Reducing Nonconformances Increases Cost Savings by $1.9M

The Issue

A renowned medical device manufacturer was encountering a considerable volume of nonconformances (NCs) during their labeling process, creating bottlenecks and delaying the delivery of products to the client base.

Before BUNKA: What They Already Tried

Efforts to eradicate labeling errors resulted in the introduction of additional verification stages, an overhaul of the label processing form, augmentation of related SOP steps, and investments in new printing technology. Enhanced staffing levels and elevated overtime were enforced to sustain line momentum.

Observation: What We Saw

Our ethnographic examination revealed misplaced rolls of defective labels, noncompliance with one-piece flow operations, and inconsistent application and completion of the new labeling form. Printers were disorganized throughout the production chain. Labeling mistakes, ranging from inaccuracies to illegibility, were regrettably normalized, admitting no need for escalation. The revised form proved deficient in accommodating essential details, thus inviting omissions and unreadability.

BUNKA Deep Insight: What We Learned

The leadership and the workforce had come to accept significant work-in-progress (WIP) as an operational norm. Both labels and resultant waste were overlooked in financial deliberations due to minimal individual costs. The propensity was to cast operators and inadequate training as culprits for the pervasive nonconformities. A reluctance to confront procedural wastefulness was evident, compounded by the operators’ desire for family time over mandated overtime. Leadership and supervisory roles, bound to fixed salaries, felt unduly burdened by the required weekend attendance. Crucially, a comprehensive appreciation of the repercussions of waste and WIP on customer fulfilment was notably absent.

Strategic Action: What We Did

Our intervention strategy encompassed:

1. Nominating a local change champion in label processing
2. Revamping the labeling form for clarity, ease of use, and to ensure the recording of essential data
3. Instituting tailored GMP training for plant personnel, emphasizing rigorous form completion and requisite authentication
4. Realizing a rearrangement of the production attributes to streamline workflows and curtail mistakes 
5. A thorough reengineering of the labeling SOP to enhance operational efficiency
6. Creating and entrenching behavioral metrics to identify and mitigate sources of nonconformities
7. Formulating a systematic plan aimed at eradicating nonconformances within 12 months

Results: The BUNKA Impact

The following outcomes were accomplished:

1. A 50% reduction in nonconformities within the initial 8 weeks The complete elimination of nonconformities inside 7 months, surpassing the original 12-month target
2. A realization of annualized cost savings amounting to $1.9 million, directly attributable to the reduction in labeling errors 
3. A contraction of backorders (BO) by 50%
4. An enhancement in yield by 75%
5. A 60% diminution in overtime requirements
6. An upsurge in ‘right first time’ executions, fostering a stronger alignment with consumer expectations

Through the adoption of BUNKA’s insights and strategic actions, the medical device manufacturer not only reformed their labeling process but also manifested a significant financial turnaround, heightened productivity, and a deeper connection with their customer base. This case exemplifies the tangible benefits of a meticulous and systematic approach to quality management and operational efficiency within the medical device manufacturing sector.