In times of war, it is a common misconception of the general public that after one or two battles, the war will be over, the troops will return home, and peace will be restored. This is the power of naiveté coupled with hope and a great pair of blinders.
This same coupling of naiveté and hope has similar effects on medical device manufacturers confronted with UDI compliance, leading many to view UDI as a project that will consume time and resources for a period of time up until the compliance date, then the chaos will subside, and calm will be restored. As the third wave of manufacturers prepares to breach the beach heads of UDI compliance, seasoned veterans from the first and second waves of compliance continue to make adjustments to data, requirements, and procedures, and wage battle against the masses that declare “the project is over – move on!”
Yes, UDI Compliance is a project that must be managed to ensure, budgets are not over-extended, tasks are completed and milestones are hit and timelines are met. But more than that, UDI is a significant change to a QMS, affecting multiple processes and business functions and leading to the potential for gaps and oversights if not properly planned.
The most critical piece of advice for medical device manufacturers assessing how to implement UDI (and health care facilities faced with their own UDI implementations) is to address UDI compliance as more than just a project with a start and end date. Consider it for what it must be to be effective and successful – a process incorporated throughout your established quality management system.
To do this, keep in mind the following:
- Start with a QUALITY PLAN to outline the overall impact to the QMS processes and regulatory requirements
- Review the QUALITY MANUAL to identify the sections of the QMS that need to be revised
- Determine how UDI will be incorporated into the CRITICAL BUSINESS FUNCTIONS
- Identify the DOCUMENTS and RECORDS that need to be updated
- Provide TRAINING to all personnel who will work with UDI in their processes
- Perform a RISK ANALYSIS to determine the potential risks associated with UDI and mitigate those risks
Involve all departments in the planning process and don’t underestimate how widespread the effect UDI has on your processes.
Remember to consider:
- Management Review – keep management informed of the project status and process impact; this will keep them engaged and supportive of changes
- Monitoring & Measurement – identify quality indicators and performance standards to measure the UDI processes and barcode quality
- Purchasing – requirements or procedures suppliers will need to incorporate and follow
- Receiving Inspection – procedures for product labeling inspection and barcode verification
- Warehouse Management and Inventory – can UDI be used internally to improve efficiencies
- Sales, Customer Service and Marketing – educate personnel on UDI benefits and how to address customer questions they might receive
- Production – train personnel on how to identify barcode non-conformances
- Regulatory – communication of significant change to Notified Body and Authorized Rep
UDI compliance is not a “one and done” project. It is a process that needs to be sustainable beyond the life of the company and adaptable to other country regulations as needed. Adding barcodes to labels and uploading information to the GUDID is not sufficient to show compliance. True compliance involves proactive integration into the quality management system and understanding of benefits beyond the supply chain.
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