ISO-9001 Process

Sonalysts’ processes for design and fabrication of any prototype hardware are described in each of the following sections.

Design and Development Planning

For most products, the customer defines and provides a system specification describing the product requirements. If a specification is not provided, Sonalysts will prepare the system specification. The specification will also identify the criteria for validating that the final product complies with the specification.

In addition to the product specification, a System Requirement Verification Matrix (SRVM) will be completed, ideally before the project design and production phases officially kick off. An SRVM will be generated, in every case, before the first design review. The SRVM will contain, at a minimum, the following information:

  • Design verification requirement
  • Applicable (governing) document and paragraph
  • Method of verification

For most projects, a project schedule or ‘Network Plan’ will be developed. The design schedule will include all major tasks and milestones from the contract award or program start date through validation of the system. The schedule will include a sufficient level of detail to facilitate tracking the schedule and cost performance. The schedule will identify all design reviews, customer reviews, and major milestones. The schedule will be the primary tool for evaluating the cost and schedule performance of the project.

Design Review

The number and depth of internal technical reviews will be tailored to each program and dependent upon the technical risk level. The timing of technical reviews is also critical. If the review is conducted too early, the item for review may not be adequately defined. Conversely, if the review is too late, design corrections may be both difficult and costly to implement. The Project Leader is responsible for scheduling design reviews.

Design Verification

Design verification is the process of verifying that the product complies with the requirements. It may occur at subassembly stages or at any point in the process determined appropriate by the design engineer. The methods for verifying the design include analysis, inspections, tests, and measurements. The verification results will be documented in engineering notebooks or technical notes and are subject to technical reviews, as required.

Design Validation

After the product has been successfully verified, the product will be validated through an acceptance test process. The purpose of testing is to validate that the product complies with the specified product requirements. The criteria and methods for validating the product will be specified either by the customer or Sonalysts. The methods for validating compliance with the requirements may be analysis, inspections, tests, demonstration, qualification by extension, or physical measurements. Even when not required by the contract, the customer(s) should approve any and all test procedures, plans, etc.

The process and procedures for validating the product are described in acceptance test procedures. If the format and contents of the test procedure are not contractually specified, the test procedure should include the following items:

  • List of test equipment required with set-up instructions
  • Required environmental conditions
  • Unit under test operating instructions
  • Step by step procedures for performing the validation operation with tolerances
  • List of the pass/fail recording test results