REGULATION AND STANDARDS COLUMN
European requirements
 |
When medical device manufacturers operate under a full quality assurance system to demonstrate conformity with the European medical devices Directives, they must comply with the Directives’ requirements for the control of nonconforming products. These requirements specify that a quality system must include a means for monitoring the ability of that system to achieve the desired design and product quality, including the control of products that fail to conform. This is extremely general and the European Directives rely on technical standards to provide the details of how these requirements can be met.
The necessary details for the control nonconforming products are found in EN ISO 13485:2003, Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes. Readers should refer to Clause 8.3, Control of Nonconforming Product, for the detailed requirements. In brief, they require
- a documented procedure
- the identification and control of nonconforming product to prevent their unintended use or delivery
- specific options for managing nonconforming products such as taking action to eliminate the nonconformity, authorising their use providing they comply with regulatory requirements, or taking action to preclude their original use or application
- records of the nature of nonconformities and the actions taken
- reverification when a nonconforming product is corrected
- appropriate actions to be taken regarding the effects or potential effects of a nonconformity when it is detected after delivery or use
- documentation of rework processes in a work instruction that has undergone the same authorisation and approval procedure as the original work instruction
- a determination of any adverse effects of rework on the products.
Some companies encounter difficulties in complying with the European requirements. For example, sometimes nonconforming procedures are developed, but not always followed. In other cases, companies fail to determine the adverse effects of rework on the product. Some companies do not understand the actions that constitute rework. When doubts on the definition of rework occur, companies should refer to ISO 9000:2000, Quality Management Systems, Fundamentals and Vocabulary, which is a normative reference of ISO 13485. ISO 9000:2000 defines rework as “action on a nonconforming product to make it conform to the requirements.” Thus, any action taken on a nonconforming product to make it conform to requirements constitutes rework and it is not selected actions as defined by the company.
US requirements for nonconforming product
The US requirements for controlling nonconforming product are contained in section 820.90, Nonconforming Product, of the US Quality System Regulation (QSR) of the US Code of Federal Regulations (CFR), 21 CFR Part 820. They are similar to the requirements in ISO 13485. For example, section 820.90(a) requires the development of documented procedures that address the identification, documentation, evaluation, segregation and disposition of nonconforming product.
However, there is an important additional requirement, which is not in ISO 13485. The evaluation of nonconformance also requires a determination of the need for an investigation and notification of the persons or organisations responsible for the nonconformance. This evaluation and any investigation must be documented. Therefore, quality system procedures and any quality forms that are used to document nonconforming product control should include a means for documenting the evaluation and any related investigation of a nonconforming product.
This requirement is often not met by companies because they assume that conformity to ISO 13485 means that they comply with the requirements of the US regulations. Companies should be aware that if a failure to comply with this US requirement is identified during a US Food and Drug Administration (FDA) quality system inspection, it will be considered as an important inspection observation. This is because FDA places enormous importance on the need to fully investigate the underlying or “root cause” of nonconforming product to prevent recurrence. Table I shows an example of this type of observation contained in a Warning Letter, which was found on the FDA web site. FDA posts Warning Letters on its web site: www.fda.gov/foi/warning.htm
Another common mistake that companies make is that they assume that nonconforming product applies only to the medical device itself. Section 820.3(r) states that “product means components, manufacturing materials, in-process devices, finished device and returned devices.” Therefore, the requirements specified in 820.90 apply to all these categories of product.
US requirements for rework
) |
Table 1: Item listed in a US Warning Letter to a device manufacturer regarding failure to meet nonconforming product requirements.
(click image to enlarge) |
The US requirements related to rework are similar to those in ISO 13485, but a seemingly unimportant difference from the requirements in ISO 13485 sometimes leads to a failure to fully comply with US regulations. Section 820.90(b)(2) of the QSR requires that procedures for rework include retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications. Clause 8.3 of ISO 13485 requires that the rework process is documented in a work instruction that has undergone the same authorisation and approval procedure as the original work instruction. In most cases it could be expected that conformity to ISO 13485 results in a reworked product that meets its current approved specifications, however, this does not always occur. This is because the work instruction may undergo the same authorisation and approval procedure, but may not specifically require that the reworked product meet its current approved specification. This has led to a failure to comply with the US requirements.
There is another difference between European and US requirements related to rework that leads to failure to comply with US requirements if a company conforms only to ISO 13485. Section 820.90(b)(2) of the QSR requires that rework and reevaluation activities, including a determination of any adverse effect from the rework on the product, are documented in the device history record (DHR). The DHR or the production record includes or refers to the location of device dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records and other information and data that demonstrate that the device is manufactured in accordance with approved specifications. There is no European requirement to document rework and reevaluation activities in the DHR.
Avoiding noncompliance
 |
Maria E. Donawa
Donawa Consulting, Piazza Albania 10, I-00153 Rome, Italy, tel. +39 06 578 2665, e-mail: medonawa@donawa.com www.donawa.com |
The most important means of avoiding noncompliance with US requirements for the control of nonconforming product is to carefully review the provisions of the QSR that relate to nonconforming products, principally Section 820.90. In addition, Section 820.100(a)(1) requires that corrective and preventive action procedures include the requirement to analyse quality data such as work operations and concessions to identify existing or potential causes of nonconforming product. Furthermore, section 820.100(a)(3) requires that procedures include requirements for identifying the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems. Therefore, the control of nonconforming product is closely related to corrective and preventive action policies and procedures; however, the requirements related to each are different and they need to be clearly understood and should result in procedures that can be easily followed.
Companies seeking additional guidance from FDA on the requirements related to the control of nonconforming products can review FDA guidance documents including applicable chapters of the FDA Medical Device Quality Systems Manual: A Small Entity Compliance Guide and the Quality System Inspection Technique Inspection Handbook. These can be downloaded from the FDA web site: www.fda.gov/cdrh/comp/gmp.html
In addition, the ISO Technical Report (TR) 14969:2004, Medical Devices, Quality Management Systems, Guidance on the Application of ISO 13485:2003, was developed to assist companies in the development, implementation and maintenance of quality management systems intended for conformity to ISO 13485. It provides useful information on approaches to use to conform to ISO 13485. The TR also includes guidance on the control of nonconforming products. For example, the TR states that nonconforming procedures should involve identification of the nonconforming product to ensure that it can be distinguished from the conforming product and the evaluation of the nature of the nonconformity.
The TR also states that the purpose of procedures for controlling nonconforming products should be to document the existence and source of the nonconformity. The need to document may seem obvious to many companies, but the control of nonconforming components during the production process has led some manufacturers to adopt activities that do not comply with the requirements for controlling nonconforming products. For example, they have assumed that if during the production process a defective component is replaced with a functioning component, then documentation of the nonconformity is unnecessary. This assumption has led to the failure of those companies to comply with European and US requirements for controlling nonconforming products.
For companies that are marketing in Europe and the US, the challenge is to develop procedures that comply with both sets of requirements, yet are not excessively burdensome. For example, there is more than one acceptable method for documenting defective components during the production process. A discussion of the various methods of documenting nonconformities is beyond the scope of this article. However, it is critical to establish procedures that require this documentation and avoid burdensome procedures that are difficult to understand or that are overly complex and lead to backlogs in completing nonconforming documentation. For example, a procedure for controlling nonconforming products that was implemented in a medical device company required a detailed report to be completed for any component part that was identified as being defective and needing to be scrapped. This quickly led to a significant backlog of uncompleted reports not long after the procedure was introduced. Prudent companies will avoid this by taking time to ensure that requirements are met, but in a pragmatic and effective manner.
Dr Maria E. Donawa physician, pathologist and pharmacist with 25 years’ regulatory experience, worked with the US FDA before becoming President of Donawa Consulting, an international consultancy firm, which provides clinical research, quality management system, regulatory affairs, and European Authorised Representative services to medical technology companies.
