Effective Nonconformance Management Key to FDA and ISO Compliance

For Life Science Companies

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

A product's quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in 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 ISO international standards, which apply to manufacturers of a wide range of consumer goods.

Whatever the manufacturer decides to do, it must document the entire process of nonconformance disposition to show that the action was justified and performed properly.

FDA compliance is mandatory for life sciences manufacturers and related industries covered by the agency's jurisdiction. Non-life science manufacturers 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 countries where they want to sell their products.

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FDA Warning Letter

A Warning Letter sent by the FDA to Advanced Imaging Research Inc., a manufacturer of head and body coils for magnetic resonance imaging (MRI) systems, illustrates the importance of material conformance to product quality.

An FDA inspection had revealed that the company's neonatal MRI coil device history records reflected out-of-specification discrepancies that rendered the coils as nonconforming. "Your firm did not perform re-tests, did not document and trend the nonconformance, nor did you quarantine the products," according to the Warning Letter sent by the FDA in April 2006. The agency asked the company for a written response, as well as a status update on the corrective and preventive action (CAPA) that the company must perform to avoid recurrence of the nonconformance.

An FDA 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. While the ISO sector does not have an equivalent of a Warning Letter, a nonconforming product that is not corrected properly could mean loss of ISO certification, and consequently, either loss of opportunities in overseas markets, and/or end of business contracts with customers that require ISO certification.

In both FDA and ISO environments, a nonconforming product that causes injury or death could also mean liability lawsuits for the manufacturer.

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 nonconformancedisposition:

  • FDA's Quality System Regulation (QSR) requires medical device manufacturers to establish and maintain procedures to control product that does not conform to specified requirements. The disposition of the nonconforming product 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).
  • ISO/TS 16949, which specifies the application of ISO 9001:2000 for automotive manufacturers and theirsuppliers, calls for the control of nonconforming products to prevent their unintended use or delivery (Clause 8.3).
  • ISO 9001:2000 requires management reviews, including examination of product conformity data (Clause5.6.2). Organizations also must ensure that any nonconforming product is identified and controlled to prevent its unintended use or delivery (Clause 8.3).
  • ISO 13485: 2003 requires management reviews, including examination of product conformity data (Clause 5.6).

  • ISO 14001:2004 requires establishment and maintenance of nonconformance management procedures (Clause4.5.3).

Handling Nonconformance

In handling nonconforming materials, regulated companies typically go through this procedure: identification, documentation, evaluation/investigation, segregation, and disposition.

A manufacturer usually handles the nonconforming material 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 thrown away.
  • Return - Nonconforming parts/components are sent back to supplier.
  • Use as is - A nonconformance may be minor (no significant impact on product's form or function) and the material can be used as is.

Whatever the manufacturer decides to do, it must document the entire process of nonconformance disposition to show that the action was 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 future recurrence of a similar nonconformance. In this sense, the nonconformance disposition process is closely related to the CAPA process.

In the case of FDA-regulated medical device, pharmaceutical, and biotech companies, certain regulations require them to implement CAPA as part of the resolution of material nonconformance issues. Under QSR (21 CFR Part820.100), 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 conclusion (21 CFR Part 211.192).

Common 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 manual 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, which could result in delayed resolution. A nonconformance process that's not connected to the CAPA system could pose 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 in someone's desk, and for a sequential process such as nonconformance, it could mean a 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 Challenges

Every common challenge experienced by regulated companies from disconnected processes to tracking can be resolved with the right automation tools and solutions. Companies often remain one step behind others in their industry simply from a lack of willingness to invest in both short-term and long-term solutions that will move their company to the forefront. Automation solutions can provide both short-term and long-term solutions and when chosen carefully are often at the top of any company's "best investment" lists.

To learn more about automated nonconformance management solutions and other quality process automation tools, please feel free to view the Downloads section below.


Material nonconformance is usually unexpected, and always unwanted. But with proper handling, a manufacturer can turn the situation around, and find ways to prevent future nonconformances and to further improve product quality. Technology has a lot to offer to ease the burden of nonconformance disposition, and it would be wise for any forward- looking company to take advantage of it.