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
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.
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.
A major quality event such as a product recall can have a devastating effect on a company including on its bottom line performance. The McKinsey Center for Government report, The Business Case for Medical Device Quality, 2013, revealed that between 2003 and 2013, on average, one company per year had suffered a 10 percent drop in share price after a single major quality event such as a product recall. Recalls lead to the more obvious tangible costs such as litigation and revision surgery but the intangible costs such as brand damage, loss of market share, and the loss of potential sales of new and existing products can be just as damaging. (See Figure 2)
How Accreditation Supports Process Validation
Process validation is an aspect of process control which is currently causing significant issues in the medical device industry. Indeed, it could be argued that in critical manufacturing processes, certain aspects of process validation, as currently practiced and defined in FDA guidance, may be eliminated or reduced to a simpler more costeffective level of application. An effective accreditation program may be the support tool needed to achieve this.
The current methodology of Installation Qualification (IQ), Opera tional Qualification (OQ), and Product/ Part Qualification (PQ) poses a number of challenges. It is predicated on practices used in the pharmaceutical industry where there are many interrelated variables. Pharmaceutical processes can be expensive, difficult to understand and control reliably, and are often very challenging to scale up to full production from smaller scale laboratory settings.
Significantly, IQ-OQ-PQ methodology may not be readily applicable to some medical device critical manufacturing process methodologies due to the heavy dependence on extensive detailed documentation, large amounts of prescribed data gathering in highly specific formats that vary from one OEM to another, and the extensive use of statistics or other metrics.
In addition, IQ-OQ-PQ methodology does not necessarily preclude problems in critical manufacturing processes due, in part, to a lack of requirements for a subject matter expert to direct and evaluate the validation effort. Nor is there any recognition of the participation of an on-site subject matter expert in determining the extent of application of many of the detailed requirements within a process validation protocol. It also presumes a very low level of industryconsensus definition of requirements and standardization within the critical manufacturing process to be validated.
In the case of the current process validation methodology, there seems to be an underlying assumption that the critical manufacturing process and its proper execution is “ab initio” from the standpoints of raw material definition, equipment design and capability, and personnel competency. Using heat treat as a more detailed example: in the view of each OEM it is as if the material to be heat treated, the furnace to be used, and the personnel doing the heat treatment have never been produced, never existed, and never did any heat treating, respectively, before the time of the process validation at hand. The net effect is that suppliers across the industry are busy expending resources to validate the same processes over and over again through an expensive and non-value-added methodology upon controlled materials, previously validated equipment, and experienced personnel.
Since 2012, industry leaders have been exploring ways to utilize the currently available knowledge base and competency within supporting industries and critical manufacturing process organizations to produce a system of process validation that is flexible, economic, and can assure compliance to a very high degree.
“Ultimately, the goal is to achieve a consistently high level of product quality from our special process vendors. Presently, every OEM has nuances in their specific expectations that lead to differences in process validation…requirements. This places a burden on the supply chain, as they must meet all customer requirements. There are limited common requirements. I really believe in the mission of creating a program where the industry can collaborate to define requirements and establish a consistent assessment methodology,” explains Bruce Dall, Senior Staff Quality Engineer – Metallurgy, at Stryker Corporation, Kalamazoo, MI.
Instead of the redundancy that exists in the current system, a detailed first article inspection approach as described in SAE AS9102 may represent a good replacement for an IQ-OQ-PQ, presuming all other factors can be demonstrated to be in control at the supplier level. Add an accreditation system to these same requirements, and an OEM can be assured that the supplier knows what is expected of his or her quality system in order to perform the processes required, has the necessary controls and equipment in place, retains a certain level of technical expertise to manage all of this to a successful outcome, and can demonstrate compliance on a job-by-job and periodic basis.
For the most common materials and processes, the degree of control afforded by these standardized, industry-consensus specifications may be adequate for those design authority requirements that line up squarely with the specifications noted and an accreditation of the supplier which indicates periodic detailed and thorough industry oversight. Both conditions of qualified equipment and practices and qualified personnel are satisfied at the most cost-effective level possible. (See Figure 3)
However, where a design authority requirements do not line up with the industry-consensus controls it would be prudent to require a full process validation or other engineering qualification in order to assure compliance. But that could be done by the exception, not as the rule.
This article was written by Ed Engelhard, Vice President of Corporate Quality, Solar Atmospheres, Souderton, PA, and Connie Conboy, Director, Strategy and Business Development, Performance Review Institute, Warrendale, PA, which administers MedAccred. For more information, Click Here .