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01. What
is your "Completed Staff Work" concept?
This is a term borrowed
from the military. It simply recognizes that finding problems is easy.
What's hard is recommending the appropriate solution(s) for a given
client's resources, capabilities, culture..., and then implementing the
solution(s) that result in an improved client condition.
"Completed Staff
Work"(TM) consists of:
o Joint identification of
a problem's root cause(s);
o Joint identification of
solution(s) within the constraints of client ability to implement;
o Joint selection of the
most viable solution;
o Rationale for that
selection;
o Steps to implement;
o Assistance in
implementation;
o Monitoring mutually
agreed upon metrics to verify successful implementation.
02. How
are you different from other consultants?
In two primary ways:
2.1. John E. Lincoln is one of few
medical products regulatory consultants in the U.S. who have actually
designed and built the products and processes / systems that we now
assist companies to regulate.
He has designed software
algorithms, written code, and taught programming back in the old BASIC
and COBOL era, designed plastic injection molded parts tooling and
processes, designed components and finished products, developed
manufacturing fixturing, processes, and test procedures, spec'd and
purchased production equipment, trained personnel, defined and contracted
for independant lab tests for biocompatability, validated packaging
sterile barrier seals and EtO sterilization processes, obtained US FDA
marketing clearances, led projects and administered budgets, to bring
those products to market.
John developed the first
list, 8-pages long, of the steps necessary to bring a new product to
market in 1983, for a device division of a major multinational
pharmaceutical company. This list became the basis for the plant's Design
Control procedure in 1996.
He intuitively employed
the concept of cross-functional teams in 1982, before the practice became
a standard, greatly reducing time-to-market. This radical departure
virtually eliminated the problems associated with the then traditional
"throw it over the wall" disconnects between R&D and
manufacturing, now known as "design transfer", which is still a
source of quality non-conformances in new product development.
2.2. J. E. Lincoln and Associates LLC believes
that improvement in the client condition is the only criteria by which
consulting success can be measured; not "deliverables" such as
"needs assessments", "gap analysis", extensive
reports... While we may use these tools, that's all they are,
"tools", and a consideration of a client's culture, ability and
motivation to make needed changes become the underlying rationale for
agreement on metrics by which to measure success, development of
recommendations, assistance in implementation, and monitoring of results
against those agreed-upon metrics.
We work with the client to
"make change happen", in incremental "phases", each
building on the previous, each designed for a fast team
"success", while all helping the client to grow internal
expertise to replace us, and replicate that project's success on their
own. We believe only this proven methodology can be the proper definition
and true measure of a consulting project's success.
Another major difference
is in our compliance audits / gap analysis philosophy and implementation,
what we call our "Positive Audit Philosophy"(TM). Most audits
frequently end up hurting the very personnel / department(s) that are
trying to improve a company's compliance effort, and who generally
contract for the audit -- QA / RA. Negative audit findings are
incorrectly but frequently blamed on those same personnel by senior
mangement (conventiently forgetting Dr. Deming's 7th Point,
"Institute Leadership", 8th Point, "Drive Our Fear",
and 14th Point, "Take Action to Accomplish the Transformation [by
sr. management]").
We avoid this common
problem by conducting post-audit meetings with the contracting person(s).
Here we review the draft audit report, to: 1) assure phrasing / tone /
wording is correct -- however, we do not omit any negative findings; 2)
differentiate between violations mandating corrective action, referencing
the applicable reg, and recommended but optional changes / 'best
practices', the "c" in cGMP; 3) verify that remediation has not
been overlooked; 4) assist to initiate positive action where necessary;
and 5) then include that activity in the formal audit report.
This "Positive Audit
Philosophy"(TM) is also in agreement with our "Completed Staff
Work"(TM) concept, where we acknowledge that finding problems is
easy, while solving them within a given company's culture can be very
difficult. This recognizes that audits should be tools for positive
change, not negative 'pinning blame'.
03. What
does "Business Success From Regulatory Compliance"(TM) really
mean?
This means that we do not
stress regulatory compliance because "it's the law" (even
though it is). Instead compliance should be desired and followed, even in
principle, because it can be designed and implemented so as to benefit a
company in a competitive, business sense.
Requirements such as:
o Design Control's Design
Reviews can drive fast cycle product-to-market by acting as formal
"gates", adding structure and predicability (in time /
resources) to R&D and manufacturing engineering activities, and
result in a product with minimal non-conformances.
o Validation activities if
properly structured and implemented can contribute to the bottom line in
reduced fall-off, rework, recalls, liability, while providing increased
user confidence / loyality.
o Quality / CGMP data /
trending can be part of a company's "scorecard" or
"dashboard", as required under periodic Management
Responsibility / Review.
o Risk analysis and
product / process / software validation files can provide valuable
training tools for new technical and marketing / sales hires. It can
become a key means of redirecting limited resources to areas of highest
risk to user / patient / clinician, as well as assisting in financial
allocations -- all done by traceability techniques.
o Similar advantages
accrue from CAPA, HACCP, P&PC, and so on.
A company focused in such
a manner will move away from a QC ("gotcha") vs. Production
("we've got to ship it no matter what") mentality, to a true
team approach, with collaboration between all disciplines, from a
project's inception, or "Start" date under product Design
Control, avoiding "throwing it over the wall" during Design
Transfer, product realization activities -- through pilot, production /
first-lot-to-stock -- and throughout a product's complete field history /
life cycle. Similar principles apply to regulatory issues requiring a
change from "business as usual".
04. How
do you charge?
J. E. Lincoln and
Associates LLC charges by the project. If you desire a proposal, we will
review your situation and develop a proposal, listing all the elements we
will provide, key milestones, the total charges for the proposed project,
and payment intervals. Typically we require a portion of the fee prior to
start. All this is spelled out in the proposal, with no obligation to you
to accept. There is typically no charge for the proposal. Travel and
similar expenses are in addition, as indicated in the proposal. You will
always know the cost of a project before it starts.
05.
Aren't consultants always looking for ways to expand scope/cost of a
project?
This is a common complaint
against consultants, and, sadly, it has some validity. However, our goal
is to make each proposed project stand-alone: e.g.,
o Most contain a training
element;
o Where applicable, the
electronic template is also provided.
o So, when the project is
complete, your people are able to implement and/or maintain it.
If we notice other areas
needing attention during the implementation of a project, we will mention
it to the one who hired us. That one can then request a proposal from us,
from others, do it in-house, or totally ignore it. While we do not
prolong our stay at a client, we are interested in being considered for
additional work should such a need arise in the future which would match
our capabilities.
06. Do
you provide "Reengineering"?
NO! Not in the commonly
defined use of the word. We have turned down attempts by senior
management to engage us to reduce / eliminate staff.
Here's our rationale:
o Reengineering for RIF
(reduction in force) is usually an indication of senior management
failure, and they're only hiring an outside consultant to provide a
scape-goat, not to better their long-term position;
o It may be an attempt to
maximize short-term profitability (and maximize bonuses), at the expense
of a company's long term viability and regulatory compliance;
o It frequently hurts the
very entity(ies) that contracted with us, e.g., the QA / RA departments,
who are viewed as overhead;
o Recent studies of
companies who vigorously pursued wholesale "reengineering"
revealed that they did enjoy a brief period of increased profitability
and shareholder value. But, follow-up of those same companies after a
year or more showed all lost market share and position in their industry;
they lost much core expertise, sowed distrust in their remaining
employees, and many additional skilled employees the companies wanted to
retain left at the first opportunity.
However, we do practice
"reengineering" in the ancient meaning of the word, i.e.,
looking at processes with an eye to measure and refine, and eliminate
redundancy or queues (today's "Lean" and "Six
Sigma"). And if we locate misuse of talent, or malfeasance, that
information will be passed on to those who engaged us.
07. What
does the "Associates" in your company's name imply?
Our associates are
individual consultants having their own businesses, but who contract to
work as sub- or co-contractors on a project if mutually agreed to by all
parties beforehand. They are not direct employees of our firm, but may be
paid by us, or by the client, depending upon the agreed-to terms prior to
their engagement. Under these types of arrangements, combined with the
Internet, e-mail, fax, and express mail, we have developed temporary
virtual teams.
One recent project, with
documentation coordinated by us, involved teams from the U.S. (CA and
UT), Germany, and France, involving robotics, ultrasonic ranging, and
related control and imaging software -- it was successfully (timely and
cost-effectively) concluded. Our cleared 510(k) received commendation
from the FDA's reviewer for our innovative incorporation of their MAUDE
database for risk analysis.
08. Do
you coach?
We coach individuals or
management teams. Our coaching covers the body of knowledge in areas
discussed elsewhere on our website, as well as the just as
important soft skills, both of which are necessary to facilitate
leadership of a project, department, or company. "Soft skills"
include dress and grooming, body language, speech / voice techniques,
grammar, vocabulary, public speaking, interview skills, team selection /
building, a history of successful conducting of projects, starting with "small successes", and the setting and achieving career goals.
We also present workshops
and provide coaching in achieving success in consulting.
09. What
about confidentiality?
This is another common
concern expressed by companies, especially those considering a consultant
for the first time. We provide a Confidentiality / NDA Agreement prior to
any serious discussions, even prior to the proposal stage, if such is
required. And, we will sign a client-supplied Confidentiality Agreement /
NDA in lieu if that is preferred. We do reserve the right to the use and
dissemination of information which is common knowledge to the industry;
if this is a concern, it would be ironed out in preliminary discussions,
and, if necessary, clearly defined in writing, prior to the start of
serious assessments.
10. How
can I sample your work without engaging you?
Hopefully, this site is
providing some idea of our qualifications.
In addition, samples of
the writing (and thinking/approaches)of John E. Lincoln, principal
consultant of J. E. Lincoln and Associates LLC, are at other locations on the
web, e.g.,in three MD&DI magazine articles, at article
1 , Help Desk...Training, July 1997, at article
2 , Handling Biologically Contaminated Product, Sept
1999, and at article
3, Avoiding Warning Letters, Feb 2002.
And our method of incremental participatory / partnering consulting, by
"phases", automatically provides for a short term, low cost,
low risk "trial".
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