Read how JD Consulting helped to solve a thorny packaging and sterilization problem and not only helped to prevent waste, but also empowered the manufacturing department to effectively implement a quality process.

Problem:

Sterile package seal strength rejects of a short shelf life implant device resulted in expensive product scrap, and more significantly, unhappy customers with rescheduled surgeries.

Investigation and Analysis:

JD Consulting found that inherent limitation in the sealer design was the major source of the seal quality variability and the current sealer could not hold the necessary tolerances. Additionally, the sealing operators depended upon the Quality Control Department to provide seal strength data, which was usually too late to be helpful.

Solution:

Based upon previous relationships and experience, after a thorough analysis of the client needs and capability, JD Consulting located a simpler more robust sealer more appropriate to the short run volumes characteristic of the production line. After a personal trip to the equipment manufacturer to verify supplier claims and ensure adequate technical support for the client, JDC expedited the purchase, shipment, calibration, new procedures and IQ/OQ/PQ validation.

Additionally, JD Consulting recommended and expedited the purchase of new test equipment so that the production staff could test their products as part of the manufacturing process. We were able to cut through the usual red tape and have the equipment delivered and installed the next week. Operators were trained in SPC techniques and given responsibility to make adjustments within validated parameters.

Results:

Final inspection seal rejects dropped to zero following production start with the new package seal equipment. The product now passes sealing specifications before and after sterilization while the operators document that the process (6 SIGMA) is within specifications. The client now has high confidence that the packaged product is sterile and safe to use. The manufacturing supervisor reports  a much empowered staff since they no longer depend upon another department; they know that the product is made right the first time!

Jack Dhuwalia
© 2011