Quality System Assessment

The International Organization for Standardization (ISO) has outlined quality principles and the procedures for implementing a quality management system in ISO 9000, ISO 9001 and other documents. In many fields such documents serve as the basis for regulation. However, it is not uncommon for organizations to attain ISO certification but still be plagued by serious quality challenges.

Ultimately the quality of products and processes produced by a manufacturer is a result of its entire manufacturing system. Successful organizations recognize that quality is not the responsibility of a single department or activity; rather it is the responsibility of the entire organization from the executives to the production floor; from the planners and marketers to the sellers and distributors.

Quality needs to be managed as system. A quality system is more than the documents that define it. A good quality system is characterized by:

  • Adherence to well defined standard operating procedures and policies that minimize variation in production and throughout the organization
  • Proactive identification of potential problems and customer-oriented solutions
  • Discipline and prioritization of resources to implement and document solutions on a sustained basis.

Exponent engineers and scientists are ideally suited to help companies transition their approach to quality from a reactive stance of constant firefights and quality escapes to a proactive position where problems are identified, corrected, and permanently prevented from recurring. Methods and tools Exponent can apply include:

  • Quality system assessment and benchmarking
  • Quality System Inspection Technique (QSIT)
  • Corrective and Preventive Action (CAPA) systems
  • Statistical data collection and analysis tools.