Is the Inspect and Replace Methodology Right for Your Organization?
By Jarrett Cooper
Thermo Fisher Scientific
In today’s laboratory, especially during these turbulent economic times, reducing costs is vital. One preventative maintenance (PM) methodology that may help your organization achieve this goal is called Inspect and Replace, which allows practitioners to utilize instrument usage data, performance metrics and common sense rather than the Original Equipment Manufacturer’s recommendations to determine when to replace parts on a given instrument.
As a result, the Inspect and Replace PM methodology may reduce unnecessary parts replacement during a maintenance event, reduce labor costs by replacing parts only when needed, extend the life of parts that may be prematurely replaced, and help reduce instrument downtime when a preventative maintenance event is being performed.
Replacement Parts and Maintenance Schedules
OEMs typically develop a list of recommended replacement parts and a maintenance schedule based on a maximum usage calculation and a Mean Time Between Failure metric gathered in its factory. These recommendations are similar with what you might see in a car ownership manual (e.g. Replace your oil and oil filter every 3,000 miles).
The benefit of this list is that it provides end users with an estimate of the maintenance that will occur over the entire year to ensure performance and longevity of their instrument. On the other hand, this list tends to be general and does not accurately take into account every instrument’s specific usage. For example, the list may not discern whether instrument A is performing Normal Phase Chromatography or Reverse Phase Chromatography, two distinct activities that cause dissimilar wear and tear on a HPLC.
This lack of clarity causes many labs to pause when considering the Inspect and Replace PM methodology as end users fear the performance of their instruments will be negatively impacted if they do not follow the OEM’s part-replacement guidelines. However, organizations that have pursued an Inspect and Replace PM methodology often find that basing parts replacement on usage not only leads to an extended lifetime on parts but may also leads to cost savings.
Case Study: HPLC Instrument
Let’s examine this issue more closely by utilizing a common laboratory instrument: a High Performance (Pressure) Liquid Chromatography system. In this example, a scientist with 12 years of HPLC experience utilizes the system to perform stability testing on Product X. The HPLC is a dedicated system and no other analysis is performed using this system. The solvents utilized in the analysis are methanol and water and approximately 50 samples are analyzed each month.
From the information above the criticality of the instrument to the laboratory’s need is “moderate” as it is only used monthly. The solvent conditions are very mild, and the number of injections is very low. With such a system, does it make sense to replace every part each year per the OEM’s recommendations? Not necessarily.
In this case, should the end user utilize the Inspect and Replace PM methodology, he will reference the existing OEM recommended parts list and then validate it to determine if the recommend parts are needed. For example, if the OEM recommended parts list states that the end user should replace the HPLC’s pistons every 600 liters of solvent pumped or every year (assuming the pistons have been properly maintained, stored and rinsed after usage), and the end user’s pump is currently only showing 300 liters of solvent pumped after one year, is it really necessary to replace? It may be found that through inspection and historical instrument performance data that the end user can continue to use these pistons for another 300 liters before replacement is necessary. Cost savings then arise.
Should My Laboratory Utilize The Inspect and Replace PM Methodology?
Inspect and Replace can be incorporated at any level at any time, but provides the greatest impact in large laboratories with varying OEM instrumentation. Other considerations include:
Are the instruments currently under the manufacturer’s warranty? Many manufacturers specify a strict compliance to their preventative maintenance schedules. In many cases, if the end user doe not replace all parts outlined by the OEM, it may void the instrument’s warranty.
Are the instruments under a lease agreement? Does the company leasing the instrument have any stipulations for preventative maintenance that may prevent the end user from incorporating the Inspect and Replace PM methodology?
What does your current Standard Operating Procedures (SOP) state? A review of your current SOP’s should take place prior to incorporating the Inspect and Replace PM methodology. For example, some companies working under Good Manufacturing Practices (GMP) SOP’s may require and only allow for service to be provided by the OEM. This is not to say that the Inspect and Replace PM methodology cannot be used, just that these SOP’s may need to be reviewed and revised for the incorporation of the methodology prior to implementation.Are all your instruments from the same vendor? Given the volume of similar instruments, you may find that a negotiated discount with the OEM may out weigh incorporating the Inspect and Replace PM methodology.
Other Factors
When choosing to implement an Inspect and Replace methodology end users should consider the following:
§Criticality of the Instrument
§Instrument Use
§ Instrument Parameters
§ User Experience
§ Utilization Counter
§ Solvent Considerations
§ Environment and A ge of the Instrument
§ Regulatory Compliance
Conclusion
Before an end user considers utilizing the Inspect and Replace PM methodology, it is wise for the end user to consult with their organization on many of the issues and questions raised in this article. If Inspect and Replace PM’s are deemed a good fit for your organization, one of the benefits that will result is that you’ll establish a historical baseline of the instrument(s), the factors that influence the maintenance schedule, and the frequency to which these maintenance events are performed. Most importantly, cost savings will occur.
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