From repeatable rigour and experienced expertise, to highly ethical and transparent practices
Alasdair Leckie, VP Audit Services, Rephine
As in any other area of life and business, the calibre and value of an auditing service and product will vary depending on the provider involved. This will have a bearing on the results and their credibility, which in turn has an impact on the risk being measured and managed. Put another way, auditing is far from a tick-box exercise. It is integral to maintaining and demonstrating quality and safety, and at Rephine we take that very seriously.
At our recent Symposium, I explored how we set and attain the highest standards – consistently and demonstrably. We place considerable emphasis on the Gold Standard we have set for ourselves, and for the industry globally, and it is no coincidence that these efforts are now synonymous with our brand.
But what do we mean by our ‘Gold Standard’ approach to auditing?
In essence it’s a process we have ‘refined’ over a great many years, to ensure a consistently high-quality, impartial and ethical audit service.
Experience, expertise & process rigour
At the root of this lies our deep experience. We’ve been operating now for over a quarter of a century now, during which time we’ve conducted more than 4,500 audits. From this extensive experience, we’ve encountered every different kind of situation and scenario – amassing a wealth of knowledge which has allowed us to distil and hone an optimised model.
Crucially, we’ve learned too that an effective approach to auditing must be flexible, and leave room for continuous improvement – based on changes in the industry, and changes in the requirements of the different stakeholders within the audit process.
This deep experience is matched by the high level of expertise of our auditors, which is essential to support the overall quality of the service we provide to our clients globally. It is the consistent professionalism of our auditors, for instance, that has gained such trust among the manufacturers we audit, which in turn encourages their cooperation, transparency and openness.
Our Gold Standard approach is further supported by our internal quality management system, which is based on ISO 17020 and supports the production of consistent, high-quality audit reports.
Clearly, our service must be impartial, to ensure our report users can trust and rely on the absolute objectivity and integrity of our audit reports.
Just as importantly, the audit service must fulfil the needs of the stakeholders involved, which means maximising the limited time our auditors have on site – which could be no more than 1-2 days. Our approach ensures that our auditors use that time in the most efficient way to enable them to produce a high-quality outcome, based on the real risks identified during the audit.
But let’s do deeper beneath the surface, to highlight the difference a Gold Standard audit can make in practice, starting with the independence of Rephine’s audit process.
Impartiality, confidentiality & transparency
During any audit, whether internal or external, it is important that the auditor is independent to the area or the organisation being audited to eliminate any chance of bias or barrier to complete objectivity. Any potential conflict of interest would call into doubt the findings, undermining the report’s credibility and the high ethical standards we hold ourselves to.
At Rephine, we pride ourselves on the watertight integrity of our reports and findings. Complete objectivity is expected by the regulators too, who have strict rules about potential conflicts of interest in quality/safety audits. EMA, for instance, points to the potential for conflict if there is an existing commercial relationship between the organisation performing the audit and the organisation being audited; or a personal conflict on the part of the auditor if they have been employed by the organisation being audited within the last three years, or have a financial interest in it. All of this should be addressed in technical contractual arrangements, too.
Because our quality management system is based on ISO 17020, we’re already in a strong position to ensure there are no conflicts of interest. To demonstrate complete impartiality to the reader of the audit report, each Rephine auditor will sign a declaration of the absence of conflict of interest for each audit that they conduct, which is included in the audit report. We also assess impartiality as part of our auditor qualification process, and our contract with them.
At the other end of the spectrum, we also have a service agreement between Rephine and each audit sponsor, based on Chapter 7 of EU GMP Part 1, which outlines the responsibilities of each party to the commitment to impartiality in an audit. Last but not least, we ensure that all of our employees are fully trained and conduct their roles and responsibilities in a way that mitigates any risks linked to potential conflicts of interest.
Confidentiality and transparency are crucial within the audit process, too – and are again key elements of Rephine’s Gold Standard auditing. Confidentiality is established through associated agreements and employment contracts (and extensive training), as well as via confidentiality/non-disclosure agreements with other stakeholders and clients etc.
Again, our internal systems support all of this, being designed to limit access of confidential information to those that require it to process a request.
Trust in audit reports also relies on transparency, however – and this extends across the audit lifecycle to ensure the integrity, integrity and ultimately the usability of the audit report.
The importance of groundwork in focusing inspections
Once all of these foundational qualities have been established, the role of Rephine’s expertise, experience and optimised processes come into their own. That’s in ensuring that the report sponsor gains everything they need from an audit, and that nothing important is overlooked – even if there are time constraints affecting the work auditors can perform on site.
We perform a lot of important groundwork, for instance, to establish what is already known, what may have come up before, and any other considerations that will help focus our auditors’ time on site. We conduct as much preparatory work as possible before the on-site assessment – a process we further honed during the pandemic, when there were very real physical limitations to on-site audits. All of this means that our time on site can be very focused, on the critical areas of interest or specific factors requiring follow-up, alongside the usual considerations of a more general audit.
Because our auditors are highly experienced, and work hard to engage positively with auditees – including the all-important groundwork ahead of time – Rephine is adept at extracting maximum information during inspections. We know what to look for, what’s important, and how best to elicit the key information needed – for instance by communicating clearly and double-checking responses.
We’re also very clear and consistent in the way we set out and structure our reports, so that they are easy to digest by the Qualified Persons or other interested parties who want to get straight to what’s important.
To discover more about our auditing services, our extensive library of live, pre-existing audit reports, or the way we work, get in touch with our experts