Tag Archives: practices

  • Best Practices of Smart Consultants

    … your project. No one likes gossip. If this sounds like you, you might be the team Gossiper. Focus on the task at hand and do not complain about your fellow consultants to each other. Not only is it unprofessional, but it’s not nice. Why not be a better you this 2015?  Disclaimer: This piece wasn’t meant to poke fun at stereotypes, but rather shed light on personalities that practically anyone, no matter what the industry, can all agree are not acceptable work practices to ensure success! …

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in other industries, yet the pharmaceutical industry continues to cling to practices that were right …

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • Waste Removal

    … as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice. Don’t overlook the obvious. The effort to remove the most …

  • Fishbone Analysis

    … fishbone diagram follows a simple, yet systematic approach to understanding the potential downfalls of each of the mechanisms in a biopharmaceutical process (i.e. materials, methods, machines, measurements, environment, and people.) Using fishbone analysis, a team of researchers creates a list of reasons to identify various problems in their findings. When utilizing this technique, one of the best practices involves creating a simple chart (template) for the responses of the research time, …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … company and the workforce equally. This communication role will be vital if the grassroots is to be activated and ideas and practices are to go viral in terms of their acceptance. Through a structured training program the consultant can educate the senior management, core team and workforce in the philosophy and importance of the key steps that will need to be embraced and lay the necessary groundwork to ensure that the initiative gathers continuous momentum. When the going gets tough the …

  • Lean Product Change–Over in an FDA Regulated Environment

    Some would argue that there is a conflict between the idea of lean practices and a highly regulated quality compliant environment. However, upon closer analysis this is not necessarily the case. Both Lean and Compliance have very definite requirements to operate properly and it’s this discipline of implementation and execution that can bind both rather than separate them as “end-game” outcomes. Compliance requires systematic control of elements connected to and driving manufacturing …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … will require constant attention so that new working practices become habits which are automatic actions of human behavior.   Achieving successful 5S implementation like all of Lean implementation will require significant commitments from senior management and the workforce to overcome the inevitable resistance that is naturally associated with significant change. Overcoming this resistance through cultural change will be the real challenge in implementing this Lean tool, but organizations …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    … implementation of new practices driven from data gathered through metrics collection and analysis processes. Such new practices often include the implementation of new signs, charts and andons. Andons are mechanisms which employ light to indicate/transmit information such as with the use of Real-Time controllers for example. Pharmaceutical Consultants & Life Science Consultants skilled in these ideas and their use in Lean Manufacturing strategies understand that the use of these visual …

  • The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.

    … savings as a result of the removal of waste. In our experience, we have found that most companies follow a pattern of “Invented Here” philosophy which is a culture that inhibits their ability to break out and be truly innovative. This sadly results in wasteful & inefficient practices which ultimately hurts the company’s productivity and profitability. However, positive case studies show that once initiated, programs using these simple tools can produce sustainable programs and this is …