Johnson & Johnson

johnson and johnson health care systems modality solutions

"Unlike most of my experiences over the past 30 years with consultants I can easily answer the question did they (Modality Solutions) add value for the time and dollars spent, ABSOLUTELY!”

- Harold L. Ledet, Director of Quality and Compliance

Johnson and Johnson’s Memphis Logistics Center (MLC), responsible for medical device distribution, was faced with a backlog of complex NCs and CAPAs within the cold chain unit. Due to resource constraints and mounting quality issues, the MLC needed to seek additional process engineering support specifically to address these issues and conduct a process redesign in their Cold Chain operation. Additionally, the Johnson and Johnson team needed quick training to transition into independently resolving complex NCs and CAPAs in the future.

Modality Solutions led the effort to:
  • Structure and conduct investigations
  • Identify root causes
  • Determine corrective and preventative actions
  • Define plans to close CAPAs


Our engineers used Six Sigma and Lean techniques to implement the following changes:
  1. Re-wrote the pick, pack, and ship process used for high value shipments to make the process more streamlined - saving time and reducing errors
  2. Developed new procedures and training around the use of dunnage in cold chain shippers to reduce damage
  3. Created and trained on new procedure for the management of gel ice to ensure shipments are being controlled at the proper temperature
  4. Developed a new receiving process that includes metrics, well defined workflow, roles and responsibilities, and achieved a cleaned up the receiving dock from a backlog of freight to be received


Modality Solutions engineers came up to speed quickly to help the Johnson and Johnson team move 4 complex CAPAs into effectiveness monitoring within three weeks of arrival to support upcoming internal compliance audits and continued work on CAPAs and close out a backlog of cold chain NCs. The CAPA and NC investigations performed by the Modality Solutions uncovered root causes to NCs which only had been suspected but had not be proven. This ultimately allowed for process changes to be made to prevent future NCs.

"We immediately began to see a significant improvement in the reduction of CAPA’s and Nonconformance’s as well as Process Redesign, SOP changes, and the subsequent Training to implement the changes. They did a great job in being persistent with our organizations in the coordination of changes and training. They utilized some very creative techniques in the development of training which we will adopt going forward "