Summer 2008 Issue

By Jeff Viney and Ric Kositzke, Thermo Fisher Scientific

It’s no secret that Life Science companies are often lured by cost savings when purchasing non-OEM parts for their instrumentation. But in the increasingly complex world of capital asset maintenance, this approach to parts replacement can be risky if organizations fail to perform due diligence prior to selecting a parts vendor. Risks range from loss of productivity if the non-OEM part causes instrument downtime to unexpected costs if the part causes irreparable damage to the instrument.  

Before delving into this issue further, let’s first establish a definition of a non-OEM part. In short, a non-OEM part is manufactured to meet the performance of the original manufactured part and may post similar performance metric results, e.g., Mean Time Before Failure (MTBF).

The following are three major points to consider prior to committing to a non-OEM parts vendor.  

When a non-OEM part should be used
In general, organizations should purchase a non-OEM part for a particular instrument under the following circumstances: 

• The instrument utilizes mature technology. Established instrument technology such as FT-IR spectrometers, HPLC instruments, and GC/MS and LC/MS instruments have given suppliers many years to develop, test and refine their non-OEM parts.
• The instrument has a large installed base and features high-demand parts. High-volume instruments and parts broaden the pool of qualified suppliers that supply non-OEM parts.
• The non-OEM part is backed by a warranty. If the supplier has proven performance based on historical use and has a warranty period on par with the OEM, you should consider the part.

Is the supplier reliable? 
Has the supplier earned quality accreditation – ISO certification, for example – that provides assurances that the organization has production, delivery and quality standards? Further, does the company follow a practical continuous process improvement methodology such as Lean Manufacturing or Six Sigma that examines and, theoretically, reduces operational inefficiencies and in this case, part malfunctions? Does the supplier perform internal auditing to assure best practices are in place for inventory availability, financial stability and other key factors? Does the organization price competitively? Approximately, fifteen to twenty percent under the OEM part cost is the norm. Do you feel good entrusting your organization’s capital assets in the hands of this supplier? Do they have any references whom you may contact?

What is your organization’s operational environment?
If the non-OEM part does not perform as well as advertised, does your organization have a reliable back-up instrument that can be utilized to handle the new workload? In that same vein, does your organization operate in a 24-7 environment where an instrument failure may cause untold lost productivity? Are your instruments under warranty? For many organizations, parts replacement must follow a strict adherence to the OEM’s warranty so as to prevent voiding. In addition, GLP (Good Laboratory Practices) or cGMP (current Good Manufacturing Practices) standards must be considered when operating in regulated environments. Finally, Standard Operating Procedures (SOPs) must be reviewed and, possibly, rewritten to account for this non-OEM part use.

Just as important as understanding the suppliers and the reliability of non-OEM parts, it is even more important to have a process for monitoring the performance of the instrument and these parts.  As a result, many organizations have partnered with an asset and service management provider that removes this burden so companies can focus on their core competencies. A good asset and service management provider can effectively assess any instrumentation and quickly identify non-OEM part opportunities. Clearly, the asset and service management provider should have a non-OEM parts strategy that entails a thorough internal process to examine the efficacy of these parts while helping minimize costs and maximize uptime.