Raw Material Sampling (1) – Pharma

  • Client sub sector: Pharmaceutical manufacturing
  • Summary results of the Lean Ireland engagement: The time to sample raw material reduced by 45%, and the process resource requirement reduced from 4 to 3 people. In addition the error rate reduced by 91%.
Customer satisfaction
Teamwork
Streamlined processes
Reduced costs

Problem statement

The current sampling process for in-coming raw materials wastes resources and results in production delays. Of the batches sampled to date, an average failure rate of 30% (n=40) is observed.

Objective

The objective of this engagement was to prevent delays in production and minimise impact to operational areas. This would be achieved by streamlining and error proofing the process, and creating  a manufacturing pull-based system for the sampling/testing of materials

Lean Ireland consulting/training work

The project was completed by a cross functional team of client employees, who undertook two-day Certified Lean Six Sigma Yellow Belt Training with Lean Ireland. The training provided the DMAIC (define, measure, analyse, improve and control) project framework for the team, plus a varied toolset to enable the team to work through the project phases. The Lean Ireland facilitator provided project mentoring on a regular basis throughout the project lifecycle. 

Detailed results of the client work

The yellow belt  team used the lean six sigma DMAIC process and toolset to improve the process. In the Define phase the Yellow Belt team completed a gemba walk, a summary and detailed process map and a voice-of-the-customer exercise. This identified several failures in the process to be quantified and root caused.  A Fault vs. Fix matrix in the Analyse phase enabled the team to identify a suite of improvements to online applications and standard operating procedures (SOPs). Online sampling forms were error proofed and a group mailing list created for sampling updates. The revised process flow had 18% fewer steps, reduced the error rate by 91%, reduced the average sampling time by 45% and reduced the resources required from 3 to 4 people to 2 to 3 people, depending on the sampling procedure. 

Level of Lean Ireland of engagement

Certified lean six sigma yellow belt (CLSSYB) training course facilitated by Lean Ireland to ISO 13053-1 standards. Project completed by CLSSYB  candidate teams. Total consultant days involvement was approximately 10 days, for training and mentoring 3 separate YB project teams on site. and online. 

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