IATF 16949:2016 Clause 8.3.4.4 Product approval process

The standard requires the supplier to comply with a product and process approval process recognized by the customer. The product approval process, or PPAP is intended to validate that products made from production materials, tools, and processes meet the customer’s engineering requirements and that the production process has the potential to produce product meeting these requirements during an actual production run at the quoted production rate. The process commences following design and process verification during which a production trial run using production—standard tooling, subcontractors, materials, etc. produces the information needed to make a submission for product approval. Until approval is granted, shipment of production product will not be authorized. If any of the processes change then a new submission is required. Shipment of parts produced to the modified specifications or from modified processes should not be authorized until customer approval is granted. When one considers the potential risk involved in assembling unapproved products into production vehicles, it is hardly surprising that the customers impose such stringent requirements. The process is similar in other industries but more refined and regulated in mass production where the risks are greater. The requirements for product approval are defined in the reference manuals. You may not need to prepare product approval submissions for all the parts you supply. The applicability of product approval process is affected by several factors so definitive solutions cannot be offered. The fundamental requirement is that if you supply product to the automotive customers you need a product approval process in place. If you have been supplying parts for some time without product approval then you should confirm with your customer that you may continue to do so. The documentation required varies but is likely to include the following:

• Production part submission warrant — a form that captures essential information about the part and contains a declaration about the samples represented by the warrant
• Appearance approval report — a form that captures essential information about the appearance characteristics of the part
• Design records, including specifications, drawings, and CAD/CAM math data
• Engineering change orders not yet incorporated into the design data but embodied in the part
• Dimensional results using a pro forma or a marked up print
• Test results
• Process flow diagrams
• Process FMEA
• Design FMEA where applicable
• Control plans
• Process capability study report
• Measurement systems analysis report

The data on which the product approval submission is based should be generated during the process verification phase.When we speak of design in IATF, we think of the APQP. For submission of data and document to customer, we extract them from APQP files But in practice, many organizations do not start with APQP, but will base on PPAP directly for planning and for warrant submission. It saves time, no redundant work, and all the data and rules for approval are given here. This is what the clause say, a method initiated by the customer. So you can safely use this method for product and project management. And there is no need to do both APQP and PPAP for the same project. For submission, we have to approve info (e.g. ECN, PPAP) etc from sub-suppliers, before onward submission to customer. You should have evidence of this.If customer does not specify a method, you can use an internally- defined method for PPAP, complying to the outputs specified in 8.3.5, 8.3.5.1, 8.3.5.2 as applicable.For project scheduling, use a Gantt Chart, and lay out your tasks according to sequence. Most importantly, your trial and mass production dates should be based on the master schedule, from the customer. Inputs from customer are usually drawings and technical specs, and PSW form. This is not sufficient however. You need to ask for master schedule, a PPAP list, and lessons learned, if the part is new to you.

Clause 8.3.4.4 Product approval process

The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the customer. The organization shall approve externally provided products and services per ISO 9001:2015 clause 8.4.3 Information for external providers , prior to submission of their part approval to the customer. The organization shall obtain documented product approval prior to shipment, if required by the customer. Records of such approval shall be retained. NOTE Product approval should be subsequent to the verification of the manufacturing process.

Use the customer provided or recognized process provided one exists, otherwise use the appropriate OEM PPAP reference manual. Make your suppliers use the same procedures or manual as you do. If supplier PPAP’s are done by your purchasing function that is located offsite, make sure that both the offsite purchasing process as well as the PPAP process is identified in your QMS processes. The standard requires the supplier to apply the product approval process to subcontractors. Your subcontractors may not need to supply product approval submissions for all parts they supply but there are situations where subcontractor product approval submissions
are required. For example, GM requires product approval of all commodities supplied by subcontractors to first tier suppliers. The standard does point out that suppliers are responsible for subcontracted material and services so if your submission relies on your subcontractors operating capable processes, you should be requesting a product approval submission from them.

Verification of changes
The supplier should verify that changes are validated including all subcontractor changes and, when required by the customer, additional verification/ identification requirements shall be met. Following product approval any change to the product or the processes producing it needs to be assessed for its impact on the conditions of product approval. You need close contact with your subcontractors because you need to capture any changes they make and perform an impact assessment. This can be difficult if you are using proprietary products. Your contract with your supplier needs to require the supplier to notify you of any changes in product or process. Quite minor changes may have significant effect on the product you supply to your customer. In some cases, suppliers may not accommodate your requirements, especially if the order value is small.

Notification of changes
All changes to be notified to customers which may require customer approval. Customer approval is likely when:

• Products are modified.
• A discrepancy on a previously submitted part has been corrected.
• Changes are made to the production process, materials, tooling, subcontractors, etc.
• Production has been inactive for 12 months or more.
• Shipment has been suspended due to quality problems.

The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the customer.

Establishing, implementing, and maintaining a product and manufacturing approval process conforming to customer requirements is crucial for ensuring product quality, consistency, and customer satisfaction. This process typically involves several steps and controls to ensure that the products meet the specified standards. Here are the key components of such a process:

1. Understanding Customer Requirements: The organization must thoroughly understand the specific requirements and expectations of the customer concerning the product. This includes product specifications, quality standards, delivery schedules, and any other relevant criteria.
2. Documentation and Standard Operating Procedures: Develop clear and comprehensive documentation that outlines the entire product and manufacturing approval process. This should include standard operating procedures (SOPs) for each step involved in the process.
3. Design and Development: If the product requires design and development, the organization should have a well-defined process for designing the product according to customer requirements and validating the design before moving forward.
4. Risk Assessment: Conduct a risk assessment to identify potential risks associated with the product and its manufacturing process. Implement measures to mitigate these risks effectively.
5. Supplier Evaluation and Control: If the organization relies on suppliers for components or materials, it should have a supplier evaluation and control process in place. This ensures that the suppliers meet the necessary standards and can consistently deliver materials of the required quality.
6. Prototype and Sample Approval: Before starting full-scale production, create prototypes or samples of the product for the customer’s review and approval. This step helps identify any potential issues early in the process.
7. Manufacturing Process Validation: Validate the manufacturing process to ensure it can consistently produce products that meet customer requirements. This may involve conducting process capability studies and performance qualification tests.
8. Product Inspection and Testing: Implement inspection and testing procedures to verify that each product meets the specified requirements. This includes in-process inspections and final product inspections.
9. Non-Conformance Management: Establish a system to manage non-conforming products or processes. This includes identifying, documenting, investigating, and taking corrective actions to prevent recurrence.
10. Continuous Improvement: Regularly review the product and manufacturing approval process to identify opportunities for improvement. Implement corrective and preventive actions as necessary to enhance the overall process.
11. Customer Feedback and Satisfaction: Gather customer feedback to measure customer satisfaction and use this input to drive further improvements in the product and manufacturing approval process.
12. Training and Competence: Ensure that employees involved in the product and manufacturing approval process are adequately trained and competent to perform their tasks effectively.

By following these steps and maintaining a robust product and manufacturing approval process, the organization can meet customer requirements, produce high-quality products, and build strong relationships with its customers.

Production part approval process

The Production Part Approval Process (PPAP) is a standardized method used in the automotive and other manufacturing industries to ensure that suppliers can consistently produce parts that meet the required quality standards. PPAP is a critical step in the product development and manufacturing process, particularly in industries with stringent quality requirements.The main objectives of PPAP are to:

1. Demonstrate Capability: Suppliers need to demonstrate their ability to produce parts consistently and meet the specifications defined by the customer.
2. Verify Processes: PPAP ensures that the production processes are well-defined, controlled, and capable of producing parts that meet the required quality levels.
3. Identify and Mitigate Risks: By conducting a thorough review of the production processes and part characteristics, potential risks and issues can be identified and addressed before full-scale production begins.
4. Provide Evidence: PPAP serves as evidence that the supplier has met all customer requirements and is ready to commence production.

PPAP involves several key elements and documentation, including:

1. Part Submission Warrant (PSW): A document signed by the supplier’s authorized representative, indicating that all PPAP requirements have been met.
2. Design Records: Detailed engineering drawings, specifications, and other technical documentation related to the part.
3. Engineering Change Documents (if applicable): Any changes to the part design or manufacturing process must be documented and communicated.
4. Process Flow Diagram: A visual representation of the production process, including all stages and steps involved.
5. Process Failure Mode and Effects Analysis (PFMEA): A risk assessment tool used to identify potential failure modes in the production process and their effects on the part’s quality.
6. Control Plan: A plan that outlines the key controls and inspections at each stage of production to ensure quality requirements are met.
7. Measurement System Analysis (MSA): An assessment of the measurement tools and techniques used to inspect the parts, ensuring accurate and reliable measurements.
8. Dimensional Results: Detailed measurements of the part, demonstrating that it meets the required specifications.
9. Material Certifications: Certificates from the material suppliers confirming the quality and specifications of the raw materials used.
10. Appearance Approval Report (AAR): A report demonstrating that the part’s appearance meets the customer’s aesthetic requirements.
11. Initial Sample Inspection Report (ISIR): A report summarizing the results of the initial part inspection.
12. Records of Compliance: Records demonstrating compliance with customer-specific requirements and any industry or regulatory standards.

Once all the PPAP documentation is complete and approved, the supplier is authorized to proceed with production. PPAP is usually conducted for new parts or significant changes to existing parts and is typically required before full production begins or when transitioning to a new supplier. The specific PPAP requirements may vary depending on the customer and industry standards.