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8 Design Control Issues Found During FDA Inspections

No. 5. Design controls do not just address the product.
FDA disagrees with the comments that suggest that the design output should be restricted to physical characteristics of the device. Design output is more than just the device specifications. Design output includes, among other things, the specifications for the manufacturing process, the quality assurance testing and the device labeling and packaging. It is important to note that the design effort should not only control the design aspects of the device during the original development phase, but also all subsequent design and development activities including any redesign or design changes after the original design is transferred to production.

No. 6. Design reviews are not necessarily problem-solving sessions.
Design review participants are typically not responsible for establishing final solutions, although they may do so in many small operations. FDA makes it clear during inspections that although the design review participants need not propose solutions, they should ensure that solutions to any identified problems are adequate and implemented appropriately. Many participants during design reviews do not have the education, background and competencies to make final decisions concerning, for example, technical solutions moving forward, but in fact should scrutinize what has been done in terms of the “big picture.” Not having a sign-in sheet for design review sessions is one thing. Not having the appropriate individuals in attendance at subject-specified design reviews can cause much consternation during FDA inspections.

No. 7. Changes to the design plan are expected.
A design plan typically includes at least proposed quality practices, assessment methodology, recordkeeping and documentation requirements and resources, as well as a sequence of events related to a particular design or design category. These may be modified and refined as the design evolves. However, the design process can become a lengthy and costly process if the design activity is not properly defined and planned. The more specifically the activities are defined up front, the less need there will be for changes as the design evolves. On the other hand, if you make the design plan too specific without built-in flexibility, then you will have a hard time keeping on track and completing the plan on time. This is a fine line that companies have to straddle; during inspections, the design plan is challenged from beginning to end and credibility is established (or not) when the plan is not at least followed “in spirit.” Having too much flexibility accomplishes the same negative outcome.

No. 8. Design validation using productions units or their equivalents follows successful design verification.
Certain aspects of design validation can be accomplished during the design verification, but design verification is not a substitute for design validation. Not knowing the difference during an inspection can be a major deterrent to eventually establishing safety and efficacy. Also, design validation should be performed under defined operating conditions and on the initial production units, lots or batches or their equivalents to ensure proper overall design control and proper design transfer. When equivalent devices are used in the final design validation, the manufacturer must document in detail how the device was manufactured and how the manufacturing is similar to and possibly different from initial production. Where there are differences, the manufacturer must justify why design validation results are valid for the production units, lots or batches. Manufacturers should not use prototypes developed in the laboratory or machine shop as test units to meet these requirements. Prototypes may differ from the finished production devices. I find that during inspections it is discovered that the “equivalence justification” is not documented properly and in totality. This is a very difficult task, because you end up being on the defense right from the beginning of the conversation with the inspector—not a good place to be.

Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. There are many variables with timing issues that aren’t always confluent, and resources that paint surrealistic pictures. Defending design issues for a project that can last years is daunting and just waiting for mistakes to happen. It is easy to sit back and pontificate about “how it should be.” From my experiences, to defend your company during an FDA inspection by using people who have not experienced design controls first hand is risky, at best. Having someone with practical experience with 21 CFR, Part 820.30 and having a savvy design engineer sitting across the table from FDA during an inspection doesn’t guarantee success, but it sure helps. All FDA inspectors are not design engineers, but most of them can sense when a design controls process is out of control.

John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC