An audit is a broad term that describes any number of investigation activities based on the particular purpose of the audit. In order for a quality system to continue operating optimally, it must be regularly audited to identify potential flaws. Audits may be used in a variety of situations and be performed by both internal and external entities. An audit’s objectives may be aimed at continuous improvement or remediation of problems or simply an informational inquiry, into a supplier’s sourcing practices, for example. Distinct from a regulatory inspection, an audit is not necessarily performed to ensure compliance, but is used to honestly determine how things stand and identify patterns over time. This information is necessary to make evidence-based decisions that directly impact quality operations. Below are several tips and tools that can help you complete quality compliance audits effectively.
Traditionally, auditors and auditees have maintained a somewhat adversarial relationship. However, as the rate of change in regulations, technologies, and markets is ever increasing, this perception is also shifting. An auditor can become a critical ally and not just a critic. Auditors may be chosen from within an organization or be an independent third-party. The auditor is tasked to make pointed observations and analyze them for patterns — also called findings — in order to draw conclusions. The auditor can then present a report to all parties involved. An auditor that utilizes digital quality audit tools, including digital reporting, is a valuable partner that can help pharmaceutical companies achieve their performance goals and fulfill compliance requirements.
An effective audit observes and measures any product, service, process, or system (related processes with a common goal) against a standard or requirement. The International Organization for Standardization (ISO) has established itself as the global standards authority with a prevalence of more than 24,000 standards currently documented, published, and distributed throughout the world.1
Internal quality audits play a prominent role in each of the most popular ISO standards, such as ISO 9001:2015, ISO 13485:2016, and ISO 140091:2015. Fortunately, this makes it possible to find quality audit management software that is designed to take compliance to these and other similar standards into account.
It’s nonsensical to say you can see into your quality processes and products without actually taking the time to look. Audits are necessary to this end. However, this doesn’t mean they are easy. Establishing a regular schedule and outlining auditing procedures can go a long way to streamline the process. Using automated compliance audit software you can easily follow pre-determined steps and schedules that you have outlined and ensure that you don’t miss any of them. Automation is the natural response to the demands of a quality management system (QMS) and to the limitations of maintaining one manually. It becomes much more feasible to regularly perform audits and continuously monitor your system using a purpose-built software solution.
Your quality system is only as good as the records you keep. In order to effectively utilize audit findings, it is important to keep an accurate record of them. Auditors can compare findings over time to discover patterns. The most accurate and thorough way to record audit findings is at the time of the audit. This can be done effectively using quality audit management software. Auditors can easily complete the audit by following standardized forms that outline the procedures and provide a way to electronically record their findings. As soon as the audit is complete, any data that is recorded can be used for analysis and decision-making.
Coordinating multiple audits, tracking remediation efforts, and trying to find anything about the audit after the fact are some of the challenges of auditing that necessitate using quality audit tools. Companies that continue to rely on a paper-based quality audit system are lacking essential tools that are readily available in automated quality audit systems. They struggle to complete their auditing responsibilities and often make the following mistakes and oversights:
Companies that use a digital QMS, on the other hand, can instantaneously pull electronic records, in addition to a quality manual and other relevant documents, as part of an audit or afterward. Each record includes an audit trail maintained within the system that establishes the identity of all users who enter or confirm critical data. If companies are using an integrated platform, they can connect audit findings with standard operating procedures (SOPs), corrective actions/preventive actions (CAPAs), and training records. This gives them real-time visibility into their system and a real way to adhere to their own quality processes and improve their QMS as needed.
Perhaps the most useful quality auditing tool that quality professionals can use nowadays is a cloud-based software-as-a-service (SaaS) audit management solution. Remote audits are becoming increasingly common in order to fit with remote and hybrid work models that characterize current quality environments. The U.S. Food and Drug Administration (FDA) is also having to come around to this approach and allow remote compliance audits under certain circumstances.
The necessities and benefits of quality audits include making sure you’re doing things in the best way possible and establishing credibility in the marketplace. For example, completing an audit and being able to able to qualify for an ISO certification makes it easier to navigate international trade requirements. Further, audits can form the basis of successful compliance inspections and give you confidence in your quality processes and products. Investing in digital, and better yet, cloud-based quality audit tools allows quality leaders to meet the standards necessary to compete in a technologically advanced market. To find out more about how MasterControl’s quality auditing tool fulfills ISO requirements, read our “Quality Audit - A Tool for Continuous Improvement and Compliance” white paper.
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