Problem statement
This liquid project for injection contains and active ingredient, Active A, that intermittently showed low OOS results. This had a significant impact on the QC, operations, technical services, QA and planning departments. There were delays the supply of product to customers, causing damage to the organisation cerdibility and reputation in the marketplace.
Objective
Decrease the number of Low OOS Active A results from 18 % to 1 % by the end of a 6 month project cycle.
Lean Ireland consulting/training work
This project was completed by certified lean six sigma green belt (CLSSGB) candidate who undertook a customised in-house 10-day onsite training programme facilitated by Lean Ireland. The training involved interactive workshops, academic assignments and team-based project work within the organisation. The DMAIC (define, measure, analyse, improve and control) project framework, plus a varied toolset for each phase enabled the GB lead and the cross-functional team to work through the project phases. The Lean Ireland facilitator, a certified black belt, provided project mentoring on a regular basis throughout the project lifecycle. Certification was achieved by completing the two academic assignments, and presenting the completed project to a certification review board comprising organisation managers, certified green belts and the Lean Ireland black belt assessor.
The certified lean six sigma green belt (CLSSGB) training course is facilitated by Lean Ireland to ISO 13053-1 standards. Total consultant days involvement was approximately 15 days, including training, project mentoring and certification for a CLSSGB cohort of 12 candidates.
Detailed results of the client work
The GB team reviewed the physical manufacturing process; the supporting written procedures, and the product specifications (marketing authorisations) by market. Of particular value in the Define phase was the team gemba walk. The team observed the dispensing of a few hundred Kg of the active powder which came in bags of several kilos in weight. An anomaly was detected in the supplier actual vs. claimed weights, and also inconsistenies in the dispensing process across shift teams.
In addition the team performed a thorough review of finished product specifications and registered manufacturing packages for different territories. As differing territories had 2 differing active specifications, the laboratory had adopted, in the past, a narrow USL and LSL specification band that met all territories’ requirements.
In the improve phase, the weighing and dispensing process was error proofed, and the organisation changed to making product specifically for the 2 groups of territories. Cpk improved dramatically from the generic 0.35, to 1.16 and 1.17 for the 2 respective territories. The reject rate fell from 18% to 1%. The cost savings on the reduction in investigations was considerable, and the client’s reputation was restored in the market.