April was supposed to be Quality Month at PCL. Since COVID swept our nation in early March 2020, we were forced to delay that till a later date! Most folks in the medical device packaging industry would agree that the different departments within a company might not have a clear vision of what the quality department does or what its purpose is. Our hope is that after a month of dedicating a few days a week to Quality department education that our team has more knowledge of what this important department does for PCL!

WHY Quality Month?

In the medical device industry, quality is everything. A commitment to quality ensures that we can maintain our ISO 17025 and A2LA accreditation, and more importantly maintains our ability to do business with our current customers and gain prospective customers.

Often people understand how to do something in the lab, but they do not know or fully understand the “why”. This is where the quality department steps in, we work to become experts of the requirements of ISO 17025, test standards and standard operating procedures and answer the question of “why”. For example, the quality team implemented the use of a job jacket to ensure all work order paper records that move through the lab are organized and all in one place for test technicians. What a newly hired lab technician may not understand is that we implemented this system to reduce the risk that important documentation could be misplaced or lost and ensure any important communication regarding the test plan is always with the test samples. While it may be a simple step or task, often these small details are what ensure the quality of our products and services.

In hosting “Quality Month” the quality department hopes to help better establish a culture of quality, and showcase the idea that quality is not just a department, but a mindset and a way to conduct all aspects of business. Ensuring that our products and services meet and exceed our customers’ expectations is everyone’s responsibility, and therefore quality is everyone’s responsibility. Here at PCL we are also moving from a focus on compliance to a focus on improved quality outcomes. While it is important to “check the boxes” of compliance, we also strive to make our quality management system work for us through continuous improvement and ensure we are all equipped with the tools to be successful.  Our management team recently established a new company mission statement and core company values, which also work in parallel to our company’s Quality Policy. Our commitment to quality starts with our core values and will continue to become a part of everyone’s daily endeavors.

We often use the analogy that the lab is like a locomotive. Our director of operations is the conductor, he operates the engine of the train. Our sales department and engineering team help provide the coal; fuel necessary to keep the train moving. Laboratory technicians help to shovel the coal into the engine, and operations can then determine how fast or slow the train will go. The quality department helps ensure the tracks are laid, the coal is the correct type of coal that our engine can use, ensures everyone has had training for their task, the engine is certified for use, and helps manage maintenance and service of the train. Management holds the map and determines which direction the train will take and helps communicate any signs or signals along the way. Without everyone doing their part the train could sit in the station unused, or derail…or go over a cliff. We are all an integral part of the train and are all working towards the same goal of delivering the payload (i.e. test results to you, our client), or ensuring the passengers reach their destination (i.e. launching a new product). By staying focused on quality along the way, everyone can ensure the train functions as efficiently and effectively as possible.

Quality Month Activities

Each week we plan to have a leadership member explain how their department interacts with and considers quality. We will host activities that showcase a quality process or concept and we will have “Swag Grab” challenges to test our team’s knowledge.

While quality is probably the department that keeps everything held together, there is still some mystery around what it is and how ingrained it is in each department. Our hope is for quality month to teach everyone what it is and to shine a light on how quality is ingrained in each department! Along the way, we plan to test our team’s knowledge and reward all their hard work.