Tag Archives: defects

  • Waste Removal

    … specific case, you’re not alone. Many researchers find that some components are just too vital to eliminate. Especially when it comes to raw materials, as it is vital that you deliver and check for defects before they are put to use. With that being said, you cannot always eliminate waste, but you can most certainly minimize it as much as possible. Now let’s get to it. It’s important to first eliminate components in your research that are most easily able to be eliminated, otherwise known …

  • Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.

    Reliable performance is a must in any industry but no more so than connected with the production of Life Science Products such as pharmaceuticals and medical devices. Poka-Yoke, the Japanese term used in Lean operations refers to the process of mistake proofing or providing a fail safe mechanism that will assure reliable operation. Eliminating defects or preventing operational mistakes can have a major effect on process capability, product specifications and operational efficiency, just to …

  • Supreme Court Rules that Design-Defect Vaccine Injury Claims are Pre-empted

    The Supreme Court ruled on February 22, 2011 that the National Childhood Vaccine Injury Act of 1986 (NCVIA) bars state-law design-defect claims against vaccine manufacturers. The Act had eliminated a manufacturer’s liability for a vaccine’s unavoidable, adverse side effects but was silent on the manufacturer’s liability for a vaccine’s design-defects. The Court stated that the language of the relevant provisions of the act suggested that “the design of the vaccine is a given, not …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … 75% of drug recalls can be attributed to manufacturing defects, the compartmentalized nature of the departments within the process, and burdensome regulatory compliance concerns among others. Further complicating the situation is the growing use of contract manufacturing organization’s (CMOs) which require companies to manage increasingly complex external relationships without compromising quality. According to Nigel Smart, Managing Partner of Smart Consulting Group, “With so much …

  • Lean Laboratory Saves Time and Money for Pharmaceutical Industry

    … value stream mapping – a process which identifies each step as either valuable or invaluable. The following seven wastes don’t add value to lab work flow and should be carefully monitored: •    Transportation of goods •    Inventory storage •    Movement of people •    Waiting •    Over-production •    Over-processing •    defects Storage and waiting steps contribute to 90% turnaround time. Value stream maps create a much better workflow within the lab …

  • What is Lean Manufacturing and Its Benefits?

    … can be implemented in two ways – one which focuses mainly on reducing waste and one which is more process based.  All implementations of lean methodologies focus on using fewer resources, less space, less manpower, less capital and less time to produce products and services with fewer defects and more overall value to the end customer. Lean manufacturing methods identify seven key “muda” or areas of waste after the production process is in place: 1)    Transportation, when used to move …

  • The Pharmaceutical Industry Gets Six Sigma and Lean Manufacturing

    … supply, and launch of new products.  Timing is critical for the success of a new drug, thus, companies must reduce production timings to take full advantage of the market.  Lean manufacturing and Six Sigma offer value stream mapping and process modeling concepts capable of reducing these cycles and costs, making the processes and staff, more efficient. -defects.  These are a huge risk for pharmaceutical companies.  No one wants to risk making people ill or to cause a death.  Lean’s …

  • Lean Operational Compliance in the New Pharmaceutical Industry Environment

    … they’ve been doing business for the past decades and move toward waste reduction, inventory reduction, higher capacity utilization,  higher productivity and attempt to achieve the goals of zero lost information, zero defects, zero bureaucracy, zero misalignment, and zero lost opportunities. The focus of lean systems is to eliminate waste and reduce processes to their most streamlined and value-adding expressions. The same definition of such processes, their investigation and streamlining to …

  • Risk analysis and Quality Systems in Development of LEAN Compliance Systems in Pharmaceutical Development and Manufacturing

    … misalignment, team based operations, zero lost information, zero defects and zero waste of creativity in quality control systems. The risk is then controlled by installing quality systems within the process and doing away with the end-process testing view of quality and compliance. Risk analysis and quality system analysis then go hand-in-hand when defining the elements of the development and manufacturing process, the investigation of each element, the streamlining process and the controls set …

  • Lean Six Sigma and Process Excellence to the Rescue

    … PAT, Pharmas are changing their focus to two management approaches: Lean manufacturing and Six Sigma, with the intention of reducing waste to meet customer demand and market changes, and to lessen the variation in products and processes, to avoid product defects. Lean and Six Sigma are powerful tools to improve quality, compliance, productivity, costs, and speed, allowing for the Pharma to provide better products in a cheaper and faster way. But it doesn’t stop there.  To effectively …