Miguel E Guerrero, Lean Sensei, Managing Partner, Synergis Corp., a BioTeknica sister company
The output of any process, whether business, operational, or economic, should result in outcomes that exhibit high quality, low cost, and timely delivery. Yet, in the medical device and health industry there has been more emphasis placed on quality system processes (and the wastes associated with quality, such as defects, rejects, rework, etc.), and less focus on cost and delivery. Typically, cost is directly proportional to expenses: how well we manage waste and how efficiently value is created. Delivery is also associated with managing waste (e.g., delays are a primary source of waste). Unfortunately, to deliver quality we often incur waste (excessive inspections, rework, etc.).
Quality Systems processes include a wide array of processes ranging from PPC (Production and Process Controls) to PDP (Product Development Process), Supplier Management, Complaint Management, and others. We will briefly review the impact of Lean Management Systems on Complaint Management.
Our team has been deploying Lean processes in the medical device industry since the early 1990s and has developed solutions for the Complaint Management Process, Production and Process Control, Supply Chain Management, New Product Development, and other supporting business processes. We benchmarked many processes in the life sciences, industrial, transportation, and automotive industries, both in the US and outside the US. Our approach is three-tiered, with phase one focused on conducting an audit to assess the issues and opportunities present. The team deploys a set of Lean processes, methods, and practices that enhance organization and order.
Based on audit results, measurable threshold boundaries are clearly defined. The next phase is to focus on the “flow,” i.e., observing and enabling the process to move freely and unobstructed, with the team designing and deploying the process steps to support continuous flow. Because of the increased velocity of the flow, delinquency and/or late processing of complaints all but disappear and the average time to process complaints is radically reduced.
During the third and final phase, the team focuses on confirming identification of root causes, employing new processes that address root causes, and linking the results to other QS processes. This new normal of continually searching for gaps and reducing or eliminating them leads to Operational Excellence through continuous improvement.