In time, audits can be considered one of the strongest tools to diagnose and improve the health of an organization.
Accepting audits as important learning tools (rather than pain points) will change an organization’s overall attitude toward the process and help to better clarify their significance. To begin gaining a more positive perspective on audits, let’s examine three crucial benefits:
1. Staying Compliant with Regulations
Many of the ISO regulations—including ISO 13485—have guidelines in place to carry out and document many processes. Requirements for facets like document control, corrective action, and validation and traceability of processes are outlined in detail. Audits are important for ensuring companies adhere exactly to those guidelines.
There are even requirements outlining how an audit ought to be conducted. Those will be explored in depth later, but it serves as an additional reminder that audits are extremely important to maintaining an organization’s standards.
Audits also help to maintain these standards over time. If a company isn’t checking up on its processes on a regular basis, small issues may snowball into critical issues over time. Products will suffer as processes slip away from compliance. In an industry where patients’ health and wellness depends on products functioning properly, an organization cannot afford any weak areas that could lead to nonconformities or lower quality products.
2. Keeping Suppliers up to Company Standards
Audits don’t just benefit internal processes; they improve supplier relationships as well. They can be used as diagnostic tools to determine the supply chain’s health. This is important because a weakness in the supply chain can cause nonconformances, or even a halt in production.
Audits put positive pressure on suppliers to make sure their processes are in order as well. This is productive on two levels: it helps them comply with regulations for the manufacturing of their products and services, and suppliers are held accountable to a company’s specific standards based on audit requirements.
Suppliers can then be trusted to deliver products that are up to specification every time, keeping the supply chain strong. Audits can then serve as the bridge between pieces of an organization’s supply chain, promoting quality control at all stages.
3. Managing Risk
Many new standards have shifted toward risk-based thinking, where quality processes are aimed at reducing risk. Audits can also become a tool to identify, mitigate, and ultimately reduce risk.
Identify: Audits expose gaps in processes and functions that might otherwise go unnoticed until it is too late. Using audits as a diagnostic tool helps to uncover these risks and implement preventive controls before any issues arise.
Mitigate: When audit findings reveal issues, the next move can be prioritized using risk. Events that present greater risks should be dealt with first via corrective action, while those with less potential impact can be tackled after critical issues.
Reduce: Regular audits can reduce an organization’s risk at a high level. When controlling the potential issues in an organization, high-risk events are often eliminated before they happen, and low risk events are mitigated before they escalate. Follow-up audits can also verify the effectiveness of corrective actions. If successful, a previous issue should not appear in the next set of findings—reducing risk overall.
Strategies for Effective and Efficient Audits
Once the important role of audits in an organization is understood, companies can start building a process to quickly and efficiently carry them out. This may seem like an overwhelming task, but merely requires five simple steps:
1. Adopt a Strategy
Since audits involve a wide variety of an organization’s processes, looking to high-level standards for a strategy that encompasses all operations is a good initial step. Companies can look to standards like ISO to build an audit meeting their requirements. Also, basing the remainder of operations on those standards increases the likelihood of total compliance, since specific standards are already being followed.
This becomes even more helpful when multiple certifications and validations are required. An automated quality management system (QMS) eliminates any duplicate work within a strategy. That way, everything is pulled from the same system, which is already certified under a family of standards.
Whether using an external audit company or conducting audits internally—either scheduled or unplanned—organizations must be prepared. The easiest way to prepare for an audit is to utilize an automated QMS to handle many of the preparation tasks, including:
Schedule: Easily coordinate with internal and external parties via the software. This keeps the lines of communication open and automated.
Organize: Keep all checklists and supplementary documents in one central location. This saves time when conducting the audit and prevents forgetting important steps.
Review: Looking back at previous audit history can help to plan for the next one. Looking at strengths and weaknesses from past audit results provides focus areas to watch out for.
To take preparation one step further, try conducting a dry run of the audit. If an organization knows its audit is coming from an external party, it can take the time to conduct an audit internally first—leaving ample time to correct any uncovered issues.
3. Ask Questions
Audits are learning opportunities; be sure to ask the right questions to get the most out of them. Some important questions to ask are:
“How can I prioritize the launching of corrective actions as a result of the audit?” Although this may vary from business to business, a risk tool like a risk matrix is an effective way to sort events by their potential impact.
“How can I fix these issues?” Sometimes, audit findings have quick fixes. Other times, a full investigation including a root cause analysis must be launched.
“Is this accurately documented?” Many standards require specific documentation—plus, it’s important for process improvement that all documents are accurate and centrally located.
“What’s next? Are there any areas where further training is necessary? Are there additional documents needed to explain or record an event? Are there any process gaps that need to be filled?” Thinking ahead to the next step allows quick resolution of an issue, while working toward preventing similar issues.
Asking these questions (and any pertinent additional ones) gives a more complete overview of an organization’s audit. It’s more prudent to ask the team a lot of proactive questions, rather than being unprepared and dealing with the consequences after the fact.
4. Pay Attention to the Details
When carrying out audits and gathering the results, it really is all about the details. So how do organizations ensure that none of these small, but critical, pieces of information fall through the cracks?
Utilizing technology enables capture of all information quickly and with little effort. Sometimes, a photo more adequately provides detail—with less room for confusion or error than a lengthy text or email. A technology-based audit system permits attachment of photos and other documents to replace lengthy write-ups.
Technology-based solutions can also capture information in the moment with mobile audit capabilities. Capturing data as it happens ensures accuracy and lets companies sync and compare audit findings from multiple audits or sites. Additionally, the way information can be captured is quicker and more efficient—firms can take photographs, attach documents, flag items as important, and analyze risk from anywhere.
5. Follow Through and Follow Up
Audits don’t mean very much unless the results drive improvement and increase quality. Following through on the results is arguably the most important step in conducting an audit.
Automating audit follow-up processes is much more efficient than taking time and risking potential errors associated with entering the findings manually into spreadsheets and Word documents. An organization can instead easily sync the results of its mobile audits to its QMS, simplifying the integration process.
Once all of the information is gathered, the corrective action process can begin and weaknesses exposed by the audits can be improved. Don’t forget to revisit these issues often in order to check the effectiveness of the corrective action and any implemented preventive controls.
The audit can then be finalized by exporting it as a PDF, in order to share and save the process and findings. Now the entire team can be informed quickly, without taking any unnecessary time.
Organizations should embrace audits, not fear them. Taking the time to truly understand the importance of audits is a good initial step to accept them as a helpful tool.
Then, organizations can either build a process if they don’t have one, or fine-tune the current process to make audits a more efficient and effective means of identifying and correcting systemic issues. Regularly updating the audit process and conducting audits keeps organizations in compliance with regulatory bodies and ensures the safety of products.
Alexa Sussman is a marketing content writer for EtQ. She is responsible for developing and writing content for EtQ, a leading enterprise quality and compliance management software vendor, as well as traqpath, EtQ’s compliance and event-tracking solution.