Our Process

Process validation at PM Machine means dotting the i's and crossing the t'shttp://duke-mfg.com In other words, scrutinizing our process every step of the way so we can guarantee the outcome you expect. This is vitally important if the predetermined requirements of the product can only be assured by manufacturing cell to test areas.

Consistent results must be produced before we can move into full production. PM Machine follows these guidelines:

  • Installation Qualification (IQ)
  • Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer's approved specification and that the recommendations of the supplier of the equipment are suitably considered.

  • Operational qualification (OQ)
  • Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.

  • Performance Qualification (PQ)        
  • Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.

  • Process Validation        
  • Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.

  • Process Validation Protocol         
  • A document stating how validation will be conducted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results.

  • Verification
  • Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.

By validating processes for design, manufacturing and test methods, we can often reduce time to market for new products. Our operators are trained/certified and we have copious records and documentation of our validation activities. Other benefits to our process validation includes: Improved overall quality, elimination of scrap, reduced costs, and improved customer satisfaction.