QM Knowledge: Initial Sample Inspection Report

• Definition
• Goals
• Procedure
• ISIR in Quality Management
• Areas of Application

The initial sample inspection report (ISIR) is an important part of the sampling process, because it documents the results of the tests on the "initial sample". Before a product can be manufactured in series, it must be produced under realistic conditions of series production and presented to the customer for inspection. This initial production is called the initial sample.

The initial sample inspection report allows the supplier to prove that the delivered products meet the customer's quality requirements. It contains important information and confirmation that the requirements for the product and its quality have been fulfilled. In addition, the actual values of the initial sample parts are presented to the customer. The customer then checks whether the target values have been achieved, evaluates the report and informs the supplier of the result: Ideally, approval is given; in other cases, approval is not given or is given only with conditions.

An initial sample inspection report is carried out according to different specifications of the customer and is intended to check whether the product is suitable for series production and can indeed be reproduced in constant quality. In order to find this out, a previously agreed number of samples from the delivery concerned are examined and the results are documented in the initial sample inspection report.

The aim is to avoid errors in series production right from the start. In addition, the ISIR can be used to reach basic agreements between the customer and the supplier. Initial sample inspection reports can vary in scope and complexity.

Ideally, test production shows that the initial sample already meets all quality requirements. However, if defects come to light in the initial sample, the part approval process must be repeated until all quality requirements are met. For this purpose, a new initial sample inspection report must be prepared each time, in which all changes, whether improvements or deteriorations, are documented.

Important: The ISIR is binding. If the product concerned is produced again, this must be done under constant conditions and based on this initial sample. Only under these conditions an ISIR is of real use, as it can thus reliably determine the expected quality of a product.

The connection between the initial sample inspection report and quality management lies in the importance of the ISIR for the implementation of the requirements that the ISO 9001 places on companies. Especially in the context of product development and manufacturing, the initial sample inspection report is an instrument for meeting these requirements.

• In the context of the required quality control of products and processes, the ISIR supports the documentation of the control by collecting and recording test results and quality data for the initial samples.
• The documentation of processes and results plays an important role in ISO 9001. The initial sample inspection report fulfills this role by formally documenting the first batch and its conformance to defined specifications.
• Since the ISIR also allows potential quality risks to be identified at an early stage and eliminated even before series production, it also pays dividends in terms of the risk management required by ISO 9001.
• Due to the above-mentioned aspects, the initial sample inspection report primarily supports continuous improvement – from product to process quality in companies.

In order to meet the high quality requirements, the initial sample inspection report is always necessary, for example in the automotive industry – depending on customer requirements either by PPF according to VDA Volume 2 (Produktionsprozess- und Produktfreigabe, German for: Production Process and Product Approval) or according to PPAP (Production Part Approval Process).

Whether companies are launching a new product on the market for the first time and want to test it thoroughly beforehand, or whether a supplier part is put through its paces before it is incorporated into the final product – the applications in which the initial sample inspection report applies are many and varied. It is therefore desirable for many companies to create the initial sample inspection report as efficiently as possible. A comprehensive CAQ solution can help:

Through (partially) automated processes for data entry, processing, and evaluation, the time required for ISIR creation can be minimized. In addition, human errors during data entry can be avoided. As a result, companies receive more consistent and accurate inspection results. The integration of data from CAD programs or MES systems is another plus point for a software solution.