In the last month or so at my Internship at Paramount Metal Finishings I have learned some about Quality Control. The company I intern for is not a medical device company however applications can be applied. The company takes military equipment and coats them with various solvents to make them rust resistant. So let say we do get rust on the parts what do we do? Well we have Quality Control come to us and tell us that such an such parts have rust. We ask questions like did they get dried off completely in the oven? Were they exposed to humidity or water before being coated? These are questions which can be answered by the platers that work on the line. Now another issues can be on the chemistry side. Is the concentration of the various tanks within “spec range” ? Did some add something to lower the concentration in the tank or opposite? In general, quality control comes to the chemical lab to ask us questions since we typical have the answer. In order to validate these questions we will take a small load of parts to run an analysis on them while other parts are being done.

An often over-looked aspect of quality is training. As listed in the lecture and in the question above, training is one of the key aspects of quality control that must have a system in place to ensure employees at all levels have the appropriate training and are kept up to date with latest revisions of procedures, work instructions, and other documentation. Prior to starting work at Ethicon, I had thought of the training department as a separate entity from Quality that fulfilled general company requirements, however I quickly learned the importance of maintaining training at all levels of an organization and how that impacts the quality and performance of our products. For example, training operators in finished goods release lab on the latest test methods ensures accurate data measurements that reflect whether the product should be released or not. If the operators are not trained to the latest revision, they may be testing against out of compliance specifications and release non-compliant products to the market, which may be harmful to patients. The entire process is connected and highly dependent on quality controls that are put in place.

As highlighted before risk management and training are critical aspects of ensuring quality of medical devices. The research conducted during risk assessment lays out scenarios that illustrates a medical device's potential use and misuse, financial implications or barriers, as well as good lab and manufacturing practices. Adequate training of personnels that are responsible for testing and inspections should be a nonnegotiable for maintaining quality standards. However, most 483 and Warning Letter observations are a result of poor design controls. That being said, none of these could be done without a proper quality design plan. The proportional correlation between medical device recalls and design problems hints toward the need for design controls to be laid out in the this phase for production of safe and effective products within FDA standards.

Lindholm, C., Notander, J. P., & Höst, M. (2014). A case study on software risk analysis and planning in medical device development. Software Quality Journal, 22(3), 469-497.

I worked as a risk management intern (Quality Assurance) in a medical device company and I can say with confidence that one of the most important things to consider while maintaining a quality management system in this field is preventative controls. Preventative controls are procedures or design facets that allow for the mitigation of some risks on a device. For example, if the risk is a "deep infection due to biological contaminants," some preventative controls might be cited with the sterilization procedure, the packaging, etc. of the device. It's extremely important to be careful when deciding preventative controls for a device since it is easy to cite a preventative control that has nothing to do with mitigating it's associated risk. To be able to work on preventative controls, one must be logical and detail-oriented. In addition, one must have a vast knowledge on the device itself and what procedures go into making and preparing the device for the market.

I personally have familiarity working on quality, specifically in the medical device industry. In quality assurance, the management and verification of Corrective Action Preventive Action (CAPA) is essential to ensuring that issues in the quality or efficiency of a product or process is where it should be. This also includes the adjustment of guidelines and procedures when errors arise and requires amendments. Although corrective actions are absolutely necessary when a situation arises, it is significantly more pertinent for the situation to never arise again due to any controllable factor. The preventative action taken, either implemented during the design process or during manufacturing, it is essential to maintain legitimacy for legal medical devices regardless of class, and to hold absolute highest quality of product.

While working as an intern for a commercial technical operations team, I was exposed to the change control process. The company I worked for had been aiming to expand the scope of their biologics developments. The amount of site locations focusing on biologics grew. With this, management saw it to be important to establish an updated change control progress that would ensure no negative substantial impact. The directors from each site were required to undergo training. This training gave information on the step by step process on the requirements needed to initiate a change control. This process is very important in maintaining the product quality. It involves a coordinated effort with multiple departments to enact a desired change into the manufacturing process without negative impact on the product function while remaining within the established acceptable ranges. For example, a change control process would be required if the downstream development team changed the solution used in the filtering process. This process is one way to avoid deviations, unexpected events that occur. Usually deviations require an investigation and evaluation to determine its severity. The change control process can help avoid future deviations. Based on my experience, I saw how specifically management commitment, management of risks, training, maintenance, and preventive controls keep the product quality up to standards.

Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our product, is analyzed to assess its reliability and accuracy in the measuring the targeted value. The tool used was tested between 3 people for a sample of 10 parts and we had to make that the process on how everyone did it was accurate and according to the procedure. This included training each operator before-hand and explaining every small detail so that they can replicate the exact procedure. Moreover, the parts needed to be processed within the same batch as to ensure there is no variance between different lots. During the test, the data was collected from each person and a moderator was there to make sure that the procedure was adhered to.   

The data was then processed in Minitab and the potential capability index, which is a measure of the potential capability of a process to produce products within specification limits, was analyzed. Usually, a value a Cpk value of 1 or higher is desirable because it indicates that the product meets the specifications within the margin of error. 

Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our product, is analyzed to assess its reliability and accuracy in the measuring the targeted value. The tool used was tested between 3 people for a sample of 10 parts and we had to make that the process on how everyone did it was accurate and according to the procedure. This included training each operator before-hand and explaining every small detail so that they can replicate the exact procedure. Moreover, the parts needed to be processed within the same batch as to ensure there is no variance between different lots. During the test, the data was collected from each person and a moderator was there to make sure that the procedure was adhered to.   

The data was then processed in Minitab and the potential capability index, which is a measure of the potential capability of a process to produce products within specification limits, was analyzed. Usually, a value a Cpk value of 1 or higher is desirable because it indicates that the product meets the specifications within the margin of error. 

I appreciate that the original topic starter had mentioned thinking from the patient’s point of view. I believe this is a highly important notion for the medical device industry. There are standards such as ISO 14971 that allow for risks to be mitigated by evaluating the probability and harm of a product. Although not a perfect system, one of the most essential aspects is the continuous identification of potential hazards or harmful materials throughout a product’s lifecycle, ensuring that there is nothing out of standard procedure. By thinking about this standard, we can avoid harm to the patient.

From experience in FDA classes, risk management is ultimately about how different factors play a role in mitigating product related risks. For example, if an employee is poorly trained or a job design is flawed, even the most perfect management structure can fail! This is why it is important for companies to commit and provide a clear organizational structure for these risks to be managed. For those of you in industry, how do you avoid risk in your daily tasks? In what way do you think of the patients while conducting these tasks?