Are you going after quality the wrong way?

If you want to assess the status of quality culture in your organization, ask your operators a simple question, “Who is responsible for quality?” If the answer is quality control or quality assurance, you may have a problem costing your organization more than you know.

Nearly all manufacturers that serve the life sciences or any other highly regulated industry make quality control a key part of their process. Unfortunately for many manufacturers, this often falls into the category of too little, too late. When QC or QA happens at the end of a lengthy and expensive process, or when there’s too much reliance on one specialized team or group or inspectors to serve as the quality control police, the result is a great deal of scrap, rework, and extra headcount, all of which drive costs up and deteriorating profitability. 

Get back in the business of manufacturing quality products, not inspecting them.

We recently worked with a medical device manufacturer looking for improvement opportunities within its existing quality systems. Like many organizations, this company relied on a large team of full-time inspectors to do product testing at the end of the line. The inspectors were good at their job. That wasn’t the problem. They weeded out the defects, just as they were expected and paid to do. But what if those defects could have been identified much earlier in the process? For this medical device manufacturer, rethinking the approach to quality opened up the opportunity to reduce full-time quality control headcount by up to 55% in some of plants while reducing rework and significantly boosting overall financial performance.

Here’s a closer look at how companies can successfully transform their quality approach. 

5 steps to establishing high quality culture in manufacturing:

  1. Start at the top with the right mindset
  2. Build quality into products and processes during design and development
  3. Make quality everyone’s job
  4. Engage your suppliers in the quality effort
  5. Build a problem-solving culture

  1. Start at the top with the right mindset. Shifts in culture are a tall task for any organization to tackle. The work goes beyond changes to systems and processes (i.e. checking the boxes) and addresses underlying mindsets and behaviors.  And it must start at the very top of the organization. In other words, a quality culture can only have meaning if senior staff makes it a part of how business is done and looks at quality capabilities as the cornerstone of enterprise-wide improvement.

    Executives and top company leaders must first fully buy into the importance of quality and understand the true potential impact on the bottom line. Then, they need to introduce processes as well as validation methods to bring teams on board and nurture a commitment to quality as part of the daily work and expectations.

    A good way to infuse quality in the daily routine is to make sure discussions around production focus on speed to market and stress quality metrics, such as first time yield (FTY) and rolled throughput yield (RTI) that measure good units coming out of the process the first time. With these kinds of conversations and measures in place, senior management sets the expectation that products are launched on time and at the right cost, but also at the right level of quality.

  2. Build quality into products and processes during design and development. Manufacturers that are truly committed to quality culture design and develop products and processes that reflect that commitment. They recognize their responsibility to understand the voice of customer and translate it into a product that can be manufactured at the right level of quality with good components that suppliers can supply. 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 great tools for facilitating this kind of work. These tools offer ways to systematically recognize and evaluate potential systems, products, or process failures and identify solutions for mitigating or lowering those risks during design and development. DFMEA and PFMEA work best when implemented with a cross functional team that includes proper representation and participation by engineering, procurement, operations, field service, customer service, and other key players with input into products and processes and/or a stake in the quality outcome.

    Obviously, it takes time and effort to do the proper level of analysis. For this reason, many organizations elect to simply “copy and paste” existing processes or stick with the way things have always been done. But as our client recognized, high levels of failure at final test almost always map back to gaps in the development process. The only way to avoid the resulting rework and scrap is to go step by step through the process and engage the team in identifying and solving for all potential points of quality failure.

  3. Make quality everyone’s job. Investing in DFMEA and PFMEA sends a message that everyone has a role to play in quality. The analysis also provides the framework for addressing gaps in all aspects of the business, from the shop floor to the top floor, with defined actions and appropriate metrics.

    With our medical device manufacturing client, one opportunity we identified was to introduce in-process inspection capabilities to catch defects in high-risk areas much earlier in the assembly process. Instead of passing quality issues or misassembled product down the line and waiting for QA to flag the problems at the end of the process, the recommended process changes require operations to complete inspection at each step. The sooner the issue is caught, the easier and more cost effect it is to address.

    Further, assigning broad ownership for quality functions and initiatives to employees reduces reliance on inspectors and allows this role to shift from that of policing quality to enabling other functions and driving greater value for the business.

  4. Engage your suppliers in the effort. Quality culture can and should begin even before raw materials enter a facility. As part of the quality culture revamp at the medical device manufacturer, we worked with procurement to implement upfront supplier selection and criteria changes designed to reduce risk and frequency of quality issues.

    A key recommendation was to introduce a supplier certification program based on supplier score card results. Materials from any supplier meeting the certification criteria would require less sampling at the company, reducing incoming inspection time by 20-30% and thus reducing the number of full-time employees needed for inspection.

    Further, by shifting responsibility for ensuring and properly documenting quality to the suppliers, the program reduced paperwork for the manufacturer. It also decreased the number of quality issues addressed at the manufacturing plants and eliminated the added hassle, time, and costs involved in returning defective material to the suppliers.

    Organizations that take this approach need to expect higher upfront costs from their suppliers. This should be built in the contracts and agreements that document the agreed upon supplier processes for ensuring and validating quality. However, the end result will be lower total costs. It is more cost effective for suppliers to address this issues with components before they reach the manufacturer. Manufactures can also avoid the capital and operational costs involved in setting up and maintaining internal quality control facilities and hiring and training onsite staff to do the work.

  5. Build a problem-solving culture. In manufacturing operations where the quality culture is the strongest, this efforts go beyond risk mitigation and early identification of issues to include real-time problem solving at all levels of the organization. Operators are empowered to solve the issues they see in their daily work with supporting processes for exploring the root causes of quality defects and putting action plans into place to address those causes and measure the impact.

    Establishing this type of culture requires a further investment in training and mentoring along with process changes the enable the work. It’s also important to ensure that employees are spending the appropriate amount of time to investigate and close out issues. Too long or too short of a timeframe can indicate that problem solving capabilities need to be further developed to deliver the greatest benefit for the organization.

Establishing a quality culture is challenging work well worth doing.

Many manufacturers, and those in the medical devices or other highly regulated industries, in particular, commit to delivering high quality product to customers. But there’s a lot of room to improve the way is approached and achieved. Making quality a part of the culture and integrating it into every aspect of the operation can be a major shift requiring significant process change and investment at the forefront. However, quality culture and capabilities pave the way to new and better ways of working. And they always lead to higher efficiency and improved financial performance down the road promising significant ROI for manufacturers that are ready and willing to go after it.


Meet the Expert



Nero Haralalka
Director, US Consulting

Nero Haralalka has extensive experience in lean manufacturing and back office process improvement. He is one of our leading subject matter experts in statistical problem solving.