Lean Office
Lean Office - Introduction
Lean Office Links
MDS Nordion is a world leader in the supply of isotopes for medical purposes. It is a highly regulated business, and this is reflected in many internal processes. Several factors contributed to the recognition for a need to change these processes and find opportunities to streamline the work. We saw that the principles of Lean could be applied to the office.
A team of people worked with Lean Advisors Inc. (LEAD) to change these processes through Value Stream Mapping. We will describe our path from recognition and barriers, through the training, the Current State, developing the Future State and its implementation plan.
Our company operates as part of the life sciences industry and that creates an important context for our procedures. As a result there are extremely strict quality controls and highly detailed regulatory constraints. These conditions face any company making treatment devices for medical applications and patient care.
Every procedure we have in making our products has checks and balances as well as a well-documented paperwork trail. Each change in procedure or specification is part of a change process which is much more onerous than one you would find in non-medical industry.
Lean Office - Current State
We had many design changes but mission-critical customer, product quality, or safety issues did not drive most of them. Instead, a large part of our work processing changes was driven internally by the need to improve small design and manufacturing options or to integrate minor parts changes. These types of changes were still important to our own efficiency and competitiveness even if they did not directly affect the quality, safety or customer acceptance of our products. We applied the same arduous paperwork process to these changes as to those that were mission-critical. Most importantly, these processes were identical in effort and time elapsed, regardless of the nature of the change.
Another driver in our look at changing the paperwork process was the pending installation of a new ERP (Enterprise Resource Planning) system. It's vital to look at and rationalize your processes before installing an ERP otherwise you are, as they say, just "paving the cow paths"!
There are some very strict regulatory (FDA) restrictions on electronic document management including approval signature processes. These restrictions are unique to organizations in the highly regulated life sciences and medical devices field.
The issue before us was how to continue to fully comply with regulations while improving our turnaround time and efficiency.
