Process Excellence in the Manufacturing Value Chain

Learn how J&J is using Six Sigma, Lean and other techniques to achieve process excellence in its manufacturing operations.

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The pharmaceutical industry is facing serious challenges today to maintain revenues, margins and compliance in a more competitive global environment. Companies can no longer afford to tolerate batch rejections, back orders and nonconformance issues, and many are taking decisive steps to prevent these problems from occurring in the first place.

Johnson & Johnson's response to these challenges was to establish a corporate "Process Excellence" program several years ago. The program was designed to provide a systematic method for measuring, analyzing and improving all the company's business processes, continuously. Its goal was to identify critical areas where improvement would create breakthrough results in market penetration and organizational speed, and reduce the cost of doing business. The program was designed to allow the company to make continuous improvements in cost and defect reductions and productivity, and to leverage improved compliance as a competitive advantage.

As a growing number of pharmaceutical companies are realizing, the toolkits and methodologies of Six Sigma and Lean can add significant value. Each is useful, even when applied in isolation. However, they become even more powerful when integrated. So, instead of applying these techniques individually, J&J is using dashboard metrics, Six Sigma, Lean and Design Excellence, to address manufacturing improvement.

Six Sigma addresses the need to reduce variability, Lean attempts to reduce waste and improve the flow of value to the customer, while Design Excellence aims to apply both these concepts, proactively, to design and development processes. This article will review some of the key concepts and methods involved, discuss how they have been integrated and applied at J&J's Pharmaceutical Sourcing Group Americas (PSGA), and some of the results achieved so far.

Achieving success with this integrated approach requires the following:
  • A strong clear "Case for Action" for making the given process change, including a business case based on data
  • Use of prioritization tools to ensure adequate selection of projects and scope of work
  • Use of tools to ensure control and institutionalization of improvements
  • A jointly developed and shared vision aligning executive leadership and associates in manufacturing


First, let's review some of the basic principles and tools involved in this integrated approach to process excellence.

Lean Manufacturing aims to eliminate waste and establish a total quality ethic, with quality at the source. It includes partnerships with customers, and improving process reliability on the manufacturing floor. It aims to simplify, integrate or automate processes whenever possible, and integrates continuous improvements.

Ancillary related concepts include:

Rhythm, the idea that there is a "natural" or preferred sequence of manufacturing operations that will minimize changeovers and setups.

Poka yoke, principles of error reduction or "mistake-proofing." The goal, in this case is to:


  • Make it more difficult to create errors
  • Ensure that it is possible to reverse them
  • Make it obvious when errors are occurring
  • Detect deviations from procedure or fixed value (for example, number of parts)


These concepts must then be implemented in process design, resulting in less complex processes and procedures that can tolerate error without resulting in product defects.

Tools used include:

Value Stream Mapping. This set of exercises is critical for any continuous improvement plan. VSM examines how any particular task is handled now, and how it might be handled more efficiently in the future, and provides a structure for implementing improvements.

The exercise allows teams to distinguish between activities that add value to operations or are absolutely necessary to deliver customer requirements and those than don't add value, which can be eliminated. It also allows teams to differentiate both of these categories from "sustaining activities," which aren't necessary to delivery customer requirements, but may be necessary to sustain the business, or can't be eliminated due to constraints. Sustaining activities are typically incorporated into the new process, but may be targeted for gradual elimination during continuous improvement. Several factors, including the time required for each activity, are collected and analyzed in value stream.

Value stream has been employed for several operations and processes within our facilities. Typically this involves mapping the whole process, including details of every stage and measurements of time required to execute. These exercises have led the teams to eliminate non-value added activities, streamline others. This has been achieved by implementing optimized procedures for changeovers and investingin new equipment, in order to further improve efficiency.

Five Ss - The five Ss stand for: Sort, Set in Order, Shine, Schedule and Score. 5S is a method that focuses on organizing the workplace, and the way that materials and equipment are set up in the workplace. It also standardizes work procedures, reducing waste and opportunities for errors.

Six Sigma - which probably needs no definition, measures the degree of variability as number of deviations per unit number of processes, operations or products. It is an organizational approach to performance excellence which aims, systematically, to eliminate variation by Defining, Measuring, Analyzing, Implementing and Controlling processes, abbreviated as DMAIC. Within Six Sigma projects, a variety of tools are employed. These include:

Failure Mode and Effects Analysis (FMEA) - a systematic group of activities that is intended to recognize and evaluate the potential failure of a product, piece of equipment, or process, and the effects that failure could have. Solutions that would eliminate or reduce the chances of that failure occurring are identified, and the entire processe is documented. FMEA identifies existing and potential failures and their causes and effects, and prioritizes failure modes based on a "Risk Priority Number' (RPN):

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