November 28, 2016
Audits – a quality control tool that can’t be absent in a product development program
Nowadays, it becomes more and more important to control the various stages and (outsourced) processes in the development of a medical device. It is therefore not surprising that the revised ISO 13485:2016 is more stringent when it comes to (outsourcing) processes. Here, we take a closer look at some important quality control tools for internal and outsourced processes: audits and inspections.
Is there a reason to be become nervous for an audit or inspection? The answer is no, as long as you are “inspection-ready” at any time
Let us start with clarifying a common misunderstanding that the terms audits and inspections are interchangeable. Although inspections and audits share their commitment to quality by assuring compliance to laws and regulations and by protecting the rights, safety and welfare of patients, there is a clear difference. Basically an audit is a quality tool to test one’s own quality process and an inspection is a ‘check’ by a third party (usually authorities) of the output of one’s quality system.
On the one hand, the audit is defined by ISO 14155:2011 as a ‘systematic independent examination of activities and documents related to clinical investigation to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP [Clinical Investigation Plan], standard operating procedures, this International Standard and applicable regulatory requirements’. It is, as such, a method to ensure the quality of all processes. After all, as defined by ISO 9001:2015 the Sponsor of a clinical investigation is responsible for implementing a quality system, including the development of an audit program. The Sponsor can decide to audit their internal procedures, as well as processes outsourced to critical suppliers e.g. the expert CRO they are working with or laboratory facilities. Further, they can audit investigational sites participating in their clinical studies. Additionally, a Sponsor may be audited by a third party, e.g. Notified Body. The European Commission Recommendation (2013/473/EU) outlines the importance of verifying the continuous day-to-day compliance with legal obligations. Therefore, the European Commission expects Notified Bodies, in addition to surveillance audits for product assessments and quality system assessments, to perform unannounced audits.
On the other hand, there are regulatory inspections. Inspections are performed by regulatory authorities such as the MHRA, IGZ or FDA. The major objective of regulatory inspection programs is protecting the public against risks to their health, safety, and welfare by ensuring the safety and quality of Medical Devices. The regulatory authorities are not limited to the Sponsor’s own facilities when performing their inspections. They often include participating investigational sites, laboratory units, or other critical suppliers as part of the inspection. Routine inspections will typically be announced, but organizations or investigational sites with a history of violations will not be granted this luxury, and the inspector may show up unannounced. Also, compliance follow-up inspections, to review actions taken by a manufacturer in response to a previous inspection, are usually not announced.
Is there a reason to become nervous for an audit or inspection? The answer is no, as long as you are “inspection-ready” at any time. Ensure that you have carefully developed a quality system and have implemented adequate quality control tools, such as the earlier mentioned audit program to control the internal and outsourced processes, including reporting of results of audits and subsequent necessary corrective and preventive actions.
Not only the manufacturer’s facilities should be inspection-ready at any time, also the investigational clinical sites participating in your clinical studies should be. The quality of investigational sites has a significant contribution to the quality of a clinical study. So, it is not surprising that within clinical studies typically the high-risk investigational sites will be selected to perform audits. High-risk investigational sites, i.e. those sites with a high probability of noncompliance, may therefore induce a risk for compromising the quality of a study. Early-stage diagnosis, a systematic and independent examination, followed by re-alignment can literally mean the difference between success and failure of the investigational device study. So make sure that your audit program defines the requirement to perform investigational site audits to monitor and control the site’s performance and to prepare them for external audits and inspections. As leading medical device clinical research organization in Europe, Factory-CRO is experienced in performing site audits and to prepare your investigational sites for audits and inspections. In line with this, Factory-CRO also developed the “International Clinical Trial Rescue” Program for Medical Devices, that may be interesting for your study. This early-detection program is designed to help medical device companies to test their own efforts, effectively saving the study from ultimately being rejected by European regulators or the FDA.
by Rolinde Menzo