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Disposition of Nonconforming Materials-21 CFR 820.90 Compliance

Disposition of Nonconforming Materials-21 CFR 820.90 Compliance focuses on determining a disposition method, including scrap, return to supplier, rework, use as is, etc. Part 3 in our series will address process interactions with the nonconforming material process.

Sorting Disposition of Scrap Disposition of Nonconforming Materials 21 CFR 820.90 Compliance

In our previous blog, (http://bit.ly/Auditing-NCRs-Part1) we focused on requirements to identify and segregate nonconforming materials. Once nonconformities are labeled and locked in your quarantine cage, what do you do next?

The next step in the process for controlling nonconforming materials is to determine a disposition. The most common dispositions are:

  • Scrap
  • Return to Supplier (RTS)
  • Rework
  • Use As Is (UAI)

Some companies also have dispositions of sort and repair. Sort is not a disposition, and often creates confusion for anyone auditing records of nonconforming materials. Sorting is the process that you must perform when a lot of material fails to meet acceptance criteria, but some of the individual units within the lot meet the acceptance criteria. In this scenario, the following sequence of events is recommended.

Sorting

First, the lot is segregated from conforming product and an NCR number is assigned. Next, the lot is 100% inspected for the defect and the results of the inspection are recorded on the inspection record. It is important to record the specific number of nonconforming units on the NCR record–not the total amount inspected. The final step is to release conforming product back into the production process or warehouse, and the Material Review Board (MRB) will disposition the units identified as nonconforming.

If identifying nonconforming product requires an inspection method that is not typically performed, then the inspection plan needs to be corrected, or a corrective action plan is needed. New and unforeseen defects may indicate a process change, a change in the raw materials or inadequate training of personnel at your company or your supplier. An investigation of root cause is needed, and it is recommended to consider documenting this investigation as an internal CAPA or a Supplier Corrective Action Request (SCAR).

Material Review Board (MRB)

Most companies have a “Material Review Board” (MRB) that is responsible for making the decision related to disposition of nonconforming material. Typically, the MRB will be scheduled once per week to review the most recent nonconformities. The board usually consists of a cross-functional team, such as:

  • Quality Assurance
  • Research & Development
  • Manufacturing
  • Supply Chain
  • Regulatory

The reason for a cross-functional team is to review potential adverse effects of rework and potential risks associated with a UAI disposition. If rework is required, the cross-functional team will typically have the necessary expertise to create a rework instruction and to review and approve that rework instruction–including any additional inspections that may be required beyond the standard inspection work instructions.

Scrap

If the material is going to be scrapped, there is no risk to patients or users. Therefore, the entire MRB team should not be required in order to scrap product. Because there may be a cost associated with the scrap of nonconforming product, it is recommended that someone from accounting and a quality assurance representative approve scrap dispositions. Other departments should be notified of scrap, but a trend analysis of all nonconforming product should be reviewed by each department and by top management during management reviews. Auditors and FDA inspectors specifically, will be looking for evidence of statistical analysis of nonconforming material trends and then implementation of appropriate corrective actions.

Return to Supplier (RTS)

Returning nonconforming material to the supplier that produced it is the most common disposition, but the trend of RTS should continuously be improving. If the trend of RTS is not improving, your supplier qualification process or your supplier control may be inadequate. The best way to ensure that the trend is improving is to initiate a SCAR. Some companies automatically wait until they have a trend of nonconforming material before initiating a SCAR. However, if you wait until a defect occurs twice, you are doubling the number of nonconformities for that root cause. If you wait until a defect occurs three times, you are tripling the nonconformities. For this disposition, there also does not need to be approval from the entire MRB. Typically, only someone from the supply chain management and quality assurance are needed to return nonconforming product to a supplier.

Rework

Almost every auditor looks for a specific phrase in the procedure for Control of Nonconforming Material: “The MRB will review and document the potential adverse effects of rework.” Most companies are doing this, but the procedures often do not specifically state this requirement, and rework instructions are often missing any specific inspection instructions that have been added to reduce risks associated with the rework process. Repeating the normal inspection criteria is seldom adequate for reworked product, because the rework process typically results in different defects.

Another phrase that auditors and inspectors are looking for is the requirement to document the rework instructions, and to have the instructions reviewed and approved by the same functions that reviewed and approved the normal production process. This requirement is often not specifically stated in the procedure, and FDA 483 inspection observations are commonly issued for this oversight.

Use As Is (UAI)

The UAI disposition should be rare. When I see a large number of NCRs with a disposition of UAI, I expect one of two reasons for this situation. First, the NCRs are for cosmetic defects where the acceptance criteria are too subjective and inspectors need clear guidelines regarding acceptable blemishes and unacceptable nonconformities. The visual inspection guides used during solder joint inspection for printed circuit boards is an excellent example of best practices for clearly defining visual inspection criteria. Personally, I prefer to use a digital camera to take pictures of representative “good” and “bad” parts. Then I create a visual inspection chart with a green, smiley face for “good” and a red, frowny face for “bad.” The best inspection charts identify the proper inspection equipment and quantitative acceptance criteria with pictures and symbols instead of words.

The second reason for a larger percentage of UAI dispositions is that the product specifications exceed the design inputs. For example, if a threaded rod needs to be at least 1” long, but a 1.25” long is acceptable, then you should not approve a drawing with a specification of 1.00” +/- 0.05”. Often, the legend of drawings will define a default tolerance that is unnecessary. A more appropriate specification would be 1.13” +/- 0.12”. No matter how much work it is to specifically define tolerances for each dimension on a drawing, the work required to do this at the time of initial drawing approval is much less than the work required to justify a UAI disposition. FDA inspectors will consider a UAI disposition as a potential adulterated or misbranded product, and a formal Health Hazard Evaluation (HHE) may be required to justify the reason why product is not recalled.

Regardless of the disposition of product, the decision for disposition should be a streamlined process that is not delayed unnecessarily. In order to ensure that your nonconforming material dispositions are effective and processed in a timely manner, our next blog (http://bit.ly/MDA-Blog) in the series about control of nonconforming materials will focus on process interactions, monitoring and measuring of nonconforming product and when to initiate a CAPA or SCAR to prevent more NCRs.

Posted in: ISO Certification

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Auditing Nonconforming Materials: 21 CFR 820.90 Compliance

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

Identification and Segregation 3 Auditing Nonconforming Materials: 21 CFR 820.90 Compliance

Nonconforming material is not a “bad” thing in and of itself. In fact, 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 product that is accepted and released, while 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 product 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 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 then should be delivered to the manager’s desk in a red bin.

Some people argue that you need a large area to store 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 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 any 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 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 product, you need to read our next blog (http://bit.ly/MDA-Blog) about control of nonconforming materials.

Posted in: ISO Auditing

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