Risk based internal audit- an effective approach

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

Shabbir Dhamani

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Internal audit- An integral part of a Quality Management helps define the effectiveness of a Quality & Food Safety (Q&FS) system. In the world of changing regulatory environment when more and more standards need to be complied with and more focus is on Q&FS without any increase in resources and time. It is critical to apply a risk based approach to prioritize the processes or standards according to risk involved from food safety and/or quality perspective. These audits can be done at different levels of the business depending on where the risk lies, it can be conducted against the internal or external standards and also it can be targeted to process audits based on the internal procedures of the company depending on risk. The audits can also be targeted to dig deep into any particular trend of issues to identify improvement opportunities which is ideally conducted by the subject matter experts of the issue and in some instances a completely independent auditor can look at the system from a new set of eyes to evaluate its effectiveness. The internal auditor play a critical role to conduct this activity therefore selection of auditors, training and competency of auditors and conducting the audits with experienced auditors will provide a good platform to evaluate the system effectively to drive continuous improvement as the internal auditors are expected to know the system better and at the same time the auditors are required to update themselves to the regulatory environment. The approach of the internal auditors must be such that they look at obtaining evidence and evaluating it objectively to determine the extent to which an audit criterion is fulfilled to drive systemic improvement rather than targeting any personal issues or literal compliance issues as systemic issue can also address personal issues as well as compliance by helping the audit identify the adequate correction and/or corrective actions. The effectiveness of the internal audit system can be demonstrated when the internal audits helps identify maximum improvement opportunities to prepare a company for its external audits and there are no surprises in that audit which were not identified in the internal audits. Therefore, an effective internal audit system, not only drive continuous improvement of its Q&FS system but can also be beneficial towards cost saving for the company and also help building trust in customers mind that will help towards the growth of the company. Once the systems in place it can help demonstrate Henry Ford?s words, ?Quality means doing the right thing when no one else is looking? is followed and Q&FS will become a habit.