A user’s decision to purchase custom factory automation can be a momentous one. The capital investment will probably be significant – in the hundreds of thousands or millions of dollars. The system purchased will probably represent the core of the production process for many years. And being custom, there may be nowhere the user can go to see the system needed already in operation. The lack of a rigorous specification process can have serious consequences.
Developing a comprehensive system specification, and developing the right context for specification development, is key to mitigating risk. In this series of technical notes we will share with you our experience in system requirement specification, touching on system standards development, process audit, economic value justification, specification development and the vendor selection process.
Custom systems are designed to meet manufacturing needs that, for the most part, are specific to individual clients and individual processes. It usually is not feasible to design elements of these systems in advance. However, one of several things that a user of custom systems can do to structure the purchasing process is to develop and document a standard set of methodologies, reference procedures and approved system elements for use over a range of requirement specifications.
Some standards are set by regulators or industry associations, and should be clearly referenced in the system user’s master standards document. Examples include; NEC, NFPA and NEMA for electrical standards; OSHA, ASME and ANSI for machine safety and calibration standards, IEEE for software and control guidelines, and; ISO, various cGMP guides and GAMP for automated equipment quality system guidelines.
Other standards are set by the machine users themselves, and will vary by market and by type of application. For example, materials of construction standards will be different for a user of aseptic pharmaceutical automation than for a user in the field of automotive part manufacturing. Internal standard categories – both in terms of preferred brands and general guides - might include;
A user’s equipment standards document, therefore, is one item in its risk mitigation toolkit. It is only as effective as the thought and effort put into its design and application. If you are thinking of purchasing factory automation and need advice on developing your own machine standards, Systematix would like to help. Please contact Don Weber for assistance.