Is using Power Query in Excel to random sample acceptable per ISO 13485, FDA, and EU MDR requirements?

When evaluating the acceptability of using Power Query in Excel for random sampling within the frameworks of ISO 13485, FDA regulations, and EU MDR requirements, several factors must be considered. Each of these standards emphasizes the importance of adherence to quality management and validation of processes, particularly in the medical device sector.

Understanding the Standards

ISO 13485 Overview

ISO 13485:2016 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specifically for medical devices. One of its critical components is ensuring that organizations maintain proper validations for tools and processes used in quality management. While ISO 13485 does not explicitly mention specific software tools like Power Query, it necessitates that any software or system used must be validated to ensure it operates effectively within the context of medical device quality control.

FDA Regulations

The FDA provides guidance on statistical practices and the use of software in the context of 21 CFR Part 820, which governs Quality System Regulation (QSR). It emphasizes the need for validation and documentation to demonstrate that software tools yield the expected outcomes in compliance with predefined protocols. Again, while not specifically described, the use of Excel and Power Query must be justified through validation efforts to comply with these regulations.

EU MDR Requirements

In a similar vein, the EU Medical Device Regulation (MDR) requires that manufacturers implement QMS processes to ensure device safety and performance. The MDR places a strong emphasis on risk management and performance evaluation, which includes the validation of software tools used in data analysis and sampling. Any tools that contribute to investing data integrity and process reliability in clinical and operational environments should meet rigorous validation standards.

Validation of Power Query for Sampling

Acceptability of Power Query

When using Power Query in Excel for random sampling, there are several key steps to ensure compliance with ISO 13485, FDA, and EU MDR:

1. Validation: You must perform a validation of the Power Query tool customized for your particular sampling needs. This includes documenting all procedures and results to ascertain that the tool functions as intended and delivers accurate, repeatable sampling results.

2. Standard Operating Procedures (SOPs): Develop and maintain SOPs for using Power Query in random sampling. These SOPs should detail the methodology, provide instructions for users, and describe how the data will be managed and interpreted.

3. Documentation: Keep comprehensive records of all sampling processes carried out using Power Query. This should include the configuration of the tool, how sampling parameters are set, and any modifications made to the tool over time.

4. Risk Management: Incorporate risk management principles that evaluate potential errors or biases introduced through the sampling method. This aligns with the FDA's emphasis on understanding and mitigating risks in quality management processes.

5. Periodic Review: Regularly review and audit the use of Power Query in the sampling process to ensure ongoing compliance with regulatory requirements. This aligns with continuous improvement principles embodied in ISO 13485.

Conclusion

In conclusion, using Power Query in Excel for random sampling is permissible under ISO 13485, FDA, and EU MDR requirements, provided that it is accompanied by thorough validation and robust documentation practices. Organizations engaged in using such a tool must ensure that they adhere to the rigor and integrity expected by regulatory standards. By establishing reliable processes, maintaining compliance, and focusing on continuous improvement, manufacturers can effectively utilize Power Query while meeting necessary regulatory obligations.

If you're considering implementing Power Query for your sampling needs, evaluate your current systems and prepare to document and validate your approach to maintain compliance with applicable regulations.