Auditing Nonconforming Materials: 21 CFR 820.90 Compliance

This blog, “Auditing Nonconforming Materials: 21 CFR 820.90 Compliance” focuses explicitly on the identification and segregation of nonconforming materials. 

Nonconforming material is not a “bad” thing in and of itself. A total lack of nonconformities is conspicuous. There are three critical aspects to verify when you audit nonconforming materials:

1. nonconforming materials are identified and segregated
2. disposition of nonconforming materials is appropriate
3. feedback from the nonconforming material process interacts with other processes 

Identification & Segregation

Failure to adequately control nonconforming materials is one of the top 10 reasons why companies receive FDA 483s (http://bit.ly/FY2013-483-Data-Analysis). There is no requirement for locked cages in a Standard or 21 CFR 820 (http://bit.ly/21CFR820-90), but you must identify nonconforming materials and keep them segregated from conforming product. How you identify the nonconforming material is also up to your discretion. I do not recommend anything that is colored green because people associate the color green with a product that is accepted and released. In contrast, anything red is typically associated with danger, caution, or rejected. I prefer to keep things simple. Therefore, a red sticker, red tag, or placing a part in a red bin usually works.

I believe in eliminating duplication of work whenever possible. Therefore, I think it’s silly when a procedure requires you to document information on a red sticker or tag that is also on a Nonconforming Material Record (NCR). Every NCR must have traceability to the physical product, and marking the number of the NCR on the red sticker or tag is a simple way to accomplish this. (i.e., NCR # 32).

If you have a barcoding system, you eliminate the possibility of misreading an NCR number, but it’s overkill. Another silly requirement is to attach a hard copy of the nonconforming material record to the box containing the nonconforming product. Every time you revise the NCR, you won’t remove the original and attach a new copy to the box. Furthermore, many auditors just look for a box of products in the quarantine area that is missing a hard copy of the nonconforming material record.

My preference is to have red stickers or tags placed on a nonconforming product at the location it is found and then placed into a red bin. At least once a day, or whenever you perform a “line clearance”, I recommend that the contents of the red bins are moved to a centralized location for nonconformities.

At that location, there should be a log and a computer to either print out a new NCR or to enter information into an electronic record. This centralized location should be visible to the production manager or the quality manager from their desk. The person delivering the nonconformity should complete the next entry in the log and record the number on the sticker or tag. Then, the NCR should be completed with the required information. The NCR should then be delivered to the manager’s desk in a red bin.

Some people argue that you need a large area to store the nonconforming product in the warehouse–in case you have a large quantity of nonconforming product. I disagree. If you have a great deal of nonconforming material (i.e., your red bins are filling rapidly), then you need to stop production and get the situation resolved immediately. This is why you have a CAPA process.

If your inspectors are finding nonconforming product at incoming inspection, this means your supplier shipped nonconforming material. Don’t tolerate nonconforming material from suppliers. Reject nonconforming material and make your suppliers initiate corrective actions.

If the problem is with:

• Your inspection method, you need to validate your inspection method (i.e., gage R&R studies).
• Your inspection device, quarantine it, and get another calibrated device.
• Your specification, fix it now.

Every other type of problem found during an incoming inspection should result in a buyer, or another person responsible for supplier quality management, contacting the supplier ASAP. Ideally, you want all incoming rejected product to be returned the same day it is received. 

How to Audit Identification and Segregation

When I’m auditing this process, I look first for proper identification and segregation. There are three places where auditors need to ask and observe how nonconforming material is identified and segregated: 1) incoming inspection, 2) in-process inspection, and 3) final release (http://bit.ly/21CFR820-80). It is also critical that auditors verify that nonconforming materials are removed from production areas at the end of each lot as part of the line clearance procedure. If this is not done, then there is a risk of losing traceability to the lot.

Auditors should ask how nonconforming material is identified and then verify that the procedure states this. Searching for deviations from the procedure is easy if the procedure was not well written, but these are audit findings of little value. Quality Managers should address this issue when they write the procedure. What is far more important is to verify that everyone is segregating nonconforming material immediately.

• Red bins are your “friend” and they belong on the floor.
• Yellow typically indicates that something is waiting to be inspected.
• Green typically means that something passed inspection and has been accepted.

Auditors should look for situations where multiple parts are in the process of being inspected at the same time. Unless inspection is automated and involves a fixture, I don’t recommend allowing an inspector to inspect more than one part at a time.

As an auditor, once I have verified that the product is adequately identified and segregated, then I look to see how nonconformities are dispositioned. That is the subject of a future blog. If you have a quarantine area that is bursting with rejected components and incorrectly built products, you need to read our next blog (http://bit.ly/MDA-Blog) about the control of nonconforming materials.