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Audit Backroom Preparation

In this article we focus on how to prepare the audit backroom for a smooth audit.

You may have been hosting your audits without much preparation or strategy, and things have been working out so far. If this is the case, great. But you may have noticed that audits are getting more stressful and this may be already affecting the results in terms of nonconformances and ‘483’ letters.

If you have ever been in a FDA or TGA audit backroom, you’d know the importance of preparation and communication. No wonder some quality managers call it the ‘War Room’.

The front room is where the auditor, quality manager, and scribe are. The front room is a clean, professional and (usually) friendly environment. The backroom is full of laptops, documents and records, several team members (quality, regulatory, etc.), everyone fetching evidence, investigating issues, or preparing as a subject matter expert.

The purpose of having a backroom is to have one place where:

– most of the audit evidence is fetched

– evidence is checked against the actual request

– all supporting records are collated (these may not have been requested by the auditor)

– subject matter experts are prepped for the questions the auditors may ask

One of the crucial elements for having effective audit is a functioning, efficient backroom. Backroom can comprise of one staff with access to everything, or a team of 10 people each working in a different sub-area of quality (e.g. CAPA, Validations, Document Control).

Often, however, we see companies using backrooms that actually become a hindrance instead of providing support since they are not managed effectively. In such cases the backroom creates several delays in responding to requests and needless to say, the auditors get more and more frustrated as clock moves forward. This means a sub-optimal audit. Hence, we recommend using AuditMan for everything related to audits.

The number of the backroom staff depends on the size of your organisation and type of your audit, but for all audits and most companies having a backroom means a more effective audit.

Another key element is the level of communication between backroom and boardroom (front room). It is absolutely important that the staff in the backroom are not in the dark, and know what is happening at the moment in the front room. What is the auditor looking at now? What are they going to do next? Are we behind the audit plan or ahead? Is the auditor frustrated because a record he needs is not ready yet? This is exactly one reason that we created AuditMan so that there is great communication between the rooms (via scribe, audit request statuses, comments, and…whispers hidden from auditors).

Below points will help you have a backroom that fully supports your front room:

  • Have process (or better, a procedure document) for assembling a backroom for unannounced audits. One of the most common reasons for getting non-conformances for such audits as that there is inadequate processes for handling the audit when the auditor knocks on the door. We have drafted a procedure for you to implement and use.

 

  • Ensure there are laptops for each person in the backroom logged on into the ERP, CRM platforms and documents and records. Make sure there is at least one healthy printer, highlighters, stationary, folders, sticky notes, and ink stamps (e.g. stamps for “Controlled”, “Uncontrolled”, “Obsolete”, “Confidential”, etc.).

 

  • Ensure there is plenty of supplies in the backroom, water, food, and snacks. You don’t want to run out of these when you need it the most.

 

  • If your company uses hard copies, ensure those Manila folders are organised, whether it is colour-coding or post-it notes. Separate internal audits, CAPAs, Supplier records, batch records, management reviews, etc.

 

  • Print out the audit plan of A3 (or larger!) and place it on the wall.

 

  • For larger backrooms, ensure there is a scribe in the front room who is typing everything that happens somewhere that the backroom can see, at all times. For some audit types (such as FDA/TGA) audits, a scribe is mandatory.

 

  • Never broadcast the audit room using webcams, or microphones without prior agreement of the auditors. But please bear in mind, such requests are usually turned down by auditors.

 

  • If the auditor requests an evidence, your backroom can also start predicting the auditors next questions and fetch the documents or records. Example: auditor asks for a CAPA form, but your backroom fetches both the CAPA form and the records related to the CAPA form such as evidence of verification. Quality manager will decide how much of the evidence will be handed to the auditor.

 

  • We often see one person running between the backroom and front room passing the requests. This usually makes auditors angry, causes delays, and is not best practice. The resources can be much better utilised by using audit management platforms. Have a scribe or an audit management platform do all of these for you.

 

  • Ensure all audit evidence pass from the backroom, checked, and passed to the front room.

 

  • All staff must pass from the backroom, get prepped, and then go to the audit room. Simply brief the subject matter experts on (1) what the auditor already knows, and (2) what needs more explanation (3) give the subject matter a copy of their procedure to bring to the audit room.

Important note: A backroom is absolutely not intended for ‘correcting’ documents and records before presenting to the auditor. If you do any of these (1) the auditor most probably spots ‘quick fixes’, (2) matters may escalate, (3) it is illegal to fix records

We hope you find the above useful for your audit management. Reach out to us if you’d like to try AuditMan for your next audit and take control of your audits for better results. You can also check out our comprehensive Audit Checklists for all medical device standards and regulations.

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