ISO 9001 is the internationally recognized standard for quality management of design/development, production, installation and servicing activities.

A Quality Management System (QMS)should be established and include the following documentation:

• Statement of quality policy.
• Procedures designed to ensure that activities are preformed in line with best practices.
• Work instructions which interpret the procedures in context of particular departments or functions.
• Accepted codes and standards relevant to the procedures and work instructions.

There is a clear need for well documented and understood job descriptions, responsibilities, and authority levels. The QMS used to support simulation must document the responsibilities and authority levels related to the:

• Acceptance, maintenance and release of simulation software.
• Specification, approval, maintenance and release of analysis procedures.
• Specification and review of analysis plans.
• Checking and approval of individual simulation analyses.
• Approval of engineering reports.

NAFEMS Quality Systems Supplement (QSS) is the definitive interpretation of the requirements of ISO 9001 in the context of finite element analysis (FEA). Defined categories of importance are:

• Category 1 - vital - malfunction or failure endangers human life, property, and/or the environment.
• Category 2 - important - poses serious danger to human life or causes damage beyond normal limits of liability.
• Category 3 - advisory - analyses not covered by Categories 1 and 2, where product failure may cause financial embarrassment to the fabricator or manufacturer.

These three categories provide the basis from which to specify the level of competence of the personnel required to preform each analysis. The staff assigned to the project must have experience of performing the type of analysis required and the applications experience of working on the particular product type to be analyzed.

The QSS requires that activities are assigned to personnel on the basis of personnel competence. QSS requires that personnel engaged in FEA, software development or procurement shall have qualifications, training and experience appropriate to the task. QSS also requires that records relating to all aspects of personnel competence be maintained. Contributions to personnel competence come from academic or professional qualifications, design analysis experience, FE modeling and problem solving experience. QSS states that analyses may be carried out and supervised by a single person who meets all of the requirements for personnel competence, or alternatively by a team who do so collectively.

Successful projects are undertaken with staff competent to fulfill the following roles:

• Supervisor - responsible for the work of analysts in assessing the structural integrity of products.
• Analyst - responsible for the formation of the finite element models and their solution.
• Software consultant - advises on the use of the finite element software selected to solve the problem.
• Independent checker - checks and assures the specification, implementation, solution and interpretation of the analyses and their results.

Product analysis will include the following activities:

• Contract review - QSS provides a framework for simulation contracts.
• Analysis planning - The analysis plan controls the complete simulation project.
• Analysis task allocation - Individual analyses will be allocated to competent analysis teams.
• Analysis execution - Define solution strategies, build models, apply boundary conditions, solve, develop usable results.
• Results checking and assessment - Check model accuracy and verify simulation results.
• Documentation - Develop project and analysis records for review, presentation, and archiving.

A Project Analysis Plan is the document which will be used to control the complete analysis project. An outline Project Analysis Plan will have been required to estimate the costs of undertaking the analysis project. The Project Analysis Plan will include the following:

• The purpose of the analysis, data to be produced and their required accuracy.
• The scope and category of importance of the analysis.
• Data required for the analysis and their accuracy.
• The analysis procedures, quality assurance procedures and work instructions required.
• Relationship of the analysis to other elements of the project, including elapsed time allowed for the complete analysis and its individual phases.
• Resource requirements.

Project, quality and analysis plans and specifications control the project and may require updating during execution.

If qualified analysis procedures are not routinely used, it is quite possible that safety critical structures and products would be analyzed in an inconsistent manner between organizations and possibly even within the same organization. Analysis procedures provide the foundation upon which safe and reliable finite element analysis can be built, and thus their development represents an important task to be managed from within the Analysis Function. Adequate documentation of the analysis procedure is important, as without it, the analysis procedures are likely to be used in an inconsistent manner

When using a finite element consultancy offering a general analysis service, it is likely that the customer for the analysis will be familiar with the design codes, standards and assessment methods usually associated with his product and may thus be co-opted as part of the analysis team. Structural and product design should also utilize outside resources to help evaluate current and future needs.

Management of Finite Element Analysis - Guidelines To Best Practices, G.A. Beattie, NAFEMS, 1995.