Accidental Non-Compliance – An Unnecessary Risk
In a regulated industry, the consequences of producing non-compliant documents can be severe. Fines and law suits can be financially damaging. Poor publicity can result in lost business. And those responsible can lose their jobs.
Do the documents produced by your company comply with the laws and regulations that apply to your industry? How can you be sure?
If you answered, “Because we checked the documents when they were designed,” you might be in for a surprise. Content that was perfectly fine when the documents were first developed may no longer meet the letter of the law; for lots of different reasons.
In some industries, the number of regulations has recently increased or will soon increase (as the result of regulations such as the Patient Protection and Affordable Care Act), as have enforcement activities. Making sure documents are fulfilling all the current requirements for disclosure, language, and readability is becoming increasingly more difficult. And the trend is toward more regulation – not less.
How Non-compliant Documents are Accidentally Created
- The system that was used to create electronically-delivered documents was different from the system that generates printed output
- The developers changed one version of the documents but others (such as a year-end version) were not updated
- Manual document change verification failed to catch language/wording errors
- Changes verified in the test environment were never migrated to production
- New versions accidently got rolled back due to a system or server problem
- Regulated text was pre-printed on documents and a carton of old material somehow got used in production
- Resources were stored on the printers as forms and some printers were not updated with new versions
- Hardware or software changes resulted in different fonts, margins, or layouts, resulting in truncated content
- The logic to place variable text blocks unknowingly failed under certain data conditions
- Private data became visible through the envelope window when inserter operators loaded the wrong material
A complex problem
The list of potential accidents could go on and on. Conditions that result in regulated documents falling out of compliance or breaching customer privacy are numerous and vary from company to company. Would your current procedures keep you from making mistakes like those above? If not, will you accept responsibility should something like this happen on your watch?
Failing to comply with regulatory requirements in some industries carries significant penalties. In other cases, the financial risk may be lower. But generating inaccurate documents has a negative impact whenever it happens. Whether it is a direct financial fine, increased calls to customer service, reprinting and re-mailing, or a blow to the company’s reputation, there is a price to be paid.
Managing Document Solutions
Fortunately, document producers today have the ability to minimize their risk. Making the necessary investments to do so seems to be a prudent move. But while I’d like to tell you that software alone can make regulatory compliance errors obsolete, it just isn’t possible. Automated solutions can be an extremely effective first line of defense. But reducing your exposure to accidental non-compliance must still involve some manual procedures as well.