By Fred Bickel, ProPharma Group
Risk-based testing has been in play for several years now. By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or processes. These cost-saving opportunities may not be obvious at first glance, but upon a closer look, they can offer real and tangible savings.
Before we look at how to attain the potential savings, we should first explore the process for determining criticality of a system. To determine criticality, answer a series of questions about the system. Below are some examples that have been used in the industry to help determine whether a system is critical or non-critical:
If any of these questions are True, then the system is likely critical and should be tested and maintained as such. If that is not the case however, cost savings can potentially be realized.
When performing impact assessments, a typical outcome results in a listing of instruments that are either critical or non-critical. Ensuring that only critical instruments fall into the routine calibration program can lead to substantial savings, especially over time.
Let’s look at this concept in further detail:
Let’s assume that you have a system with 20 instruments monitoring the process. Many of these instruments are for system performance and are not critical to the quality of the process.
These non-critical instruments are good candidates for your engineering change management program. The savings continue throughout the lifecycle by not calibrating these instruments at the same frequency as you calibrate the critical instruments. Similarly, if one of these non-critical instruments does need to be changed, you might not need all of the associated paperwork and testing that would accompany a qualified system.
In the ASTM E2500 scenario, only the engineering change management program would be involved, perhaps through the work order process. Your critical instruments would still be changed through the quality unit change management process.
For a simple system, a per-instrument number might look like the below cost breakdown in the event of an instrument failure:
|Activity||Non-Critical Instruments||Critical Instruments|
|Work Order (Engineering/Maintenance)||$250|
|Change Order (QA/Engineering/Maintenance)||$350|
|Change Order Review(s) (QA)||$1000|
|Change Order Initiation Approval (QA)||$200|
|Changes Made (Recalibration) (Engineering/Maintenance)||$75||$75|
|Change Order Completion Approval (QA)||$200|
|Instrument Back In Service||----||----|
Keep in mind that this is just one example of how savings could be realized. While we do not propose that any critical instrument not be appropriately monitored, we do acknowledge that if an instrument is truly part of a non-critical system, then you could stand to gain significant savings over the instrument’s lifecycle.