Thank you to all who commented on my last post (Has Anything Really Changed in Clinical Quality – April 25th 2018). I enjoyed the comments, especially the insight that sometimes we can be our own worst enemy in the way we present audit findings. All the comments are available on my LinkedIn article here. I would like to write a series on the elements of Clinical Quality Management Systems, but perhaps let’s just take a detour to address the writing of Clinical Quality audit reports.
Over the years I have seen the best and the worst. I have read audit reports where I needed a translator, and I have read audit reports the size of a book with so much detail that somewhere along the way I would lose the will to live. I have also been faced with unbelievable complexity in trying to respond electronically to audit reports. However, I have also some read some brilliant audit (and inspection) reports where the text was short and crisp, the examples given were a clear illustration of the issue, and I could read and quickly digest what the issues were and what needs to be done and by when. So, what do I think constitutes a great audit report? These are some of my favorites points, I’m sure you will have your own:
- There needs to be somewhat of a balance between positive and negative findings; praise is always a good thing. I know an audit report cannot list all the good things, but at least try and capture things people are proud of. Wouldn’t it be great to see an audit report that said e.g. “the training function exceeded the SOP requirements with on time training for April 2018.”
- Be clear on what constitutes critical, major and minor observations (or whatever definition you use). Critical observations, in reality, are very few and far between - don’t water down the severity by giving too many. Focus on risks that matter.
- I know it’s hard because there is always an inherent variability with individual auditors, but aim to be as consistent as possible with auditor training.
- If you have a Clinical Quality Management system that can filter the severity of findings, then do you need to write up every minor finding? These can be handled in alternative, systematic ways, you can simply say, “the entire area of _____ needs to be reviewed and addressed as many non-conformances were noted” and just give one or two examples.
- The clinical audit report itself – let’s aim for no more than 2-3 pages. I know, sometimes it’s just not possible. However, people have short attention spans and your audience should be able to read and digest in one sitting. Tabulate, bullet point, and have a clear and easy to read template.
- I do like to see the reference regulations or guidelines that are used. It can help to take away controversy.
- Write the audit findings in a way that the recipient can understand: avoid jargon, and think about your audience. (Too many acronyms? Add a glossary!)
- Make sure the customer experience of responding to audit reports (manually or electronically) is a delight to experience.
Personally, I think how we present our audit findings is a major contributor to the inherent Quality culture of a company. We all know the SMART acronym (Specific, Measurable, Achievable, Realistic and Timely), I also like to add BEST – Be Brief, Engage, Simplify and Teach. Let’s create a call to action to make our Clinical audit reports a joy to read!
About the Author: Jane Wood is the Principal of YourEncore's Quality Center of Excellence. With over 40 years global experience, Jane has led small and large teams of Quality professionals to mitigate risk and develop R&D Quality solutions. Jane currently leads a team of subject matter experts offering in-depth experience in all sections of Quality and GxP.