ISO 9001 First Article Inspection Report Template

Introduction

Any organization that wants to implement the ISO 9001 Quality Management System must have an advanced quality control system. One of the key elements within this system is the First Article Inspection report. The main purpose of this document is to ensure that the first part produced is suitable for the customer’s initial requirements. Moreover, the report allows one to identify production problems and control issues in advance and thus prevent further losses. This article focuses on the concept of First Article Inspection and its relationship with ISO 9001. Furthermore, it discusses the necessary contents of the report template.

First Article Inspection Overview

First Article Inspection (FAI) is a documented independent inspection of a representative part produced at the beginning of the production process. The central purpose of FPA is to verify that the production process can deliver components that meet all design specifications and purchase order requirements.

The main purposes of the first inspection include checking design and process capabilities, reducing risks, ensuring the supplier’s ability to meet requirements, providing confidence in the production process, and meeting contract requirements. FPA should be used in every project that requires the introduction of new parts, testing of suppliers or subcontractors, or changes in design, materials, and production processes. Furthermore, the first inspection should also be carried out when the same part has not been produced for a long time (12-24 months).

ISO 9001 Quality Management System is the standard that includes requirements for implementing a quality management system within the organization. The FPA procedure is not specified in this standard. However, organizations use such a type of inspection since it can help demonstrate compliance with a significant number of requirements within ISO 9001.

Specifically, the first inspection helps meet the conformity requirements within the following elements of the standard:

• 8.1 Operational planning and control – first article inspection helps plan and control the production process.
  
  

• 8.2 Requirements for products and services – FPA ensures that product requirements are established, met, and reviewed during the design and development process and throughout the duration of the contract.
  
  

• 8.5 Production and service provision – FPA is used to ensure process control. When using this inspection, organizations fulfill the requirements of 8.5 concerning control of the production and service provision process.
  
  

• 8.6 Release of products and services – FPA provides a verification review confirming that the product meets all requirements.
  
  

• 9.1 Monitoring, measurement, analysis, and evaluation – product inspection allows for collecting and analyzing relevant data needed to monitor and measure the performance of processes and products.
  
  

• 10.2 Nonconformity and corrective action – when non-conformities are detected, the organization takes action to eliminate them, which aligns with the requirements of 10.2.

First article inspection is an essential process for an organization that wants to meet the requirements of ISO 9001. This procedure is not mandatory; however, it is a proactive way to prevent failures and deviations. In other words, FPA allows an organization to shift from a reactive to a preventive quality management system.

Elements of First Article Inspection Report Template

The report on the first inspection is used to register and analyze data received from checking the first parts produced. Therefore, the template should be developed in detail to ensure that all necessary data can be collected. However, it is a generic document; thus, there may be variations from company to company.

1. Administrative Information

This part of the report contains general information about the inspection, including the following:

• Part number and revision.
  
  

• Report number.
  
  

• Supplier information.
  
  

• Customer information.
  
  

• PO number.
  
  

• Date of inspection.
  
  

• Inspector’s information (name and signature).

2. Part Identification, Description, and Characteristics

The next step while filling out the report is to identify the part. Thus, the following information should be included:

• Drawing Number and Revision.
  
  

• Materials and specification.
  
  

• Serial Number(s) of First Article Inspection parts.
  
  

• Reference Designation (Process ID).

3. Inspection Data/Characteristic Accountability

One of the most critical sections of the report is Inspection Data. The central idea of this part is to identify and record all characteristics of the inspected product. This information should be grouped in accordance with a ballooned drawing:

• Char no.: a characteristic number in accordance with the ballooned drawing.
  
  

• Requirement/specification: requirement or specification from the drawing (for example, 25 +/- 0,05mm).
  
  

• Actual measurement/observation: measurement result or observation.
  
  

• Equipment used: equipment used for measurement (for example, Caliper ID: C-001).
  
  

• Pass/fail: pass/fail statement.
  
  

• Non-conformance reference: non-conformance report reference in case of failure.

4. Material and Process Certified Evidence

Another critical part of the first inspection report is Material and Process Certified Evidence. This section provides information on certificates and traceability evidence in accordance with the applicable standard:

• Material certificates.
  
  

• Special process certificates.
  
  

• Traceability records.

5. Non-Conformance Management

Furthermore, the report should contain information on non-conformances. Thus, this section should include:

• Description of non-conformance.
  
  

• Root cause analysis (reference to NCR).
  
  

• Corrective action.
  
  

• Disposition.

6. Approval

The report should also include an approval section, namely:

• Inspector’s signature and date.
  
  

• Quality representative’s signature and date.
  
  

• Customer representative’s signature and date (in case of customer approval required).

7. Attachments

Finally, the report should include a section that lists all of the attachments provided. Some of the most common ones are:

• Ballooned drawing.
  
  

• Calibration certificates.
  
  

• Material/process certificates.
  
  

• Non-conformance reports (NCRs).
  
  

• Photos/videos.
  
  

• Tooling/gauging list.

ISO 9001 First Article Inspection Benefits

Using the report template described above brings a variety of benefits to the organization.

• First, it minimizes errors and risks associated with the first parts produced.
  
  

• Moreover, using this type of inspection helps improve the communication between the buyer and the seller regarding the specifications of the produced parts.
  
  

• At that, a standard report template ensures that the buyer and seller have the same understanding of the requirements, reducing the risk of deviations.
  
  

• Finally, using the report reduces costs by reducing the time spent on rework and facilitates the approval process.
  
  

• Additionally, it helps the seller demonstrate their commitment to quality control to the buyer.

Furthermore, the report proves that the seller cares about the quality of the products produced.

• Thus, the report will help the seller retain customers since buyers perceive the company as a reliable partner that follows all product requirements.
  
  

• Finally, the document will minimize the seller’s costs since it will help detect problems at an early stage, saving the costs associated with rework.

Implementation Guidance

While using the report on the first inspection, it may be helpful to follow some best practices.

• First, the parties should agree on the requirements, namely, whether the inspection should be conducted, the documents provided, etc.
  
  

• The best option is to use ballooned drawings since they allow to clearly specify the requirements for the inspection.
  
  

• It is also critical to ensure that all measuring instruments are calibrated in accordance with the requirements.
  
  

• Finally, it is also a good practice to involve quality specialists with extensive experience in performing FPA.

Industry Specific First Article Inspection Requirements

While ISO 9001 does not specify the requirements for the FPA procedure, some industries have industry-specific procedures and documents.

• AS9102: One of the most common standards is AS9102, which is used primarily by the aerospace and defense sectors. According to this standard, the report should include three forms for first article inspection, namely: an overview, a detailed report, and a summary.
  
  

• PPAP (Production Part Approval Process): Another standard that should be applied while inspecting the first production parts is PPAP (Production Part Approval Process). This is a standard used by the automotive industry to ensure that all parts produced by the supplier are consistent with the specifications of the buyer.
  
  

• Medical industry requirements: Finally, the medical industry should follow the regulation concerning medical devices, which includes requirements for design control and process validation. However, the regulation does not specify a standard for the first article inspection report.

Conclusion

First article inspection plays a critical role in ensuring the quality of the products produced. The report on FPA helps the seller identify and resolve problems that may arise at the beginning of the production process. As a result, it will reduce costs associated with rework, eliminate the risk of late delivery, and facilitate the approval of the product. Finally, it will contribute to building a long-term partnership with the customer. Thus, the report is a vital element of the quality control system of the seller under ISO 9001. However, the document should be developed in detail to ensure that it includes all information that the seller and buyer need.