Top 3 Ways to Quench Your GMP Staff: When Money Doesn′t Win the Day Any More.

This may surprise some - but money and company benefits are not the only - maybe not even the most important factor in keeping a Pharmaceutical Quality System (GMP) well staffed. Everyone knows that a decent work environment matters big time - especially in the western working world. But here are three issues that tend to be underestimated or dismissed too easily - because it is hard to address them.

#1 Pace of Change, Shifting Priorities too Often

Every change in company structure, quality system structures, or simply project priorities means the GMP system must follow suit. But this takes time. Change management will demand a host of reviews, process and document adjustments, trainings, and even regulatory filings. You will notice quickly when the pace of change is too fast - namely when the company and its system have not yet completed the most recent change, and already must drop the ongoing adjustment for the next priority to supersede it. This must fail eventually. And only few employees will go along with this kind of work for too long. It is unfulfilling, extremely demanding (and not paid better necessarily than other jobs), and downright frustrating. I could name plenty of people who switched jobs from one pharmaceutical company to another because of this very issue - and I could name even more who are currently thinking of resigning at this very moment.

An effective GMP-system can be run in such an environment only with extreme difficulty, and this forces incompliance and sometimes even illegal regulatory shortcuts. Not good! Not at all! And funny enough: the very same companies that suffer from this predicament advertise publicly terms such as work-life-balance and sustainability while turning all blind eyes on themselves. And people will leave. Additional costs for onboarding of replacements could have been avoided.

#2 Leaving People Alone with Responsibility

Time and again we encounter companies where leading staff does almost everything to avoid taking responsibility in writing - they simply don′t sign anything in their GMP line of work, but leave it up their their line workers or subdepartment leaders (or even consultants) to assume more signature responsibility than they need to. "This is not something a Head of Quality should have to sign" - or: "I can tell You what You should do - but I cannot sign for it". It reminds the well-rounded reader of Schiller′s Mary Stuart, where poor Sir Davison is forced to take on the Queen′s responsibility - so she can get out of the blame if it goes wrong. In more modern words: GMP cowardice. This is poison for a pharmaceutical quality system, because it undermines the loyalty of employees as they see they are being misused. The company′s quality culture suffers (and this is a GMP-issue!) - and employees who notice that they are being taken advantage of in such a way will become cold to their quality task and toward the company as their work home. They might not leave, but neither will they go the extra mile any more. And every GMP quality system depends on this - at least to some degree.

#3 Demanding Performance in the Face of Effectless Meetings

It has become a tremendous down-slowing trait of some pharmaceutical companies to bind ressources in a vast number of recurrent meetings. Jour-Fix, StandUp-Meetings - at least still before the Covid-19 era, You name it. Agile project management principles and a quality management standard such as GMP simply can′t get married easily - and the divorce is almost guaranteed. And talking about issues will not replace the need for defined processes that should have prevented the issues on the meeting agenda in the first place.

The most extreme example I have experienced was an online company meeting with more then 30 participants, it lasted almost 3 hours, and only 3 people talked - to each other - not to the others. And there were no takeaways for the others. An instant loss of at least 4.000,- Euros / Dollars in work time. Now imagine this on a weekly basis, or add company wide meeting culture like this to Your abacus: It is quite evident that this will burn a hole into even the deepest pocket of a company′s finances over time.

But the real issue is this: when a company sucks in its employees into the vortex of meetings, typically a majority of participants (1) have nothing to contribute, (2) do not really need to hear what′s shared by the others, but also (3) cannot really use the time to actually pursue the work they should do. And then comes the performance review of the very same people, where superiors remind them of timelines or performance goals saying "You need to become more effective!". Watching this as an outsider or consultant is very painful. Good people, wasted in blatantly bad management. And good people who will decide against You as a leader, and against their company when critical times come. And of course: leaving employees with a lack of work time to follow the GMP system or to get GMP done due to fruitless meetings is a GMP deficiency and - all things considered - a breach of drug regulating law.

What You can do to improve?

Provide clarity and direction, by not constantly changing Your company or its direction to the degree of forcing GMP incompliance and forcing people into it. This will literally set people up to fail.

Actively confront GMP-Cowardice in Your Ranks. Where people have a lot to say and a lot of authority, they need to take ownership of it - in a GMP system this means IN WRITING, not in letting others write and sign.

Make wise decisions as to whom You allow to define Your company′s or Your department′s meeting structure and needs. Take an honest look at the benefit that comes from Your meetings. Wherever You can put workflows in their place. That is how it works in a pharmaceutical quality system - or any good quality system for that matter.