End of the year quality check

By Kelly Huckabone

December 2018

The end of the year is almost upon us and it important to remember to do an assessment of any open quality events/initiatives as part of your risk program. This quality check will ensure you follow up and close out open quality events that could impact your Quality Management System.

Here is an example I have used in the past:

Task Y/N Action to be taken
Are internal audit findings closed out?                                               
Are external and customer audits closed out?    
Are there any open deviations that need to be addressed?    
Are there any open Change Management Requests that require action?    
Are there any overdue training which needs addressing?    
Have you closed out any outstanding complaints?    
Are there any open CAPAs that need addressing?    
Have you completed the 2019 internal audit plan?    
Are there any open project action items that require escalation?    
Make a list of key initiatives for 2019    

Quality is an ongoing journey and by using tools and techniques to help stay organized and on track your QMS will continue to evolve in the right direction.

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About the Author

Kelly Huckabone is the North American Audit Program Manager who oversees Unity Lab Service’s internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with ASQ, and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.

Contact me at kelly.huckabone@thermofisher.com if you have any questions.