There are many proverbs that allude to the lack of planning leading to failure: “If you fail to plan, you are planning to fail!” (Benjamin Franklin), “Organizing is what you do before you do something, so that when you do it, it is not all mixed up” (AA Milne) and, “Give me six hours to chop down a tree and I will spend the first four sharpening the axe” (Abraham Lincoln) are just a few. Whichever proverb you prefer, it’s 100% true that planning thoroughly for an audit will leave you in a better place than not!
Preparing for an audit can feel overwhelming, especially if you’ve never been through the process before or if you are auditing an area which you are less familiar with. The good news is that, with the right approach, it becomes manageable and you will feel in control. Here, we include a few pointers to make the most of your planning time. Generally, the same approach applies to an audit of an external party (for example, a supplier or transport provider), or for a self-inspection in your own organisation.
Understand the scope and expectations
• Understand what the audit aims to achieve, the scope of the audit, and the regulations / guidance (“standards”) that you will be auditing against.
• If you are auditing in a team, be clear on what your roles are and how you will share the review tasks. Assign a lead auditor who should be responsible to manage the time and direct the other auditors when required. This helps prevent confusion and sets clear expectations across the team.
Finalise the logistics / practicalities
• Consider how much time have you allocated for the audit and is it reasonable to ensure all areas are covered; you may need to adjust the areas that can be audited accordingly.
• If you are travelling to another site; research timings to get there and understand if there are any specific site health and safety rules (such as clothing or other health and safety briefings). If you have special requirements (dietary or otherwise), let the site know in advance so they can accommodate.
• If the audit is remote, think about how the sharing of documents will work on the day and whether it is feasible to review any documents in advance.
• Will the documents and records be in a language you can understand? If not, think about how you will manage that during the audit. In all cases, request a list of SOPs and quality manual / site master file for advance review.
Research / Information Gathering
• Review previous audit reports to identify areas which need focus this time – you may want to verify some corrective actions have been implemented as planned when you are auditing.
• Speak to internal Subject Matter Experts (SMEs) to determine if there are any high-risk areas that might need more focus (KPIs may indicate some performance or quality issues that warrant a closer look).
• Whilst an agenda can be adjusted on the day, ensure that you are allocating sufficient time to the areas in scope and are able to focus on higher risk activities.
• If the audit covers areas where you are less familiar, do your research and talk to SMEs to increase your understanding.
Finalise the agenda
The previous stages will enable you to draft your agenda, allocating time taking a risk-based approach.
• Your agenda should include the basics such as site being audited, date of audit, auditor, purpose and scope, applicable standards, areas to be audited.
• Add guidance timings to the different areas you will be reviewing.
• If you are in an audit team, decide how you will divide and conquer to make the most of the time (and lean on your experience and specialisms where appropriate).
Check lists and memory aids
• Review documents such as quality manual, (and/or site master file), including site plans and organisation charts to understand the auditee operations in advance.
• Some auditors like to use a checklist or a memory aid to ensure focus on those key areas and so areas identified as important to cover are not missed on the day. This can also help to highlight the applicable regulations so you can review evidence of compliance directly against the requirement. If you do use a checklist, adjust it to fit the agenda.
Spending time on the planning will significantly reduce the stress levels and give you the basis for a well organised risk-based audit.
If you’re looking for independent audit support, HTF Associates Ltd have a team of experienced auditors who can help – just send a message to discuss your needs.
email: enquiry@htfassociates.co.uk
