Successful Cell Therapy in Saudi Arabia is the only outcome

2021-08-02T09:13:15.000Z

“If you want to make no mistakes, stop working”. While this approach would definitely eliminate mistakes, it is not the right thing to do. In fact, I think that “not working” in itself is a mistake, don’t you think? Aside from this, there are right ways to reduce/eliminate errors.

I’ll first briefly describe mistakes, then talk about how to prevent them. In cell and gene therapy (C&GT) field, regulators call mistakes “deviations”. Basically, deviations are actions taken (or not taken) in a way that contradict the standard (e.g. policy, procedure, production document, etc.), i.e. deviating from the standard. Here is how foundation for the accreditation of cellular therapy (FACT) defines it:

“Deviation: The action of departing from an established course of action or accepted practice”

Types of deviations

There are two types of deviations:

• Planned: is an intended deviation that the lab management and quality assurance (QA) have given permission for before it occurs. For example, per the standard operating procedure (SOP) of the liquid nitrogen (LN2) freezer, the LN2 level need to be maintained in the range of 7-12 inches. Due to a delay in LN2 supply, the lab management and QA approved the level of LN2 to drop below 7 inches then be refilled.
• Unplanned: is an unintended deviation that accidentally committed without prior approval of lab management or QA. For example, the biannual periodic review of certain document was due on November 5th of 2021. The document was skipped in error and was not reviewed until January 15th of 2022.

We just finished describing the deviations and identified their types. Now it makes since to talk about ways to prevent them. Often, deviations are the manifestations of deeper causes (root causes). Therefore, for a durable improvement we need to focus on fixing the root causes.

How to reduce deviations?

1. Preparation: before initiating a process, make sure you have all required material, equipment, personnel, facility, and documents.
2. Readiness: ensue materials are approved for use, equipment is calibrated, personnel are trained, facility in status, and documents are approved. Also, ensure the documentation of all this is completed.
3. Communication: assignment should be clearly communicated to all involved personnel, management, and QA.
4. Verify: let a second trained person review the process and ensure all documents are in place. Also, consider having a verifier for each critical step.
5. Back up: prepare to replace material, equipment, and personnel if needed for an emergency.
6. Automate: when applicable, utilize electronic systems that monitor and alert such as expiration date of reagent, level of LN2, or due date for training.
7. Be on the lookout: continuously monitor the operations and exclude any potential source of error. For example, if a specific reagent lot presented signs of suboptimal quality, stop using this lot, remove it from production, replace it with an approved lot.

Handling of deviations is not so pleasant, but consider the positive side. Deviations point to weaknesses in your system that went unnoticed. By fixing these and similar weaknesses you build a robust system. As I mentioned elsewhere, always plan for the built-in quality, it pays off down the road. By implementing the deviation reduction ways in your processes, you significantly reduce the chances of errors, and if they occur, they would be minor ones.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us