Culture of Better Quality: The Role of Robust Internal Audits

One of our customers is a leading manufacturer of specialty chemicals. To produce these chemicals, the company uses vegetable oils - among other raw materials. The company's customers operated in a wide range of industries including home and personal care, pharma, nutrition, and agricultural products. The company is also growing at a rapid pace, with a combination of organic growth and scale-up through acquisitions.

One of the key goals of the company was to improve quality performance and inculcate a culture of quality across the organization - across locations. After evaluating several QMS solutions in the market, the company chooses ComplianceQuest for the following reasons:

• The company needed a next-gen document control system in addition to other QMS functionalities including audit management, CAPA handling, and nonconformance management.
• It wanted a better way to handle internal audits, to drive continuous improvement of QMS process and workflows
• It needed a robust cloud-based solution that was easy to scale as new customers, factories, or acquired companies got integrated with the company
• Seamless compliance with ISO and 21CFR Part11 requirements

It also helped that CQ's audit management module integrated seamlessly with the document, training, change, nonconformance, supplier, CAPA, and incident management modules.

The Need for Stringent Internal Audits

Despite the best intentions, rules, and procedures - the chance of failures, nonconformances, and slip-ups is high. Also, in a constantly evolving business environment, as the industrial processes and technologies change, new risks and opportunities arise, pushing the organizations operating in those industries to come up to speed. This can lead to gaps in processes that may go unnoticed till it is too late. As businesses grow, in the rush to expand and scale up, there could be new challenges that need to be addressed to ensure the quality and safety of operations.

Audits perform the function of helping businesses evaluate and assess the effectiveness of the controls they have in place. Internal audits ensure that the risk management, governance, and internal control processes continue to be relevant and effective. Moreover, internal audits also alert the top leaders about any noncompliance, irregularities, and breach of contracts and agreements. This can help take corrective action in a timely manner before external audits or the product is dispatched to the client/marketplace. Any lapses can be identified and rectified and risk management improved.

Making Internal Audits Effective: 5 Key Steps

Internal audits are a very critical part of quality assurance as they enable identifying risks, challenges, and opportunities. Therefore, quality leaders and management must ensure that the audits are conducted periodically and diligently, the findings are reviewed and follow-up action is taken.

To ensure the effectiveness of the internal audits, the company must follow a five-step process.

Step 1 - Planning: Internal audits require detailed planning covering factors such as:

• When it should be conducted
• What should be the scope
• How it will be conducted
• Where or which part of the company will be audited.

This will help the auditors to prepare appropriately, allocate the necessary time, and ensure that the audit is comprehensive and fruitful. For areas with problems and high risks, audits must be performed more frequently.

Step 2 - Preparation: Once the plan has been finalized, the audit team must prepare by understanding the scope of operations that is being audited so that they will know what to observe, what questions to ask, what to expect, and so on. They must also review earlier reports of internal audits to get insights as well as to identify areas that need to be checked thoroughly due to repetitive issues, if any. At this stage, preparing checklists would be a good idea as it will ensure nothing gets missed during the audit.

Step 3 - Conducting the Audit: The audit can be conducted once the preparations have been made. Alerting the relevant team of the impending audit is a good idea so that they can prepare for it too and have the right point of contact ready to interact with the audit team. The audit team will inspect the site to ensure:

• It conforms to the relevant standards or requirements as needed
• Collect evidence and information from different sources, such as documentation, forms, and employee interviews.
• Examination and evaluation of the site
• Record findings

Step 4 - Audit Findings and Collaboration: The findings of the internal audit must be shared as a report, highlighting the issues discovered, the key areas needing improvement, and recommendations. This must be reviewed by the team leaders, quality leaders, and top management for follow-up action.

Step 5 - Act: Based on the recommendations, the leaders must prioritize areas for rectification, assign roles and responsibilities, ensure action is taken, measure impact, and continuously improve.

Audit frequency should also be influenced by the results of previous audits and any changes which you are aware of may affect the process. So, if you have a problematic process or area, it makes sense to audit it more frequently for a while until a solution is implemented and has been seen to be effective.

Advantages of ComplianceQuest Audit Management Software

Audits may not happen as frequently as required due to the need for businesses to meet their production deadlines. The benefits of audits are also not evident since there are no direct cost benefits.

However, a well-conducted audit will help businesses save on costs by identifying risks before they become issues and ensuring quality to boost brand reputation. As it involves observation of the shopfloor as well as interviews with workers, it will help engage the people on the ground for gathering insights on issues and how to improve them for a more effective solution. This will increase employee participation in quality management and create a culture of quality.

The ComplianceQuest Audit Management Software ensures the proper scheduling, conducting, reporting, and follow-up of audits to increase their effectiveness, the organization’s compliance, and employee engagement. It helps with

• Planning, scheduling, conducting, and reporting audits
• Setting up policies based on audit findings
• Conduct risk assessment
• Escalate to CAPA as needed
• Improve supplier quality
• Document audit finding responses
• Solicit feedback from the supply chain without giving up ownership of tasks
• Access audit reports from anywhere, anytime
• Access reports and dashboards for data-driven decision making

To know more about how the CQ Audit Management Software can improve the quality of your organization,

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