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The QA Pharm

Quality Insider

Seven Success Criteria for Hiring (and Working with) a GMP Consultant

You cannot subcontract your problems

Published: Monday, April 16, 2012 - 10:38

The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with an experienced good manufacturing practices (GMP) consultant.

1. Define the scope of work before you start scouting for a consultant.

There is nothing worse than throwing a bunch of consultants at a problem without knowing the boundaries of the project or defining the expected results. Unfortunately, it happens all the time. It ends in frustration for all parties involved, and the tragedy is: Nothing gets better.

A formal scope of work helps both the client and the consultant to set expectations of each other and agree on basic assumptions that are critical to success. A draft scope of work is the basis of a discussion with the prospective consultant, and the final version becomes a formal understanding to which both parties can agree. Sometimes it is beneficial to have an initial scope of work that is limited to a survey of the present situation with recommendations for an approach to the problem and a breakdown into phases or discrete chunks of work.

2. Determine the hard and soft skills required.

Consultants have been everywhere and done everything. (If you don’t believe this, just ask them.) Resumes are inflated, and each consultant universally saved his previous client from the jaws of destruction. Many arrive like a one-person wrecking crew. Their know-it-all and negative behaviors will overshadow any remnant of dignity that your work group has left.

Explore the range of skills necessary to do the job, and ask pointed questions about how the candidate’s skills were applied to previous situations. Some skills may be hard technical skills, while others may be the soft skills needed to engender trust and collaboration with your team. In the back of your head you should be thinking, “Will the skills of my people be better as a result of having worked with this consultant?”

3. They really must have worked in the industry.

With due respect to my Food and Drug Administration (FDA) friends, especially those who are now consulting, it really is better to hire someone who has actually made medicine, not just conducted inspections. The reason that FDA experience is highly valued is because the client thinks that it will get some insider perspective on what the right answer is—or what the FDA will be looking for at the next inspection. There are plenty of people who can tell you what’s wrong, but fewer people who offer a range of solutions or who have been responsible in their careers for results.

Inspection results have never been, and never will be, the true measure of future performance. Look for someone who understands the complexity of operational, technical, social, and cultural issues that must be considered when resolving fundamental GMP problems. Nothing replaces specific operational knowledge.

4. Avoid career quality assurance consultants.

Quality assurance (QA) experience is important, particularly when it comes to designing the interrelating elements of a quality management system. But I am skeptical when I see a resume that is all QA experience. There is nothing like having operational experience to fully understand the practical environment in which GMP systems reside. If a quality system is not practical and usable, then users will find a work-around just to survive.

Explore the operational experience of the consultant candidate and ask how that experience has made her a better QA professional and consultant. Also, there is nothing worse than a consultant that has 25+ years experience only in QA—and all at the same company.

5. Don’t write off failure.

There are some consultants who have had failures in their careers. Or it may seem like a failure to you and feel like a failure to the consultant. Experience has taught me that good people have been terminated for wrong reasons. There are those who were fired for standing up to the company against doing the wrong thing. Also, many older folks who have valuable experience were the victims of layoffs just because they were high in the salary band.

I know it goes against conventional wisdom, but be open to the person whom you sense has a “history” that he is reluctant to talk about, or gaps in a work history. It’s just not unusual these days, particularly in QA. I would take someone like that in a heartbeat over someone who had been in QA his entire career at the same company. (Talk about someone who has learned to keep his head low.) It’s more about the lesson learned, what he did next, and whether it built character.

6. Keep engaged with consultants and own the problem.

Unfortunately, some companies in trouble with the FDA hire consultants in the same way they would engage a contract manufacturer. You cannot subcontract your problem. Just like a chief medical officer, you are still ultimately accountable for results and managing the relationship. There will be no sympathy at the FDA district office if you whine about your consultants.

The consultant and the client need each other to succeed, so keep the lines of communication open. Rarely can management solve a problem without some consultant help, and for sure, a consultant cannot do it alone. Quite often the underlying problem touches on the bigger issues of company culture and leadership. The consultant needs the forum to openly discuss these issues.

7. Don’t over complicate the oversight.

Consultants are typically involved in project teams that are comprised of client system owners and subject matter experts. Although there must be management oversight, these project teams need to keep focused on getting the work done. The last thing you need is to have them distracted by preparing tedious PowerPoint updates and administrative activities to multiple layers of oversight and stakeholders.

I have always said that in the absence of real work, administrative activities will creep in and fill the void. Be sure that the consultant and your people who comprise the team are allowed to focus on what you chartered them to do.

Readers, would you care to share advice from your experience working with GMP consultants?


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).


On Hiring a Good Consultant

I read with great interest the criteria the author spells out for hiring a good consultant. I respect his opinion. However, here are some other perspectives, from the view point of a manufacturing engineer who has become a QA consultant. They are applicable to all industries, including, and especially, the pharma industry which has often manufacturing done overseas, whose raw materials also come from yet further removed overseas/US domestic suppliers.

1. Scope of Consultancy: While nothing is better than a well-defined consultancy project, practical realism makes it obvious that such "balck and white" clear delineation of the scope of a consulting project is rare, in any field. What seems to be more applicable is that a general area of consultancy should be defined, identifying the sub-topics. Deadlines or expected goals should also be defined, as well as the terms of compensation.However, there, the definition of the scope stops, since the goals to be achieved, often prove to be a target that is moving farther and farther afield. So, a fixed definition of the scope leaves the consultant with limited responsibilities- the company who hires him suffers.

2. Knowledge of QA: There is no such thing as a "pure" manufacturer, these days. What this means is, every manufacturer, (and yes, especially the "pharma" and "food supplements manufacturer") buys his raw materials and partially processed materials from some set of suppliers. Given this indisputable fact, having an efficient inspection and QA process is the logical, and mandatory first step to ensure quality in the finished products. First hand knowledge of Quality Assurance, Inspections, Acceptance Sampling, tests on selected samples, and day-to-day hands on experience in accepting and rejecting lots supplied by raw material providers is thus, crucially important. Also, first hand knowledge of accreditations required for testing labs, inspection agencies and certification bodies, is indispensable.  FDA inspectors who are knowledgeable, and/or any QA professionals (especially with ASQ-Certifications) who are proficient and with experience in these areas, are worth their weight in gold, in pharma and food supplement manufacturing. With all due respect, it would be nothing short of hazardous to assume that mere knowledge of manufacturing, however "first hand", can address this situation.

3. Communication, Skills plus soft/hard skills: It goes without saying that by definition, a consultant must have excellent proficiency in getting the "buy-in" for his ideas at all levels , from top management, down to the line operators. Thus, ability to communicate, through Powerpoints, phones, e-mails, and plain old word of mouth, so as to get the bset cooperation from the people, is a mandatory requirement.