Patient Safety is the Perspective for Prevention

When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I asked the question why should we focus on regulatory inspection remediation instead of prevention of inspection remediation?

For those of you who have been involved in regulatory inspections and for those of you that haven’t, lets step back, take a minute, and look at the big picture. What are your observations from where your point of view? Does it focus on patient safety?

In this document I will present actual scenarios where if we change our day-to-day outlook and concentrate on the actual goal at hand, which is, ensuring that patients receive safe and effective products, we can potentially reduce or prevent having to remediate the outcome of regulatory inspections.

Scenario 1
During a regulatory inspection it is discovered that the reconciliation does not add up on an assigned lot of major components used in a Class III medical device. The major component is missing and cannot be found.

What does your patient safety view about Scenario 1 tell you? We don’t know if there was a miscount of the lot of components. We do not know if the component was accepted or rejected, or even inspected and tested as per specified acceptance criteria.

The result suggests that it is not known whether an acceptable component that met specification was used in the medical device. Patient safety could be compromised.

Stop, take a step back address the component reconciliation issue from a patient safety view.

Scenario 2
During a regulatory inspection it is discovered that sterility audits are not being performed.

Sterility audits are performed to confirm the sterility assurance level. The audit is required to designate that a product is “sterile”.

What does your patient safety view tell you about Scenario 2? We cannot confirm the sterility assurance level of the product.

The result is that we do not know whether the product is sterile. Patient safety could be compromised.

Why did this happen? Address it from a patient safety point of view.

Scenario 3
During a regulatory inspection it is discovered that product claims being made were not included in the product regulatory filing.

What does your patient safety view tell you about Scenario 3? You got it! That the product may not perform as expected.
The result is that patient safety could be compromised.

What is missing in the system that could have prevented this? Address it from the patient safety point of view.

Scenario 4
During a regulatory inspection it is discovered is that data integrity could be breached in the use of lab equipment for product acceptance.

What does your patient safety view tell you from Scenario 4? Maybe unauthorized entry into testing equipment, deletion of testing records, and possible testing of product into compliance could all result from Scenario 4. These are just a few possibilities arising from Scenario 4.

The result is that data integrity may have been breached in the use of the lab equipment for product acceptance testing. Patient safety could be compromised.

Why did this happen? Address it from a patient safety view.
I have provided four scenarios where through regulatory inspections found that patient safety could have been compromised.

The work we do every day is important to the safety and efficacy of the pharmaceutical products. During our day to day work we often get caught up in the minutia and forget the goal at hand.

Would the inspection results for these four scenarios have changed, knowing what we needed to provide from a quality, compliance and regulatory stand point on a daily basis to ensure patient safety? I believe they would have.

We cannot prevent all inspection remediations, but we can help reduce them and prevent some from happening in the future.

Each day, whatever the situation, take a step back and look at the big picture. Ask yourself, “Am I focused on patient safety?”