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. However, Avoiding these problems is not impossible. Ensuring your documentation contains certain characteristics that, once implemented and maintained, will not only improve your compliance efforts but also benefit your bottom line.
Challenges faced when developing successful compliance documentation
Ensuring your documentation is compliance-ready can seem as daunting as a marathon. But even marathons are run one stride at a time. Preparing for one is simply a matter of implementing the proper exercises. Put your documentation through the proper exercises and the compliance marathon is achievable.
Effective compliance documentation has seven characteristics
The following seven characteristics of effective compliance documentation offer a clear path to success in the compliance venture your organization must run.
1. Accuracy
- Does your documentation accurately reflect compliant behaviors and processes?
- Are your employees performing their work according to these documented methods?
2. Accessibility
Both auditors and employees must be able to easily find and access your compliance documents. Auditors will not only check to see that THEY can access the documents easily, but also that employees can (and do!) access them. This proves 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.
3. Comprehensiveness
Comprehensiveness also applies to BOTH auditors and employees. Does the documentation contain not just most but ALL the required content, at a sufficient level of detail. It’s required for the employees to be sure they are performing their job duties compliantly. Auditors will be looking for this level of detail.
4. Clarity and User-Focus
The documentation must be user-focused and easy to follow. It must be tested to make sure that:
- Employees can easily understand it.
- After looking at it, employees know exactly what they need to do to be compliant.
One critical audit check is determining if what the documents tell the employees to do is exactly what they are doing.
5. Agility and Adaptability
Processes necessarily change over time, and the steps employees make to maintain compliance must change with them (and vice versa). Documents must be easily revised to reflect these changes. One sure pathway to out-of-date, non-compliant documentation is to make them difficult to update.
6. Technology
Users increasingly moved away from paper documentation. Your documentation must be in a technically capable, accessible, organized, and online content management system (CMS). that can grow and change as your processes and compliance tasks change.
7. Standards and Scalability
Create and maintain a set of defined documentation standards. Apply these standards to new documents as well as existing ones. If you do not have a team of professional documentation developers, this step is even more important. employees who are not professional technical communicators, but are tasked with authoring documentation, must consult and follow the established standards closely to ensure that:
- Documents continue to accurately reflect current compliance procedures.
- Documents show exactly what employees are doing.
These seven characteristics 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.
Need help creating documentation that passes compliance audits? We want to help! Contact us today to learn how our experienced technical writers can help you save time and money — AND pass your audits!
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