Are You Approaching High-Quality Production the Wrong Way?
To evaluate the quality culture in your organization, ask your operators, “Who is responsible for quality?” If the response is quality control or quality assurance, there might be an issue costing your organization more than anticipated.
Most manufacturers serving the life sciences or other highly regulated industries consider quality control crucial. However, for many, this often results in too little, too late. When QC or QA occurs at the end of a lengthy and costly process, or there’s too much reliance on specialized teams for quality control, the result is excessive scrap, rework, and increased costs, all of which erode profitability.
Focus on Producing Quality Products, Not Just Inspecting Them
We recently collaborated with a medical device manufacturer seeking improvements within its quality systems. Like many, this company relied on a large team of inspectors to test products at the end of the line. The inspectors were effective, but the approach was reactive. By identifying defects earlier in the process, the manufacturer could reduce quality control headcount by up to 55% in some plants, while decreasing rework and significantly enhancing financial performance.
Here’s a deeper dive into transforming your quality approach successfully.
5 Steps to Building a High-Quality Production Culture:
- Start with the Right Mindset
- Integrate Quality in Design and Development
- Make Quality Everyone’s Responsibility
- Include Your Suppliers in the Quality Effort
- Cultivate a Problem-Solving Culture
Start with the Right Mindset.
Changing culture is challenging for any organization. It requires more than system and process changes; it addresses underlying mindsets and behaviors. This transformation must begin at the top. A high-quality production culture is meaningful only if senior staff makes it integral to the business and views quality capabilities as central to enterprise-wide improvement.
Executives must fully embrace the importance of quality and recognize its potential impact on the bottom line. They need to implement processes and validation methods to bring teams on board and foster a quality commitment as part of daily work and expectations.
Emphasizing high-quality production in daily discussions by focusing on speed to market and stressing quality metrics, such as first-time yield (FTY) and rolled throughput yield (RTI), sets the expectation for products to be launched on time, at the right cost, and with the right quality.
Integrate Quality in Design and Development.
Manufacturers committed to a high-quality production culture design and develop products and processes that reflect this commitment. They understand the voice of the customer and translate it into products that can be manufactured with the right quality components from suppliers. They convert product quality and technical requirements into process requirements with built-in controls and mistake-proofing capabilities.
Design Failure Mode Effects Analysis (DFMEA) and Process Failure Mode Effects Analysis (PFMEA) are invaluable tools for this work. They systematically recognize and evaluate potential failures and identify solutions for mitigating risks during design and development. DFMEA and PFMEA are most effective when implemented by a cross-functional team with representation from engineering, procurement, operations, and other key players involved in the quality outcome.
Many organizations opt to “copy and paste” existing processes, but high levels of failure at final tests often trace back to gaps in development. Avoiding rework and scrap requires a step-by-step analysis and engaging the team in identifying and resolving potential quality failure points.
Make Quality Everyone’s Responsibility.
Investing in DFMEA and PFMEA signals that everyone plays a role in quality. This analysis provides a framework for addressing business gaps, from the shop floor to the top floor, with defined actions and appropriate metrics.
For our medical device manufacturing client, we recommended introducing in-process inspection capabilities to catch defects in high-risk areas earlier in the assembly process. Instead of passing issues down the line, the recommended changes require operations to inspect at each step. The earlier an issue is caught, the easier and more cost-effective it is to address.
Assigning broad ownership for quality functions reduces reliance on inspectors and shifts their role from policing quality to enabling other functions and driving greater business value.
Include Your Suppliers in the Quality Effort.
A high-quality production culture can and should begin before raw materials enter a facility. We worked with procurement to implement supplier selection and criteria changes designed to reduce risk and quality issues frequency.
Introducing a supplier certification program based on scorecard results was key. Certified suppliers’ materials require less sampling, reducing inspection time by 20-30% and full-time inspection staff.
By shifting quality assurance responsibility to suppliers, paperwork decreased, quality issues at manufacturing plants diminished, and the hassle and costs of returning defective material were eliminated.
Organizations should anticipate higher upfront supplier costs and incorporate these into contracts. The result is lower total costs, as suppliers address component issues before reaching the manufacturer, avoiding the costs of setting up internal quality control facilities and training onsite staff.
Cultivate a Problem-Solving Culture.
In operations with a strong quality culture, efforts extend beyond risk mitigation and early issue identification to include real-time problem solving at all organizational levels. Operators are empowered to resolve daily issues with processes supporting root cause exploration and action plans to address causes and measure impacts.
Establishing this culture requires further investment in training and mentoring, along with process changes that enable the work. Ensuring employees spend the right amount of time investigating and resolving issues is crucial. A timeframe that is too long or too short indicates the need to further develop problem-solving capabilities for maximum organizational benefit.
Building a High-Quality Production Culture is Challenging but Rewarding.
Many manufacturers, particularly in medical devices or other highly regulated industries, aim to deliver high-quality products. However, there’s room to improve the approach and achievement. Integrating quality into every operation aspect can be a significant shift requiring upfront investment. Yet, high-quality production culture and capabilities pave the way for new and better ways of working, leading to higher efficiency and improved financial performance, promising significant ROI for committed manufacturers.
