I have previously mentioned the built-in quality in multiple posts, and I thought, maybe I should dedicate a post to discuss it a little further. I apologize in advance to our quality folks for maybe not using their terminology, I want to explain the built-in quality in simpler terms.
Built-in Quality Defined
You hear the term built-in a lot in electronics world, but in laboratory world! In electronics, built-in indicate that certain feature(s) are included as integral part of your gadget, like built-in speaker or camera. Built-in quality means that the “quality” feature is an integral part of your process; sounds exciting, right?
Built-In Quality, How To?
Building quality in your process is composed of two phases:
Phase I. Identify the quality points in the relevant steps of your process; these are the points that if not controlled could negatively impact the rest of the process. Identifying these points requires a knowledge / experience of the process. Let me list few examples:
- From the 100+ products your laboratory had processed, you know that a final concentration of 10%-15% of anticoagulant in your starting product is the suite point that prevents clotting without negatively impacting the cells viability, i.e., when controlled, you get to work with a product of high quality.
- The literature supports your experience that turning the “Break” off during product centrifugation results in a quality separation; clearly defined layers.
- In programming the magnetic activated cell sorter (MACS) you found that having a second technologist to verify the programming process eliminates the programming-related errors and results in a quality selection with no deviations.
Phase II. Implementing the quality points in your process. This phase requires that you:
- Assess the current situation to identify where changes need to be made in order to implement the points identified in Phase I.
- Make the changes.
- Train those involved on the new process.
I will use the same example of Phase I here:
1. After assessment, you found that the following is needed:
- Provide additional quantities of anticoagulant to your technologists.
- Revise the processing documents and standard operating procedure (SOP) to add steps to calculate, and to add the amount needed of the anticoagulant to reach the right concentration.
- Train your staff on the new process.
2. After assessment, you determined you need a new centrifuge with a “Break” capability. Next you need to revise the processing documents and SOP to add the “Break” activation mandate, and finally train your staff on the new process.
3. After assessment, you determined you need more of your staff to be trained on the MACS. You also determined you need to revise the processing documents and SOP to add space for step verification. Finally, you need to train your staff.
By doing this, you ensure all products processed are 10-15% anticoagulant, have the “Break” off during centrifugation, and are verified during MACS programming. Now your process drives quality without intervention.
Use this as a model for your process design, it saves you time of fixing the process down the road and get you highest possible quality. Yes, this may not eliminate all errors, but it takes care of issues you know they matter for product quality.
Tip: you can use this model to implement the regulatory mandates in your process, as a result, you would have a compliant process.
Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.
About the author
Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here