7QC Tools: My bitter experience with statistical Process Control (SPC)!

    Amrendra Roy

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    I just want to share my experience in SPC.

    In general, I have seen that people are plotting the control chart of the final critical quality attribute of a product (or simply a CQA). But the information displayed by these control charts is historical in nature i.e. the entire process has already taken place. Hence, even if the control chart is showing a out of control point, I can’t do anything about it except for the reprocessing and rework. We often forget that these CQAs are affected by some critical process parameters (CPPs) and I can’t go back in time to correct that CPPs. The only thing we can do is to start a investigation.



    Instead, if we can plot the control chart of CPPs and if these control charts shows any out of control points, IMMEDIATLY WE CAN FORECAST THAT THIS BATCH IS GOING TO FAIL or WE CAN TAKE A CORRECTIVE ACTION THEN AND THERE ITSELF. This is because CPPs and CQA are highly correlated and if CPPs shows an out of control point on its control chart, then we are sure that that batch is going to fail.


    Hence, the control charts of CPPs would help us in forecasting about the output quality (CQA) of the batch because, the CPP would fail first before a batch fails. This will also help us in saving the time that goes into the investigation. This is very important for the pharmaceutical industry as everyone in the pharmaceutical industry knows, how much time and resource goes into the investigation!


    I feel that we need to plot the control chart of CPPs along with the control chart of CQA, with more focus on the control chart of CPPs. This will help us in taking timely corrective actions (if available) or we can scrap the batch, saving downstream time and resource (in case no corrective action available).

    Another advantage of plotting the CPP is for looking for the evidence that a CPP is showing a trend and in near future it will cross the control limits as shown below, this will warrant a timely corrective action of process or machine.


    CQA: Critical Quality attribute

    CPP: Critical Process Parameter

    OOS: out of specification

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    3 thoughts on “7QC Tools: My bitter experience with statistical Process Control (SPC)!”

    1. Dear Dr Roy,
      I aagree with your CPP concept provided the defined CPP’s are true for its specified range. Normally as per the industry practices CPP’s are beiing established by R&D without conducting appropriate positive and negative experiments within and beyond the defined CPP range.

    2. I agree CPP (factor) tends to be more predictive than CQA (symptoms). That’s the reason why risk assessment should be done to the level of CPP’s as well.

      – Sun of QbDWorks.com

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