Standardizing Best Industry Practices

Medical device companies require highly visible, timely

and accurate manufacturing and quality management

systems to maintain high-quality standards and meet

rigid requirements. Effectively meeting ISO 13485, ISO

9001, FDA 21 CFR Part 11 and 21 CFR 820 compliance

standards, and efficiently documenting Device Master

Records (DMR) and Electronic Device History Records

(eDHR) are imperative conditions for the success of

manufacturing businesses and the continued prosperity

of medical device manufacturers. Additionally, medical

device companies must maintain Good Manufacturing

Practices (GMP) through consistent training and con-

tinuous quality improvements. Compliance should not

be an afterthought for the quality department, but an

integrated part of all business processes for internal op-

erations and supplier management.

Electronic Record Collection

eDHR technology has long been predicted in the medi-

cal device industry. FDA regulations encourage medical

device companies to harness the latest auto ID and data

collection technologies to improve their delivery systems.

Specifically, FDA regulations address electronic process-

ing of printed materials used in production, product com-

ponents, quality assurance, packaging, labeling, instal-

lation, maintenance and services. These procedures are

targeted because manual processes lead to endless paper

trails. Not only does the continued use of paper require

larger physical storage space, it also complicates data

retrieval, creating a labor intensive and extensive system.

Make it Lean

It is necessary for medical device companies to apply

lean concepts to their production cycles as well. With

an emphasis on product lead-time reduction, com-

panies must establish a real-time visibility system

of their production shop floor. This new visibility

reveals waste quickly and gives companies the

opportunity to redesign the production flow. A lean

manufacturing system will also help companies

detect and address quality trends and other

product issues promptly, which, in turn, will

improve products’ time to market.

Ready for the New Workforce?

In preparation for the retirement of its most expe-

rienced workers, medical device manufacturing

facilities must leverage new technology to educate

and assist new talent quickly. Facility managers

also need to modernize shop floor practices, such as

incorporating visual-training aids and best practices

into intuitive work instructions. Technology alone

won’t solve all of the workforce problems though.

Companies need to capture the expertise and lessons

learned from their most experienced employees to

pass along to the new workers.

MEDICAL DEVICESCurrent market conditions have created a highly competitive and challenging environment for the medical device industry. With stricter FDA regulatory oversight, increasing material costs and rising off-shore competition, the need to innovate, produce high-quality devices and reduce the time to market has never been greater. Both medical device and bioscience companies are also looking for ways to improve efficiency in their processes, and remain competitive and compliant with the various regulatory bodies that govern the world’s markets. In addition, like many American industries, the medical device industry is struggling to prepare for the upcoming workforce turnover as experienced workers retire.

1

Collecting All Available History

Solumina collects all eDHR as devices go through the production cycle, accu-

mulating the device’s process and consumption history, including the materials,

components and subassemblies used for each unit. A device’s eDHR is assembled

in real time, which virtually eliminates

companies’ indirect cost of accumulat-

ing and validating this important data.

Solumina’s strict adherence to data col-

lection ensures that each device meets the

highest quality standards and compliance

regulations. Non-acceptable data, such as

out-of-limit data collections or duplicate

serial numbers, are immediately identified

and resolved. The parts cannot be moved

into finished goods inventory until all of

the collected data are validated.

Implementing High-Quality Standards

Solumina’s robust Corrective Action and Preventive Action (CAPA) system allows

companies to defend against regulatory scrutiny and avoid FDA warning letters.

Solumina addresses the critical activities in CAPA, such as verifying or validating

corrective and preventive actions, commu-

nicating within the organization, provid-

ing relevant information for management

review, and documenting the activities

essential to effectively manage product

and quality problems.

Figure 1: Solumina excels in manufacturing complex, discrete medical devices.

SOLUMINA CAN HELPSolumina’s ability to promote collaboration among engineering, quality and operations, integrate engineering data, and facilitate lean manufacturing makes it an invaluable tool for medical device production. Constraints related to paper-based processes are eliminated. Solumina provides real-time visibility to the shop floor and a real-time problem resolution system that extends into the supplier network.

2

Ensuring Compliance throughout the Manufacturing Process

Solumina provides a complete work process and inspection management system

that standardizes best-in-class quality management processes. These processes

are tightly integrated with the production system to ensure the delivery of qual-

ity products consistently and with confidence. Solumina’s process control and

enforcement mechanisms also ensure full compliance with ISO 13485, ISO 9001,

FDA 21 CFR Part 11 and 21 CFR 820 regulations. Specifically, Solumina contains

the required technical elements to comply with FDA 21 CFR Part 11 standards – a

must for all software used to produce and manufacture quality medical devices.

Easy-to-Use Interface

Another benefit of using Solumina to manufacture medical devices is its ease of

use on the shop floor. The software’s user interface includes all of the required

information at the operator’s fingertips. Work instructions can be as simple as text

or as sophisticated as 3D-model animations, videos and dynamic slide shows with

built-in data collections and signature prompts. Additionally, the user interface

is configured to display only the options required for the current job and provide

speed buttons for the most-used commands. These are just a few of Solumina’s

advanced features that reduce errors and create a lean environment.

Figure 2: Solumina is uniquely designed to manage the product lifecycle, beginning with a product’s design and process quality specifications into the supply chain, continuing

with the manufacture of component parts, the assembly of the product, and the aftermarket service of each product unit until retirement.

3

Reduce Scrap and Rework

By identifying quality issues in real time, Solumina reduces scrap and rework.

Solumina provides complete visibility into quality processes, storing all of the his-

tory on each unit to be accessed at any time. The complete product genealogy

ensures that each unit meets quality standards throughout the production cycle.

Solumina also reduces process and product variability with its sophisticated sta-

tistical process control (SPC) and CAPA features that alert operators of inconsis-

tencies. Solumina’s true closed-loop system also provides real-time feedback to

monitor a unit’s production.

Increase Time Operators Work with Tools

Solumina radically improves the efficiency of facilities’ shop floor. Operators

spend more time doing the job they were trained to do, and less time looking for

documents or waiting for corrections or repair instructions. Solumina’s enhanced

work instructions greatly reduce learning curves and the potential for mistakes.

Managers can also make quicker decisions and assignments using Solumina’s

graphical view of the work schedule, resources and constraints. Additionally, all

of the information required to do a job is displayed for the operator, including the

latest version of drawings, specifications and parts. Operators are automatically

alerted to conditions holding up a job with time-delay tracking.

Reduce Cost of Regulatory Compliance

Solumina provides a full audit trail of the work process from design to execu-

tion and inspection, including unit history for the entire tree of subassemblies

and components. By collecting these careful records, Solumina is able to meet

the strictest process management and integrity requirements for the medical de-

vice industry, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, 21 CFR 820 and

2011/65/EU standards.

ROIiBASEt’s Solumina software substantially improves medical device facilities’ manufacturing environment in measurable ways. Facilities can expect to see returns on their investments in a few months in multiple areas on the shop floor – from reducing scrap and rework to shortening cycle times, while maintaining quality standards.

Figure 3: Orthopaedic production is an ideal avenue for Solumina because of its ability

to manage thousands of product variations.

4

Faster Training for New and Current Employees

In Solumina’s paperless system, new and current employees are introduced to

intuitive software that displays everything that they need to perform a job.

Additionally, Solumina complements and easily integrates with engineering

(CAD, PLM) and enterprise software systems (ERP), so administrative tasks are

performed and submitted online, leaving operators with more time to perform

and perfect the job they were trained to do.

Improve Quality

Quality issues impact the ability to meet schedule and cost objectives. Solumina

provides reports and charts to view quality metrics and drill down into problem

areas for more details. Solumina has also incorporated Six-Sigma process control

and oversight into its software. Solumina identifies and removes the causes of

defects, and minimizes manufacturing and product variability.

Shorten Cycle Times

Solumina harmonizes with CAD, PLM and ERP systems. This straightforward

integration creates seamless coordination among all of the software systems and

results in better coordination in the production flow. Companies will no lon-

ger have to rely on a patchwork of legacy systems that involves countless hours

of reconciling to make sure the correct data were used. To maintain constant

visibility of the shop floor, Solumina also manages work in process through

its production control information board. Shop supervisors and production

schedulers will be able to take advantage of this board to view valuable informa-

tion – such as order statuses, scheduled start and stop times and crews assigned –

to make the most efficient use of production cycles. Minor adjustments to sched-

ules can quickly and easily be made in real time from the screens, keeping the

shop floor engaged and on schedule.

5

Figure 5: Solumina supports easy, online illustrated work instructions.

Figure 4: Solumina provides seamless control over manufacturing processes, your

supplier network and full compliance.

Reduce Process and Product Variability

Solumina’s sophisticated CAPA system addresses key quality areas, including

event management, risk assessment, root cause analysis, implementation and

checking. All of the data and documentation tied to a product are tracked through-

out the manufacturing process, making it easy to determine where a component

was used and if that component met quality specifications. Solumina also moni-

tors processes to identify the areas where enhanced work instructions are needed.

Solumina also provides consistent process control by guaranteeing each operator

meets certification qualifications, each tool used is properly calibrated, the lat-

est process documentation is used, and the proper change procedures for process

instructions are utilized.

Improve Product Warranty Recall

Solumina captures lots and serial numbers throughout the manufacturing process

in case of a warranty recall. Effected products can be identified quickly by lot or

impacted serials, greatly reducing the cost and time involved in a paper process.

Reduce Indirect Labor Costs

Solumina removes waste in the information flow throughout operations and the

supply chain by eliminating procedures that are based on routing paper docu-

ments. Solumina’s effective use of eDHRs streamlines both validation and col-

laboration among the engineering, quality and operations departments. Because

data are validated in real time, all of the wasteful hours collating and verify-

ing DHRs are eliminated. With Solumina, changes in the work instructions are

deployed to the shop floor in real time, ensuring the latest versions are used.

6

Figure 6: Solumina collects eDHR as devices go through the production cycle in real

time, eliminating paper-related costs and dramatically reducing production times.

27442 Portola Pkwy Suite 300 Foothill Ranch, CA 92610

P: 877.422.7381 • F: 949.598.2600www.solumina.com

Solumina is a revolutionary Operations Process Management (OPM) software suite that is uniquely designed to manage the product lifecycle for companies specializing in discrete, complex manufacturing. Solumina can function as a standalone solution or can be seamlessly integrated into Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) solutions, allowing users to capitalize on shop floor efficiency without sacrificing enterprise planning and execution capabilities.

Solumina also streamlines procedures essential to comply with process and quality management requirements in highly regulated industries, including medical devices, aerospace and defense, nuclear, industrial equipment and high-tech electronics.

More papers and resources available for download at the Library section of our website: www.solumina.com.

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