A process map is one of the most fundamental tools for effectively managing and continually improving business processes conducted at a company. Since we often find life sciences companies lacking adequate maps of important processes (despite detailed SOPs), I thought it would be useful to provide a brief overview of the value of process maps and share some techniques for creating them and making them more effective.
Posts Tagged ‘Operational Excellence’
The Case for “Good” Process Maps
Monday, August 30th, 2010Can Operational Excellence and Compliance coexist? History shows they must and experience proves they can.
Monday, May 10th, 2010I recently read an excellent article (http://immelresources.com/HistoryofGMPs.pdf) recounting events that led up to the formation of the FDA and subsequent key laws. As an Operational Excellence (OE) person, it’s tempting to view compliance as a pain, but this reminded me of the real importance of regulatory oversight.
One of the things that can drive Operational Excellence (OE) folks crazy is the extent of inefficiency and seemingly non-value added work that occurs around maintaining compliance in a life sciences company. Tracking deviations, conducting bio-burden tests, documenting process changes and rigorously controlling documents doesn’t fundamentally change the product coming out of the bioreactors and going into patients. Instead, it is all part of the safety net and oversight that makes it harder for faulty drugs or devices to get out the door. For an OE practitioner dedicated to streamlining operations, eliminating waste, and maximizing customer value, it can be frustrating to slog through layers of red tape and quality systems to drive valuable improvements in the business. Wouldn’t our jobs be so much easier without compliance requirements? Wouldn’t drugs be cheaper? (more…)
Is Operational Excellence Relevant in R&D?
Tuesday, February 16th, 2010I recently asked this question in the Linked In Pharmaceuticals Operational Excellence Group online forum which resulted in an enthusiastic and insightful dialogue.
Lean, Six Sigma and all of the other buzz words under the umbrella of Operational Excellence are traditionally applied to activities linked directly to commercial production. More recently, administrative and service functions have also been targeted. So, why not R&D?
