Anthony Clyne Presents about Lean Manufacturing In a GMP Environment

People working in various GMP environments face common challenges implementing lean tools.  A workshop in Beijing had people from diverse fields as a Stem Cell Laboratory, Biscuit Factory, Pharmaceutical, and a Beverage Bottling Plant.  All had a common interest to share best practice implementing lean manufacturing in a GMP environment.

GMP is Good Manufacturing Practice and is required to manufacture safety critical products.  These factories are highly regulated and demand a high level of cleanliness and microbiological control.

Participants identified the various ways to influence behaviour to achieve a true 5S culture.  The 5s culture is to have cleanliness as a natural part of every task.  This behaviour is learnt as a conscious behaviour but then becomes natural after repetition.

The behaviour needs to be reinforced with tools and processes that support the task of cleaning.

It is not just cleaning but a relentless quest to keep the machines going that differentiates a compliant plant from a world class plant.  Quick change over and successfully reducing downtime are two methods to achieve a world class plant.

Participants were lead by Justin Tao to discuss and share TPM’s role to eliminate unplanned machine stops.  Integrating operator tasks to Tighten, Lubricate, and re- Align  (TLA).

TLA raises the operator awareness of the machine condition.  This attention to detail and knowledge results in small deviations being detected before they become breakdowns.  Packaging machines have many finely tooled moving parts and some of which need to be straightened routinely.  TXM have described this as Re-Align.  Operators are trained by mechanical maintainers to use go / no go gauges and calibrated spacing tools.  These tools ensure the moving parts remain in the centre of their operating range resulting in much fewer small stoppages when applying papers, wrappers, blisters, label position, unit cartons, and box cartons.