THE TOP 10

FREQUENTLY ASKED QUESTIONS

 

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(30K) , Help Desk...Training, July 1997, at article 2 (46K) , Handling Biologically Contaminated Product, Sept 1999, and at article 3 (26K), Avoiding Warning Letters, Feb 2002. Also, an excerpt from The Device Validation Forum, one of John's past column's in The Journal of Validation Compliance.

Reprints of other articles, including CAPA, software V&V (verification and validation), Risk Management, and other medical device / pharmaceutical / quality / regulatory affairs subjects, or of a sample copy of a past newsletter, are available by e-mail request to jel@jelincoln.com . 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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Last updated 02/08/2016.