Industry experts and auditors both stress that one of the main causes of non-compliance is not having documented the compliance correctly. If auditors can’t find and comprehend the documented evidence of your compliance, or if your practices differ from what is shown in those documents, undesirable consequences can result, including longer/more costly audit processing and even costly fines, shut-downs, and legal consequences. But it is possible to avoid these problems simply by ensuring your documentation contains certain characteristics that, once implemented and maintained, will not only ensure your compliance efforts but act as a benefit to your bottom line as well.
The challenges faced when developing successful compliance documentation
When it comes to compliance testing, ensuring your documentation is up to the task can seem as daunting as a marathon. But even marathons are run one stride at a time, and to prepare for one is simply a matter of implementing the proper exercises. Put your documentation through the proper exercises and the compliance marathon is eminently achievable.
Effective compliance documentation has seven characteristics
The following seven characteristics of effective compliance documentation, when seen individually, offer a clear path to success in the compliance venture your organization must run.
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Accuracy |
There are two things to check for: 1. Does your documentation accurately reflect compliant behaviors and processes? 2. Are your employees performing their work according to these documented methods? |
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Accessibility |
Not only auditors but also your employees must be able to easily find and access your compliance documents. The auditors will not only check to see that THEY can access the documents easily, but also that employees can (and do!) access them as well, which will prove to them that compliance is taken seriously, is documented, AND is being monitored by the people who must demonstrate the compliant behavior as part of their workday. |
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Comprehensiveness |
As with accessibility, comprehensiveness applies to BOTH auditors and employees. Does the documentation contain not just most but ALL the required content, at a sufficient level of detail, for the employees to be sure they are performing their job duties compliantly? Auditors will be looking for this level of detail. |
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Clarity and User-Focus |
The documentation must be easy to follow and user-focused. It must be tested to make sure that a) employees can easily understand it and b) after looking at it they know exactly what they need to do to be compliant. One critical audit check will be to determine whether what the documents tell the employees to do is exactly what they are doing. |
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Agility and Adaptability |
Processes necessarily change over time, and the steps employees make to maintain compliance must change with them (and vice versa). It is critical that documents are easy to revise to reflect these changes. One sure pathway to out-of-date, non-compliant documentation is to make them difficult to update, so this should never be the case. |
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Technology |
Users have moved increasingly away from paper documentation. It is critical that your documents are in a technically capable, accessible, organized, on-line content management system (CMS) that can grow and change as your processes and compliance tasks do the same. |
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Standards and Scalability |
A critical aspect of keeping documentation clear, focused, and uniform is to create and maintain a set of defined documentation standards. These standards need to be applied as new documents are written, but also as the existing ones are revised. This characteristic is even more critical if you do not have a team of professional documentation developers; employees who are not professional technical communicators, but are tasked with authoring documentation, must consult and follow the established standards closely to ensure that a) the documents continue to accurately reflect current compliance procedures, and b) they show exactly what employees are doing. |
The seven characteristics in the above table will greatly benefit your compliance effort. Leave any one of the seven out and you may be at risk of failing your next compliance audit. Importantly, remember that good, clear, concise documentation, which accurately reflects exactly what your employees are doing, is not just good for passing an audit, it’s great for keeping your operations as smooth and efficient as possible. Review your current documentation and see how it looks based on these criteria.