Nonconforming Material Archives | Cloudtheapp

Material Review Board (MRB): Purpose, Process, and FDA Requirements

Cloudtheapp Inc. — Fri, 10 Jul 2026 03:15:14 +0000

TLDR

A Material Review Board (MRB) is the cross-functional body that decides what happens to nonconforming material, accept, rework, scrap, or return to supplier. FDA requires documented disposition decisions under 21 CFR Part 820 (QMSR), and ISO 13485 imposes similar requirements under Section 8.3. Without a functioning MRB process, your quality system will accumulate unauthorized dispositions, undocumented deviations, and the kind of record gaps that generate FDA Form 483 observations during inspections.

What is a Material Review Board?

A Material Review Board is a cross-functional committee authorized to evaluate nonconforming material and make binding disposition decisions. The board typically includes members from quality assurance, engineering, manufacturing, regulatory affairs, and procurement. The exact combination varies by organization size and the nature of the nonconformance.

The MRB is not an ad hoc committee. It operates within a documented procedure, with defined roles, quorum requirements, and required signatures. Every decision the MRB makes must be traceable, appearing in an audit trail that regulators can follow from initial detection of the nonconformance through to final disposition and any associated corrective action.

In some organizations, the MRB is also called a Material Review Committee (MRC). The name is secondary. What matters is that the function exists, the authority is defined, and the records are complete.

Why the MRB process matters under FDA regulation

Under 21 CFR Part 820, now consolidated into the Quality Management System Regulation (QMSR) aligned with ISO 13485, manufacturers of medical devices must maintain documented procedures for identifying, documenting, evaluating, segregating, and disposing of nonconforming product. The regulation does not prescribe the exact structure of an MRB, but it requires that anyone who authorizes a disposition decision is qualified and that the decision itself is documented.

According to a white paper published by Pathwise on nonconforming materials compliance, inadequate procedures for nonconforming product appeared among the top ten most frequently cited observations on FDA Form 483 inspections based on FDA FY2015 Inspectional Observation Summaries. [Source: Pathwise] That pattern has persisted. The MRB is where those inadequacies most often originate; because the process is undocumented, the review team is not qualified, or the disposition decisions lack the justification a regulator expects to see.

ISO 13485 Section 8.3 states that organizations must identify and control nonconforming product to prevent its unintended use or delivery. The standard requires documented procedures defining responsibilities for review and disposition. For organizations pursuing ISO 13485 certification or maintaining FDA compliance, the MRB procedure is not optional.

The four disposition options

When the MRB reviews a nonconforming material or product, it has four disposition paths available. Each carries specific documentation and, in some cases, regulatory notification requirements.

Accept as-is

The MRB determines that the nonconformance does not compromise safety, identity, strength, purity, or quality, and that the product is fit for its intended use despite falling outside specification. This decision requires documented technical justification. For medical devices, use-as-is disposition for product that has already left the facility may trigger MDR reporting obligations depending on the nature of the nonconformance. The justification must be in writing, signed by authorized personnel, and linked to the original nonconformance record.

Rework or repair

The nonconforming material can be brought back into conformance through a defined rework process. Rework must itself be controlled: it needs a procedure, personnel qualification records, and post-rework inspection documentation confirming the product meets specification after rework is complete. Reworked product should be re-inspected and re-tested before release. The rework process must not introduce new risks.

Scrap

The material is destroyed or rendered unusable and disposed of in a controlled manner. Scrap decisions still require documentation; including what was scrapped, how much, why, and how the physical destruction was controlled. This prevents scrapped material from re-entering the supply chain.

Return to supplier

Nonconforming incoming material is returned to its source. This disposition typically initiates a root cause investigation on the supplier’s side and may require a Supplier Corrective Action Request through your Supplier Quality Management process. The MRB record should document the return authorization, the supplier notification, and any commitments on corrective action timelines.

Who sits on the MRB

The composition of the MRB depends on what type of nonconformance is being reviewed. A minor dimensional deviation on a purchased component may need only quality and engineering. A sterility failure in a finished medical device requires quality, regulatory, manufacturing, and potentially the design authority.

The procedure should define the minimum required attendees for different categories of nonconformance and who has signature authority; meaning who can formally approve a disposition decision. At minimum, quality assurance must be represented and must concur with every disposition. Engineering input is required when the decision involves technical acceptance criteria or rework feasibility. Regulatory affairs is required when the nonconformance has a potential safety or reporting implication.

Ad hoc decisions made outside the defined process, someone verbally approving a disposition on the production floor without a written record, are exactly what generates 483 observations. The entire point of the MRB is to create a controlled, traceable decision pathway.

What the MRB record must contain

The FDA requires that nonconforming product handling be fully documented. An MRB record that will survive an inspection should include the following:

A unique identifier for the nonconformance
Description of the product or material, including lot number, quantity, and location
Description of the nonconformance, what specification was not met and how the deviation was detected
Names and roles of MRB members who participated in the review
The disposition decision with written technical justification
Signatures of authorized reviewers and the date of each signature
Whether a CAPA was initiated as a result of the disposition
Disposition completion date and confirmation of physical handling (scrap certificate, rework inspection results, return shipping records)

For use-as-is dispositions, the technical justification must be especially detailed. Inspectors look for specificity: what risk assessment was performed, what data supported the decision, and who had the authority to accept the product outside specification.

Common MRB failures that generate 483 observations

Most MRB-related 483 observations fall into a few recurring patterns. Knowing them makes it easier to design a process that avoids them.

No documented procedure. The organization handles nonconforming material but has no written MRB procedure defining roles, responsibilities, quorum, and decision criteria. This is a direct 820.90 / QMSR violation.

Incomplete records. The disposition decision is recorded but the technical justification is absent, signatures are missing, or the link between the nonconformance and any resulting corrective action is broken. Inspectors follow the paper trail. Gaps in it raise questions.

Unauthorized dispositions. Someone without defined authority approves a disposition. This happens when the formal MRB process is bypassed under production pressure. The procedure must define who has authority, and that authority must be exercised formally.

No segregation. Nonconforming material is not physically separated from conforming product while awaiting MRB review. If nonconforming material can mix with released product, the control system has failed at a fundamental level.

No CAPA linkage. The nonconformance is dispositioned but no systemic corrective action is initiated for recurring issues. A pattern of use-as-is decisions on the same nonconformance with no CAPA will draw scrutiny from any auditor reviewing the trend data.

How a digital QMS strengthens the MRB process

Paper-based MRB processes introduce delays and documentation risks that a modern eQMS removes. When a nonconformance is detected in a paper system, someone physically walks the form to each MRB member, collects signatures, and files the completed record. That process is slow, easy to lose track of, and difficult to audit in real time.

A digital QMS automates the MRB workflow. When a nonconformance is created, the system routes it to the appropriate reviewers based on product type, nonconformance category, and defined quorum rules. Each reviewer receives a notification, reviews the record in the system, and applies an electronic signature. The audit trail is automatic; every view, comment, and approval is timestamped and attributed. When a CAPA is required, the system links the two records permanently.

Cloudtheapp includes Nonconforming Material and Supplier Quality Management as part of a platform with 60+ pre-built quality, compliance, and operations applications. The Nonconforming Material module supports full MRB workflow routing, disposition tracking, and CAPA linkage, with electronic signatures that meet 21 CFR Part 11 requirements. Inspectors who request nonconforming product records find a complete, searchable history, no missing signatures, no ambiguous dispositions.

To see how this works in practice, schedule a demo with the Cloudtheapp team.

MRB in the context of audits and continuous improvement

The MRB does not operate in isolation. Its outputs feed directly into the broader quality system. Every disposition generates data, what failed, how often, at what stage of production, from which supplier. When that data is trended, it becomes the raw material for systemic improvement.

During internal audits, quality teams should review MRB records as a leading indicator of systemic problems. A pattern of repeat nonconformances with use-as-is dispositions and no corresponding CAPA signals that the organization is managing symptoms rather than root causes. Internal and external auditors will interpret that pattern the same way.

When a nonconformance warrants corrective action, the deviation CAPA record should reference the originating MRB decision so that anyone reviewing the CAPA later understands the full context. This linkage is the kind of traceability that regulators expect in a mature quality system.

Setting up a compliant MRB procedure

If your organization lacks a formal MRB procedure, or if the existing one has gaps, here is where to start.

Define scope. The procedure should specify what triggers an MRB review. Some organizations use a tiered system where minor deviations go through a streamlined single-reviewer approval and major or safety-related nonconformances go to the full board. Document the criteria for each tier.

Define membership and authority. Name the roles, not necessarily specific individuals, that must be represented at each tier. Define who can authorize each disposition type. Use-as-is and scrap may carry different authority requirements.

Define the record format. Whether you use a digital system or a controlled paper form, the record format should be defined in the procedure and all required fields should be explicit.

Define timelines. Nonconforming material should not sit unreviewed for weeks. Set maximum review timelines by nonconformance category and build in escalation paths when reviews are not completed on time.

Connect to trending. The MRB procedure should reference how nonconformance data is compiled, analyzed, and reported, whether monthly, quarterly, or at management review. A deviation report on a recurring nonconformance without trend data attached is a missed opportunity for systemic improvement.

Conclusion

The Material Review Board is one of the most operationally visible parts of a quality system. It is where nonconforming material gets reviewed, documented, and decisively handled, or where the process breaks down under production pressure and creates the documentation gaps that inspectors find later. A well-designed MRB procedure, supported by a digital QMS that enforces workflow and captures every step automatically, removes the manual friction and the compliance risk. The records are complete. The decisions are traceable. The audit trail holds.

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Clear the Fog, and the Path to Non-Conforming Material Process Becomes Visible

Wael Zebdeh — Tue, 07 Feb 2023 15:19:06 +0000

The Non-conforming material process can often be a murky and confusing subject, with many nuances and intricacies to navigate. However, by taking the time to understand this process and the steps involved, you can help to “clear the fog” and ensure that your organization can effectively manage and disposition any non-conforming materials that may arise.

At its most basic level, non-conforming material refers to any material that does not meet the specified requirements or standards set forth by your organization or industry. This can encompass a wide range of issues, from materials that are not of the correct quality or quantity to those that are improperly manufactured, packaged, or labeled. Whatever the reason for the non-conformance, it is important to have a clear and well-defined process in place for dealing with these materials, to maintain the quality and integrity of your products, as well as to ensure compliance with any regulatory requirements.

Several types of non-conforming material can arise during your operations. Some of the most common include:

Out-of-specification (OOS) materials: These are materials that do not meet the specified requirements or standards for quality, quantity, or other factors.
Out-of-tolerance (OOT) materials: These are materials that do not meet the acceptable tolerance levels for specific characteristics or attributes.
Mislabeled or mispackaged materials: These are materials that are incorrectly labeled or packaged, which can lead to confusion and potential safety issues.
Damaged or defective materials: These are materials that have been damaged or are otherwise faulty, and which may pose a risk to the quality of your products or the safety of your customers.

Once you have identified non-conforming material, the next step is to determine the appropriate material disposition. This can take several forms, depending on the nature of the non-conformance and the requirements of your organization or industry. Some of the most common material dispositions include:

Repair: This is when the material is repaired or modified to bring it into compliance with the required standards.
Re-work: This is when the material is processed or manufactured again to correct any non-conformances.
Acceptance: This is when the material is accepted for use despite the non-conformance, typically with the understanding that the material will be subject to additional inspections or tests.
Scrap: In the context of non-conforming material, scrap refers to material that does not meet the required specifications or quality standards set by the company. This material may be the result of manufacturing defects, incorrect processing, or a failure to meet customer requirements. The decision to scrap non-conforming material should be based on a thorough evaluation of the costs and benefits of doing so.
Return to Vendor (RTV): This is the process for handling non-conforming material where the material is returned to the supplier or manufacturer for correction or replacement. This process is typically used when the non-conformity is the result of a mistake made by the supplier or when the material does not meet the specified requirements agreed upon in the purchase agreement.

By having a clear and well-defined non-conforming material process in place, you can ensure that any non-conforming materials are properly managed and disposed of in a timely and effective manner. This can help to maintain the quality and integrity of your products, as well as to ensure compliance with any regulatory requirements. Whether you are just starting to implement this process in your organization or are looking to improve upon existing procedures, taking the time to “clear the fog” and understand the non-conforming material process can help you to achieve your quality and compliance goals.

Non-conforming material is closely linked to the receiving and inspection processes, as it is through these processes that the presence of non-conforming material is typically first identified. During the receiving process, materials are inspected for compliance with the specified requirements, and any non-conforming materials are noted and documented. The inspection process then provides an opportunity for a more detailed examination of the materials and a determination of the appropriate material disposition.

The non-conforming material process is also closely linked to the corrective action process, as the identification of non-conforming material can often be a trigger for the initiation of corrective action. The goal of the corrective action process is to eliminate the root causes of issues and prevent them from recurring in the future. To achieve this goal, it is important to thoroughly investigate the cause of the non-conformance and to implement effective and sustainable corrective actions.

The benefits of a well-designed and properly implemented non-conforming material process are numerous. By effectively managing and disposing of non-conforming materials, you can:

Maintain the quality and integrity of your products, which helps to ensure customer satisfaction and loyalty.
Comply with regulatory requirements, which helps to minimize the risk of fines, penalties, and other legal or financial consequences.
Improve the efficiency and effectiveness of your operations, by reducing the amount of time and resources required to manage non-conforming materials.
Identify and eliminate root causes of issues, which helps to improve the overall quality of your products and to minimize the risk of future non-conformances.

By taking the time to understand and effectively implement the non-conforming material process, you can help to ensure the continued success and growth of your organization, while also helping to protect the interests of your customers and other stakeholders.

Despite its many benefits, the non-conforming material process is not without its challenges, and there are several common mistakes that organizations make when implementing this process. Some of the most common mistakes include:

Failing to properly document non-conforming materials: It is important to thoroughly document non-conforming materials, including the nature of the non-conformance, the materials affected, and the disposition of the materials. Without proper documentation, it can be difficult to track the status of non-conforming materials and determine the appropriate course of action.
Not following established procedures: It is critical to follow established procedures for the handling and disposition of non-conforming materials to maintain the integrity of the process and to minimize the risk of errors or oversights.
Not conducting root cause analysis: To effectively eliminate the root causes of non-conformances, it is essential to conduct a thorough root cause analysis. This can help to identify the underlying causes of issues and to implement effective corrective actions.

Another challenge associated with the non-conforming material process is the manual nature of the process, which can be time-consuming and prone to errors. For example, a company may have a manual process for tracking non-conforming materials, which involves manually entering data into a spreadsheet. This process can be painful, especially if the person responsible for tracking the data is not meticulous or detail-oriented.

Communicating issues related to non-conforming materials to suppliers can be a hassle, as it requires careful coordination between the receiving organization and the supplier. Some of the common challenges that organizations face when communicating issues to suppliers include:

Lack of clear communication channels: It can be difficult to establish clear and effective communication channels between the receiving organization and the supplier, particularly if the supplier is located in a different region or country.
Different expectations and interpretations of non-conformance: Different organizations may have different expectations and interpretations of what constitutes a non-conformance, which can lead to misunderstandings and difficulties when communicating issues to suppliers.
Time delays in resolution: It can take time for suppliers to resolve issues related to non-conforming materials, particularly if the issue is complex or if the supplier is not equipped to handle the issue quickly.

To remedy these issues, organizations can take several steps, including:

Establishing clear and effective communication channels with suppliers: This can involve setting up regular meetings or conference calls between the receiving organization and the supplier or using collaboration tools such as email, instant messaging, or project management software.
Standardizing definitions and expectations of non-conformance: Organizations can establish standardized definitions and expectations of non-conformance to ensure that all parties are on the same page and to minimize misunderstandings.
Implementing a supplier performance management system: Organizations can implement a supplier performance management system to track the performance of suppliers and to identify areas for improvement.

The digitalization of the non-conforming material process can bring several benefits to organizations, including:

Increased efficiency: Digitalization can streamline the process of tracking, reporting, and resolving non-conformances, reducing the risk of errors and oversights and enabling organizations to respond more quickly and effectively.
Improved accuracy: By automating the tracking and reporting of non-conformances, digitalization can reduce the risk of human error and improve the accuracy of the process.
Better visibility: By centralizing all non-conforming material data in a single repository, digitalization can provide organizations with better visibility into the status of non-conformances and enable them to track trends and identify areas for improvement.
Improved collaboration: Digitalization can enable organizations to collaborate more effectively with suppliers and other stakeholders by providing a centralized repository for all non-conforming material data and by enabling real-time communication and collaboration.

Integrating the Non-Conforming Material (NCM) process with an Enterprise Resource Planning (ERP) system is crucial in ensuring the smooth and efficient functioning of the NCM process. The ERP system contains the master data for product and material listing, which is essential in initiating the NCM process. The ERP can serve as the source of truth regarding the material status, such as whether it is on hold or released. This information is a critical output of the NCM process and must be easily accessible to all stakeholders. By integrating the NCM process with the ERP system, companies can ensure that all relevant information is available in one central location, reducing the chances of errors and increasing the efficiency of the process. Additionally, the integration of the NCM process with the ERP can help to eliminate manual data entry and minimize the risk of data loss, thus leading to better decision-making and improved overall process performance.

With the increasing use of AI, machine vision, and machine learning, the non-conforming material process is likely to evolve and become more sophisticated. For example, AI algorithms could be used to automatically detect and classify non-conformances in real time, reducing the risk of human error and improving the accuracy of the process. Additionally, machine vision and machine learning algorithms could be used to analyze large amounts of data related to non-conformances, helping organizations to identify patterns and trends and to identify opportunities for continuous improvement. These advances are likely to improve the efficiency, accuracy, and effectiveness of the non-conforming material process, making it a critical component of any quality management system.

Cloudtheapp provides a quality management solution that can be used to fully automate the non-conforming material process, as well as related processes like inspection, receiving, CAPA (Corrective and Preventive Action), Out of Specification, and more. The solution enables organizations to track, report, and resolve non-conformances in real-time, providing real-time visibility into the status of non-conformances and enabling organizations to respond quickly and effectively.

One of the key benefits of Cloudtheapp is its extreme configurability, which enables organizations to tailor the process to their exact requirements. With Cloudtheapp, organizations can customize the process to meet their specific needs, from the types of non-conformances they track to the data they collect and report. This level of configurability can help organizations to optimize the process and to ensure that it meets their specific quality management needs.

The digitalization of the non-conforming material process can bring many benefits to organizations, including increased efficiency, improved accuracy, better visibility, and improved collaboration. With a quality management solution like Cloudtheapp, organizations can fully automate the process and customize it to meet their exact requirements, enabling them to effectively track, report, and resolve non-conformances and to continuously improve their quality management systems.

Cloudtheapp leverages real-time analytics to help organizations get to the root causes of issues and address them effectively. The solution provides real-time data and insights into the status of non-conformances, enabling organizations to identify trends, track progress, and make data-driven decisions. With this information, organizations can quickly identify the root causes of issues and implement effective corrective and preventive actions to eliminate them.

Cloudtheapp also provides a seamless way to connect with suppliers without leaving the system, enabling organizations to collaborate more effectively with their suppliers and resolve non-conformances more quickly. The solution provides a centralized repository for all non-conforming material data, enabling organizations to track and report on non-conformances in real time and collaborate with suppliers without leaving the system to resolve issues.

To further support the non-conforming material process, Cloudtheapp provides an API integration tool that enables organizations to connect with the systems they need to support the process, such as ERP systems. This tool is highly configurable, enabling organizations to fit the integration to their exact needs and requirements. With this tool, organizations can easily integrate Cloudtheapp with their existing systems, ensuring a seamless, end-to-end solution for their quality management needs.

In conclusion, Cloudtheapp provides a comprehensive solution for the non-conforming material process, leveraging integrated analytics, collaboration tools, and API integration to help organizations effectively track, report, and resolve non-conformances. With its configurable API integration tool, organizations can easily connect with the systems they need to support the process, ensuring a seamless, end-to-end solution for their quality management needs.

Cloudtheapp’s EQMS digital solution has been successfully implemented by customers in multiple industries to manage their non-conforming material process with ease. These customers have reported a significant improvement in the efficiency, accuracy, and visibility of their non-conforming material process.

Cloudtheapp provides a comprehensive, end-to-end solution for quality management, enabling organizations to track, report, and resolve non-conformances more efficiently and effectively.

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About Cloudtheapp

Cloudtheapp is a No-Code Cloud Platform built for the compliance world. Our vision is to provide you with the most configurable easy-to-use Quality Management and Regulatory Compliance SaaS software on the market. Start with our ready-made applications, use them as is, or configure every aspect of their design, but don’t stop there; using our Validated Compliance” No-Code” platform we want you to automate every other internal process you have, build an application for it, without writing a single line of code or script, and without any additional installs or infrastructure, then see the magic of how ALL applications would integrate to complete your compliance story.

Cloudtheapp has been founded by experienced professionals who have a proven track record in building successful global software. Three decades of industry experience helped us create the most sophisticated compliance & digital transformation tool to bring solutions that address real challenges for the compliance industry.

Our solutions allow you to reach out to suppliers, auditors, consumers, or any other external party, assign them records, get their feedback, and collaborate without the hassle of separate disintegrated solutions and tedious back-and-forth emails.

Cloudtheapp is light to operate and administer so that your staff can focus on building your quality products.

Wael Zebdeh

CTO at Cloudtheapp

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