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Nonconformance is a word no quality manager wants to hear.
Many quality managers dread nonconformances, wishing that they lived in a world with perfect processes that delivered perfect products. Unfortunately, that isn’t our world. That doesn’t mean, however, that a nonconformance is all bad.
Examined holistically, a nonconformance can be considered both a risk and an opportunity.
A nonconformance is a risk if you fail to address known issues—causing issues to snowball into recalls, legal liabilities, or even harm to end users.
It’s an opportunity if you address it through formalized procedures that effectively identify, control, evaluate, and correct the root cause of the nonconformance—using findings to fuel continuous improvements to your product and processes.
The key to transforming a nonconformance into an opportunity is how well you can construct your nonconformance report. In this article, you’ll learn the seven steps to take to write an effective nonconformance report.
A nonconformance is a product or process that doesn’t fulfill a specific requirement established by the company, such as a disconnected process or defective product.
Nonconformances are most commonly uncovered during verification, inspection, or testing activities. If your test findings reveal misalignment in your requirements, that’s a nonconformance. The severity of nonconformances can range from minor to major.
There are two types of nonconformances in the medical device industry:
The U.S. Food and Drug Administration (FDA) provides a useful example of each:
A component you receive from a manufacturer that’s the wrong length is a nonconforming product.
A machine set to the wrong setting that produces imperfect materials is a nonconforming process.
It’s important to note that a nonconforming process—the latter example—can lead to nonconforming products.
Nonconforming products can come in many varieties. Let’s look at some additional examples of nonconformances from our article 4 Tips for Handling Nonconformances:
The parts you received from a supplier don’t match your order.
A manufactured product doesn’t match your specifications.
Software you rely on has a bug that makes it less reliable.
The examples are wide-ranging because the possibilities for nonconformance are themselves wide-ranging. The medical device manufacturing process is inherently complex, and any step in that complex journey can become a misstep.
FDA and ISO take a broadly similar approach to nonconformances.
Essentially, FDA wants you to have a process in place for addressing nonconformances that includes identifying the problem, controlling affected product, taking action, and reworking the policies and procedures that led to the problem in the first place.
FDA 21 CFR Part 820.90 details three components of addressing a nonconformance:
Control of the nonconforming product
Review and disposition of the nonconforming product
Rework policy and procedure
The quality system regulation for medical devices states, “The procedures [for dealing with a nonconformance] shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product.”
ISO takes a similar stance, especially in terms of rework.
ISO 13485:2016 – 8.3.4 defines rework as the process whereby a company eliminates a nonconformance and realigns a process or product with its requirements.
Itay Abuhav, author of ISO 9001: 2015 — A Complete Guide to Quality Management Systems, breaks rework into these six stages:
Accepting the need and inputs for rework
Planning and documenting the rework activities
Reviewing and approving the rework activities
Documenting the relevant training on the procedure
Performing the rework
Validating the result of rework and reinspection
As you can see, FDA and ISO share views on the same problem and essentially the same solution: identify nonconformances, control nonconformances, fix nonconformances, and document nonconformances.
A nonconformance report is a retrospective document. Once you identify a nonconformance, you must start to produce this document. To write an effective nonconformance report, follow the 7-step process listed below, and then document your findings and the actions taken. You can also download our free template for nonconformances to help guide you through the process.
Using these steps as launching points, you’ll learn what constitutes effective nonconformance management and how that leads to a high-quality nonconformance report.
The first step of writing an effective nonconformance report is to control the nonconformance.
This step needs to be taken immediately after a nonconforming product or process is identified. Nonconforming product can be identified at any stage of the production process. The nonconformance could be a product that is about to ship or arrive at a customer.
In fact, in one of my previous manufacturing roles, I had to pull nonconforming product back to our facility that was in the process of being shipped to a customer. I was only able to do so because my quality team on the production floor was able to quickly identify the nonconformance before the shipment arrived at the customer. We ultimately avoided a potentially negative impact on end users of the nonconforming product.
A nonconformance may also be a part that is used in other assemblies. Identification of a product made with the nonconforming part can be challenging. It can also be costly to rework or scrap as more labor has been consumed in the assembly process.
Nonconforming processes should be shut down until a root cause of the nonconformance is identified and addressed. If product or parts are impacted, then these need to be controlled as nonconforming product.
The controlling action occurs any time new nonconforming product or processes are identified and should not wait on a material review board (MRB) to convene, as this may be too late.
Typically, nonconforming product is controlled in a Quality Control Hold. On a production floor this may be a closed off area to hold the nonconfoming product that is only accessible by the quality team. Having the nonconforming product or processes controlled gives you the time to properly assess the nonconformance and make the appropriate decisions.
The second step is to review the nonconformance that was found.
One way to do this is to convene a material review board (MRB). Your company should determine the members of this group prior to the occurrence of a nonconformance. MRB members are responsible for reviewing the nonconformance and determining next steps.
It’s important to note that one part of the review process involves controlling and segregating the nonconforming product, if not already completed. The last thing you want is for the problematic part to advance into manufacturing or a defective product to interface with end users.
FDA requirements for nonconforming product can be found in 21 CFR 820.90(a).
After you review the nonconformance, you will need to identify the disposition action you will take to correct the nonconformity. Disposition is a term that covers whatever action you take for corrective measures.
Note that disposition might mean taking no action at all. According to FDA, “the regulation provides you with the flexibility to decide if an investigation is necessary or not.” If a nonconformance is the result of an already known process problem, you may choose not to initiate a separate investigation.
More likely, however, is that your nonconformity falls into one of the following five types of disposition categories:
Scrap: Used when you decide to destroy a product instead of use it.
Return to supplier: Used when the supplier ships the wrong component or piece and it must be returned.
Downgrade: Used when a problem is found with a new version of a medical device following a change. Until a solution is identified, the previous version is to be used.
Use as is: Used when an unimportant defect is found with one of your products, such as a cosmetic flaw, and it’s determined that the product can still be used as intended.
Rework: Used when a product fails to meet certain stage requirements during quality assurance testing, but a correction can be made that still allows it to meet specifications after retesting. (Note that you must document said rework in your device history record (DHR).)
Even if you take minimal action, you must track all actions taken with regards to the nonconformance. If you find yourself scrapping more products than usual, for example, you may be on the trail of discovering a process nonconformance rather than a product nonconformance.
The goal of root cause analysis is to find the primary cause of a nonconformance and determine whether further investigations (if any) are necessary.
The complexity of medical device manufacturing means there will likely be numerous possibilities for the cause of a nonconformance. Your goal isn’t to find any reason a nonconformance occurred but to find the reason.
Create a problem statement that encompasses all the information you can gather about the nonconformance, including actual impact and potential impact. Conduct the necessary research to uncover this data so you have objective evidence you can provide as needed.
The Greenlight Guru Visualize interface, powered by machine learning (ML) and natural language processing (NLP) technologies built into the medical device QMS software, allows you to easily navigate the depths of your quality system data, saving you time while also improving the quality and accuracy of your work.
After gathering the necessary data, you will then need to determine all of the factors that might have caused the nonconformance. As you investigate, include team members who were involved in the process leading up to the nonconformance, as well as any available experts who are knowledgeable about this type of nonconformance.
With that team assembled, you can use root cause investigative methodologies, such as failure modes and effects analysis (FMEA), fishbone diagram, five whys, or fault tree analysis.
Using one or a combination of these methodologies will lead you to determining the root cause. Be persistent. Keep peeling back layers until you’ve found the fundamental problem.
Minor actions specific to the root cause may be completed in the nonconformance. These may include retraining activities, clarifying work instructions, or refining cosmetic acceptability, for example.
When the nonconformance has high criticality to product, impacts multiple processes, or has become a systemic trend then further corrective action through a CAPA may be necessary. As FDA puts it, “[N]onconformances are a gateway mechanism for CAPA.”
Any of the types of flaws we categorized in step two can be reason for initiating a CAPA investigation if enough of them recur.
Remember that CAPA is best used when problems are systemic, high criticality, or otherwise ambiguous and overly complex. If your company is CAPA happy, you can create a burdensome amount of work.
For a more detailed look at CAPA, refer to our Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices.
Monitoring for effectiveness (if actions to correct root cause have been completed) may seem more passive than the other steps, but is no less important.
After taking actions to address the root cause of the nonconformance, you will need to monitor your processes and the products produced during which to ensure that the nonconformance originally identified does not recur.
Ideally, the steps you took eliminated the problem, and the nonconformance doesn’t reappear after testing or upon a closer inspection.
If it does recur, it’s a sign that your root cause determination was not accurate, in which case you will need to go back to step three and dig deeper to determine if additional problems exist beneath the initial issue that was found.
Documentation should be generated throughout all steps of this process. Your nonconformance report should include documentation showing completion of all steps of the nonconformance and include all relevant details and actions taken during the process.
Ensure that your nonconformance report guides whomever is reading—whether they be auditors or team members examining previous nonconformances— through your nonconformance management process. Review and approval should be completed as actions are taken and once the nonconformance is finalized.
Considering all of the work that goes into effective nonconformance management, it may be tempting to settle with a bare minimum version when writing a nonconformance report. But your nonconformance report is an opportunity—a point of leverage you can use to ensure that key improvements stick.
Use these best practices to write a well formulated nonconformance report:
Document: After you identify nonconforming products, document what you did with them. This includes whether or not (and why) you used them despite a nonconformance. Include signatures.
Categorize: Separate minor and major corrections. Make sure your nonconformance report clearly identifies which nonconformances required local corrections and which required corrective action.
Ownership: Determine process owners who will own and improve the nonconformance report and its associated procedures over time. Meet with stakeholders weekly to go over which nonconformances are open, closed, or in progress.
Track: Track data across time to see if nonconformances are becoming more common in certain areas. When you sit down to write the nonconformance report, you might notice a product problem is actually a process problem. It may be appropriate to create a CAPA to address any systemic nonconformances.
Standardize: Include a standard operating procedure (SOP) that clearly details how employees should use the nonconformance report and any provided templates.
Review: Regularly review your nonconformance management processes as your company grows to ensure that it still suits your company’s capabilities and needs.
These best practices distinguish a good nonconformance report from a great one.
FDA also provides a helpful template for helping manufacturers address nonconformances that can serve as a useful resource when initiating this process.
Most nonconformance procedures tend to be reactive and defensive in nature. Quality managers likely recognize that a proactive, preventive approach would be better, but their processes are often stymied. Why? They’re working in a system that is working against them.
But it doesn’t have to...
Nonconformance management software from Greenlight Guru puts you in a position of leverage.
You can centralize and consolidate your quality processes, enabling you to see past ancillary flaws and find the root cause of nonconformances.
You can assign tasks to your team, track progress, and manage follow-ups.
You can provide information to auditors in a few clicks.
The Greenlight Guru Visualize interface lets you to easily navigate the depths of your quality system data through machine learning and natural language processing technology built into the medical device QMS (MDQMS) software.
If you want to effectively manage nonconformances in a predictable, controlled environment, invest in the best QMS solution for your medical device company, Greenlight Guru MDQMS.
Looking for an all-in-one QMS solution to advance the success of your in-market devices that can integrate your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →
Barret is a Medical Device Guru with over 17 years of industry experience. His medical device career began with supporting design development and product testing before moving into product ownership, including management of contract manufacturers and suppliers. Prior to joining Greenlight Guru, Barret served as a...