Manufacturing Nonconformities – Examples & How to Prevent

Even with the high-tech nature of modern manufacturing set-ups, many businesses suffer from products rolling off the production line with identifiable issues and quality defects. Examining these products shows that they don’t meet the specifications, and therefore, can not be shipped to customers.

Additionally, sometimes employees on the shop floor utilize production methods that don’t adhere to what industry standards suggest. These non-standard methods can also result in the defective products mentioned above.

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Simply, nonconformances are products that don’t meet the specifications established by manufacturers or regulators. Nonconformances are more than just defective physical products. The term also refers to when processes used in production do not align with standard operating procedures (SOPs) and approved work instructions.

In this post, we’ll explore what drives nonconformances across products and processes, and how manufacturers can avoid falling foul of necessary standards and regulatory bodies.

Nonconformances constitute a significant issue for manufacturing businesses across every industry. When workers utilize non-standard practices, they’re bound to create finished products that don’t meet the specifications laid out in the device master record.

As a result, manufacturing companies face significant setbacks in their operations. For instance, the brand can damage its public reputation for making and distributing defective products to its customers.

In addition, the cost of nonconformance due to the fines levied by regulatory bodies can significantly set a manufacturing business back. Not only that, but recalls and rectification measures increase production costs and take up valuable production time.

Nonconformances in a manufacturing environment can fall into one of two buckets – major and minor. Manufacturers differentiate between these two nonconformance categories depending on the impact the issue has on production and the organization.

Furthermore, these two groups are identified upon examining the ease of detection and rate of recurrence. Differentiation also involves exploring the scope and difficulty of the recommended rectification measures.

Understanding the differences between nonconformances and corrective actions is critical to ensuring consistent understanding and use of your quality management system. As discussed, a nonconformance occurs when a production process or the product itself fails to meet a specific requirement (ie. regulatory standards, customer requirements, or defined organizational processes).

A corrective action, on the other hand, are the actions taken by a business to identify the root cause of problems that may lead to nonconformities. Corrective actions are often used in the context of Corrective and Preventive Actions (CAPA), the methodology used to identify the source of quality issues and take steps to ensure the problem does not happen again.

Manufacturing nonconformances that fall into the “major” nonconformances category are often particularly challenging to identify and isolate. They occur frequently, making them a nuisance and a significant productivity inhibitor. As a result, they can easily make their way to clients, creating an environment ripe for customer dissatisfaction.

Indeed, this group of nonconformities can negatively impact the entire manufacturing process and business. Falling foul of critical standards set by ISO or FDA can result in hefty fines, detrimental public relations, and increased costs and waste.

Allowed to fester, major nonconformances will adversely affect a manufacturer's operations.

This type of manufacturing nonconformance doesn’t occur regularly. And when it does show up, manufacturing personnel can detect it easily and quickly address it.

These isolated cases are easier to solve, allowing the production process to remain on track. As such, these kinds of nonconformances rarely ever make their way to the customer.

Although seemingly inconsequential, these nonconformities can affect a manufacturer’s ability to adhere to necessary standards.

Understanding what types of issues to look out for makes it significantly easier to identify and reduce nonconformances from happening across your operations. Some of the most common nonconformances that we come across include:

Issues that significantly affect the production process - These types of issues can include human errors or malfunctions in machines and equipment that negatively impact product quality.

Unauthorized changes to critical documents - Documents like work instructions and SOPs are critical to defining the processes that need to take place during a production process. It is imperative that manufacturers are able to track and manage the changes to these documents to demonstrate that the end product meets the specifications and requirements of industry standards and regulatory bodies.

Misplaced or lost documents - Similarly, it is critical for manufacturers to be able to access and distribute key documents in order to prove compliance as necessary.

Significant deviation from requirements and specifications - Particularly in industries where compliance with regulatory standards must take place, deviations from necessary specifications can be costly and detrimental to a business. Manufacturers must ensure that products meet the defined regulatory requirements as deviations could cause health and safety issues for end consumers.

Failure to implement recommended corrective action - When a CAPA is conducted, it is crucial for the corrective action to be implemented so that the source of quality issues is not replicated in the future. Failure to implement the recommended corrective action is likely to lead to additional nonconformances.

The remedy for nonconformances consists of identifying the problem, fixing it, and ensuring that it doesn’t happen again.

Here’s how to go about this process:

1. Identification of the root cause: Sourcing the root cause of the non-adherence to standards and specifications is the premier step in getting back on track. Root cause analysis allows manufacturers to get to the bottom of the issue.

2. Documentation: Quality managers should craft and avail documentation furnishing information about the nonconformance. This includes documents on the issue, materials, segregation and disposition.

Additionally, documentation should include signatures of the relevant employee or manager and standard operating procedures and work instructions.

3. Nonconformity evaluation: This stage entails determining the need for investigation. If a similar problem occurred earlier, the investigation might not be necessary. However, corrective and preventive action should be taken to prevent a recurrence.

Furthermore, the responsible individuals should be notified. Details unearthed from this stage should also be added to the paperwork in the previous step.

4. Segregation: The defective product should be cordoned off in a separate area to ensure that it doesn’t slip into regular distribution.

5. Disposition of nonconforming product: The product can be used as-is with minor cosmetic nonconformance. On the other hand, manufacturers can scrap unusable defective products. Alternatively, they can be repurposed for different functions.

Furthermore, manufacturers can revert to earlier versions of the product as they search for a solution.

To prevent manufacturing businesses from incurring the cost of nonconformance, manufacturers should:

• Follow standard operating procedures (SOPs) when running production processes.

• Train employees to ensure that they’re conversant with compliant practices.

• Regularly test products off the production line before sending them out.

• Crosscheck product and process standards against the ISO 9001 audit checklist.

In regulated manufacturing, nonconformance control is part of staying compliant. It isn’t just a quality tool; regulators expect documented processes for identifying, investigating, and resolving issues. The level of scrutiny varies depending on the standard or agency.

ISO 9001
This standard sets the structure. You need to document nonconforming outputs, control them so they don’t slip through, and take corrective action when needed. Auditors usually look at how you use that information to prevent repeat problems.

Clause 8.7 (ISO 9001:2015):
“Ensure that outputs that do not conform to requirements are identified and controlled to prevent unintended use or delivery.”

FDA 21 CFR Part 820
For medical devices, the FDA expects a documented process that covers investigation, root cause analysis, and corrective or preventive actions. Weak or missing records are a common reason for Form 483 observations.

21 CFR 820.90:
"Manufacturers must “establish and maintain procedures to control product that does not conform to specified requirements.”

GMP
GMP requirements from the FDA or EMA place heavy weight on traceability. That means complete records when issues involve raw materials, equipment, or people. In pharma and biotech, the expectation is clear: find problems early, investigate them properly, and document the response before the product reaches a patient.

What Auditors Look For
Auditors want evidence. Were the steps followed? Was the issue escalated? Did corrective action work? If the process is fragmented, you risk compliance findings and customer impact.

Digital systems help by enforcing consistency, linking root cause work to corrective actions, and keeping a full trail of signatures, dates, and decisions.

Traditional paper-intensive conformance practices aren't effective in a fast-paced and smart manufacturing environment. Instead, digital tools are the norm in new-age manufacturing plants.

These tools make the documentation process more manageable and efficient. For instance, digital solutions provide customizable nonconformance forms, allowing manufacturers to tailor the documents to align with their unique operations.

Additionally, digital tools allow detailed quality event descriptions, going as far as providing rich media uploads for more detail. Further, they make for better traceability and accountability by requiring names and signatures of individuals filing nonconformance reports.

Finally, advanced digital solutions are equipped with analytic capabilities, providing more insight into the overarching quality management operation.

Non conformances create both cost and regulatory risk. ISO 9001, FDA, and GMP all expect documented processes for how they’re handled. Clear investigation, proper records, and preventive actions matter. Digital systems make this easier by improving traceability and cutting down on repeat issues.