IATF 16949:2016 Clause 9.2.2.4 Product audit

Product audit is defined as an examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards and customer requirements). A product audit is a systematic examination and evaluation of a company’s finished products to ensure they meet specified quality standards, customer requirements, and regulatory compliance. The primary purpose of a product audit is to assess the conformance of the actual product to its intended design and performance specifications. Product audits take place after manufacturing is complete, but before the product reaches the customer. If a product doesn’t meet standard requirements or specifications, the auditor documents the findings and logs a non-conformance.While each company will have its own procedures for addressing non-conformances, the process typically includes:

• Identifying the problem
• Containing the non-conformance
• Reworking or repairing the products, if possible
• Disposing of nonconforming products if you can’t rework or repair them
• Determining the necessary countermeasures for preventing recurrence

Product audits can help a manufacturer improve quality, profits, customer satisfaction, and loyalty. There is one catch: you must do them consistently and effectively, taking steps to identify process errors that are the root cause of defects. If you don’t, you’ll still see high internal failure rates and an increased likelihood of defects going undetected until they reach the customer. The of the most important aspects of the product audit process is that it doesn’t just involve the product management team. While they are certainly key contributors, it is truly a 360-degree review of product strategy and product development. That means that representatives from the sales team to quality assurance to customer support should be participating, because the items being audited impact all of these departments.Like all projects, the audit should begin with a kick-off meeting, including the auditor(s), executive sponsors and stakeholders. This meeting should clearly communicate the purpose of the audit and that full participation is expected from all relevant departments. It should also set the tone that while this audit will undoubtedly uncover and identify shortcomings in the current product management process, this is an opportunity for improvement and not assigning blame or fault.The next phase is a documentation review, where the auditor should be given access to all relevant documents and tools used in the product management process (both templates and actual work product). This is the forensic stage of the audit where the auditor can cross-reference what exists vs. what should be in place.The third step is interviewing staff. These interviews will mostly be conducted one-on-one between the auditor and each relevant staff member, which will encourage participants to be as honest and open as possible as well as allowing the interview to get in-depth on the related topics. A key to the interview process—which can be augmented with written or online surveys—is asking all participants the same questions to rate the effectiveness and quality of different parts of the process. These individual responses will be critical to the final ratings and can drive prioritization for areas of improvement. Next, the auditor will aggregate the results of the reviews and interviews to compile their findings. The final report can be delivered as a presentation and/or as a written document, but both formats will contain the same information. The goal of the report is to score every single element of the current product management situation so gaps can be identified and weaknesses addressed. The official process can conclude with a workshop where the results are reviewed in a group setting with all relevant stakeholders. Based on the called out deficiencies in the current process, action plans can be developed and tasks assigned to improve things. The final item on the agenda should be determining when the next audit should be conducted so progress can be measured and new opportunities for improvement can be identified.

Key aspects of a product audit may include:

1. Inspection and Testing: The auditor inspects and tests randomly selected samples of finished products to verify that they meet the defined criteria, specifications, and quality standards.
2. Conformance to Specifications: The product is assessed against predetermined criteria, such as dimensions, tolerances, materials, functionality, and performance, to confirm whether it aligns with the intended design and requirements.
3. Customer Requirements: The product is evaluated to ensure that it meets the specific requirements and expectations of the customers.
4. Regulatory Compliance: The product audit verifies whether the finished product complies with relevant industry regulations, safety standards, and legal requirements.
5. Product Packaging and Labeling: The auditor examines the product’s packaging and labeling to ensure they are accurate and appropriate for the product’s intended use.
6. Traceability and Documentation: The auditor checks the product’s traceability back to the production process and confirms that all necessary documentation, such as production records and quality control reports, is complete and accurate.
7. Non-Conformance Identification: If any deviations or non-conformities are found during the product audit, they are documented, and appropriate corrective actions are recommended.
8. Sampling Techniques: Depending on the size of the production batch, the auditor may use various statistical sampling techniques to select representative samples for evaluation.
9. Continuous Improvement: Product audits provide valuable feedback to the organization, enabling them to identify areas for improvement in their production processes and enhance product quality over time.

Product audits are essential in ensuring that products meet the required quality standards and conform to customer expectations. By conducting these audits, companies can detect potential product defects or issues early on, prevent non-compliant products from reaching customers, and uphold their reputation for producing high-quality goods. Additionally, product audits contribute to maintaining compliance with industry regulations and building trust with customers, leading to increased customer satisfaction and loyalty.

Clause 9.2.2.4 Product audit

The organization is to audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization must define the approach to be used

Auditing products at appropriate stages of production and delivery to verify conformity to specified requirements is an essential quality management practice that ensures products meet the established standards and customer expectations. By conducting these audits at critical points throughout the production process and during delivery, the organization can identify and address any non-conformities early on, preventing defective or non-compliant products from reaching customers. Here’s how the organization can implement this process effectively:

1. Identify Critical Stages: Determine the key stages in the production process and delivery where product quality and conformity are critical. These stages may include raw material inspection, intermediate checkpoints during manufacturing, final product inspection, packaging, and shipping.
2. Define Audit Criteria: Establish specific criteria and requirements that products must meet at each identified stage. These criteria should align with the specified requirements, customer expectations, and any relevant industry standards or regulations.
3. Develop Audit Plans: Create detailed audit plans for each stage, outlining the scope, objectives, methods, and resources for conducting the audits. The plans should also specify the frequency of audits at each stage.
4. Inspection and Testing: Conduct inspections and tests at each stage to verify product conformity. This may involve visual inspection, dimensional checks, performance testing, or any other relevant assessment methods.
5. Document Review: Review documentation and records related to each product, such as material certifications, process control data, inspection reports, and quality records, to ensure that the products meet specified requirements.
6. Sample Selection: Use appropriate sampling techniques to select representative samples for evaluation at each stage. The sample size and method should be statistically sound and based on the level of confidence required.
7. Root Cause Analysis: If any non-conformities are identified during the audits, perform a root cause analysis to understand the underlying reasons for the issues. Address these root causes to prevent recurrence.
8. Corrective Actions: Implement timely corrective actions to address identified non-conformities and ensure that products are brought into compliance before proceeding to the next production stage or shipment.
9. Continuous Improvement: Use the audit findings to identify opportunities for process improvement and enhance product quality over time. Continuously update audit criteria and methods based on feedback and lessons learned.
10. Reporting: Document the audit results in comprehensive reports, including findings, non-conformities, corrective actions, and opportunities for improvement. Share the reports with relevant stakeholders and management.

By conducting product audits at appropriate stages of production and delivery, the organization can maintain consistent product quality, prevent defects, and ensure customer satisfaction. This systematic approach to quality control helps the organization deliver products that meet or exceed customer expectations and comply with all specified requirements. Additionally, it contributes to building trust with customers and stakeholders by demonstrating a commitment to producing reliable and conforming products.

Customer specific approaches

When an organization is required to audit products using customer-specific approaches, it means that each customer may have their own unique set of requirements and expectations for how product audits should be conducted. These requirements could include specific audit criteria, evaluation methods, sampling techniques, documentation, and reporting formats. The organization must adhere to these customer-specific approaches during the product audit process. Here’s how they can execute these audits effectively:

1. Understand Customer Requirements: Thoroughly review the requirements and expectations of each customer regarding product audits. This may involve studying contracts, quality agreements, specifications, and any other relevant documents provided by the customers.
2. Develop Customer-Specific Audit Plans: Based on the customer’s requirements and any industry standards or best practices, the organization should create tailored audit plans for each product audit. These plans should outline the scope, objectives, audit criteria, methods, and resources to be used in the audits.
3. Training and Competency: Ensure that the auditors who will conduct the product audits are well-trained and competent in using the customer-specific approach. They should be familiar with the audit criteria and methodologies required by each customer.
4. Compliance with Customer Standards: During the product audit, strictly adhere to the customer’s prescribed audit standards and procedures. The auditors should apply the specified evaluation methods, use the appropriate sampling techniques, and collect the required data accordingly.
5. Document Review: Thoroughly review all customer-specific requirements and documentation related to the product being audited. This may include checking product specifications, quality control records, and any other relevant documents provided by the customer.
6. Report Generation: After each product audit is completed, generate a comprehensive report that aligns with the customer’s reporting format and includes all the relevant findings, non-conformities, and recommendations for corrective actions.
7. Communication with Customers: Maintain open and transparent communication with customers throughout the audit process. Share the audit results, address any customer concerns, and collaborate on implementing corrective actions when necessary.
8. Continuous Improvement: Use the product audit findings to drive continuous improvement efforts in the production process. Implement corrective actions promptly and monitor their effectiveness over time.
9. Follow-Up Audits: In some cases, follow-up audits may be required to verify that corrective actions have been effectively implemented and to ensure sustained improvements.

By conducting product audits using customer-specific approaches, the organization can demonstrate its commitment to meeting customer expectations and delivering products that consistently meet the required quality standards. This approach also helps build strong relationships with customers and enhances the organization’s reputation as a reliable and quality-driven supplier.

Organization’s approach

when specific product audit approaches are not defined by the customer, it becomes the responsibility of the organization to establish and define the appropriate approach to be used during the product audit process. This involves creating audit plans and methodologies that align with the organization’s own quality standards, industry best practices, and regulatory requirements.Here are the steps the organization can follow to define the product audit approach:

1. Internal Standards and Procedures: The organization should review its internal quality management system and existing audit procedures. These standards should be based on recognized quality frameworks such as ISO 9001 or industry-specific standards, if applicable.
2. Best Practices: Research industry best practices for product audits. Look into guidelines and recommendations provided by industry associations, regulatory bodies, and quality management experts.
3. Risk-Based Approach: Consider adopting a risk-based approach to product audits. Identify critical products, processes, or areas with higher risks or impact on customers and focus auditing efforts accordingly.
4. Sample Selection: Determine the appropriate sampling techniques to be used during the product audit. Random sampling, stratified sampling, or other statistical methods may be employed based on the organization’s objectives and the characteristics of the products being audited.
5. Audit Criteria: Establish specific audit criteria that address product specifications, quality standards, customer requirements, and relevant regulatory compliance.
6. Audit Checklist: Develop an audit checklist that outlines the key areas to be examined during the audit. This may include product specifications, materials, manufacturing processes, inspection procedures, and documentation.
7. Audit Team: Assemble a qualified and competent audit team with knowledge and expertise relevant to the products being audited.
8. Document Review: Ensure that all relevant documentation, including product specifications, quality records, inspection reports, and related documentation, are reviewed during the audit.
9. Audit Scope: Define the scope of the product audit, including the extent of coverage and the frequency of audits for different products or product categories.
10. Reporting: Establish a standardized reporting format for the product audit results. The report should include findings, non-conformities, root causes, corrective actions, and opportunities for improvement.
11. Continuous Improvement: Use the audit findings to identify areas for improvement in the production process and to drive continuous improvement efforts across the organization.

By defining their own approach to product audits when customer-specific requirements are not provided, the organization can ensure that their product audit process is consistent, effective, and aligned with their own quality objectives and industry best practices. This proactive approach also enables the organization to maintain control over product quality and demonstrate their commitment to delivering high-quality products to their customers.