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Auditing the Nonconforming Material Process-21 CFR 820.90-Part III

This blog, “Auditing the Nonconforming Material Process-21 CFR 820.90 identifies process interactions with the nonconforming material process. 

auditing for compliance 21CFR 829.90 Auditing the Nonconforming Material Process 21 CFR 820.90 Part III

Nonconforming material is not a “bad” thing in and of itself. In fact, having no nonconformities is conspicuous. There are three critical aspects to verify when you are auditing 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

This article focuses on the third aspect–process interactions. The most efficient method for auditing process interactions is to use turtle diagrams, because turtle diagrams provide a systematic framework for identifying process linkages (http://bit.ly/Process-Approach).

Turtle Diagram Step 1

The first step of completing a turtle diagram involves identifying the process owner and obtaining a brief description of the process. This typically will not lead directly to identification of process interactions–unless the person being interviewed describes the process using a process flow diagram.

Turtle Diagram Step 2

The second step of completing a turtle diagram is where the auditor identifies inputs of raw materials and information to the process. For nonconforming materials, the key is to review the incoming inspection record and the trend of nonconformities from the supplier. In a thorough investigation of root cause for nonconforming raw materials, an investigator may recalculate the process capability for each dimension to determine if the process capability has shifted, since the original process validation by the supplier.

Turtle Diagram Step 3

In the third step of completing a turtle diagram, the auditor documents the flow of product and information when the process is done. The transfer from one process to another will often involve an in-process inspection, and updating of the product status. The best practice is to identify these in-process inspection steps in a risk control plan as part of the overall process risk controls for product realization. Although risk control plans are not required in most companies, they will become more prevalent as companies update their quality systems to a risk-based process for compliance with the 2015 version of ISO 9001.

Turtle Diagram Step 4

The fourth step of the turtle diagram identifies calibration, maintenance and validation that is applicable to the process being audited. It is common for nonconformities to occur when measurement devices are out-of-calibration, or equipment is not adequately maintained. Therefore, auditors should always ask what device was used to measure a nonconformity, and what equipment was used to manufacture product. Auditors should also review calibration and maintenance records for evidence that corrections are being made on a frequent basis.

Whenever frequent corrections are needed, the probability of devices being out-of-calibration and/or equipment malfunctioning increases. Auditors should also verify that the process parameters in use match the validated process parameters. Ideally, validation of process parameters is also directly linked to process risk analysis, and in-process inspections are performed whenever process capability is inadequate to ensure conforming parts. If an auditor observes a high frequency of nonconformities, then an in-process inspection should be implemented for containment and the validation report should be compared to current process performance.

Turtle Diagram Step 5

The fifth step of completing a turtle diagram involves identification of personnel and sampling training records. The procedure for control of nonconforming material should be required training for anyone that is responsible for initiating, investigating or completing a nonconforming product record (i.e., NCR). Critical interactions to verify for effectiveness are related to process changes. If a procedure changes, training may need to be updated. An auditor should verify that there is a mechanism for tracking which revision of the procedure each person is trained to. In addition, training records should verify that training requirements are documented, training is effective and that the person is able to demonstrate competency by correctly completing the sections of an NCR form. The auditor can review completed records to verify competency, but the auditor can also interview personnel and ask hypothetical questions.

Turtle Diagram Step 6

The sixth step of completing a turtle diagram involves identification of all applicable controlled documents, such as: procedures, work instructions and forms. The auditor should also verify that the process for control of external standards is effective. In the case of controlling nonconforming product, there are seldom any applicable external standards. However, it is critical to verify that the current forms and NCR identification methods are being used for control of nonconforming product.

Turtle Diagram Step 7

The seventh and final step of the turtle diagram is data analysis of metrics and quality objectives for a process. For control of nonconforming product, there should be evidence of statistical analysis of nonconforming product in order to identify the need for corrective actions. This is a requirement of 21 CFR 820.250. This data analysis should then be used to quantify process risks that may be used for decision-making and to explain those decisions during regulatory audits.

The above process interactions are just examples, and auditors may identify other important process interactions during the course of an audit. Each process interaction that touches a record of nonconforming product is a potential audit trail that could lead to value-added findings to prevent future nonconformities.

If you need help improving your own process for controlling nonconforming product, or with auditing in general, please email Rob Packard.

Posted in: ISO Auditing

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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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