Auditors and industry experts agree that poor documentation is a root cause of non-compliance. When auditors can’t easily find and understand the information they need in your documentation, or see that the documentation doesn’t match up with actual practices, the consequences range from the headaches of longer, costlier audit processes to major catastrophes like fines, shut-downs or even litigation.
Why is it difficult to create successful compliance documentation?
Think of compliance as an extreme challenge, like an Iron Man Triathlon for your documentation—an ultimate test of its robustness, adaptability and fitness. Compliance can place tremendous demands on even the best documentation. And just as you’d train your body and mind before competing in a triathlon, before you submit your documents to the test, you need to make sure they're in great shape and up to the challenge.
7 features of successful compliance documentation
To help you make sure your documentation can go the distance, we’ve compiled a list of seven essential features of successful compliance documents. Before you submit your documents to an audit team, evaluate them against this list. To ensure that you’ll pass the audit with flying colors, your compliance documentation must be
- Accurate: Verify the accuracy of your content, and make sure it matches up with how employees actually perform their work.
- Accessible: Make sure that auditors as well as employees are able to quickly access the document and locate the information they need.
- Comprehensive: The devil is in the details. Do your documents include all of the required content, at the right level of detail, for the employees who rely on it as well as for the regulators who examine it?
- Clear and user-focused: Check for clarity and usability. Employees must understand exactly what they need to do, and auditors want to see clearly how what they’re reading matches up with what employees are doing.
- Agile and adaptable: Has anything changed since your document was written? If it’s not easy to revise and update in response to changing regulations or changing practices, then your documentation can quickly become obsolete—in other words, useless, and non-compliant.
- Technology-compatible: This has become an urgent issue, as users increasingly access documentation on-line instead of on paper. Content management systems (CMS) offer the promise of centralized control as well as quick and easy re-purposing of content. If you’re implementing a CMS, you’ll need to modularize, organize and structure your content in ways that are compatible with how the new system “thinks.” Will your documentation be ready to make this transition?
- Standardized and scalable: This is another important issue. Some organizations still have teams of technical writers who create documentation, but many now routinely give authoring responsibilities to employees who aren’t professional technical communicators. This can be highly problematic unless you implement standards for how content is written, and provide everyone who writes with a skill set that ensures their output will be clear and user-focused.
If your documentation is weak in any of the above areas, you may be at risk of failing your next audit. But the good news is that there’s a lot you can do to fix these problems and create user-focused and audit-ready documents.
Before we share some of our proven strategies for improving your compliance documentation with you in the coming weeks, we’d like to know how your documentation measures up against our criteria and what problem areas you have found!