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Lean Manufacturing: Efficiency in Pharma, Biotech, Medical Devices

Lean Manufacturing and Quality

Lean Manufacturing - 31 May 2017

Lean manufacturing has been defined as the systematic elimination of waste in manufacturing systems. While I am certainly not an expert on lean implementation, I have seen firsthand the tangible benefits of the application of lean thinking to quality processes.

Aspects of waste addressed by lean principles include:

  • Transport/routing time
  • Processing complexity
  • Review and collaboration time
  • Serial approval time
  • Publishing time and cost
  • Distribution time and cost
  • Retrieval of previous revisions time
  • Lost/misplaced documents time
  • Nor right-first-time activities – time and cost
  • Deviations time
  • Delays in training – time
  • Not utilizing worker talents
  • Improper use of computer systems

If we think about our quality system as its own process, we quickly see where an investment in lean analysis and implementation can deliver real savings in time and resources. If you have not considered having this analysis done, I encourage you to discuss it with a lean professional.

"Once you have begun to ask questions, you may well find many opportunities to enhance the process to make it both more effective and more satisfying for colleagues to manage."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

Lean Implementation: Document Practices

The evaluation of document practices can yield similar benefits through systematic elimination of wasted effort. Clear status of document progress, electronically accessible documents, and a robust system for metric evaluation, training and document control as provided by a good Enterprise Quality Management System (EQMS) will benefit the organization.

Reduced cycle time for document review and approval and effectively using people’s time at the computer will provide the opportunity for quality colleagues to focus on continuous improvement opportunities, rather than wasting their time searching for documents or “working around” cumbersome processes.

The following are some thoughts on good practices for the evaluation and escalation of issues:

  • Identify the scope of the problem as clearly as possible. Is the issue related to part of a batch, an entire batch, multiple batches, multiple products? A good data management system can be invaluable in conducting data analysis for determining what the problem is (as well as identifying what it is not).
  • If I walk a typical product file (or raw material file or stability file) through the system, how much waiting time can I measure?
  • Ask colleagues if they ever have to go looking for a required document. Are documents available when required for them to do their job?
  • Look at each step in the review and release process and ask what value it adds. You may be surprised to find process steps that were implemented long ago that no longer provide any value.
  • Ask how priorities are established for document review and processing. There should be a link between what is required by the manufacturing and supply schedule, and the scheduling of document processing.
  • Ask for the most frequent cause of documentation “defects” – missing or incomplete documents that require further processing or follow-up before document approval can be completed.

Once you have begun to ask questions, you may well find many opportunities to enhance the process to make it both more effective and more satisfying for colleagues to manage. An Enterprise Quality Management System and the services of a lean leader can be a terrific investment in optimizing quality systems, and by extension, organizational effectiveness.

About the Author
John Carkner is Senior Consultant in SOLABS’ Quality Assurance & Best Practices Unit and has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

Other Recent Articles from John Carkner
Apr. 26, 2017: Issue Escalation: 5 Tips for Communicating with Senior Management
Mar. 22, 2017: Quality and Safety Have A Lot in Common
Feb. 1, 2017: FDA Contract Manufacturing Guidance and EQMS

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