The value of an industry-recognized accreditation has been long acknowledged, but difficult to quantify in tangible terms. In 2010/2011, the International Accreditation Forum (IAF), the global association of accreditation bodies, surveyed businesses around the world to get an understanding of the drivers for seeking certification, the factors involved in choosing a certification body, and the extent of any benefit derived from the certification process. A total of 4,191 respondents completed the survey from 41 different economies across a diverse range of industries. The report can be found HERE .

A Strong Role to Play

Fig. 1 – A subject matter expert auditor inspects cable and wire harnesses production process. (Image Credit: Global Technologies)
The survey found that 1,272 (47 percent) of respondents explained that the primary driver behind seeking accreditation was to improve internal business operations and processes. Another 937 (32 percent) reported that their customers required it. Other reasons cited included using it as a marketing tool or to achieve a competitive advantage.

A total of 83 percent of those who responded (1,713 businesses) agreed or strongly agreed that the certification process had added value to their organization, while 2,787 (79%) of businesses stated that achieving certification had helped them meet the requirements of regulators.

According to the FDA, design-related failures were the leading cause of medical device recalls in the years 2010 to 2012, accounting for 36 percent. Issues with materials or component control constituted 28 percent of recalls and process control accounted for 17 percent. In terms of reducing the risk of recalls caused by poor process control, an accreditation system has an important role to play, in particular when considering critical to quality processes. These are processes where, once they have been performed, it cannot be determined if there is deficiency in the product without destroying the product as part of the evaluation. (See Figure 1)

Due to the fact that the efficacy of the process cannot be validated after the process has taken place, the accreditation of critical processes is essential to medical device integrity. A key part of an accreditation system for critical processes is the development of questions to be asked during the audit. The content of these questions, and the areas on which they focus, drive those companies who achieve the accreditation to meet clearly defined requirements, stemming from customer specifications and industry standards.

There are many advantages to harmonizing requirements in the medical device industry. An important benefit would be to provide consistent and standardized critical process accreditation accepted by the medical device industry, resulting in fewer redundant on-site audits by multiple OEMs.

The view that accreditation has a role to play in simplifying current process validation methodologies is shared by industry leaders.

“On the topic of consistency, in the medical industry, there’s a system of determining the ability of any given process to produce conforming product, called process validation. To date, although there is guidance from the FDA, flow down to comply, from a supplier’s perspective, is very individual to the OEM and that makes it hard to do it in a manner that is value-added for both parties and effective on product,” says Ed Engelhard, Vice President of Corporate Quality for Solar Atmospheres Inc., Souderton, PA.

Fig. 2 – An in-progress audit of the injection molding process. (Image Credit: BMP Medical)
Having one streamlined industry criteria would permit in-depth critical process audits by subject-matter experts that are compliant and consistent with accepted industry technical standards. In addition, it would ensure greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, MDD, ISO 13485, etc.) and assist with improving flow down of OEM requirements to subtier suppliers. Finally, establishing medical device industry-accepted and consistent technical requirements would support greater focus on process discipline, greater operational efficiency, and continuous improvement resulting in higher quality and lower overall cost. (See Figure 2)

For many organizations, standards are raised as each accredited company ensures its activities are fully compliant. Audit criteria can therefore be viewed as a tool to improving overall performance with the subsequent benefit likely to be a reduction in recalls as a result of defective product.

Medical device manufacturers work hard to minimize the risk of recalls, internally through stringent quality controls and procedures, and externally through oversight of their suppliers. However, despite these efforts, the overall number of medical device recalls is continuing to trend upwards. There was a 15 percent increase in recorded events during the first quarter of 2015 compared with quarter four in 2014, according to the Medical Device Recall Report FY2003-FY2012, FDA CDRH Office of Compliance, Division of Analysis and Program Operations, and according to official FDA data, a 97 percent increase in the overall number of recalls between 2003 and 2012.