Holding an AS9100 certification is a major achievement for any company in the aerospace industry. However, meeting the stringent requirements of this standard can present unique challenges. As businesses grow, maintaining compliance and preparing for audits often feels like solving a mystery.
The pressure to stay on top of documentation, risk management, and continual improvement is immense. Yet, the benefits of AS9100 certification far outweigh the challenges.
In this blog, we will explore the common questions faced by AS9100 certification holders. We’ll focus on three key challenges: preparing an audit checklist, tips to stay compliant with regulations, and how to manage audit findings.
By discussing these areas, we aim to provide practical insights to help you make your next audit smoother. Let’s start by understanding the basics of the AS9100 standard.
What Do You Need to Know about the AS9100 Standard?
AS9100 is a critical standard for quality management systems in the aerospace industry. Developed by the International Aerospace Quality Group (IAQG), AS9100 was first released in October 1999. It replaced the earlier AS9000 standard to create a unified quality standard for the aerospace industry. The most recent revision, AS9100 (or AS9100D), was published in 2016.
This version includes updates aligned with ISO 9001:2015 and introduces new requirements focused on risk management and product safety. AS9100 adds over 100 specific requirements to those found in ISO 9001. Being AS9100 certified can significantly enhance a company's marketability. Certified organizations are listed in the Online Aerospace Supplier Information System (OASIS), which is used by companies to find reliable suppliers.
In a nutshell, this certification improves your business’s market value. That’s why preparing an AS9100 audit checklist is crucial. Let’s figure out what values it adds to your business.
How Does an AS9100 Audit Checklist Help Your Business?
An AS9100 audit checklist is an essential tool that helps your business stay on track with the certification requirements. In the US only, 9044 AS9100 certifications were issued by May 2023. This tells you the recent trend of this certification in the aerospace manufacturing industry.
However, following this trend or getting this certification is not easy. An internal audit may help. To prepare for an internal audit, you should follow a checklist. We are listing the benefits down:
- Helps identify gaps in processes before audits.
- Improves internal audit efficiency and effectiveness.
- Reduces the risk of non-compliance and penalties.
- Provides clear guidelines for consistent performance.
Having a reliable audit checklist is only part of the equation. To truly succeed, it's crucial to understand the core components of the AS9100 standard. In the next section, we'll explore these key elements and how they directly shape your business operations.
Key Components of AS9100 Internal Audit
An AS9100 internal audit focuses on a set of core components that ensure compliance with industry standards while fostering continual improvement. Each component plays a vital role in maintaining a quality management system (QMS). Let’s break down the key areas that internal auditors evaluate:
- Context: Understanding the external and internal factors that influence your organization is crucial. This includes identifying customer needs, regulatory requirements, and market trends that impact your operations.
- Leadership: Leadership plays a central role in driving quality within the organization. Auditors assess whether leadership is fully engaged in maintaining and improving the QMS.
- Planning: Planning involves setting clear objectives and strategies for achieving compliance and continuous improvement. This component ensures that processes align with the company’s goals and the AS9100 standard.
- Support: Auditors check if the organization provides adequate resources, training, and infrastructure to support the QMS. This includes assessing employee competence and the availability of necessary tools and systems.
- Operation: This component evaluates how well operational processes are implemented and monitored. It focuses on whether processes deliver consistent quality and meet customer requirements.
- Performance Evaluation: Auditors assess how the company monitors and measures the effectiveness of its QMS. This includes reviewing key performance indicators (KPIs), audit results, and customer feedback.
- Improvement: Continuous improvement is a key aspect of AS9100. Auditors examine whether your organization is taking corrective and preventive actions to address non-conformances and improve processes.
- Risk Management: Identifying and managing risks is critical. Internal audits assess whether the company has effective risk management strategies in place to minimize potential disruptions.
- Controls: Controls are necessary to confirm that processes are being followed and that the QMS is effective. Auditors review your controls and procedures to verify that they are adequate and functioning properly.
- Counterfeit Part Management: In aerospace, counterfeit parts can pose serious risks. Auditors check if your organization has the right systems to detect, prevent, and manage counterfeit parts in the supply chain.
- Product Safety Requirements: Ensuring compliance with safety regulations is essential. Auditors evaluate whether safety protocols are integrated into the QMS and whether safety requirements are consistently met in the products.
- Configuration Management: This component focuses on ensuring that product designs and configurations are properly documented and controlled. Auditors assess whether changes to designs are appropriately managed to maintain consistency and quality.
Maintaining these key components is enough for an internal audit. But how do you prepare for an audit? Let’s find out.
How Do You Prepare for an AS9100 Audit?
A structured audit program is essential to successfully navigate an AS9100 audit. The program should cover everything from defining the audit criteria to reporting results and taking corrective actions. Here are the critical steps involved:
- Audit Program: A comprehensive audit program outlines the overall approach to external audits. It specifies what areas to audit, when, and how the audits will be conducted. This program is key to making sure your AS9100 audit process is systematic and thorough.
- Audit Criteria and Scope: Clear criteria are essential to define what will be reviewed in the audit. The scope outlines the boundaries of the audit, specifying which processes, departments, or functions will be assessed.
- Select Auditors & Perform Audit: Selecting qualified auditors is critical to getting accurate audit results. These individuals should understand AS9100 standards and be capable of identifying gaps. Once auditors are selected, they conduct the audit based on the Established QMS.
- Report Audit Results: After the audit, the findings must be documented clearly. This report should highlight strengths, weaknesses, and areas for improvement in your quality management system.
- Correction and Corrective Action: When non-conformances are identified, corrective actions must be taken. These actions fix issues and prevent them from recurring in the future.
- Maintain Audit Records: Keeping thorough and accurate audit records is essential for tracking improvements and compliance. These records help you demonstrate progress during future audits and can be valuable for ongoing improvement.
However, your business will not be ready if you just follow these steps. It needs to be prepared for all the questions that could be asked in the audit. In the next section, we will explore what questions you can expect in the AS9100 audits effectively.
Key AS9100 Audit Questions: You Should Know for Your Audit
Since each auditor is different, you can expect a variety of questions while attempting an audit. The specific set of AS9100 audit questions they use will vary depending on the audit plan they’ve created for your organization. Your company will only know the exact scope and areas to be evaluated once the auditor shares their plan before the scheduled visit.
However, there are some common AS9100 audit checklist questions that will prepare your organization for the external audit. Here are some of those general questions broken down for different stakeholders within your organization.
Questions for Employers
- How do you communicate the quality policy and objectives to your staff?
- What is your process for defining roles and responsibilities within the quality management system?
- How do you assess whether the QMS aligns with company goals and customer requirements?
- How do you track the performance of suppliers and ensure they meet AS9100 standards?
- Are there procedures in place for managing non-conformances and corrective actions?
- How do you determine the training needs of your employees related to the QMS?
- How often do you review the effectiveness of the quality management system?
- What measures do you take to ensure compliance with regulatory and safety requirements?
- How do you evaluate the effectiveness of internal audits?
- What strategies do you have in place to manage risks to product quality and operational performance?
Questions for Employees
- Do you understand the company’s quality policy and your role in maintaining it?
- How do you ensure your work meets the company’s quality objectives?
- Can you identify any areas where processes could be improved?
- Are you familiar with the procedures for reporting non-conformances or issues you encounter?
- How do you access the necessary resources and training to perform your job effectively?
- Can you explain how you contribute to meeting customer requirements?
- Are you trained on safety procedures related to your job and the products you work with?
- How do you monitor and measure your own performance within the QMS?
- Are there any challenges you face in following the quality management procedures?
- How do you provide feedback on the effectiveness of current processes?
General Questions
- Are your processes regularly reviewed for compliance with AS9100 standards?
- How do you document and manage changes to product design and processes?
- How is customer feedback incorporated into your quality management system?
- Do you maintain records to verify compliance with the QMS?
- How do you measure and track product performance throughout its lifecycle?
- Are there mechanisms in place for evaluating risks related to product quality and safety?
- How do you address counterfeit parts and materials in the supply chain?
- Is your management team involved in reviewing audit results and corrective actions?
- Are you following procedures to ensure environmental and safety compliance?
- How do you handle corrective actions to prevent the recurrence of non-conformances?
These questions cover a wide range of areas and should give you a solid foundation to assess your company's AS9100 compliance. To assist your business further in this process, Contact BPR Hub, a cloud-based platform today. Let’s discuss some tips that will prepare your team for the audit.
Internal AS9100 Audit Training and Preparation Tips
Preparing for an internal AS9100 audit can feel overwhelming, but it doesn’t have to be. The audit's purpose is to evaluate the effectiveness of your quality management system (QMS) and identify areas where improvements can be made. A well-prepared team and a clear audit plan will set you up for success. In this section, we'll go over some essential tips to help you prepare for your internal audit and make the most out of the process.
1. Stay Calm and Focused
Remember, an AS9100 audit checklist is designed to assess how your organization’s processes are functioning, not to critique individuals. It's an opportunity to see what’s working well and where improvements are needed. If you approach the audit with a calm mindset, it will be easier to identify opportunities to strengthen your system.
2. Review the Audit Plan
Before the audit, you’ll receive an audit plan that outlines the scope and objectives. This is your roadmap for preparation. Make sure your team reviews the plan thoroughly. It’s important to understand what will be assessed and what documentation will be required. If anything is unclear, reach out to your auditor or certification body for clarification.
3. Don’t Be Afraid to Admit When You Don’t Know Something
During interviews or audits, it’s perfectly acceptable to admit you don’t have an answer. Don’t feel pressured to make up information. Auditors value honesty, and if you’re unsure about something, simply say you’ll follow up later with the correct information. Transparency helps build trust during the audit.
4. Take Internal Audits Seriously
An internal AS9100 audit is just as important as an external audit. It’s a chance to identify weaknesses or gaps within your QMS before the formal audit takes place. The internal audit helps prepare employees and management for what’s to come. Don’t treat it as a checklist exercise—invest time in making it a comprehensive review.
5. Address Nonconformities Proactively
Identifying nonconformities is a critical part of the AS9100 audit checklist. However, it’s not enough to just document them. You need to have a plan to fix any issues and prevent them from recurring. This is where your corrective actions come into play. The goal is continuous improvement, so be proactive about resolving any weaknesses the audit uncovers.
6. Conduct a Management Review
A management review can uncover areas for improvement that might not be immediately obvious. This review should be done well in advance of your internal audit, giving you plenty of time to resolve any issues. It’s an important step to ensure your QMS is running smoothly and that you’re meeting AS9100 standards.
7. Track Your Progress
One of the most important elements of your internal audit is showing how you’ve tracked progress against your quality objectives. Be prepared to present evidence of the progress made on your goals over time. Demonstrating this will show auditors that your QMS is not just compliant but is actively working to improve and meet objectives.
8. Pre-Audit Check
If you haven’t already, consider scheduling a pre-audit or gap analysis. While auditors can’t tell you exactly how to prepare, a pre-audit helps identify any areas of concern before the actual audit. This is a great way to get a head start on making adjustments. It will also give you a chance to meet the auditor and establish a positive relationship.
These preparation tips will ensure that your internal AS9100 audit runs smoothly and that you’re ready for the external audit when the time comes. Next, we’ll explore how to report non-conformances found in the audit.
How to Report Non-Conformances in the AS9100 Audit?
Managing audit findings effectively is crucial for maintaining compliance and improving your quality management system. But what’s more important is to report non-conformances. Here's how to approach it:
- Identify the Non-Conformance: Clearly document the issue, including the affected process and potential impact.
- Classify the Severity: Determine whether the non-conformance is major, minor, or an opportunity for improvement.
- Report to Relevant Stakeholders: Notify the appropriate team or department responsible for addressing the issue.
- Root Cause Analysis: Investigate the cause of the non-conformance to prevent recurrence.
- Implement Corrective Actions: Develop and track actions to resolve the issue and prevent future occurrences.
Using a cloud-based platform like BPR Hub, non-conformances can be logged, tracked, and managed in real-time, ensuring efficient resolution and compliance monitoring.
Let’s understand how using a cloud-based platform can enhance your audit process and improve overall efficiency.
Choose BPR Hub to Manage AS9001 Audit in Your Business
BPR Hub is a cloud-based platform designed to streamline business process management, offering real-time data access and collaboration tools. BPR Hub’s Audit Hub is an in-house platform that simplifies the audit process, providing a centralized space to manage audit findings. It can also track corrective actions and monitor compliance.
By automating workflows and offering intuitive reporting tools, BPR Hub ensures that audit processes are efficient, transparent, and easy to manage. This platform empowers organizations to stay compliant and continuously improve their quality management systems.
So, don’t wait until next year to improve your business quality with BPR Hub's assistance. Claim a 100% Free Demo to Get Started Today!
Frequently Asked Questions
1. What is the difference between an internal and external AS9100 audit?
Internal audits are conducted by your team to evaluate the effectiveness of your QMS, while external audits are performed by a certification body to determine compliance with AS9100 standards.
2. How often should an AS9100 audit be conducted?
AS9100 audits should typically be conducted annually, with internal audits taking place throughout the year to maintain continuous improvement.
3. What is the role of top management during an AS9100 audit?
Top management must ensure that the QMS is aligned with organizational goals and actively participate in the audit process, especially during the management review.
4. Can an AS9100 audit be conducted remotely?
Yes, many auditors now offer remote audits using digital tools and platforms, especially for document review and interviews, though on-site audits may still be required for certain assessments.
5. What should employees focus on during an AS9100 audit?
Employees should focus on demonstrating their understanding of the quality management system, adhering to established processes, and providing clear, accurate information when asked. It's important they stay calm, be honest, and show how their work aligns with the organization's quality objectives.