Producing an Audit Report: What Happens Next
Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’ approach and in their eyes, if it’s not documented, it didn’t happen!
The structure of your audit report should include:
- Details of the auditor and auditee
- A summary of the audit process
- Area or procedure that was audited
- Findings from the audit
- Final conclusions
- Re-audit schedule
- Distribution list
- Sign off
When writing your audit report, document clearly your findings and link these to the relevant guideline, standard or regulation clauses.
Documenting
If when auditing the storage areas of medicinal products, you find that temperature control monitoring equipment has not been calibrated at defined intervals based on a risk and reliability assessment, this is a non-conformance against EU GDP Guidelines Chapter 3, Section 3.3 and can be documented as such in your audit report.
It is also worth noting that the main purpose of performing audits is to check for compliance. Therefore, it is important to document key areas where operations or procedures were compliant as well as non-compliant in your report. If you find that temperature monitoring equipment has been positioned in accordance with the results of a mapping exercise, this is in conformance with EU GDP Guidelines Chapter 3 Section 3.2.1 and can be documented as such on the audit report.
When writing your audit conclusions, be sure to also include a statement to which the audit criteria have been fulfilled. Advise that only a sample area has been audited, unless a full QMS audit has been completed. You can also add any implications for the next audit within this section.
In the event of non-conformances or deficiencies, it is important that these are investigated and corrected either internally or by the external company.
Further Support and Training
Learn more about audit reports, what they should contain and how to effectively manage post audit follow up by registering for our cost effective ‘Introduction to Auditing’ training course. The online format of the course enables you to take the course at a time convenient to you and your organisation.
If your organisation could benefit from support with performing audits writing audit reports or post audit remediation work, Paradigm Shift Consulting offer a range of auditing services and can support your organisation every step of the way. Contact us today for a free 5-minute consultation to see how Paradigm Shift can help you ensure compliance within your organisation.
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