by Richard A. Vincins
Preparing for and conducting an audit are the initial components of the audit process; writing a good audit report is the final step. However, auditors are often frustrated when their audit reports are not taken seriously or used effectively because they do not provide meaningful information. This article will discuss how to write a great audit report so that whether it’s used internally or externally, the audit report conveys the proper information. We will discuss some of the best practices for audit report writing to ensure that the content of an audit report is not merely sufficient. This article will also cover writing audit reports for both internal audits and external audits, such as supplier audits or compliance audits. It will conclude with another important aspect of writing a great audit report: timely distribution so the results of the audit are kept fresh and current.
Know your audience
One of the more difficult aspects of writing an audit report is understanding your intended audience. This may seem like common sense, but many audit reports are confusing to the recipient or not at the right level. This is particularly true for compliance audits where the findings are written in regulatory jargon so that the meaning of the finding is not clear. Writing a great audit report requires that you put yourself in your audience’s perspective to make sure the content is understandable and what the audience expects. Internal audit reports are typically sent to the process owner or department manager. They will expect to see a list of specific findings. Generally, internal audit reports can be written with more technical terms because the reader will understand the relation to the processes at the company. This may not be true when writing external audit reports.
When sending external audit reports to a recipient such as supplier or contract manufacturer, he or she will want to see more of a narrative of the issues that were found during the audit. In fact, the audit findings may need to be written in plain terms that may come close to sounding like recommendations so that the external party knows what actions must be taken. The audience of the audit report may not have adequate knowledge of regulations or standards referenced in the report. If the report contains technical terms or regulatory terms from a standard that the auditee may not be familiar with, then the audit report will be confusing to him or her. Writing the report with the auditee’s experience in mind will ensure that it is not disregarded because the recipient does not understand it.
Use a standard templates for your audit report
Another way of writing great audit reports is to standardize them, which can be accomplished through using templates. Developing a standardized report template for audits will also ensure that multiple auditors are conveying similar information. Typically, organizations already have an internal audit report for their quality systems. However, many organizations do not utilize the same report for external audits or allow different departments to publish their own external audit report. This results in suppliers or contract manufacturers not receiving consistent information or receiving inadequate information from the auditors.
A standard template allows the company to convey to external parties the proper information of the audit criteria, audit findings, and what is expected from the organization in the future. This may include a clear delineation of audit findings that require corrective action. By having a standard template for internal audits and external audits the organization conveys the correct and complete information to the recipient.
Generate a clear and concise list of findings
The list of findings in the audit report needs to be generated at the appropriate level for the recipient and provide enough detail that the finding is understood. An audit report might be reviewed by the auditee weeks later and he or she may have already forgotten what was covered during the audit. If the finding in the audit report does not convey the deficiency appropriately, the auditee may not apply the corrective action needed to resolve the issue. Audit findings are not easily applied to different situations, so an audit finding statement may not be able to be “reused” in the audit report. However, it may be possible to utilize an audit checklist that will help the organization keep consistency between audits performed at different times.
Internal audit reports typically include more technical information than all personnel at the company would understand. When writing an audit report for an external audit, this may require more simplistic phrases or the audit findings written in plain context. The external parties may not have the expertise to understand how an audit finding relates to their overall business because they may not have a quality management system (QMS) implemented. The following two statements show a comparison between an audit finding written for an internal audit report and the same finding written for an external audit report. This example shows that the same audit finding can be interpreted or read differently by the audience depending on their knowledge and experience with quality systems.
- Internal audit report: There is no evidence of employee training as there was no training record completed for the quality system procedures. According to the training chart, form 6.2-1-2, the employees must be trained on required procedures according to their job description. Specifically, two employees’ training records were reviewed with no evidence of completed training records to the required quality system procedures because the form 6.2-1-1 was not completed.
- External audit report: There is no record that employees have been trained on their specific job functions. Without a record to show that employees are properly trained, the quality of the product cannot be fully assured. The training must be completed to support that the products of Company X are made consistently to specification.
Another method to be applied for writing a great audit report is to not use “wishy-washy” words or “gobbledygook” (long phrases with no meaning). Make the audit finding statements clear and concise. Write the findings without emotion or feeling words so that the audit report is fact-based. Don’t confuse the recipient of the audit report by writing around the issue or trying to soften its message. Doing so makes it less likely the appropriate corrective action will be applied or the auditee may even choose not to do anything because he or she doesn’t understand the report. The audit finding must be written concisely with clear statements that relate back to the observation because the audit report may be reviewed weeks later.
Timely distribution of the audit report
Although it may not be directly related to the writing of an audit report, the timely distribution of the audit report is still an important aspect of the audit process. The audit report could be the best audit report ever produced, but if it’s sent to the auditee a month after the audit, the report loses much of its relevance. A great audit report is one that is sent in a timely manner to the auditee whether it is an internal or external audit report. A good rule of thumb is to send the audit report within five to 10 working days. Beyond 10 working days the recipient may not take the audit report seriously. In fact, audit reports that are not sent to external parties in a timely manner lose much credibility for the organization. When a great audit report has been written, make sure this is also sent promptly to have the most benefit.
To write a good audit report takes practice. To write a great audit report takes much more practice. Hopefully the discussion presented in this article will help bridge that gap to present much better audit reports, be they for internal or external audits. Before you begin writing the audit report think about your intended audience. Don’t write to yourself, as you are writing think about saying the statement to your intended audience. Use standard templates for the audit report to stay consistent while providing the correct information to the auditee each time. Ensure that the audit findings are clear and concise to convey the appropriate level of detail. Then make sure that the audit report is sent in a timely manner so the audit does not lose its priority.
About the author
Richard A. Vincins, CQA, CBA, RAC(US, EU) is the vice president of quality assurance with Emergo Group, a global medical device consulting firm with headquarters in Austin, Texas. He is responsible for the implementation of quality systems, conducting quality system audits, training on quality system tools, and providing regulatory expertise in national and international regulations. Vincins has more than 20 years of experience in the medical industry, including worldwide regulatory compliance efforts for in-vitro device, medical device, and pharmaceutical companies.