the problems of counterfeit medicines by developing regulations to safeguard the supply chain. By 2019, more than 75% of the world’s prescription medications will be considered under different legislations. Implementation of a robust serialization process can help organizations curtail counterfeiting. Currently, pharmaceutical manufacturers are putting in maximum efforts to comply with various government and industry standards for quality, traceability, and safety.

Various serialization machines are employed to ensure traceability of products from the manufacturer to the end customer. With an increased demand for pharmaceutical equipment and machinery, decision-makers have become careful regarding capital investments and purchase decisions intended to achieve cost-optimization. Overall equipment effectiveness (OEE) is one of the most fundamental factors that are considered while making key purchase decisions like acquiring pharmaceutical inspection machines.

The purpose of this white paper is to provide an overview of OEE and the various components that are involved in measuring OEE of a product inspection equipment.

And verification as “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. ”2Validation is restricted to mean the demonstration of the suitability of a method or process for its intended purpose, whereas verification involves the determination of whether the previously validated method is suitable for use in given specific experimental conditions. Validation are performed to confirm whether equipment is as per design specification and right equipment has been selected but carried out only once at the time of installation of the equipment or whenever equipment goes under modification (Re-validation), whereas Verification are performed once a year to confirm whether the equipment is performing as expected specification or enhanced specification. Internal QA team play a critical role while leading this activity along with external independent third party. Routine Performance MonitoringRoutine performance monitoring involves a series of performance verification checks completed at frequent, regular intervals. Operators and production executives to evaluate if the equipment is operating within the limits set. These tests are performed by the internal QA or production team regularly while production or before and after product changeover but varies from company to company.

Overall Equipment Effectiveness (OEE): OEE is an important factor to consider when making a pharmaceutical equipment buying decision. OEE—originally described by Seiichi Nakajima in the 1960s—determines the effective utilization of equipment in a manufacturing environment. The International Society for Pharmaceutical Engineering (ISPE) document states the following: “Levels of OEE performance are highly variable and it is important to set expectations accordingly. A continuous processing plant in oil or chemicals will often have OEE rates of 90% or more. A multi-product, sterile pharmaceutical packaging line will often have OEE rates of less than 10%. It is therefore important to recognize realistic and achievable target levels for the equipment in question.

Availability rate4 (percentage of time a machine is ready to produce, working correctly, and not in the process of changeovers or adjustments) = It is measure of how often the system is up and running. It is often referred to as Uptime, which is calculated by the ratio of actual versus Planned production time. Performance rate4 (ratio of output compared to an output standard) = It is measure of maximum output achieved as compared to designed output and can be described as performance. Performance is Ratio of Net Run Time to Run Time. Quality rate4 (ratio of good output compared to actual output) = Industry sometimes refers to this as First Pass Yield, which is a computation of the good units produced as percentage of total units produced or ratio of Good Count to Total Count produced.

OEE Parameter

Effects of using Inspection Equipment

Availability

• Contribute to reduction of re-work times.
• Timely identification and rejection defective products can prevent damage to equipment, hence further avoiding unscheduled downtime.

Performance

Contributes in quickly setting up production equipment and informing production team for scheduling downtime.

Quality

Contributes in timely identify deviation in process parameters and setting course of corrective action. Hence, helps reducing in start-up rejects and production rejects. Considering the above, we can surmise that OEE is most effective when utilized to determine the scope and steps of process performance improvement1 and not to determine the output of an individual machine or component. Despite the emphasis laid on process control and consistency by the Food and Drug Administration guidelines, inconsistencies are often observed in many facilities. These inconsistencies mean non-compliance to current Good Manufacturing Practices (cGMPs) and can lead to process inefficiency and loss of productivity.

Conclusion

OEE is an important factor that is considered by buyers to ensure effective purchasing decisions. The OEE concept, however, only scratches the surface of the process involved when choosing appropriate pharmaceutical inspection equipment to improve production cost-effectively. It is imperative that buyers expand their knowledge on this subject. Vision inspection system helps the industry to cut-down the production downtime and higher reject rate due to false rejection. Therefore, it is evident that Quality and consequently the overall equipment effectiveness (OEE) can be improved substantially, which in turm serves as a substantial contribution toward the betterment of production and revenue. Vision inspection can ensure 100% of the products are inspected and are adhering to standards, at the same time identifying and removing non-conforming products. Capabilities of vision inspection can vary from basic to complex.

Todays, Vision Inspection technologies not only inspect each label in real-time but also track foreign objects like plastic, bolts, washers, etc on tablet counting machine. Such capabilities help companies to avoid unnecessary product recalls and their associated costs. Apart from detection of defective products, inspection equipment can help achieve better runtime data. Buyers can achieve superior OEE if they can determine the causes of these defects and take preventive actions accordingly. The OEE of a plant is usually compared with standard World Class OEE. OEE can be benchmarked typically as 60%, which indicates substantial room for improvement and practical whereas a score of 100% is considered as perfect production, producing only good parts, in fastest possible time with no stoppages [endnoteRef: 5]. Thus, monitoring OEE is beneficial and vital aspect of quality control process, increasing efficiency and profitability, enhancing production processes.