Quality Audit
Quality Audit
Quality Audit
Internal Quality Audit
What Is an Internal Quality Audit Procedure?
An internal quality audit process assesses the quality management systems (QMS) of your organization. These audits ensure the compliance of businesses with established standards, like ISO 9001. It’s all about identifying conformance gaps to the standard and areas for improvement within the organization.
The primary purpose of these audits is to:
- Evaluate how well your QMS is set up and performing.
- Identify areas for improvement classified into five distinct categories.
- Ensure compliance with internal policies and external regulations.
Quality audits focus on finding out any potential gaps, inefficiencies, and risks in your processes. Auditors assess procedures, data records, workflows, and audit results to make sure that all your operations are running smoothly and efficiently. Any gaps and areas of improvement are classified into one of the following four different categories:
- Nonconformities (Nc’s): These are deviations from established standards, procedures, or regulations that require corrective action depending on their severity. Nonconformities can be:
- Major-non conformities: Require immediate action as they can result in business disruption or stoppage due to not being able to meet specific standards or regulations.
- Minor nonconformities: These are minor issues that don’t immediately affect compliance with standards but should be addressed asap.
- Opportunities for Improvement: These are observations and suggestions by the auditors for improvement to current systems and processes to improve them or further comply with standards and best practice
- Recommendations: These are recommendations made by the auditors to improve compliance with quality standards or address any gaps or weaknesses in the system.
Observations: refers to notes made by the auditors regarding areas that may need further monitoring or investigation to prevent issues in the future.
The Role of Internal Quality Audits in Ensuring Quality Standards
While external audits are becoming the norm for many different businesses, companies are getting more focused on identifying vulnerabilities, understanding their compliance, and identifying any risks to business continuity as well as compliance with regulations. That’s where internal audits step in to ensure the business is on the right track.
Internal audits help organizations to meet and maintain essential quality standards, like ISO 9001. These audits help businesses to make their quality management system (QMS) more effective, compliant, and continuously improving processes and thus output quality.
By regularly conducting internal audits, businesses can:
- Stay compliant with industry standards, regulations, and internal policies.
- Improve efficiency by identifying unnecessary steps, bottlenecks, or delays in processes.
- Reduce risk by catching issues early before they escalate and affect business.
- Enhance customer satisfaction by ensuring products or services consistently meet quality standards.
Why Do Internal Audits Matter?
- Companies with regular internal quality audits experience:
- A 25% higher likelihood of successful ISO 9001 certification success (ISO 9001 CONSULTANTS)
- Reduced costs associated with non-compliance, re-work of documentation, and re-audits.
- Up to 15% operational efficiency improvement, especially in manufacturing(GoAudits)
Difference Between Internal and External Audits
Before moving ahead, it’s better to understand the difference between internal and external quality audits.
Generally speaking, internal audits are carried out internally by the organization itself, generally by a Quality assurance department that understands the audit process for an ISO standard that is trying to be obtained. The audit typically covers the topics previously discussed. In contrast, external audits are independent audits conducted by a third-party audit firm that has both an understanding of the ISO standards and has been certified by an external body to conduct audits and provide certification to other organizations that meet the criteria for certification of a certain ISO standard.
Typical Quality Audit schedule
Below is an example of a typical internal quality audit schedule for a manufacturing business; it covers the areas that will be audited and the flow of the internal audit, which resembles an external audit.
Comprehensive Facility Assessment Plan
1. Audit Planning
Audit planning is essential for the success of any internal audit. It involves:
- Defining your scope of the operation and departments being audited and audit objectives.
- Selecting the audit stakeholders, both internal and external, including the PIC of each department being audited and who will be in charge of document control.
- Ensure all documentation, evidence, records, procedures, and policies are available for the audit.
- Setting a schedule for when the audit will take place.
Precise planning ensures the audit is focused and aligned with your company’s overall objectives.
2. Conducting the Internal Audit
When conducting an internal audit, the goal is to gather information on process performance, records and compliance to a certain ISO standard, mainly ISO 9001 for quality and ISO 22000 for food safety. This step includes:
- Reviewing processes, operating procedures, and document records to ensure they align with established standards.
- Engaging with staff to gather feedback and identify gaps and inefficiencies.
- Observing workflows to detect bottlenecks or non-value-adding activities.
This step helps to collect concrete data and ensures the effectiveness of the audit quality.
3. Audit Reporting
Once the audit is complete, it’s time to summarize the results. The audit report should:
- Identify strengths and areas of improvement in the quality management system and any other relevant department.
- Offer actionable recommendations for corrective actions classified in one of the four categories of NCs, opportunities for improvement, suggestions, and observations.
- Use clear visuals, such as charts or graphs, to present data and make findings easy to understand on the issue and what needs to be done.
The goal of audit reporting is to present findings that are easy to understand and act upon.
4. Follow-up and Continuous Improvement
After the audit, follow-up is essential to ensure that corrective actions are implemented and improvements are tracked. This involves:
- Monitoring the effectiveness of corrective actions and closing the gaps.
- Tracking progress with key performance indicators (KPIs).
- Continuously refining processes based on audit feedback.
This ensures that the improvements made during the audit are sustainable over time.
Key Benefits of Internal Quality Audits
Regular internal quality audits enable you to stay proactive about quality rather than reactive, helping you achieve long-term operational success.
Here’s how:
1. Identify Inefficiencies and Waste
Lean manufacturing is all about reducing waste. Internal audits help identify inefficiencies where resources like time and materials are being wasted. Use audits to streamline processes, improve resource allocation, and cut waste.
2. Improve Quality and Compliance
Regular internal audits ensure that quality standards are consistently met and processes comply with ISO 9001 and other regulations to improve product performance and customer service. This compliance helps to spot non-conformance issues early while providing high-quality products.
3. Promote Employee Engagement and Upskilling
Internal audits often highlight areas where employees can improve their skills. Auditors engage employees in the audit process and use these insights to foster a culture of learning and continuous improvement.
4. Prepare for External Audits
Internal audits help you get ready for external audits for ISO 9001 from certifying bodies like TUV SUD, Bureau Veritas, SGS, Lloyds Register group, Intertek, etc. This proactive approach reduces stress and helps organizations in addressing issues firsthand before the external audit.
5. Drive Continuous Improvement
Continuous improvement (Kaizen) is the core of internal quality audits. During an internal quality audit, auditors monitor key performance indicators (KPIs), like performance metrics and quality metrics. The findings help them to address recurring issues and improve processes.
How to Optimize Your Internal Audit Process
A streamlined internal audit means a more efficient path to compliance and continuous improvement.
Follow these key steps to make your internal audits more effective:
1. Appoint the Right Auditors
Auditors must be trustworthy, knowledgeable, and have strong interpersonal skills. It’s best to make sure your auditors are trained in ISO 9001 and ISO 19011. It ensures a successful quality audit.
Tip: A well-trained audit team helps reduce compliance risks and boosts operational efficiency.
2. Use Effective Tools
Use practical documentation tools that cover all ISO 9001 requirements. The right tools make evaluations simpler and more consistent.
Pro Tip: Regular use of checklists and forms minimizes the risk of missing important areas. Employ a document control clerk to ensure all records are kept well and filed appropriately.
3. Standardize the Audit Process
Create a standardized process for your audits to make them a core part of your regular evaluation system.
Key Questions to Ask During Reviews:
- Can employees describe what they do?
- Do employees follow the described procedures?
- Are employees effective in their tasks?
By addressing such questions, you can align your audits with ISO 9001 standards.
4. Engage Stakeholders with Closing Meetings
Hold a closing meeting right after the audit to discuss findings with all stakeholders. Clearly state all your findings. Highlight both strengths and areas for improvement to achieve collaboration and accountability.
Why It Matters: Involving stakeholders promotes transparency and motivates everyone to take responsibility for reaching quality goals.
5. Gather Feedback for Future Improvement
After each audit, ask for feedback from those involved. This input can help you refine your audit process and identify areas for improvement.
Tip: Use suggestions to make future audits more effective and fairer.
Conclusion
Internal quality audits are essential for the effectiveness of quality and operational efficiency. By using audits to identify waste, improve compliance, and engage employees, you can measure the effectiveness of quality practices, ensuring customers are receiving quality products time and time again, complaints are dealt with professionally in a timely manner, and the organization is driving continuous improvement to improve quality further.
Some of these tools and concepts are listed below:
The items above cover a wide range of areas but are a basic mix of areas and activities within most businesses which should be covered by most quality management systems. The inclusion of the items above and the level of attention given to these during a quality audit will vary because of two things; the size and complexity of the business and the particular standard to which the business is certified to be compliant with or trying to comply with. Some businesses which comply with iso9000 (the most comprehensive standard) may audit a much larger set of activities and areas of the business than the ones stated above.