Realistic Audits – Preparation

As contract auditors, the one area that we are frequently asked to reduce time for in proposals is preparation. I often wonder whether the client company realises what a false economy this actually is. Unfortunately, this is usually a decision made by the finance or contracts group who have a poor understanding of what is actually involved in preparing for an audit, and are merely concerned about cost. ADAMAS has always emphasised that preparation is the key to a thorough and successful audit. However, how much preparation is enough? There is a balance between doing enough preparation to ensure the audit progresses smoothly, to going overboard and spending a great deal of time reading documents that could be read during the audit, or that have no real relevance to the audit.
For pharmacovigilance (PV) systems audits this can be a particularly difficult balance. I have received up to 120 different documents to read before starting a PV systems audit – which is somewhat difficult to achieve, even with a generous preparation time of three days! This can be contrasted with service provider qualification audits, where one often just has a contract, organisation chart and list of SOPs, as well as the website information.
The view we take at ADAMAS is that you should have read enough information to be able to prepare a detailed audit plan and agenda, and to understand the scope of the audit thoroughly, so that the auditor can walk into a site or organisation feeling confident that they know what needs to be done, and avoid looking confused and muddled – this would not be good for their credibility (which is extremely important for an auditor).
It’s also not recommended to prepare whilst travelling to the audit! Although some clients have asked us to do this – we rarely do. We believe in keeping client information confidential, but also it is not good practice to leave preparation to the last minute.
In summary, good quality and efficient preparation is important to the overall success of an audit and delivery of a quality product.