Effective Nonconformance Management Key to FDA and ISO Compliance

2020-bl-nonconformance-management_715x320A product's quality, reliability and safety depend to a great extent on its conformance to specifications that have been tested, proven safe and approved by the appropriate regulatory body. This is particularly critical for products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances and other consumer goods.

For this reason, the proper handling of nonconforming products is incorporated in Food and Drug Administration (FDA) regulations covering drugs, medical devices, and biologics, and in the standards developed and published by the International Organization for Standardization (ISO), which apply to a wide range of consumer products.

FDA compliance is mandatory for life sciences manufacturers and related industries covered by the agency's jurisdiction. Non-life sciences manufacturers must comply with other federal regulations, but most of them also adhere to ISO quality standards, either voluntarily or as part of compliance with requirements of the countries in which they plan to sell their products.

FDA Nonconformance Warning Letters

An FDA nonconformance warning letter serves as a formal means of communication for pointing out violations that could lead to legal and/or administrative sanctions, if such violations are not corrected promptly.

A recent warning letter sent by the FDA to Greiner Bio-One North America, a medical device manufacturer of plastic products used primarily in biotech and blood/specimen collection fields, illustrates the importance of material conformance to product quality. An FDA inspection revealed the company had not reported certain product testing failures as nonconformances as required by established procedures, nor could the device maker provide documentation demonstrating compliance with the 21 CFR 820.250(b) regulation on sampling methods.

"Procedure requires a verification of the first test," stated the FDA’s warning letter sent in April 2020. “There is no procedure to investigate the cause of a first analysis which identified a nonconformance and was not used.”

The warning letter noted the company had initiated a formal corrective and preventive action (CAPA) following the inspection to rectify the nonconformance issue and that the agency’s investigators would evaluate the effectiveness of the corrections in their next inspection to verify the manufacturer’s ability to avoid its recurrence.

When not appropriately addressed, nonconformance issues like the one experienced by Greiner Bio-One can have serious ramifications for a manufacturer, whether it is subject to FDA or ISO quality requirements. In both FDA and ISO environments, a nonconforming product that causes injury or death can result in liability lawsuits for the business.

While the sectors subject to ISO standards do not have an equivalent of an FDA nonconformance warning letter, a nonconforming product that is not corrected properly could mean the loss of ISO certification. Such an event would likely trigger the loss of opportunities in overseas markets, the end of business contracts with customers that require ISO certification and perhaps even product recalls.

Nonconformance Regulations and Standards

FDA regulations and ISO standards exist primarily to protect consumers, but they also help manufacturers avoid the consequences of unsafe and poor-quality products by making them integrate quality into their operations.

The following are some of the FDA regulations and ISO standards that require appropriate nonconformance disposition:

  • FDA's Quality System Regulation (QSR) requires medical device manufacturers to establish and maintain procedures to control products that do not conform to specified requirements. The disposition of nonconforming products must be documented (21 CFR Part 820.90).
  • FDA's Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals require the testing of components for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR Part 211. 84).
  • The ISO 9001:2015 quality management systems standard requires management reviews of product conformity and process performance data (Clause 5.6.2). Organizations also must ensure that any nonconforming product is identified and controlled to prevent its unintended delivery or use (Clause 8.3).
  • The ISO 13485:2016 standard for medical devices requires organizations to plan and implement the monitoring, measurement, analysis and improvement processes needed to demonstrate product conformity and ensure conformity of the quality management system (Clause 8.1).
  • The ISO 14001:2015 standard requires organizations to react to nonconformities that occur in their environmental management systems and take action to control and correct them (Clause 10.2).
  • IATF 16949:2016, which superseded ISO/TS 16949, incorporates the structure and requirements of ISO 9001:2015 for automotive manufacturers and their suppliers. It calls for the control of nonconforming products to prevent their unintended use or delivery (Clause 8.7).

Handling Nonconformance

Manufacturers of regulated products typically go through the following sequence when handling nonconforming materials:

  • Identification.
  • Documentation.
  • Evaluation/investigation.
  • Segregation.
  • Disposition of nonconforming materials.

A manufacturer usually handles nonconforming materials by performing any of the following:

  • Rework – The nonconformance is fixed to make the material, component or product comply with approved specifications.
  • Regrade – Nonconforming materials are reassigned for an alternative use or use category.
  • Scrap – Nonconforming materials are discarded.
  • Return – Nonconforming parts/components are sent back to the supplier.
  • Use As Is – A nonconformance may be minor (i.e., it may have no significant impact on product's form or function) and the material can be used in its current condition.

Whatever the manufacturer decides to do, they must document the entire process of nonconformance disposition to show that the actions were justified and performed properly.

Nonconformance and CAPA

A common way of handling nonconformance is by fixing the product or material. Increasingly, however, manufacturers realize that they must not only fix existing problems, but also avoid the future recurrence of similar nonconformances. In this sense, the processes involving the disposition of nonconforming materials are closely related to CAPA processes.

In the case of FDA-regulated medical device, pharmaceutical and biotech products, certain regulations require their manufacturers to implement CAPA as part of the resolution of material nonconformance issues. Under the QSR (21 CFR Part 820.100), medical device manufacturers are required to establish a CAPA procedure that will investigate the cause of any product nonconformance and identify action that would prevent the recurrence of such nonconformance.

The CGMP regulations for finished pharmaceuticals similarly require that any failure of a batch, or any of its components, to meet specifications must be thoroughly investigated and documented, including the investigation's follow-up and conclusions (21 CFR Part 211.192).

Common Nonconformance Challenges

Implementing an effective and efficient nonconformance disposition process is far from easy. The following are some of the common challenges faced by companies, especially those using disparate and/or paper-based systems, in handling material nonconformances:

  • Disconnected Processes: In manual or hybrid systems, the reporting of and response to a nonconformance are likely to be disconnected processes, which inevitably results in delayed resolution. A nonconformance process that's not integrated with the CAPA system within a common platform poses serious problems in terms of the timeliness and accuracy of data collection and the thoroughness of documentation, all of which are critical to compliance.
  • Poor Turnaround: A manual system is inherently inefficient. Paperwork may languish on someone's desk, and for a sequential process such as nonconformance, that could mean a significant delay in resolution of the incident.
  • Poor Tracking: It is time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.

Addressing Nonconformance Challenges

Every common nonconformance challenge experienced by companies in regulated spaces — from disconnected processes to tracking — can be resolved with connected digital tools and integrated solutions. Companies often remain one step behind leaders in their industry simply because they’re not willing to invest in both short-term and long-term solutions that will move their company to the forefront. Advanced digital tools can provide both short-term and long-term solutions and, when chosen carefully, are often at the top of companies’ "best investment" lists due to the rapid turnaround for return on investment (ROI).

To learn more about automated nonconformance management solutions and other integrated quality process automation tools, visit MasterControl’s nonconformance management software page.


Material nonconformance is usually unexpected, and always unwanted. But with proper handling, a manufacturer can turn the situation around by finding ways to prevent future nonconformances and further improve product quality. Advanced digital technologies have a lot to offer to ease the burdens of nonconformance disposition, and it would be wise for any forward-looking company to take advantage of the innovative tools best suited to their needs.


Jason Clegg is MasterControl's director of marketing strategy. His experience covers more than 20 years of marketing, from traditional paper-based campaigns to digital media. Clegg has directed MasterControl's marketing growth from a small document control company to an international provider of quality management solutions.

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