Quality professional Sarah-Jayne Henderson CQP MCQI outlines how to host a remote audit effectively for a paper-based system.
It may seem surprising that so many companies are still paper-based in this era of ever-expanding information technology (IT). However, it is still relatively common practice in some industries, such as the life sciences.
There are a few reasons for this. Sometimes companies are left behind in the technological race in certain areas, as they prioritise high-end equipment for manufacturing of products over an electronic quality management system (eQMS).
The same companies are often heavily regulated and rely on vast amounts of data to support their products. Data, its integrity and how it is actually stored is paramount.
It’s therefore important that data is clear, concise, legible and stored safely for a very long time – depending on the lifecycle of the product. Understandably, some companies are a little resistant to change. Even when there are good electronic back-up systems for a computer, it must be put through a thorough validation prior to taking away any paper-based system, to ensure data is protected and fully retrievable.
This all takes time and money, as well as a little knowledge and IT know-how. These are just a couple of the reasons some companies choose to delay moving to a paperless system to document their procedures, data, reports, and so on.
So how do you host a remote audit using a paper-based system? Well, there are not really that many options.
My first port of call was to get familiar with a video communications platform. Microsoft Teams seems to work well, but of course there are plenty of other options such as Zoom, Skype and WebEx that are commonly used in the business world.
Next, is the organisation of documents. As it’s a paper-based system, lots of scanning will be involved. You may be lucky and have this already done for you. The majority of companies do have a document repository.
During my initial contact with the auditor, I request they sign a confidentiality agreement. This includes references to data protection and outlines some important points for audit conduct, including no electrical recording devices to be used for the duration, before, or after the audit, no screenshots/photographs to be taken and no copying/downloading of documents from the shared drive.
The confidentiality agreement is approved by the company legal team before setting up and using a file on Microsoft SharePoint to share documents securely. I can control who has access to the files, if they can read or edit them, or both. Once the file has been created, relevant documents can be uploaded the evening before the audit is due to commence.
It is important to set a deadline to cut access to those documents so that the audit does not drag on. This should be agreed with the auditor early on so that there are no surprises later. Keep organisation of the documents simple; auditors like an easy life and a bit of structure. Use folders to store procedures by topic, such as ‘training’ or ‘validation’.
When agreeing on an agenda for the audit, there may be a request to host a virtual tour of your facility via smartphone or tablet. This takes some consideration. For example, you may require input from health and safety if it involves going into an area where certain chemicals are used. Once you have come up with a plan to overcome these hurdles, consider who you want to host the tour. Tours in some companies may mean jumping between buildings and departments, so it is preferable to have several subject matter experts (SMEs) join a Teams invite for each part of the tour.
As a person who works remotely, I remain on the call as the host and have a team member guide the tour on site by joining the same call as me and the auditor. In this instance, I act as a kind of backroom support, who notes and prepares document requests and helps to ensure a seamless transition from one part of the tour to another.
Once the agenda and documents are prepared, the audit itself takes place. I always try to have SMEs on standby, ready to answer specific questions from the auditor – for example, the author of a specific deviation. I find it easier to set-up one meeting invite on Teams and use the link to join the call as required.
It starts with an opening meeting and a presentation providing an overview of the company. The opening meeting normally includes the auditor, the audit host and anybody else who is deemed relevant, such as the heads of departments. Following on from this, you may decide to have a virtual tour, then a review of any requested documents. SharePoint can be used to share these.
Once the audit is complete, it is useful to have the SMEs and heads of departments on the call for the closing meeting with the auditor, who will usually provide feedback regarding the conduct of the audit, as well as any observations. It is always expected that the regulatory guidelines or internal procedures that are not being complied with are stated for each observation.
Finally, at the end of an audit, it is good to request feedback on the audit from your peers. I find having a ‘lessons learned’ session with your colleagues shortly after the audit is useful as you can all throw a few ideas around as to how to make improvements for next time. A remote audit is certainly a collaborative effort and one way to keep your business moving forward during a pandemic.
Attribute to original publisher/ publishing organization: Quality professional Sarah-Jayne Henderson CQP MCQI, https://www.quality.org/knowledge/remote-control-hosting-audit-paper-based-companies