Effective Management of Nonconforming Products in Medical Device Manufacturing 

Explore the challenges and best practices in managing nonconforming products within the FDA’s Quality System Regulation (QSR). Learn how to implement effective quality management systems and foster continuous improvement in medical device manufacturing. 

The Quality System Regulation (QSR) is a detailed regulation developed by the Food and Drug Administration (FDA) for medical device manufacture. In short, it comprises requirements that a device manufacturer must fulfil to maintain an effective quality management system. These systems are essential for generating safe and effective medical devices that comply with regulations and are suitable for their purpose. 21 CFR Part 211, Sec. 820.90 refers to the control of nonconforming products and is an essential for building any solid quality system. 

Nonconforming Product 

Nonconforming product is a product or service that does not meet requirements or approved specification Such products must be identified and managed to ensure their safety, efficacy, and marketing. 

Problems in Following Rules of FDA: 

Apart from complying with 21 CFR Part 211, Sec. 820.90, medical device manufacturers have a lot of burning issues. Among these are some of the main challenges: 

Identification and documentation:

Tracking nonconforming products and documenting instances of nonconformance is only possible with an adequate documentation and tracking system. This means defining procedures to identify, document, and isolate nonconforming products to be recorded for later evaluation and investigation. 

Evaluation and Investigation

Evaluating whether investigation is needed and the impact of nonconformity can be tricky. To address such issues effectively, manufacturers shall evaluate and determine the level of severity of the nonconformity and identify the root cause of such nonconformity followed by corrective actions. It is essential that all reports are appropriately evaluated and investigated so that recurrence can be prevented and product quality is improved. 

Disposition and Rework:

Harsh decisions regarding proper disposition of affected product can be difficult. Clear procedures should be defined by the manufacturers for disposition such as if the product is good or can be reworked to specifications or should be scrapped. Well-defined and effectively executed rework procedures, including retesting and re-evaluation, if necessary to confirm that the product conforms to its currently approved specifications. 

Adherence to DHR:

Device History Record (DHR) is an essential part of the process of manufacturing, containing detailed history of production and control of each medical device. Manufacturers are therefore required to keep a detailed record of everything surrounding the handling of non-conforming products, their rework and re-evaluation to meet the requirements around Device History Records (DHR). 

Timely communication:

Communicating in a timely manner to those responsible for the nonconforming product is essential for effective corrective action. Effective communication enables a collaborative approach to identify the cause of the issue, the appropriate corrective actions, and how to limit a recurrence in the future. 

How the Industry is Approaching the Challenges: 

To address the issues,Follow strategies and best practices by medical device manufacturers after the implementation of Sec.820.90: 

Strong Quality Management Systems:

Manufacturers establish complete quality management systems that allow them to identify nonconforming issues beforehand. Includes establishing effective systems for product assessment, root cause analysis, corrective and preventive actions. Manufacturers can decrease the number of such nonconforming products by preventing rather than reacting to issues. 

Training / Skill Development

Training employees about regulations, processes for dealing with nonconforming products encourages a culture of compliance and improvement. The availability of qualified and experienced staff will help to handle the nonconformance efficiently, which can enable a faster resolution and less strain on production timelines. 

Elimination of Manual Processes and Data Management: Sophisticated technologies and software solutions help you automate the identification, documentation, and evaluation of nonconforming products. Using the automated systems also makes it easier for you to keep the record and minimize the errors and mistakes from happening. Manufacturers can overcome this by using digital tools which offers better accuracy and accessibility of data. 

Collaboration and Communication:

Clear communication between departments and stakeholders helps in the immediate resolution of any issues related to nonconforming products. Working in collaboration enables both a bigger perspective of your nonconformance cases and faster decision making.  

Cross-Functional Teams:

You can leverage cross-functional teams to work together to identify the root cause, impact and corrective actions. 

Continuous Improvement:

A culture of continuous improvement is essential to achieve long-term success with the management of nonconforming products. Manufacturers must regularly review their quality management processes to ensure continuous improvement and understand where these processes can be improved or steps that can be taken to avoid an NCM incident from occurring in the first place. 

To escape the burdens of Sec.820.90: Examine the myriad ways medical device manufacturers approach the subject of 820.90. Effective quality management systems are implemented to identify and address nonconformities before they become an issue, fostering a culture of continuous improvement. Through focusing on employee training and skill development, manufacturers are confident of having the right people needed to manage nonconformance, if it occurs, in the right way. 

Conclusion

Using advanced technologies and process automation allows us to expedite nonconformance identification and documentation while increasing data accuracy and availability. Additionally, it encourages a team-oriented work environment and open communication so that teams from different departments can work together smoothly to solve nonconformance issues quickly and efficiently. 

Get in touch with us today at BioBoston Consulting to find out how we can assist your organization.