Quality Management Systems Potential LLC Brochure

Quality Management Systems
Potential

Potential

Your partner in achieving quality
system value beyond compliance

Services Overview
Quality Management Systems Potential LLC | 15098 Yellow Pine St. NW, Andover, MN 55304 | (612) 709-0673 | qmspotential@aol.com
© 2013 QMS Potential LLC – All rights reserved.

Potential
About QMS Potential LLC
QMS Potential LLC is a Minnesota based consulting firm focused on helping medical device
companies avoid the common pitfalls lurking in most quality systems.

Company founder and President Steve Gompertz has over 20 years of medical device industry
experience. His career includes roles in quality systems development and implementation, project
management, engineering automation, configuration management, audit, and software
development for large companies like St. Jude Medical, Boston Scientific, Medtronic, medium size
companies including Vital Images and 7-Sigma, and small startups including Orasi Medical and
Omnyx. He is known for turning around failing or insufficient quality systems, reinvigorating poor
performing organizations, and redirecting struggling projects. He holds a B.S. in Mechanical
Engineering from Lehigh University, and certifications in quality management, biomedical auditing,
project management, and configuration management.

Mr. Gompertz is also an Adjunct Instructor for St. Cloud State University where he helped develop the Master of
Science in Medical Technology Quality degree program, and is now developing and teaching courses in Quality &
Regulatory Fundamentals, Risk Management, and CAPA.

Mr. Gompertz has developed a Quality Systems Maturity Model merging Risk Management and CMMI® concepts to
create the only method available to quantitatively measure a quality system's effectiveness and potential. He is also
responsible for coining the term, "dysfunctional compliance" to describe the situation where a company meets all
regulatory and statutory requirements but still experiences significant quality issues due to not addressing quality from
a true systems perspective.

QMS Potential LLC provides services in the following areas:

– Quality Systems Assessment
– Quality Systems Development
– Audit Preparation & Response
– Quality Systems Education
– Quality Systems Tools Selection

Each of these service areas is described in more detail on the following pages.


Potential
Quality System Assessment
The regulations and standards applicable to the medical device industry all establish in one form or another
that Management has a responsibility to evaluate the effectiveness of the quality system, but provide little
guidance on how to do so. Metrics are usually established for individual QS processes, and internal audits
provide a subjective view of shortcomings via so-called “major” and “minor” non-conformances, but nothing
provides an overall quantitative assessment of the quality system as a whole or by process area.

QMS Potential LLC has combined concepts from the ISO 14971 standard on Risk Management and the
Capability Maturity Model® developed by the Carnegie Mellon Software Engineering Institute to create a
scale that clearly shows the state of your quality system.

QMS Potential LLC can use information
from your existing audit, CAPA, or other
non-conformance processes, or perform
new audits, to quickly assess the current
state of your QS and its individual
processes. The assessment can then be
repeated periodically to provide a clear
indication of improvement; perfect for
presentation at management review
meetings.

How mature/capable do you think your
QS is today? Are you sure?


Potential
Quality System Development
How often do you think your employees
look at your quality manual? Too often
medical device manufacturers adopt a
quality manual that simply “parrots” the
requirements noted in FDA regulations
and ISO 13485 resulting in a document
that provides no value to the reader, or
create an imposing 40+ page
monstrosity that overwhelms readers.

The real issue in both cases is usually
that the manufacturer hasn’t really
mapped out the quality system, so that
the quality manual and all other QS documents don’t fit
together. Such a quality system may pass audits by virtue
of being able to meet the requirements for written
procedures, but fails to establish a culture of
quality, compliance, or effectiveness.

QMS Potential LLC recognizes that the key word in building
a quality system is “system”, and can help architect a QS
that makes sense to employees, thrills auditors, and most
importantly, drives a focus on quality. Focusing only on compliance often creates what we call “dysfunctional compliance”,
where a company meets all regulatory requirements but still experiences significant quality issues.

Let QMS Potential LLC help your company break away from outdated approaches that fail to produce good results, and
implement a quality system that will actually drive success.


Potential
Audit Preparation & Response
With an effective quality system in place, your organization should always
be “audit ready”, at least in terms of meeting all the requirements that an
inspector will want to verify, but your chances for a successful audit are
much better if you have a procedure and training in place so that
everyone involved knows exactly what they should and shouldn’t do.

Does the receptionist know who to contact when an FDA inspector shows
up unannounced? Do you have a predetermined location for where the
inspector can work? Where will all the gathering of requested records
take place, and who will do it? Do subject matter experts know what to
expect from the inspector?

QMS Potential LLC can help establish an external audit management
process, and train employees on what to expect.

What if your current quality system doesn’t pass an audit? Do you know how to properly respond to an FDA Form
483 or ISO Non-Conformity Report so that you avoid more serious actions such as a Warning Letter or loss of
ISO certification, or worse?

QMS Potential LLC can help you establish an effective audit response process, or provide guidance on
responding to existing non-conformance reports or warning letters. Simple mistakes can lead to serious
consequences and public embarrassment that can decrease confidence in your products.


Potential
Quality Systems Education
Let’s face it, employees generally aren’t very excited about
attending training on quality topics. Nobody really likes sitting
through lectures, but having employees who truly understand
your quality system, their role, and how it benefits them and the
company is critical to effectiveness; not to mention being a
regulatory requirement.

QMS Potential LLC founder and President, Steve Gompertz,
has a reputation for making quality systems training interesting
and even fun. His use of clear training materials, real-world
examples, and interesting anecdotes ensures students stay
engaged during the training and retain what they’ve learned
afterwards.

QMS Potential LLC can develop and deliver training on individual topics, or create an ongoing quality systems
curriculum. And, we can train your staff to become the trainers.


Potential
Quality Systems Tools Selection
Still relying on paper-based records, or home-grown stand- CAPA / NC
alone software tools to manage quality information? A mature,
fully capable optimized quality system requires integrated Inspection/
Complaints
SPC
processes and information. Even in a well architected quality
system with engaged, well-trained employees, achieving the
system’s full value requires integrated processes and
information. Reliance on paper, re-entry of redundant
Document
information in multiple systems, or custom bridges between Management
Audit
systems can be inefficient and unreliable. Quality
Management

However, picking integrated automated systems can be tricky,
and very expensive if the wrong choices are made. Calibration & Training
Maintenance Management

QMS Potential LLC can help by guiding you on developing clear
requirements that will make it easier to evaluate system
Supplier Risk
vendors, understanding what vendors are really saying, and Quality Management
applying effective project management methods to implement
chosen solutions successfully.

QMS Potential LLC founder and President, Steve Gompertz, has almost 30 years of experience with systems
implementations as a developer, implementer, and customer. He worked with the first Product Lifecycle
Management (PLM) system before there was even a name for it, and is known for implementing solutions that work
the first time and continue to work for years. His insights can give you the advantage in working with tech-savvy
solutions vendors all too willing to sell you solutions they don’t actually have.


Potential

Potential

Contact us today to get started on
implementing an effective quality system that
truly creates business value!

Phone: 612-709-0673
Email: qmspotential@aol.com


Quality Management Systems Potential LLC Brochure

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