Sterile-Fill Reject Reduction: Charter Scope and Sponsor Pressure
A contract sterile-fill manufacturer runs one vial line across three shifts and two vial sizes. The line fills five products, with a 45-minute changeover between products. Over the last 12 weeks the overall reject rate is 4.8% against a customer target of 1.2%. Rejects are concentrated after changeovers and on Product B, which accounts for 38% of volume but 61% of rejects. Scrap and rework are estimated at $1.2 million annually. The sponsor wants a Black Belt project to reach 0.8% overall reject rate in 10 weeks and has asked the team to include a $450,000 capital request for a new filling pump in the charter. The team includes operations, maintenance, and QA, but no finance representative. A preliminary Pareto shows missing stoppers, fill-weight outliers, and particulate defects. The line has no documented operational definition for 'reject' or 'changeover complete.' The sponsor says the goal is non-negotiable because the customer has threatened to dual-source.
1. Assess whether the 10-week, 0.8% overall reject-rate goal and project scope are appropriate. What would you propose to the sponsor?
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Assessment: The 4.8% baseline is an aggregate over five products, two vial sizes, and three shifts, so it is not a valid single baseline for a 10-week goal. Product B is 38% of volume but 61% of rejects; a quick stratified calculation puts the non-B products near 2.5% and Product B near 7.7% (0.61 x 4.8 / 0.38). A drop from 4.8% to 0.8% is an 83% reduction, and no capability or root-cause evidence supports that in 10 weeks. Proposal: Define reject and changeover complete operationally; stratify baseline by product, shift, and changeover window; confirm repeatability of reject classification; set a data-based goal such as reducing Product B post-changeover rejects by 50% in 12 weeks while holding others, with an overall stretch target. Keep scope on changeover and Product B first, not the whole line. Reasoning: A Black Belt charter needs a verified baseline, a defined opportunity, and a goal the team can influence. The customer threat justifies containment and prioritization, not an unsupported target.
2. What team and stakeholder gaps exist, and how would you close them before Define sign-off?
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Gaps: Finance is missing, so the $1.2 million COPQ is unvalidated and benefits cannot be signed off. Maintenance is present but no engineering or automation owner for the filler. The customer quality engineer and line operators from all three shifts are absent; changeover defects are shift-dependent. Actions before Define sign-off: Add a finance controller to validate scrap, rework, and lost-capacity costs; add the filler engineer and a night-shift operator; map stakeholders using influence and interest and define a communication cadence with the sponsor and customer. Interview operators to capture the informal changeover sequence and failure modes. Confirm voice of the customer: the 1.2% target and dual-source threat should become a CTQ and a containment plan. Reasoning: A team without finance cannot defend COPQ, and without all shifts it will miss the conditions that create post-changeover defects. Stakeholder gaps are a Define-phase risk, not an execution detail.
3. How should the capital request be handled within a DMAIC charter?
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Handling the capital request: A DMAIC charter should not include a $450,000 capital request before root causes are confirmed. Capital is an Improve-phase solution, not a Define-phase scope item. Put the pump request in a separate parking lot or capital project, with a decision gate after the Analyze phase. What to tell the sponsor: If data show the pump addresses a dominant root cause, the team will build a business case with validated COPQ, expected reject reduction, payback, and risks; if not, capital would mask the process problem. Charter language: 'Evaluate filling-pump replacement as a potential solution after root-cause confirmation; no capital commitment in this phase.' Reasoning: Mixing capital into the charter biases the team toward a predetermined solution and can bypass DMAIC logic. It also confuses project benefits with capital approval. The Black Belt should protect the method while keeping the sponsor engaged.