PLEASE TYPE RESPONSE

Quality Management

Read the Ethics Personal Case study and then write a 1-2 page response as to how you would have handled the problem and why you would do it that way (the basis for your reasoning).

Personal Case Study - Ethics

As a quality supervisor over the medical device area, you have the responsibility to release or reject each lot of sterile devices for shipment to the customer (hospitals) based on the final inspection results. Defect definitions are as follows:

Critical defects are those which can harm or cause even death to the patient.

Major defects are those that do not function properly or are considered unsalable.

Minor defects are those that are aesthetic in nature and may only be noticed by a qualified technician or a nurse who is very familiar with the set.

The results of several final inspections are as follows:

Lot # Qty Critical defect limit Critical defects found Type

Lot 7H345 10,000 2 3 Pinhole leakers

Lot 7H357 8,000 2 2 Pinhole leakers

Lot 7H456 12,000 2 4 Pinhole leakers

Lot 7H789 10,000 2 3 Pinhole leakers

Pinhole leakers are very small pinholes in the tubing that may cause the set to become non-sterile.

Each set is worth about $5 and rework is almost impossible since it invalidates the sterilization method.

The VP of Corporate Quality has called the Quality Manager at your facility (your boss) and told him to release the sets due to the need and the risk the company is willing to take. The QM more than once tells you to release the sets (verbally).

To release with your name on the paperwork could lead to liability charges against the company and you should something happen to a patient. If you elect not to release is a career-limiting move for you and would likely result in being moved to a less important position and potentially is pressured into resigning or leaving the company.

What would you do and what it your reasoning?

My response: I did not release the sets and told him I would not put my name on the paper, but I would put his name on the paperwork. I did not release the sets due to ethical reasons:

1. The lots failed final quality inspection

2. I felt that a loss of life or the potential was more valuable than the value of each lot.

3. I felt the potential of lawsuits against the company (and even myself) could.

Alternate ways to view this is:

1. The hospitals needed the sets to help save patients lives and the defect rate was barely over the acceptable limit so the risk would be worth it to save patients lives. After all, the VP of Quality had a bigger view of the picture.

2. The loss of destroying or trying to rework the rejected lots is too great and it may be worth the risk to release them for use since the need is so great. Results: I would not sign and someone higher released the lots. I left the company within 2 months. Six months later I heard they had a recall on the rejected lots.