Innovation Meets Compliance
Process Design

PLM Process Design and Architecture

For many companies processes are not defined well or exist only in a tribal-knowledge based approach often using tools not suited for the job. While this may work in a limited sense for start-up companies without formalized product offerings, sustained quality and product development (especially in regulated industries) will require a more formal controlled approach. Without it, sustained product quality cannot exist and it is likely that the organization will be at risk from regulatory findings. Integware has witnessed “good” companies first hand be devastated by the regulatory agencies due to poor PLM process design. Even if compliance controls exist, processes may still be poorly designed and enforced resulting in increased operating cost and decreased revenue opportunities and not to mention employee stress.

Integware brings a team of experts to help you develop or optimize your product lifecycle processes or aspects of them using industry best practices, adjusted as needed to any unique needs within your organization.

To do this, Integware will use the results of the product lifecycle evaluation as well as any other established process measures to assess the existing process. Our team will then lead your subject matter expert (SME) team through an on-site workshop event called a “Kaizen” (a Japanese word for improvement) to help redesign your processes.

The purpose of this activity goes beyond productivity and efficiency. A lean and well organized process can significantly cut cost, reduce waste and improve top line revenue. In addition, it can also reduce stress on the workforce by allowing them to work regular business hours as opposed to significant periods of overtime to get a product released or a change implemented. Your employees will spend their time on value-add activities vs. mundane, administrative tasks.

Once the process is designed and agreed to we document the process both graphically and in a formal Standard Operating Procedure (SOP). You will then measure the process through agreed to metrics that will be defined in the SOP.

Example process areas:

  • Design Controls / New Product Introduction
  • Engineering Change Management
  • Management of Documents
  • Corrective Actions
  • Complaint Management