Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions
Quality Challenges Create Waste
In a perfect world, all products are designed and manufactured to 100% of their design specifications; all people are trained and certified; and, all equipment is properly maintained and calibrated. All incoming supplies are used in the manufacturing processes, and there are zero deviations or defects. This nirvana product paradise does not exist in our world.
Instead of quality nirvana, every organization deals with quality challenges including product and process deviations; customer complaints; untrained and non-certified people; product defects; supplier CAPAs; and supplier nonconformances.
These challenges scream waste!
Waste is the byproduct of not creating the perfect product. A perfect product has zero waste: no deviations, no defects, no out of specifications, no nonconformances and ultimately no customer complaints. And while it may not be reasonable to reach this nirvana, reducing waste has significant impact toward meeting your continuous improvement goals.
Reduce Waste to Trend Toward Zero
As a result of these unavoidable quality challenges, Life Sciences organizations need quality management systems to track and measure quality events, and lead the organization closer toward perfection through continuous improvement.
Where there are quality challenges, there are waste costs. The time to record a complaint, the time to verify and investigate the complaint, and then the time to correct the product’s problem are costs inherent with a product that is not perfect. When you add the costs of identifying, verifying, investigating, and resolving deviations, nonconformances, and inspections to the equation, this large number is the cost of a creating a non-perfect product.
Measuring is Essential for Continuous Improvement
The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.
To improve anything, it is essential to measure everything. During this measurement, deviations are identified; nonconformances become visible; out of specifications and out of tolerances surface. All of these events represents the many facets of waste.
Identifying your trouble areas for creating waste requires tracking and measuring various quality metrics. Then you must investigate to identify the root causes, and resolve the deviations to reduce waste. Some of the basic items to track include the number of employee certifications past due, the number of nonconformances or CAPAs for each product, how many customer complaints you receive for each products, etc. Other areas to focus on will be your incoming supplies, the number of failed inspections, and the overall performance of your suppliers.
Moving beyond this basic tracking and measuring and into more in-depth quality analytics can be your next phase once you have a handle on which areas are creating the most waste for your organization. This post on how to get started with quality analytics is a good resource when you reach this stage.
Automation Brings You Closer to Perfection
Going back to our list of quality challenges, I mentioned untrained people or un-certified personnel, and not using 100% of incoming supplies for manufacturing as two examples of items that contribute to waste. Here are some ways an automated software solution can impact these areas:
Leverage a Training Management Program
As part of a quality management software system, a training management software solution can keep track of employee training records and requirements, and automatically notify staff when they need to be retrained on a topic or process through both online or document training, and classroom-based training. A previous post discusses the principle of implementing and measuring a training program in greater detail.
Initiate Incoming Inspections
Have a tightly controlled process for managing incoming inspections. The more you can control the incoming quality from your suppliers, the better your manufactured products and processes will become. You can learn more about implementing risk-based incoming inspections in this post.
Control Your Processes
Materials received from suppliers are not the only thing you need to control. As you’re well aware, manufacturing in the Life Sciences requires nearly all processes to be controlled. The best way to do so is with automation. To get closer to perfection, many companies have already outgrown manual systems for measuring and tracking their quality events. Automated quality management software is the next logical step in your pursuit of perfection. In fact, there are often different circumstances that can lead to its necessity, as detailed in this article about when to automate.
Shining a perpetual beam of focus on the product, process and people involved illuminates the many facets of waste. Once waste is measured and visible, then it is possible to eradicate the waste. For example, once a defect has been captured, the root cause must be investigated to determine if a CAPA is needed. Then it must be determined whether a corrective action must be implemented to correct the problem and help eradicate future waste from this defect.
As any organization reduces its deviations, outdated certifications, nonconformances and other quality-related maladies, the organization approaches the perfect product.
It will be a long road to travel, but the pursuit of perfection eventually forces wastes toward zero.
Pursue Quality Perfection
with Pilgrim as Your Partner
Pilgrim’s solution experts can review your current quality processes and show you how to get the most out of them using SmartSolve®.