The Audit Team is Coming Tomorrow. What’s in YOUR files?

If you are in a highly regulated industry, you understand how tense things get when it is time for a documentation audit, especially from outside auditors attached to a regulatory agency. Some of that tension would fade if everyone who creates documents understands what is required of the document.

A documentation audit often concerns whether a company is following its written operating procedures governing the documentation process. These operating procedures must be part of the continuing education curriculum- for periodic review or, most particularly, when the procedure changes.

If you create documents, such as customer support or incident documentation, make certain all the elements required by the OP are present. If they are not available, you must say so and say why. All steps must be addressed and accounted for, there is no assuming that the information just wasn’t there or wasn’t pertinent.

If the documentation concerns an investigation of a problem, all steps taken during the investigation must be put into the document and each element of the document must have a corresponding document or other written proof of statements made in the element.

For instance, if a widget from your company loses its cogwheel, the investigation must proceed according to the OP and a written investigation, signed and dated, must be obtained from the investigator. It is not enough for an engineer to look at the widget and say,”Huh! Just a loose spring”. The engineer must write down that it is a loose spring; if there is an issue with springs coming loose in general, he must write down the steps that will be taken to eliminate loose springs if needed. He might need to perform an inspection of the widgets currently in the warehouse. Perhaps include whether there is an upward trend in complaints about lost springs. Sign, date, pass along to whomever keeps the documentation straight.

Depending on your industry, a series of bad audits indicating poor documentation processes can result in fines and other punitive action. You need to be able to put your hands on the required set of documents anytime and they must be complete.

I know, most people don’t like to document what they did, they just want to do. But it must be impressed upon them how important it is and what the consequences are for failure to follow the rules.

If it turns out to be your fault something is missing, it may only be a slap on the wrist. Or it could mean your job. Know which of these consequences is most likely in your industry.

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