2019

STANDARDS OUTLOOK

Consulting Quandaries

10 challenges and ways
to overcome them

by Les Schnoll

For those of you who provide professional consulting services, you attempt to provide your clients with the same level of advice you would to employers. You also try to follow the principle that "the client is always right" (barring something unethical or illegal).

For the most part, your recommendations and efforts are gladly accepted, and you continue to coach your clients on best practices, industry expectations and regulatory and standards compliance. Your primary contacts are usually knowledgeable and keep the pressure on for you to provide those deliverables on a timely basis.

Inevitably, though, you will come across clients that have no sense of urgency, and it will become your responsibility to encourage them to allow you to meet your contractual obligations by compelling their organizations to show some signs of life.

As a consultant, you sometimes must walk the fine line of being (appropriately) assertive and going too far, thus alienating your difficult clients. I’ve learned to read people and know when to push and when to pull back—and it’s not a simple thing to do. While I will draw the line at unethical or illegal behavior, I also want to remain in business, so I’ve learned to deal with occasional idiosyncratic behaviors—thus, the consultant’s quandary.

Challenges and lessons

My list of the top 10 challenges consultants face, in no particular order, includes:

1. Constantly changing priorities. Whether it’s a start-up or a well-established business, many organizations just can’t determine their priorities. Today, the priority may be bringing product A to market and obtaining regulatory approvals, and two days later, product A becomes a nonstarter, and product B is in the forefront. One week later, product A is back front and center. Or, last month, a key initiative was process validation; now, that project is changed to updating standard operating procedures.

While this constant shifting can be annoying, it shouldn’t be a big deal from a consultant’s standpoint. Assuming the regulatory filing system is robust, when the eighth highest priority (which was No. 1 two weeks ago) is again shifted up, restarting the activity is simple.

While consultants want to run a profitable business, most don’t want their clients to spend money without a tangible return. I periodically remind clients that have a difficult time setting priorities that I don’t want them to waste their money—especially because they have to pay me for work that I perform for them regardless. This approach allows me to guide their prioritization and help them develop a strategy that best fits their corporate goals and objectives.

Lesson: Thoroughly understand your client’s short term and long-term objectives.

2. Having four-legged employees. Most people love their pets, and some take that affection to extremes. If an organization is manufacturing nuts and bolts, bringing a pet into work may not be an issue. If your business is one that manufactures aerospace products, food, drugs or medical devices, however, it is not a good idea to allow Fido to roam through the manufacturing area, or to let Kitty Cat climb atop an open blending tank and leap across it onto a filling line.

Aside from the potential health risks and product adulteration, you never know when a U.S. Food and Drug Administration (FDA) investigator will pay you a visit. Pet sounds emanating from a packaging area will get the investigator’s attention and will 100% of the time result in a regulatory violation being issued to the organization. To the FDA or the U.S. Department of Agriculture, finding a pet on premises is no different from finding an insect or rodent infestation.

Lesson: Advise your client of the potential consequences of bringing their pet to the workplace. Provide your client real examples of what can happen—such as FDA Form 483 or a warning letter.1

3. Keeping commitments. After consultants land a project, many tend to complete it as expeditiously as possible. This is a no-brainer, especially if obtaining additional information from the client isn’t required. If, however, you must rely on others to make a decision, provide additional documentation, or review and approve a draft, that process can take considerably longer than expected.

More often than not, if I need copies of labeling or data to complete a document or submission, I find patience is a virtue. Waiting can be especially irritating if I set aside time for a client based on commitments to provide me with what I need by a certain date. Friendly reminders can only be given a limited number of times. Escalation to someone higher on the organization chart is a possibility and a probable solution, but may result in alienating your key contact.

I’ve had to resort to escalation a few times and, fortunately, the requests were taken the right way and reinforced the concerns about the individual who did not deliver as promised. In such situations, however, it is critical to know your client and have a handle on internal politics before using this approach.

Lesson: Tread lightly and exhaust all other possible solutions before going around or through your primary contact. Always begin the conversation with something similar to: "I know that everyone is busy with important projects, but is there anything else I could do to help move this along?"

4. Asking hypothetical questions. A potential kiss of death for a consultant is the phrase: "What do you think about … ?" Similar to situations in standards or quality system auditing, hypothetical questions are fine for consultants if they are reasonable.

When I teach quality auditing and review potential types of questions auditors may ask, I use the example of: "What would you do if your procedure requires you to check your pH meter every morning with a pH 7.0 buffer and a pH 10.0 buffer, and you ran out of the 7.0 buffer?" It is hypothetical, but it has a reasonable possibility of occurring.

A hypothetical question that is practically unanswerable would be something akin to: "Your pH meter sits on a laboratory bench that faces north. The meter is read by parallax (lining up the needle with the mirror), but at high noon on the summer solstice, the sunlight reflects directly on the mirror and you can’t see it to obtain a correct reading. What would you do?"

Consultants also face normal and extreme hypothetical questions. In some cases, there is no way to provide your client a reasonable or adequate response. So what should you do?

If I find a question borders on the ludicrous, I generally respond back with: "I would need considerably more data before I can provide you an accurate answer to that question," and explain what I would need to follow up appropriately. If the information is actually provided, the question can be answered.

Lesson: Be certain you have all of the facts and necessary background information before you answer a question in a way that would not bode well for you or your client.

5. Ignoring requirements. It is amazing how many organizations decide to delve into a regulated industry without knowing its products are regulated or knowing what regulations are involved. Other organizations simply decide they don’t care what the requirements may be—they’re going to do what they want to in spite of the requirements.

On one hand, this situation is fertile ground for a consultant—helping the organization and its staff navigate the path to compliance can be extremely satisfying. On the other hand, fighting the management team and trying to convince it to change its thought processes is fraught with aggravation and results in many hours of nonvalue-added activity.

While these obstacles can usually be successfully addressed, it is always beneficial for a consultant to know about them before getting too involved.

Lesson: Perform due diligence on your potential client. You may decide to continue with the engagement if you come across issues, but at least you will know about them ahead of time and can prepare for future discussions.

6. Making midstream changes. Many consultants have likely encountered a client or project in which, after spending a considerable amount of billable hours (which is great for the consultant but not so much for the client), the client decides to make one or more significant change midstream.

I’ve experienced instances in which medical devices were redesigned after 95% of a premarket notification was written; designations for a drug were changed from prescription-use only (Rx) to over-the-counter and back to Rx again—all within a three-week period; product development priorities were changed almost hourly; and the organization asked for desired regulatory strategy and plans to be modified just before the submission was put into an express-mail envelope.

A successful consultant must be able to juggle many balls at once without dropping any of them. Many organizations make similar types of changes internally, and working with a consultant doesn’t mean their philosophies change.

Lesson: Get used to changes. They will always be part of the process. If frequent changes are bothersome to you, it’s best to select another career.

7. Dealing with a dearth of decisions. This challenge goes hand-in-hand with midstream changes, as both represent an inability to make a decision. There are times a consultant is at a point when a project’s completion relies on a client’s decision or the client’s provision of a document. The consultant may pencil in time for a client, only to learn the client can’t come to a decision or provide the necessary document.

The only way for the consultant to combat these situations is to be flexible and have a sufficient number of projects in the pipeline to fill in the dead time.

Lesson: Market yourself so you have multiple projects to work on if one is delayed.

8. Playing the field. It usually is not productive or beneficial for an organization to play one consultant against another, or to ask one consultant what he or she thinks about another one. The process of asking the same question to multiple professionals until the "right" answer is obtained eventually will result in that answer being inappropriate. During this process, the organization contact will change a question or a scenario slightly until he or she gets the desired response.

From the consultant’s viewpoint, having a potential client ask you to position another consultant in an unflattering manner will come back to bite you. The consulting community is close-knit, and backstabbing is not well accepted.

Lesson: Beware of doubled-edged swords, and make every attempt to keep things neutral.

9. Getting urgent requests. It is not unusual for a consultant to receive a call from a client asking if he or she has any available time because an urgent project requires immediate attention and must be completed within the next 72 hours. The client asks for a proposal (which must be provided within the next eight hours) that will be reviewed and elevated for approval.

The client promises to execute the proposal the next day so this critical activity can be initiated immediately. Then, the consultant waits and waits, but there is no response. Generally, the situation really isn’t a life or death one, and a couple of weeks later—and, incidentally, past the date the job needed to be completed in the first place—the client gets back to the consultant with a signed proposal.

If you, as the consultant, want to continue to do business with your client, you must remember that urgent requests that don’t materialize are simply part of the business.

Lesson: Never put all of your eggs in one basket. Not all projects are a sure thing—even so-called urgent ones—so make certain one client does not provide you with the majority of your income.

10. Dealing with a know-it-all. I’ve saved the most aggravating challenge (aside, of course, from the client who refuses to pay) for last. This scenario involves a client that evidently believes its internal personnel are not suited to adequately complete a project and decides to hire a qualified consultant to complete it.

The spurned employee decides he or she has been slighted, is actually the most qualified person to complete this project and is going to let the consultant know it. This results in a project taking double the time it would have because the consultant must address infinite questions and challenges levied by the employee.

This is counterproductive, and if the project is billed at an hourly rate, the client will end up paying way too much for the service. If the project is to be invoiced at a flat rate for the deliverable, the consultant winds up on the losing end. The only remedy for this is to deal only with your primary contact at the organization, who hopefully is not the problem employee.

Lesson: Establish the primary contact at the organization up front with the client, and who else should be contacted in the event of significant issues with the project.

Always be prepared

Consulting can be a rewarding profession, but it is not always a walk in the park. The novice consultant may have the erroneous impression that all that’s necessary is to hang up your shingle, contact your previous associates and watch the business come rolling in.

No matter how long the consultant has worked in the industry, challenges always exist. You must be prepared to deal with them quickly and courteously while focusing on helping the client and completing the work on time.

Patience, flexibility and the ability to provide alternative solutions are keys to being a successful consultant because you will inevitably find yourself faced with many unique situations.


Reference

  1. U.S. Food and Drug Administration, Inspections, Compliance, Enforcement and Criminal Investigations, New Rich City Co., July 3, 2012, www.fda.gov/iceci/enforcementactions/warningletters/2012/
    ucm310936.htm
    .

Les Schnoll has more than 35 years of experience in industries regulated by the Food and Drug Administration (FDA). He is a senior member of ASQ and an ASQ-certified quality engineer, auditor and manager. A former member of the U.S. technical advisory group to ISO technical committee 176, he is currently the principal of Quality Docs LLC, providing quality and regulatory consulting services to the FDA-regulated industries. He also teaches several courses in master’s degree programs in regulatory affairs at Arizona State University in Phoenix and Northeastern University in Boston.


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