How to Do a Quality Audit: Practical Steps to Follow
Quality audits are crucial for organizations to keep away inconsistencies in their operations and grow steadily. While many have achieved certifications like ISO 9001 to ensure establishment of the most effective Quality Management System (QMS), audits are always a necessary process that have to be conducted at periodic intervals. They are focused on both their products and operations. Therefore, they help in identifying whether the implemented quality management strategies or QMS is actually driving results. However, the big question still for many organizations is how to do a quality audit? Well, that is the topic of today’s web blog. Here we have provided brief explanation of an audit process followed by the steps to conduct an audit. Have a read.
What is a Quality Audit?
A quality audit is a systematic process involving the evaluation of business operations by some dedicated officials (who have assessment skills) and obtaining insights or data from the evaluation. The findings from the evaluation are then used to know the extent to which the QMS or quality control strategies are effective in improving their operations.
Audits are essential to identify the major deviations in your processes from the determined paths and examine the root causes behind them. It is henceforth useful for determining the corrective measures required to eliminate the deviations and achieve the desired results.
The key purposes to conduct an audit inlude:
• Ensuring compliance with quality management standard like ISO 9001
• Ensuring compliance with the organization’s goals and strategies
• Ensuring the effective implementation of QMS or other quality management framework organization-wide
• Ensuring compliance with other regulatory or statutory requirements
The key reasons to do an audit include:
• Looking for opportunities in various areas/business processes to improve
• Looking for best practices that could be used in some processes for further efficiency
• Looking for preventive actions/corrective actions in the areas where faults or weaknesses are identified
• Looking for some improvements that will focus on raising the customer satisfaction
Here we explain the steps involved in the audit process.
Step-by-Step Explanation of How to Do a Quality Audit
These are the four practical steps that are involved in a quality audit, and you should follow them methodically to make your audit successful and constructive.
Planning and Scheduling
Success and smooth execution of the audit process depend on how well planning of the process is done. Planning starts with scheduling dates of the audit, i.e., deciding the start date and how long it will take. Next, you should decide who is going to lead the audit process as well as other members to participate in it. The plan should hence define the following:
• Line of assessment activities in a feasible timeline
• Details of the assessment procedures and tools
• Success parameters that are to be used as benchmarks and deviations from them will be measured
• Departments, processes, services and products that are to be audited
• Employees who are to be interviewed during the audit process
At this stage of planning, the lead auditor should also determine the necessary documentation such as quality objectives and quality policies that are also to be examined.
This is the phase when the lead auditor along with the other participants need to study your company’s QMS and its related frameworks. They should take a closer look at the documented procedures of the QMS and decide how to assess them. At this time, they mostly prepare a checklist or a verification list. That will be then used as a guide during the actual audit so that none of the aspects are missed. The checklist should also include the key observations or outcomes to be looked for in the audit so that auditors do not fail to include anything in the audit report. In short, the checklist should be used as a mandatory guide to successfully execute the quality audit.
As the scheduled date arrives, you can commence the audit process. The auditors will collect as much information as possible from the processes, departments, or products examined. The collected information is the key to successful auditing as they determine if your departments, processes, or products are in line with the established quality standards or regulations.
At this stage, the auditors are going to interview employees who are closely related to the quality management processes. They ask them questions, enquire about their roles and note the important points. Depending on their findings or the interview answers, the audit scope and checklist may be expanded leading to further evaluation and delay in the completion of audit.
At the end of the audit, the auditors prepare a report of their findings with maximum emphasis placed on the non-conformities identified. They are the situations where any process or aspect of your product does not adhere to the standardized process or product aspect.
Follow-Up and Decision-Making
Once the quality audit is completed, it is time to take real action. This implies meetings and discussions between the auditors with your company’s top management leaders. Together they review the key problem areas and nonconformities in your QMS or processes mentioned in the audit report.
The leaders also critically analyze the audit observations to determine whether any improvements are required in any process or department. The auditors in the meetings provide recommendations to correct the issues and then your leaders need to take the final call.
The quality audit process can seem complex, but it is actually not if the planning and preparation go well. These four simplified steps explain how to do a quality audit flawlessly and derive positive results from it. However, there are certain principles of audits that apply to any organization, regardless of the management system/processes that are to be audited. They are ethical conduct, objectivity and impartiality, cooperation, fair presentation, and professional touch. To ensure your quality audit is conducted by following all these principles, you can hire our expert auditors at Compliancehelp Consulting LLC.
We are a team of professional ISO consultants assisting and guiding organizations in different fields to achieve compliance with various certification standards with services like gap analysis, internal audits, and certification readiness assessments.