The Recipe for An Easy Audit

16 Oct

Add This to Your “Recipe Book”

All of us have a favorite recipe that has been passed down for generations. In my family, it is our apple pie recipe. Each of my cousins claims that their mother created the recipe. I know for a fact, from my Mother, who was very transparent and humble, that all the Aunties found the same recipe from Burl Ives, known for his folk songs, and better known in our family for creating the apple pie recipe that was passed down from generation to generation. Problem was, that over time, the recipe recorded by hand on paper and handled over many decades, was almost unreadable. Luckily, I have a pretty good memory and given a previous course in linguistics during my college years, I was able to reconstruct it and digitize it. Yes, if you ask, I will share it with you.
Count sheets and preference cards are also recipes that folks in sterile processing need every day to perform their tasks. Like a bill of materials, a count sheet is a recipe for putting sets together, identifying the quantity of each, and providing instructions in a specific order for specific procedures. Whether it's a count sheet or a pick list, these systems work best when they are digitized. Nevertheless, how many are still on paper, on a post-it, index cards, or taped to a container, placed in a paper bag, or even a peel pack despite that being disallowed. Have you found the ideal way yet to affix these printed recipes to a system without ink smearing or without tape which Joint Commission is currently citing as a no-go? With a robust digital system, should The Joint Commission ever come to town to conduct an audit, you will be ready if you have digitized the contents and stored them in the cloud.

High Quality Tracking Software

Here is our “recipe” for an easy audit, that we used to pass a recent surprise visit from the FDA. The core of our "family" recipe is high-quality asset management software with a robus document management system. We utilized for our internal use a similar cloud based software, like CaseTrak360, to keep Case Medical operating, organized and prepared for a surprise visit. No more paper documents, or record keeping. Everything is paperless, and easy to find. We can show exactly how a component or final product, was manufactured, what equipment was used, when it was callibrated/serviced, the people who were involved in production, and the components down to the raw materials. This instant access to information means there was no panic when the FDA came to town. We simply had a few meetings to gather the information requested in folders. Everything needed was easy to find at a button press.

Finding Information Can Be Easy-Peasy

Having a defined organizational structure of what goes where, and who has access to what, is critical for retriving what's needed so you don’t get lost in the process. We at Case Medical have spent a lot of time organizing our digital files by project, improving our role-based access control, separating in-process from finished work, and archiving old material. We learned the hard way, surviving two floods, four moves, and a supply chain crisis when even paper was not available. There is a famous saying “garbage in, garbage out”, and that absolutely applies to digital systems. If you upload a disorganized mess, then your digital system will be a disorganized mess. You have to put in the work to get your files organized and to stay organized so you can find what you need when it's needed.

Our Ingredient List for an Easy Audit

If you have an upcoming regulatory audit, there is a lot you can do to make the process go smoothly. Preparation isn't necessary if you have an effective document management system. When a company or healthcare facility is notified of an upcoming audit, the audit scope, including the audit criteria (or protocols), will be provided.

Sometimes in a checklist. If you have an understanding of what's needed and identified any gaps, minor deficiencies that can easily be corrected before the audit. Personnel who are comfortable with the audit process are prepared. Utilize asset management software everyday to avoid surprises. Here's a recipe you might find useful:

-Identify the scope and purpose of the audit
-Determine the documentation needed
-Be sure you can locate it
-Gather a strong team with knowledge of the system and the operations
-Keep your digital records updated and in folders so they can be easily found
-Archive what is not needed

If you would like the digital copy of our family pie recipe, click here.


If you schedule a CaseTrak360 demo, we'll send you a pie.

Contact us at [email protected] if you have any questions or wish to learn more about Case Medical’s products and services.

Kindest Regards,

Marcia Frieze and the Case Medical team

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