main routes between Nanjing and Shanghai. Changzhou University Town also is near the park and features six schools that
support the region’s vocational training needs.
It’s critical to explore such resources when making the decision
for a facility—whether it’s your first or your 10th. Taking advantage
of local synergies definitely helps with the Lean process.
Alignment with the company’s other operations also were analyzed.
The firm maintains its engineering and tooling fabrication capabilities for prototypes, less complex molds and liquid silicone
rubber molds in Singapore. It also has a manufacturing facility
in Xiamen, China. Since the markets the company serves have a
high degree of custom tooling as well as assembly and packaging automation, Forefront Medical typically supports its customers’
full product life cycles and often is the sole source for production.
Product development and tooling design/validation are critical elements in taking both measurable and hidden costs out of the product. A flexible research and development structure was designed to
leverage existing engineering infrastructure, while localizing some
tooling fabrication and maintenance functions.
Jiangsu has a full-scale commercial tool room with integrated
support from the Singapore team. This provides the resources necessary to maintain tooling on-site, while tapping the resources of
the Singapore engineering staff for new tool design. Actual tooling
fabrication may be done in Singapore, Jiangsu or at third-party suppliers depending on complexity of the tool and project requirements.
Jiangsu’s engineering team uses the same design and mold flow
analysis software found in Singapore for collaboration during the
design and development phase. The Jiangsu team handles product
prototyping, the scale-up of molds and tools, pilot runs, validations
and product life-cycle management activities, accessing Singapore
team resources as needed. This strategy also eliminates three potential sources of hidden costs.
First, leveraging the Singapore team’s expertise and resources,
eliminates the learning curve of a green field operation, and plus,
provides Jiangsu with the ability to pull specialized resources as
needed from a centralized product development organization.
Second, the on-site tool room facilitates regular preventative
maintenance, which translates to less unscheduled downtime
and higher product quality. Finally, an in-house facility also significantly shortens the amount of downtime for tool repair, compared to the time typically required by third-party tooling repair
facilities. Plus, it eliminates the transport costs associated with
using a third-party firm.
The company’s product development processes reflect Lean
manufacturing philosophy in three ways.
First, all processes and design tools are standardized so internal teams collaborating globally have the same frame of reference. In addition, customer teams have a clear understanding of
the critical path and key review points. The company also operates a technical center in the United States to better support
customer design teams in their time zone.
Second, design processes are focused on eliminating as much
non-value-added time and cost as possible. In the past three
years, the company’s engineering team has introduced nine new
products in product development cycles that averaged eight to
nine months. Materials expertise, in-house rapid prototyping ca-
pability and in-house tooling fabrication capabilities are key fac-
tors in achieving this speed.
Finally, the team is focused on design for manufacturability at
both the product and tooling level. Mold-flow analysis is used to
ensure efficient molding with minimal scrap and minimization
of secondary finishing processes. The design validation process
looks closely at design assumptions on target labor use and run
rate, and changes are made if that analysis indicates the initial
assumptions were incorrect.
Lean philosophy also was applied in facility design. The facility is approximately 76,000 square feet and has Class 100,000 and
10,000 clean rooms. The layout is designed to support a smooth
production flow by sequencing operations in the order they typically occur in the manufacturing process. Production areas are
designed with line-side stocking of raw materials. In molding,
there is a centralized feeding section for high-volume production
and batch support for high-mix, low-volume production. The layout is designed to minimize work-in-process queues, operator
movement and finished goods transport distance. Facility manufacturing capabilities include injection molding, extrusion, blow
molding, assembly and packaging.
The Quality Portion of the Equation
The focus on quality is driven by standardizing processes at all facilities and aligns closely with Lean manufacturing philosophy and
tools. The 5S (also called“five pillars”) philosophy (sorting, set in
order, sweeping or shining, standardize and sustain) is used as the
foundation to create a well-organized, visual factory environment
where inefficiency becomes very obvious and quickly is eliminated.
Six Sigma tools such as Define, Measure, Analyze, Improve,
Control are used in kaizen events to rapidly address areas targeted for improvement. All managers are either green belt or
black belt certified and experienced in use of Lean manufacturing principles.
All facilities, including Jiangsu, are registered to ISO 9001:2008
and ISO: 13485:2003. The focus on third-party quality certifications does not stop there. All facilities also are compliant to MDD
93/42/EC which is the Medical Devices Directive for the European Community; MHLW Japan’s Pharmaceutical Affairs Law
and Ministerial Ordinance #169; ISO 15378, which is focused on
primary packaging materials for medicinal products; ISO 14001,
which is focused on environmental management; ISO 18001,
which is focused on occupational health and safety management;
and ISO 27001, focused on information security management.
All facilities are U.S. Food and Drug Administration and
Japan registered as foreign contract manufacturers. The Jiangsu
facility currently holds a CFDA manufacturing license for Class
The focus on supplier quality includes a stringent supplier selection
process plus the regulatory materials qualification process related