System suitability failure in chromatographic analysis

[hetramrana]

We established system suitability criteria before and end of batch analysis specifically for each chromatographic analysis. If there is any failure in system suitability during initial stage, we shall not proceed for batch analysis. And if there is any system suitability failure at end (bracketing injection) wherein batch analysis occurred, we shall not consider that batch result for reporting however it passes the batch specification. We established the system suitability again with some action as a part of chromatographic troubleshooting like washing, conditioning, priming etc whatever required at that time and perform the analysis again. After getting system suitability criteria initial and end of analysis, the result is considered for final reporting. My question is : Is detailed investigation is required based on investigation tools like 5 Why, FMEA, Fishbone etc. for system suitability failure in chromatographic analysis. Most of the cases we did not find any root cause of system suitability failure even after getting the service engineer involved into investigation. During the trending it looks like repeat failure like RSD failure with same proposed action. In our case we record all the system suitability failure, record all the action taken with historical review of such failure and keep all the data with batch analysis. If there is system suitability failure at end of analysis and the batch under impact is under OOS result than we file OOS and investigated as per OOS guidelines. Kindly guide us for handling the system suitability failure in chromatographic analysis w.r.t. detailed investigation required or not.

[Multidimensional]

In simple terms, you need to bring someone in who is an experienced professional that can fully review your method, practices, training and data. Clearly their is a problem that must be solved before you proceed. It could be something simple such as your settings and/or parameters may be irrational or could show a lack of understanding and training to run the methods. Without a professional on-site, it is impossible to help you (the web is useless for such things as they must be conducted on-site).

[Chromavore]

You are already documenting so much you might as well add why to the list of who what where and when.

Reading over your post again it seems like you are already documenting corrective actions so is it just that you are not documenting the why, or not interrogating it?

E.g. we had a system suit fail, cleaning the system fixed the problem, no more questions.

Or, we had a system suit fail, cleaning the system fixed the problem, Dave was asked why he didn't clean the system after he used it and he said he thought I was gonna do it before my analysis but we can't write that in the equipment report sooo. . .

System suit fails happen and often have an obvious root cause so an RCA is unnecessary, if you are having a lot of them though root cause analysis is going to tell you if it's a serious training/equipment/method problem or if Dave is at it again.

From a regulatory standpoint things like proper training and equipment maintenance are a requirement so again if you are seeing a lot of failures (a lot being totally arbitrary) an auditor might ask why/how are you controlling that so having a bunch of root cause analysis along with corrective actions from those is always going to support you through any audits.

Best of luck.
Chromavore.