Inspection or Audit
Jennie Clark CQP MCQI
Passionate about management systems development and improvement, delivering excellence as an author, auditor and trainer.
Normally an issue associated, IMHO, with safety management systems rather than quality or environmental management systems, there is often confusion between inspection and audit. Organisations who have had safety processes in place for far longer than their management system will often be well versed in undertaking ‘safety inspections’ in their factory or on worksites. These are often ‘tick box’ exercises, with a checklist designed to remind the ‘inspector’ of what they need to look at.
I remember seeing an inspection report, presented as an audit, which had the topic ‘waste management’ and the outcome of a tick. I probed further to gain understanding of just what the tick indicated. I was told it meant that waste management on site was ‘ok’. The checklist had been augmented with a photograph, which clearly showed paint cans in a general waste skip. Ho hum. I pushed further, asking if the check had included a review of the waste disposal process and looked at the waste transfer notes? It hadn’t, so we pulled them in to review. Bearing in mind this was a construction site with construction waste it was rather strange to find the transfer notes coding the site as a food production unit, disposing of hospital waste. But of course the record of inspection had given the organisation’s management the gentle glow of confidence that everything was ‘ok’ when it sadly was far from it.
So what’s the difference between inspection and audit? I turned to AI for a definition and it threw up the following:
An inspection and an audit are two distinct processes used in various contexts, such as quality management, compliance assessment, or financial review. While both involve examining and evaluating certain aspects of a system, organization, or process, there are fundamental differences between the two. Here's a general distinction between inspections and audits:
Inspection:
An inspection typically focuses on verifying compliance with established standards, regulations, or requirements. It involves a systematic examination or review of specific elements, components, or procedures to identify any deviations, defects, or non-conformities. The primary purpose of an inspection is to ensure that a product, service, or process meets specified criteria, quality levels, or safety standards. Inspections are often conducted by internal or external inspectors who are responsible for checking the compliance of the subject under scrutiny. The focus is generally narrower and more targeted compared to an audit.
Audit:
An audit, on the other hand, is a broader and more comprehensive evaluation of an organization, system, or process. It involves an independent and systematic examination of activities, records, controls, and practices to assess their effectiveness, efficiency, accuracy, and compliance with applicable standards, policies, or regulations. Audits are typically conducted by qualified professionals who are impartial and objective, often known as auditors. The scope of an audit is broader, encompassing multiple areas or functions, and aims to provide an overall assessment of the subject being audited. Audits often include a review of documentation, interviews with personnel, analysis of processes, and may involve sampling techniques to draw conclusions.
In summary, inspections are focused, targeted assessments that aim to identify deviations from specific standards or requirements, whereas audits are comprehensive evaluations that assess the overall effectiveness, compliance, and efficiency of systems or processes.
I like the distinctions drawn between the two in this text. For me audits are far more than tick box inspections. They are about delving into the process, looking at how it is working and asking two vital questions around the process ‘is it effective’ and ‘is it efficient’? These overlay ‘are we complying’ and to me are more important. We can comply but do so ineffectively and inefficiently and if our audits are about driving forward improvement (remember that audit sits in the performance evaluation section of the standards) then we need to lift our heads up above pure compliance and look at where we can and should improve.
Audits take skill to deliver well. Too many people take on the role without having any skill or competence to deliver it. That competence comes from understanding the processes being audited AND understanding the framework which they are delivered against – not just the organisation’s own procedures or controls but the standards themselves. If the auditor doesn’t understand the requirements in the standard how can they evaluate the process controls against those requirements? If they then go on to audit compliance against non-compliant process controls what value is added to the business?
Are you clear on what you inspect, and what you audit? Are your audit team really competent to deliver the audit programme you have in place? What improvements is your
Retired Chemist, Auditor and Quality Professional, Vice-Chair of the CQI Audit Special Interest Group
1 年In pharma, we distinguish between audits - either internal or third party, which look for compliance with defined standards - and inspections, which are carried out by regulatory authorities, for licensing purposes (new products or ongoing supply). Internal compliance audit functions will also carry out "mock inspections" to prepare for a regulatory visit.