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Are You Ready for a Client Audit?

Client audits should never be a struggle, they should also never be viewed from a negative point of view. At the end of the day, auditing is part of the territory and there are ways to ensure you get the most out of them.

Think of the benefits an audit can bring to your organisation, it ensures you and all of your staff are on the same page in terms of procedures and ultimate goals, audits also give you the opportunity to have contact with your client. You should use every client touch point to your advantage to grow and galvanise relationships.

The Hark team has over 12 years’ experience in the pharmaceutical industry under our belts and we’ve conducted hundreds of audits in that time.

Here are some of our tips to ensure you not only make it through an audit with flying colours but you also capitalise on the benefits they can bring:

  • Always be audit-ready! – The key to any audit is preparation so always be expecting an upcoming visit. This is where access to automated, real-time monitoring comes in to its own and if you’re able to pull data from any date, instantly, with the press of a button, you’ll never have to worry about file preparation again!

  • Gain some intelligence on the auditors to find out their areas of expertise and focus. LinkedIn can be great for this and it never hurts to create a relationship with your auditors

  • 2-3 weeks before the client audit the auditor will contact you and usually ask for a time and location for your audit and will send through your audit program. The Program will allow you to plan your audit route. Use this opportunity to offer advice on local hotels, restaurants and the best routes to find you

  • 1-2 weeks prior, you may be asked to send through some documentation in advance. By sending through these documents it significantly helps the auditor in their preparation and highlights areas that may need additional or less focus. These are the documents you’ll need to have at the ready so try to get into the habit of updating these on a regular basis:

    • Site Master File (SMF) describes the site, major activities, key personnel, site layout etc.
    • Quality Manual (QM) is an ISO9001 document that describes the whole quality Management System
    • Organisation Chart
    • Master list of documents
  • All of these documents help the auditor to gain an initial understanding of the organisation and allows them to arrive well-prepared

  • Know your documentation and define your tour routes – it’s useful to define routes through your facility for the audit tour. Ensure that you have designated hosts at each area who are trained up and capable of answering auditors questions. To prepare your hosts, it might be useful to practice some mock questions and answers

  • Be pro active! – it’s the final point but may be the most important to keep in mind, never view audits as a headache, think positively about how they give you opportunities to learn new procedures and innovative techniques from the auditor. Remember, they travel the country viewing the facilities of your competitors every day, don’t be afraid to ask them their opinion on the next big trend or innovation that could be applicable to your business. You have a very knowledgeable person in your midst, make the most of the opportunity!

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