The FDA Is Watching: What You Need to Know about Nonconforming Products

Dan O’Leary, president of Ombu Enterprises, explained the requirements for handling nonconforming products during an FDAnews webinar last month. The following is adapted from that event.

When companies investigate product nonconformity, what should they be looking for?

O’Leary: What’s the nature of the nonconformity, and why did it happen? Presumably, you’ve implemented adequate procedures, so this shouldn’t have happened. This is going to lead to an understanding of the cause of the problem — that’s going to have many of the elements of corrective action.

What are some appropriate statistical tools other than trend analysis?

O’Leary: One of the things that you might be interested in is Pareto analysis, which can help you analyze why these problems are happening, based upon their frequency or the nature of the problems.

You could do a scatter plot, for example. If you think there’s a relationship between nonconforming material and some of the nonconforming product and some of the parameters in the production process.

You also might conduct some kind of analysis to determine if there’s a difference between shifts. For example, is there a statistically significant difference between the nonconformance rate on first shift versus the second, or summer versus winter, or Monday versus Friday?

When using a contract manufacturing organization for a finished product, what suggestions would you have for managing nonconforming product when the CMO is responsible for its own manufacture and quality system?

O’Leary: If you’re using their quality management system, you need to ask how they’re going to handle nonconforming material. So, you want to look at all of their procedures.

You want to be very careful that you clearly specify what dispositions they’re allowed to make. If they’re making nonconforming material, it’s probably OK for them to make a scrap disposition, because it’s not going to end up in your company. On the other hand, they should not be making use-as-is or concession disposition without your explicit approval.

If they’re doing rework or repair, then you have a somewhat similar situation. There’s an obligation to document it in the device history record. You need to be clear who’s managing the device history record. All of this is usually going to be spelled out in a quality agreement of some sort.

I would look at all of these dispositions, decide which ones the contract manufacturer is allowed to make on its own, as well as which ones require your approval. You need to write it all up — typically in a supplier agreement.

In a procedure for nonconformity and defect awareness, what should be included in defect awareness?

O’Leary: The people doing this kind of work need to have a clear understanding of how to tell the difference between what’s conforming and what’s nonconforming.

One way is to — on a periodic basis — figure out what kinds of problems you’re having and make sure the people who are doing verification and validation activities are aware of, for example, the most recent nonconformances in the last six months.

In some companies, there may be photographs of what nonconforming material looks like, or even there samples of conforming and nonconforming products. We used to do this when I was involved in a lot of work that required hand soldering. We had photographs and models of what a good solder joint looked like and what a bad solder joint looked like. And that’s how we trained the inspectors and the people who were doing the job.